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Table 1 Overview of methods and outcome measures

From: Patient safety in Dutch primary care: a study protocol

Objective 1: To determine the frequency, type, impact, and causes of incidents affecting primary care patients

Method: retrospective patient record study

Outcome measures: practice type, patient sex, patient age (category), social status of patient, recording of possible communication problems, patient's risk, number of contacts in study year, urgency of the request for help, having seen health professional(s) outside the practice for the same health problem, accuracy of record keeping, question of whether the event was an incident, description of the incident, action(s) taken afterwards.

Analysis of incidents: type of incident, cause (by Eindhoven Classification Model class [27]), actual harm (by the severity-of-outcome domain of the International Taxonomy of Medical Errors in Primary Care [32]), probability of severe harm or death (as judged by the reviewers).

Objective 2: To determine the type, impact, and causes of incidents reported by healthcare professionals

Method: prospective incident-reporting study.

Outcome measures: information about the reporting person (e.g., function), patient's year of birth. patient's sex, description of the incident, action(s) taken afterwards, possible consequences of the incident, and suggestions how to prevent similar incidents in the future.

Analysis of incidents: type of incident, cause (by Eindhoven Classification Model class [27]), actual harm (as defined by the severity-of-outcome domain of the International Taxonomy of Medical Errors in Primary Care [32]), probability of severe harm or death (as judged by the reviewers).

Objective 3: To get insight into the patient safety management of primary care practices

Method: written survey

Outcome measures:

Practice characteristics (practice type, number of health professionals in the practice, proportion of patients < 75 years old, proportion of patients with low social status, mean number of hours of patient contacts and management tasks per week, and whether the practice has an educational function);

Topics related to quality and safety management (e.g., existence of joint policy, annual report, quality aspects of the annual report, policy plan, quality system, standard procedure for complaints, registration of incidents and near incidents, and method of processing digital data);

Safety culture of the practice (e.g., is it easy to discuss incidents within the practice, learn from each other's mistakes, express concerns about patient care, ask questions for clarity, correct follow-up of incidents, and report concerns about patient safety?).