Type: DissertationSubject: HealthcarePages: 80 , Double Spacing (275 words/page)Academic level: MasterSources: 60Style: HarvardOrder Description to investigate the impact of a change in protocol for t

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to investigate the impact of a change in protocol for the medical management of a first trimester miscarriage. change in nice guidance

Type: DissertationSubject: HealthcarePages: 80 , Double Spacing (275 words/page)Academic level: MasterSources: 60Style: HarvardOrder Description to investigate the impact of a change in protocol for t
Introduction and literature review Justification for the study What is already known What needs to be researched Methodology and fieldwork How the research will be undertaken and why With whom the research will be undertaken and why How data will be collected Analysis and Discussion What lies within the data? Application of the literature to the findings Relevance of the findings to practice What has been discovered and what is new? The purpose of this guide is to set out clearly the objectives, structures and processes of the dissertation and to provide guidance that will be of help to the student. It should be read through carefully and kept for reference. This guide should be read in conjunction with the student programme handbook. Eligibility to start dissertation Students can only start their Dissertation after they have accumulated 120 credits as per programme requirements. Some programmes have a compulsory “must pass component” prior to this module. Topic Selection In selecting a topic for your dissertation, you should first identify one that is of relevance to your practice, of personal interest, and is manageable, in terms of access to relevant people, information, equipment and the amount of time available to gather data. The dissertation should be defined and you should avoid developing too many areas for investigation- typically within a Masters dissertation one phase of research only is undertaken. Learning and Teaching Strategies To help you with your planning, four workshop sessions will be delivered by the module leader and members of the team. Note that these are not formal teaching; instead they will encourage you to build on the learnt materials from HEST 5001 and other modules, through discussion within the group and identification of key texts. For full time students on the MSc Nursing the module leader will arrange a series of tutorials in semester one, which will prepare your for collection of materials in semester two, and writing up in semester three. Module Aims and Learning Outcomes By the end of the module the student will be able to; Critically discuss the identification of research topic and the production of a research proposal which, where necessary, involves gaining ethical approval Critically debate and analyse the justification of an appropriate methodology for their chosen research area Critically analyse and evaluate the literature related to their chosen research area, synthesizing unique practice related insights into the cited literature Critically evaluate the methods of collection and analysis of data at an advanced level Synthesize sustainable conclusions from research of their chosen topic area and make recommendations for future research or practice innovation Module Characteristics This module is designed to provide students with the opportunity to undertake a major piece of original research, which will incorporate and test both the academic and practice elements of the course Indicative Module Content The module involves devising and designing a research project and the submission of proposals for research. Ethical procedures and gaining access to sources of investigation are also an essential part of the module. The postgraduate student will also use the skills of analysing research using theoretical perspectives. They will endeavour to produce work that is potentially unique, and which provides a basis of innovation in the student’s practice area. Assessment of Dissertation The dissertation will be assessed in the light of the following criteria, the student having: Undertaken a comprehensive literature search, including, where appropriate, non-traditional sources and been able to complete a literature review which critically explores a range of perspectives and contemporary debates. Demonstrated understanding by planning and conducting an investigation using research design(s)/method(s) appropriate to the field of study. Clearly presented findings appropriate to the evidence and the research question(s)/ focus and research objectives. Drawn on academic and professional understanding in offering a critical analysis and discussion of the data. Identified and discussed the main issues which arise through the dissertation, particularly in relation to theory building and practice development. Employed accurate and consistent referencing and references according to prescribed guidelines. Presentation of the Dissertation The dissertation must be word processed using a size 12 font. It should be 1.5 spaced on A4 paper. Printing should be on one side of the page only All pages must be numbered Abbreviations: These should be explained in full where they are first used. If abbreviations are used repeatedly, provide a glossary at the beginning of the work, e.g. after the contents page. Referencing must follow the revised Harvard system. Correct referencing is essential for degree level work. Marks will be lost for inadequate referencing. Two bound copies must be submitted on the agreed date. One copy will be retained. The standard regulations for extensions and deferrals apply to the dissertation. A standard dissertation front page is included at the back of the module guide. Standard marking guidelines will be used, and are included in the module guide. Excellent academic technique is expected for your dissertation. Do not lose marks through poor technique. This includes lapses of: Referencing Grammar Structure Vocabulary You must make full use of your dissertation supervisor to plan and review your work to get good marks.
Type: DissertationSubject: HealthcarePages: 80 , Double Spacing (275 words/page)Academic level: MasterSources: 60Style: HarvardOrder Description to investigate the impact of a change in protocol for t
Title  To investigate the impact of a change in protocol for the medical management of a first trimester miscarriage.   Introduction   In recent years there have been changes in the way that first trimester miscarriage is managed and treated (Nielson et al 2013). Miscarriage is when a pregnancy ends before the fetus would be considered able to survive outside the uterus (National Institute of Health and Care Excellence [NICE] 2017. In the UK,  this is considered to be before 24 weeks’ gestation and is more common in the first trimester, the first twelve weeks of pregnancy (Schreiber, Crenin, Alto et al 2018).  It is thought to occur in one in four pregnancies so therefore represents a large number of appreciable morbidity in both primary and secondary care (Lusink, Wong, De Vries et al 2018). Initial presentation to medical services is often associated with lower abdominal pain in early pregnancy, with or without vaginal bleeding (Schreiber, Crenin, Alto et al 2018). Vaginal bleeding and or abdominal pain in early pregnancy is the most common reason for women to attend emergency gynaecology departments and accounts for 50,000 inpatient episodes in the UK annually (Bourne 2015). It must be noted that not all patients that present with pain and or bleeding in early pregnancy experience a miscarriage. However, numbers quoted in most literature quote 25%, this is an average as miscarriage becomes increasingly more common with maternal age (Maconochie et al 2007, Nybo et al 2000).  Miscarriage is diagnosed by Ultrasound imaging and can described as either; threatened miscarriage, anembryonic pregnancy, inevitable, early fetal demise and incomplete miscarriage. Increased access to ultrasonography has likely improved diagnosis of miscarriage rather than increasing incidence of miscarriage (NICE 2017). (see table 1) It is argued that most miscarriages are likely to be due to chromosomal abnormalities, however, the cause of most miscarriages is unknown despite considerable research into fertility treatments and recurrent miscarriage (Schreiber, Crenin, Alto et al 2018). Table 1 Types of Miscarriage  (Jurvovic, Overton,Bender-Atik 2013) Threatened miscarriage Vaginal bleeding in early pregnancy with or without associated abdominal pain or cramping with closed cervix. Anembryonic pregnancy Intrauterine pregnancy sac with absent fetus Inevitable miscarriage Vaginal bleeding in early pregnancy with or without associated abdominal pain or cramping with open cervix. Early fetal demise or Missed miscarriage Intrauterine pregnancy with fetus present with absent fetal heart activity. May be symptomless. Incomplete miscarriage Pregnancy tissue retained in uterus often with associated vaginal bleeding and or pain without well-defined gestational sac   Prior to the introduction of antiprogestogens and prostaglandins (Mifepristone and Misoprostol) for management of an incomplete miscarriage, the gold standard treatment was surgical suction evacuation under general anaesthetic (El Refaey H , Hinshaw, Henshaw 1992). Following the publication of the NICE guidance in 2012 this was changed to prostaglandin only treatment. This was subsequently followed up in a NICE routine surveillance paper in 2017; advice for further studies was noted. Options for treatment are currently either conservative management and await events, medical management with misoprostol only, moving away from surgical interventions and Mifepristone. NICE (2012) suggest that in 90% of women the use of prostaglandin only will be an effective treatment to complete miscarriage. The change in the treatment protocol is outlined in table 2. Conservative management as described by NICE (2012) is to await events with open access to an appropriate emergency gynaecology unit or early pregnancy assessment unit (EPAU) should support be required. Miscarriage can take several days or sometimes weeks, especially if those patients that have remained symptomless (Lusink et al 2018). This is often not acceptable to women that want to have closure and carry on with normal activities (Furlund 2017).  The uncertainty of how long it will take to pass fetal tissue, and miscarriage event to be concluded, is often a reason for women to decide on intervention with medical or surgical managed miscarriage (Furnlund et al 2017).      Surgical management of miscarriage, under general or local anaesthetic with electrical or manual vacuum suction minimises time for miscarriage to be completed but carries a small risk,1 in 1000, of complications (Royal College of Obstetricians and Gynaecologists 2019) These include perforation, cervical tear, intra-abdominal trauma, haemorrhage, infection, Ashermanns syndrome and risks associated with preterm birth (Lemmers et al 2016) Medical management, under investigation in this paper, can be also take a number of days or weeks to conclude. This can also be unacceptable to some women (Lusink et al 2018). Medication prescribed for management of miscarriage was a combination of two drugs mifepristone and misoprostol (see table 2 ). Currently misoprostol only is prescribed for treatment of incomplete miscarriage. Prior the NICE Guideline published in 2012 a two-step approach to medical management was common practice. This was administering two drugs mifepristone and misoprostol 24-48 hours apart as remains current practice for termination of unintended pregnancy (Saraswat, Ashok and Matter 2014). Table 2 Medical Management of Miscarriage Treatment Protocols Medical management pre NICE 2012 Protocol A Medical management Post 2012 to current Protocol B Mifepristone 200mg followed by Misoprostol 24-48 hours later 2 doses 800 micrograms followed 4 hours later 400 micrograms if pregnancy tissue not passed. Mifepristone is a steroidal antiprogestogen as well as an antiglucocorticoid. In the presence of progesterone, mifepristone acts as a competitive progesterone antagonist. Therefore to induce miscarriage, It causes blockade of progesterone receptors, this then causes degeneration of endometrial decidua and softening of the cervix. Breakdown of decidua caused by mifepristone indirectly leads to placental detachment  (Saraswat, Ashok and Matter 2014) Misoprostol 2 doses 800 micrograms followed 4 hours later 400 micrograms if pregnancy tissue not passed Misoprostol is a synthetic prostaglandin analogue that has antisecretory and protective properties. It is prescribed “off licence” as a potent uterine stimulant for the treatment of a missed miscarriage. (Saraswat 2014)             Rational for study The interest for this study relates to changes in the clinical practice protocol for management of miscarriage in 2013 following publication of the new NICE guidance in September 2012 which superseded the Royal College of Obstetricians and Gynaecologists green top guideline (2006).  In the unit where the study will occur both mifepristone and misoprostol were prescribed for incomplete miscarriage management.  Since this change in practice, anecdotal evidence suggests that locally, senior clinicians’ perceive there to be a noticeable increase in readmission of patients and numbers of patients requiring further medical or surgical treatment to complete a miscarriage.     Aim of Study To investigate the impact of a change in protocol for the medical management of a first trimester miscarriage.      Primary Objectives  To identify whether a change in protocol has increased the number of readmissions since implementation of the NICE guideline (2012).   Secondary Objectives    To investigate if vaginal bleeding pretreatment is linked to treatment outcomes.    To explore numbers of patients requiring further medical or surgical treatment to complete the miscarriage To compare the two treatment protocols outlined in table 2 in terms of outcomes   Inclusion Criteria:  Women diagnosed with missed miscarriage by pelvic ultrasound scan in the first 15+6 weeks of pregnancy (this is the gestational age used as a cut off point in EPAU for obstetric care) that choose to have medical management of miscarriage; in two separate comparison years.  Exclusion Criteria:  Women whom opted for alternative methods of miscarriage management initially (expectant or surgical)  Women experiencing retained products of conception following termination of ongoing unintended pregnancy.    Research Method  To investigate the impact of change in protocol for the medical management of a first trimester miscarriage, a retrospective clinical notes audit comparing two separate years of data will be carried out. . Clinical audit is a part of the continuous quality improvement process (Hexter 2013). It consists of measuring a clinical outcome or a process against well-defined standards, in this case an established body of evidence that validates the guidance from NICE in 2012. It is intended to compare two separate years of data to compare outcomes of protocol A (prior to protocol change in 2013 ) and protocol B, current practice post protocol change (see table 2 )   This study will employ a quantitative method to measure the numbers of patients requiring re admission and additional treatment following an incomplete miscarriage and any correlation in symptoms prior to diagnosis. In this study the comparison between clinical practice and the standard may lead to the formulation of a strategy, in order to improve care quality (Henkel and Shaw 2018). Only information about miscarriage attendance will be accessed as part of the study and no other information will be identified including subsequent attendances. Audit permission will be sought from the Trust Clinical Management Group (CMG) audit lead as part of organizational permissions; followed by hospital ethics approval and IRAS.   Data Collection Anonymised data sets will be analysed for numbers of patients requiring re treatment to test the hypothesis.. Access to patient notes will be required which will be requested via the hospital’s internal electronic management system.  These clinical notes will be identified by the trust code for medical management of miscarriage and system numbers noted to enable them to be requested. This will identify women that have had a medically managed miscarriage during that year. The data analyst in the local trust will be contacted to ensure accurate selection of patients for the study as stated on the inclusion criteria, to safeguard only retrieving the required case notes. Case notes will be kept in a locked filing cabinet on the unit that the patient will have attended and returned to file as soon as the required information has been documented on a spreadsheet, which will be kept on a hospital password protected computer drive.    A spreadsheet designed to answer the proposed question will document and record:     Expected gestational age at first attendance   Vaginal bleeding present at first attendance Retained products of conception, diagnosed via ultrasound report Gestational sac intact or not seen on ultrasound report Number of readmissions Required for re-treatment, medical or surgical    Patient information will be completely anonymised and non-identifiable in a spreadsheet following the extraction of the required information from the case notes.     It must be noted that only information related to the study will be accessed. Analysis It is intended to analyse the data in numbers of patients needing further treatment and whether they had symptoms, with comparison of numbers of patients having mifepristone, and analysing the data sets form each cohort.  Data sets will be tested using chi square. It may be that rather than correlational, causal -comparative methods as the study is post event. Dissemination of Findings The audit data analysis will be disseminated for educational and learning purposes. Results will also be shared as part of the organisation’s audit group as required by hospital polic. In the event of key findings being of interest it could inform further research and the possibility of care improvement for patients moving forward. Effects of the change in treatment protocol may have differing variables that may require further studies. References BOURNE T (2015) A missed opportunity for Excellence: the NICE guideline on the diagnosis and initial management of ectopic pregnancy and miscarriage, Journal of Family Planning Reproductive Health Care, 41:13-19 BRADLEY E, HAMILTON-FAIRLY D (1998) Managing miscarriage in Early pregnancy assessment Units. Hospital Medicine (59) pp 451-456. EL REFAEY H , HINSHAW K , HENSHAW R, SMITH R. TEMPLETON A (1992) Medical management of missed abortion and anembryonic pregnancy. British Journal Medicine, 305:1399 FURNLAND A, JOKUBKIENNE L, SLADKEVICIUS P , VALENTINE L. (2017) Misoprostol vs expectant Management in women with early non-viable pregnancy and vaginal bleeding :a pragmatic randomised controlled trial . Ultrasound Obstetrics and gynaecology (51) pp24-32 HENKEL A, SHAW K. (2018) Advances in the Management of Early Pregnancy Loss. Current opinion Obstetrics and Gynaecology 30:419-424 HEXTER AT (2013) How to conduct a clinical audit : a guide for medical students. Manchester Royal Infirmary. National AMR JURVOVIC D, OVERTON C, BENDER-ATIK R (2013) Diagnosis and Management of First Trimester Miscarriage. British Medical Journal 346:3676 LEMMERS M, VERSCHOOR MA, HOOKER AB , OPMEER BC, LIMPINS J, HUIRNE JA et al (2016) Dilation and curetage increases the risk of subsequent preterm Birth : a systematic review and meta-analysis. Human Reproductive Medicine. 31(1) LUSINK V, WONG, DE VRIES B , LUDLOW J (2018) Medical management of miscarriage : Predictive factors of success . Australian and New Zealand Journal of obstetrics and gynaecology. (58) pp 590-593 MACONOCHIE N,DOYLE P, PRIOR S, SIMMONS R .(2007) Risk factors for first trimester miscarriage-results from a UK -population based case-control study. British Journal of obstetrics and Gynaecology 114:170-86 NEILSON J, HICKEY M, VAZQUEZ J (2006). “Medical treatment for early fetal death (less than 24 weeks)”. Cochrane Database, Database of Systematic Reviews (3) [online] CD002253. NICE (2012) Ectopic pregnancy and miscarriage: diagnosis and initial management Clinical guideline [CG154] Published date: December 2012 NICE (2017) Ectopic pregnancy and miscarriage: diagnosis and initial management Clinical guideline [CG154] 4 year Surveillance NYBO ANDERSEN, A M et al. (2000) Maternal age and fetal loss: population based register linkage study, British Medical Journal, (Clinical research ed.) 320(7251) pp 1708-12. ROYAL COLLEGE OF OBSTETRICIANS AND GYNAECOLOGISTS [ Online] Available at https://www.rcog.org.uk/globalassets/documents/patients/patient-information-leaflets/pregnancy/pi-early-miscarriage.pdf [accessed on 4/4/19] SARASWAT L, ASHOK PW, MATHUR M (2014) Medical Management of Miscarriage. The Obstetrician and Gynaecologist. 16:79-85 SCHREIBER C, CREININ M, ATRIO J , SONALKAR S, RATCLIFFE J, BARNHART K (2018) Mifepristone Pre-treatment for the Medical Management of Early Pregnancy Loss. The New England Journal of Medicine, 378 (23) SHIERS C.(2003) Abnormalities of early pregnancy. Myles’ Textbook for Midwives. 14th Edition. Churchill Livingstone 10


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