1.13 An external review may be regarded as, e. g.

• a review by experts (in the field covered by the guideline) that have neither been involved in the guideline development nor its commentaries,
• the acceptance for publication in a scientific journal based on a peer-review process,
• a review by medical self-government committees. The answer YES presupposes that at least the availability of a list of the reviewers' names.

1.14 The answer YES presupposes at least a description of the methodology used as well as a clear statement on the commentaries' influence on the final wording of the recommendations.

1.13 Als externe Begutachtung kann z.B. angesehen werden:

• das Begutachten durch Experten (für den von der Leitlinie betroffenen Bereich), die weder an der Erstellung noch an der Kommentierung der Leitlinie beteiligt waren,
• die Annahme zur Publikation in wissenschaftlichen Zeitschriften aufgrund eines Gutachterverfahrens,
• die Begutachtung durch Gremien der ärztlichen Selbstverwaltung. Die Antwort ,,JA" setzt voraus, dass zumindest eine Namensliste der Gutachter vorliegt.

1.14 Die Antwort ,, JA" setzt zumindest eine Beschreibung der verwendeten Methoden voraus, sowie eine klare Stellungnahme, wie sich die Kommen- tierungen auf die endgültige Formulierung der Empfehlungen auswirkten.

• Beschreibung der Pilotversuche

Ulkopuoliset lausunnot
Valmis suositusluonnos jaetaan Käypä hoito - toimitukselle sekä hoitosuositustyöryhmän osoittamille ulkopuolisille asiantuntijoille, useimmissa tapauksissa ao. erikoisalan ylilääkäreille yliopisto- ja keskussairaaloihin, potilasjärjestöille ja muiden terveydenhuollon ammattiryhmien edustajille. Suositus lähetetään myös arvalla valituille terveydenhuollon eri toimintatasoja edustaville yksiköille. Laaja lausuntokierros edistää tiedottamista suosituksesta, ja sitouttaa lausunnon antajia suosituksen käyttäjiksi.

…. Työryhmän vetäjä ja vastuutoimittaja sopivat työryhmän ehdotusten perusteella lausuntokierroksen perusjakelua täydentävän jakelun (esim. muiden työryhmän asettaneen erikoisalan ylilääkärit, erilliset asiantuntijat). Vastuutoimittaja konsultoi päätöksestä päätoimittajaa ja tarvittaessa muuta toimitusta.

Kaikista suosituksista lähetetään lausuntopyyntö ainakin seuraaville tahoille:

1. viiden yliopistosairaalan asianomaisen erikoisalan ylilääkäri;
2. kaikkien keskussairaaloiden asianomaisen erikoisalan ylilääkäri;
3. kolmen alue- tai paikallissairaalan asianomaisen erikoisalan ylilääkäri;
4. viiden suuren terveyskeskuksen yhden terveysaseman ylilääkäri;
5. viiden pienen terveyskeskuksen ylilääkäri;
6. potilasjärjestö(t), jo(t)ka toimivat suosituksen käsittelemän terveysongelman alueella;
7. erikoislääkäriyhdistykset, joita suositusaihe koskee; vähintään ne, joiden edustaja on ollut mukana suositustyöryhmässä, ja
8. muut suositustyöryhmän toivomat lausunnonantajat.

Consultation with stakeholders is an integral part of the NICE guideline development process. Comments received from stakeholders are a vital part of the quality-assurance and peer-review processes, and it is important they are addressed appropriately.

First consultation

Draft versions of the full and NICE versions of the guideline are available on the website for the first consultation and registered stakeholders are informed that the documents are available. The guideline may also be sent to expert peer reviewers identified by the NCC, and non-registered stakeholders may view the guideline versions on the NICE website. The Institute encourages people, however, to comment through their registered organisation if appropriate. Comments are also received from members of the GRP. The GRP members send comments to the Institute via the GRP Chair, aiming to ensure that:

• the guideline is clinically relevant
• any major areas of concern are identified
• the guideline contains realistic expectations for NHS service providers.

The Chair is expected to ensure that:

• all elements of the agreed scope have been addressed
• the guideline produces recommendations for the NHS only, and not for other bodies (for example, education, social care)
• there is explicit documentation covering the search of evidence, inclusion and exclusion of studies
• it is clear how the recommendations have been derived from the evidence where appropriate, and there is a detailed record of how consensus has been achieved.

If there are any queries or concerns about significant issues raised, the NCC should contact the Commissioning Manager at the Institute to discuss an appropriate response as soon as possible. Once any changes have been agreed by the GDG in response to comments received, modifications need to be made to both the full version and the NICE guideline prior to returning the documents to the Institute for the second consultation. Any changes in the recommendations also need to be translated into the information for the public. It is essential for developers to keep an audit trail of what changes have been made, where, by whom, and for what purpose.

Second consultation

Three versions of the guideline – the full guideline, the NICE guideline and the information for the public – are made available for consultation on the website during the second consultation, and stakeholders are informed that the documents are available. Stakeholders’ comments on the second draft of the guideline should be limited to noting whether initial comments have been addressed appropriately in the guideline. They are asked not to raise new issues, except for those specifically relating to the information to the public, or to new information included since the first consultation, but any new issues will have to be responded to in the usual way.

• Comments will also be received from the GRP members.

The GRP Chair reviews the revised guideline, and cross-checks changes against comments and the developers’ responses to these. The Chair will receive the information for the public for comment, but again, he or she is not expected to comment on the NICE guideline. The overall purpose is to:

• identify major and substantive areas of concern for discussion with panel members at the teleconference (see below)
• identify any minor changes that are required. These can be communicated to the Institute either in a written report, or by submitting the guideline itself with annotations.

At the end of the second consultation, a teleconference is held to enable the GRP members to discuss major areas of concern, either in the guideline per se or in the way the stakeholder comments have been addressed. The teleconference is chaired by the GDG Chair and is also attended by representatives from the Institute (Executive Lead, Guidelines Programme Director, Commissioning Manager and Coordinator). The Patient Involvement Unit (PIU) provides a written report. The discussion and conclusions are condensed into a formal report from the Chair to the Institute, advising on the suitability of the guideline for publication. The report is prepared by the Guideline Commissioning Manager. Following consultation, the guideline documents should be amended again where necessary, still maintaining the audit trail. Responses to any comments made by the Review Panel should be made on separate tables provided by the Institute. If a requested change has not been made, an explanation will be required.

• Example
  

All SIGN guidelines are reviewed in draft form by independent expert referees, who are asked to comment primarily on the comprehensiveness and accuracy of interpretation of the evidence base supporting the recommendations in the guideline. The comments received are carefully tabulated and discussed with the chairman and with the guideline development group. Each point must be addressed and any changes to the guideline as a result noted or, if no change is made, the reasons for this recorded. Reviewers should not have been involved in the development group, although they may have participated in the national open meeting held to discuss the draft guideline (see item 20).

• Development annex (peer review details)