Klinisk institutt 1

Midtveisevaluering - Kristin Harris

Midtveisevaluering for ph.d.-graden ved Universitetet i Bergen for kandidat Kristin Harris

Kristin Harris er tilknyttet Klinisk institutt 1. Veiledere er Arvid Steinar Haugen, Stig Harthug, Erik Søfteland og Asgjerd Litlere Moi.


Development and Implementation of Surgical Safety Checklists for Patients to Use Before Admission and Before Discharge (PASC) - a Stepped Wedge Cluster RCT



In today’s healthcare service, there is an increased focus on patient safety and quality of care. Introduction of Surgical Safety Checklists in peri-operative medicine have shown to improve quality through the treatment process, and contributes to reduce serious complications and mortality.1, 2 Still, the uptake of interventions in hospitals from large scale patient safety programs are slow.3, 4 The national Norwegian patient safety program «In Safe Hands 24/7» aim to mitigate preventable complications by 25%.5 The goal of this research project is to develop checklists for surgical patients to use before surgery and before hospital discharge to enhance patient safety, and involvement.


The method used in the identification of patients’ risk elements was an explorative qualitative study design where post-operative patients, surgeons, ward physicians, ward nurses, and secretaries from five surgical specialties took part in focus group interviews. Eleven focus groups were conducted including 25 post-operative patients and 27 healthcare workers at one tertiary teaching hospital and one community hospital in Norway. Based on their experiences, participants were asked to identify perceived risks before and after surgery. Inductive content analysis was used as described by Graneheim and Lundman.6

In the development and checklist validation phase, we have used a modified Delphi process to develop the checklists based on the results in our first study. Then surgical patients (n=300) are validating the checklists using content validation index. We are aiming for an 80% agreement combined with a risk evaluation on each checklist item to keep them within the final surgical safety checklist.

Lastly, we will test the effect of patients’ surgical checklist in a stepped wedge cluster-randomized controlled trial with stage implementation of checklists-interventions for the six surgical patient groups (Gastrointestinal, general surgery, breast- and endocrinology, ENT and Maxillo-fascial, Neuro, and Thoracic surgery), where we will measure patient complications and hospitalisation time. There will be n=2100 patients in the control group and n=2100 in the intervention group.


The introduction of checklists as "WHO Surgical Safety Checklist" and the Dutch "Surgical Patient Safety System" has shown to reduce complications, mortality and hospital stay. 1,2 In the Western Norway Regional Health Authority Trust it is mandatory to use the checklist for Safe surgery and there is an ongoing research project that combines both Safe surgery and SURPASS (ClinicalTrials.gov, Identifier: NCT01872195). A governmental aim is to reduce the number of preventable adverse events by at least 25%. However, this will require additional efforts for this rate to be achieved. Hence, the next step to reach this goal is to engage patients to optimise their preparations before surgery and preparations for the post-discharge period by developing of patients’ own surgical checklists. By using these checklists, patients will be able to control that they have received the right information, performed the right preparations before surgery and planned their own discharged together with healthdcare workers. This research project is also in line with the current Norwegian Parliament’s national health policies and hospital plan (2016-2019) was the aim is to create patients' health care7.


1.         Haynes A, Weiser T, Berry W, Lipsitz S, Breizat A, Dellinger E, Herbosa T, Joseph S, Kibatala P, Lapitan M, Merry A, Moorthy K, Reznick R, Taylor B, Gawande A. A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population. NEJM 2009; 360:491-499.

2.         Haugen AS, Søfteland E, Almeland SK, Sevdalis N, Vonen B, Eide GE, Nortvedt MW, Harthug S. Effect of the World Health Organization Checklist on Patient Outcomes: A Stepped Wedge Cluster Randomized Controlled Trial. Annals of Surgery 2015; 261(5):821-828.

3.         Leape L, Berwick D, Clancy C, Conway J, Gluck P, Guest J, Lawrence D, Morath J, O’Leary D, O’Neill P, Pinakiewicz D, Isaac T. Transforming healthcare: a safety imperative. Quality and Safety in Health Care 2009; 18(6):424-428.

4.         Moran J, Scanlon D. Slow Progress On Meeting Hospital Safety Standards: Learning From The Leapfrog Group’s Efforts. Health Aff (Millwood) 2013; 32(1):27-35.

5.         Nilssen H. Program for pasienttryggleik i Helse Vest 2013. Accessed 06.13, 2016.

6.            Graneheim, U.H. and B. Lundman, Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Education Today, 2004. 24(2): p. 105-112.

7.            Solberg R. Parliament announcement 11 (2015-2016). Nasjonal helse- og sykehusplan (2016-2019). Healthcare Department, ed. Regjeringen.no: Government, 2015. pp. 146.