The new opt-out Dutch National Breast Implant Registry – Lessons learnt from the road to implementation

Rakhorst, Hinne; Mureau, Marc A.M.; Cooter, Rodney D.; McNeil, John J; Hooff, Miranda L. van; Hulst, René van der; Hommes, Juliëtte; Hoornweg, Marije J.; Moojen-Zaal, Laura; Liem, Patricia; Mathijssen, Irene M.J.

doi:10.1016/j.bjps.2017.04.003

Cited by 49 publications

(32 citation statements)

References 18 publications

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“…A recent report by the Dutch Institute of National Health reported a lack of compliance of breast implant producers to CE requirements (Rakhorst et al, 2017). Problems have emerged with a variety of breast im-plantswithconsequencesforthepatients′health.In2010,thePIP (Poly Implant Prothèse) implant scandal, with rupturing and leaking implants, clearly showed the limitations in the available data and revealed the lack of a system to even "track and trace" the patients.…”

Section: The Dutch National Breast Implant Registrymentioning

confidence: 99%

“…Problems have emerged with a variety of breast im-plantswithconsequencesforthepatients′health.In2010,thePIP (Poly Implant Prothèse) implant scandal, with rupturing and leaking implants, clearly showed the limitations in the available data and revealed the lack of a system to even "track and trace" the patients. A recent report by the Dutch Institute of National Health reported a lack of compliance of breast implant producers to CE requirements (Rakhorst et al, 2017). The need for an independent implant registry was expressed by the medical profession.…”

Section: The Dutch National Breast Implant Registrymentioning

confidence: 99%

“…The experience when creating that multinational database can, however, be transferred also in more general terms when creating a treatment register as referred here. Hurdles of starting a patient registry including funding, medical ethical issues, benchmarking, quality assurance, governance, and collaboration was presented by Rakhorst et al(2017).…”

Section: Con Cern S When E S Tab Lis Hing a Reg I S Termentioning

confidence: 99%

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Dental Implant Quality Register—A possible tool to further improve implant treatment and outcome

Klinge

Lundström

Rosén

et al. 2018

Clinical Oral Implants Res

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The Board of EAO (European Association for Osseointegration) has discussed an initiative to explore the conditions to establish a Dental Implant Register. It was suggested to bring this issue to the EAO Consensus Conference 2018 for a discussion and to possibly propose relevant and manageable parameters. This article presents some select examples from quality registers in the medical field. Based on the experience of established registers, essentially in the medical field, factors considered to be of importance, if and when establishing a Dental Implant Register are introduced and discussed.

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Section: The Dutch National Breast Implant Registrymentioning

confidence: 99%

Section: The Dutch National Breast Implant Registrymentioning

confidence: 99%

Section: Con Cern S When E S Tab Lis Hing a Reg I S Termentioning

confidence: 99%

See 1 more Smart Citation

Dental Implant Quality Register—A possible tool to further improve implant treatment and outcome

Klinge

Lundström

Rosén

et al. 2018

Clinical Oral Implants Res

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“…A shortcoming of the project was a selection bias, as only patients able to consent were included in the registry. As orthopaedic and trauma departments often deal with fragility fractures of older and not contractually capable patients, a bypass through an opt-out system, as used in Scandinavia 10,17 or the Netherlands 21 APS -contributed as leader of the BFCC Project by helping to find statistical methods to analyse data quality of the registry and proofreading the manuscript AG -contributed by enrolling patients into the study AW -contributed to the availability of data from the hospital information system and statistical analysis GH -contributed by enrolling patients into the study Table Titles Table 1. Items, levels, and indicators for scoring of data quality.…”

Section: An Outlook To Monitoring Data Quality In the Futurementioning

confidence: 99%

Validating a transnational fracture treatment registry using a standardized method

Frese

Gode

Heinrichs

et al. 2019

Preprint

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Aim Subsequent to a three-month pilot phase, recruiting patients for the newly established BFCC (Baltic Fracture Competence Centre) transnational fracture registry, a validation of the data quality needed to be carried out, applying a standardized method.Method During the literature research, the method of “adaptive monitoring” fulfilled the requirements of the registry and was applied. It consisted of a three-step audit process; firstly, scoring of the overall data quality, followed by source data verification of a sample size, relative to the scoring result, and finally, feedback to the registry on measures to improve data quality. Statistical methods for scoring of data quality and visualisation of discrepancies between registry data and source data were developed and applied.Results Initially, the data quality of the registry scored as medium. During source data verification, missing items in the registry, causing medium data quality, turned out to be absent in the source as well. A subsequent adaptation of the score evaluated the registry’s data quality as good. It was suggested to add variables to some items in order to improve the accuracy of the registry.Discussion The application of the method of adaptive monitoring has only been published by Jacke et al., with a similar improvement of the scoring result following the audit process. Displaying data from the registry in graphs helped to find missing items and discover issues with data formats. Graphically comparing the degree of agreement between the registry and source data allowed to discover systematic faults.Conclusions The method of adaptive monitoring gives a substantiated guideline for systematically evaluating and monitoring a registry’s data quality and is currently second to none. The resulting transparency of the registry’s data quality could be helpful in annual reports, as published by most major registries. As the method has been rarely applied, further successive applications in established registries would be desirable.

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“…In the medical field, several hundred quality registers have been established, most often at the initiative of the respective professional societies (Emilsson, Lindahl, Koster, Lambe & Ludvigsson, ; Manning et al., ; Rakhorst et al., ). These initiatives have been regarded as a positive professional act to improve patient care.…”

Section: Implant Registermentioning

confidence: 99%

The 5^th EAO Consensus Conference 7–10 February 2018, Pfäffikon, Schwyz, Switzerland

Hämmerle

Klinge

Schliephake³

2018

Clinical Oral Implants Res

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The new opt-out Dutch National Breast Implant Registry – Lessons learnt from the road to implementation

Cited by 49 publications

References 18 publications

Dental Implant Quality Register—A possible tool to further improve implant treatment and outcome

Dental Implant Quality Register—A possible tool to further improve implant treatment and outcome

Validating a transnational fracture treatment registry using a standardized method

The 5^th EAO Consensus Conference 7–10 February 2018, Pfäffikon, Schwyz, Switzerland

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The new opt-out Dutch National Breast Implant Registry – Lessons learnt from the road to implementation

Cited by 49 publications

References 18 publications

Dental Implant Quality Register—A possible tool to further improve implant treatment and outcome

Dental Implant Quality Register—A possible tool to further improve implant treatment and outcome

Validating a transnational fracture treatment registry using a standardized method

The 5th EAO Consensus Conference 7–10 February 2018, Pfäffikon, Schwyz, Switzerland

Contact Info

Product

Resources

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The 5^th EAO Consensus Conference 7–10 February 2018, Pfäffikon, Schwyz, Switzerland