A systematic review to determine the effectiveness of preparatory information in improving the outcomes of adult patients undergoing invasive procedures

A systematic review to determine the effectiveness of preparatory information in improving the outcomes of adult patients undergoing invasive procedures A. McDonnell Objective: to determine the effectiveness of preparatory information, in improving the outcomes of adult patients undergoing invasive procedures. Review methods: following the development of a broad search strategy, 126 citations were retrieved.Tightly defined inclusion criteria were applied, following which, 30 studies remained.The validity of these studies was assessed using a 5-point scale, which led to the exclusion of a f u r t h e r nine studies. Limitations in data analysis within p r i m a r y studies resulted in the loss of a f u r t h e r three studies. Results: a broad qualitative overview of the 18 included studies is given.This process takes into account methodological rigour and highlights similarities and differences between studies.There were insufficient raw data presented in primary studies to proceed to a meta-analysis. Summary and implications: there is insufficient robust research to assess the impact of preparatory information on post-procedural outcomes. Analysis of the 18 included studies demonstrates that there is little evidence to suggest that preparatory information alone given p r i o r to invasive procedures has a significant positive impact on measures of recovery, particularly length of stay and state anxiety measured by the STAI State Scale. The robustness of the review process and results are considered and possible sources of bias discussed.The practical implications of the results for health care are discussed. Keywords: systematic review, patient education, preoperative care

INTRODUCTION

The NHS Centre for Reviews and Dissemination defines a systematic review as: Ann McDonnell University of Sheffield School of Nursing and Midwifery, Bartolome House,Winter Street, Sheffield $3 7ND, UK

'...a scientific tool which can be used to summarise, appraise, and communicate the result and implications of otherwise unmanageable quantities of research'. (NHS Centre for Reviews and Dissemination 1996, p 1)

Clinical Effectiveness in Nursing (1999) 3, 4-13 9 1999HarcourtBrace& Co. Ltd

Systematic reviews are particularly important in health care today in view of the current 'information overload' that exists. Systematic reviews have the capacity to pull together information from individual studies, highlighting common themes and inconsistencies. When the results of individual studies are pooled using the statistical techniques of meta-analysis, the statistical power of single studies can be increased, resulting in more meaningful and 'actionable' conclusions (Antman et al. 1992).

Effectiveness of preparatory information in improving outcomes of adult patients

Unlike the traditional 'narrative' review, which may be little more than a subjective assessment of a small fraction of the literature, systematic reviews aim to be rigorously designed, unbiased and reproducible. This paper describes the methods used to conduct a systematic review in an important area of clinical practice - the provision of information prior to invasive procedures. The complexities of the process and the study's limitations are presented along with the results of the review, to provide the reader with some insights into this challenging approach.

BACKGROUND An invasive medical procedure is defined as: '...any operative or diagnostic technique that usually involves the use of instruments and requires the penetration of tissue or the invasion of a body orifice'. (Home et al. 1994, p 8) These procedures are stressful life events to which the majority of the population are subject at some time. The consequences of an invasive procedure for an individual range from minor discomfort and a small element of risk, to danger, pain, anxiety, fear, lengthy hospitalization, disruption in activities of daily living, altered body image or an unfavourable diagnosis, such as cancer. Keeping patients well informed is an integral part of today's health-care culture. A recent Audit Commission Report indicated that lack of information regarding treatment is a frequent source of patient complaints (Audit Commission 1993). This reflects the findings of many early patient satisfaction surveys such as Cartwright (1964), Hugh-Jones et al. (1964) and Spelman et al. (1996), which led to a proliferation of research in the field of preoperative instruction. Conducted since the 1960s, these studies focused on the effects of preoperative instruction on a variety of postoperative outcomes, such as anxiety, pain, vomiting and length of stay. Landmark studies include Dumas and Leonard (1963), and Egbert et al. (1964) in the USA and Hayward (1975) in the UK. This large body of research has led to a general acceptance that preoperative instruction is beneficial. Potential benefits include reductions in psychological morbidity and pain, and reduced length of stay. The latter could result in substantial reductions in hospital costs. In order to establish the extent to which the effectiveness of preparatory instruction prior to invasive procedures has been the subject of previous systematic review, the following databases were searched: 9 9

DARE (on-line) The Cochrane Library, 1996 (Issue 3)

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9

5

Medline (1990--1996) - using a modified version of the NHS Centre for Reviews and Dissemination search strategy for identifying reviews in Medline CINAHL (1982-1986) - using a modified version of the NHS Centre for Reviews and Dissemination search strategy for identifying reviews in CINAHL

and in addition, reference lists from papers obtained were hand searched. Five reviews (Mumford et al. 1982, Devine & Cook 1983, Devine & Cook 1986, Hathaway 1986, Suls & Wan 1989, Devine 1992) were found. Despite differences in size of treatment effects, all these meta-analyses conclude that preparatory instruction results in measurable benefits for adult surgical patients in a variety of recovery measures. However, existing reviews have important limitations: 9 9 9

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only studies prior to 1989 are included all reviews are American in origin one review (Suls & Wan 1989) focuses purely on preparatory information, however, the remainder include interventions which encompass other forms of preparatory instruction as well as the provision of information, e.g. skills training, psychosocial support two reviews (Devine & Cook 1983, Devine & Cook 1986, Devine 1992) exclude day surgery two reviews (Devine & Cook 1986, Devine 1992) focus on methodological issues in their classification of interventions for analysis. Those reviews which focus on more substantive issues use broad categories, e.g. organization and content the classification of the type of invasive procedure is again broadly focused, e.g. surgery meta-analysis using effect size (ES) is performed. Little information is given on the method of extracting data from primary studies and little detail provided on how studies were combined statistically.

For practitioners wishing to deliver evidencebased health care it remains unclear which form of preparatory instruction-information, education or psychosocial support offers most benefits for their patients. Uncertainty also remains about which delivery mode is most effective, e.g. booklets, individual visits or group sessions. This has important implications in terms of costeffectiveness. Since some preparatory interventions take longer than others to deliver and may require extra staff training, interventions may have different costs associated with them. Provided they yield comparable patient benefits, clinicians may wish to replace expensive and time consuming interventions with simpler methods.

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Clinical Effectiveness in Nursing

Date Languages Country Format Searching on which part

1980-present day (in first instance go back as far as databasesallow) English Any Mainly journal articles, but also books, reports, conference literature and these a)thesaurus searching using subject headings in title, abstract or full text where available (see Table 2) b)freetext searching using keywords in title, abstract or full text where available (see Table 2)

Subject headings t o search on

Keywords t o search on

MeSH headings: SURGERY RADIOGRAPHY PRE-OPERATIVE CARE PATIENT EDUCATION

Information giving Invasive procedures Patient information Leaflets Videos Printed material Audio-visual Preparatory instruction Preoperative instruction Booklet Preparatory information Preoperative informatio and surgery Radiological investigation Catheterization Invasive procedure Operative Endoscopy

The provision of information is likely to be the least expensive and most simple preparatory intervention to administer. However, in the metaanalysis which focused on information alone (Suls & Wan 1989), confidence intervals for some effect sizes included negative values, indicating some uncertainty that the effects of information are always beneficial. This review, therefore, focused purely on the provision of information and excluded studies which included education or psych 9 support as part of the preparatory instruction package.

OBJECTIVE OF T H E R E V I E W To determine the effectiveness of preparatory information in improving the outcomes of adult patients undergoing invasive procedures, e.g. surgery, radiological investigations. The main hypothesis tested was that the provision of information has no effect on patient outcomes (the null hypothesis). A second hypothesis was that the format of the information, e.g. written, verbal or audio-visual makes no difference to its effectiveness. A third hypothesis was that the type of information, e.g. sensory, procedural or combined sensory/procedural makes no difference to its effectiveness. In addition, the review explored: 9 0

characteristics of the invasive procedure, e.g. surgery, diagnostic procedure methodological rigour of included studies

REVIEW METHODS

Search strategy Initially, a broad search plan was developed, the parameters of which are listed in Tables 1 and 2. This broad plan was adapted for use on 11 databases. In addition: 9 9

Patient Education and Counseling from 1982-1996, was handsearched Reference lists for any review articles retrieved were also searched

In order to avoid 'selection bias', all citations retrieved were reviewed according to the following inclusion criteria, which were left deliberately broad: Inclusion criteria 1: 1. 2. 3. 4.

Adult subjects English language Presence of comparison group Intervention is/likely to be preparatory information giving 5. Published.

Citations for which insufficient detail was available, were included at this stage. The results of this process are summarized in Tables 3 and 4. All references were entered on EndNote Plus 2 (a reference database and bibliography maker). This enabled studies to be accessed through textword searches. Full copies of all included studies (n = 126) were then obtained.

Effectiveness of preparatory information in improving outcomes of adult patients

Total number of citations found

Database Medline Express 1966- I/97 ASSIA 1992-1996 ACP Journal Club 199 I - I / 9 7 DHSS Data-3/97 HELMIS-3/97 Psyclit 1974-12/96 Science Citation Index-3/97 Healthstar 1986-1996 CINAHL 1982-1996 Embase 1986-3/97

ENB Heatthcare-3/97

Journal/review article handsearched Patient Education and Counseling Webber (I 990) O'HalloranO(1995) Hunt (1975) Vallejo (1987) Roy (1981) Teasdale 0993)

Cochran (1984)

Inclusion

97 7 0 23 3 538 97 0 43 432 6

7

Citations meeting inclusion criteria I 0 3 0 2 I 29 13 0 8 5 6

Total citations found 18 17 18 S 8 3 II

7 17 18 5 8 3

I1 9

9

criteria

The search strategy described yielded 126 citations which met Inclusion Criteria 1. Inclusion Criteria 1 had been deliberately broad so that potentially relevant studies would be included rather than excluded. Following retrieval of copies of all papers, a more tightly defined version of these criteria was applied: Inclusion criteria 2: Published English Adult patients (19-80 and over) Presence of comparison group which is a control or placebo control group 5. Intervention is preparatory information, prior to an invasive procedure 6. Invasive procedure is defined as:

Owing to constraints on time and resources, each study obtained was assessed for inclusion by one reviewer only. Decisions were coded and recorded on Endnote. During this process, a number of dilemmas arose. Decisions made as a result are presented here in order to present a full description of the review process: 9

1. 2. 3. 4.

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'...any operative or diagnostic techniques that usually involve the use of instruments and require the penetration of tissue or the invasion of a body orifice'. (Home et al. 1994, p 8) 7. Exclude interventions which include information in combination with other elements of a preparatory package, e.g. education, psycho-therapeutic interventions 8. Include interventions which include information as one of a number of treatment arms, as long as this treatment atm involves information only and is not combined with any other element of a preparatory package 9. Outcomes are measured following invasive procedure, not prior to or during procedure.

Citations meeting inclusion criteria I

9

In some studies the intervention group did not meet the inclusion criteria, but the placebo control group did. The validity of extracting data from the placebo control group for the purpose of comparison with the nonintervention control group was considered. These studies were excluded on the basis that overall analysis would be compromised and would involve using data for a purpose for which it was not originally intended (n = 2) In some studies, the subjects were aged >15 or not stated. These studies were included at this stage, with a view to conducting a crude sensitivity analysis to determine the implications of this decision at the stage of data synthesis (n = 4) Some studies included a treatment group who received information booklets/videos which included information on exercises such as breathing and leg exercises. These studies were included at this stage, since in the absence of practice and feedback, they could be more appropriately classed as information rather than education. A crude sensitivity analysis to determine the implications of this decision at the stage of data synthesis was planned (n = 5)

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Clinical Effectiveness in Nursing

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Where insufficient detail was provided to determine whether the intervention was information or education, study was excluded (n = 1).

The number stage = 30.

of

included

studies

at

this

Assessment of validity of primary studies The assessment of study validity is a crucial feature of any systematic review, reflecting an important attempt to reduce bias. Since studies of high quality are likely to be least biased (NHS Centre for Reviews and Dissemination 1996), the NHS Centre for Reviews and Dissemination (CRD) recommends grading studies in a hierarchy according to the research design. All included studies were controlled trials, therefore this approach was inappropriate. Features of study methodology may also result in threats to validity and the systematic assessment of possible methodological flaws is crucial, in order that flawed studies can be excluded from further analysis or the implications of these flaws assessed through later sensitivity analyses (NHS Centre for Reviews and Dissemination 1996). A variety of scales and checklists exist for the purpose of assessing the quality of primary studies. However, a recent review of 25 scales revealed that only one had been developed following rigorous, accepted procedures to establish its psychometric properties (Moher et al. 1995). Jadad et al. (1996) describe the generation of a scale to assess the quality of reports of randomized controlled trials (RCTs) in pain research. This process used established methodological procedures including preliminary conceptual decisions, item generation and assessment of face validity, followed by field trails to assess consistency, frequency of endorsement and construct validity and the generation of a refined instrument. This instrument includes three items which are directly related to the reduction of bias and is 'simple, short, reliable and apparently valid' (Jadad et al. 1996). Since none of the items in the instrument are specific to pain reports, the authors endorse its application in other fields of health care. In the absence of strong empirical evidence to indicate which scale/checklist is likely to produce the most accurate assessment of validity (Moher et al. 1995), the tool developed by Jadad et al. (1996) was applied to all included studies. ' J A D A D ' scores for included studies ranged from 0 to 3, with nine studies scoring 0. Studies which were zero rated were excluded from the review on the basis that they were so seriously flawed in methodological terms, that their internal validity was compromised and their inclusion would jeopardize the accuracy of the review. All other studies were retained, with a view to

exploring the impact of the degree of potential methodological bias on the conclusions of the review, at a later stage. Number of included studies remaining = 21.

Data extraction In order to extract relevant data from included studies accurately and without bias, a data extraction form was developed. This was based on Example A3.1 presented in CRD Report 4 (NHS Centre for Reviews and Dissemination 1996) and adapted for use in the field of preparatory information giving. Data extraction was performed by the same reviewer who conducted previous study assessment. Owing to time and resource constraints, no attempt was made to contact study authors for further information on missing or unclear data. In studies where outcomes were measured prior to or during the invasive procedure as well as postprocedure, only the data on post-procedural outcomes were extracted. This was only possible when these data were reported and analysed separately against controls. Similarly, in some studies, only one of the treatment groups was relevant to this review, e.g. the information group, and not groups receiving psychological or educational interventions. Only the data from the relevant treatment (and control) group were extracted. This was only possible when these data were reported and analysed separately against controls. Three studies were excluded at this stage since treatment groups were not analysed separately against controls. Number of included studies remaining = 18.

Data synthesis and investigation of differences between studies A broad qualitative overview of the included studies was conducted as advocated in CRD Report 4 (NHS Centre for Reviews and Dissemination 1996). This process considers all study results taking into account methodological rigour and highlighting sin~larities and differences between studies. During this process, key elements considered were: 9 9 9 9 9 9 9

Characteristics of study subjects Nature of invasive procedure Type of information (sensory, procedural or combination) Method of information delivery, e.g. booklet, visit Number of subjects Nature of controls Nature of outcome measures.

For the outcome measures considered, there were insufficient data on sample size, standard deviation

Effectiveness of preparatory information in improving outcomes of adult patients and effect size, to proceed to a meta-analysis, i.e. a statistical synthesis of study findings.

RESULTS OF T H E R E V I E W Overview of included studies In relation to the main features of the 18 included studies, a number of clear issues emerged: 9 9 9 9

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Most studies (n = 16) are North American in origin A wide variety of outcome measures are used Many of these are subjective rather than objective measures of recovery Many of the outcomes measures were developed for individual studies and are not instruments with established psychometric properties Subject numbers are small (range = 24-81 subjects) Nature of invasive procedures varies widely Attrition is dealt with in most studies by excluding all data on withdrawals and drop outs, whatever the reason, i.e. these are explanatory rather than pragmatic trials Information is provided in a variety of formats, e.g. written, audio-tapes, visits No studies include information on the costs of the intervention Overall quality of the studies (assessed using 'JADAD' criteria) is poor, particularly in relation to methods of randomization and methods of dealing with attrition. No study scored more than 3 out of 5 points Raw data on results are not always reported in full Eight studies include treatment groups not relevant to this review, necessitating extraction of relevant data.

Length of stay Table 5 summarizes the raw data for length of stay (LOS) in the ten studies using LOS as a measure of recovery. LOS was significantly shorter in the intervention group/s in two studies only. LOS values are not reported in two studies. The n value in relation to each statistical test is only reported in four studies. Standard deviations for LOS are only reported in three studies. Confidence intervals are not reported in any of the included studies. Figure 1 illustrates the range of differences in mean LOS across all studies. Further analysis explored variables which might explain these effect sizes and are summarized later.

State scale of the Speilberger State-Trait Anxiety I nventory Table 6 summarizes the raw data for State-Trait Anxiety Inventory (STAI) in the six studies using STAI as a measure of recovery. State anxiety was significantly lower in the intervention group/s in one study only. STAI values are not reported in one study. The n value in relation to each statistical test is only reported in three studies. Standard deviations for STAI are reported in all studies where values are stated. Confidence intervals are not reported in any of the included studies. Further analysis explored variables which might explain these effect sizes and are summarized below.

SUMMARY OF KEY F I N D I N G S 9

The most commonly used (and comparable) outcome measures are: 9 9

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Length of Stay ( L O S ) - 10 studies State Scale of the Speilberger State-Trait Anxiety Inventory (STAI) (Speilberger, et al. 1983) - six studies Mood Adjective Checklist (MACL) developed by Johnson et al. (1978) based on previous work (Radloff & Helmriech 1968) - three studies.

As MACL values were only reported for one study (Johnson et al. 1978) no further analysis was performed on this outcome measure. Further analysis focused on LOS and State Anxiety measured by STAI. Points made in relation to each of these should be interpreted with caution. Most studies showed n o significant effects for information. The studies which demonstrated a significant effect for information on LOS did not demonstrate a significant effect for State Anxiety and vice versa.

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There is insufficient research to assess the impact of preparatory information on postprocedural outcomes Analysis of the small number of studies (n = 18) which do address this demonstrates that there is little evidence to suggest that preparatory information given prior to invasive procedures has a significant positive impact on post-procedural outcomes, particularly LOS (two studies only) and State Anxiety measured by the STAI State Scale (one study only) Studies which show significant positive effects for one outcome measure, did not necessarily demonstrate positive effects for other outcome measures For STAI, the only significant effect size was in the study with the highest number of subjects (n = 77) There is some evidence (from three studies) that information may not improve outcomes for all personality types

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Clinical Effectiveness in Nursing

Author

n

Butler et al.

68*

Christopherson & Pfeiffer Hill

41"

20**

LOS values (SD)

Difference in mean L O S (C-I) in days

Statistical tests

II 10.28(4.74) C 10.38(5.53) II 10.08 12 2. I C 13.3 II 3.31 (0.59) C 3.19(0.79) II 5.97 12 5.78 C 6.36

0. I

n.s

II 3.22

(gender used as covariate) Control group had longerLOS, but n.s F = 2.05, P > 0.05

-0.12

n.s (age used as covariate) Sensory info group significantly shorter LOS Dunnett's t (3.64) = 3.45, P < 0,001) (effect for preoperative fear and interactions extracted) n.s. Test statistics not reported.

Johnson et al. (a)

36*

Johnson et al. (b)

Not reported ***

Values not reported

Values not reported

KIos et al. (I 980)

Not reported

II High preoperative

High preoperative fear 0.7 Low preoperative fear

***

fear 5.09 Low preoperative fear 5.64 C High preoperative fear 5.79 Low preoperative fear 4.45 17.2 C 7.6

- I . 19

16.70

0.05

Langer et al.

Not reported

Lindeman & Stetzer Ridgeway & Mathews Wilson

176**

II 0.39 12 0.58

High preoperative fear: n.s Low preoperative fear: II significantly longer LOS. F (I, 18) = 4.84, P < 0.05 (age used as covariate)

0.4

C 6.65 40** 35*

Values not reported I 5.96(0.76) C 6.99(0.98)

Values not reported

n.s.

Test statistics not reported 1.03

LOS significantly shorter (P < 0.0 I) than control linear regression used to remove variability due to age, type of operation and coping ability score)

Where n is reported for individual tests, this figure is given on table* Where n is not reported for individual tests, the figure for treatment group sizes is given on table** Where n is not reported for each treatment group, no figure is given on table***

INCREASE IN LOS,

' DECREASE IN LOS

Christopherson I1 Christopherson I2 Wilson Klos (High pre-op fear) Johnson~I2 Langer Johnson I1 Butler Lindeman Klos (Lee pre-op fear) -1.5 -1 -0.5 0 0.5 1 1.5 2 2.5 3 3.5

n,s, n.s. P
Effect size Fig. I Effect sizes illustrating the apparent effects of information on length of stay (LOS) in 10 randomized trials of preparatory information giving prior to an invasive procedure

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T h e r e is some evidence that different types of i n f o r m a t i o n m a y h a v e different effects o n postprocedural outcomes, a l t h o u g h this is unclear T h e effect o f the format o f i n f o r m a t i o n on postprocedural outcomes, i f any, is unclear T h e relationship between the effectiveness of i n f o r m a t i o n and the nature/extensiveness of the i n v a s i v e procedure, if any, is unclear T h e r e is some evidence to suggest that not using p l a c e b o controls for attention m a y result in bias (no significant effects were f o u n d in the four studies using placebo controls).

A N A L Y S I S OF T H E R O B U S T N E S S OF T H E RESULTS Whilst a n u m b e r o f steps, already outlined, were taken to m i n i m i z e the possibility of bias during the review process, it is a c k n o w l e d g e d that the m e t h o d used was susceptible to bias in a n u m b e r of areas: Systematic reviewers a c k n o w l e d g e that even with the use of explicit inclusion criteria, decisions regarding inclusion of individual studies r e m a i n partly subjective and susceptible to ' r e v i e w e r bias' (NHS Centre for Reviews

Effectiveness of preparatory information in improving outcomes of adult patients

Author

n

Butler et al.

77*

STAI State Scale values ( S D )

Difference in mean STAI State Scale values (C-I)

Baseline I 27.93(25.24) C 42.65(29.06) Postoperative 121.57(18.44) C 31.15(22.93) Postoperative II 28.45(7.6) 12 33.06(9.0) C 34.67(7.3)

9.58

II 6.22 12 1.61

41'

Flam et al.

30**

Values not reported

Values not reported

Hartfield & Cason

24*

Postoperative

II 9

II 42.5(12.7)

12-7,4

Analysis of between groups differences postoperative not reported For II only, State scale of STAI significantly decreased from preoperative (but post-intervention) to postoperative period (P<0.00 I) Analysis of between group differences postmyelogram for anxiety and sensation awareness not reported Between groups effect signif, F(2,20) = 4.2, P= 0.03 (Trait-anxiety used as covariate) Fischers exact test for multiple comparison of means: between II and 12 significance difference d = 16.625, P<0.05 between II and C n.s. between 12 and C n.s. Order of means from highest to lowest: I I - C - 12, but differences n.s. State anxiety on STAI lower in information group than placebo control, but higher than for nonintervention control - no analysis of statistical significance reported n.s (type of surgery, sex, age, and race used as covariates)

12s8.90i. I) C 51.5(6.3)

59**

Scott & Clum

Not reported

Post-op II 36.1(17.5) CI 37.8(15.4) C2 34(8.5) II Sensitizers 36.2(7.9) Avoiders 38.5(9.9) C Sensitizers 36.7(7.0) Avoiders 35.5(11.1)

Statistical tests

Within subject effect for time of testing significance F(1,68) = 8.64, P=0.004 Between subject effect for group significant F(1,68) = 7.8 I, P=0.007 (gender used as covariate)

Christopherson & Pfeiffer

Reading

II

CII.7 C2-2. I

II Sensitizers 0.5 Avoiders -3.0

W h e r e n is reported for individual tests, this figure is given on table* W h e r e n is not reported for individual tests, the figure for treatment group sizes is given on table** W h e r e n is not reported for each treatment group, no figure is given on table ~"*

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and Dissemination 1996). The NHS CDR recommend the independent assessment of all studies by more than one reviewer to minimize this threat to validity (NHS Centre for Reviews and Dissemination 1996). This was not feasible in the context of this review. The NHS CRD recommend masked assessment of studies at the inclusion stage, i.e. the removal of information regarding authorship, institutions, journal titles, results and conclusions, to reduce the possibility of reviewer bias. Jadad et al. (1996) found that blind assessment produced significantly lower and more consistent scores than open assessment during development of their quality assessment tool. Blind assessment was not possible in the context of this review. The quality assessment tool used within this review (Jadad et al. 1996) was not subject to further assessment of validity and reliability to confirm its value within this research context. Jadad et al. (1996) acknowledge that their instrument relies on published information in reports, and may result in the assumption that a trial is deficient when this is not so, where reporting is not detailed.

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Where raw data were missing, time constraints meant that no attempt was made to contact study authors to supply further information. The data extraction process may have resulted in three studies being excluded unnecessarily owing to lack of detailed reporting of study results. Owing to resource constraints, this review included studies published in English only. A recent review indicated that this may affect the results of a systematic review (Gregoire et al. 1995). Owing to time constraints, this review included published studies only. Publication bias also has the potential of affecting the results of a systematic review, since the nature and direction of study findings may affect the decision to publish (NHS Centre for Reviews and Dissemination 1996).

In addition to these, uncertainty surrounding three decisions on inclusion, may also threaten the robustness of the results. These are: 1. The decision to include studies where the subjects were aged >15.

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Clinical Effectiveness in Nursing

2. The decision to include studies where information was presented as a booklet/video, which included information on exercises, such as breathing and leg exercises. 3. The decision to include studies with a 'JADAD' score of 1 or above instead of 2 or above. A crude sensitivity analysis was performed to assess the implications of each of these on the robustness of the results. This demonstrated that decisions to exclude affected studies from the review would result in the following conclusions: 9 9

There is no evidence for beneficial effects of information on state anxiety measured by STAI A significant reduction in LOS is shown in one study only.

The robustness of the review has, therefore, been shown to be affected by uncertainty surrounding inclusion criteria. More rigorous application of criteria surrounding age, study quality and definition of the intervention would have resulted in only one study remaining which demonstrates significant positive effects for information for the recovery measures selected. However, overall review conclusions regarding lack of evidence for the effectiveness of preparatory information remain unaffected.

IMPLICATIONS

FOR PRACTICE

This review has demonstrated that there is insufficient evidence to confirm the effectiveness of preparatory information alone, given prior to invasive procedures, on post-procedural measures of recovery. However, neither has this review demonstrated that preparatory information is harmful in this context. There is no basis for suggesting that healthcare providers should discontinue current practice in this area, particularly given that many initiatives, such as the provision of leaflets, are likely to be relatively inexpensive. However, the introduction of costly new information-only programmes without further evaluation of their clinical effectiveness and cost-effectiveness is not recommended. Therefore, new packages of information should be devised only within the context of a RCT. This review evaluated the provision of information alone, and unlike previous reviews (Mumford et al. 1982, Devine & Cook 1983, Devine & Cook 1986, Hathaway 1986, Devine 1992) did not include treatment packages which delivered information alongside teaching, e.g. leg exercises or psychosocial support (relaxation training). Many studies were discarded because they included educational (n = 24) or psychosocial elements (n = 19). Given this large number, it is likely that many treatment packages currently being delivered combine information with one of these elements. This review has not attempted to assess whether these adjunct

interventions are either effective or ineffective. Therefore, there is no justification for the discontinuation of these treatments. However, purchasers and providers will be aware that these treatment packages are likely to be more costly in terms of staff time than information alone, and should, therefore, review the evidence for their effectiveness before introducing new programmes.

RECOMMENDATIONS PRACTICE 9

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Current practices of providing preparatory information prior to invasive procedures should not be discontinued New information-only packages, which are costly should be introduced only within the context of a RCT New treatment packages which combine information with educational or psychosocial preparation should not be introduced without reviewing the evidence for their effectiveness.

CONCLUSION Although this review has not established the effectiveness of preparatory information, this is not equivalent to establishing that preparatory information is ineffective or has harmful consequences. This message is particularly important since many nurses and doctors include information-giving as part of their everyday work. Information may be imparted in time specifically allocated, or while delivering other more practical elements of nursing/medical care. To abandon this practice may have far reaching implications for the nurse/doctor-patient relationship, and public and professional beliefs about the importance of holistic health care. These effects may last beyond the immediate postprocedural recovery period. This review also highlights the need for further rigorously designed trials on a wider scale than seen hitherto. Given the relatively small number of published studies on this subject, the current political emphasis on informed choice and the climate of consumerism within the NHS, the effects of preparatory information need to be established. Finally, the current impetus surrounding the promotion of evidence-based practice within nursing needs to be sustained by rational and rigorous appraisal of its knowledge base. Systematic reviews can make an important contribution to this endeavour.

ACKNOWLEDGEMENT The author would like to acknowledge the support and guidance given by-Andrew Booth, Director of Information Resources, ScHARR, during the conduct of this study.

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