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Fig. 2

Cochrane Risk of Bias graph. Review authors’ judgements about each risk of bias item presented as percentages across all included studies

Table 5

Comparison of randomised controlled trials (RCTs) which had high risk of bias compared to the proportion lost to follow-up during post-trial follow-up (PTFU). A summary of those RCTs with no risk of bias are also detailed

This systematic review identified that PTFU methods varied and many trials used overlapping approaches which were more costly than needed. Data was limited on retention rates and so it was difficult to draw any firm conclusions on which method was best for PTFU.

Our main findings suggest that most PTFU published in the last 11years does not appear to be designed in a cost-effective manner. Cost of PTFU was shown to vary widely and not many trials used incentives to retain participants. Despite only a third of trialists providing complete financial information for PTFU, follow-up by clinical appointment appeared to be the most expensive method, as might be expected given the resource implications. Postal or telephone correspondence in addition to data linkage did not appear to increase the cost per participant per year considerably. However, the effect of inflation over the 11years included in this systematic review, makes quantitative comparison of cost differences difficult. Given the limited data available we have not attempted to adjust for inflation.

Data linkage or access to medical records is likely to be the most cost-effective method of following participants due to minimal staff required. However, a number of trialists highlighted the limitations of this approach, noting it to be time-consuming and frustrating with increasing regulatory costs and country-specific restrictions. In the UK, the process of accessing data electronically has become more stringent and costly, and markedly different to the processes which were encountered 10years ago. There is also an issue of the data lagging behind by up to 2years in some countries, which can impact on the completeness of results for a trial. Despite this, data linkages to national registries and electronic health records have been shown to be a valid and reliable method of PTFU [ 12 , 13 , 14 , deals cheap sale with credit card Manolo Blahnik LaserCut Leather Mules the cheapest for sale wMYTIH
].

When designing this systematic review, we anticipated that papers published in the early half of the last 11years would choose more traditional methods of PTFU, e.g. clinic- and telephone-based approaches, and more recent trials may increasingly use data linkage where available. However, this has not been the case. The majority of trials have used a variety of different methods to capture data for the same primary outcome. We were, therefore, unable to compare retention rates by each type of method used. In addition, sparsity of complete data in the review (typically poor reporting of the final number of participants at the end of the follow-up period) limited the ability to assess retention rates achieved with different PTFU methods.

We found limited evidence of high risk of bias in the methodology of the in-trial periods. A likely explanation for this is that the majority of the trials included in this review were well-designed, large RCTs in which results were published in high-impact journals. Furthermore, trials which employ poor methodology or have had negative results are more likely not to engage in PTFU due to lack of funding or interest.

Due to new guidelines (Consolidated Standards of Reporting Trials (CONSORT)) recommending increasing transparency in the reporting of RCTs, a more complete capture of data would be likely for any future study [ 16 ]. Research into appropriate methods in PTFU can only occur if there is transparency of the logistical and financial implications including number of participants lost to follow-up.

Post-trial follow-up of large RCTs can contribute significantly to the scientific value of a trial by determining the longer-term magnitude of the effects of an intervention. PTFU is valuable to ensure that there are no long-term hazards or beneficial effects which have been missed due to the common short in-trial periods for following up participants. However, it is not widely used as shown by the small number of eligible trials which had PTFU from the original search strategy.

Data linkage and the use of registries appear to be the most plausible and economical approach to PTFU. These methods also have the advantage of providing data for a wide range of endpoints. Improvement of electronic reporting and informatics could lead to better reporting and allow this type of method to be widely used.

Cochrane Central Register of Controlled Trials

Founder and director JK Design GmbH

Julia Körner

Founder and director JK Design GmbH

Julia Körner is an award-winning designer working at the convergence of architecture, product and fashion design - specialised in additive manufacturing and robotic technology. Her work stands out, recognised at the top level of these disciplines, where it has been featured internationally in world-renown museums, institutions and publications. She is founder and director of JK Design GmbH. Her recent collaborations involved 3D-Printed fashion pieces developed with Haute Couture Houses for Paris Fashion weeks and Hollywood Entertainment Productions. Julia is a graduate of the Architectural Association, London and University of Applied Arts, Vienna; she is a faculty member at the University of California, Los Angeles.

Achim Menges

AA Dipl. (Hons.) RIBA II, Architect BDA, AKH Director ICD Uni Stuttgart, Institute for Computational Design and Construction

Achim Menges

AA Dipl. (Hons.) RIBA II, Architect BDA, AKH Director ICD Uni Stuttgart, Institute for Computational Design and Construction

Professor Achim Menges
 AA Dipl.(Hons.) RIBA II, Architect BDA, AKH Professor Achim Menges, born 1975, is a registered architect and professor at the University of Stuttgart, where he is the founding director of the Institute for Computational Design and Construction since 2008. He also is Visiting Professor in Architecture at Harvard University’s Graduate School of Design since 2009. Achim Menges practice and research focuses on the development of integral design processes at the intersection of morphogenetic design computation, biomimetic engineering and computer aided manufacturing that enables a highly articulated, performative built environment. His work is based on an interdisciplinary approach in collaboration with structural engineers, computer scientists, material scientists and biologists. Achim Menges has published several books on this work and related fields of design research, and he is the author/coauthor of numerous articles and scientific papers. His projects and design research has received many international awards, has been published and exhibited worldwide, and form parts of several renowned museum collections, among others, the permanent collection of the Centre Pompidou in Paris. Achim Menges is a member of several international research evaluation boards and a member of numerous scientific committees of leading peer-reviewed international journals and conferences.

Silvia Olp

Management aed e.V., Society for Advancement of Architecture, Engineering, Design

Silvia Olp

Management e.V., Society for Advancement of Architecture, Engineering, Design

Silvia Olp is the vice management of the aed, e.V., aed Society for Advancement of Architecture, Engineering, Design Stuttgart. She initiated the aed neuland, which is an award for young designer and she is head of communication for Phoenix Design Stuttgart/Munich. Her interest regarding technology and design is the aim to popularize it. Newcomers are close to her heart.

Dirk Simon

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