The public expect safety to be a priority within health services. However, estimates show that as many as one in 10 patients are harmed while receiving hospital care [1
]. Strategies to improve safety have focused on developing incident reporting systems, and changing systems of care and professional behaviour. However, there has recently been a growing interest in involving patients in safety initiatives. Indeed, patient involvement in safety orientated activities very much reflects recent UK government policy aims for people to be generally more involved in their care [5
]. Internationally, patient involvement is also a key priority with the World Health Organisation's World Alliance for Patient Safety (WHO, WAPS) citing mobilisation and empowerment of patients as one of six action areas that will be taken forward in its 'Patients for Patient Safety' programme [7
]. This approach advances the development and use of interventions to promote and support patients' (and their representatives) roles in securing their own safety in health care contexts. Patients are in a unique position to contribute to both learning about safety and improvements to the safety of health care systems, by feeding information about safety issues they have identified or experienced, into local and national safety reporting systems.
Despite international emphasis on patient involvement in safety there is a dearth of research evidence on the acceptability to patients and equivocal evidence to date that such involvement leads to improvements in safety. The evidence that exists indicates that patients are willing and able to participate in error prevention strategies [8
] and have the potential to improve safety [9
]. However, many factors hinder patient participation including acceptance of the new patient role, lack of medical knowledge, lack of confidence, co-morbidity and sociodemographic factors [13
]. Thus, there is clearly a need to understand further how patients can best be involved and how they can act to improve safety of care.
Reason's well known model of organisational safety [14
] states that organisational accidents are a result of a number of factors including active failures on the part of the individual (for example, attentional slips, or mistakes in decision making), and 'systems failures' encompassing latent failures (for example, budgeting or rostering descisions) and local working conditions (for example, equipment unavailable, ward or unit understaffed). These failures are often referred to as 'contributory factors'. Based on these ideas, measurement tools have been developed in high-risk industries to monitor organisations' 'safety health' [15
]. However, currently no general means of assessing organisational safety or 'systems' failures exists within the NHS [although see a recent paper exploring this in relation to operating rooms and intensive care units: [17
]]. Furthermore, no specific measures of organisational safety exist that ask for the views of customers or patients, despite patients being well placed to observe the organisation of their care and the practices around them. Scales measuring patients' perceptions of healthcare are available, for example measures of patient satisfaction [18
] but these have been criticised for being subjective, unreliable and with little validity [21
]. Therefore, there is a need for reliable and valid tools that allow patients the opportunity to provide feedback on the safety of their care environment to inform local and organisational changes to improve patient safety.
Learning from error is a key element of patient safety [23
], and one way to learn is through the reporting and analysis of patient safety incidents. A patient safety incident (PSI) has been defined as "any unintended or unexpected incident which could have or did lead to harm for one or more patients receiving NHS care" [24
]. This definition usefully encompasses a variety of situations relating to patient safety, across both adverse events themselves (e.g. medical, surgical or diagnostic error), and near misses (e.g. situations or processes which could have resulted in preventable harm to a patient, but were averted). Historically, efforts to learn from incident reports have been focused on staff-led reporting systems [25
], with little attention paid to the potential of the patient as a valuable source of information about patient safety [11
]. Indeed, it has been argued by some authors that the patient is uniquely placed to contribute to the quality and safety of their own care [30
], with recent empirical work demonstrating the feasibility and value of patient reporting [for review: [31
]; also [32
]]. However, no study to date has attempted to systematically develop and evaluate the most effective method of patient reporting. In addition, no study has attempted to link reporting of patient safety incidents to mainstream quality improvement mechanisms.
The aim of the current study is to develop and test a patient measure of organisational safety and patient incident reporting tool which will be used separately, or in combination, to help the NHS respond and learn quickly from failures in organisational systems as well as patient safety incidents. Specific objectives related to the development of the two tools are as follows:
Developing the Patient Measure of Organisational Safety (PMOS)
1. To determine the most appropriate way of assessing patients perceptions of organisational safety (study 1)
2. To develop a draft PMOS using previous literature and additional qualitative interviews with patients (study 2)
3. To explore acceptability and understanding of the draft PMOS using semi-structured interviews with patients and health professionals (study 3).
Development of the Patient Incident Reporting Tool (PIRT)
4. Based on views of patients and health professionals, to develop 3 different mechanisms for capturing patient reports of patient safety incidents experienced whilst receiving treatment in hospital (study 4).
5. To identify which of the 3 mechanisms is a) most effective in generating reports and b) most acceptable to patients and health professionals (study 5).
Testing the PMOS and PIRT
6. To explore the effectiveness and reliability of the PMOS in detecting patient perceptions of organisational safety (study 6).
7. To compare the error incidence and quality of reports from the PIRT with other standard methods used in practice (case note review and the trust staff-led incident reporting system) (study 6).