To explore if informative electronic discharge summaries contribute to patient safety and satisfaction following day case cholecystectomy?

Abstract – Discharge summaries should be effective and informative tools for patient and their GP’s when they have been discharged from the hospital setting, however this does not appear to be the case. Patients are being discharged from acute settings with inappropriate, unsafe and unsatisfactory information for both the patients and their community providers. Some researchers who have undertaken topics like this research have found that patients are being left at risk due to lack of information and communication during their discharge, alongside the information lacking to their GPs’. This proposal aims to examine if there is a patient safety issue due to the lack of information being provided on the electronical discharge summaries and measure if patients are happy with the service provision they currently received. A literature review will be undertaking to emphasise any inadequacies between the literature reviewed.

An interpretivist phenomenographic approach will be used for this research, with a sample study of 30 participants undertaking the day case laparoscopic cholecystectomy at a local hospital on the Day Unit. This will be a qualitative study, collating primary data and a semi-structured interviewing technique with a questionnaire that allows the researcher to collect and expand the vital information from the participants. Ethical approval with be requested prior to the commencement of this proposed research. All information obtained from this research will be disseminated and plans will be discussed to improve patient safety, communication and satisfaction on electrical discharge summaries to the community.  255 WORDS

Abbreviations:

Below is a list of abbreviations used within this research proposal:

RCN– Royal College Nursing

RCS – Royal College of Surgeons

GMC– General Medical Council

HIQA – Health Information and Quality Authority

NHS – National Health Service

GP – General Practitioner

50 Words

 Table of Content:             Page

Abstract           2

List of abbreviations         3

Table of contents          4 – 5

Background           6 – 7

Rationale           8

• Objectives          8
• Research Question         8

Literature Review           9 –

• Introduction
• Data Search Strategy
• Themes
• Conclusion

Methodology

• Introduction
• Different Research Paradigms

• Positivism
• Post-Positivism
• Interpretivism
• Constructivism

• Approach
• Study Design
• Sampling Strategy and Sample Size Determination
• Criteria for Sample Selection

• Exclusions criteria
• Data Collection Methods and Tools

• Observation – Structured/Unstructured
• Interviewing – Structured/Unstructured/Semi-Structured
• Questionnaires

• Quality Control

• Validity and Reliability
• Credibility
• Transferability
• Dependability
• Confirmability

• Data Analysis

Ethics

• Autonomy
• Beneficence
• Non-Maleficence
• Confidentiality
• Fidelity
• Justice
• Veracity

Limitations

Dissemination

(120 Words)

Background – Communication appears to be one of the biggest barrier that we currently facing between hospitals families and their community care providers (New, McDougall and Scroggi, 2015). Communicating with patient on discharge is a pivotal aspect of their discharge process in ensuring patients self-manage their care following having laparoscopic cholecystectomy’s (Briggs, et al., 2009). This is also an effective method of gaging patient satisfaction during his process and if the encountering poor communication places increase pressure on the patient and community teams to care for the patient on either inaccurate or partial information (NHS England, 2016). According to the HIQA in 2013, “A safe, reliable healthcare depends on access to, and use of, information that is accurate, valid, reliable, timely, relevant, legible and complete”. Information should be proficiently and effectively shared maintaining all patient data protection regulations is of high importance (HIQA, 2013). Failing to adhere to these can lead delays for patients, and potentially serious consequences which could place the patient at risk, with unnecessary duplications in testing (HIQA, 2013 and NHS England, 2016).

The introduction of laparoscopic cholecystectomies for day-case patients where first performed in May 2005, it was planned to have a performance target rate of 75%, with the care of wounds and post-operative issues falling to the care of the patients GP (Briggs, et al., 2009).

When patients are discharged from hospital it is clearly outlined in the NHS Standards, (2016), that is supported by the ‘Academy of Medical Royal College’, that’ “Clinicians should give sufficient, clear and timely information to all patients (and where appropriate their families, carers, care co-ordinators and key-workers) about results and treatments at discharge”. (NHS England, 2016).

Patients following their procedure and who are ready to be discharge should be have a full explanation as mentioned above, their procedure and any post-operative management plans, if appropriate changes to their medication and any wound care management (HIQA, 2013 and NHS England, 2016). All the essential and informative information should then be documented on the patients’ electronic discharge summary in detail, along with any changes to medication, wound care management etc. and given to the GP within the standard initiative of 48hr time frame (HIQA, 2013 and NHS England, 2016).

It is very apparent when undertaking the literature research for this review that there is a limited amount of information surrounding the topic that is being researched. The researcher has identified areas that has mentioned some of the key words that is being explored and analysed the information that is available.

This research proposal will look at the electronical discharge summaries to explore and identify if there are issues that can be improved within our local hospital regarding the discharge process and communication within these vital tools.

Rationale – It has become an increasing concern that when patients are being discharge from hospital after attending day case cholecystectomies and they are being discharged without the appropriate self-management information, and lack of detailed information for their GP’s (Belleli, Naccarella and Pirotta, 2013). This is having implications on both the patients and the follow-up care that the GP is expected to provide as they do not have the information to base the care giving on (NHS England, 2016).

This is posing a risk to patient safety and when patients are discharged home without the appropriate information or education, more complaints are being received by hospital trusts and NHS England relating to these issues and for some patients’ causes adverse effects and re-admission into hospital (NHS England, 2016).

Objectives – the objectives of this proposal are:

• To identify the type of information provided to patients on discharge summaries.
• To determine if the information supplied on the patient discharge summaries are accurate and relevant.
• To evaluate, understand and improve patients experience during the discharge process of day case cholecystectomies.

Research Question:

• To explore if informative electronic discharge summaries contribute to patient safety and satisfaction following day case cholecystectomy?

Literature Review

Introduction – A literature review enables researchers to find similarities, either positive or constructive, between relevant journals or books that provide theoretical, historical and contextual material to help towards structuring research (Punch, 2016).

The most complex and susceptible time during a patient’s hospital journey is their period of discharge (Markey-Wainga, et al., 2016) When patients are being discharged from hospital it is part of the hospital responsibility to ensure that the patient receives the appropriate follow-up and adequate information to enable the to transfer into the community without any problems (NHS England, 2016). However, this does not appear to be the case, Markey-Wainga, et al., in 2016 stated that patients do not fully understand the discharge instruction they are being given. Belleli, Naccarella and Pirotta, (2013), stated that the transition for healthcare into the community is a high-risk area when handovers are given from one organisation to another healthcare provision. Lehnbom, et al., (2014) agree with this statement, however they focus on the increased risk that insufficient medication information has on patient safety and health, and that numerous studies had shown that on the discharge summaries medications where listed as either inaccurate or incomplete. Hammad, et al., (2014) feel that patient harms are caused through the poor communication and lack of clinical information given by hospital providers to the community carers, Markey-Wainga, et al., (2015) also feel the quality of discharge summaries and instructions varies between providers. The GPs need to ensure that the information that they are receiving relays all the vital information that is needed to help them treat and care for patients in the community, and the medication aspect is the third most vital aspect of a discharge summary, following the diagnosis, and admission (Lehnbom, et al., 2014). Markey-Wainga, et al., (2015) feel that the and quality of the discharge instructions improve patient satisfaction. Belleli, Naccarella and Pirotta in 2013, undertook a review which stated that over 44% of discharge summaries contained no medication information, and that only 34% GPs received the patient’s summary before their appointment. In a different study that was carried out it was reported that 99.1% of the discharge summaries where marked as unclear due to the fact that it had information was missing (Lehnbom, et al., (2014).

It is process in most organisation to evaluate a patient’s satisfaction on their discharge by using patient surveys to help improve patient experience and processes (Markey-Wainga, et al., 2015). New, McDougall and Scroggie, (2015), claim that a large proportion of patients and their families felt the information and communication was poor with regards to their discharge process. A study was undertaken by Markey-Wainga, et al., (2015), which claimed that patients had positive comments regarding the discharge process, however the discharge information needed further work.

Data search Strategy – This literature review was undertaken using Google, the Cochrane library, the Royal College of Surgeons’ (RCS) library, RCN library, Bedford Hospital Library, PubMed database and CINAHL database. The keys words used were: “informative”, “discharge summaries”, “patient safety”, “satisfaction”, “day case” and “cholecystectomy.

Themes – there have been several themes that have been identified whilst undertaking this literature review and these are as follows:

• Incomplete and inappropriate discharge summaries
• Patient safety and risk
• Patient satisfaction was poor regarding the discharge information
• Lack of communication between discharge process and patients

Conclusion – in conclusion to this literature review it is evident that there is currently still issues with discharge summaries being inappropriately written, and the essential information documented in the summaries. There is also issues with the community providers receiving the discharge summaries despite government initiative being put into place for these to be adhered to. It was very difficult, due to the lack of research to find arguments and disagreements against people disagreeing to the issues that have been raised which gives the impression that there are areas of concerns to be explored and one that needs to be addressed nationally.  New, McDougall and Scroggie in 2015, have stated there is currently no strategies on the discharge process regarding research that can improve this.

Methodology

Introduction – Methodology is a vital part of any research paper and sets boundaries for the theoretical and philosophical speculations for how the research should be conducted (Kumar, 2014), which consists of how the overall framework and research strategy will be used via the method or methods adopted and why those were used (how we study the topic) (Little, Carter, 2007 and Punch, 2016). Our perception of nature and life with reality is defined by our ontological opinions which guides our views on the nature of our comprehensive or epistemological perspectives (Creswell, et al., 2018). These are both structured ways of thinking which supports the rational for the chosen method or methods for the research question, which is also known as the methodology (Bunniss and Kelly, 2010).

Ontology can be defined as “the philosophical ground surrounding (the study of) the nature of reality (all that is or exists), and the different entities and categories within reality (what we believe is reality), whereby Epistemology is the “theory of knowledge”, and the exploration to how we reach that knowledge (Creswell, 2013 and Bryman, 2014). Theoretically, epistemology is concerned regards to why we do things a certain way and not others (reality), and ontology is more focused on what the consensus is and how we reached them (knowledge and truth) (Creswell, et al., 2018). These both are important elements within philosophy of knowledge (Scotland, 2012). The term method or methods are used to describe the action/undertaking of the research, and the tools in which you are going to explore your research with (Salazar, Crosby and DiClemente, 2015). In any research study it is pivotal to decide which Method or methods are more appropriate to the research and which are more designed to answer the research question, also to explore any gaps that the research has identified, these methods are used known as ‘paradigms’ (Parahoo, 2014). Little and Carter, (2007) argue that the three essential elements of research are epistemology, methodology, and methods, which if carried out effectively should deliver the framework for the implementing and appraising of the quality of qualitative research (Little and Carter, 2007). Paradigms typically means “model/design or specimens” (Salazar, Crosby and DiClemente, 2015). They are carefully chosen techniques that assist in the application of the data which helps understand circumstantial factors and any relations between these factors (Corbin and Strauss; 2008).

When discussing the principles and approaches to the main paradigms it is essential to have an awareness of the concepts of Qualitative and Quantitative research, and their difference. This allows one to have an insight of the authors rationale for why they choose the research designs and methods they did any not the others.

Quantitative research is also known as ‘empirical research’, as this is used to symbolise an approach to the exploration of the research by means of explored experience which gives the study clarity and reality (Bryman, 2012). This involves methods that explore social interaction by means of statistical and numerical data (Watson, 2015). Sale, Lohfeld and Brazil, (2002), felt that when using quantitative methods, it was very difficult to access some of the spectacles that is encountered within medical elements with research because they are more focused on social interactions and perspectives, such as lived in scenarios. Sale, Lohfeld and Brazil, (2002), the main purpose of quantitative data is measuring and comparing contributing relationships between variables within a purely objective framework.

Qualitative research is known as “a valid research methodology”, and when using qualitative research methods, you are collating open-ended data that is then formed to develop themes (Campbell, 2014). This is a research that is used to understand the context things that happen (for example: life experiences) and the meaning that is relayed to the researcher by the study from the information gained (Parahoo, 2006). Basically, qualitative research undertakes the “why and how of decision making “and Quantitative is research we can measure, verify and find similarities (Creswell, 2013 and Bryman, 2016). Kumar, (2014) feels that using both qualitative and quantitative methods within research can be a very compelling element and is desirable as this gives full understanding and diverse knowledge from different styles within the research. Kumar senses that to stringently use one approach to all the research could lead to complications that are confusing and unsuitable (Kumar, 2014). We will be discussing mixed methods later in this section. Bryman, (2014), discussed the view that there does not seem to be much dissimilarities between qualitative and quantitative other than when undertaking quantitative research, they carry out measurements and qualitative researchers’ do not. He continues to argue that other authors have also suggested that the dissimilarities are not as fabricated as once thought, but more that the existence or absence of quantification (Bryman, 2014).

The mixed method approach has emerged over the past two decades as the third approach, alongside quantitative and qualitative status (Kumar, 2014). This is considered an approach to social enquiry due to being able to incorporate and

combine both quantitative, qualitative research within a single project (Bryman, 2016). However, Kumar, (2014) states that it is yet to develop its adapted body of investigation with methods and procedures, and the important question that splits the two leading paradigms is whether the methodology of the subject being explored can be applied to social singularities (Kumar, 2014). Sale, Lohfeld and Brazil, (2002) stated that the only conclusive dispute for mixing quantitative and qualitative approaches in any given study is to contest the primary assumptions of the two paradigms themselves. A comprehensive argument could be that both qualitative and quantitative approaches are based on the beliefs of positivism, not constructivism or interpretivism (Sale, Lohfeld and Brazil, 2002). Bryman (2016) states that because different epistemological suggestions between two research strategies differs when using mixed methods, counsel researchers not to agree the unsupported expectations that the methods are complementary (Bryman, 2016). Parahoo, (2014), disagree and feel that using mixed methods bring different perspectives to what is being studied. He states that all methods have their own weakness and that using mixed methods provides the research with strength and perspective, whilst also portraying the importance of reality and influence of the human experience (Parahoo, 2016).

The speculations around qualitative and quantitative paradigms arose around the late 19th century during the positivism-idealism debate, and inherited differences scarcely discussed or acknowledged in the using of mixed method designs, this is due to the positivism paradigm becoming the more the prime element of substance in health and social science (Sale, Lohfeld and Brazil, 2002).

Different Research paradigms: – The importance of understanding the different types of paradigms are essential in ascertaining the concepts of the research design and its theoretical background (Creswell, 2013). Saunders, Lewis and Thornhill, (2016) stated, in their opinion some paradigm groups did not affiliate or exhibit the data needed, which made this unsuitable for research methods and therefore it is very important to ensure carefully the paradigms you are using within your research (Saunders, Lewis and Thornhill, 2016).

Punch, (2016) states there are main 4 alternative inquiry paradigms, that are used more predominately than the other paradigms, some of these are:

• positivism,
• post-positivism,
• Interpretivism.
• constructivism.

Positivism – is philosophical position within science and mathematics that produces law-like overviews to be verified through experiment observations, this emphasises the positivist focus on the ‘empiricist method design ‘to ensure real data and facts that are not bias or influenced. (Saunders, Lewis, Thornhill; 2016). It has become the main component within health and social sciences more than any other paradigm and derives from the emphasis on the positives sciences. It focused on testing the systematised experience rather than that of conjecture and unproven theories (Parahoo, 2014). Positivism is an epistemological position that is mainly used with quantitative research, its aim is to produce a hypothesis to enable investigation and allow explanations and theories to prove the objective, by identifying causes which influence outcomes. (Scotland, 2012, Bryman, 2014 and Saunders Lewis, Thornhill, 2016)

Post-positivism – emerged from positivism during the 20th century, (Scotland, 2012). It explores connecting similarities, which is why investigative and corrective studies are used (Creswell, 2103). It is claimed that more than average data is collated and because of this information overload the information collected is uncertain, and on many occasions the hypothesis is not proved but also not rejected (Scotland, 2012). According to Creswell, (2013), post-positivism is element that evaluations and corrects the positivism paradigm. In positivist research, sociologists tend to look for similarities, or ‘correlations’ between two or more variables. This is known as the comparative methods (Bryman, 2016).

Interpretivism – is an approach to social research that is more qualitative, using methods such as unstructured interviews or participant observation, to understand people’s behaviour (Punch, 2016). It has a subjective perspective towards paradigm positivism and was established as a critique of this (Saunders, Lewis and Thornhill, 2016). It is their belief that people are individuals and that everyone experiences life differently despite having the same ‘objective realities’ as to why people act or react the way they do, which is the reason that scientific methods are not appropriate or required (Punch, 2016 and Saunders, Lewis, Thornhill, 2016). This is generally and inductive processes that is mainly used in qualitative research methods, but where a range of data can be interpreted (Saunders, Lewis and Thornhill, 2016). Within the interpretivist domain is incorporated the Phenomenographic approach which has transformed the way that researchers and teachers think about the procedures and results of learning (Stenfors-Hayes, Hult and Dahlgren, 2013). For the past 20 years the phenomenography approach has been effectively used in health and medical research. This approach explores the primary person opinion through their lived experiences through participant interviews (Creswell, 2013)

Constructivism – Many different labels have been used for this paradigm, and constructivists believe that reality is the creation of human intelligence linking with the day to day life experiences and accepts reality as a concept of the human mind, therefore reality is perceived to be subjective (Punch, 2016). Corbin and Strauss, (2008), feel that constructivism means “human being”, and knowledge is constructed or made by the mind as adverse to being discovered. The mind creates perceptions of models and themes from life experiences (reality) which is continuously tested and adapted as further new experiences are explored (Corbin and Strauss, 2008). This paradigm is focused on developing a subjective and inter-subjective understanding stance of the human behaviour (Plack, 2005). Plack, (2005), feels that the constructivist paradigm is the ‘truth’ paradigm, and states, “a matter of the best-informed and most sophisticated construction on which there is consensus at a given time”. This is a qualitative, inductive process and has been documented as a socially constructed and mind dependent paradigm (Plack, 2005).

The paradigm that has been chosen for this this research proposal is the Interpretivism paradigm which is a qualitative process. The reason this has been chosen above any of the others is because it allows the researcher to interview patients who have experienced the same phenomena, but each will have difference perspectives of that experience, and this process allows the researcher to explore why each patient feels the way they do about their experience.

Approach: – When carrying out our day to day activities, we are performing inductive and deductive approaches to gather data, which is different depending on which approach we use (Parahoo, 2014). An inductive approach is known to be a qualitative process and collates empirical data which is gathered to formulate the hypothesis or theory of the research. (Trochim, et al., 2006). The deductive approach is a quantitative process, and is opposite to inductive, as this is an information generated hypothesis, which directs the data collection and analysis dependant on the already collated information that assisted in the hypothesis (Creswell, et al., 2018). Creswell, et al., (2018), also stated that the deductive process is theory based and is focused on the “top – down” approach, using theoretical information i.e. laws/rules and accepted processes. Whilst the inductive process is from the “bottom – up” and uses people opinions to build elements and generate a connection between those elements (Trochim, et al., 2006 and Creswell, et al., 2018).

Study Design: Parahoo, (2014) stated that one of the most important decisions in designing a research is what data is going to be collected and from whom. Cohort, cross sectional, case-control and longitudinal studies are jointly referred to as observational studies and are the studies that are the realistic methods of studying various problems (Mann, 2003) Within medical research studies case control studies change and their goal is to deliver data on the whole population being researched, whereas, case control studies typically include only individuals within a specific characteristic (Schmidt, Cohlmann; 2008). Cohort studies are used to study frequency, causes, prognosis over certain periods and are followed-up over periods of time (Mann, 2003 and Parahoo, 2014). The longitudinal study where data is collated at certain points/intervals, this allows the researcher to highlight any changes or similarities that have taken place over the process of the research (Parahoo, 2014).

According to Mann (2003), the cross-sectional studies are fast and inexpensive which is why it is deemed as a positive and the finest asset to regulate occurrence. A disadvantage to the use of cohorts is that it is mainly used with randomised controlled trials to which they may be unethical, and because this is a randomised control which is a qualitative method (Mann, 2003). All the above are not considered suitable for the research proposal that is being undertaken as they would not allow the appropriate information and interview techniques to be explored effectively, which means that the research would not have the data it needed to analyse the hypothesis.

The Phenomenographic approach of research explores people’s lived experience, and their perceptions of the same experience, and with regards to this research all participants will have undergone a laparoscopic cholecystectomy as a day case, but each will have different perceptions and experiences even though undergoing the same procedure (Stenfors-Hayes, Hult and Dahlgren, 2013).

The study design that will be used for this proposed research is Phenomenographic approach. The advantages of using this design is that it allows the researcher to interview patients who have undertaken ‘the lived experience’, and as mentioned previously this approach allows the researcher to find out what the patients think and feel about the experience they have just undertaken.

Sampling Strategy and Sample Size Determination – Punch, (2016) stated that ‘you can’t study everyone everywhere doing everything’, so it is important to give thought to the sampling aspects that will be using within the research.

A purposeful sampling structure will be undertaken for this research as this allows the researcher to get the full range of possible responses, with as few people as possible, which allows the most diverse participants to be interviewed. This is commonly used in qualitative research and allows the researcher to ascertain the participants who would be able to provide the finest data (Kumar, 2014). With regards to this research it allows the researcher to choose the participant that will hopefully given the more in-depth and informative responses in in-order to utilise the best data.

They are participants of all ages, and genders, who are undergoing the same procedure as a day case procedure, however each patient will all have different co-morbidities and therefore the risks associated could be different.

The sample size of this proposed research will be 30 participants who will be attending the day unit in a set given time.

Criteria for sample selection: The inclusion criteria that have been identified within this research are as follow:

• Patients undertaking a cholecystectomy as a day case procedure.
• Patient who consent and agree to participate in the study.
• Any patients under the age of 18 year
• s of age.
• Any adult male or female over 18 years of age.

The exclusions criteria are as follows:

• Patients who did not given consent to partake in this study.
• Patients that lack capacity, consent for signed in patient’s best interest.
• Patients who are already booked for overnight stay.
• Patients who were admitted overnight following complications after surgery.
• Patients that where operated on late in the afternoon and where not suitable for day case procedure

Data collection methods and tools:

There are many alternative methods and tools to data collection and it is essential that due care and attention is sought when deciding what data collection processes, we are more suitable for the research (Corbin and Strauss, 2008). This ensures full awareness and benefits for the proposed study in gathering the most appropriate data (Gerrish, Lacey and Cormack, 2010). Kumar, (2014) stated that no method of data collection can guarantee 100% accurate and concise information, however the quality that is generated will depend on what design and method is chosen.

Primary data collection is the collating of unique data for a specific objective and means a person/people gather the data from the original source first hand (Kumar, 2014). This can be by means of observation, interviewing, and questionnaires. Observation– There are a few different types of observation designs –         Structured/ Unstructured Observation: is this is a systematic and selective process of observing (watching and listening) to the interactions and occurrences of participates during an observed period (Kumar, 2014).  In structured conservation it allows the questions that are asked to the recipients (if any) would be totally structure pre- arranged questions, with an objective to measure specific aspects of the project being observed (Parahoo, 2014).  Limitations to a structured observed research, is that participants ’movements/behaviour is different when they know they are being watch, and the categorisation of a behaviour and under which sub-heading/unit it would fall under, and therefore it could be disinterested under incorrect area, which leads to misinterpretation of data (Parahoo, 2014).  Un-structured Observation – allows the researcher to undertake the observation in an open and free method ensuring that there should be no pre-determined variables or objectives (Kumar, 2014 and Parahoo, 2014).

Interviewing – this is commonly used with collating information and are many forms of interviewing techniques. When undertaking this process, it is essential to ensure the person to person contact, either by way of face to face, or telephone communication, with a clear objective in mind and with two or more individuals (Kumar, 2014). The research can also record the responses of the participant, and the research can attempt to explore the participants opinions, and beliefs during the interviewing process (Kumar, 2014). Structured/Unstructured Interviewing – Structured is where the interview questions are already present and no deviation from these questions are accepted (Punch, 2016) These can be either open or closed ended questions which have been pre-examined to provide the interpretation needed by the participant, allowing them to perceive the question in their own way (Kumar, 2014). There is no flexibility of that in the unstructured interviewing techniques and the main advantage of using this method is it provided a standard unified approach to the information, which ensures the contrasting of data collated (Kumar, 2014 and Punch, 2016) Unstructured Interviews: is where the researcher is given virtual autonomy with regards to the construction of the observation, contents and the enquiry that are being discussed, changing the format that is being asked if it is deemed appropriate (Kumar, 2014). This is very useful when exploring deeper questing techniques into certain areas, however the limitation to this is the skill set needed by the researcher of having to ask ‘off the cuff’ questions, so would need someone of more experience (Kumar, 2014). This is both a qualitative and quantitative process, as the information obtained would depend on the question being asked. Semi-structure Interviewing – this is more used in adaptable and multi- approach designs and have a structure with regards to the information they want to ascertain, but with more flexibility in the sequencing in the manner it is carried out, to enable more in-depth questioning if the it is deemed appropriate by the researcher (Robson and McCartan; 2016). It was stated by Robson and McCartan; (2016), that the advantages of using this method other that the flexibility this provides is that it is recommended when the researcher is the interviewer and when you have small numbers of participants. This is the reason this structure has been chosen for this project to allow the flexibility to explore the question further if deemed appropriate, for instance, if asking a patient if they understood the information provided, and they reply ‘no’, then the interview could continue this by asking, “what was it you did not understand”?

Questionnaires – there are many different methods that questionnaire can be approached by participants, they can be post mailed, emailed, handed in person and online, plus more, and the type that you use will depend on the research you are undertaking. Questionnaires are the main instrument for accumulating data in survey research, and where uniformed questions that are subjected around the research topics and can sometimes be confused with interviews (Robson and McCartan; 2016).

Secondary data collection is information or data that is collect via another source and used within the research, i.e. documents, publications, previous research and service records etc (Kumar, 2014).  A positive to secondary data is that it is financially more restrained that primary collection, and information may be more obtainable to secondary data collection that that of primary collection (Kumar, 2014).

The using of more that two data collection method is also a valued and repeatedly used approach that helps increase the severity of the research, this also reduces the risk of validity to your research, this method is called the triangulation process.

The method that will be used within the proposed research is the semi-structured interviewing approach, the rationale for using this process is to allow the researcher person to person contact with participants using the basis of structured questions. This also allows autonomy and flexibility whilst undertaking the questioning. The freedom to be able to explore in depth, if appropriate, questions that are not answers adequately, to improve and create a more robust response and gain more valuable feedback.

Quality Control – The importance of validity and reliability within research is pivotal, as without this research would be deemed an unreliable or invalid and therefore would not be meaningful.

Validity tests the suitability of the methods, designs, sampling and data analysis to ensure they are appropriate for the planned research proposal and that the questions are effective to answer the proposed research question, which shows the results and conclusions to be that of a valid context (Leung, 2015).

Reliability in qualitative research is the process of the exact same questionnaire where an independent researcher should be able to arrive at similar/results (Leung, 2015 and Noble, Smith, 2015). It has been argued that these terms are not a suitable framework for qualitative research (Kumar, 2014 and Noble, Smith, 2015). The terms that are deemed suitable are: credibility, transferability, dependability and confirmability (Kumar, 2014 and Noble, Smith, 2015).

Credibility – Patients will be explained thoroughly the study topic and questions to ensure they fully understand the rationale and questions being asked, this is to enable them to reflect their feelings and opinions accurately relating to their experience of the discharge procedure. The use of questionnaire significantly reduces the risk of research bias, as all patients will be asked the same questions in the same manner. Known as internal validity in quantitative research (Noble and Smith, 2015).

Transferability – If the questionnaire was to be used within another study of the same nature or organisation there is no reason at this time that it would produce any difference in results, even if carried out over a longer timescale. Known as external validity in quantitative research (Kumar, 2014).

Dependability–ensuring that all questions are clear and transparent and are not left open to misinterpretation (Noble and Smith, 2015). Patients will be given informative handouts explaining the study topic.  The questionnaire that is going to be used will be piloted prior to the study to assess the inter-rater reliability, which allows time for any amendments to be made (Noble and Smith, 2015). This is also known as reliability within quantitative research (Noble and Smith, 2015).

Confirmability – this is similar to reliability in quantitative study but is also an objectivity domain. Once all the information has been collated and the data has been analysed with the results, this will be checked by a totally independent person to ensure that truth value, consistency and applicability have been explored and no judgements of bias or distortion have been undertaken (Kumar, 2014 and Noble, Smith, 2015).

Data Analysis:

To ensure adequate understanding and interpretation of the data collected for this research

Ethics

All parts of research had ethical aspects, which if not considered could lead to the research being deemed unethical or refused approval, but most importantly could have seriously implications on the participants (Punch, 2016). The researcher must ensure that when compiling the proposed research, they are aware of their organisations ethical policies, and ensure ethical approval is requested and approved, before undertaking the study (Punch, 2016). Ethical research involves human subjects or individuals raises unique and complex ethical, legal, social and political issue (Beauchamp and Childress, 2013).  It is mainly interested in the study of ethical issues that arise when people are involved as participants in research (Wendler, 2017). Ethics is important within clinical research it sets standards and guidelines for the researchers who under take it (Wendler, 2017). This was created following the discovery of inhumane behaviour with participants during research experiments (This was known as the Nuremberg trials). It does agree that research needs to be undertaken, but it ensures the safe standardised practice, as mentioned below in the 7 principles of ethics, and that all patients are treated and maintained the same way.

Ethics is not always followed appropriately as documented during the Tuskegee Syphilis trials that were carried out between 1932 – 1972, and is a great example were ethical concepts are ignored all through the trial and it was ceased in 1972 because it was deemed “ethically unjustified” (Tulchinsky and Varavikova, 2014). The trials focus was to examine 399 already infected African America men, and 201uninfected men of the US public, however none of these participants were informed, aware or consented to partake in the trial (Autonomy) (Tulchinsky and Varavikova, 2014). Participants were also offered forms of bribery/manipulation in the means of: free funerals, insurance and assistance, free transportation to and from examinations, free medications and hot meals on the day of examinations (beneficence, Justice), due to the socio-economic deprivation at this time this was of huge temptation to those who needed food and supplies during this period (Beauchamp and Childress, 2013). Participants were places at risk because when penicillin became available during this trial it was not offered or explained to the participants leaving them infected (Non-maleficence) (Beauchamp and Childress, 2013).

When discussing clinical research, it is important to understand informed consent. This is ensuring patients are given all the information so that they can make an informed decision about their care but also whether to partake in the research (Kumar, 2014). Ensuring the participant is aware of all the aspects of the research, what it entails, what the researcher is hoping to achieve by this research, and any adverse issues that may occur during the research, all information needs to be disclosed (Parahoo, 2014). The research could be deemed unethical and inappropriate should all the information not be disclosed to the participant, or if information is withheld, which could also lead to the ethical approval also being withdrawn.

Ethical approval will be sought from Bedford Hospital Ethical Committee and Anglia Ruskin University Facility of Medical Science Ethical Research Committee. There is no conflict of interest for this research proposal as this is self-funded.

According to Schröder-Bäck, et al., (2014) there are 7 principles within the ethical process, these are:

1. Autonomy – this refers to every individual’s right of self-determination, independence and freedom to make their own choices (Parahoo, 2014). Consent will be requested to access patient medication records and discharge summaries. No identifiable information relating to the patient will be used. The only information obtained will be the age and gender of the patient. The right to withdraw consent is the participants right and respected
2. Beneficence – refers to perception that researchers should always have the wellbeing of the participant as high priority over any research study (Saunders, Lewis and Thornhill; 2016). This research this ensures that the study is being undertaking to improve patient and GP communications with the hospital, and the information contained within the discharge summaries.
3. Nonmaleficence – refers to an obligation to refraining from causing harm to others.  ‘Do no harm’, is an essential code of the Hippocratic tradition, but does not appear in the Hippocratic body (Beauchamp and Childress, 2013, GMC, 2014 and RSC, 2014). The research will give assurance that whilst undertaking this study no participants who have undergone a day case laparoscopic cholecystectomy will be subject to harm, either physical or psychological, and the interview will cease immediately should the participant become unwell during the interview.
4. Confidentiality – The hospital data protection policy will be followed continually, alongside the Data Protection Guidance (2018), which will ensure all patient data is secure and confidential and only used for this research. The interview manuscript/questionnaires will not be disclosed to any third parties and stored within under data protection guidelines. Any information sent will be sent via secure recorded post.
5. Fidelity – this is a devotion to one’s professional duties (Purtillo, 2005). For the proposed research this is gaining a rapport and trust with your participants whilst in hospital, as building trust is essential (Parahoo, 2014).  Assurance will be given that patient can change their mind in partaking in the study should they feel unwell or unwilling to do so.
6. Justice – This is ensuring non-bias, non-judgemental research, and ensuring that the participants needs come before the objective of the study (Parahoo, 2014). All participates will be treated the same and research will not be guided in the researchers favour to get the outcome they want/need (Parahoo, 2014).
7. Veracity – Refers to the being truthful, accurate, and open with participants/patients (Parahoo, 2014). Participants will be given all the information relating to this research from the outset, and all responses will be honest, the participant will be given full disclosure to the information obtained about them. Any violation of a patient’s trust could end up with them withdrawing consent and exiting from the study.

Limitations – the limitations that has been found during this proposed research is as follows:

• The Phenomenographic study design chosen may be limited to the data obtained
• Lack of funding and therefore resources to undertake the research
• Time restraints on undertaking the research

This research proposal did not give sufficient timeframe to communicate with GP practices (this would be another proposed plan for further research).

Dissemination – the findings of this research will be disseminated by the following means:

• Staff/medical meeting to present the findings
• Placed on Hospital intranet
• Report placed on governance information board for staff/patients to read
• Presentation to the Surgical Management Group
• Publication of report findings