eEurope 2002 : Quality Criteria for Health related Websites Background A number of organisations have begun to provide specific tools for searching , rating , and grading this information , while others have set up codes of conduct by which site providers can attest to their high quality services . The aim of such tools is to assist individuals to sift through the mountains of information available so as to be better able to discern valid and reliable messages from those which are misleading or inaccurate . Introduction Health related web sites are now amongst the most frequently accessed sites on the internet with current estimates indicating that there are now over 100,000 sites offering health related information -LSB- 1 -RSB- . As a result of the wealth of information available and its apparent popularity , a number of organisations have begun to provide specific tools for searching , rating , and grading this information , while others have set up codes of conduct by which site providers can attest to their high quality services . The aim of such tools is to assist individuals to sift through the mountains of information available so as to be better able to discern valid and reliable messages from those which are misleading or inaccurate . Recognising that European citizens are avid consumers of health related information on the internet and recognising that they are already using the types of rating system described above , the European Council at Feira on June 19-20 2000 supported an initiative within eEurope 2002 to develop a core set of Quality Criteria for Health Related Websites . Accordingly a series of meetings was held during 2001 which drew together key players from Government departments , International Organisations , non-governmental organisations and industry , to explore current practices and experiments in this field . Some sixty invited participants from all the Member States , Norway , Switzerland , and the United States of America took part in the kick-off meeting of June 7-8 , 2001 : they included delegates from industrial , medical , and patient interest groups , delegates from Member States ' governments , and key invited speakers from the field of health information ethics . These individuals , and many others , also took part in the web-based consultation which was open from august to November 2001 -LSB- 2 -RSB- . The focus of the discussions was primarily on the reliability of health related websites as a potential vehicle for health related messages , rather than on the substance and content of the health messages themselves . The specific aim was to draw up a commonly agreed set of simple quality criteria on which Member States , as well as public and private bodies , may draw in the development of quality initiatives for health related websites . These criteria should be applied in addition to relevant Community law -LSB- 3 -RSB- . As a result of the meetings , as well as a web-based public consultation , a core set of quality criteria was established . The criteria may be used as a basis in the development of user guides , voluntary codes of conduct , trustmarks , accreditation systems , or any other initiative adopted by relevant parties , at European , national , regional or organisational level . By using a common set of criteria as a starting point , such initiatives can develop in a focused manner across the European Union . The objectives for the criteria were defined as follows : The quality criteria should address issues of both supplier and user education : one document that simultaneously tells suppliers how to comply with key quality criteria and educates users as to what they ought to expect from a good health website ; The quality criteria should address both passive information-giving sites as well as sites that allow for transactions between service or information providers and users -LRB- i.e. information , products and services -RRB- . The quality criteria should facilitate compliance with EU Directives , other current guidelines , and technical standards relevant to this area . It should be noted that the objective was not to develop a method for the implementation of such criteria at a European level . Although some actors in the field have called for an EU trustmark for health related websites which would operate in a way similar to the CE marking of certain goods -LSB- 4,5 -RSB- , such initiatives are not within the ambit of the eEurope2002 action . They may , however , be considered within future eEurope action plans and other European programmes . Quality Criteria for Health Related Websites Developed in widespread consultation with representatives of private and public eHealth websites and information providers , other industrial representatives , public officials , and representatives of government departments , international organisations , and non-governmental organisations . These criteria should be applied in addition to relevant Community law Transparency and Honesty Transparency of provider of site - including name , physical address and electronic address of the person or organisation responsible for the site -LRB- see Article 5 and 6 Directive 2000/31/EC on Electronic Commerce -RRB- . Transparency of purpose and objective of the site Target audience clearly defined -LRB- further detail on purpose , multiple audience could be defined at different levels -RRB- . Transparency of all sources of funding for site -LRB- grants , sponsors , advertisers , non-profit , voluntary assistance -RRB- . Authority Clear statement of sources for all information provided and date of publication of source . Name and credentials of all human/institutional providers of information put up on the site , including dates at which credentials were received . Privacy and data protection Privacy and data protection policy and system for the processing of personal data , including processing invisible to users , to be clearly defined in accordance with community Data Protection legislation -LRB- Directives 95/46/EC and 2002/58/EC -RRB- . Updating of information Clear and regular updating of the site , with date of up-date clearly displayed for each page and/or item as relevant . Regular checking of relevance of information . Accountability Accountability - user feedback , and appropriate oversight responsibility -LRB- such as a named quality compliance officer for each site -RRB- . Responsible partnering - all efforts should be made to ensure that partnering or linking to other websites is undertaken only with trustworthy individuals and organisations who themselves comply with relevant codes of good practice . Editorial policy - clear statement describing what procedure was used for selection of content . Accessibility Accessibility - attention to guidelines on physical accessibility as well as general findability , searchability , readability , usability , etc. . Relevant Community Law is listed in reference 3 . Terms in italics are further discussed in the Glossary of Terms . It should also be noted that while this Communication is addressed to the Member States of the European Union and private or public bodies operating in those States , due consideration should be given to the global nature of information disseminated through websites . Accordingly bodies adopting measures to implement the criteria should be aware of the fact that their information will be accessed by many individuals of different nations and cultures . In particular , attention should be paid to the fact that the developing world is a keen consumer of health information and that culturally specific content should be clearly identifiable as such . Textbox 1 sets out the resulting quality criteria ; the ensuing text then explores some of the ways in which they may be implemented . This illustrates what could be done at national or regional level to promote high quality , accessible health related information to the European citizen . The table may easily be detached from the present text to form a simple reminder of the key Quality Criteria for Health related Websites . Tailoring the Criteria For Different Types of Health Related Content The criteria set out above are designed to be applicable to the development and maintenance of a health related site irrespective of the type of information or audience to whom the information is targeted . However , one essential quality criterion is that a health-related web site should state clearly what is its target audience and that care should be taken to ensure that both the style and nature of the information , and its presentation , are appropriate for the chosen audience . A number of the respondents to the consultation on the draft criteria , which was conducted between August and October 2001 via the eEurope website , identified the need to address not only site development and maintenance , but also the specific quality issues particular to health related content -LSB- 6 -RSB- . When tailoring the content to a chosen audience , a number of factors should be borne in mind in addition to those set out above which should govern the construction of a site . These factors may be considered under the same broad headings as the general site development criteria : Transparency of Health Related Content Transparency of the health related objectives of the provider of the information , including the purpose and objective of content provision , should be clearly defined and stated . Where advice or information on particular conditions , lifestyles or medications is given , funding from producers of products thereby implicitly or explicitly endorsed should be transparent to the site user . Existing Community legislation already contains information and transparency requirements . For example Article 5 of Directive 2000/31/EC on electronic commerce concerns the general information to be provided by an Information Society Services provider ; Article 6 of Directive 2000/31 which concerns additional information to be provided in the case of commercial communications which are part of or constitute an information society service and Article 10 of Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data also applies . Authority of Health Related Content Providers Where a policy of using only accredited medical professionals to generate content is adopted , this should be clearly stated and adhered to . Where a mixed group of content providers is used , -LRB- medical professionals , journalists , personal testimony , etc -RRB- the category of content provider of each item should be clearly identifiable . Where scientific evidence is cited , the sources of such evidence should be easily identifiable to the user . Where a medicinal product is recommended , EU legislation on Medicinal Product advertising should be adhered to , and any documents authorised by a regulatory authority should be made available to the site user . Where advice is offered , the site provider should always include a reminder that internet based advice , whether personalised or not , can not replace a face to face consultation with a healthcare practitioner . Privacy and data protection of Health Data Where any personal information is collected and further processed by the site user , including data processing invisible to the users , the requirements of Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data , in particular article 8 on sensitive and health data , should be carefully assessed and full compliance assured . Updating of Health Related Information Where specific health related data are provided , the relevance of such content should be regularly verified . Accountability for Health Related Content Where specific health related user feedback is provided by the site , particularly where personalised medical advice is offered , every effort should be made to ensure that such advice is bona fide and that advisors are suitably qualified to offer advice . Accessibility in Health Related Content Where a particular type of audience is targeted -LRB- eg children -RRB- , the presentation and content of information should be appropriate to the chosen target audience . The use of a metadata labelling system may be used to make health data more findable . Such a system may also be used in conjunction with quality criteria to give higher ranking by search engines to those sites or pages labelled as complying with defined quality criteria . Apply International or European standards , wherever possible , in order to facilitate notably the interoperability between different services and the cross-border provision of web based health services . Implementation of the Quality Criteria For Health Related Websites Issues for the European Community The purpose of the eEurope 2002 action on Quality Criteria for health-related Websites was to encourage the adoption of a common set of basic quality criteria for such sites . The issue of whether and how these criteria might be implemented at European level was not within the terms of the action . The implicit assumption was that this was a matter to be addressed in Member States at national or regional level , making use of the wide range of private and not-for-profit organisations which are already operating systems for implementing quality criteria for health-related websites . In view of the rapid increase in health-related websites in the European Union and the increase in the number of European Union citizens consulting such sites , it could be argued that there would be merit in the Community establishing its own system for implementing agreed quality criteria . Such a Community-sponsored system would however require considerable resources to set up and operate , and it is unclear that it would offer clear value added to the Member States . The Commission therefore considers that at the moment the difficulties inherent in a Community system would outweigh any possible advantages . Nevertheless , the issue of how and how effectively quality criteria are being implemented is of considerable significance at the European level . To ensure that European citizens have access to reliable health information on the Internet implies not only that there is a consensus on the necessary quality standards , but that those standards are satisfactorily implemented right across the European Union . This does not mean that the same method of implementation should be used everywhere - indeed it must be doubtful that any particular mechanism would be appropriate in all circumstances and in all countries For example , in pharmaceuticals the Commission is considering ways of meeting the growing demand by patients to be able to access information directly about their medicines . The Commission has included proposals within the current review of EU pharmaceutical legislation , Review 2001 , to take account of this growing demand . This has also been recently reinforced by the work of the High Level Group on Innovation and Provision of Medicines - G10 Medicines - which has covered this area in their reports . However , whatever system adopted , there should be clarity about the mechanisms being used in the different Member States and the extent of the involvement of the national and regional health authorities . With the forthcoming enlargement of the European Union , this requirement for transparency becomes even greater . Some Examples of Methods of implementing Quality Criteria Simple Codes of Conduct A number of organisations have adopted an approach similar to that described in this Communication , of setting up meetings and consultations between experts in order to establish by consensus a set of quality criteria . The eHealth Code of Ethics adopted in May 2000 by the Internet Health Coalition -LSB- 7 -RSB- is perhaps the best known of such ` codes of conduct ' . The object of this and other similar codes is to offer a process of self-assessment by health site providers . However , a basic code of good conduct , or set of quality criteria will form the basis of all the approaches described below . The way in which such codes are implemented varies . Where the code is adopted by an umbrella organisation , such as the Pharmaceutical Group of the European Union , then the organisation itself seeks to ensure that all members comply with the code . In other cases a code has been adopted for the purposes of in-house application only , as in the case of the American Medical Association . Although other organisations may cite the code , and claim to use it , the organisation developing the code makes no attempt to ensure that other parties are in fact implementing it . The costs of the code of conduct approach are generally rather low , requiring only an initial outlay on meetings to draw up the code . However , the benefit of such codes can also be rather limited given the absence of effective enforcement mechanisms . A code of conduct which addresses issues concerning the protection of personal could in itself form a Code of Conduct relevant to a specific area of practice as foreseen in Article 27 of Directive 95/46/EC on Data Protection . Any such draft community code , and amendments or extensions to existing Community codes , may be submitted to the Working Party established by Article 29 of Directive 95/46/EC on data protection . Similarly , a Code of Conduct which addresses the particular issues of electronic commerce in the health domain may be drafted in accordance with the framework foreseen in Article 16.1 of the Directive 2000/31/EC on Electronic Commerce . Self Applied Code of Conduct or Quality Label A next step in the implementation of a code of conduct can be characterised as the self applied quality label . In such a case a third party organisation develops a code of conduct and allows those who undertake to abide by the terms of the code to display a label , seal or logo which certifies compliance with the code . The oldest , and perhaps best known , of such labels is the Health on the Net Foundation -LRB- HON -RRB- -LSB- 8 -RSB- label whose eight point set of quality criteria is currently used by more than 3000 internet sites worldwide . A site provider wishing to use the HON label has to make a formal application and a commitment to strictly observe all the HON code principles . Compliant sites identify themselves by the HON code hyperlink -LRB- or `` active '' -RRB- seal displayed at a prominent location . The seal is termed ` active ' because clicking on it links the user to the HON site . Conformity with the HON code principles is verified by the team of checkers at HON. HON can not prevent dishonest operators from simply cutting and pasting the HON code seal onto their Web sites in a bid to enhance their credibility . It does , however , conduct random checks on subscribers to ensure they remain compliant with the HON code . By way of additional policing , the Internet community is invited to report misuse of the label . The costs of this system of applied labelling are not very high , requiring a relatively small team to process applications for use , maintain random checks of sites displaying the label and respond to any reports of misuse . The benefits may be significant in drawing to the attention of users the importance of the criteria inherent in the label . However , the benefits must be weighed against the requirement of the users of the sites to understand the nature of the label , and perhaps more importantly , to care about its aims and objectives . User Guidance Tools A further application of the code of good conduct takes the form of a user guidance tool . In this case compliance with a code is demonstrated not by a label , but by a link to a guidance tool which invites the user to check for him or herself if a site and its contents comply with pre-set criteria . A typical such tool is displayed by the site as a logo on which the user may click to reveal a series of questions with which to interrogate the site so as to assess whether the information offered is trustworthy . Such tools may be specific to a particular type of information , such as DISCERN -LSB- 9 -RSB- which provides a brief questionnaire through which users gain a valid and reliable way of assessing the quality of written information on treatment choices for a health problem . Other tools seek to give guidance on the trustworthiness of any health-related information . An example of this is NETSCORING -LSB- 10 -RSB- , which uses a questionnaire of 49 criteria falling into eight categories : credibility , content , links , design , interactivity , quantitative aspects , ethics , and accessibility . Yet other tools are targeted at particular categories of internet users . For example , the QUICK -LSB- 11 -RSB- tool seeks to provide children with a step-by-step guide to assessing health related information on the internet . While such tools are frequently adopted for the guidance of users by national health portals -LRB- such as National Health Service DIRECT in England and Wales -RRB- , they may also be used as site development tools by authors and publishers of information since they define the standards which users are entitled to expect . The financial costs of the user guide are low , often not extending beyond the initial development costs . However , the burden of the use of this kind of tool falls on the internet user , mostly because of the time it takes to apply , which reduces the incentive to use it . Filtering tools Where a guidance tool is provided by a third party to a user to apply for him or herself , a filtering tool is applied to provide a searchable database of filtered and accredited information . Such filtering tools are often based on the gateway approach to organising access to Internet . The fundamentals of this approach are that Internet resources are selected for their quality and relevance to a particular target audience . They are then reviewed and resource descriptions created , which are stored , generally with the associated metadata , and generally in a structured database . The consequence of this effort is to improve the recall , and especially the precision , of Internet searches for a particular group of users . An example of this type of tool is found in the OMNI site -LRB- Organising Medical Networked Information -RRB- -LSB- 12 -RSB- which provides a gateway to evaluated , quality Internet resources in health and medicine , aimed at students , researchers , academics and practitioners in the health and medical sciences . The costs of such a filtering tool are relatively high in that a team of trained experts must be employed to search for , abstract and classify information on the internet in order that it may be entered into the database . The benefits of such a tool , for the initiated user , are also high since it provides a valuable shortcut to individual searches of the internet using non-specific search engines . Third Party Quality and Accreditation Labels The most advanced , and also most costly , of the mechanisms available for implementing quality criteria for health related websites , is the third party accreditation system . A third party issues a label to certify the compliance of the site with the criteria of evaluation . A range of implementations fall into this category , from lower cost intra-organisation bodies for quality certification , acting in a similar to the notified bodies used in CE marking , to high cost external independent assessors who perform audits and grant accreditation . At present no third party accreditation bodies are fully operational in Europe , although two noteworthy pilots are running in MEDCERTAIN -LRB- a demonstration project of the European Union `` Safer Internet Action Plan '' -RRB- and TNO QMIC , a pilot study of the Netherlands Organisation for Applied Scientific Research . In the case of MEDCERTAIN -LSB- 13 -RSB- a series of levels of accreditation are envisaged , starting with a self-certification label in which the provider of the site uses the MEDCERTAIN metalabelling system which incorporates a machine read language to describe and evaluate health information on the Internet . These labels are then in turn used to place a given item of site correctly within a gateway system , such as the OMNI system described above . The next level envisaged by MEDCERTAIN is one in which non-medical experts personally check the site for compliance with the level 1 tagging and also against the agreed set of quality criteria . The highest level involves medical assessment of the content and a rating of the content by relevant healthcare professionals . The QMIC -LSB- 14 -RSB- system , on the other hand , envisages a system similar to the ISO 9000:2000 standard . The QMIC system is based on a complex set of standards drawn up by the third party -LRB- TNO in this case -RRB- but implemented by the site provider through an internal ` quality certification body ' who is in turn regularly assessed by the third party organisation to ensure that it is performing its function of internal quality assurance properly . The site , once duly assessed by the internal notified body is then admitted to a portal maintained by the third party who undertakes to ensure that the sites linked into the portal are applying the internal quality assurance system with due care . Purposes of Implementation of Quality Criteria For Health Related Websites The general purpose of any quality initiative , whatever method of implementation is chosen , must be the protection of the consumer . However , in some cases that general purpose may be best achieved through educating the user of the service while in other cases the provider of the service will be the target of the quality initiative . In order to assist in the selection of an appropriate implementation method , the targeted purposes of the various methods are examined in more detail below Educating Users In their daily lives as consumers of information delivered via the traditional media , most people learn to use a wide range of assessment tools : judging the nature of the outlet providing the information -LRB- a general or specialist bookshop or a work exclusively available from the author -RRB- , the look and feel of the publication as a whole -LRB- a magazine with several contributions or a one page pamphlet -RRB- . In addition , most people know whom to contact for further information -LRB- librarian , bookshop assistant , publisher -RRB- . In the world of internet content , however , it is less evident what are the relevant indicators of quality . It is for this reason that quality marks and user guides have proliferated , namely to educate the consumer and to provide a recognisable `` quality '' label which site creators may use to promote their sites . Accordingly , for such codes to be effective it is highly important that the public are informed about the existence of the Codes through public education campaigns . Assisting searchers The purpose of quality marks is not , however , simply to provide access to qualified information but also to assist the citizen in coping with the torrent of information which a search on a health related subject might produce : it has been said that `` trying to get information form the internet is like drinking from a fire hose . You do n't even know what the source of the water is '' -LSB- 15 -RSB- . In order to try to manage the flow from the fire hydrant into a steady stream from a tap , some organisations have developed and applied tools for rating web sites in order that they may offer pre-selected and more easily searchable sources to their consumers -LRB- see for example OMNI or MEDCERTAIN -RRB- . Educating Site Providers The problem is not only with the torrent of information , but also with the behaviour of its purveyors . Whilst it may take considerable effort to find an outlet for unusual or extreme ideas in the traditional media , virtually anyone with a modicum of computer skills and very little money can create their own website . The objective of many of the code of conduct initiatives is therefore to educate both the providers and consumers of information about the processes and good practices that a website should be able to demonstrate . In order to educate not only the provider , but also the consumer of information a further set of actors have developed a wide range of user assessment tools . Such tools are usually in the form of on-line check lists which ask the consumer to check off types of information as they find them : statement of aim , explicit statement of source of information , explicit date of information , etc. . Some may be rather short -LRB- HON -RRB- , some quite detailed -LRB- NETSCORING -RRB- ; some are aimed at specific markets -LRB- DISCERN - for treatment choices -RRB- and some aimed at children -LRB- QUICK -RRB- to mention but a few . Assuring Quality Most of the organisations publishing and administering such codes operate on a simple selflabelling processes in which the site provider undertakes to follow the code and in return displays its `` trustmark '' relying on spot check and vigilant users to identify those who are not complying with the given code of conduct . While this may not be as effective as a fully policed trustmark system of the type we are used to seeing as regards , for example , electronic products , it nonetheless addresses a need in a reasonably effective manner . Conclusions The eEurope initiative was launched by the European Commission on 8th December 1999 , with the adoption of the Communication ` eEurope - An Information Society for all -LRB- COM -LRB- 1999 -RRB- , 687 final , of 8.12.1999 -RRB- ' . The `` eEurope 2002 Action Plan - An Information Society For All '' , was adopted by the Commission on 14th June 2000 , and politically endorsed by the European Council in Feira -LRB- Portugal -RRB- on 19-20 June 2000 . It detailed the policy actions which are required to meet these objectives by 2002 . The eEurope 2005 Action Plan -LRB- COM -LRB- 2002 -RRB- 263 final , of 28.5.2002 -RRB- , was adopted by the Commission on 28 May 2002 and politically supported by the European Council in Sevilla -LRB- Spain -RRB- on 21 - 22nd June 2002 . It , notably , set the objective for Europe to have , by 2005 , '' Modern online public services '' . To achieve this objective , one of the proposed actions is to promote e-health services . It also commits the Commission to monitor '' actions taken by Member States to make health information as accessible as possible to citizens as well as initiatives to implement quality criteria for web sites '' . In this respect , the e Europe 2005 Action Plan affirms that '' it is critical that e-health content and services are developed efficiently , are available for all and health related web sites comply with established quality criteria '' . With respect to the enlargement of the European Union it should also be noted that the eEurope + Action Plan , which was adopted by the accession States to mirror the eEurope 2002 Action Plan , includes similar action on quality criteria for health related websites . Accordingly it will also be important to monitor the activities undertaken pursuant to that Action Plan . This Communication sets the scene for the implementation of a core set of quality criteria in Member States for health related web sites , within the context of the relevant existing Community legislation -LRB- as listed in footnote 3 -RRB- and in accordance with the requirements of that legislation . The set of quality criteria is based upon a broad consensus among specialists in this field , health authorities , and prospective users . It is now to be expected that national and regional health authorities , relevant professional associations , and private medical website owners will : implement the Quality Criteria for Health Related Websites in a manner appropriate to their website and consumers . develop information campaigns to educate site developers and citizens about minimum quality standards for health related websites . draw on the wide range of health information offered across the European Union and localise such information for the benefit of citizens -LRB- translation and cultural adaptation -RRB- . exchange information and experience at European level about how quality standards are being implemented . Finally , within the context of the Information Society activities and as part of the implementation of the European Union public health programme , consideration will be given to the possibilities of developing and operating a joint action , with the plans drawn up under eEurope , to improve availability to the general public on the Internet of information on health matters , and considering the possibilities for establishing a system of recognizable Community seals of approval for Internet sites .

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O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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Outcome of prenatal depression and risk factors associated with persistence in the first postnatal year : Prospective study from Rawalpindi , Pakistan Background Rates of prenatal and postnatal depression in developing countries are high . Prolonged depression during the postnatal period is associated with impaired infant growth and development . Little is known about the factors predicting the persistence of prenatal depression beyond the first few postnatal months . 1 Introduction The rate of postnatal depression in developing countries ranges from 16 % to 35 % -LRB- Ghubash and Abou-Saleh , 1997 ; Patel et al. , 2002 ; Aydin et al. , 2005 ; Cooper et al. , 1999 -RRB- and is a major contributor to the ` burden of disease ' in these countries . Depression around childbirth is associated with low birth weight and impaired weight gain in the first year of the infant 's life -LRB- Rahman et al. , 2004 -RRB- . The outcome is worse in infants whose mothers remained persistently depressed from the third trimester throughout the first postnatal year . It is , therefore , important to predict which mothers , depressed prenatally , are likely to remain depressed throughout the next year . Relatively fewer studies have examined the long-term outcome of postnatal depression . A recent review of studies from developed countries concluded that in about 30 % women with postnatal depression , symptoms persist for up to a year after giving birth -LRB- Goodman , 2004 -RRB- . There are no studies exploring the long-term outcome of postnatal depression in developing countries . Such longitudinal studies identify the course of depressive disorder and the factors that promote persistence thus helping to formulate effective preventive and treatment strategies -LRB- Weich and Araya , 2004 -RRB- . They can also help in targeting limited health resources in developing countries towards those at the greatest risk of poor outcome . In an earlier paper -LRB- Rahman et al. , 2003a , b -RRB- , we assessed 632 women in rural Pakistan and found that 160 -LRB- 25 % -RRB- of the sample had ICD-10 Depressive disorder . In this paper , we present the results of the one-year follow-up of those mothers who were depressed in the third trimester of pregnancy . 2 Method 2.1 Study area , subjects and sampling The study was carried out in a rural sub-district of Rawalpindi , Pakistan . This is a mainly agrarian low-income rural area about 60 km south-east from the city of Rawalpindi . All married women aged 17 to 40 in their third trimester of pregnancy -LRB- n = 701 -RRB- were identified from 10 Union Councils -LRB- each consisting of 5 -- 10 villages ; total population 150,000 -RRB- over a period of 4 months -LRB- Fig. 1 -RRB- . Subjects were identified by obtaining official lists from 120 government-employed Lady Health Workers -LRB- LHWs -RRB- working in the area , who routinely collect data on new pregnancies . Six-hundred and seventy out of 701 -LRB- 95 % -RRB- agreed to take part . Written informed consent was obtained from all subjects after the procedure had been fully explained . Fourteen -LRB- 2 % -RRB- were excluded because of a physical illness or complication of pregnancy , 21 -LRB- 3 % -RRB- had anxiety disorder and 3 -LRB- 0.5 % -RRB- had learning disability and were excluded . Out of the remaining , 160 were diagnosed with ICD-10 Depressive Episode , giving a prevalence rate of depressive disorder in the prenatal period -LRB- T1 -RRB- of 25 % . Out of these 160 , four had infants born prematurely and were excluded from this study . Two mothers discontinued due to severity of depression . Ten mothers had stillbirths or neonatal deaths , and 1 newborn had a congenital abnormality and were excluded . Fourteen subjects dropped out of the study . Thus , one hundred and twenty-9 mothers were assessed at 3 months -LRB- T2 -RRB- , 6 months -LRB- T3 -RRB- and 12 months -LRB- T4 -RRB- postnatal . 2.2 Data collection Mental state assessments were carried out at all time points by two trained and experienced clinicians using the Schedules for Clinical Assessment in Neuropsychiatry -LRB- SCAN -RRB- , developed by the World Health Organization as an internationally validated semi-structured interview generating ICD-10 diagnoses of Depressive Disorder -LRB- World Health Organization , 1994a -RRB- . All interviews were carried out after translation , back-translation and cultural adaptation of the interview schedule using an established procedure -LRB- Rahman et al. , 2003a , b -RRB- . Interrater reliability was established prior to the study when both interviewers independently assessed 20 women -LRB- 10 had clinical depression -RRB- and agreed on the diagnosis of 19 -LRB- κ = 0.90 -RRB- . Psychological symptoms were assessed at T1 by the same interviewers using the Self-Reporting Questionnaire -LRB- SRQ-20 -RRB- -LRB- World Health Organization , 1994b -RRB- . This consists of twenty items designed to identify psychological symptoms associated with anxiety and depression . Each item has a yes/no answer . The time span refers to the individual 's feelings over the past 30 days . Each item is scored 0 or 1 . The maximum score is therefore 20 . Disability in mothers was assessed at T1 using the Brief Disability Questionnaire -LRB- BDQ -RRB- -LRB- VonKorff et al. , 1996 -RRB- . This is an 8-item questionnaire that rates current problems in carrying out daily activities on a scale of 0 -LRB- not at all -RRB- to 2 -LRB- definitely -RRB- , with a maximum score of 16 . This instrument has been validated in a 15-center cross-national , multilingual study -LRB- VonKorff et al. , 1996 -RRB- . Socio-demographic variables -LRB- age , education , employment , family structure and composition -RRB- were assessed at T1 by the same interviewers using a specially designed Personal Information Questionnaire -LRB- PIQ -RRB- . Education was categorised into no education versus at least four years primary education . Four years of schooling was chosen as a cut-off because many Pakistani female children attend primary school for four years , after which many children from low-income families stop attending . Family structure was categorised into nuclear family -LRB- parents and children only -RRB- or extended family -LRB- three generations , or one or both parents with married sons , their wives and children -RRB- . Socioeconomic status was assessed at T1 by inquiring if the household was in debt and by asking Lady Health Workers , who lived in the same locality and had intimate knowledge of the families being studied , to rate the household on a 5-point Likert scale ranging from 1 -LRB- richest -RRB- to 5 -LRB- poorest -RRB- . A single dichotomous variable of ` poverty ' was created by combining these 2 measures , i.e. , subjects who were both in debt and rated below 3 on the socioeconomic 5-point Likert scale were classified as being poor . Maternal financial empowerment within the household was measured at T1 by asking the mothers if they were given a lump-sum amount of money for day-to-day household expenses , and whether they could take independent decisions about its use . Mothers who answered ` yes ' to both questions were classified as financially empowered within the household . Social support was assessed by inquiring if the woman received any support during pregnancy from relatives or friends . A brief list of life events and difficulties was administered at T1 . These were derived from the Life Events and Difficulties Schedule -LRB- LEDS -RRB- -LRB- Brown and Harris , 1989 -RRB- , a semi-structured instrument that measures events and difficulties experienced during the previous year . LEDS has been translated and culturally adapted for use in the study area -LRB- Husain et al. , 2000 -RRB- . Based on the data from this study , 9 types of events or difficulties that accounted for the majority of the severe events and difficulties reported in that population were used in a modified semi-structured interview . We recorded only those events and difficulties which rated as severe according to the Brown and Harris Rating Scale . In order to do this we discussed the context in which they occurred with the local lady health worker -LRB- who lived in the same community and had intimate knowledge of the families being studied -RRB- . 2.3 Statistical analysis All analyses were carried out with STATA , version 7 -LRB- StataCorp. , 2001 -RRB- Subjects who were depressed at all 4 time points -LRB- persistent cases -RRB- were compared with the rest -LRB- non-persistent cases -RRB- . T-test was used to compare psychological symptoms , disability and life event scores . Univariate analyses -LRB- relative risk , Fisher 's two sided exact p -RRB- was performed between potential risk factors and chronic depression . Associations were considered significant at the 5 % level . The simultaneous effects of the measured risk and protective factors on persistent depression were analyzed using logistic regression analysis , including all the variables studied in the model -LRB- listed in Table 1 -RRB- . The study was approved by the ethics committees of Rawalpindi Medical College , Pakistan and University of Manchester , UK . 3 Results 3.1 Sample characteristics 129 depressed women completed the one-year follow-up . Their average age was 27.5 years -LRB- SD = 5.3 -RRB- . All were married , the average age of marriage being 20 years -LRB- SD = 2.8 -RRB- . Forty-four percent were uneducated ; only 4 % were employed outside the home . Eighty-eight percent of the fathers were employed and about 22 % of them were absent from home for 6 months or more due to employment in the cities . The average reported monthly family income was 2500 rupees -LRB- US$ 42 -RRB- . Sixty-seven percent of the families were rated below 3 on the 5-point socioeconomic scale by the LHWs and 53 % of the households were in debt . Sixty-two -LRB- 48 % -RRB- were in debt and rated below 3 by the LHWs and were classified as ` poor ' in this study . Nine percent were primigravid , 16 % already had one child , 21 % two children , 17 % three children and the remaining 37 % had three or more . Thirty-seven percent lived in nuclear families -LRB- parents and children only -RRB- while the remaining lived in extended families -LRB- three generations , or one or both parents with married sons , their wives and children -RRB- . Fifty-seven percent delivered at home with a traditional birth attendant , 98 % without any reported complication . The gender of newborns was equally distributed . Of the 129 women , 121 -LRB- 94 % -RRB- were depressed at 3 months , 98 -LRB- 76 % -RRB- at 6 months and 80 -LRB- 62 % -RRB- at 12 months . Eighty out of 129 -LRB- 62 % -RRB- mothers depressed during the third trimester of pregnancy were still depressed at 12 months postnatally but 7 of these had not been depressed at 6 months ; thus 73 -LRB- 57 % -RRB- were depressed at all time points . A comparison of the 73 women who had persistent depressive disorder with the remainder on scores of the Self-Reporting Questionnaire , Brief Disability Questionnaire and Life Events Checklist is shown in Table 1 . Persistent depression was significantly associated with SRQ score and BDQ score , and weakly associated with Life Events score . Unadjusted relative risks with other factors are shown in Tables 2 and 3 . Persistent depressive disorder was associated with having an uneducated husband , family size -LRB- 5 or more children -RRB- , poverty and lack of a confiding relationship . Independent predictors of persistent depression selected by multiple logistic regression were : high score on the SRQ in the third trimester of pregnancy -LRB- odds ratio -LRB- OR -RRB- 1.3 , 95 % CI 1.1 to 1.6 , p < 0.01 -RRB- and poverty -LRB- OR 3.1 , 95 % CI 1.2 -- 8.4 , p > 0.05 -RRB- -LRB- Table 4 -RRB- . 4 Discussion To our knowledge , this is the first study from the developing world exploring the course of prenatal depression and factors predicting its persistence during the first year of the newborn 's life . The study was community based and used standardised and valid instruments to diagnose depression . Depression around childbirth is a serious public health problem in south Asia , affecting about one in four women -LRB- Patel et al. , 2002 ; Rahman et al. , 2003a , b -RRB- . Recent studies also provide strong evidence that maternal depression is associated with poor growth in infants living in poor communities in developing countries -LRB- Rahman et al. , 2004 ; Patel et al. , 2004 -RRB- , and the outcome is worse in infants of mothers with persistent depression . In developed countries , maternal depression is associated with long-term cognitive , emotional and behavioural problems in children , and the impact is worse where the depressive episode is severe or prolonged -LRB- Grace et al. , 2003 ; O'Connor et al. , 2002 -RRB- . Therefore , prolonged maternal depression has serious consequences not only for the mother but also for infant growth and development . The main findings of this study are that over half of mothers depressed in the third trimester of pregnancy continued to be depressed one year after giving birth . In similar studies from developed countries , depressive levels have been found to decrease steadily over time . In an early prospective study from USA , O'Hara et al. -LRB- 1984 -RRB- followed up 99 women from second trimester of pregnancy to 6 months after giving birth , and found that although almost one half of the subjects had depressive scores that would place them in the mildly depressed range during the second trimester , less than 12 % of the subjects were in the mildly depressed range at the 9-week and 6-month follow-ups . In a more recent American study , Campbell and Cohn -LRB- 1997 -RRB- followed up 70 women meeting the criteria for clinical depression at 2 months postnatal and found that at 4 months postnatal , 48 % continued to be depressed ; at 6 months 30 % and at 12 months , 24 % continued to meet the criteria for depression . Beeghly et al. -LRB- 2002 -RRB- followed up 106 women with high depression scores at 2 months postnatal and found that 35 % and 31 % continued to have high scores at 6 and 12 months respectively . Rubertsson et al. -LRB- 2005 -RRB- followed up a national cohort of Swedish women and found that out of 333 women with high depression scores in early pregnancy , 79 -LRB- 24 % -RRB- continued to have high scores at one year postpartum . A follow-up study of an Australian cohort from early pregnancy till five years after birth suggested that in the majority of women who experienced depressed mood after birth , the symptoms were not severe and did not continue beyond a few weeks -LRB- Najman et al. , 2000 -RRB- . In our study , prevalence of antenatal depression is high and comparatively fewer women recover in the first year after childbirth . The low rate of recovery could be due to the adverse circumstances experienced by many women in developing countries . Persistent depression was associated with several factors that preceded the birth : poverty , already having 5 or more children , an uneducated husband , and lack of a friend or confidant . Similar factors have been reported in studies from poor communities in developed countries . Horowitz and Goodman -LRB- 2004 -RRB- found that women still depressed two years after giving birth were more likely to be poor and have less social support . Bernazzani et al. -LRB- 1997 -RRB- found that lower occupational status , lower income , prenatal depression and stressful life events in 12 months prepregnancy were associated with depression persisting at 6 months postnatal . Yonkers et al. -LRB- 2001 -RRB- found that persistent postnatal depressive symptoms were linked with the presence of other young children at home . In the current study , multivariate analyses suggested poverty to be the major predictor of persistence of depression after severity of depressive symptoms in the prenatal period was adjusted for . The gender of the newborn did not predict persistence . In south Asia , giving birth to a female infant was found to be associated with postnatal depression -LRB- Patel et al. , 2002 -RRB- , especially in mothers who already had more than two girl-children -LRB- Rahman et al. , 2003a , b -RRB- . The preference for male children is deeply rooted in South Asia . Women are often blamed for the birth of girls . However , this study suggests that the effects of having a female child on the mother 's mood may only be transient . Similarly , lack of social support during pregnancy -LRB- in terms of assistance provided in daily activities -RRB- was not associated with persistence while lack of a confidant or friend was . It may be that there are qualitative differences in the type of social support that predicts a worse outcome of depression , and studies using better measures of social support may be required . While only physically healthy mothers were included in the study , we did not include any physical measures to screen mothers for common physical problems such as anaemia or iodine-deficiency . However , chronic malnutrition in the mothers indicated by a low body-mass index was not significantly associated with persistent depression . Other limitations include a relatively small sample size and the fact that all the women came from one sub-district of Rawalpindi . Cross-sectional epidemiological studies in Pakistan suggest that the prevalence rate of depressive disorder in women is high even in the non-postnatal period -LRB- Husain et al. , 2000 ; Mirza and Jenkins , 2004 -RRB- . Other longitudinal studies would be required to try and understand the origins of depression in these women , which may well pre-date the first pregnancy , or even have its onset in adolescence . However , the postnatal period assumes importance because of the impact of maternal depression on the infant 's development . Thus , early identification of mothers whose depression is likely to persist and providing extra support could improve outcomes in both mothers and their infants . The strongest predictor of persistent depression in this study was a high score on the SRQ-20 in the third trimester pregnancy . Recent meta-analyses suggest that psychological symptoms -LRB- mainly depression and anxiety -RRB- during pregnancy , along with past history of psychiatric illness are primary risk factors for postnatal depression -LRB- O'Hara and Swain , 1996 ; Beck , 2001 -RRB- . The few studies that have explored the long-term outcome of postnatal depression suggest that depressive symptoms during pregnancy -LRB- Bernazzani et al. , 1997 ; Verkerk et al. , 2003 -RRB- not only predict early postnatal depression but are also associated with persistence of depression . The utility of the SRQ-20 in predicting persistent depression suggests that this questionnaire , which has been specifically developed for use in primary care in developing countries , could also serve as a useful screening instrument during the antenatal period .

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O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O

postnatal depression
developing countries
pakistan