Developing a research agenda for patient safety in primary care. Background, aims and output of the LINNEAUS collaboration on patient safety in primary care.

This paper is an introduction to a supplement to The European Journal of General Practice, bringing together a body of research focusing on the issue of patient safety in relation to primary care. The supplement represents the outputs of the LINNEAUS collaboration on patient safety in primary care, which was a four-year (2009-2013) coordination and support action funded under the Framework 7 programme by the European Union. Being a coordination and support action, its aim was not to undertake new research, but to build capacity through engaging primary care researchers and practitioners in identifying some of the key challenges in this area and developing consensus statements, which will be an essential part in developing a future research agenda. This introductory article describes the aims of the LINNEAUS collaboration, provides a brief summary of the reasons to focus on patient safety in primary care, the epidemiological and policy considerations, and an introduction to the papers included in the supplement.

Good practice statements on safe laboratory testing: A mixed methods study by the LINNEAUS collaboration on patient safety in primary care.

BACKGROUND: The systems-based management of laboratory test ordering and results handling is a known source of error in primary care settings worldwide. The consequences are wide-ranging for patients (e.g. avoidable harm or poor care experience), general practitioners (e.g. delayed clinical decision making and potential medico-legal implications) and the primary care organization (e.g. increased allocation of resources to problem-solve and dealing with complaints). Guidance is required to assist care teams to minimize associated risks and improve patient safety. OBJECTIVE: To identify, develop and build expert consensus on 'good practice' guidance statements to inform the implementation of safe systems for ordering laboratory tests and managing results in European primary care settings. METHODS: Mixed methods studies were undertaken in the UK and Ireland, and the findings were triangulated to develop 'good practice' statements. Expert consensus was then sought on the findings at the wider European level via a Delphi group meeting during 2013. RESULTS: We based consensus on 10 safety domains and developed 77 related 'good practice' statements (≥ 80% agreement levels) judged to be essential to creating safety and minimizing risks in laboratory test ordering and subsequent results handling systems in international primary care. CONCLUSION: Guidance was developed for improving patient safety in this important area of primary care practice. We need to consider how this guidance can be made accessible to frontline care teams, utilized by clinical educators and improvement advisers, implemented by decision makers and evaluated to determine acceptability, feasibility and impacts on patient safety.

A safety incident reporting system for primary care. A systematic literature review and consensus procedure by the LINNEAUS collaboration on patient safety in primary care.

BACKGROUND: Incident reporting is widely used in both patient safety improvement programmes, and in research on patient safety. OBJECTIVE: To identify the key requirements for incident reporting systems in primary care; to develop an Internet-based incident reporting and learning system for primary care. METHODS: A literature review looking at the purpose, design and requirements of an incident reporting system (IRS) was used to update an existing incident reporting system, widely used in Germany. Then, an international expert panel with knowledge on IRS developed the criteria for the design of a new web-based incident reporting system for European primary care. A small demonstration project was used to create a web-based reporting system, to be made freely available for practitioners and researchers. The expert group compiled recommendations regarding the desirable features of an incident reporting system for European primary care. These features covered the purpose of reporting, who should be involved in reporting, the mode of reporting, design considerations, feedback mechanisms and preconditions necessary for the implementation of an IRS. RESULTS: A freely available web-based reporting form was developed, based on these criteria. It can be modified for local contexts. Practitioners and researchers can use this system as a means of recording patient safety incidents in their locality and use it as a basis for learning from errors. CONCLUSION: The LINNEAUS collaboration has provided a freely available incident reporting system that can be modified for a local context and used throughout Europe.

Patient safety improvement programmes for primary care. Review of a Delphi procedure and pilot studies by the LINNEAUS collaboration on patient safety in primary care.

BACKGROUND: To improve patient safety it is necessary to identify the causes of patient safety incidents, devise solutions and measure the (cost-) effectiveness of improvement efforts. OBJECTIVE: This paper provides a broad overview with practical guidance on how to improve patient safety. METHODS: We used modified online Delphi procedures to reach consensus on methods to improve patient safety and to identify important features of patient safety management in primary care. Two pilot studies were carried out to assess the value of prospective risk analysis (PRA), as a means of identifying the causes of a patient safety incident. RESULTS: A range of different methods can be used to improve patient safety but they have to be contextually specific. Practice organization, culture, diagnostic errors and medication safety were found to be important domains for further improvement. Improvement strategies for patient safety could benefit from insights gained from research on implementation of evidence-based practice. Patient involvement and prospective risk analysis are two promising and innovative strategies for improving patient safety in primary care. CONCLUSION: A range of methods is available to improve patient safety, but there is no 'magic bullet.' Besides better use of the available methods, it is important to use new and potentially more effective strategies, such as prospective risk analysis.

A research agenda on patient safety in primary care. Recommendations by the LINNEAUS collaboration on patient safety in primary care.

BACKGROUND: Healthcare can cause avoidable serious harm to patients. Primary care is not an exception, and the relative lack of research in this area lends urgency to a better understanding of patient safety, the future research agenda and the development of primary care oriented safety programmes. OBJECTIVE: To outline a research agenda for patient safety improvement in primary care in Europe and beyond. METHODS: The LINNEAUS collaboration partners analysed existing research on epidemiology and classification of errors, diagnostic and medication errors, safety culture, and learning for and improving patient safety. We discussed ideas for future research in several meetings, workshops and congresses with LINNEAUS collaboration partners, practising GPs, researchers in this field, and policy makers. RESULTS: This paper summarizes and integrates the outcomes of the LINNEAUS collaboration on patient safety in primary care. It proposes a research agenda on improvement strategies for patient safety in primary care. In addition, it provides background information to help to connect research in this field with practicing GPs and other healthcare workers in primary care. CONCLUSION: Future research studies should target specific primary care domains, using prospective methods and innovative methods such as patient involvement.

[Summary of the 'Stroke' guideline of the Dutch College of General Practitioners' (NHG)]. / Samenvatting van de NHG-standaard 'Beroerte'.

The Dutch College of General Practitioners (NHG) guideline 'Stroke' covers the diagnosis, management and long-term care of stroke in general practice. Patients with neurological symptoms suspected to be due to cerebral infarction or haemorrhage should be transferred directly to a stroke unit. The specialized care provided by these units, including emergency interventions (e.g. intravenous thrombolysis) and early mobilization help improve outcomes. If neurological symptoms have resolved completely, the patient should be referred to a TIA service as soon as possible, preferably within 1 day. Stroke often leads to permanent disability and neuropsychological impairments. The general practitioner (GP) should provide patients and caregivers with information and support, and should be alert to the psychological consequences of stroke, both in patients and caregivers. Secondary prevention measures are started as soon as the diagnosis of stroke is confirmed. GPs should regularly evaluate and monitor risk factors and compliance.

Measuring system safety for laboratory test ordering and results management in primary care: international pilot study.

The systems-based management of laboratory test ordering and results handling is a significant patient safety concern in primary care internationally. In this pilot study, we describe the testing of a method to systematically measure and monitor compliance with basic safe performance in this area in different European primary care settings. The findings show high overall compliance with the safe system measures developed although the data indicates performance variation within and between the different systems audited, which suggests that aspects of the reliability (and safety) of these systems could be improved by care teams. However, the overall utility of the method is still to be determined and this will require testing on a greater scale in more diverse practices with larger samples of patients and blood tests, and using different technology support systems.

Organisational targets of patient safety improvement programs in primary care; an international web-based survey.

BACKGROUND: Organisational problems contribute to many errors in healthcare delivery. Our objective was to identify the most important organisational items in primary care which could be targeted by programs to improve patient safety. METHODS: A web-based survey was undertaken in an international panel of 65 experts on patient safety from 20 countries. They were asked to rate 52 patient safety items on a five-point Likert scale which regards importance of each item for use for educational interventions to improve patient safety. RESULTS: The following 7 organizational items were regarded 'extremely important' by more than 50% of the experts: the use of sterile equipment with small surgical procedures (63%), the availability of adequate emergency drugs in stock (60%), regular cleaning of facilities (59%), the use of sterile surgical gloves when recommended (57%), the availability of at least one adequately trained staff member to deal with collapse and need for resuscitation (56%), adequate information handover when a patient is discharged from the hospital (56%) and periodically training of GPs in basic life support and other medical emergencies (53%). CONCLUSION: Seven organisational items were consistently prioritized; other items may be relevant in specific countries only. The logical next step is to develop and evaluate interventions targeted at these items.

Complaints against family physicians submitted to disciplinary tribunals in the Netherlands: lessons for patient safety.

PURPOSE We analyzed the disciplinary law verdicts concerning family physicians, submitted to the Dutch disciplinary law system, to identify domains of high risk of harm for patients in family practice. METHODS The Dutch disciplinary law system offers patients the opportunity to file complaints against physicians outside a legal malpractice system, without possibility of financial compensation in case of verdicts in which the physician was found to be at fault. We performed an analysis of 250 random disciplinary law verdicts on Dutch family physicians submitted to disciplinary tribunals and published between 2008 and 2010. Our analysis focused on clinical domains represented in the verdicts with serious permanent damage or death. RESULTS Of the 74 complaints with a serious health outcome, 44.6% (n = 33) were related to a wrong diagnosis, 23.0% (n = 17) to insufficient care, 8.1% (n = 6) to a wrong treatment, 8.1% (n = 6) to a late arrival at a house visit, 5.4% (n = 4) to a late referral to the hospital, and 1.4% (n = 1) to insufficient information given; 9.5% (n = 7) consisted of other complaints. The wrong or late diagnosis-related cases mostly consisted of myocardial infarction and stroke (35.1%) and malignancies (33.7%). The family physician was disciplined as a result of 37 of these 74 complaints (50%). Logistic regression analysis showed that a serious outcome was associated with a higher probability of disciplinary measures (B=0.703; P =.02) CONCLUSIONS The disciplinary law system in the Netherlands differs fundamentally from a legal malpractice system. It can be used to learn from patients' complaints with a view on improving patient safety.

What do primary care physicians and researchers consider the most important patient safety improvement strategies?

BACKGROUND: Although it has been increasingly recognised that patient safety in primary care is important, little is known about the feasibility and effectiveness of different strategies to improve patient safety in primary care. In this study, we aimed to identify the most important strategies by consulting an international panel of primary care physicians and researchers. METHODS: A web-based survey was undertaken in an international panel of 58 individuals from eight countries with a strong primary care system. The questionnaire consisted of 38 strategies to improve patient safety. We asked the respondents whether these strategies were currently used in their own country, and whether they felt them to be important. RESULTS: Most of the 38 presented strategies were seen as important by a majority of the participants, but the use of strategies in daily practice varied widely. Strategies that yielded the highest scores (>70%) regarding importance included a good medical record system (82% felt this was very important, while 83% said it was implemented in more than half of the practices), good telephone access (71% importance, 83% implementation), standards for record keeping (75% importance, 62% implementation), learning culture (74% importance, 10% implementation), vocational training on patient safety for GPs (81% importance, 24% implementation) and the presence of a patient safety guideline (81% importance, 15% implementation). CONCLUSION: An international panel of primary care physicians and researchers felt that many different strategies to improve patient safety were important. Highly important strategies with poor implementation included a culture that is positive for patient safety, education on patient safety for physicians, and the presence of a patient safety guideline.

Prevalence and consequences of patient safety incidents in general practice in the Netherlands: a retrospective medical record review study.

BACKGROUND: Patient safety can be at stake in both hospital and general practice settings. While severe patient safety incidents have been described, quantitative studies in large samples of patients in general practice are rare. This study aimed to assess patient safety in general practice, and to show areas where potential improvements could be implemented. METHODS: We conducted a retrospective review of patient records in Dutch general practice. A random sample of 1,000 patients from 20 general practices was obtained. The number of patient safety incidents that occurred in a one-year period, their perceived underlying causes, and impact on patients' health were recorded. RESULTS: We identified 211 patient safety incidents across a period of one year (95% CI: 185 until 241). A variety of types of incidents, perceived causes and consequences were found. A total of 58 patient safety incidents affected patients; seven were associated with hospital admission; none resulted in permanent disability or death. CONCLUSIONS: Although this large audit of medical records in general practices identified many patient safety incidents, only a few had a major impact on patients' health. Improving patient safety in this low-risk environment poses specific challenges, given the high numbers of patients and contacts in general practice.

Patient safety in Dutch primary care: a study protocol.

BACKGROUND: Insight into the frequency and seriousness of potentially unsafe situations may be the first step towards improving patient safety. Most patient safety attention has been paid to patient safety in hospitals. However, in many countries, patients receive most of their healthcare in primary care settings. There is little concrete information about patient safety in primary care in the Netherlands. The overall aim of this study was to provide insight into the current patient safety issues in Dutch general practices, out-of-hours primary care centres, general dental practices, midwifery practices, and allied healthcare practices. The objectives of this study are: to determine the frequency, type, impact, and causes of incidents found in the records of primary care patients; to determine the type, impact, and causes of incidents reported by Dutch healthcare professionals; and to provide insight into patient safety management in primary care practices. DESIGN AND METHODS: The study consists of three parts: a retrospective patient record study of 1,000 records per practice type was conducted to determine the frequency, type, impact, and causes of incidents found in the records of primary care patients (objective one); a prospective component concerns an incident-reporting study in each of the participating practices, during two successive weeks, to determine the type, impact, and causes of incidents reported by Dutch healthcare professionals (objective two); to provide insight into patient safety management in Dutch primary care practices (objective three), we surveyed organizational and cultural items relating to patient safety. We analysed the incidents found in the retrospective patient record study and the prospective incident-reporting study by type of incident, causes (Eindhoven Classification Model), actual harm (severity-of-outcome domain of the International Taxonomy of Medical Errors in Primary Care), and probability of severe harm or death. DISCUSSION: To estimate the frequency of incidents was difficult. Much depended on the accuracy of the patient records and the professionals' consensus about which types of adverse events have to be recognized as incidents.

Patient safety in primary care has many aspects: an interview study in primary care doctors and nurses.

RATIONALE, AIMS AND OBJECTIVES: Scientific definitions of patient safety may be difficult to apply in routine health care delivery. It is unknown what primary care workers consider patient safety. This study aimed to clarify the concept of patient safety in primary care. METHODS: We held 29 semi-structured interviews with a purposeful sample of primary care doctors and nurses regarding their perceptions of patient safety. The answers were analysed in an iterative procedure with respect to common themes. RESULTS: A broad range of specific aspects of primary care were named in relation with patient safety. Medication safety was most frequently mentioned. Most items were categorized as organizational, while the remaining aspects were linked to culture or professionalism. Scientific definitions of patient safety were not mentioned, but some primary care workers gave 'do not harm the patient' as a short definition for patient safety. CONCLUSION: Patient safety programmes have mostly targeted specific issues, such as incident reporting and medication safety. However, doctors and practice nurses had a broad view of what constitutes patient safety in primary care. This has implications for the measurement and improvement of patient safety in primary care.

Patient safety features are more present in larger primary care practices.

OBJECTIVES: This study aimed to explore whether specific characteristics of a general practice organization were associated with aspects of patient safety management. METHODS: Secondary analysis of data from 271 primary care practices, collected in 10 European countries. These data were collected by a practice visitor and physician questionnaires. For this study we constructed 10 measures of patient safety, covering 45 items as outcomes, and 6 measures of practice characteristics as possible predictors for patient safety. RESULTS: Eight of the 10 patient safety measures yielded higher scores in larger practices (practices with more than 2 general practitioners). Medication safety (B 0.64), practice building safety (B 0.49) and incident reporting items (B 0.47) showed the strongest associations with practice size. Also measures on hygiene (B 0.37), medical record keeping (B 0.30), quality improvement (B 0.28), professional competence (B 0.24) and organized patient feedback items (B 0.24) had higher scores in larger practices. CONCLUSION: Larger general practice practices may have better safety management, although through our measurements no causal relationship could be established in this study.

Patient safety in primary care: a survey of general practitioners in The Netherlands.

BACKGROUND: Primary care encompasses many different clinical domains and patient groups, which means that patient safety in primary care may be equally broad. Previous research on safety in primary care has focused on medication safety and incident reporting. In this study, the views of general practitioners (GPs) on patient safety were examined. METHODS: A web-based survey of a sample of GPs was undertaken. The items were derived from aspects of patient safety issues identified in a prior interview study. The questionnaire used 10 clinical cases and 15 potential risk factors to explore GPs' views on patient safety. RESULTS: A total of 68 GPs responded (51.5% response rate). None of the clinical cases was uniformly judged as particularly safe or unsafe by the GPs. Cases judged to be unsafe by a majority of the GPs concerned either the maintenance of medical records or prescription and monitoring of medication. Cases which only a few GPs judged as unsafe concerned hygiene, the diagnostic process, prevention and communication. The risk factors most frequently judged to constitute a threat to patient safety were a poor doctor-patient relationship, insufficient continuing education on the part of the GP and a patient age over 75 years. Language barriers and polypharmacy also scored high. Deviation from evidence-based guidelines and patient privacy in the reception/waiting room were not perceived as risk factors by most of the GPs. CONCLUSION: The views of GPs on safety and risk in primary care did not completely match those presented in published papers and policy documents. The GPs in the present study judged a broader range of factors than in previously published research on patient safety in primary care, including a poor doctor-patient relationship, to pose a potential threat to patient safety. Other risk factors such as infection prevention, deviation from guidelines and incident reporting were judged to be less relevant than by policy makers.

A cluster randomized controlled trial aimed at implementation of local quality improvement collaboratives to improve prescribing and test ordering performance of general practitioners: study protocol.

BACKGROUND: The use of guidelines in general practice is not optimal. Although evidence-based methods to improve guideline adherence are available, variation in physician adherence to general practice guidelines remains relatively high. The objective for this study is to transfer a quality improvement strategy based on audit, feedback, educational materials, and peer group discussion moderated by local opinion leaders to the field. The research questions are: is the multifaceted strategy implemented on a large scale as planned?; what is the effect on general practitioners' (GPs) test ordering and prescribing behaviour?; and what are the costs of implementing the strategy? METHODS: In order to evaluate the effects, costs and feasibility of this new strategy we plan a multi-centre cluster randomized controlled trial (RCT) with a balanced incomplete block design. Local GP groups in the south of the Netherlands already taking part in pharmacotherapeutic audit meeting groups, will be recruited by regional health officers. Approximately 50 groups of GPs will be randomly allocated to two arms. These GPs will be offered two different balanced sets of clinical topics. Each GP within a group will receive comparative feedback on test ordering and prescribing performance. The feedback will be discussed in the group and working agreements will be created after discussion of the guidelines and barriers to change. The data for the feedback will be collected from existing and newly formed databases, both at baseline and after one year. DISCUSSION: We are not aware of published studies on successes and failures of attempts to transfer to the stakeholders in the field a multifaceted strategy aimed at GPs' test ordering and prescribing behaviour. This pragmatic study will focus on compatibility with existing infrastructure, while permitting a certain degree of adaptation to local needs and routines.

Variation in requests for imaging investigations by general practitioners: a multilevel analysis.

OBJECTIVES: To describe the variation in the numbers of imaging investigations requested by general practitioners (GPs) and to find likely explanations for this variation. METHODS: Cross-sectional survey of the use of eight imaging investigations by 229 GPs collaborating in 40 local GP groups from five regions in the Netherlands during 1997. A multivariable, multilevel regression analysis was used to link these data with survey data on professional characteristics such as knowledge about and attitude towards test ordering, and with data on contextual factors such as practice type or experience with feedback on test-ordering data. RESULTS: Data for 221 GPs (97%) were available. After adjustment for practice size and working time, the median number of imaging investigations ordered per GP was 148 (interquartile range 71 to 300), with large differences (up to twofold) between the regions (P<0.001). Overall, chest X-rays were the largest single category (median = 48 interquartile range 17 to 100). GPs working in a group practice requested, on average, 34% fewer investigations than their colleagues working in single-person practices (95% confidence interval 17 to 48%). CONCLUSIONS: Only practice type was found to be associated with the number of imaging investigations requested, adjusted for practice size and working time factor. No further explanations were found for the inter-regional differences. Future studies on the ordering of imaging investigations by GPs should attempt to delineate contextual from regional factors.

Improving test ordering in primary care: the added value of a small-group quality improvement strategy compared with classic feedback only.

PURPOSE: We wanted to evaluate the added value of small peer-group quality improvement meetings compared with simple feedback as a strategy to improve test-ordering behavior. Numbers of tests ordered by primary care physicians are increasing, and many of these tests seem to be unnecessary according to established, evidence-based guidelines. METHODS: We enrolled 194 primary care physicians from 27 local primary care practice groups in 5 health care regions (5 diagnostic centers). The study was a cluster randomized trial with randomization at the local physician group level. We evaluated an innovative, multifaceted strategy, combining written comparative feedback, group education on national guidelines, and social influence by peers in quality improvement sessions in small groups. The strategy was aimed at 3 specific clinical topics: cardiovascular issues, upper abdominal complaints, and lower abdominal complaints. The mean number of tests per physician per 6 months at baseline and the physicians' region were used as independent variables, and the mean number of tests per physician per 6 months was the dependent variable. RESULTS: The new strategy was executed in 13 primary care groups, whereas 14 groups received feedback only. For all 3 clinical topics, the decrease in mean total number of tests ordered by physicians in the intervention arm was far more substantial (on average 51 fewer tests per physician per half-year) than the decrease in mean number of tests ordered by physicians in the feedback arm (P = .005). Five tests considered to be inappropriate for the clinical problem of upper abdominal complaints decreased in the intervention arm, with physicians in the feedback arm ordering 13 more tests per 6 months (P = .002). Interdoctor variation in test ordering decreased more in the intervention arm. CONCLUSION: Compared with only disseminating comparative feedback reports to primary care physicians, the new strategy of involving peer interaction and social influence improved the physicians' test-ordering behavior. To be effective, feedback needs to be integrated in an interactive, educational environment.

Block design allowed for control of the Hawthorne effect in a randomized controlled trial of test ordering.

BACKGROUND AND OBJECTIVE: To evaluate the value of balanced incomplete block designs in quality improvement research, and their capacity to control for the Hawthorne effect. METHODS: General practitioners teams were randomized into three arms and received an intervention on test ordering, relating to tests for two groups of clinical problems (A tests and B tests). In the two trials within the block design, we tried to control for the Hawthorne effect by comparing the complete intervention in both arms on either the A (arm I) or B tests (arm II); the arms acted as blind controls for each other. In the classical trial, the complete intervention on B tests (arm II) was compared with a control arm without any intervention on B tests (arm III). RESULTS: The trials with the block design yielded statistically significant changes in the numbers of A tests ordered (P=.013), but not in the numbers of B tests ordered (P=.29). In the classical design, the complete intervention reached a marginally significant change in the B tests (P=.068). The Hawthorne effect was the same for both arms of the block design. In the classical design, the effect could to some extent be attributed to the Hawthorne effect. CONCLUSION: Our block design allowed us to control for the Hawthorne effect. Suitable use of block designs may further our knowledge of nonspecific effects in quality improvement research.

Comparing cost effects of two quality strategies to improve test ordering in primary care: a randomized trial.

OBJECTIVE: To determine the costs and cost reductions of an innovative strategy aimed at improving test ordering routines of primary care physicians, compared with a traditional strategy. DESIGN: Multicenter randomized controlled trial with randomization at the local primary care physicians group level. SETTING: Primary care: local primary care physicians groups in five regions of the Netherlands with diagnostic centers. STUDY PARTICIPANTS: Twenty-seven existing local primary care physicians groups, including 194 primary care physicians. INTERVENTION: The test ordering strategy was developed systematically, and combined feedback, education on guidelines, and quality improvement sessions in small groups. In regular quality meetings in local groups, primary care physicians discussed each others' test ordering behavior, related it to guidelines, and made individual and/or group plans for change. Thirteen groups engaged in the entire strategy (complete intervention arm), while 14 groups received feedback only (feedback arm). MAIN OUTCOME MEASURE: Running costs, development costs, and research costs were calculated for the intervention period per primary care physician per 6 months. The mean costs of tests ordered per primary care physician per 6 months were assessed at baseline and follow-up. RESULTS: The new strategy was found to cost 702.00, while the feedback strategy cost 58.00. When including running costs only, the intervention was found to cost 554.70, compared with 17.10 per primary care physician per 6 months in the feedback arm. When excluding opportunity costs for the physicians' time spent, the intervention was found to cost 92.70 per physician per 6 months in the complete intervention arm. The mean costs reduction that physicians in that arm achieved by reducing unnecessary tests was 144 larger per physician per 6 months than the physicians in the feedback arm (P = 0.048). CONCLUSION: On the basis of our findings, including the expected non-monetary benefits, we recommend further long-term effect and cost-effect studies on the implementation of the quality strategy.