The theoretical framework of assessment

Theories about the conduct of research (the philosophy of science) are important because they have influenced the progression of the systematic and rigorous research practices and methods, and the selection of methods. Scientific research methods entail the methodical or systematic enquiry of the phenomena of interest through thorough investigation using the senses, usually sight and hearing, complimented by technical instruments, correct

measurement, and finally, experimentation through the careful manipulation of an

intervention in controlled conditions and investigation and determination of the outcome. An important characteristic of scientific research methods is that the practice systematic. This means that an established set of guidelines and methods, which are rigorously complied with, and against which the research may be assessed, form its basis. Overall, the goal of scientific research is that the influence of other factors – including the inquirer’s influence – on

research findings is significantly reduced.

In addition to being systematic, it is imperative for scientific research to be rigorously conducted to reduce contamination and improve the precision of research findings through the following processes: comprehensive documentation of the research processes, objective data collection or observation, systematic collection, analysis and interpretation of the data, thorough maintenance of comprehensive research records, validity checks using additional research methods, repeated measures of the phenomena of interest, and reliability – testing by a different trained investigator using the same methods, measurement and analyses tools, to generate the same outputs or results.

The method of enquiry chosen depends on the investigator’s position or their perception of how society works. An investigation, which starts with an idea, followed by development of theories and hypotheses, which are in turn tested by data is termed deduction. If research however starts with data collection followed by constructing hypotheses for testing from them, this method is described as induction. Deductive and inductive analyses form a huge aspect of scientific research and knowledge.

In the current study, both deductive and inductive analyses were relevant: the current

literature suggests that medication errors are common in older patients and in children due to factors, which may include polypharmacy, diminishing pharmacokinetics and

hypotheses are established, and data is collected to test these hypotheses. On the other hand, the systems of identifying, recording and reporting medication errors at Clinical

Commissioning Groups, CCG (and formerly Primary Care Trusts, PCTs) level have not been previously characterised by primary research. The analyses of data generated from PCT/CCG surveys will guide the construction of hypotheses for testing in an inductive process.

Theoretical perspectives or paradigms govern every aspect of a scientific research. Research questions are therefore based on collection of assumptions, called paradigms. Paradigms are essential because they guide the focus and provide frameworks for interpreting findings. The reformulation of theories or perspectives where existing paradigms are altered is in turn provided by research observations. Although an enquirer’s theoretical perspectives cannot be completely ignored throughout a research process, sources of bias, which undermine validity and reliability, should be consciously reduced through the rigorous and objective process of research.

The philosophical framework of deductive logic formed the basis of scientific research previously. Francis Bacon and John Locke established empiricism or inductive methods based on the need for making observations as opposed to just theoretical statements.

Following Karl Popper’s proposal that knowledge is gained by falsification of hypotheses, the hypothetico-deductive method was birthed, and forms the basis of modern scientific methods.

In theory, scientific research methods consist of rules and systems, based on the hypothetico-deductive method against which research can be evaluated. Practically however, scientific research is based on a less formal and somewhat haphazard mix of the rules of deductive and inductive or probabilistic paradigms – ‘a mixture of empirical conception and the certainties of deductive reasoning.

The different types of paradigms, which can be used to inform and guide an investigator’s research, include the following:

 Grounded theory: This is commonly employed in social science. The process of identifying theory from data that has been systematically collected and analyzed is referred to as grounded theory. Most of the hypotheses and concepts are worked out systematically from the data during the course of research to generate a theory from the data. It is a theory, which occurs inductively from the study of the interests it

represents. There is therefore a reciprocal relationship between data collection, analyses and theories.

 Constructivist grounded theory: The Constructivist grounded theory underlines multiple individual realities (Charmaz, 2000 as cited in Bowling, 2014). It involves concurrent data collection and analyses, where analytic codes and categories are developed from the data as opposed to a priori hypotheses, establishing middle-range theories, not grand theories to describe processes, applies theoretical sampling as opposed to representative sampling to verify conceptual categories, and undertaking literature review after the analyses. There is controversy that this theory leads to artificial manipulation of data, which is contradictory to the original theory (Piddephatt, 2006 as cited in Bowling, 2014).

 Positivism: The enquirer’s perception about society governs this method of

investigation. It assumes an external reality, which guides the determination of facts

 Functionalism: This is a positivist approach, which focuses on the social system.

Illness is viewed in relation to its impact on the immediate social system, and the consequences thereof. Anything, which interferes with the social system and its values are described as dysfunctional, and those, which contribute to its functioning as functional. It is a system of holistic science.

 Phenomenology: The phenomenological philosophy proposes that research

observation should come before theory because ‘it initiates, reformulates, deflects and clarifies theory,’ (Merton 1968 as cited in (Bowling, 2014)). Phenomenology is based on the paradigm that knowledge is socially built through the interaction of

individuals, and that this understanding is undermined with the tools of positivism.

Phenomenology is based on individuals’ interaction between individuals in their natural existence. The tools are open-ended, unstructured, in-depth interview or participant observation.

As Ann Bowling surmises, the question should not be about choosing between quantitative methods or positivism and phenomenology or qualitative methods, but about the

identification of novel ways to combine both in studies as they can compliment each other and produce rich research outputs (Bowling, 2014). Qualitative techniques are useful in

straightforward, responsive to valid and reliable investigation. The use of triangulated or multiple methods of enquiry, if anything increase accuracy, validity and provide usefulness of the quantitative data that has been collected. The current research uses a mixed method approach to investigate the prevalence and nature of prescribing and monitoring error in primary care.

The deliberation in this thesis was to acknowledge and understand which paradigm was most appropriate to answer the research questions raised from the literature on medication errors in primary care. Methodological consideration was given to

1. The nature and source of information 2. Access to information and data collection 3. Analyses and interpretation of research findings

4. Implications of conclusions and contribution to existing scientific knowledge

2.3 Positivism

The principles of biomedicine are based on positivism. Positivism accentuates positive facts and aims to identify laws using quantitative methods. It describes a systematic observation and measurement of matter, which are believed to be free from the value judgement of the scientist due to the availability of objective systems of measurement. It is based on the premise that theories are examinable using the deductive principles of the scientific method, and is the central philosophy underlying quantitative scientific methods. In social sciences, Positivism assumes that external stimuli are necessary to alter human behaviour, and that it is possible to investigate social phenomena using the principles of the natural scientist. Surveys and experimental methods, and statistical techniques of analyses are the most popular

positivism tools. Many of the methods used in health and healthcare research are based on the positivist belief. For example, structured interviews reduce the influence of the instrument and the enquirer on the respondent. Positivism is somewhat over dependent of experimental method and does not combine adequately, qualitative methods, which are believed to be able to provide understanding of human behaviour and social processes.

In the current study, the rational principles of the hypothetico-deductive method of positivism was recognised as a theoretical framework for the production of knowledge on medication

errors in primary care based on the investigator’s assumption. The hypothetico-deductive method underlies modern scientific research. In this method, a hypothesis is developed from existing theory, and consequences deduced from that theory are tested against empirical data.

If the hypothesis is false, the enquirer can develop a new one. If not, other tests or enquiries are used to attempt falsification. This means removing falsehood, rather than verifying

theories brings about scientific progress. Operationalism, which states that the principles used in empirical research must be measured in terms of the indicators used to determine them influenced the challenge of accuracy inherent in the scientific hypothetico-deductive method.

With respect to the current research, an operational definition of what constitutes a

prescribing error in primary care is central to achieving objective measurements. A system of rules and procedures, which forms the basis of the research and following the principles of the hypothetico-deductive method, and against which the study can be evaluated constitutes the theory of the modern and rational scientific method. Research needs to be conducted systematically and rigorously while eliminating or reducing sources of bias. In practice however, the distinction between empiricism and deductive reasoning is less marked.

A scientific objective approach to identifying medication errors through the retrospective review of medical records in older patients and in children, using operational definitions, forms and objective assessment of prescriptions, and the use of quantitative and statistical analyses to interrogate the data from these studies, are based on the principles of the scientific hypothetico-deductive or positivist theory based on hypotheses and estimates of predictions that prescribing errors affect these vulnerable patient groups more than the rest of the population.

Although the multidisciplinary group of experts who judged the severity of errors followed established principles and rules of determination of prescribing error severity judging, their judgements were not completely value free as demonstrated by Williams and Ashcroft (Williams & Ashcroft, 2009).

The current study did not seek to explore the meaning of prescribing errors from the patients’

or practitioners’ perspectives in a qualitative or phenomenological enquiry as this was recently studied through focus groups and interviews and published by Slight and colleagues (Slight et al., 2013). However, the findings of Slight and colleagues, and the hypotheses developed thereof, on the causes of prescribing and monitoring errors in primary care have

The aspect of the study, which sought to characterise the PCT/CCG systems of managing medication errors in primary care combines a quantitative deductive and qualitative inductive methods of enquiry. The section below discusses previous studies, which have investigated medication errors and those that employed this strategy.