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Will publicly funded psychotherapy in Canada be evidence based? A review of what makes psychotherapy work and a proposal

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Abstract

Jurisdictions in Canada, notably in Ontario and Quebec, are proposing a laudable goal of increasing publicly funded access to psychotherapy. Ontario and Quebec will likely follow the lead of the Increasing Access to Psychotherapy (IAPT) program in the United Kingdom and train psychotherapists to provide cognitive–behavioural therapy. Results from IAPT provide some important lessons about taking an approach that prefers one brand of psychotherapy. We argue that such policy decisions are based on a medical model approach to psychotherapy that makes erroneous assumptions about what psychotherapy is, what is the nature of the evidence, and how training and services should be delivered. In this article, we review critically these assumptions and the state of the art of the research about what makes psychotherapy work. Psychotherapy is effective and preferable to antidepressant medication. Differences between psychotherapies account for a small proportion of variance in patient outcomes. The largest known predictors of patient outcomes are patient factors (coping style, resistance/reactance, interpersonal problems, culture) and therapeutic relationship factors (therapeutic alliance). Also notable are therapist factors (facilitative interpersonal skills, empathy, and managing countertransference), and practices like progress monitoring. Canadian jurisdictions should note that training therapists to adapt treatment and interpersonal stances to patient characteristics, to develop and maintain the therapeutic relationship, to enhance therapist facilitative interpersonal skills, and to engage in progress monitoring has a greater chance of achieving a reduction in the burden caused by depression and anxiety among their citizens than focusing on delivering a particular brand of psychotherapy.

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... For example, in the UK, the Improving Access to Psychological Therapies (IAPT) program is primarily built upon training in and delivery of CBT nation-wide, while PDT methods are seldom used and taught. This is despite the limited and perhaps dubious evidence of the efficacy of CBT delivered in the IAPT program (Shedler, 2018;Tasca et al., 2018). ...
... Second, three of the largest trials of time-limited CBT for depression indicate recovery rates to be around 30%, suggesting that most patients may require other interventions that would not be offered if only a single treatment is available (Bruijniks et al., 2020;Elkin, 1989;Gibbons et al., 2016). Estimates of actual rates of patient recovery after receiving CBT in the IAPT program are likely to be significantly lower than the 50% recovery rate claimed by some (Clark, 2018), largely because the findings are for treatment completers only, are not based on follow-up data, and ignore the high dropout rate (Tasca et al., 2018). Further, an uncontrolled study suggested that only 9.2% of those declared as 'recovered' by the IAPT program after receiving CBT were actually recovered when reassessed by a diagnostic interview (Scott, 2018). ...
... The treatment is time-limited and often based on a stepped care approach beginning with guided online modules. Despite being made aware of the weak, inconsistent, or dubious evidence in support of IAPT (see Tasca et al., 2018 for a review), the Ontario government has gone ahead with their plans for IASP. Routine outcome measurement is not done in Ontario public mental health services to evaluate such implementations. ...
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Many people identified as having common mental disorders in community surveys do not receive treatment. Modelling has suggested that closing this “treatment gap” should reduce the population prevalence of those disorders. To evaluate the effects of reducing the treatment gap in industrialized countries, data from 1990 to 2015 were reviewed from four English-speaking countries: Australia, Canada, England and the US. These data show that the prevalence of mood and anxiety disorders and symptoms has not decreased, despite substantial increases in the provision of treatment, particularly antidepressants. Several hypotheses for this lack of improvement were considered. There was no support for the hypothesis that reductions in prevalence due to treatment have been masked by increases in risk factors. However, there was little evidence relevant to the hypothesis that improvements have been masked by increased reporting of symptoms because of greater public awareness of common mental disorders or willingness to disclose. A more strongly supported hypothesis for the lack of improvement is that much of the treatment provided does not meet the minimal standards of clinical practice guidelines and is not targeted optimally to those in greatest need. Lack of attention to prevention of common mental disorders may also be a factor. Reducing the prevalence of common mental disorders remains an unsolved challenge for health systems globally, which may require greater attention to the “quality gap” and “prevention gap”. There is also a need for nations to monitor outcomes by using standardized measures of service provision and mental disorders over time.
Article
Background: In the psychological therapies, patient outcomes are not always positive. Some patients leave therapy prematurely (dropout), while others experience deterioration in their psychological well-being. Methods: The sample for dropout comprised patients (n = 10 521) seen by 85 therapists, who attended at least the initial session of one-to-one therapy and completed a Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at pre-treatment. The subsample for patient deterioration comprised patients (n = 6405) seen by the same 85 therapists but who attended two or more sessions, completed therapy and returned a CORE-OM at pre-treatment and post-treatment. Multilevel modelling was used to estimate the extent of therapist effects for both outcomes after controlling for patient characteristics. Results: Therapist effects accounted for 12.6% of dropout variance and 10.1% of deterioration variance. Dropout rates for therapists ranged from 1.2% to 73.2%, while rates of deterioration ranged from 0% to 15.4%. There was no significant correlation between therapist dropout rate and deterioration rate (Spearman's rho = 0.07, p = 0.52). Conclusions: The methods provide a reliable means for identifying therapists who return consistently poorer rates of patient dropout and deterioration compared with their peers. The variability between therapists and the identification of patient risk factors as significant predictors has implications for the delivery of safe psychological therapy services. Copyright © 2016 John Wiley & Sons, Ltd. Key practitioner message: Therapists play an important role in contributing to patient dropout and deterioration, irrespective of case mix. Therapist effects on patient dropout and deterioration appear to act independently. Being unemployed as a patient was the strongest predictor of both dropout and deterioration. Patient risk to self or others was also an important predictor.
Article
A meta-analysis examining temporal changes (time trends) in the effects of cognitive behavioral therapy (CBT) as a treatment for unipolar depression was conducted. A comprehensive search of psychotherapy trials yielded 70 eligible studies from 1977 to 2014. Effect sizes (ES) were quantified as Hedge's g based on the Beck Depression Inventory (BDI) and the Hamilton Rating Scale for Depression (HRSD). Rates of remission were also registered. The publication year of each study was examined as a linear metaregression predictor of ES, and as part of a 2-way interaction with other moderators (Year × Moderator). The average ES of the BDI was 1.58 (95% CI [1.43, 1.74]), and 1.69 for the HRSD (95% CI [1.48, 1.89]). Subgroup analyses revealed that women profited more from therapy than did men (p < .05). Experienced psychologists (g = 1.55) achieved better results (p < .01) than less experienced student therapists (g = 0.98). The metaregressions examining the temporal trends indicated that the effects of CBT have declined linearly and steadily since its introduction, as measured by patients' self-reports (the BDI, p < .001), clinicians' ratings (the HRSD, p < .01) and rates of remission (p < .01). Subgroup analyses confirmed that the declining trend was present in both within-group (pre/post) designs (p < .01) and controlled trial designs (p = .02). Thus, modern CBT clinical trials seemingly provided less relief from depressive symptoms as compared with the seminal trials. Potential causes and possible implications for future studies are discussed. (PsycINFO Database Record (c) 2015 APA, all rights reserved).
Article
In the context of multiple treatments for a particular problem or disorder, it is important theoretically and clinically to investigate whether any one treatment is more effective than another. Typically researchers report the results of the comparison of two treatments, and the meta-analytic problem is to synthesize the various comparisons of two treatments to test the omnibus null hypothesis that the true differences of all particular pairs of treatments are zero versus the alternative that there is at least one true nonzero difference. Two tests, one proposed by Wampold et al. (Psychol. Bull. 122:203–215, 1997) based on the homogeneity of effects, and one proposed here based on the distribution of the absolute value of the effects, were investigated. Based on a Monte Carlo simulation, both tests adequately maintained nominal error rates, and both demonstrated adequate power, although the Wampold test was slightly more powerful for non-uniform alternatives. The error rates and power were essentially unchanged in the presence of random effects. The tests were illustrated with a reanalysis of two published meta-analyses (psychotherapy and antidepressants). It is concluded that both tests are viable for testing the omnibus null hypothesis of no treatment differences.
Article
Evidence-based practice involves the consideration of efficacy and effectiveness, clinical expertise, and patient preference in treatment selection. However, patient preference for psychiatric treatment has been understudied. The aim of this meta-analytic review was to provide an estimate of the proportion of patients preferring psychological treatment relative to medication for psychiatric disorders. A literature search was conducted using PubMed, PsycINFO, and the Cochrane Collaboration library through August 2011 for studies written in English that assessed adult patient preferences for the treatment of psychiatric disorders. The following search terms and subject headings were used in combination: patient preference, consumer preference, therapeutics, psychotherapy, drug therapy, mental disorders, depression, anxiety, insomnia, bipolar disorder, schizophrenia, substance-related disorder, eating disorder, and personality disorder. In addition, the reference sections of identified articles were examined to locate any additional articles not captured by this search. Studies that assessed preferred type of treatment and included at least 1 psychological treatment and 1 pharmacologic treatment were included. Of the 644 articles identified, 34 met criteria for inclusion. Authors extracted relevant data including the proportion of participants reporting preference for psychological or pharmacologic treatment. The proportion of adult patients preferring psychological treatment was 0.75 (95% CI, 0.69-0.80), which was significantly higher than equivalent preference (ie, higher than 0.50; P < .001). Sensitivity analyses suggested that younger patients (P = .05) and women (P < .01) were significantly more likely to choose psychological treatment. A preference for psychological treatment was consistently evident in both treatment-seeking and unselected (ie, non-treatment-seeking) samples (P < .001 for both) but was somewhat stronger for unselected samples. Aggregation of patient preferences across diverse settings yielded a significant 3-fold preference for psychological treatment. Given evidence for enhanced outcomes among those receiving their preferred psychiatric treatment and the trends for decreasing utilization of psychotherapy, strategies to maximize the linkage of patients to preferred care are needed.
Article
The recent economic evaluation of an Improving Access to Psychological Therapies (IAPT) service conducted by Mukuria and colleagues[1][1] is a welcome addition to the evidence base pertaining to this programme. This was a non-randomised comparison but it appears that the authors have used
Article
Empirical evidence shows that treatment failure is a significant problem and one that practitioners routinely overlook. A substantial minority of patients either fail to gain a benefit from the treatments offered to them, or they outright worsen by the time they leave treatment. Intervening in a timely fashion with such individuals cannot occur if practitioners are unaware of which cases are likely to have this outcome. Prevention of treatment failure describes procedures and techniques that can be used by clinical practitioners and administrators to identify patients who are at risk for treatment failure. The book summarizes evidence that convincingly shows that a shift in routine care is needed, and that such a shift can be accomplished easily through integrating specific methods of monitoring patient treatment response on a frequent basis in routine care. Treatment response is placed in the context of historical views of healthy functioning and operationalized through the use of brief self-report scales. Providing alert-signals to therapists, along with problem-solving tools, is suggested as an evidence-based practice that substantially reduces patient deterioration and increases the chances of the return to normal functioning. The book also provides illustrations on how accumulated data resulting from monitoring patient treatment response can be used to improve systems of care. (PsycINFO Database Record (c) 2012 APA, all rights reserved)
Article
this chapter will describe Interpersonal Psychotherapy (IPT) for depression, including the theoretical and empirical bases, efficacy studies, and derivative forms, and will also make recommendations for its use in clinical practice Interpersonal Psychotherapy (IPT) is based on the observation that major depression—regardless of symptom patterns, severity, presumed biological or genetic vulnerability, or the patients' personality traits—usually occurs in an interpersonal context, often an interpersonal loss or dispute / IPT is a brief, weekly psychotherapy that is usually conducted for 12 to 16 weeks, although it has been used for longer periods of time with less frequency as maintenance treatment for recovered depressed patients with major depression / the focus is on improving the quality of the depressed patients' current interpersonal functioning and the problems associated with the onset of depression (PsycINFO Database Record (c) 2012 APA, all rights reserved)
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history and development / inclusion/exclusion criteria / dynamic issues in depressed patients / treatment goals / theory of change / techniques / case example / training / empirical evidence for the approach (PsycINFO Database Record (c) 2012 APA, all rights reserved)
Article
The aim of this research was to examine the extent to which the use of research-specific procedures in psychodynamic psychotherapy impacts upon treatment effectiveness and which variables moderate this potential relationship. Effects of audio/video recording of sessions, use of treatment manuals, and checks of treatment fidelity were examined. A meta-analysis was conducted on randomized controlled trials of psychodynamic psychotherapy. Forty-six independent treatment samples totaling 1615 patients were included. The magnitude of change between pretreatment and posttreatment aggregated across all studies (45 treatment samples) for overall outcome was large (d = 1.01), and further improvement was observed between posttreatment and an average 12.8-month follow-up (d = 0.18). Subgroup analyses comparing studies that used research-specific procedures and those that did not revealed that for posttreatment data no differences in treatment effects were found. However, the use of treatment manuals and fidelity checks were significantly associated with improvement between the end of treatment and follow-up assessment. Within the limitations of analyses, this data offered preliminary evidence that use of research-specific procedures does not contribute in a negative manner to posttreatment outcomes in psychodynamic psychotherapy, and their use contributes to positive differences that emerge with time. These findings, although observational in nature, make a case for reconsidering how dimensions of clinical utility and experimental control may be integrated in psychodynamic psychotherapy to enable further elucidation of principles that evidently work. (PsycINFO Database Record (c) 2012 APA, all rights reserved).
Article
Although the relationship between the therapeutic alliance and outcome has been supported consistently across several studies and meta-analyses, there is less known about how the patient and therapist contribute to this relationship. The purpose of this present meta-analysis was to (1) test for therapist effects in the alliance-outcome correlation and (2) extend the findings of previous research by examining several potential confounds/covariates of this relationship. A random effects analysis examined several moderators of the alliance-outcome correlation. These included (a) patient-therapist ratio (patient N divided by therapist N), (b) alliance and outcome rater (patient, therapist, and observer), (c) alliance measure, (d) research design and (e) DSM IV Axis II diagnosis. The patient-therapist ratio (PTR) was a significant moderator of the alliance-outcome correlation. Controlling for several potential confounds in a multi-predictor meta-regression, including rater of alliance, research design, percentage of patient Axis II diagnoses, rater of outcome and alliance measure, PTR remained a significant moderator of the alliance-outcome correlation. Corroborating previous research, therapist variability in the alliance appears to be more important than patient variability for improved patient outcomes. This relationship remains significant even when simultaneously controlling for several potential covariates of this relationship.
Article
This study examined the relationship of early alliance ruptures and their resolution to process and outcome in a sample of 128 patients randomly assigned to 1 of 3 time-limited psychotherapies for personality disorders: cognitive-behavioral therapy, brief relational therapy, or short-term dynamic psychotherapy. Rupture intensity and resolution were assessed by patient- and therapist-report after each of the first 6 sessions. Results indicated that lower rupture intensity and higher rupture resolution were associated with better ratings of the alliance and session quality. Lower rupture intensity also predicted good outcome on measures of interpersonal functioning, while higher rupture resolution predicted better retention. Patients reported fewer ruptures than did therapists. In addition, fewer ruptures were reported in cognitive-behavioral therapy than in the other treatments. (PsycINFO Database Record (c) 2010 APA, all rights reserved).
Article
In this article, we review the history and definition of countertransference as well as empirical research on countertransference, its management, and the relation of both to psychotherapy outcome. Three meta-analyses are presented, as well as studies that illustrate findings from the meta-analyses. The first meta-analysis indicated that countertransference reactions are related inversely and modestly to psychotherapy outcomes (overall weighted effect r = -.16, p = .002, 95% CI [-.26, -.06], k = 10 studies, N = 769 participants). The second meta-analysis suggested that countertransference management factors that have been studied to date play little to no role in actually attenuating countertransference reactions (r = -.14, p = .10, 95% CI [-.30, .03], k = 11 studies, N = 1065 participants). However, the final meta-analysis revealed that managing countertransference successfully is related to better therapy outcomes (r = .56, p = .000, 95% CI [.40, .73], k = 7 studies, N = 478 participants). We conclude by summarizing the limitations of the research base and highlighting the therapeutic practices predicated on research.
Article
In this article, we review the existing empirical research on the topic of therapeutic alliance ruptures in psychotherapy. Ruptures in the therapeutic alliance are defined as episodes of tension or breakdown in the collaborative relationship between patient and therapist. Two meta-analyses were conducted. The first reviewed studies examining the relation between rupture-repair episodes and treatment outcome ( r = .24, z = 3.06, 95% CI [.09, .39], p = .002, k = 3, N = 148). The second meta-analysis reviewed the research examining the impact on treatment outcome of training therapists in the use of alliance rupture intervention principles (prepost r = .65, z = 5.56, 95% CI [.46, .78], p < .001, k = 8, N = 376). Both meta-analyses provided promising evidence regarding the relevance of alliance rupture-repair processes to therapeutic outcome. The limitations of the research reviewed are discussed as well as practice implications for repairing the inevitable alliance ruptures in psychotherapy.
Article
This article introduces the special issue of Psychotherapy devoted to evidence-based therapy relationship elements and traces the work of the interdivisional task force that supported it. The dual aims of the task force are to identify elements of effective therapy relationships (what works in general) and to identify effective methods of adapting or tailoring treatment to the individual patient (what works in particular). The authors review the structure of the subsequent articles in the issue and the multiple meta-analyses examining the association of a particular relationship element to psychotherapy outcome. The centrality of the therapy relationship, its interdependence with treatment methods, and potential limitations of the task force work are all highlighted. The immediate purpose of the journal issue is to summarize the best available research and clinical practices on numerous elements of the therapy relationship, but the underlying purpose is to repair some of the damage incurred by the culture wars in psychotherapy and to promote rapprochement between the science and practice communities.
Article
Most meta-analyses have concluded that psychotherapy and pharmacotherapy yield roughly similar efficacy in the short-term treatment of depression, with psychotherapy showing some advantage at long-term follow-up. However, a recent meta-analysis found that selective serotonin reuptake inhibitors medications were superior to psychotherapy in the short-term treatment of depression. To incorporate results of several recent trials into the meta-analytic literature, we conducted a meta-analysis of trials which directly compared psychotherapy to second-generation antidepressants (SGAs). Variables potentially moderating the quality of psychotherapy or medication delivery were also examined, to allow the highest quality comparison of both types of intervention. Bona fide psychotherapies showed equivalent efficacy in the short-term and slightly better efficacy on depression rating scales at follow-up relative to SGA. Non-bona fide therapies had significantly worse short-term outcomes than medication (d = 0.58). No significant differences emerged between treatments in terms of response or remission rates, but non-bona fide therapies had significantly lower rates of study completion than medication (odds ratio = 0.55). Bona fide psychotherapy appears as effective as SGAs in the short-term treatment of depression, and likely somewhat more effective than SGAs in the longer-term management of depressive symptoms.
Article
Patients' expectations have long been considered a contributory factor to successful psychotherapy. Expectations come in different guises, with outcome expectations centered on prognostic beliefs about the consequences of engaging in treatment. In this article, we define outcome expectations and present assessment methods and clinical examples of outcome expectations. Our research review includes a comprehensive meta-analysis (N =8,016 patients across 46 independent samples) of the association between pretherapy or early-therapy outcome expectations and posttreatment outcomes. The overall weighted effect size was d=.24, p<.001, indicating a small but significant positive effect of outcome expectations on adaptive treatment outcomes. We also provide a narrative review of mediators of the expectation-outcome link and patient factors that relate to their outcome expectations. Finally, we discuss limitations of the research base and offer therapeutic practices based on our findings.
Article
Client preferences are recognized as a key component to evidence-based practice; however, research has yet to confirm the actual influence preferences have on treatment outcome. In this meta-analysis, we summarize results from 35 studies that have examined the preference effect with adult clients. Overall, clients who were matched to their preferred therapy conditions were less likely to drop out of therapy prematurely (OR=.59, p<.001) and showed greater improvements in treatment outcomes (d=.31, p<.001). Type of preference (role, therapist, or treatment type) was not found to moderate the preference effect, but study design was found to be a significant moderator, with randomized controlled trials showing the largest differences between preference-matched clients and nonmatched clients. These results underscore the centrality of incorporating patient preferences when making treatment decisions. Clinical examples and therapeutic practices are provided.
Article
Attachment theory, developed by Bowlby to explain human bonding, has profound implications for conducting and adapting psychotherapy. We summarize the prevailing definitions and measures of attachment style. We review the results of three meta-analyses examining the association between attachment anxiety, avoidance, and security and psychotherapy outcome. Fourteen studies were synthesized, which included 19 separate therapy cohorts with a combined sample size of 1,467. Attachment anxiety showed a d of -.46 with posttherapy outcome, while attachment security showed a d of.37 association with outcome. Attachment avoidance was uncorrelated with outcome. The age and gender composition of the samples moderated the relation between attachment security and outcome: samples with a higher proportion of female clients and a higher mean age showed a smaller relation between security and outcome. We discuss the practice implications of these findings and related research on the link between attachment and the therapy relationship.
Article
The authors investigated recent trends in the use of outpatient psychotherapy in the United States. Service use data from two representative surveys of the U.S. general population, the 1998 (N=22,953) and 2007 (N=29,370) Medical Expenditure Panel Surveys, were analyzed, focusing on individuals who made more than one outpatient psychotherapy visit during that calendar year. The authors computed rates of any psychotherapy use; percentages of persons treated for mental health conditions with only psychotherapy, only psychotropic medication, or their combination; the mean number of psychotherapy visits of persons receiving psychotherapy; and psychotherapy expenditures. The percentage of persons using outpatient psychotherapy was 3.37% in 1998 and 3.18% in 2007 (adjusted odds ratio=0.95, 95% CI=0.82-1.09). Among individuals receiving outpatient mental health care, use of only psychotherapy (15.9% and 10.5% in 1998 and 2007, respectively; adjusted odds ratio=0.66, 95% CI=0.48-0.90) as well as psychotherapy and psychotropic medication together (40.0% and 32.1%; adjusted odds ratio=0.73, 95% CI=0.59-0.90) declined while use of only psychotropic medication increased (44.1% and 57.4%; adjusted odds ratio=1.63, 95% CI=1.32-2.00). Declines occurred in annual psychotherapy visits per psychotherapy patient (mean values, 9.7 and 7.9; adjusted β=-1.53, p<0.0001), mean expenditure per psychotherapy visit ($122.80 and $94.59; β=28.21, p<0.0001), and total national psychotherapy expenditures ($10.94 and $7.17 billion; z=2.61, p=0.009). During the decade from 1998 to 2007, the percentage of the general population who used psychotherapy remained stable. Over the same period, however, psychotherapy assumed a less prominent role in outpatient mental health care as a large and increasing proportion of mental health outpatients received psychotropic medication without psychotherapy.
Article
The "probability of superiority estimate" (PS) estimates the probability that a randomly sampled client from a population given a treatment will have an outcome that is superior to that of a randomly sampled client from a population given another treatment. The meta-analytic clinical outcome literature was examined to calculate mean PS (PS) for comparisons involving therapy versus control, therapy versus placebo, therapy versus therapy, and placebo versus control. The range of PS was found to be approximately .7 +/- .2, with median PS greatest when therapy and control are compared (Mdn PSTC = .70, where T = therapy and C = control) and least when 2 therapies are compared (Mdn PSTT = .56). Results suggested that there is more to therapeutic success than placebo effects (Mdn PSTP = .66, where T = therapy and P = placebo) and that placebo is typically better than do-nothing control conditions (Mdn PSPC = .62). The present exceptionally large study, controlling for dependencies and confounding variables, may put to rest the question of the superiority of therapy to placebo. It also appears that the strength of effect of therapy is typically at least average among the effects of independent variables in psychology.
Article
A scheme is proposed for determining when a psychological treatment for a specific problem or disorder may be considered to be established in efficacy or to be possibly efficacious. The importance of independent replication before a treatment is established in efficacy is emphasized, and a number of factors are elaborated that should be weighed in evaluating whether studies supporting a treatment's efficacy are sound. It is suggested that, in evaluating the benefits of a given treatment, the greatest weight should be given to efficacy trials but that these trials should be followed by research on effectiveness in clinical settings and with various populations and by cost-effectiveness research.
Article
This article describes three families of effect size estimators and their use in situations of general and specific interest to experimenting psychologists. The situations discussed include both between- and within-group (repeated measures) designs. Also described is the counternull statistic, which is useful in preventing common errors of interpretation in null hypothesis significance testing. The emphasis is on correlation (r-type) effect size indicators, but a wide variety of difference-type and ratio-type effect size estimators are also described.
Article
Evidence-based medicine is valuable to the extent that the evidence base is complete and unbiased. Selective publication of clinical trials--and the outcomes within those trials--can lead to unrealistic estimates of drug effectiveness and alter the apparent risk-benefit ratio. We obtained reviews from the Food and Drug Administration (FDA) for studies of 12 antidepressant agents involving 12,564 patients. We conducted a systematic literature search to identify matching publications. For trials that were reported in the literature, we compared the published outcomes with the FDA outcomes. We also compared the effect size derived from the published reports with the effect size derived from the entire FDA data set. Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Separate meta-analyses of the FDA and journal data sets showed that the increase in effect size ranged from 11 to 69% for individual drugs and was 32% overall. We cannot determine whether the bias observed resulted from a failure to submit manuscripts on the part of authors and sponsors, from decisions by journal editors and reviewers not to publish, or both. Selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients.