Postgraduate Certificate and Diploma in Health Research. Programme Specification

Transcription

1 Postgraduate Certificate and Diploma in Health Research Programme Specification 1. Awarding Institution / Body: University of Oxford 2. Teaching Institution: University of Oxford, Department for Continuing Education and Department of Primary Health Care Department of Statistics 3. Programme Accredited by: University of Oxford 4. Final Award: Postgraduate Certificate in Health Research, Postgraduate Diploma in Health Research 5. Programme Title: Health Research 6. UCAS Code: N/A 7. QAA Benchmarking Group: N/A 8. Date of Programme Specification: October Aims of Programme: The Health Research programme exists in order to enable students to: develop skills of research design and data analysis in both qualitative and quantitative research. to evaluate critically, health research. identify, critically appraise and incorporate the results of medical and social science research into the day-to-day decision making of clinical, scientific and administrative practice. apply the principles of evidence-based practice in health care settings. plan how to implement the findings of research to improve health care use theories and principles underpinning clinical research to inform their own research practice. 10. Intended Learning Outcomes and the means by which they are achieved and demonstrated: Knowledge and understanding: At the end of the course students will be able to: demonstrate a knowledge of the principles, methods and techniques appropriate for solving evidence-based health care/health-research problems and be able to translate (through a critical comprehension of the relative advantages and disadvantages) that understanding into good clinical practice; demonstrate a range of research skills enabling them to complete research successfully, either as part of a research team or as an individual; acquire, interpret and analyse biological information with a critical understanding of the appropriate contexts for their use through the study of the existing primary literature in the field; apply skills and expertise gained across the medical and biological sciences expected of professional researchers. Students will know and understand: health-care organizations, their management and the changing context in which they operate; the ethical issues in health research and research governance; methods to integrate and synthesise different sorts of information, from diverse sources, when making both individual patient and health-policy decisions in a wide range of situations; the key issues for evidence-based practice in their own professional area or specialty; how to work comfortably in situations of uncertainty and make sound judgements in the absence of definitive evidence; research methods and concepts in the field of health and health care.

2 Cognitive / Intellectual Skills: All graduates of the Postgraduate Certificate in Health Research will be able to: understand the role of most commonly used methods appropriate for specifying problems through a critical comprehension of the relative advantages and disadvantages of these methods; understand and express the main principles of some commonly applied techniques and methods; explain the rationale for the selection of tools used in the analysis of phenomena. In addition to the above all graduates of the Postgraduate Diploma in Health Research will be able to: demonstrate an ability to apply health research techniques appropriately for the solution of research questions; be able to apply health research solutions in a novel manner when analysing health research problems. At the end of both the Postgraduate Certificate and Diploma (though the Diploma will allow greater opportunities for development) all students will be able to: present and communicate information about research evidence and evidence-based practice clearly in written, electronic and oral forms to a range of audiences; direct and be committed to their own future lifelong learning. Research Skills: At the end of both the Postgraduate Certificate and Diploma (though the Diploma will allow greater opportunities for development) students will be expected to have developed a range of transferable skills including: managing their own learning and research and conducting an independent and effective study applying analytical techniques; analytical problem specification; applying research outputs to good clinical practice; analysis of abstract problems (identification, separation, specification and formulation). Discipline-specific Practical Skills: finding and appraising quantitative and qualitative research evidence critically and efficiently and understand what the results mean in different contexts and for different healthcare decisions; producing a robust research protocol, for a variety of different types of research question, in a format that can be submitted as an application for research funding. Achievement of Learning Outcomes The intended learning outcomes (above) are achieved using the following teaching and learning strategies. Lectures and online material: present and explore core ideas in the subject areas of the field of Health Research; review the current literature, including books and journals; provide a thorough grounding in subjects that may be new to the student (depending on the student s background). Practical sessions: provide a structured opportunity for students to practise techniques and methods of analysis for problems in Health Research; promote discussion and sharing of ideas in the practice of clinical analysis; provide a structured opportunity to develop analytical and numerical solutions to problems with guidance. Guided reading: specify recommended texts, key articles and other materials in advance of, or following, lecture classes for the purposes of discussion and further research. Course assignments: 2

3 enable students to tackle problems in Health Research relevant to the analysis of data; allow students to reflect on their learning in the context of the wider curriculum. Expert (guest) lectures: provide an opportunity to enquire of the experience and knowledge of renowned scientists and clinicians; allow an opportunity to reflect collectively upon experiences using real examples. 11. Programme structures and requirements, levels, modules, credits and awards The Postgraduate Certificate programme will involve the study of 3 compulsory modules, each with a written assignment usually of no more than 5000 words. The Postgraduate Diploma programme will involve the study of a further 3 modules each with a written assignment. This will consist of 3 modules chosen from a list of options. Currently most modules will be taught in face-to-face classes with additional online support. Some modules, subject to their suitability, may be offered as online modules. Postgraduate Certificate and Diploma (via subsumption) Compulsory Modules Module 1: The Practice of Health Research Formulate and define a research question clearly and cogently; Understand which types of study design (trials, observational, qualitative etc.) are most appropriate for which types of clinical questions; Establish criteria for accepting and rejecting good and bad evidence; Appraise a research paper to: o Identify whether the hypothesis of a paper is concerned with the efficacy of intervention, o causality, test accuracy or determining the magnitude of the health problem; Identify which study type has been used, and judge how this affects the interpretation of the results; Calculate and interpret measures of disease frequency and measures of association; Identify and assess the implications of the main forms of bias (selection, measurement, confounding, lead time, and length bias) in epidemiological and clinical medicine research; Appraise basic study types: diagnostic accuracy studies, prognostic cohort studies, treatment trials, prevalence surveys; Appraise the methods of a systematic review, and understand their importance and limitations; Know which are the best sources for finding reliable research evidence and other information; Undertake both (i) comprehensive and sensitive and (ii) rapid and specific literature searches; for specific topics or questions; Summarise the methods, key findings, and quantitative results of valid studies; Calculate quantitative measures such as relative risk, relative risk reduction, absolute risk, and Number Needed to Treat; Interpret measures of statistical uncertainty such as p-values and confidence intervals; Provide an analysis of the implications of acceptable studies for clinical or public health practice. Module 2: Introduction to Study Design and Research Methods Study Design Describe in detail different types of research methodologies; Identify the strengths and weaknesses of the different study designs; Assess whether research studies are using the best approach to statistical analysis; Statistical Analysis Describe methodologies that are used to investigate the effects of health care interventions; Have a basic understanding of the approaches to statistical analysis that can be used with these methodologies; Develop an understanding of the types of approaches that can be used for statistical analysis in each type of study design. Protocol Development 3

4 Understand the different stages of research, such as Phase I, II, III (and their equivalents for complex interventions), and the different requirements for each stage; Identify various facets that form a successful research protocol, for different types of health research; List some of the challenges of preparing a research protocol, and develop strategies for addressing them. Module 3: Bioethics and Good Clinical Practice (Online) Foundations of ethics Genetic testing Genetically modified organisms Presenting and argument Protocol & Associated Documents o GCP compliant protocol o Background and research questions o Study objectives and end points o Trial design and methodology o Eligibility criteria o Withdrawal criteria o Trial procedures and assessments of efficacy o Study treatment and accountability o Safety parameters and adverse events o Data handling and record keeping o Statistics o Direct access and source documents o Ethics o Quality aspects of the study o Protocol reviews o Associated documents Applications, Agreements, Approvals o Agreements o Defining responsibility o Ethics o Regulatory applications o Clinical Trials definition o Clinical Trials Authorisation Applications o Medical devices and the MHRA o Common application problems o Approvals checklist o Site approval o Public access database registration o Protocol amendments Trial Master Files o An introduction to the Trial Master File o Overview of regulation and GCP o Content of Trial Master File o Management and maintenance o Archive Conducting the Trial o Pre-trial activities o Standard Operating Procedures o Delegation of authority o Confidentiality and data protection o Participant identification and recruitment o The consent process o Incapacity and vulnerable participants o Amendments and reconsenting o Communicating enrolment o Conducting the visits o Drug accountability 4

5 o GCP monitoring o Source data o Records and audit trails o Ongoing review: participants o Ongoing review: trial progress Safety Reporting o The importance of safety reporting o Definitions and timelines o Adverse events o Responsibilities in safety reporting o Methods of adverse events collection o Assessing casuality o Serious adverse events o Assessing unexpectedness o Unblinding o Expedited reporting o Follow-up SARs / SUSARs o Overviews and reports o Safety monitoring committees o Annual safety reports Postgraduate Diploma Option Modules The option modules will give the student the opportunity to learn how the principles enunciated in the compulsory Postgraduate Certificate modules can be translated into practical actions in selected areas. Not all option modules will be available in every academic year. Module 4: Evidence in Practice (Clinical Epidemiology and Decision Making) Grading Evidence Assess the overall quality of a research paper or report concerned with: o defining the magnitude of a health problem o evaluating the effect of a health intervention o causal inference (including the Bradford-Hill criteria) Understand strategies for handling and adjusting for bias (selection, measurement and confounding); Distinguish which of the methodological flaws in any paper are the most important and their implications for decision making. Decisions and Recommendations Understand the other factors that influence decisions, such as quality of life, patients values, ethical issues, and economics; Understand how to integrate research in the clinical context to inform individual patient decisions taking into account the different risks, contexts and values of patients; Assess the reliability, validity and efficacy of a diagnostic test and how results should be interpreted in the context of the individual patient; Appraise and use decision analytic models and health technology assessments; Evaluate screening tests and consider their use in different populations; Consider the benefits and limitations of guidelines; Discuss the steps required in guideline development; Critically appraise a guideline; Consider the role of decision support systems in the implementation of guidelines. Module 5: Systematic Reviews Formulate a clear question for a systematic review and understand the key motivations for doing the review; Specify the eligibility criteria for a systematic review; Develop a search strategy for a systematic review; Prepare a quality appraisal and data extraction form for a systematic review; Identify, describe and discuss sources of heterogeneity among the studies in a systematic review; 5

6 Develop a statistical analysis plan for a systematic review; Conduct, report and update a systematic review; Use this knowledge to assess the quality of systematic reviews done by others. Module 6: Randomized Controlled Trials Specify a clear question for a randomized trial; Specify the inclusion and exclusion criteria for the participants in a trial; Prepare and submit an entry for the trial in an appropriate register; Identify appropriate strategies for recruiting patients, including information leaflets and obtaining consent; Prepare a clear timeline for the study, relating to both the passage of an individual patient through the trial and also to the study as a whole; Determine what resources, both financial and personal, are needed for a trial; Determine and implement an appropriate method of randomization for a trial; Prepare a statistical analysis plan for a randomized trial; Plan and implement strategies to maintain or increase recruitment to a randomized trial; Prepare a high quality report of the findings of a randomized trial; Use this knowledge to assess the quality and relevance of randomized trials done by others. Module 7: Qualitative Research Methods Overview of qualitative research o Philosophical traditions o Application of qualitative methods to evidence based health care Review of different methods including; o Phenomenology o Ethnography o Grounded theory Using qualitative methods within evaluation research, action research, and case studies methods o Common data collection methods o Approaches to data collection o Data collection tools Ethics in qualitative research Qualitative data analysis o Use of software analysis packages o Strategies for presenting and describing data Criteria for assessing qualitative research Writing up qualitative research Module 8: Statistics for Health Researchers (Online) Understand and manipulate basic mathematical and statistical techniques as preparation for more specialized courses in health care; Understand the statistical issues in the planning and analysis of research; Understand the basic statistical aspects of published research; Apply statistical analysis to cohort studies, case-control studies and randomized control trials. Module 9: The power of Bioinformatics in Modern Research Biological databases Sequence searching and alignment. Phylogenetics Gene prediction and annotation Molecular evolution The Omics The current view of the literature. 6

7 Module 10: Evidence-Based Diagnosis and Screening understand and be able to extract measures of test accuracy understand the concepts of sensitivity, specificity, repeatability and predictive values calculate sensitivity, specificity, prevalence and predictive values calculate and apply Likelihood Ratios Advanced Diagnostics Module 11: Knowledge into Action Become familiar with the evidence about the barriers and facilitating factors that may prevent or support colleagues participating in reviewing evidence and adopting an evidence-based approach Understand how to search for literature on effective strategies for disseminating evidence, teaching an evidence-based approach, planning projects, and managing change Awareness of key international and local policy initiatives to promote or support evidencebased practice Have the ability to prepare a plan for either introducing specific evidence-based practice changes and demonstrate an evidence-based approach to health care Have considered strategies to address their specific barriers to using evidence or an evidence-based approach in the workplace Develop and evaluate a plan to introduce evidence, or an evidence-based approach, in their workplace Understand the role and limitations of clinical audit as part of clinical quality improvement An introduction to the principles of guideline implementation and barriers to their uptake Other modules are in development/under consideration Global health Healthcare innovation 12. Support for learning The course director and tutors undertake to: provide an introduction to the specialist library of learning materials for the course provide advice and guidance on student matters Students will also have access to the Oxford University Computing Services (OUCS), which includes access to IT equipment (terminals, printers and scanners), the OUCS Help Centre, the Computing Services Shop, OUCS training courses, and the personal computer maintenance service. OUCS also offers remote access services including dial-up accounts and use of the Virtual Private Network (VPN) service. OUDCE offers in addition the services of a Student Advisor and an online forum for student discussion. 13. Criteria for admission The admissions policy for the course is intended to ensure that applicants are offered equality of opportunity irrespective of age, gender, disability, race, religion, nationality or ethnic origin. Applicants will be assessed on their individual merits and potential. Decisions will be based on the application of selection criteria appropriate to the course of study in a competitive context. In addition, successful candidates will satisfy the requirements of the OUDCE summary admissions policy as well as the minimum required English language criteria set by the University (higher level). Candidates will, in all but exceptional circumstances (see the Postgraduate Diploma Regulations), be admitted to the Postgraduate Certificate with optional progression on successful completion to the Postgraduate Certificate to the Diploma, provided that such a candidate: has successfully completed the final year of the Bachelor of Medicine and Bachelor of Surgery or Bachelor of Dental Surgery or equivalent; or 7

8 has an appropriate degree or equivalent professional qualification in a profession allied to medicine with at least two years post-qualification experience. Applicants will be expected to demonstrate an approach to their study which includes demonstrable skills of critical analysis, wide contextual knowledge and the ability to manage their own time. Additionally candidates should: have a good working knowledge of , internet, word processing and Windows applications (for communications with course members, course team and administration) show evidence of the ability to commit time to study and an employer's commitment to make time available to study, complete course work and attend course and University events and modules Successful candidates will normally provide evidence of all of the following: A professional interest in Health Research, evidenced by prior experience, qualification and work Motivation and ability to complete the course A clear and well argued understanding of the benefits of the course to the candidate s current employment and future prospects All potential applicants will have access to the detailed, and regularly updated, description of the course at the programme website. The admissions criteria above will be clearly stated on the website, in the Student Handbook for the programme, and in the e-handbook at the programme website. Applications to the programme must complete the University s Postgraduate Graduate Admissions application form and provide statements of support from at least two referees (details of three referees must be provided in the form) together with transcripts of previous qualifications, a CV, and complete an interview, conducted face-to-face or by telephone, with at least two members of the teaching team. Applicants whose first language is not English must meet the University s stated higher-level for postgraduate study and provide certification proving proficiency see: Academic Clinical Fellows employed within the Oxford Deanery are expected to meet the selection criteria, but will normally undergo the standard admissions procedures, although the provision of transcripts and the need for an interview may be waived given their employment status. The application form includes requests for information about: relevant prior or current work experience a statement of current role and duties in their organization or, if self-employed or unemployed, details of their most recent role or experience details of sources of financial support (students are provided, separately, with a summary of sources of financial support from sources other than their employer) details of any prior higher education career names of referees willing to offer an opinion on the suitability of the candidate for entry to the course evidence of employer commitment in the form of a signed statement, from a named individual within the company, of willingness to release the employee for attendance at the programme, and willingness to provide financial support a statement by the student of their objectives in attending the course and their reasons for seeking to register References are secured prior to interview. A telephone or face-to-face interview will be arranged for all of those who appear to fulfil the basic requirements for entry to the course. Applications may be rejected without further direct contact with the applicant, although candidates whose applications are deemed insufficient for entry to the course may, on request, receive feedback upon their application. The purpose of the interview is to: establish the applicant s level of interest, motivation and potential to benefit from the course of study clarify any uncertainties about compliance with requirements 8

9 ensure that candidates are fully informed of the standard of achievement and level of commitment required by the course of study. A successful candidate will normally provide evidence of all of the following: a professional interest in Health Research motivation and ability to complete the course a clear and well argued understanding of the benefits of the course to the candidate s current employment situation and future prospects prior academic achievement a health-related discipline at undergraduate or Master s level, or successful completion of a professional training course or at least two years professional work experience in the health service or a health-related field. Formal evidence of prior academic achievement is required. The ability of applicants to finance their study is not included among the criteria when assessing suitability for admission; however, applicants may not subsequently be admitted to the course if unable to provide evidence of their ability to pay the course fees. In cases where students anticipate difficulties with payment, all possible information and guidance on sources of financial support will be offered. 14. Evaluation and improvement of quality & standards: Methods for evaluating and improving quality and standards include: Student feedback and consultation: comments will be collected through questionnaires at least annually and through representation on committees and other informal means (students will be asked to complete feedback forms at the end of each module) and considered by course directors/course teams and acted on where appropriate. Students will be informed of the outcome. Student destination, whether employment or further study: the course director will report on destinations in the annual report to the Board of Studies. The destinations enable some assessment of the personal development achieved by the student through the course. Information will be incorporated into the HESA survey (Destination of leavers from Higher Education survey) which must be completed in respect of part-time students. Course team meetings will be held approximately monthly and formal joint standing committees at least annually at these meetings course tutors consider the current course structure and delivery arrangements and make recommendations for change and improvement. Oxford Learning Institute participation: the Institute supports the furtherance of excellence in learning, teaching and research at the University and promotes the professional and vocational development of staff. Staff will be encouraged to attend courses provided by the Institute and by OUCS as appropriate. Team teaching will be used to help spread best practice for teaching and learning techniques. The internal examiners report will comment on the standards of learning and examination performance. The external examiner moderates work to ensure the standards of teaching and assessment are appropriate and consistent. S/he will provide an annual report which is considered by the Joint Board of Studies, the OUDCE Board, the Graduate Studies Committee and EPSC of MSD and EdC. The Board of Examiners will meet annually to consider and agree marks, progression and awards. The Course Director s report will review the past year, and report any developments to the Joint Board of Studies. Detail will be provided on admissions, retention, staffing, course changes feedback and responses to feedback, student performance and any difficulties encountered with the course. The Joint Board of Studies, which will include joint MSD/OUDCE membership, will receive the Course Director s Report and the Examiners reports, reviews the programme of study, scrutinises and approves the course and examination arrangements. OUDCE committees (Assessment and Teaching Committee and Academic Board) and Divisional Committees will consider proposals for new course or changes to courses which will, inter alia, improve and extend teaching and learning opportunities. They will advise on academic policy, quality assurance and enhancement of the course provision. 9

10 The joint MSD/OUDCE Standing Committee has formal responsibility for upholding the quality of the course. It has to review and give approval for any changes to regulations. The Education Committee of Council bears overall responsibility for teaching, learning and assessment in the University. It has to consider and give approval for any changes to regulations. The CE Board/MSD review postgraduate courses five years after implementation. Periodic reviews are held of groups of courses every six years. Best practice from other HEIs is identified though reports of external examiners, attendance at conferences, reading of journals and other forms of academic communication. Accreditation by external organisations and an external advisory panel indicates that the course meets employers or outside requirements 15. Assessment Criteria: To complete the Postgraduate Certificate students must: Attend and complete the 3 compulsory modules. To complete the Postgraduate Diploma students must: Attend and complete 6 modules including the 3 compulsory Certificate modules. The Programme Director may agree to the completion of different modules to those outlined where a participant has evidence of already successfully completing similar topics at Postgraduate Certificate or Diploma level. Students will not obtain a Postgraduate Certificate or Postgraduate Diploma unless they complete the above requirements to the satisfaction of the examiners. In particular, failure to submit any assignment without dispensation automatically results in overall failure. The examiners may award a distinction for exceptional performance in the Postgraduate Certificate or Postgraduate Diploma. Candidates who fail to satisfy the examiners in any of the assignments may be permitted, normally within one year of the original failure, to resubmit work in respect of the part or parts they have failed on not more than one occasion for each assignment without being required to repeat attendance at the relevant module or modules. The assessment of coursework and examinations in the programme is based upon recognition of the following qualities: Knowledge, Understanding, Argument and Reasoning Range and depth in knowledge of the content covered in the course Command of appropriate analytical skills Logical exposition and reasoning Clarity, completeness and concise expression in analysis Presentation and Deployment Clear demonstration of the benefit of analysis of scientific data in argument Clarity in written exposition Appropriate use of literature reviews, including correct referencing Grading: All coursework will be assessed using the following grading scale (USM): Numerical Mark Distinction 70 and over Pass Fail 49 and below Relative weights of assessments: The relative weights of the components are as follows: 3 assignments for the Postgraduate Certificate from 3 modules, giving 60 CATS points; a further 3 assignments for the Postgraduate Diploma from 3 modules, giving a further 60 CATS points, totalling 120 CATS points. 16. Indicators of programme quality: 10

11 Indicators of programme quality include: Student retention and completion rates will be analysed to assess student satisfaction and the adequacy of student support; Student results profiles will be analysed to assess overall achievement and progression during the course; The annual External Examiner s report will provide impartial feedback on the course and comparison with the standards achieved by similar courses in other institutions; The annual evaluation of programme quality by students will provide a user assessment of course content and delivery; Accreditation: accreditation of a course indicates an impartial judgement of the quality of the course; Groups of courses are reviewed in detail every six years by a panel including external experts in the field; For new postgraduate courses the OUDCE Board and Medical Sciences Board (acting jointly where appropriate) carries out a five year review covering student intake, student progression, aims and objectives of the course, course structure and content, resources allocated to the course and student feedback; Employer assessments will indicate if a student has benefited in an employment context, bringing benefits to both the individual and the organisation Evidence of the quality of the Department: for example the quality of its staff (as attested by RAE, success in securing external funding, external testimony) Please Note. This specification provides a concise summary of the main features of the programme and the learning outcomes that a typical student might reasonably be expected to achieve and demonstrate if he/she takes full advantage of the learning opportunities that are provided. The information contained in this document is reviewed by the Continuing Education Board and may be checked by the Quality Assurance Agency for Higher Education. 11