Governance, audit and research





Learning outcomes


After studying this chapter you should be able to:


Knowledge criteria





  • Understand the principles of storage, retrieval, analysis and presentation of data



  • Discuss the range of uses of clinical data, its effective interpretation and associated confidentiality issues



  • List the basic principles of the Data Protection Act



  • Describe the audit cycle as applied to obstetrics and gynaecology locally and nationally (specifically related to maternal and perinatal mortality)



  • 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



  • Describe the elements of clinical effectiveness, including evidence-based practice, types of clinical trial, evidence classification and grades of recommendation



  • Describe the principles of risk management, including incident reporting



  • Contrast the differences between audit and research



Professional skills and attitudes





  • Consider the principles behind good research design and critical analysis of research, including statistics and ethical issues.





Data collection in the national health service


Patients connect with their doctors either in the primary care or in the hospital settings. 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 work-up 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 healthcare planners is to ensure that the information collected at the primary and secondary interface can then be linked to national databases to define trends in disease patterns, population needs and future health service planning.


The data also helps in carrying out epidemiological studies such as maternal mortality rates. These data also allows international comparisons such as the WHO report on Maternal Mortality and regional comparisons in caesarean section and hysterectomy rates in England.


Sources of data collection and computing systems


GP 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 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:




  • That >90 % of women eligible for cervical cytology have been screened.



Registration of births and deaths


Since 1838 there has been in England and Wales an enforced system of registration of birth and deaths. 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:



  • 1.

    A direct cause of death.


  • 2.

    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 this 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 (HES)


HES collect inpatient administrative and clinical data transcribed from patients’ case notes. The clinical data includes the principle condition causing admission, other relevant conditions and the description and date of any operation performed. The administrative data includes 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 provides 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 has 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. The National Confidential Enquiry into Patient Outcome and Death (NCEPOD) annual report analyses 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 (PNMR) are collected annually. It includes the number of stillbirths during pregnancy and deaths in the first week of life per 1000 live births. It includes all fetuses after 20 weeks of gestation or 500 g. Preterm 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 healthcare delivery among maternity units within a country and also to compare quality of care worldwide.


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.


Data Protection Act


The Data Protection Acts in the UK and Australia seek to strike a balance between the rights of the individual and the sometimes competing interests of those legitimate reasons for using personal information. Staff who hold or process personal data must abide by the following principles.


Personal information must be:




  • Fairly and lawfully processed.



  • Processed for limited purposes.



  • Adequate, relevant and not excessive.



  • Accurate and up to date.



  • Not kept longer than necessary.



  • Processed in accordance with the individual’s rights.



  • Kept secure at all times.



  • Not transferred to other countries unless the country has adequate protection for individuals.



Caldicott principles


In the UK the Caldicott Report (1997) recommended the appointment of a Caldicott Guardian in each NHS organization and that staff who handle patient identifiable information ensure that the Caldicott principles are met whenever information is transferred, i.e., by word of mouth, written, by electronic or any other means.


When you consider undertaking a clinical audit which would require review of case notes, you must seek permission from the Caldicott Guardian of your hospital. This process ensures that you observe the principles of information governance and the data extracted is annonymised. You must not store data on your private computer. You can use authorized encrypted USB drives.




Evidence-based healthcare


Evidence-based practice is the process of systematically finding and using contemporaneous research findings as a basis for clinical decision making and is an integral part of clinical governance framework. In order to facilitate the development of evidence based practice the following processes need to be applied.




  • Identify areas in practice from which clear clinical questions can be formulated.



  • Identify the best related evidence from available literature such as guidelines.



  • Critically appraise the evidence for validity and clinical usefulness.



  • Implement and incorporate relevant findings into practice.



  • Subsequently measure performance against expected outcomes or against peers.



  • Ensure staff are supported and developed through adequate resourcing of evidence-based practice, education and training programmes.



Clinical audit


Clinical audit is the systematic and critical analysis of the quality of clinical care, including the procedures used for diagnosis, treatment, the associated use of resources and the resulting outcome for the patient. Clinical audit should seek to improve the quality and outcome of patient care through clinicians examining and modifying their practice according to standards of what could be achieved based on the best available evidence ( Box B.1 ).


Mar 2, 2019 | Posted by in OBSTETRICS | Comments Off on Governance, audit and research
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