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Governance, audit and research
Learning Outcomes
After studying this appendix you should be able to:
Knowledge criteria
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Understand the principles of storage, retrieval, analysis and presentation of data.
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Discuss the range of uses of clinical data, its effective interpretation and associated confidentiality issues.
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List the basic principles of the Data Protection Act.
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Describe the audit cycle as applied to obstetrics and gynaecology locally and nationally (specifically related to maternal and perinatal mortality).
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Discuss the role of guidelines, integrated care pathways and protocols, e.g. National Institute for Health and Clinical Excellence and the Royal College of Obstetricians and Gynaecologists guidelines.
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Describe the elements of clinical effectiveness, including evidence-based practice, types of clinical trial, evidence classification and grades of recommendation.
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Describe the principles of risk management, including incident reporting.
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Contrast the differences between audit and research.
Professional skills and attitudes
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Consider the principles behind good research design and critical analysis of research, including statistics and ethical issues.
Data collection in the National Health Service (NHS)
Patients connect with their doctors either in the primary care or in the hospital setting. The first interface usually occurs in the primary care setting, and that accounts for 80% of contact between the patient and the health system.
In the hospital setting, patients are seen either in outpatient clinics or as an emergency through acute admission units. A small proportion of patients will eventually be admitted to inpatient beds, either for further diagnostic workup or requiring surgical or medical intervention. At each stage of the patient’s journey, information is collected either in paper form (case notes) or entered into electronic data systems (paperless notes).
The challenge for health care planners is first to ensure that the information collected at the primary and secondary interfaces can then be linked to national databases to define trends in disease patterns, population needs and future health service planning.
The second challenge is to assure that data sets are robust and ‘clean’ in such a format which can be easily analyzed. These data help in carrying out epidemiological studies such as maternal mortality rates. These data also allow international comparisons such as the World Health Organization (WHO) report on Maternal Mortality and regional comparisons in caesarean section and hysterectomy rates in England. Third, local quality improvement projects and cost efficiency heavily depend upon the accuracy of these data. NHS Right Care, a division of NHS England, provides data to commissioners for potential cost improvement in delivery of health care.
Sources of data collection and computing systems
General practitioner consultations and registrations
All patient interfaces with primary care are captured so that a picture can evolve on why patients are making contact with their general practitioners (GPs), such as diagnosis of depression, upper respiratory tract infection, arthritis, minor injuries, vaginal bleeding, contraceptive requirements, etc. Furthermore these data can also be used to meet national quality targets by setting alert signals, for example:
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That >90% of women eligible for cervical cytology have been screened
Registration of births and deaths
Since 1838 there has been an enforced system of registration of birth and deaths in England and Wales. As a junior doctor, you may be asked to complete a death certificate. It is important to follow the instructions carefully and make correct entries. A death certificate has two sections:
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A direct cause of death
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Contributory factors to the cause of death
It is a legal requirement to register all births irrespective of the place of birth. Therefore, it is possible to accurately know what proportion of babies have been born at home or in obstetric units.
Using these data, it is also possible to study in detail the changes in birth rates and death rates per 1000 population. Subtraction of the death rates from the birth rates gives the annual growth rate of a population.
Hospital Episode Statistics
Hospital Episode Statistics (HES) collects inpatient administrative and clinical data transcribed from patients’ case notes. The clinical data include the principal condition causing admission, other relevant conditions and the description and date of any operation performed. The administrative data include the date the patient was put on the waiting list, the source and date of admission, the specialty, the date of discharge or death and the destination on discharge or transfer. The data provide overall activity data such as number of operations performed such as hysterectomies and caesarean sections, and this information can be used in the planning of hospital services such as local needs for maternity beds.
Mortality rates statistics
These are calculated from hospital admissions. The maternal mortality data in the UK have been reported through a triennial report since 1952. These reports tell us that major postpartum haemorrhage, hypertensive disease of pregnancy, infection and venous embolic disease remain the major causes for maternal deaths. However, since 2012, the maternal mortality report is now published on an annual basis and addresses one particular theme making a bigger contribution towards maternal deaths. The National Confidential Enquiry into Patient Outcome and Death (NCEPOD) annual report analyzes data on perioperative deaths and has reported that only 22% of the high-risk group were cared for in a critical care unit, thus receiving suboptimal care leading to their deaths.
Data on perinatal mortality rates (PNMRs) are collected annually. They include the number of stillbirths during pregnancy and deaths in the first week of life per 1000 live births. These data include all fetuses after 20 weeks of gestation or 500 g. Pre-term births are the most common cause of perinatal death, followed by birth defects and small-for-gestation babies. PNMR is a major marker used to compare the quality of health care delivery among maternity units within a country and to compare quality of care worldwide. The Royal College of Obstetricians and Gynaecologists (RCOG) has been funded to study all stillbirths in depth to identify underlying cause(s) in each case to see if antenatal or intrapartum policy changes within obstetric units can reduce these losses. The RCOG publishes an annual report, Every Baby Counts, which is accessible at www.rcog.org.uk .
Morbidity rates statistics
Hospital admissions data are utilized to look at the morbidity data related to specific diseases: for example, pregnancy-related morbidity data are captured by calculating the incidence of major postpartum haemorrhage (blood loss >2.5 L), admission to intensive care unit following delivery, stroke during pregnancy, pulmonary embolism and deep vein thrombosis, etc. In Scotland all cases of severe maternal morbidity are reported to NHS Quality Improvement Scotland, and an annual report (near-miss survey) is published showing comparative data for all the obstetric units.
Research and data linkage
Linkage of records gives us a picture of the full course of illness and of the different illnesses occurring in the life of an individual. It is also possible to use record linkage between different databases to develop quality indicators such as patients’ re-admission rates within 28 days with a diagnosis of deep vein thrombosis or the number of patients having a re-operation.
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