A systematic review and meta-analysis of the effects of clinical pathways on length of stay, hospital costs and patient outcomes
- Thomas Rotter†1Email author,
- Joachim Kugler†1,
- Rainer Koch†2,
- Holger Gothe†3,
- Sabine Twork†1,
- Jeroen M van Oostrum†4 and
- Ewout W Steyerberg†5
© Rotter et al; licensee BioMed Central Ltd. 2008
Received: 07 July 2008
Accepted: 19 December 2008
Published: 19 December 2008
To perform a systematic review about the effect of using clinical pathways on length of stay (LOS), hospital costs and patient outcomes. To provide a framework for local healthcare organisations considering the effectiveness of clinical pathways as a patient management strategy.
As participants, we considered hospitalized children and adults of every age and indication whose treatment involved the management strategy "clinical pathways". We include only randomised controlled trials (RCT) and controlled clinical trials (CCT), not restricted by language or country of publication. Single measures of continuous and dichotomous study outcomes were extracted from each study. Separate analyses were done in order to compare effects of clinical pathways on length of stay (LOS), hospital costs and patient outcomes. A random effects meta-analysis was performed with untransformed and log transformed outcomes.
In total 17 trials met inclusion criteria, representing 4,070 patients. The quality of the included studies was moderate and studies reporting economic data can be described by a very limited scope of evaluation. In general, the majority of studies reporting economic data (LOS and hospital costs) showed a positive impact. Out of 16 reporting effects on LOS, 12 found significant shortening. Furthermore, in a subgroup-analysis, clinical pathways for invasive procedures showed a stronger LOS reduction (weighted mean difference (WMD) -2.5 days versus -0.8 days)).
There was no evidence of differences in readmission to hospitals or in-hospital complications. The overall Odds Ratio (OR) for re-admission was 1.1 (95% CI: 0.57 to 2.08) and for in-hospital complications, the overall OR was 0.7 (95% CI: 0.49 to 1.0). Six studies examined costs, and four showed significantly lower costs for the pathway group. However, heterogeneity between studies reporting on LOS and cost effects was substantial.
As a result of the relatively small number of studies meeting inclusion criteria, this evidence base is not conclusive enough to provide a replicable framework for all pathway strategies. Considering the clinical areas for implementation, clinical pathways seem to be effective especially for invasive care. When implementing clinical pathways, the decision makers need to consider the benefits and costs under different circumstances (e.g. market forces).
Clinical pathways represent a form of "cookbook medicine" that many perceive as an appropriate tool that contributes to quality management, cost-cutting and patient satisfaction.
For the aim of this review, clinical pathways are defined as complex interventions consisting of a number of components based on the best available evidence and guidelines for specific conditions . A clinical pathway defines the sequencing and timing of health interventions and should be developed through the collaborative effort of physicians, nurses, pharmacists, and other associated health professionals . Clinical pathways aim to minimize delays and maximize resource utilization and quality of care . They are also referred to as "integrated care pathways", "critical pathways", "care plans", "care paths", "care maps" and "care protocols".
The effectiveness of clinical pathways is under debate. However, especially in the US, up to 80 percent of hospitals already use clinical pathways for at least some indications . A number of primary studies considered the effectiveness of clinical pathways, but results are inconsistent and suffer from various biases [4–7]. Only one systematic review has been performed, specifically for stroke patients . Narrative reviews are more common, which often rely on "expert opinions" [9–11].
We perform a systematic review and a random effects meta-analysis to assess whether clinical pathways improved the outcome measures "length of stay (LOS)", "hospital costs" and "quality of care" when compared to standard care. By performing a systematic review and meta-analysis we are able to present the available evidence in a substantiated and concise way, in order to provide a framework for local healthcare organisations considering the effectiveness of clinical pathways.
We followed the methods of the Cochrane Collaboration  with some modifications, mainly concerning presentation of meta-analytic results.
Study selection criteria
Pathway characteristics and quality outcome measures of studies included
Counts and rates are presented in natural units and as percentages as far as reported
N = numer of participants n = number of events (%) = percentage
20/234 (8.5%) N.S.
Re-hospitalisation (6 months)
9/234 (3.9%) N.S.
2/33 (6.1%) N.S.
Mean Modified Barthel Index
85.6 (p < 0.05)
20/71 (28.1%) (p < 0.05)
Re-hospitalisation (3 months)
0/71 (0%) N.S.
14/56 (25.0%) N.S.
Re-hospitalisation (28 days)
6/56 (10.7%) N.S.
2/37 (5.4%) N.S.
Re-hospitalisation (6 months)
0/37 (0%) N.S.
5/38 (13.2%) N.S.
17/50 (34.0%) N.S.
Re-hospitalisation (6 months)
Mortality (12 months)
Re-hospitalisation (12 months)
Cognitive and functional scores (0–100)
7.7 (SD 2.6)
8.8 (SD 1.7) (p < 0.05)
Complete and graded exercise test
Hospitalised patients as %
Re-hospitalisation (8 weeks)
4/83 (4.8%) N.S.
Johnson, KB 2000
Unscheduled clinic visits; no hospital re-admission (2 weeks)
13/250 (5.2%) N.S.
8/250 (3.2%) N.S.
Marrie, TJ 2000
Absolute difference in rates (ARR) between pathway and control
1-sided 95% CI upper limit:
Re-hospitalisation (6 weeks)
Mortality (6 weeks)
Median Barthel Index Score (26 weeks)
Mortality (26 weeks)
6/76 (7.9%) N.S.
Complications until follow-up (27 days)
1/9 (11.1%) N.S.
Re-hospitalisation (27 days)
0/9 (0%) N.S.
Chen, SH 2004
Emergency room usage (not comparable with in-hospital complications)
13/22 (59.1%) (p < 0.05)
Re-hospitalisation (3 months)
Usui, K 2004
Please note, additional information relating to the included studies that matched these requirements or differ from each other, are given in the results section of this review.
The setting definition covered the whole range of services offered by the clinical (out- and in-patient) as well as in the in-patient rehabilitation sector. We only gathered robust evidence and limited our study selection to randomised controlled trials (RCT) and controlled clinical trials (CCT) including methodological quality criteria (please see "quality assessment and data analyses").
We considered every objective economic and patient outcome for inclusion. We pre-defined (1) in-hospital complications as a secondary disease or adverse medical occurrence during hospitalization  and (2) we defined re-hospitalization as a readmission within a specified follow up period of an index admission.
Data sources and search strategy
Clinical pathway search strategy Ovid Medline: 1966 to November Week 2 2006
(clinical path$ or critical path$ or care path$ or care map$).tw.
Health Planning Guidelines/
(guideline? adj2 introduc$ or issu$ or impact or effect? or disseminat$ or distribut$)).tw.
(professional standard$ or professional protocol or professional care map).tw.
(practice guidelin$ or practice protocol$ or clinical practice guideline$).tw.
(in-patient or hospitalized or hospitalised or hospitalisation or hospitalization).tw.
exp Outpatient Clinics, Hospital/
exp Hospital Units/
(Patient Admission or patient readmission or patient readmission or discharge).tw.
11 and 18
randomized controlled trial.pt.
controlled clinical trial.pt.
pre test or pretest or (posttest or post test)).tw.
18 and 26
Furthermore, we employed citation tracking, which examines included studies and previous reviews and contacted investigators to identify any study missed by the electronic searches.
Quality assessment and data analysis
For quality of studies (see additional File 1), we adhered to the Effective Organisation of Care Group (EPOC) module and defined three risk classes: Class I (low risk of bias), Class II (moderate risk of bias) and Class III (high risk of bias). Two reviewers independently assessed and abstracted data, on the intervention criteria, study characteristics and methodological quality. Any disagreement was discussed with a third reviewer. Studies with a high risk of bias were excluded from the review after documentation. If a primary study did not provide information about the standard deviation, we used the approximative or direct algebraic connection between the stated confidence intervals, or p-values, and the standard deviation and calculated the inverse transformation to the individual or pooled standard deviation . Prior to the actual statistical pooling of the singular effects, an adjustment of the data regarding costs due to inflation and price adjustment (OECD Health Care Price Index) was carried out . We chose the US Dollar (USD) as the basic currency. The year 2000 was chosen as a representative year for inflation and price adjustments or exchange rates.
We used Review Manager (RevMan) of the Cochrane Collaboration to calculate a pooled effect estimate, called weighted mean difference (WMD) . We used a random effects model since this model estimates the effect with consideration to the variance between studies, rather than ignoring heterogeneity by employing a fixed effect model. The effect sizes were generated using a model fitting inverse variance weights .
Heterogeneity and meta-analysis
Despite the expected clinical heterogeneity (clinical variability of the included pathway interventions) within the review, it is important to assess the comparability of the results from individual studies. A useful statistic for quantifying inconsistency is I2 = [(Q df)/Q] × 100%, where Q is the chi-squared statistic and df is its degrees of freedom . This quantifies the total variance explained by the heterogeneity as a percentage. We considered an overall test-value greater than 60% to serve as evidence of substantial heterogeneity of a magnitude were statistical pooling is not appropriate.
In a sensitivity analysis, both fixed effects and random effects models were employed to determine the causes of heterogeneity and test the confidence that can be placed in both estimates. Only robust estimations of the pooled effects with similar results in fixed effects and random effects models are included in the meta-analysis and discussed. Furthermore, sensitivity analyses were performed to test whether the effect size varied by the countries where the study was carried out (adjusting for market forces) and the year of publication, adjusting for temporal trends.
We decided previously to perform a subgroup analysis of invasive versus non-invasive clinical pathways, whereupon the distinction between invasive or non-invasive interventions refers to the nature of patient management guided by clinical pathways (i.e. clinical pathways for gastrectomy; transurethral resection of the prostate; hip and knee arthroplasty; percutaneous transluminal coronary angioplasty; etc. versus clinical pathways for asthma care; stroke; pneumonia; etc.). According to theories on health economics, invasive procedures can be standardized more easily than treatment strategies in conservative sectors due to the lower treatment variance .
Assessing publication bias
We used a funnel plot analysis to assess publication bias, i.e. the bias caused by a lower likelihood of publication for non-significant studies. The funnel plot is a scatter-plot with the x-axis representing the effects estimated from the primary studies, and the y-axis representing a measure of the sample size in each study (SE; standard error of the mean) . If publication bias is absent, the diagram shows an inverted symmetrical funnel.
However, given that publication bias poses a threat to the validity of this meta-analysis and the graphical method is subjective in nature, we also applied a statistical approach, often called fail-safe N test.
This test provides an estimate of the number of unpublished or in this context called file-draw studies (Nfs) having an average of no effect that is necessary in the analysis for reducing the pooled effect size from significant to non-significant . Using a critical d level (d crit) of -0.20, the estimate of unpublished studies was calculated with
Nfs = (Ntotal (mean d - d crit))/d crit;
where Ntotal is the total number of studies included in the Meta-Analysis and d is the overall pooled effect (WMD).
The distribution of the length of stay is limited downwards in a natural way (because of the minimum value is always 0), whereas upwards the values can scatter significantly. According to logarithmic transformation, values with this characteristic can have an approximately normal distribution . In the additional File 2 we detailed the formulas used for log transformation. Data analyses were performed using SPSS version 15.0 .
Search strategy and intervention characteristics
Evidence for meeting the minimal criterion "pathway content is minimally based on one RCT" was reported in 15 studies out of 17, which were included in the review. The study from Falconer et al. and Swanson at al. met the evidence criterion, "not sure" because we failed in contacting the principal investigators [23, 24].
The reported pathway strategies can be described as complex pathway interventions versus a "non-intervention" control group or often poorly, described as "usual or traditional care" group. Most of the experimental interventions were combined with other types of interventions like audit and feedback, educational meetings, and reminders. For 8 out of the 17 (47%) included studies, it was clear that the structured care plan was combined with a "clinical diagnostic or assessment protocol"[23, 25–31].
The evidence base for two (12%) pathway interventions was "not sure," whereas the remaining 15 interventions were minimally based on one randomized study or good evidence. The reported purpose of the pathway strategies was appropriate management or cost containment.
The hospital setting was in two studies a multi-center study comprising a range of hospitals included in the investigation [26, 30]. From the 15 remaining single center studies, 8 studies (53%) were carried out in a university (teaching) hospital setting [24, 27–29, 32–35] and 7 studies (46%) in a non-university hospital setting [23, 25, 31, 36–39].
Characteristics of studies included
Sample Size [N]
Mean Age [Years]
Grines, CL 1998
Primary Angioplasty in Myocardial Infarction
Swanson, CE 1998
Dowsey, MM 1999
Hip and Knee Arthroplasty
Choong, PF 2000
Fractured Neck of Femur
Aizawa, T 2002
Transurethral Resection of the Prostate
Kiyama, T 2003
Hirao, M 2005
Falconer, JA 1993
Gomez, MA 1996
Roberts, RR 1997
Johnson, KB 2000
Kollef, HM 2000
Marrie, TJ 2000
Sulch, D 2000
Kim, MH 2002
Chen, SH 2004
Usui, K 2004
To summarize, we examined the design and study quality of 66 studies, excluding 49 out of the 66 studies because of the high risk of bias (see trail flow, Figure 1). Characteristics (reason for exclusion: see additional File 3) of the 49 excluded studies (references to excluded studies: see additional File 4) are given in detail.
The patient was randomized to the experimental or control group in 12 out of 13 (92%) RCTs. The randomization process was clear in all such studies and justified by the authors. Referring to the individually randomized and single-center studies, the assessment of protection against contamination of the control professionals remained unclear due to poor reporting. None of the investigators reported protection against contamination (communication between experimental and control professionals) and it is possible that control subjects received the intervention. Only the investigation from Marie et al. used a robust cluster randomized design, with 19 hospitals as unit of allocation . To avoid "unit of analysis error," we conducted the meta-analysis at the same level as the allocation (19 cluster-hospitals = 19 patients).
Poor reporting also lead to difficulties in determining the assessment of the power calculations. For instance, sample-size calculation was unclear for over 60% of the included studies; hence the study sample may not have been sufficiently large. Another problem, due to poor reporting was the selection of comparators. The choice of the comparator (i.e. the control and intervention units were located either in the main building or the east building of the participating hospital) was stated and justified by the authors of the 17 primary studies. However, a clear description of what was meant by traditional care or usual care (control group) would have helped in assessing the relevance of the study to other settings.
Primary studies reporting economic data, can be described by a very limited scope of evaluation, focusing on direct hospital LOS and costs effects, rather than on a full economic evaluation . In Table 3 the quality assessment and characteristics of the 17 studies included in the review and meta-analysis are shown in detail.
Effects on LOS
Effects on patient outcomes
Effects on hospital costs
Cost data, standardized to the year 2000
Kiyama, T 2003
Kim, MH 2002
Kollef, HM 2000
Grines, CL 1998
Roberts, RR 1997
Gomez, MA 1996
Subgroup analysis: invasive versus non-invasive clinical pathways
The LOS effects were robust in terms of the sensitivity analysis concerning the different statistical calculation models (fixed versus random effects model) and the Year of publication, adjusting for temporal trends. However, we observed a trend toward greater reported LOS effects from Japanese studies with a reduction of approximately three days (WMD – 2.7), followed by studies carried out in Australia (WMD – 1.5), Canada (WMD – 1.4) and the USA (WMD – 0.8). Subsequently, we tested the hypotheses, that different market forces (reported effect sizes per country) are possibly confounding the conclusions of these review and meta-analysis. After exclusion (stepwise/iterative and all of the primary Japanese studies) of the subgroup of Japanese studies, the (calculative) overall LOS effect remained robust and statistically significant, but tended to be smaller (WMD – 1.2; subgroup "Japanese studies excluded" versus WMD – 1.5; subgroup "all primary studies" included). This applies also to the subgroup Analysis "Invasive versus non-invasive LOS effects", after exclusion of the subgroup of Japanese studies (WMD -0.6 conservative versus -2.2 invasive).
In addition, the overall odds ratios (OR) for re-admission and in-hospital complications were robust in all terms of the sensitivity analysis, indicating reliable pooled results.
Publication bias and other sources of systematic error
The LOS reduction was estimated as 25 percent (95% CI: -36% to -14%). For example, with the average length of stay of 7 days, the estimated LOS effect was approximately -1.7 days (7 days * -0.25 = -1.75 days LOS reduction). Furthermore, the pooled percentage LOS effects were similar in fixed versus random effects models (WMD -0.25 versus WMD -0.21).
In general, the majority of studies reporting economic data (LOS and hospital costs) showed a positive impact. The results suggest that clinical pathways for invasive procedures generate clearer LOS effects (WMD -0.8 conservative versus -2.5 invasive).
Clinical pathways appeared to be effective in reducing LOS and costs. Furthermore, pathways for invasive procedures showed a stronger LOS reduction by comparing the magnitudes of effect. These results may not be applied for acute rehabilitation for stroke, where reverse effects were reported (see effects on LOS, Figure 3) [23, 38]. Both trends were not statistically significant but they were in contrast to the majority of pathway effects reported in the present review. However, the question of comparability may rise as a reflection of the differing pathway components included in this review and also applies to the kind and number of providers included in the primary studies.
We did not publish our review protocol prior to the study. The review protocol for the follow-up study will be published as a Cochrane review to prevent any doubt about the comparison to be data-driven instead of protocol-driven. We determined the scope of this review question on a pilot analysis of existing primary study data resulting in a diverse set of included studies. As it is an explanatory analysis, the pooled results of the meta-analyses may only apply for the majority of included pathway conditions reporting positive effects or trends. Another limitation refers to the poorly described control conditions reported in the primary studies and implied both, the risk of contamination, and the masking of effects. Therefore, we did not pool the primary LOS and costs data from all of the 17 included studies and concentrated on examining the relationship between clinical subgroups (i.e. surgical versus non-invasive pathway conditions).
It should be noted that the development and implementation of clinical pathways consumes a considerable amount of resources. This corresponds to the fact that truly achievable costs savings depend on the number of cases (volume). This has to be included in the costs analysis. The inflation-adjusted costs for implementation (without maintenance and further development) of the pathway indication "Caesarian section" amounted to nearly $20,000 . However, since normally 20 percent of the diagnoses cover 80 percent of the cases , a considerable percentage of medical services can be dealt with using a relatively small number of clinical pathways. Therefore, the expenditures will amortize rapidly.
It is very important not to look too far into these results, as there were some limitations. Moreover, it has to be emphasised that evidence determined by meta-analysis is always exploratory in nature and should be considered with caution.
Due to the result of the relatively small number of studies meeting inclusion criteria, this evidence base is not conclusive enough to provide a replicable framework for all pathway strategies. Considering the clinical areas for implementation, clinical pathways seem to be effective especially for invasive care. The likely benefits and costs need to be considered by the local healthcare providers when implementing clinical pathways under different circumstances. This review has shown that there is not one, singular strong evidence base. Accordingly, decision-makers should also consider some limitations in relation to the generalization of these findings. Replicating the results of this review in other settings could be problematic (e.g. ceiling effects such as market forces).
The heterogeneity in design and outcomes of the studies was large and refers to the statistical heterogeneity in addition to the clinical variability of the included studies. This precluded the overall pooling of LOS and cost data, although the order of magnitude of effects indicated that there are considerable implications of using clinical pathways.
It is unavoidable that some studies will have been overlooked, despite our electronic search strategy. Studies meeting our clinical pathway definition (see Table 1 &4) were included, regardless of the fact that the term pathway was mentioned in the study and was done to avoid subjectivity. Also, studies were independently assessed and data extracted by two with any disagreement discussed with a third reviewer.
Finally, should be emphasised that the standard of the primary studies included pose a threat to the validity of the results. While the overall quality of the included studies was moderate, most demonstrated methodological weaknesses such as a small sample size available for analysis.
With respect to the totality of available evidence, the knowledge about the mechanisms through which pathways work is insufficient. Future research should focus on a better understanding of the key elements of clinical pathways that have impact on economic and patient outcomes. It is also surprising that more studies do not consider any cost effects other than those of treatment. Health-economic research should therefore concentrate on costs of development and implementation of clinical pathways.
This investigation is the first systematic review regarding the effects of clinical pathways on process and patient outcomes. We explicitly decided to expand this review and will also include less restrictive study designs in addition to randomized and quasi-randomized trials, to provide a comprehensive theoretical basis. The character of non-experimental studies makes them even more difficult to critically assess and moreover, due to the lack of MeSH terms the search results cannot be as sensitive as those for purely RCT/CCT-based reviews. Another future direction is a more comprehensive, patient-centered approach, concentrating more on patient-outcomes rather then health-economic study endpoints. The next scheduled update for this review is planned for the End of 2009.
This article is based on an oral presentation made at a two day meeting entitled 14th German-Hospital-Controller-Day (14. Deutscher Krankenhaus-Controller-Tag) held in Berlin, Germany in March (29th and 30th) 2007.
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