4.7 Article

Allowing for non-adherence to treatment in a randomized controlled trial of two antidepressants (citalopram versus reboxetine): an example from the GENPOD trial

期刊

PSYCHOLOGICAL MEDICINE
卷 44, 期 13, 页码 2855-2866

出版社

CAMBRIDGE UNIV PRESS
DOI: 10.1017/S0033291714000221

关键词

Adherence; antidepressant; depression; primary care; treatment outcome

资金

  1. Mental Health Research Network
  2. Medical Research Council (MRC) [G0200243]
  3. Estonian Science Foundation [ETF9353]
  4. MRC [U105260558]
  5. MRC [MR/K025643/1, G0200243, MC_U105260558] Funding Source: UKRI
  6. Medical Research Council [MC_U105260558, G0200243, MR/K025643/1] Funding Source: researchfish

向作者/读者索取更多资源

Background. Meta-analyses suggest that reboxetine may be less effective than other antidepressants. Such comparisons may be biased by lower adherence to reboxetine and subsequent handling of missing outcome data. This study illustrates how to adjust for differential non-adherence and hence derive an unbiased estimate of the efficacy of reboxetine compared with citalopram in primary care patients with depression. Method. A structural mean modelling (SMM) approach was used to generate adherence-adjusted estimates of the efficacy of reboxetine compared with citalopram using GENetic and clinical Predictors Of treatment response in Depression (GENPOD) trial data. Intention-to-treat (ITT) analyses were performed to compare estimates of effectiveness with results from previous meta-analyses. Results. At 6 weeks, 92% of those randomized to citalopram were still taking their medication, compared with 72% of those randomized to reboxetine. In ITT analysis, there was only weak evidence that those on reboxetine had a slightly worse outcome than those on citalopram [adjusted difference in mean Beck Depression Inventory (BDI) scores: 1.19, 95% confidence interval (CI) -0.52 to 2.90, p=0.17]. There was no evidence of a difference in efficacy when differential non-adherence was accounted for using the SMM approach for mean BDI (-0.29, 95% CI -3.04 to 2.46, p=0.84) or the other mental health outcomes. Conclusions. There was no evidence of a difference in the efficacy of reboxetine and citalopram when these drugs are taken and tolerated by depressed patients. The SMM approach can be implemented in standard statistical software to adjust for differential non-adherence and generate unbiased estimates of treatment efficacy for comparisons of two (or more) active interventions.

作者

我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。

评论

主要评分

4.7
评分不足

次要评分

新颖性
-
重要性
-
科学严谨性
-
评价这篇论文

推荐

Review Cardiac & Cardiovascular Systems

Bed rest duration and complications after transfemoral cardiac catheterization: a network meta-analysis

Erica Busca, Chiara Airoldi, Fabio Bertoncini, Giulia Buratti, Roberta Casarotto, Samanta Gaboardi, Fabrizio Faggiano, Michela Barisone, Ian R. White, Elias Allara, Alberto Dal Molin

Summary: This study assessed the effects of bed rest duration on short-term complications following transfemoral catheterization. The results showed that a short bed rest was not associated with complications, but longer duration of bed rest increased the risk of back pain. Patients can safely ambulate as early as 2 hours after the procedure.

EUROPEAN JOURNAL OF CARDIOVASCULAR NURSING (2023)

Editorial Material Mathematical & Computational Biology

The importance of plausible data-generating mechanisms in simulation studies: A response to 'Comparing methods for handling missing covariates in meta-regression' by Lee and Beretvas (doi: 10.1002/jrsm.1585)

Ian R. White

Summary: The paper compares the effects of 'modern' and 'ad hoc' methods in performing meta-regression when some covariates are incomplete, and suggests that recommendations for practical use should be based on simulation studies using a range of plausible data-generating mechanisms.

RESEARCH SYNTHESIS METHODS (2023)

Article Genetics & Heredity

Study protocol of DIVERGE, the first genetic epidemiological study of major depressive disorder in Pakistan

Maria Valkovskaya, Arsalan Hassan, Eirini Zartaloudi, Fahad Hussain, Muhammad Umar, Bakht Khizar, Inzemam Khattak, Shamshad Ahmed Gill, Shams-Ud-Din Ahmad Khan, Imtiaz Ahmad Dogar, Ali Burhan Mustafa, Moin Ahmed Ansari, Syed Hyder, Muhammad Ali, Nilofar Ilyas, Parveen Channar, Nazish Mughal, Sumera Channa, Khalid Mufti, Ali Ahsan Mufti, Mian Iftikhar Hussain, Sadia Shafiq, Muhammad Tariq, Muhammad Kamran Khan, Shahzad Tahir Chaudhry, Abdul Rashid Choudhary, Mian Nizam Ali, Gohar Ali, Ashfaq Hussain, Muhammad Rehman, Noman Ahmad, Saeed Farooq, Farooq Naeem, Tanveer Nasr, Glyn Lewis, James A. Knowles, Muhammad Ayub, Karoline Kuchenbaecker

Summary: Globally, the majority of the burden of major depressive disorder (MDD) is found in low- and middle-income countries. However, research on genetic and environmental risk factors has been limited to participants with European ancestry from high-income countries. The DIVERGE study aims to bridge this gap and investigate MDD risk factors in Pakistan.

PSYCHIATRIC GENETICS (2023)

Article Psychology, Clinical

Neuropsychological markers of antidepressant action: a secondary analysis of the ANTLER randomised controlled trial

Julia Rodriguez-Sanchez, Gemma Lewis, Francesca Solmi, Jessica K. Bone, Michael Moore, Nicola Wiles, Catherine J. Harmer, Larisa Duffy, Glyn Lewis

Summary: This study investigated the effect of discontinuing maintenance antidepressant treatment on self-referential recall and its association with the risk of relapse. The results showed that discontinuation did not affect self-referential recall at 12 and 52 weeks, and there was no association between recall and later relapse at baseline or 12 weeks.

PSYCHOLOGICAL MEDICINE (2023)

Article Medicine, Research & Experimental

Statistical analysis plan for the motor neuron disease systematic multi-arm adaptive randomised trial (MND-SMART)

Richard A. A. Parker, Christopher J. J. Weir, Tra My Pham, Ian R. R. White, Nigel Stallard, Mahesh K. B. Parmar, Robert J. J. Swingler, Rachel S. S. Dakin, Suvankar Pal, Siddharthan Chandran

Summary: MND-SMART is a multi-arm, multi-stage, multi-centre randomized controlled trial for motor neuron disease. It compares the efficacy of memantine and trazodone with placebo, and may introduce other investigational treatments later. The co-primary outcomes are ALS-FRS-R functional outcome and overall survival. The trial randomizes participants 1:1:1 to receive placebo or one of the investigational treatments, with a maximum of 531 participants. Comparisons will be conducted in four stages, with the opportunity to stop randomizations to poorly performing arms. The final analysis will be based on a statistical analysis plan finalized in May 2022.

TRIALS (2023)

Article Medicine, Research & Experimental

Using modified intention-to-treat as a principal stratum estimator for failure to initiate treatment

Brennan C. Kahan, Ian R. White, Mark Edwards, Michael O. Harhay

Summary: A modified intention-to-treat analysis, which excludes participants who do not begin treatment, can estimate the treatment effect in the subpopulation of participants who would begin treatment regardless of the assigned arm. This estimator is unbiased if the intercurrent event is not affected by the treatment arm and if participants in both arms would initiate treatment. The criteria for unbiasedness are the ability to measure participants who experience the event in each treatment arm and the reasonable assumption that treatment allocation does not affect initiation.

CLINICAL TRIALS (2023)

Article Medicine, Research & Experimental

A comparison of different population-level summary measures for randomised trials with time-to-event outcomes, with a focus on non-inferiority trials

Matteo Quartagno, Tim P. Morris, Duncan C. Gilbert, Ruth E. Langley, Matthew G. Nankivell, Mahesh K. B. Parmar, Ian R. White

Summary: This article compares three commonly used summary measures: hazard ratio, difference in restricted mean survival time, and difference in survival at a fixed time point. The study investigates the impact of assuming proportional hazards on the operating characteristics of a trial and finds that difference in restricted mean survival time is often the most powerful summary measure when assuming proportional hazards. The conclusion suggests that the choice of summary measure should be made on clinical grounds, and difference in restricted mean survival time is often the most powerful test when estimated under proportional hazards.

CLINICAL TRIALS (2023)

Article Multidisciplinary Sciences

Reliability of the retrospective Clinical Interview Schedule Revised (rCIS-R) to assess relapse in depression in primary care patients

Larisa Duffy, Louise Marston, Gemma Lewis, Glyn Lewis

Summary: We developed a retrospective Clinical Interview Schedule Revised (rCIS-R) to assess depression relapse in the previous 12 weeks, and found that it has excellent test-retest reliability and construct validity. The rCIS-R can be used in randomized controlled trials due to its simplicity and self-report format.

PLOS ONE (2023)

Article Medicine, Research & Experimental

Integrated therapist and online CBT for depression in primary care (INTERACT): study protocol for a multi-centre randomised controlled trial

Debbie Tallon, Laura Thomas, Sally Brabyn, Brian Chi Fung Ching, Jane Sungmin Hahn, Berry Jude, Mekeda Logan, Alex Burrage, Fiona Fox, Simon Gilbody, Paul Lanham, Glyn Lewis, Jinshuo Li, Stephanie J. MacNeill, Irwin Nazareth, Steve Parrott, Tim J. Peters, Roz Shafran, Katrina Turner, Chris Williams, David Kessler, Nicola Wiles

Summary: The INTERACT trial will evaluate the clinical and cost-effectiveness, as well as the acceptability to therapists and clients, of the integration of online CBT materials and high-intensity therapist-led CBT delivered remotely. If successful, this model could increase access to and equity of CBT provision.

TRIALS (2023)

Article Psychiatry

Association Between Depression and Physical Conditions Requiring Hospitalization

Philipp Frank, G. David Batty, Jaana Pentti, Markus Jokela, Lydia Poole, Jenni Ervasti, Jussi Vahtera, Glyn Lewis, Andrew Steptoe, Mika Kivimaeki

Summary: Depression is associated with an increased risk of physical illness and the most common causes of hospitalization among people with depression are endocrine, musculoskeletal, and vascular diseases, rather than psychiatric disorders.

JAMA PSYCHIATRY (2023)

Letter Mathematical & Computational Biology

Comment on Oberman & Vink: Should we fix or simulate the complete data in simulation studies evaluating missing data methods?

Tim P. Morris, Ian R. White, Suzie Cro, Jonathan W. Bartlett, James R. Carpenter, Tra My Pham

Summary: For simulation studies evaluating methods of handling missing data, generating partially observed data by fixing complete data and simulating missingness indicators repeatedly is rarely appropriate.

BIOMETRICAL JOURNAL (2023)

Article Medicine, Research & Experimental

When should factorial designs be used for late-phase randomised controlled trials?

Ian R. White, Alexander J. Szubert, Babak Choodari-Oskooei, A. Sarah Walker, Mahesh K. B. Parmar

Summary: Factorial designs, which use a combination of randomization and multiple interventions, can reduce resource and participant requirements. However, several factors need to be considered before using this design, including clinical, practical, statistical, and external issues. Key considerations include the requirement for a lower sample size and minimal interaction effects between interventions.

CLINICAL TRIALS (2023)

Article Behavioral Sciences

Cognitive Behaviour Therapy (CBT) for Depersonalization Derealization Disorder (DDD): a self-controlled cross-over study of waiting list vs. active treatment

Elaine C. M. Hunter, Cheuk Lon Malcolm Wong, Rafael Gafoor, Glyn Lewis, Anthony S. David

Summary: This article reports on a clinical audit of 36 participants with chronic DDD who completed Cognitive Behavioural Therapy adapted for DDD. The results showed improvement in all scores during the treatment period, suggesting that CBT may be an effective treatment for DDD. However, more research is needed to assess its efficacy.

COGNITIVE BEHAVIOUR THERAPY (2023)

暂无数据