A Systematic Review of the Efficacy of Adding ... - APA PsycNET

Psychological Trauma: Theory, Research, Practice, and Policy 2013, Vol. 5, No. 4, 317–322

In the public domain DOI: 10.1037/a0030040

A Systematic Review of the Efficacy of Adding Nonexposure Components to Exposure Therapy for Posttraumatic Stress Disorder Shannon M. Kehle-Forbes and Melissa A. Polusny

Roderick MacDonald

Center for Chronic Disease Outcomes Research, Minneapolis Veterans Health Care System, Minneapolis, Minnesota and University of Minnesota Medical School

Center for Chronic Disease Outcomes Research, Minneapolis Veterans Health Care System, Minneapolis, Minnesota

This document is copyrighted by the American Psychological Association or one of its allied publishers. This article is intended solely for the personal use of the individual user and is not to be disseminated broadly.

Maureen Murdoch, Laura A. Meis, and Timothy J. Wilt Center for Chronic Disease Outcomes Research, Minneapolis Veterans Health Care System, Minneapolis, Minnesota and University of Minnesota Medical School Exposure therapies are the treatment of choice for posttraumatic stress disorder (PTSD). However, a substantial number of individuals drop out of treatment or have residual symptoms. One strategy explored to improve outcomes is adding nonexposure components (e.g., cognitive restructuring, stress inoculation training) to exposure therapies. The primary goal of this review was to determine the efficacy of adding nonexposure components (“exposure plus” condition) to exposure therapies (“exposure only” condition). Eight articles met inclusion criteria. Results indicated that exposure plus yielded superior outcomes for intent-to-treat clinician-rated PTSD symptoms at posttreatment and 6-month follow-up. However, the effect size was small and not clinically significant. There were no differences between conditions on any other outcome measures. Implications and future research needs are discussed. Keywords: posttraumatic stress disorder, exposure, treatment outcome

evidence base than any other psychological treatments for PTSD and have been named the only psychological or pharmacological treatment for PTSD with sufficient empirical support (Institute of Medicine [IOM], 2007). However, despite the strength of evidence for exposure therapies, a substantial number of individuals either drop out of treatment or have residual symptoms after treatment completion. For example, a prior review of treatments for PTSD found that approximately 20% of participants drop out of exposure therapies (Hembree et al., 2003). Regarding efficacy, in a recent examination of PE therapy among female veterans, over one half of participants still met criteria for PTSD after treatment, and only 15% of participants experienced a complete remission of symptoms (Schnurr et al., 2007). One strategy explored as a method of improving outcomes is adding nonexposure treatment components, such as cognitive restructuring, progressive muscle relaxation, and affective regulation skills training, to exposure therapies. It has been hypothesized that adding such components may enhance outcomes because they operate through different mechanisms of change than exposure techniques. For example, Bryant et al. (2008) posited that cognitive restructuring techniques may enhance outcomes for exposure therapies because they work through a different mechanism (i.e., identifying and correcting maladaptive thoughts that maintain PTSD) than exposure techniques (i.e., habituation to trauma cues and modification of overgeneralized fear structures). To date, research regarding the efficacy of adding nonexposure techniques has provided equivocal results. This may be in part due to the lack of adequate power to detect small effect size differences between two active treatments for PTSD (Cahill, Rothbaum, Resick, & Follette, 2009). Although there have recently been several

For many, posttraumatic stress disorder (PTSD) is a chronic condition that may be associated with high levels of comorbidity and significant disturbances in quality of life (Brown, Campbell, Lehman, Grisham, & Mancill, 2001; Kessler, Sonnega, Bromet, Hughes, & Nelson, 1995; Mendlowicz & Stein, 2000). Fortunately, over the past 25 years several treatments for PTSD have been developed and systematically evaluated. Exposure-based therapies, such as prolonged exposure (PE) therapy, have a larger

This article was published Online First October 22, 2012. Shannon M. Kehle-Forbes, Maureen Murdoch, Laura A. Meis, and Timothy J. Wilt, Center for Chronic Disease Outcomes Research, Minneapolis Veterans Health Care System, Minneapolis, Minnesota and Department of Medicine, University of Minnesota Medical School; Melissa A. Polusny, Center for Chronic Disease Outcomes Research, Minneapolis Veterans Health Care System, Minneapolis, Minnesota and Department of Psychiatry, University of Minnesota Medical School; Roderick MacDonald, Center for Chronic Disease Outcomes Research, Minneapolis Veterans Health Care System, Minneapolis, Minnesota. This research was funded by a small project grant from the Veterans Affairs Health Services Research & Development (HSR&D) Center for Chronic Disease Outcomes Research. This material is supported in part by the Department of Veterans Affairs, Veterans Health Administration, Office of Research of Development, HSR&D. Dr. Kehle-Forbes is supported by a VA HSR&D Career Development Award. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the U.S. government. Correspondence concerning this article should be addressed to Shannon M. Kehle-Forbes, Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs Medical Center, One Veterans Drive (152/2E), Minneapolis, MN 55417. E-mail: [email protected] 317

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high-quality systematic reviews that examined the efficacy of exposure therapies for PTSD (e.g., Bisson et al., 2007; Cahill et al., 2009; IOM, 2007), with two exceptions (Cahill et al., 2009; Hassija & Gray, 2010), none have examined the efficacy of adding nonexposure components. Cahill and colleagues (2009) and Hassija and Gray (2010) both provided qualitative summaries rather than a quantitative examination of pooled data. Cahill and colleagues (2009) reported no benefit to adding nonexposure components to exposure therapies that include imaginal and in vivo exposure but suggested that adding cognitive therapy to imaginal exposure may enhance outcomes. Likewise, Hassija and Gray (2010) found that adding cognitive therapy to behavior therapy (i.e., exposure therapies) does not appear to improve outcomes and argued that cognitive therapy and behavior therapy appear equally effective with some potential added benefits to cognitive therapy (i.e., reduced guilt, detachment, and somatic complaints). However, their selection criteria did not require that the exposure therapy component within each randomized trial be constant across conditions. Consequently, comparisons between exposure therapy alone and exposure therapy plus cognitive therapy were not necessarily comparing the same exposure therapy across conditions, which complicated conclusions. In addition to including newly published studies, this review furthers the existing literature by examining this question quantitatively, examining a broad range of outcomes (i.e., PTSD symptom severity, loss of a PTSD diagnosis, symptoms of depression, and rates of treatment drop out), and holding the form of exposure therapy constant across conditions. Thus, the goal of the project presented here is to utilize meta-analytic techniques to examine the benefit or harm of adding nonexposure treatment components to exposure therapies.

Method Study Selection The data presented here were collected as part of a larger meta-analytic review. For the larger study, we searched PsychInfo and MEDLINE databases using the following keywords: exposure therapy, cognitive-behavior therapy, behavior therapy, cognitive therapy, and posttraumatic stress disorder. Searches were limited to English-language, peer-reviewed articles published between January 1980 and December 2010. Specific inclusion criteria were (a) patients diagnosed with PTSD as defined in either the Diag-

nostic and statistical manual of mental disorders, third edition (DSM–III; American Psychiatric Association [APA], 1980) or fourth edition (DSM–IV; APA, 2000), (b) more than 90% of patients over the age of 18, (c) valid and reliable clinicianadministered or self-report PTSD symptom scales as an outcome measure, and (d) treatments that were designed only for PTSD, not for comorbid conditions (e.g., PTSD and panic disorder). For the study presented here, we included randomized controlled trials that compared a treatment that delivered only an exposure technique (either in vivo or imaginal exposure; “exposure only” condition) to that same exposure treatment with at least one additional nonexposure treatment component (“exposure plus” condition). Added components were defined as unique, stand-alone, active treatment techniques (e.g., cognitive restructuring, relaxation). For example, exposure therapies that utilized virtual reality technology were not included because virtual reality cannot be applied in the absence of exposure techniques. Treatment components common to all exposure therapies (e.g., psychoeducation, providing the rationale) were not considered add-ons. Articles were evaluated for inclusion by the first author (S.K.). All questions regarding inclusion/exclusion criteria were resolved by consensus of the research team. Of the 145 articles identified and retrieved for review, 8 articles met the inclusion criteria (see Table 1). We excluded articles for the following reasons: 42 were not randomized controlled trials, 35 did not have an exposure plus comparison group, 19 did not have patients with a DSM–III or DSM–IV (APA, 1980, 2000) diagnosis of PTSD, 15 did not include a treatment for PTSD with an exposure technique, 15 were reanalyses of previously published data, 7 did not report clinicianadministered or self-reported PTSD symptom change, three did not specify patients’ age or more than 10% of patients were under age 18, and 1 was a treatment for comorbid PTSD and panic. A hand-search of references from previously published metaanalyses, review papers, and articles did not yield any additional articles.

Procedure We extracted outcomes for all exposure only and exposure plus groups at pretreatment, immediate posttreatment, and 6-month follow-up. Our primary outcome measures were clinicianadministered ratings of PTSD symptomology and self-reported PTSD symptom scales. Secondary outcomes included self-

Table 1 Included Studies and Description of Treatments Author

Exposure Only, n

Exposure Plus, n

Arntz et al. (2007) Bryant et al. (2003) Bryant et al. (2008) Foa et al. (1999) Foa et al. (2005) Marks et al. (1998) Paunovic and Ost (2001) Resick et al. (2008)

42 58 31 25 79 23 10 50

29 58 28 30 74 24 10 53

Exposure Techniques Imaginal Imaginal Imaginal Imaginal Imaginal Imaginal Imaginal Imaginal

and and and and and

in in in in in

vivo vivo vivo vivo vivo

Added Component

Hours of Treatment (sessions)

Primary Trauma

Study Qualitya

Imagery rescripting Cognitive restructuring Cognitive restructuring SIT Cognitive restructuring Cognitive restructuring Cognitive restructuring Cognitive restructuring

14.5 (10) 12 (8) 13.3 (8) 14.5 (9) 13.5–24 (9–12) 15 (10) 16–40 (16–20) 11.8 (7–12)

Physical assault Physical assault Physical assault Sexual assault Sexual assault Physical assault Refugee population CSA

57% 86% 86% 100% 100% 86% 43% 100%

Note. SIT ⫽ stress inoculation training; CSA ⫽ childhood sexual assault. a Percentage of the seven gold standards for outcome trials clearly met (Foa & Meadows, 1997).


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reported depression scores, the percentage of patients who no longer met criteria for PTSD, and the percentage of patients who dropped out of treatment. We assessed intent-to-treat (ITT) and completer data, when available. Only ITT data were reported for loss of PTSD diagnosis. We conservatively assumed that those who did not complete treatment retained their diagnosis. We evaluated included studies for methodological quality using Foa and Meadows’ (1997) standards. These standards are (a) clearly defined target symptoms; (b) use of valid and reliable measures; (c) blinded evaluators; (d) adequate assessor training; (e) manualized, specific treatment programs; (f) randomization of patients to treatment conditions; and (g) treatment adherence ratings. We report methodological quality for each study as the percentage of criteria (of a possible seven) that were clearly met. We also extracted information regarding the treatments, including the type of exposure (imaginal, in vivo, or imaginal and in vivo), the added component (e.g., cognitive restructuring), the number of sessions, and length of treatment in minutes.

Analytic Strategy When pre- and posttreatment data were provided, data were pooled within each of the comparison categories. For the few articles not providing pre- and posttreatment scores required for pooling findings, their results are presented separately. We separately analyzed completer and ITT data. Consequently, when articles reported completer and ITT data they were included in both analyses. Data were analyzed using Review Manager Version 5.0 software (Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration). When pooling data, between-group heterogeneity was incorporated using random-effects models. For continuous outcomes, between-group effect sizes and corresponding 95% confidence intervals (CIs) for each comparison group were computed using Hedges’ g (adjusted for sample size). The effect sizes can be interpreted using Cohen’s (1988) definition of small (0.2), medium (0.5), and large (0.8) effect sizes. For dichotomous outcomes (loss of PTSD diagnosis and dropout), risk ratios (RRs) and 95% CIs were computed. The RR described the multiplication of the risk that results from the intervention (e.g., the increased risk of dropout in an exposure condition vs. a nontreatment control). For example, a RR of 4.0 would imply that dropout is 4 times more likely in the exposure only condition than in the exposure plus

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condition. That is, receiving exposure only increases the excess risk of dropout by 300%. For continuous and categorical data, the statistical significance of the between-group heterogeneity was assessed by ␹2 and I2 tests (Higgins, Thompson, Deeks, & Altman, 2003). We conducted a post hoc exploratory analysis to determine potential causes of heterogeneity when comparisons resulted in a significant ␹2 test at p ⬍ .01 and I2 test of 50% or greater.

Results Eight studies compared an exposure only treatment to an exposure plus treatment. Table 1 shows treatment details for each included study. All therapies were individual and delivered in person. Treatments ranged from 8 to 20 therapy sessions and total treatment time ranged from 11.8 to 40.0 h. Five of the studies examined treatments that used imaginal and in vivo exposure, and cognitive restructuring was the most commonly added component. Adult physical assault and adult sexual assault were the most frequently reported trauma types and targets for treatment. Overall, the quality of included studies was high. Quality ratings (reported as the percent of quality standards met) ranged from 43% to 100%, with three studies meeting all seven gold-standard criteria.

Posttreatment Outcomes Seven of the eight studies were pooled; Marks, Lovell, Noshirvani, Livanou, and Thrasher’s (1998) findings could not be pooled for continuous outcomes because only pre- to posttreatment change scores were reported (see Table 2). Marks et al. (1998) was included in dichotomous pooled analyses. The ITT clinician-rated PTSD data yielded a small but significant advantage for the exposure plus group. They also found small benefits for the exposure plus condition for clinician-rated PTSD. There were no significant differences between the two groups on any other outcome measures (see Table 3). They found small benefits for the exposure plus condition for self-reported PTSD and self-reported depression (see Table 2). All of the pooled analyses demonstrated acceptable levels of heterogeneity.

Six-Month Follow-Up Outcomes All eight studies reported 6-month follow-up data. As in the posttreatment analyses, all studies except Marks et al. (1998) were

Table 2 Posttreatment Hedges g Effect Sizes and RRs for Exposure Alone Vs. Exposure Plus Other Techniques

Study

Clinician-Rated PTSD g (95% CI)

Self-Report PTSD g (95% CI)

Self-Report Depression g (95% CI)

Loss of PTSD Diagnosis RR (95% CI)

Dropout RR (95% CI)

Arntz et al. (2007)b Bryant et al. (2003)b Bryant et al. (2008)b Foa et al. (1999)a Foa et al. (2005)b Marks et al. (1998)a,c Paunovic and Ost (2001)a Resick et al. (2008)

— ⫺.35 (⫺.98, .27) ⫺.76 (⫺1.29, ⫺.23) .22 (⫺.37, .80) .00 (⫺.40, .40) ⫺.31 (⫺.94, 0.31) .12 (⫺.87, 1.11) ⫺.34 (⫺.73, .05)

.17 (⫺.32, .65) ⫺.35 (⫺.97, .28) ⫺.31 (⫺.82, .21) — — ⫺.46 (⫺1.09, .17) ⫺.12 (⫺1.11, .87) ⫺.35 (⫺.75, .04)

— ⫺.26 (⫺.88, .36) ⫺.58 (⫺1.10, ⫺.06) .61 (0.00, 1.21) ⫺.06 (⫺.38, .26) ⫺.53 (⫺1.16, .10) ⫺.48 (⫺1.49, .52) ⫺.11 (⫺.50, .28)

— 0.77 (.45, 1.32) .65 (.40, 1.07) 1.50 (.87, 2.58) — 1.30 (.79, 2.15) — .77 (.51, 1.15)

2.05 (1.01, 4.18) 1.00 (.34, 2.93) 2.26 (.80, 6.39) .30 (.07, 1.29) .84 (.56, 1.27) .63 (.17, 2.33) .33 (.04, 2.69) .82 (.53, 1.26)

Note. For studies that reported ITT and completer data, only ITT data were reported in the table. Positive effect sizes reflect more positive outcomes for the exposure alone condition. RR ⬎ 1.00 indicates the event is more likely in exposure alone condition. a Completer data. b ITT data reported, but ITT and completer data used in analyses. c On the basis of pre- to posttreatment change scores.

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Table 3 Pooled Analysis Results for the Posttreatment Exposure Vs. Exposure Plus Analyses 95% CI


Outcome Clinician-rated PTSD ITT Completer Self-report PTSD ITT Completer Self-report depression ITT Completer Loss of diagnosis Dropout

Ng

Nparticipants

g or RR

LL

UL

Z

Heterogeneity Analysis

4 5

355 232

g ⫽ ⫺.33 g ⫽ ⫺.14

⫺.61 ⫺.44

⫺.05 .17

2.30a .86

␹2 ⫽ 4.86 ␹2 ⫽ 5.20

4 4

267 131

g ⫽ ⫺.21 g ⫽ ⫺.22

⫺.46 ⫺.58

.04 .13

1.67 1.22

␹2 ⫽ 3.15 ␹2 ⫽ 3.11

4 5 5 8

351 230 304 544

g ⫽ ⫺.18 g ⫽ ⫺.05 RR ⫽ .93 RR ⫽ .97

⫺.39 ⫺.49 .68 .66

.03 .39 1.28 1.41

1.70 .22 .43 .17

␹2 ⫽ 2.98 ␹2 ⫽ 9.66 ␹2 ⫽ 8.01 ␹2 ⫽ 11.73

Note. Positive effect sizes reflect more positive outcomes for the exposure alone condition. RR ⬎ 1.00 indicates the event is more likely in exposure alone condition. LL ⫽ lower limit, UL ⫽ upper limit. p ⬍ .05.

a

pooled for the continuous analyses and all studies were pooled for the dichotomous analyses. As in the posttreatment analyses, the ITT clinician-rated PTSD analysis revealed a small, significant advantage for the exposure plus group (see Table 4). The pooled analyses did not yield significant differences for any other comparisons. Because of significant heterogeneity for ITT selfreported PTSD (I2 ⫽ 73%), we conducted post hoc analyses. The heterogeneity stemmed from Bryant et al. (2008), which strongly favored the exposure plus condition. After removing Bryant et al. (2008) from the pooled analysis, exposure only and exposure plus conditions were still not significantly different, g ⫽ ⫺.03, p ⫽ .14, 95% CI [⫺.43, 0.37], I2 ⫽ 49%. The Marks et al. (1998) article did not present follow-up data in a way in which we could calculate differences between the exposure only and exposure plus conditions. They did report the pretreatment to follow-up effect sizes. The exposure plus condition performed slightly better than the exposure only condition for clinician-rated PTSD (d ⫽ 3.00 and d ⫽ 2.90, respectively). However, the exposure only condition yielded slightly better results on measures of self-reported PTSD (d ⫽ 2.70 vs. d ⫽ 2.10) and self-reported depression (d ⫽ 1.60 vs. d ⫽ 1.50).

Secondary Analyses Because most studies examined the addition of cognitive restructuring, we also performed the posttreatment analyses using only studies in which the added component was cognitive restructuring (i.e., Arntz, Tiesema, and Kindt [2007] and Foa et al. [1999] were removed). The ITT clinician-rated PTSD analysis did not change because this analysis was originally composed solely of studies that added cognitive restructuring. The ITT self-reported PTSD analysis found a small, significant advantage for exposure plus cognitive restructuring, g ⫽ ⫺0.35, p ⫽ .02, 95% CI [⫺.06, ⫺0.62]. No other comparisons yielded significant differences.

Discussion Our systematic review examined the efficacy of adding nonexposure treatment components to exposure therapies for PTSD. This review adds to the existing literature by providing the first quantitative review of the efficacy of adding nonexposure treatment components to exposure therapies. We found a small but statistically significant advantage for the exposure plus condition for posttreatment and 6-month follow-up ITT clinician-rated symp-

Table 4 Pooled Analysis Results for the 6-Month Follow-Up Exposure Vs. Exposure Plus Analyses 95% CI Outcome Clinician-rated PTSD ITT Completer Self-report PTSD ITT Completer Self-report depression ITT Completer Loss of diagnosis

Ng

Nparticipants

g or RR

LL

UL

Z

Heterogeneity Analysis

3 5

202 214

g ⫽ ⫺.39 g ⫽ ⫺.22

⫺.75 ⫺.56

⫺.03 .12

2.12a 1.27

␹2 ⫽ 3.08 ␹2 ⫽ 5.62

4 4

267 127

g ⫽ ⫺.23 g ⫽ ⫺.38

⫺.71 ⫺.78

.25 .02

0.94 1.85

␹2 ⫽ 11.07a ␹2 ⫽ 3.72

3 5 3

200 209 202

g ⫽ ⫺.32 g ⫽ ⫺.14 RR ⫽ .77

⫺.80 ⫺.46 .56

.16 .18 1.07

1.30 0.86 1.54

␹2 ⫽ 5.37 ␹2 ⫽ 5.11 ␹2 ⫽ 3.14

Note. Positive effect sizes reflect more positive outcomes for the exposure alone condition. RR ⬎ 1.00 indicates the event is more likely in exposure alone condition. a p ⬍ .05.


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toms of PTSD. No differences were found across conditions on self-reported PTSD, loss of a PTSD diagnosis, symptoms of depression, or rates of treatment dropout. The component most frequently added to exposure was cognitive restructuring; six of the seven studies included in these analyses added cognitive restructuring. When we separately examined just those studies that added cognitive restructuring, the findings mirrored those of the main analyses, with the exception that the ITT self-reported PTSD comparison was statistically significant. Some results reached statistical significance; however, guidelines set forth by the National Institute for Health and Clinical Excellence Guideline Development Group stated that an effect size of at least 0.5 between two active treatments is required for clinical significance (Bisson et al., 2007). Using those guidelines, none of the comparisons were clinically significant. However, it is also important to note that the addition of other treatment components did not lessen the efficacy of exposure techniques. Thus, there was no harm to patient outcomes in adding nonexposure components. Given the relative equivalence of the treatments, future research should focus on comparing treatments’ outcomes in effectiveness, rather than efficacy, trials. The addition of nonexposure components has the potential to significantly affect the dissemination and implementation of evidence-based treatments for PTSD. It has been theorized that streamlining treatments by identifying necessary and sufficient components may facilitate dissemination and implementation (Barlow, Levitt, & Bufka, 1999; Fixsen, Naoom, Blasé, Friedman, & Wallace, 2005; Hollon et al., 2002). Specifically, it may be easier for clinicians to learn and effectively deliver only one treatment component and corresponding rationale (e.g., imaginal exposure). One the other hand, it may be that exposure plus therapies are more acceptable to therapists and, thus, more likely to be implemented. Therapists have significant concerns about the use of exposure therapies for PTSD, and studies have shown that such treatments are rarely used in clinical settings (Becker, Zayfert, & Anderson, 2004). The addition of nonexposure comparisons may make exposure therapies more tolerable and acceptable to a larger number of clinicians. Finally, it will be important to examine the relative cost-effectiveness and efficiency of the treatments. The trials included in this study generally administered the exposure only and exposure plus conditions over the same number of sessions, but it may be that, in clinical practice, protocols with more components would require a greater number of sessions. We must note three important limitations to this review. First, some of the pooled analyses had a small number of included studies. Small numbers can artificially inflate effect sizes and may limit the external validity of the findings. Related to this, studies may have limited their report of treatment outcomes to those with the most favorable treatment effects. Finally, it is important to note that several of the included studies did not use well-tested treatment programs (e.g., PE therapy) for the exposure only conditions. Thus, the results may be biased by relatively poorly performing exposure treatments. For example, the exposure only condition in Bryant et al. (2008) yielded smaller effects than are typically seen with exposure-based treatments (Cahill et al., 2009). Despite these limitations, we believe the findings have important implications and underscore the need for ongoing research. We suggest that PTSD treatment research move away from efficacy studies and toward comparative effectiveness designs. Issues related to dis-

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semination and implementation, such as acceptability to therapists, competency in delivering the treatment, cost-effectiveness, efficiency, and the amount of training needed to deliver the treatments, will provide essential data regarding the effect of adding treatment components to existing empirically supported treatments for PTSD.

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Received December 17, 2010 Revision received December 3, 2011 Accepted December 28, 2011 䡲