The application of quantitative methods for identifying and exploring the presence of bias in systematic reviews: PDE-5 inhibitors for erectile dysfunction

Bekkering, Geertruida E; Abou‐Setta, Ahmed M; Kleijnen, Jos

doi:10.1038/sj.ijir.3901626

Cited by 4 publications

(4 citation statements)

References 34 publications

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“…It was shown to be effective in up to 60 per cent of patients. However, with the introduction of sildenafil and other phosphodiesterase type 5 (PDE‐5) inhibitors, these have come to be the first‐line intervention for erectile disorder (Bekkering et al., ). However, not all cases respond to PDE‐5 inhibitors and there is an emerging practice of using a multi‐modal programme including PDE‐5 inhibitors combined with systemic interventions in such cases because they have synergistic effects (McCarthy and Fucito, ).…”

Section: Psychosexual Problemsmentioning

confidence: 99%

The evidence base for couple therapy, family therapy and systemic interventions for adult‐focused problems

Carr¹

2014

Journal of Family Therapy

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This review updates similar articles published in JFT in 2000 and 2009. It presents evidence from meta‐analyses, systematic literature reviews and controlled trials for the effectiveness of couple and family therapy for adults with various relationship and mental health problems. The evidence supports the effectiveness of systemic interventions, either alone or as part of multi‐modal programmes, for relationship distress, psychosexual problems, intimate partner violence, anxiety disorders, mood disorders, alcohol problems, schizophrenia and adjustment to chronic physical illness.

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Section: Psychosexual Problemsmentioning

confidence: 99%

The evidence base for couple therapy, family therapy and systemic interventions for adult‐focused problems

Carr¹

2014

Journal of Family Therapy

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show abstract

“…It was shown to be effective in up to 60 per cent of cases. However, with the introduction of Sildenafil and other phosphodiesterase Type 5 (PDE‐5) inhibitors, these have come to be first‐line intervention for erectile disorder (Bekkering et al , 2007). However, not all cases respond to PDE‐5 inhibitors, and there is an emerging practice of using multi‐modal programmes involving PDE‐5 inhibitors combined with psychological interventions in such cases because they have synergistic effects (McCarthy and Fucito, 2005).…”

Section: Psychosexual Problemsmentioning

confidence: 99%

The effectiveness of family therapy and systemic interventions for adult‐focused problems

Carr¹

2008

Journal of Family Therapy

122

111

View full text Add to dashboard Cite

This review updates a similar paper published in this Journal in 2000. It presents evidence from meta‐analyses, systematic literature reviews and controlled trials for the effectiveness of couples and family therapy for adults with various relationship and mental health problems. The evidence supports the effectiveness of systemic interventions, either alone or as part of multimodal programmes, for relationship distress, psychosexual problems, domestic violence, anxiety disorders, mood disorders, alcohol abuse, schizophrenia and adjustment to chronic physical illness.

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“…A detailed methodology can be found as a supplemental file. We updated a dataset from an earlier published systematic review on PDE-5 inhibitors [12]. We restricted our search to English, French, Dutch, or German reports from the three agents approved by the Food and Drug Administration (FDA): sildenafil, vardenafil, and tadalafil.…”

Section: Methodsmentioning

confidence: 99%

Do randomized clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups?

Feys

Bekkering²,

Singh

et al. 2014

Syst Rev

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BackgroundStudies suggest that expectations powerfully shape clinical outcomes. For subjective outcomes in adequately blinded trials, health improvements are substantial and largely explained by non-specific factors.The objective of this study was to investigate if unblinding in randomized controlled trials (RCTs) is associated with enhanced placebo effects for intervention groups and nocebo effects for placebo groups. For these effects, a secondary objective was to explore potential moderating factors.MethodsWe included RCTs that investigated the efficacy of phosphodiesterase-5 (PDE-5) inhibitors for male erectile dysfunction by comparing one PDE-5 inhibitor to placebo. In addition, to be included studies must have reported scores for change from baseline, or baseline and final International Index of Erectile Functioning-Erectile Functioning domain score (IIEF-EF), and be published in either English, French, Dutch, or German.We searched for both published and unpublished relevant trials using PUBMED, EMBASE, the Cochrane Central Register of Controlled Trials, a clinical trials register (clinicaltrials.gov) and the Food and Drug Administration clinical reviews through March 2012.We evaluated the blinding status of trials with the Cochrane Risk of Bias Tool, using the domains of allocation sequence concealment, blinding of participants, healthcare providers and outcome assessors. Across these four domains, studies that scored low risk of bias were judged to be adequately blinded and studies that scored unclear or high risk of bias were judged to be inadequately blinded.ResultsWe included 110 studies (205 journal publications and 2 unpublished sources) that involved 23,877 participants; 93 (85%), 51 (46%), 93 (85%) and 93 (85%) studies were assessed with an unclear risk of bias for allocation concealment, blinding of participant, blinding of caregiver and blinding of outcome assessor, respectively. None of the studies reported testing of blinding.None of the 205 journal publications provided sufficient details to assess allocation concealment, blinding of participants, caregivers and outcome assessors. After contacting authors for additional information, we judged five studies to be adequately (n = 1,202) and 16 to be inadequately (n = 3,006) blinded. The IIEF-EF score for placebo groups in adequately blinded trials versus inadequately blinded trials was 1.92 points (95% CI, 0.64 to 3.20) versus 1.56 (95% CI, 0.93 to 2.20), respectively. The IIEF-EF score for intervention groups in adequately blinded trials versus inadequately blinded trials was 9.40 (95% CI, 6.96 to 11.83) versus 8.33 (95% CI, 7.29 to 9.37), respectively. In a secondary analysis, prior experience with the drug affected the scores; in placebo groups with participants naïve to the intervention the score was 2.89 (95% CI, 2.33 to 3.45) versus -0.11 (95% CI, -2.06 to 1.84) with participants having prior experience. In the intervention groups, these scores were 7.99 (95% CI, 6.85 to 9.14) versus 8.33 (95% CI, 7.51 to 9.16), respectively.Unblinding lowe...

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The application of quantitative methods for identifying and exploring the presence of bias in systematic reviews: PDE-5 inhibitors for erectile dysfunction

Cited by 4 publications

References 34 publications

The evidence base for couple therapy, family therapy and systemic interventions for adult‐focused problems

The evidence base for couple therapy, family therapy and systemic interventions for adult‐focused problems

The effectiveness of family therapy and systemic interventions for adult‐focused problems

Do randomized clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups?

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