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Reaching beyond the review of research evidence: A qualitative study of decision-making during clinical guideline development
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health. Department of Learning, Informatics, Management and Ethics, Medical Management Centre, Karolinska Institutet, Stockholm, Sweden.ORCID iD: 0000-0002-5517-0803
Luleå tekniska universitet, Institutionen för ekonomi, teknik och samhälle, enheten för Industriell ekonomi.
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health. Karolinska institutet, Department of Learning, Informatics, Management and Ethics, Medical Managment Centre.
(English)Manuscript (preprint) (Other academic)
Abstract [en]

Background: The judgment and decision-making process during guideline development is central for producing high-quality clinical practice guidelines, but the topic is relatively underexplored in the guideline research literature. We studied the development process of national guidelines with a disease-prevention scope produced by the National board of Health and Welfare (NBHW) in Sweden. The NBHW formal guideline development model states that guideline recommendations should be based on four decision-criteria: research evidence; severity of the condition; cost-effectiveness; and ethical considerations. A group of health profession representatives is assigned the task of ranking condition–intervention pairs for guideline recommendations, taking into consideration the multiple decision criteria. The aim of this study was to investigate the decision-making process during the two-year development of national guidelines for methods of preventing disease.

Methods: A qualitative longitudinal case study approach was used to investigate the decision-making process. Questionnaires, non-participant observations of nine two-day group meetings, and documents provided data for the analysis.

Results: The guideline development model was adapted ad-hoc as the group encountered three main types of dilemmas: high quality evidence vs low adoptability of recommendation; insufficient evidence vs high urgency to act; and incoherence in vertical and horizontal judgments. Decision-criteria added by the group were ‘clinical knowledge and experience’, ‘potential guideline consequences’ and ‘needs of vulnerable groups’. Gender, professional status, and interpersonal skills were perceived to affect individuals’ relative influence on group discussions. Decision criteria changed over time in the group discussions.

Conclusions: The study shows that guideline-development groups make compromises between rigour and pragmatism. The formal guideline-development model incorporated multiple aspects, but offered few details on how the different criteria should be merged. The guideline development model devoted little attention to the role of the decision-model and group-related factors. Guideline development models could benefit from incorporating more guidance on if and how to integrate research evidence with other types of decision criteria, such as clinical experience and socioeconomic evidence.

Keyword [sv]
Clincal practice guidelines, guideline development, evidence-based policymaking, group decision-making, prevention
National Category
Medical and Health Sciences
Research subject
Public health
URN: urn:nbn:se:umu:diva-118178OAI: diva2:911796
Available from: 2016-03-14 Created: 2016-03-14 Last updated: 2016-03-16
In thesis
1. Mind the Gap: exploring evidence-based policymaking for improved preventive and mental health services in the Swedish health system
Open this publication in new window or tab >>Mind the Gap: exploring evidence-based policymaking for improved preventive and mental health services in the Swedish health system
2016 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background: The challenges in the utilization of scientific findings in the fields of prevention and mental health are well documented. Scholars have found significant gaps between the knowledge available and the knowledge applied in healthcare. Studies have suggested that about half of the patients receive the recommended care for their medical condition. In order to address this gap, health systems at global, national, regional and local levels have made diverse efforts to facilitate the uptake of research for example through evidence-based health policy processes. In Sweden, government agencies and health policy actors such as the National Board of Health and Welfare support and control the health care system through evidence-based policies amongst other steering tools. The overall aim of this thesis is to explore evidence-based policy processes, and to further understand barriers to implementation of policies in the fields of preventive and mental health services.

Methods: A multiple case study approach was used, and data were collected from several sources. Qualitative content analysis methodology was used. Case 1 comprises the development and early implementation of national guidelines for methods of preventing disease managed by the National Board of Health and Welfare during 2007–2014. Case 2 covers the effort to improve health care for the older population that was undertaken through an agreement between the Swedish government and the Swedish Association of Local Authorities and Regions during 2009–2014. Case 3 involves an effort to implement an adapted version of a systematic review from the Swedish agency for health technology assessment and assessment of social services on treatment of depression in primary health care. Data was collected between 2007 and 2010.

In Paper 1, the policies from Case 1 and 2 were studied using a longitudinal, comparative case study approach. Data were collected through interviews, documents and observations. A conceptual model was developed based on prior frameworks. The model was used to organize and analyse the data. In Paper 2, the guideline development process (Case 1) was studied through interviews and the collection of documents. A prior framework on guideline quality was used in order to organize the data. Paper 3 investigated decision-making processes during guideline development using a longitudinal approach. Qualitative data were collected from questionnaires, documents and observations and analysed using conventional and summative content analysis. In Paper 4, the barriers to implementation were investigated through interviews and the collection of

documents. Data were analysed using qualitative content analysis with a conceptual model to structure the analysis.

Results: The sources and procedures for policy formulation differed in Case 1 and 2, as did the approaches to promote the implementation of the policies. The policy processes were cyclical, and phases overlapped to a large degree. The policy actors intended to promote implementation, both during and after the policy formulation process.

The thesis shows variation in how the key policy actors defined and used research evidence in the policy processes. In addition, other types of knowledge (e.g. politics, context, experience) served as alternative or multiple sources to inform the health policies. The composition of sources that informed the policies changed over time in Cases 1 and B. During the policy formulation and implementation process, efforts to integrate research evidence with clinical experiences and values were associated with tension and recurrent dilemmas. On the local level (i.e. primary health care centres), barriers to implementation were found related to the innovation and among health professionals, patients, in social networks as well as in the organizational, economic and political contexts.

Conclusion: The concept of evidence holds a key position in terms of goals and means for knowledge based policymaking in the Swedish health system. Broad definitions of evidence – including research and non-research evidence - were requested and to various extents utilized by the policy actors in the studied cases. An explicit terminology and systematic, transparent methodology to define, identify, and assess also non-research evidence in policy processes would potentially strengthen the clarity and validity of these processes and also enhance policy implementation.

Particular determinants to implementation, such as the interventions characteristic, are to a considerable degree established early in the policy process, during agenda setting and policy formulation. This early phase offers unique opportunities to assess and build capacity, initiate and facilitate implementation.

Early analysis and considerations of target populations and contexts and other implementation determinants related to the specific policy scope (e.g. disease preventive guidelines) could enhance the forth-coming implementation of the policy.

Place, publisher, year, edition, pages
Umeå: Umeå universitet, 2016. 82 p.
Umeå University medical dissertations, ISSN 0346-6612 ; 1788
Evidence-based policymaking, guidelines, implementation, prevention, depression
National Category
Medical and Health Sciences
Research subject
Public health
urn:nbn:se:umu:diva-118179 (URN)978-91-7601-432-5 (ISBN)
Public defence
2016-04-08, Målpunkt R, E04, Umeå, 09:00 (Swedish)
VINNOVA, A2008-025The Kempe FoundationsForte, Swedish Research Council for Health, Working Life and Welfare, 2014-1552Sven Jerring Foundation
Available from: 2016-03-17 Created: 2016-03-14 Last updated: 2016-05-02Bibliographically approved

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