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Journal ArticleDOI

Patients’ Use of Information about Medicine Side Effects in Relation to Experiences of Suspected Adverse Drug Reactions: A Cross-Sectional Survey in Medical In-Patients

23 May 2013-Drug Safety (Springer International Publishing)-Vol. 36, Iss: 8, pp 673-680
TL;DR: The results support the view that most patients feel knowledgeable about medicines risks and suspected ADRs and value information about side effects, but that reading about side results in PILs or other medicines information sources does not lead to experiences of suspected ADR.
Abstract: Adverse drug reactions (ADRs) are common, and information about medicines is increasingly widely available to the public However, relatively little work has explored how people use medicines information to help them assess symptoms that may be suspected ADRs Our objective was to determine how patients use patient information leaflets (PILs) or other medicines information sources and whether information use differs depending on experiences of suspected ADRs This was a cross-sectional survey conducted in six National Health Service (NHS) hospitals in North West England involving medical in-patients taking at least two regular medicines prior to admission The survey was administered via a questionnaire and covered use of the PIL and other medicines information sources, perceived knowledge about medicines risks/ADRs, experiences of suspected ADRs, plus demographic information Of the 1,218 respondents to the survey, 188 % never read the PIL, whilst 65 % only do so if something unexpected happens Educational level was related to perceived knowledge about medicines risks, but not to reading the PIL or seeking further information about medicines risks Over half the respondents (560 %) never sought more information about possible side effects of medicines A total of 572 % claimed they had experienced a suspected ADR Of these 859 % were either very sure or fairly sure this was a reaction to a medicine Over half of those experiencing a suspected ADR (538 %) had read the PIL, of whom 362 % did so before the suspected ADR occurred, the remainder afterwards Reading the PIL helped 848 % of these respondents to decide they had experienced an ADR Educational level, general knowledge of medicines risks and number of regular medicines used all increased the likelihood of experiencing an ADR More patients should be encouraged to read the PIL supplied with medicines The results support the view that most patients feel knowledgeable about medicines risks and suspected ADRs and value information about side effects, but that reading about side effects in PILs or other medicines information sources does not lead to experiences of suspected ADRs

Summary (2 min read)

Jump to: [Introduction][Methods][Results][Discussion] and [Conclusion]

Introduction

  • Two large prospective studies in Liverpool hospitals have shown that 6.5% out of 18,820 admissions to medical units were caused by adverse drug reactions (ADRs), that 2.3% of patients admitted with ADRs die [1] and that 14.7% of 3,695 medical or surgical in-patients experienced an ADR during their stay. [2].
  • An evaluation of patient reporting to the YCS found that most reporters identified suspected ADRs through the timing of the event in relation to the medicine being used and/or written or verbal information about medicines. [8,9].
  • However no research has explored this in detail.
  • Studies have shown that not all patients inform health professionals about symptoms they suspect to be ADRs.[3,4].

Methods

  • Approval to conduct the study was obtained from NHS and University Research Ethics Committees and the relevant NHS Trusts.
  • Inclusion criteria Potential participants were in-patients aged 18 or over, who were prescribed at least two medicines and taking at least two medicines prior to admission.
  • Those who were still willing to take part then gave written consent, before being given the questionnaire and instructions on how to complete it.
  • All responses were entered into SPSS Version 17.0 (IBM Corporation, USA) for analysis and a quality check performed.
  • To enable quantitative analysis of responses to the open questions, previously developed categories were used for how respondents identified suspected ADRs,9 while categories for the remaining open questions were developed and agreed by the research team.

Results

  • In total 1218 questionnaires were completed sufficiently for analysis.
  • Respondents were evenly divided between those who indicated they knew a great deal or a fair amount about the risks of medicines in general and those who knew not very much or nothing at all (Table 2).
  • Severe allergic reactions, including anaphylaxis were described by 28 and other serious reactions, including liver damage, by 11.
  • A substantial majority 599 (85.9%) of respondents who claimed to have experienced a suspected ADR were either very sure or fairly sure this was a reaction to a medicine.
  • There were 41 (10.9%) further respondents who indicated that the PIL was not helpful because the suspected ADR was not listed, whilst 16 (4.1%) indicated they could not understand the leaflet.

Discussion

  • This survey found that while 74% of patients do usually read the PIL supplied with their medicines, the remainder do not or only do so if something unexpected happens, whereas over 40% seek information in addition to the PIL, mainly from health professionals or the internet.
  • The numbers of patients who were deemed by nursing staff to be unsuitable for inclusion or who refused to participate were not obtained, hence a response rate could not be calculated and there is also potential for selfselection bias.
  • Most of the patients in their study had been informed about the possibility they had experienced an ADR by a health professional.
  • Furthermore the finding that that only 36% of respondents to their survey claimed they had read the PIL before they experienced the suspected ADR lends further weight to the view that patients’ experiences of side effects are not due to awareness bias.
  • Previous work has shown that educational level and whether respondents had experienced frequent adverse effects in the past were the most important predictors of wanting to know about all possible adverse effects of medicines.[19].

Conclusion

  • These findings suggest that further support may be needed to encourage all patients to read the PIL supplied with medicines.
  • The results add weight to other findings showing that most patients are knowledgeable about medicines risks and suspected ADRs, that they value information about medicines side effects and that reading about side effects in PILs or other medicines information sources does not lead to experiences of suspected ADRs.

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Citation for published version
Krska, Janet and Morecroft, Charles W. (2013) Patients’ use of information about medicine side
effects in relation to experiences of suspected adverse drug reactions. Drug Safety, 36 (8).
pp. 673-680. ISSN 0114-5916.
DOI
https://doi.org/10.1007/s40264-013-0065-3
Link to record in KAR
http://kar.kent.ac.uk/43961/
Document Version
Author's Accepted Manuscript

0
Patients’ use of information about medicine side effects in relation to experiences of
suspected adverse drug reactions: A cross-sectional survey in medical in-patients
J Krska, Professor of Pharmacy Practice, School of Pharmacy and Biomolecular Sciences,
Liverpool John Moores University, Liverpool, UK
Charles W Morecroft, Principal Lecturer, School of Pharmacy and Biomolecular Sciences,
Liverpool John Moores University, Liverpool, UK
Corresponding author:
Professor Janet Krska, Medway School of Pharmacy, The Universities of Greenwich and
Kent, Chatham Maritime, Kent. ME4 4 TB
Tel: 01634 202950 Fax: 01634 883927
E-mail:
j.krska@kent.ac.uk
Running title:
Medicines information use and experiences of ADRs
Acknowledgements
This study was funded by Liverpool John Moores University. The authors have no conflicts
of interest to declare.
The authors are grateful to the following hospital pharmacists who facilitated the study: Lisa
Ainsworth, Marianne Charlton, Chris Herring, Jennie Simpson, Heather Smith, David
Thornton and to the undergraduate pharmacy students who administered the questionnaire.
We also thank Julia Taylor for support with data entry and quality checking.
Word count 2992

1
Abstract
Background
Adverse drug reactions (ADRs) are common and information about medicines increasingly
widely available to the public. However relatively little work has explored how people use
medicines information to help them assess symptoms which may be suspected ADRs.
Objective
To determine how patients use patient information leaflets (PILs) or other medicines
information sources and whether information use differs depending on experiences of
suspected ADRs.
Method
This was a cross-sectional survey conducted in six National Health Service (NHS) hospitals
in North West England involving medical in-patients taking at least two regular medicines
prior to admission. The survey was administered by a questionnaire and covered: use of the
PIL and other medicines information sources, perceived knowledge about medicines
risks/ADRs, experiences of suspected ADRs, plus demographic information.
Results
There were 1218 respondents to the survey of whom 18.8% never read the PIL, whilst 6.5%
only do so if something unexpected happens. Educational level was related to perceived
knowledge about medicines risks, but not to reading the PIL or seeking further information
about medicines risks. Over half the respondents (56.0%) never sought more information
about possible side effects of medicines.
57.2% claimed they had experienced a suspected ADR. Of these 85.9% were either very sure
or fairly sure this was a reaction to a medicine. Over half of those experiencing a suspected
ADR (53.8%) had read the PIL, of whom 36.2% did so before the suspected ADR occurred,
the remainder afterwards. Reading the PIL helped 84.8% of these respondents to decide they
had experienced an ADR. Educational level, general knowledge of medicines risks and
number of regular medicines used all increased the likelihood of experiencing an ADR.
Conclusion

2
More patients should be encouraged to read the PIL supplied with medicines. The results
support the view that most patients feel knowledgeable about medicines risks and suspected
ADRs and value information about side effects, but that reading about side effects in PILs or
other medicines information sources does not lead to experiences of suspected ADRs.

3
Introduction
Adverse reactions to medicines are common. Two large prospective studies in Liverpool
hospitals have shown that 6.5% out of 18,820 admissions to medical units were caused by
adverse drug reactions (ADRs), that 2.3% of patients admitted with ADRs die
[1]
and that
14.7% of 3,695 medical or surgical in-patients experienced an ADR during their stay.
[2]
In
primary care, studies which have relied on patients’ reports of ADRs, either to postal
questionnaires or telephone surveys suggest annual prevalence estimates of the order of 25-
29% in the
USA[3,4]
and 30% in the UK.
[5]
Higher estimates were found in a Dutch study
involving only anti-epileptic drugs.
[6]
Furthermore a survey of the general public found that
45% claimed to have experienced an ADR at some time.
[7]
Members of the public in the UK can report suspected ADRs directly to the Medicines and
Healthcare products Regulatory Agency (MHRA), through the Yellow Card Scheme (YCS).
An evaluation of patient reporting to the YCS found that most reporters identified suspected
ADRs through the timing of the event in relation to the medicine being used and/or written or
verbal information about medicines.
[8,9]
However no research has explored this in detail. For
example, are people more likely to seek and use medicines information after experiencing an
unusual event which they perceive as an ADR?
Furthermore, relatively little is known about the experiences of UK patients who do not
report their suspected ADRs to the MHRA. The majority of reporters have relatively high
levels of education, are likely to have high levels of health literacy and are thus unlikely to be
representative of the majority of patients who experience adverse reactions to medicines.
Studies have shown that not all patients inform health professionals about symptoms they
suspect to be ADRs.
[3,4]
One potential reason for this may be that health professionals
sometimes express dismissive attitudes about patients’ judgements concerning symptoms
they have experienced.
[10-12]
It is important to explore further and in a wider, more representative population how patients
use information about medicines, such as the patient information leaflet (PIL) or information
provided by health professionals, to help them assess symptoms they suspect are ADRs and
their experiences of discussing their views with health professionals. We have identified no

Citations
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Journal ArticleDOI
TL;DR: The majority of adverse effects were not individually associated with discontinuation from antidepressant treatment and the physical symptoms that did not reduce over time may represent symptoms of depression rather than antidepressant-induced adverse effects.
Abstract: Rationale Premature discontinuation of antidepressant drugs is a frequent clinical problem. Adverse effects are common, occur early on in treatment and are reported to be one of the main reasons for discontinuation of antidepressant treatment. Objectives To investigate the association between adverse effects occurring in the first 2 weeks of antidepressant treatment and discontinuation by 6 weeks as the outcome. To investigate the time profile of adverse effects induced by the selective serotonin reuptake inhibitor citalopram and the noradrenaline reuptake inhibitor reboxetine over 12 weeks of treatment. Methods Six hundred and one depressed individuals were randomly allocated to either citalopram (20 mg daily) or reboxetine (4 mg twice daily). A modified version of the Toronto Side Effects Scale was used to measure 14 physical symptoms at baseline (medication free) and at 2, 6 and 12 weeks after randomisation. Results Individuals randomised to reboxetine reported a greater number of adverse effects and were more likely to stop treatment than individuals receiving citalopram. Dizziness (OR 1.83; 95% CI 1.09, 3.09; p = 0.02) and the total number of adverse effects (OR 1.12; 95% CI 1.00, 1.25; p = 0.06) reported at 2 weeks were associated with discontinuation from overall antidepressant treatment by 6 weeks. Reports of adverse effects tended to reduce throughout the 12 weeks for both antidepressants. Conclusions The majority of adverse effects were not individually associated with discontinuation from antidepressant treatment. Reports of physical symptoms tended to reduce over time. The physical symptoms that did not reduce over time may represent symptoms of depression rather than antidepressant-induced adverse effects.

56 citations

Journal ArticleDOI
TL;DR: There is a multiplicity and complexity of issues surrounding medicines use, which impact on day-to-day lives for patients with long-term conditions, including quality of life.
Abstract: Background Polypharmacy is increasing and managing large number of medicines may create a burden for patients. Many patients have negative views of medicines and their use can adversely affect quality of life. No studies have specifically explored the impact of general long-term medicines use on quality of life. Objective To determine the issues which patients taking long-term medicines consider affect their day-to-day lives, including quality of life. Setting Four primary care general practices in North West England Methods Face-to-face interviews with adults living at home, prescribed four or more regular medicines for at least 1 year. Interviewees were identified from primary care medical records and purposively selected to ensure different types of medicines use. Interviews were recorded, transcribed and analysed thematically. Results Twenty-one interviews were conducted and analysed. Patients used an average of 7.8 medicines, 51 % were preventive, 40 % for symptom relief and 9 % treatment. Eight themes emerged: relationships with health professionals, practicalities, information, efficacy, side effects, attitudes, impact and control. Ability to discuss medicines with health professionals varied and many views were coloured by negative experiences, mainly with doctors. All interviewees had developed routines for using multiple medicines, some requiring considerable effort. Few felt able to exert control over medicines routines specified by health professionals. Over half sought additional information about medicines whereas others avoided this, trusting in doctors to guide their medicines use. Patients recognised their inability to assess efficacy for many medicines, notably those used for prophylaxis. All were concerned about possible side effects and some had poor experiences of discussing concerns with doctors. Medicines led to restrictions on social activities and personal life to the extent that, for some, life can revolve around medicines. Conclusion There is a multiplicity and complexity of issues surrounding medicines use, which impact on day-to-day lives for patients with long-term conditions. While most patients adapt to long-term medicines use, others did so at some cost to their quality of life.

54 citations


Cites background from "Patients’ Use of Information about ..."

  • ...Adverse effects are relatively common [36, 45, 46], can seriously Int J Clin Pharm (2013) 35:1161–1169 1165...

    [...]

  • ...Several studies suggest that while most patients read PILs, particularly the section on side effects, health professionals often fail to recognise or respond to this desire [10, 36, 37], with the potential for patients to become dissatisfied....

    [...]

Journal ArticleDOI
TL;DR: It was found that existing leaflets do not meet patients' needs and appear ineffective, and automated computer systems for leaflet tailoring with the ability to further adapt patients' information might be the best way forward.
Abstract: Medicines information leaflets can equip patients to be in control of their own healthcare and support the safe and effective use of medicines The design and content of leaflets influences patients' willingness to read them, and poor examples can cause patient confusion and anxiety Researchers examined the literature over the past 8 years to determine the content and design of medicine information leaflets that patients prefer in order to read, understand, and use them effectively It was found that existing leaflets do not meet patients' needs and appear ineffective Leaflets lack the information patients seek and may contain non-essential material, affecting patients' perception of, and willingness to read them Additionally, the acceptable leaflet length varies between patients Application of good design principles improves readability, comprehension, and ability to locate information Medicine information leaflets must meet patients' needs and be well designed Tailoring information leaflets to patient characteristics and requirements would enhance effectiveness Passive provision of pre-printed leaflets is outdated, unvalued and ineffective Using automated computer systems for leaflet tailoring with the ability to further adapt patients' information might be the best way forward

45 citations

Journal ArticleDOI
26 May 2021-PLOS ONE
TL;DR: In this paper, the authors investigated the prevalence of adverse drug reactions (ADRs) in the primary care setting and factors affecting the heterogeneity of the estimates, including age groups, ADRs definitions, study setting, and sample size.
Abstract: Background Adverse drug reactions (ADRs) represent a major cause of iatrogenic morbidity and mortality in patient care. While a substantial body of work has been undertaken to characterise ADRs in the hospital setting, the overall burden of ADRs in the primary care remains unclear. Objectives To investigate the prevalence of ADRs in the primary care setting and factors affecting the heterogeneity of the estimates. Methods Studies were identified through searching of Medline, Embase, CINAHL and IPA databases. We included observational studies that reported information on the prevalence of ADRs in patients receiving primary care. Disease and treatment specific studies were excluded. Quality of the included studies were assessed using Smyth ADRs adapted scale. A random-effects model was used to calculate the pooled estimate. Potential source of heterogeneity, including age groups, ADRs definitions, ADRs detection methods, study setting, quality of the studies, and sample size, were investigated using sub-group analysis and meta-regression. Results Thirty-three studies with a total study population of 1,568,164 individuals were included. The pooled prevalence of ADRs in the primary care setting was 8.32% (95% CI, 7.82, 8.83). The percentage of preventable ADRs ranged from 12.35-37.96%, with the pooled estimate of 22.96% (95% CI, 7.82, 38.09). Cardiovascular system drugs were the most commonly implicated medication class. Methods of ADRs detection, age group, setting, and sample size contributed significantly to the heterogeneity of the estimates. Conclusion ADRs constitute a significant health problem in the primary care setting. Further research should focus on examining whether ADRs affect subsequent clinical outcomes, particularly in high-risk therapeutic areas. This information may better inform strategies to reduce the burden of ADRs in the primary care setting.

33 citations

Journal ArticleDOI
TL;DR: How negations are used in Dutch PILs and the effects of negations on readers are studied to determine.
Abstract: PURPOSE: Under EU regulations, patient information leaflets (PILs) are required to be clear and understandable. Negations (e.g., not, no) are a linguistic aspect that may impact PIL comprehension, yet go unmentioned in these regulations. We conducted two studies to determine (1) how negations are used in Dutch PILs (study 1) and (2) the effects of negations on readers (study 2). METHODS: Study 1 was a content analysis of 30 PILs of different brands of pollinosis drugs, half of which were freely available in drugstores and half only by physician prescription. We mapped negation use in PIL sections on 'proper usage' and 'potential side effects'. Study 2 was an experiment in which participants (N = 80, Mage = 33.19 years, SDage = 13.66; 76.3% female) were presented with one of two PIL texts on proper drug usage. Texts were identical except for the use of negations. After reading, participants answered questions about comprehension, PIL appreciation and medical adherence intentions. RESULTS: Study 1 demonstrates that negations are often used in PILs as 21.0% of clauses contain at least one negation. This number is higher in sections related to potential side effects than proper usage. Study 2 demonstrates that negations decrease both actual and subjective comprehension. Negations also decrease PIL appreciation and medical adherence intentions. The reduction in medical adherence intentions is driven by the decrease of subjective and not actual comprehension. CONCLUSIONS: In general, participants prefer PILs that contain clear and comprehensible language. To increase comprehensibility, PIL designers should refrain from using negations as much as possible. Copyright © 2014 John Wiley & Sons, Ltd. Language: en

23 citations

References
More filters
Journal ArticleDOI
01 Jul 2004-BMJ
TL;DR: The burden ofADRs on the NHS is high, accounting for considerable morbidity, mortality, and extra costs, and measures need to be put into place to reduce the burden of ADRs and thereby further improve the benefit:harm ratio of the drugs.
Abstract: Objective To ascertain the current burden of adverse drug reactions (ADRs) through a prospective analysis of all admissions to hospital. Design Prospective observational study. Setting Two large general hospitals in Merseyside, England. Participants 18 820 patients aged > 16 years admitted over six months and assessed for cause of admission. Main outcome measures Prevalence of admissions due to an ADR, length of stay, avoidability, and outcome. Results There were 1225 admissions related to an ADR, giving a prevalence of 6.5%, with the ADR directly leading to the admission in 80% of cases. The median bed stay was eight days, accounting for 4% of the hospital bed capacity. The projected annual cost of such admissions to the NHS is £466m (€706m, $847m). The overall fatality was 0.15%. Most reactions were either definitely or possibly avoidable. Drugs most commonly implicated in causing these admissions included low dose aspirin, diuretics, warfarin, and non-steroidal anti-inflammatory drugs other than aspirin, the most common reaction being gastrointestinal bleeding. Conclusion The burden of ADRs on the NHS is high, accounting for considerable morbidity, mortality, and extra costs. Although many of the implicated drugs have proved benefit, measures need to be put into place to reduce the burden of ADRs and thereby further improve the benefit:harm ratio of the drugs.

2,954 citations


"Patients’ Use of Information about ..." refers background in this paper

  • ...3% of patients admitted with ADRs die [1] and that 14....

    [...]

Journal ArticleDOI
TL;DR: Improving communication between outpatients and providers may help prevent adverse events related to drugs, and many are preventable or ameliorable.
Abstract: Background Adverse events related to drugs occur frequently among inpatients, and many of these events are preventable. However, few data are available on adverse drug events among outpatients. We conducted a study to determine the rates, types, severity, and preventability of such events among outpatients and to identify preventive strategies. Methods We performed a prospective cohort study, including a survey of patients and a chart review, at four adult primary care practices in Boston (two hospital-based and two community-based), involving a total of 1202 outpatients who received at least one prescription during a four-week period. Prescriptions were computerized at two of the practices and handwritten at the other two. Results Of the 661 patients who responded to the survey (response rate, 55 percent), 162 had adverse drug events (25 percent; 95 percent confidence interval, 20 to 29 percent), with a total of 181 events (27 per 100 patients). Twenty-four of the events (13 percent) were serious, 51 (28...

1,228 citations


"Patients’ Use of Information about ..." refers background in this paper

  • ...[3,4] One potential reason for this may be that health professionals sometimes express dismissive attitudes about patients’ judgements concerning symptoms they have experienced....

    [...]

  • ...[2] In primary care, studies which have relied on patients’ reports of ADRs, either to postal questionnaires or telephone surveys suggest annual prevalence estimates of the order of 2529% in the USA[3,4] and 30% in the UK....

    [...]

Journal ArticleDOI
11 Feb 2009-PLOS ONE
TL;DR: It is concluded that approximately one in seven hospital in-patients experience an ADR, which is a significant cause of morbidity, increasing the length of stay of patients by an average of 0.25 days/patient admission episode.
Abstract: Adverse drug reactions (ADRs) are a major cause of hospital admissions, but recent data on the incidence and clinical characteristics of ADRs which occur following hospital admission, are lacking. Patients admitted to twelve wards over a six-month period in 2005 were assessed for ADRs throughout their admission. Suspected ADRs were recorded and analysed for causality, severity and avoidability and whether they increased the length of stay. Multivariable analysis was undertaken to identify the risk factors for ADRs. The 5% significance level was used when assessing factors for inclusion in multivariable models. Out of the 3695 patient episodes assessed for ADRs, 545 (14.7%, 95% CI 13.6–15.9%) experienced one or more ADRs. Half of ADRs were definitely or possibly avoidable. The patients experiencing ADRs were more likely to be older, female, taking a larger number of medicines, and had a longer length of stay than those without ADRs. However, the only significant predictor of ADRs, from the multivariable analysis of a representative sample of patients, was the number of medicines taken by the patient with each additional medication multiplying the hazard of an ADR episode by 1.14 (95% CI 1.09, 1.20). ADRs directly increased length of stay in 147 (26.8%) patients. The drugs most frequently associated with ADRs were diuretics, opioid analgesics, and anticoagulants. In conclusion, approximately one in seven hospital in-patients experience an ADR, which is a significant cause of morbidity, increasing the length of stay of patients by an average of 0.25 days/patient admission episode. The overall burden of ADRs on hospitals is high, and effective intervention strategies are urgently needed to reduce this burden.

609 citations

Journal ArticleDOI
TL;DR: The lack of good-quality evidence in this area remains a serious problem and services should improve quality and audit screen performance for identification of previously unknown permanent hearing impairment, pending evidence-based policy decisions based on the research recommendations.
Abstract: Objectives To describe and analyse in detail current practice of school entry hearing screening (SES) in the UK. Data sources Main electronic databases were searched up to May 2005. Review methods A national postal questionnaire survey was addressed to all leads for SES in the UK, considering current practice in terms of implementation, protocols, target population and performance data. Primary data from cohort studies in one area of London were examined. A systematic review of alternative SES tests, test performance and impact on outcomes was carried out. Finally, a review of published studies on costs, plus economic modelling of current and alternative programmes was prepared. Results The survey suggested that SES is used in most of England, Wales and Scotland; just over 10% of respondents have abandoned the screen; others are awaiting national guidance. Coverage of SES is variable, but is often over 90% for children in state schools. Referral rates are variable, with a median of about 8%. The test used for the screen is the pure tone sweep test but with wide variation in implementation, with differing frequencies, pass criteria and retest protocols; written examples of protocols were often poor and ambiguous. There is no national approach to data collection, audit and quality assurance, and there are variable approaches at local level. The screen is performed in less than ideal test conditions and resources are often limited, which has an impact on the quality of the screen. The primary cohort studies show that the prevalence of permanent childhood hearing loss continues to increase through infancy. Of the 3.47 in 1000 children with a permanent hearing loss at school screen age, 1.89 in 1000 required identification after the newborn screen. Newborn hearing screening is likely to reduce significantly the yield of SES for permanent bilateral and unilateral hearing impairments; yield had fallen from about 1.11 in 1000 before newborn screening to about 0.34 in 1000 for cohorts that had had newborn screening, of which only 0.07 in 1000 were unilateral impairments. Just under 20% of permanent moderate or greater bilateral, mild bilateral and unilateral impairments, known to services as 6-year-olds or older, remained to be identified around the time of school entry. No good-quality published comparative trials of alternative screens or tests for SES were identified and studies concerned with the relative accuracy of alternative tests are difficult to compare and often flawed by differing referral criteria and case definitions; with full pure tone audiometry as the reference test, the pure tone sweep test appears to have high sensitivity and high specificity for minimal, mild and greater hearing impairments, better than alternative tests for which evidence was identified. There is insufficient evidence regarding possible harm of the screen. There were no published studies identified that examined the possible effects of SES on longer term outcomes. No good-quality published economic evaluations of SES were identified and a universal SES based on pure tone sweep tests was associated with higher costs and slightly higher quality-adjusted life-years (QALYs) compared with no screen and other screen alternatives; the incremental cost-effectiveness ratio for such a screen is around 2500 pounds per QALY gained; the range of expected costs, QALYs and net benefits was broad, indicating a considerable degree of uncertainty. Targeted screening could be more cost-effective than universal school entry screening; however, the lack of primary data and the wide limits for variables in the modelling mean that any conclusions must be considered indicative and exploratory only. A national screening programme for permanent hearing impairment at school entry meets all but three of the criteria for a screening programme, but at least six criteria are not met for screening for temporary hearing impairment. Conclusions The lack of good-quality evidence in this area remains a serious problem. Services should improve quality and audit screen performance for identification of previously unknown permanent hearing impairment, pending evidence-based policy decisions based on the research recommendations. Further research is needed into a number of important areas including the evaluation of an agreed national protocol for services delivering SES to make future studies and audits of screen performance more directly comparable.

395 citations

Journal ArticleDOI
TL;DR: The research showed that patients valued written information that was tailored to their individual circumstances and illness, and that contained a balance of harm and benefit information, and there is a gap between currently provided leaflets and information which patients would value and find more useful.
Abstract: Objectives To establish the role and value of written information available to patients about individual medicines from the perspective of patients, carers and professionals. To determine how effective this information is in improving patients' knowledge and understanding of treatment and health outcomes. Data sources Electronic databases searched to late 2004, experts in information design, and stakeholder workshops (including patients and patient organisations). Review methods Data from selected studies were tabulated and the results were qualitatively synthesised along with findings from the information design and stakeholder workshop strands. Results Most people do not value the written information they receive. They had concerns about the use of complex language and poor visual presentation and in most cases the research showed that the information did not increase knowledge. The research showed that patients valued written information that was tailored to their individual circumstances and illness, and that contained a balance of harm and benefit information. Most patients wanted to know about any adverse effects that could arise. Patients require information to help decision-making about whether to take a medicine or not and (once taking a medicine) with ongoing decisions about the management of the medicine and interpreting symptoms. Patients did not want written information to be a substitute for spoken information from their prescriber. While not everyone wanted written information, those who did wanted sufficient detail to meet their need. Some health professionals thought that written information for patients should be brief and simple, with concerns about providing side-effect information. They saw increasing compliance as a prime function, in contrast to patients who saw an informed decision not to take a medicine as an acceptable outcome. Conclusions The combination of a quantitative and qualitative review, an exploration of best practice in information design, plus the input of patients at stakeholder workshops, allowed this review to look at all perspectives. There is a gap between currently provided leaflets and information which patients would value and find more useful. The challenge is to develop methods of provision flexible enough to allow uptake of varying amounts and types of information, depending on needs at different times in an illness. This review has identified a number of areas where future research could be improved in terms of the robustness of its design and conduct, and the use of patient-focused outcomes. The scope for this research includes determining the content, delivery and layout of statutory leaflets that best meet patients' needs, and providing individualised information, which includes both benefit and harm information. In particular, studies of the effectiveness and role and value of Internet-based medicines information are needed.

290 citations


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