Authors' objectives:

1. To draw up evidence-based recommendations regarding the timing, form and content of the information that should be offered to facilitate informed participation in screening; 2. to know the characteristics and quality of current written information on neonatal screening programmes for inborn errors of metabolism; and, 3. to know the appraisal of the parents and health professionals on the evidence-based recommendations of the written information that should provide the neonatal screening programmes for inborn errors of metabolism.

Authors' recommendations: In the Spanish National Health System there are not common • information documents for parents and the information provided by the different programmes displays a great variability. Benefits are barely mentioned and potential risks never mentioned. In general, the leaflets are in accordance with standard formats. The number of available materials is reduced, the topics included are variable and the language is excessively technical, making it difficult to understand. At present, the information is provided after childbirth.There is total agreement that the time more suitable for providing written information to parents is during the pregnancy and that is necessary to do so in more than one occasion (reminders).Programmes should provide written information, because it is an appropriate way to submit information for informed decision making. This information should include at least: the programme’s aim, the included diseases, the test procedure and the possible outcomes. Also the programmes must report on benefits and risks or potential damages of screening in a comprehensible form. To this end, tools should be used to facilitate understanding of numerical data such as the visual representation (pictograms) or the use of absolute numbers and rates of events.To improve the quality of the written information, the leaflets should provide simple information, concise and direct, to ensure their comprehensibility, considering the use of quality assessment tools. The information must be adapted to the needs and characteristics of users.The results of the screening test must always be communicated to the parents, who should be informed about what to do in case of not receiving them. In the communication of results the terms positive and negative should be avoided. If the result is normal, the written format is recommended but, if it is necessary to make further assessment tests, parents prefer that a health professional explain to them in detail the significance of the result and the steps to follow.The results of the test should always be registered in the “documentation” of the child.Very little research has been conducted about communication in newborn screening for inborn errors of metabolism. Further quality research about the process of communication with parents is called for, so as to enable evidence-based recommendations to be made on communication in neonatal screening programmes.It is recommended to make explicit the programmes confidentiality guarantees and, since it concerns biological tests, explain adequately the procedure, the manipulation, the storage policy and the possible residual samples use.It is recommended to develop basic information documents, accessible to all interested users, which could be used as a reference for all Spanish National Health System programmes. On this common basis, documents could be locally adapted to individual characteristics of each programme.It is recommended that the information provided on the screening conditions is based on specific Clinical Practice Guidelines (CPG). These CPG should include a citizens version, accessible to be consulted by users.

Project Status: Completed

URL for project: http://www.sergas.es/MostrarContidos_N3_T02.aspx?IdPaxina=60056&uri=/docs/Avalia-t/avaliat200704_crib-Metabolopatias.pdf&hifr=1250&seccion=0

Year Published: 2009

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Scientific Advice Unit, avalia-t; The Galician Health Knowledge Agency (ACIS)

Contact Address: Conselleria de Sanidade, Xunta de Galicia, San Lazaro s/n 15781 Santiago de Compostela, Spain. Tel: 34 981 541831; Fax: 34 981 542854;

Contact Name: avalia-t@sergas.es

Contact Email: avalia-t@sergas.es

Copyright: Galician Agency for Health Technology Assessment (AVALIA-T)