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1.  Speaking up for patient safety by hospital-based health care professionals: a literature review 
Speaking up is important for patient safety, but often, health care professionals hesitate to voice concerns. Understanding the influencing factors can help to improve speaking-up behaviour and team communication. This review focused on health care professionals’ speaking-up behaviour for patient safety and aimed at (1) assessing the effectiveness of speaking up, (2) evaluating the effectiveness of speaking-up training, (3) identifying the factors influencing speaking-up behaviour, and (4) developing a model for speaking-up behaviour.
Five databases (PubMed, MEDLINE, CINAHL, Web of Science, and the Cochrane Library) were searched for English articles describing health care professionals’ speaking-up behaviour as well as those evaluating the relationship between speaking up and patient safety. Influencing factors were identified and then integrated into a model of voicing behaviour.
In total, 26 studies were identified in 27 articles. Some indicated that hesitancy to speak up can be an important contributing factor in communication errors and that training can improve speaking-up behaviour. Many influencing factors were found: (1) the motivation to speak up, such as the perceived risk for patients, and the ambiguity or clarity of the clinical situation; (2) contextual factors, such as hospital administrative support, interdisciplinary policy-making, team work and relationship between other team members, and attitude of leaders/superiors; (3) individual factors, such as job satisfaction, responsibility toward patients, responsibility as professionals, confidence based on experience, communication skills, and educational background; (4) the perceived efficacy of speaking up, such as lack of impact and personal control; (5) the perceived safety of speaking up, such as fear for the responses of others and conflict and concerns over appearing incompetent; and (6) tactics and targets, such as collecting facts, showing positive intent, and selecting the person who has spoken up.
Hesitancy to speak up can be an important contributing factor to communication errors. Our model helps us to understand how health care professionals think about voicing their concerns. Further research is required to investigate the relative importance of different factors.
PMCID: PMC4016383  PMID: 24507747
Speaking up; Inter-professional relations; Patient care team; Patient safety; Communication
2.  Assessing the patient safety competencies of healthcare professionals: a systematic review 
BMJ quality & safety  2011;20(11):991-1000.
Patient safety training of healthcare professionals is a new area of education. Assessment of the pertinent competencies should be a part of this education. This review aims to identify the available assessment tools for different patient safety domains and evaluate them according to Miller's four competency levels.
The authors searched PubMed, MEDLINE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Web of Science, psycINFO and the Education Resource Information Center (ERIC) from the start of each database to December 2010 for English-language articles that evaluated or described tools for the assessment of the safety competencies of individual medical and/or nursing professionals. Reports on the assessment of technical, clinical, medication and disclosure skills were excluded.
Thirty-four assessment tools in 48 studies were identified: 20 tools for medical professionals, nine tools for nursing professionals, and five tools for both medical and nursing professionals. Twenty of these tools assessed the two highest Miller levels (‘shows how’ and ‘does’) and four tools were directed at multiple levels. Most of the tools that aimed at the higher levels assessed the skills of working in teams (17 tools), risk management (15 tools), and communication (11 tools). Internal structure (reliability, 22 tools) and content validity (14 tools) when described were found to be moderate. Only a small number of tools addressed the relationship between the tool itself and (1) other assessments (concurrent, predictive validity, eight tools), and (2) educational outcomes (seven tools).
There are many tools designed to assess the safety competencies of healthcare professionals. However, a reliable and valid toolbox for summative testing that covers all patient safety domains at Miller's four competency levels cannot yet be constructed. Many tools, however, are useful for formative feedback.
PMCID: PMC3203526  PMID: 21880646
Educational measurement; safety management; professional competence; health professions education; medical education; patient safety; quality measurement; crew resource management; educational outreach; academic detailing; surgery
3.  Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study) 
BMC Surgery  2009;9:4.
Recent non-randomized studies suggest that extended endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, EMR might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, EMR appears to be associated with fewer complications.
The aim of this study is to compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas.
Multicenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma ≥ 3 cm, located between 1–15 cm ab ano, will be randomized to a TEM- or EMR-treatment strategy. For TEM, patients will be treated under general anesthesia, adenomas will be dissected en-bloc by a full-thickness excision, and patients will be admitted to the hospital. For EMR, no or conscious sedation is used, lesions will be resected through the submucosal plane in a piecemeal fashion, and patients will be discharged from the hospital. Residual adenoma that is visible during the first surveillance endoscopy at 3 months will be removed endoscopically in both treatment strategies and is considered as part of the primary treatment.
Primary outcome measure is the proportion of patients with recurrence after 3 months. Secondary outcome measures are: 2) number of days not spent in hospital from initial treatment until 2 years afterwards; 3) major and minor morbidity; 4) disease specific and general quality of life; 5) anorectal function; 6) health care utilization and costs. A cost-effectiveness and cost-utility analysis of EMR against TEM for large rectal adenomas will be performed from a societal perspective with respectively the costs per recurrence free patient and the cost per quality adjusted life year as outcome measures.
Based on comparable recurrence rates for TEM and EMR of 3.3% and considering an upper-limit of 10% for EMR to be non-inferior (beta-error 0.2 and one-sided alpha-error 0.05), 89 patients are needed per group.
The TREND study is the first randomized trial evaluating whether TEM or EMR is more cost-effective for the treatment of large rectal adenomas.
Trial registration number
( NTR1422
PMCID: PMC2664790  PMID: 19284647

Results 1-3 (3)