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Masterclass in Writing RfPB Grant Applications 28 th January 2011 Carole Fogg Sophie Hyndman Helen Lloyd Presented January 2011; updated and adapted for.

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Presentation on theme: "Masterclass in Writing RfPB Grant Applications 28 th January 2011 Carole Fogg Sophie Hyndman Helen Lloyd Presented January 2011; updated and adapted for."— Presentation transcript:

1 Masterclass in Writing RfPB Grant Applications 28 th January 2011 Carole Fogg Sophie Hyndman Helen Lloyd Presented January 2011; updated and adapted for web, January 2012

2 Welcome! Introductions Aim and Objectives of the Day

3 RDS South Central: Research Design Support for NHS and Social Care Researchers Who are we and what can we do for you?

4 Some of our A-Team: Multi-disciplinary team: Statisticians Clinical Trialists Epidemiologists Qualitative Researchers Health Economists Patient/Public Experts Health Psychologists

5 What can the RDS SC do to help you? For all aspects of grant preparation, advice on: Sources of funding Literature search and review Developing and refining research objectives Study design, including health economics & statistics Planning teams and budgets Patient and Public Involvement (PPI) Research Advisor, with access to specific experts as required Research Design Advisory Panels Potential for collaboration Communications: , newsletter, website Training: research master classes

6 Question: In what way is a research grant application like a general election campaign?

7 Answer: They both require the right balance between

8 Aim To support researchers in developing successful research grant proposals, specifically, Research for Patient Benefit applications

9 Objectives To provide: An overview of funding applications, and how they relate to research governance and ethics applications An overview of NIHR funding schemes and the purpose and scope of RfPB An understanding of what reviewers expect to see in an RfPB grant application Some guidance on identifying what makes ‘good’ and ‘bad’ grant applications An introduction to the structure and content of the RfPB form An understanding of the importance of patient and public involvement in RfPB research An understanding of methodological issues important to reviewers An understanding of the resources and time required to undertake a research project An introduction to other sources of research support

10 Part 1 Research in the NHS: Funding Applications in Context

11 Important initiatives Good Clinical Practice (GCP) and the UK Medicines for Human Use (Clinical Trials) Regulations 2004 Responsibilities and accountabilities for clinical trials of investigational medicinal products Research Governance Framework for Health and Social Care (2005) Informed by above, but for research more generally Best Research for Best Health (2006) Infrastructure and systems Salvatore VuonoSalvatore Vuono. mages/view_photog.php?photog id=659

12 The purpose of these initiatives To protect the safety, dignity, rights and wellbeing of research participants To promote useful, ethical, valid, safe and affordable research To prevent futile, unethical, invalid, dangerous and extravagant research To provide research standards To define responsibilities and accountabilities To set out delivery and monitoring systems to ensure standards Research Governance Best Research for Best Health To make the UK a recognized centre of healthcare research excellence by providing a good research infrastructure To build research capacity To fund research to improve health and social care To improve and manage knowledge and information systems to simplify research processes and maximise usefulness of research

13 Among other things… A range of funding schemes for health research A system of research approvals to ensure that research is well regulated and ethical The result of these initiatives

14 What are the main ‘hoops’ to jump through? All research carried out in the NHS requires: A sponsor Ethics approval R&D approvals Most research will require: Funding Some research will require Other approvals (e.g. Clinical Trial Authorisation) Honorary contracts or research passports 1 ) Hula hoop moment from Circus Smirkus performance Image provided courtesy of Wikipedia. Permission is granted to copy, distribute and/or modify this document under the terms of the GNU Free Documentation License, Version 1.2

15 Where do I start? Sayan Samana p?photogid=2067

16 Steps to take Apply for research funding 5. Apply for R+D approval* 1. Write proposal/ protocol 7. If required, attend to research passports/ honorary contracts 6. If required, attend to other approvals* 2. Find a sponsor 4. Apply for ethics approval* * IRAS 1. May not always be in this order! Image from Office Online

17 Q. What is the difference between a research protocol and a research grant application? A.A research protocol is the definitive document that will inform the process of the research. Some R&D offices will insist on a GCP approved protocol, and provide templates for this (regardless of whether the project is a Clinical Trial of an Investigational Medical Product (CTIMP) or not) The research protocol can be used as the basis for applying for ethics and funding, and there will be an overlap, but these latter documents will have different emphases, so it is not simply a matter of cutting and pasting See Downloads 16 & 17 for GCP approved templates Steps (1) Write a research protocol and (3) Apply for funding Image from Office Online

18 Step (2) Find a sponsor i.e.: Responsibility for the initiation and overall management, including quality assurance (research protocol, team, research environment) Responsibility for the finances associated with the study Ensure all approvals obtained, e.g. ethics, clinical trial authorisation Arrangements for handling of any Investigational Medicinal Products (IMP) Ensure Good Clinical Practice (GCP), monitoring and reporting (including safety reporting) Q. Why do you need a sponsor? A.You need an organisation to be accountable for the research Image from Office Online

19 Q. Who can be a sponsor? A.Usually: Chief Investigator’s employing institution, e.g. a university or NHS trust A funding organisation Where research is for training purposes, the research supervisor (on behalf of their employer) Private sector e.g. pharmaceutical industry

20 Step (4) National Research Ethics Committee (NRES) approval Role: Protect rights, safety, dignity and well-being of research participants Facilitate and promote ethical research of potential benefit to participants, science and society. Advice on: information sheets and consent forms, GCP, procedures, use of personal data etc. Apply: online via Integrated Research Application System (IRAS) https://www.myresearchproject.org.uk/ Image from Office Online

21 Step (5) Local trust research and development office (R&D) approval Role: To give permission to conduct research in the site If sponsor, to undertake that role; if hosting research (sponsored by others), to undertake audit of a proportion of studies To ensure all relevant research-related contracts are in place Advice available: Variable and dependent on personnel/ time: NRES applications, financial aspects of study from trust perspective, more general research advice Image from Office Online

22 When do you meet them? Variable and dependent on personnel/ time: for high risk/ drug related/ device related studies, as soon as you have a protocol; some offices may be interested in these and other studies at the development stage. Apply: 1.Via IRAS Coordinated System for gaining NHS Permission (CSP) for research qualifying for the NIHR Clinical Research Network Portfolio 2.Directly to R&D Office for all non portfolio research.

23 Step (6) Other approvals IRAS captures the information needed by: Administration of Radioactive Substances Advisory Committee (ARSAC) Gene Therapy Advisory Committee (GTAC) Medicines and Healthcare products Regulatory Agency (MHRA) Ministry of Justice (National Offender Management Service) HSC research offices NRES / NHS / HSC Research Ethics Committees National Information Governance Board for Health and Social Care (NIGB). Social Care Research Ethics Committee Image from Office Online

24 Step (7) Research Passports and Honorary Contracts Q. What is a research passport? A.A set of signatures and checks from your employing organisation required prior to issuing an honorary contract or letter of access. Q. What is an honorary contract? A.A contract with an NHS trust for a researcher whose employer is not that NHS trust. Q.What is a letter of access? A.A letter permitting a researcher whose employer is not that NHS trust into the trust Image from Office Online

25 Q. When are honorary contracts needed? A.When: (a) the research is hosted in the NHS and (b) the researcher has no contract with the NHS and (c) the researcher’s activities in the NHS site will involve interacting with individual patients in a way that has a direct bearing on the quality of their care. Q.When are letters of access needed? B.When (a) and (b) above are present, but not (c) Always check with trusts what level of access they consider you need

26 Q.Why are honorary contracts needed? 1.Patients in receipt of research procedures come under the NHS duty of care and the NHS indemnity scheme applies to the researchers and their activities. 2.The researcher is accountable to the NHS organisation for their activities, explicit supervision arrangements are in place, and the researcher is made aware of the relevant NHS policies with which they must comply in their activities. 3.The researcher’s substantive employer understands the research activities and has undertaken all the necessary checks in relation to the researcher’s suitability to carry out those activities. Q.Where do I apply to get an honorary contract? A.Usually Human Resources Department of NHS Trust where you wish to do the work.

27 (1) Involving a Comprehensive Local Research Network (CLRN) Can work with investigators to: Provide NHS Support Costs for research projects Facilitate permissions Help with recruitment of sites and patients Help with data collection General advice on the research process in their area of expertise. Steps you MIGHT have to take: Image from Office Online

28 (2) Involving a Clinical Trials Unit (CTU) Can work with investigators to: Develop new trials (design, collaboration, funding, communication with Clinical Research Network, regulatory and governance issues) Manage funded trials (questionnaire design, set-up, recruitment, pharmacovigilance, data management, monitoring, analyses, report preparation) Image from Office Online

29 Part 2 – Research for Patient Benefit (RfPB) & The Importance of Sc pe Image courtesy of Wikimedia commons (Public Domain)

30 NIHR Research Programmes Research for Patient Benefit (RfPB) Programme Grants for Applied Research (PGfAR) Invention for Innovation (i4i) Health Technology Assessment (HTA) Efficacy and Mechanism Evaluation (EME) Public Health Research (PHR) Health Services and Delivery Research (NIHR HS&DR) - formerly 2 programmes: Health Services Research (HSR) & Service Delivery and Organisation (SDO)

31 Research for Patient Benefit offers… The opportunity to conduct research that: arises from daily practice in the NHS is developed between NHS and other partners is open to topic and method shows tangible health and health care benefits for patients amplifies the patient voice that encourages collaboration closes the loop between research and practice – will be implemented or drive change

32 Aims / sc pe To support projects in health services and public health research Qualitative, quantitative or mixed method research that will: – study the way NHS services are provided and used – evaluate whether interventions are effective and provide value for money – examine whether alternative means for providing healthcare would be more effective

33 RfPB will also fund research that will: pilot or assess the feasibility of projects requiring major applications to other funding bodies formally assess innovations and developments in healthcare Proposals which have emerged from interaction with patients/service users and public are particularly welcome Systematic reviews may be funded as part of a larger project or as stand alone studies. For more details, see the RfPB FAQ on systematic reviews. Aims / sc pe

34 OUT of sc pe: Lab-based or basic science research, including research based on animals Setting up or maintaining research units Proposals which are solely service developments Proposals which are solely audit, surveys, needs assessment, technology development (although may be included as part of an integrated research study) Images from Office Online

35 Read the guidance... Each RfPB competition has associated Guidance for Applicants that covers: aims scope eligibility etc For general enquires call Or Or visit Image from Office Online

36 Selection Criteria and Eligibility Applications judged on: the quality of the research proposed the significance and potential benefit of the research to the NHS All NHS organisations and other providers of NHS services in England can apply (For joint NHS/university applications funding is awarded to the NHS partner) Probably with academic partners Potentially with strong component of service user involvement. Applications with collaborations in social care and third sector providers of health and social care are also encouraged If strong case, can include academic partner outside England. Image from Office Online

37 The Application Process Full application deadline Preliminary scrutiny and is it in scope? External peer and lay review Full committee assessment Final ratification Notification of outcome Images from Office Online

38 Overall, a wide range of RfPB projects funded Based in a diversity of settings and care groups Concerned with clinical and non-clinical topics Using a diversity of methods and research techniques See the detailed report on the first three competitions – Prioritising Patients

39 Part 3 RfPB APPLICATIONS

40 A grant application, like a picture, should be: Clear Unambiguous Easy on the eye ☺ Easy on the brain Photo by Remy Steinegger; Copyright : World Economic Forum. Licensed under the Creative Commons Attribution-Share Alike 2.0 Generic license (http://creativecommons.org/licenses/by-sa/2.0/deed.en)http://creativecommons.org/licenses/by-sa/2.0/deed.en Source: Wikipedia

41 It should not be : Jumbled up Unclear Difficult to decipher Confusing

42 Or indeed something you didn’t intend it to be Original Author: David Angell (adapted by Odder). Licensed under Creative Commons Attribution 2.0 Generic Licence (http://creativecommons.org/licenses/by- sa/2.0/deed.en). Source: Wikipediahttp://creativecommons.org/licenses/by- sa/2.0/deed.en

43 Part 3 RfPB APPLICATIONS (a) What would you expect to see in an RfPB grant application?

44 Part 3 RfPB APPLICATIONS (b) Examples of ‘good’ and ‘bad’ grant application sections Group/interactive work Simon Howden For examples of good & bad grant application sections, see [weblink]

45 Part 3 RfPB APPLICATIONS (c) What a reviewer expects to see in an RfPB application form

46 Overall style Limit use of overly technical language, buzzwords and acronyms Tech Speak (defined by Edward Tenner) “Post colloquial discourse modulation protocol for user status enhancement. It's a referential system for functional-structural, microscopically specific macroscopic-object redesignation. It's a universal semantic transformation procedure. It's a holophrastic technocratic sociolect. It's a meta-semiotic mode for task specific nomenclature." Get the idea? Buzzword An important-sounding word or phrase connected with a specialized field or group that is used primarily to impress laypersons: “‘Sensitivity’ is the buzzword in the beauty industry this fall.” Alphabet soup Language laced with acronyms. "An RFP was issued by DOE; ORNL responded for the ORR." Reference: ‘Tech Speak’ as defined by Edward Tenner (1986) Tech Speak, Random House, in above website.

47 1.Research details 2.Lead Applicant Details 3.Lead Applicant CV 4.Joint Lead Applicant(s) 5.Co-applicant(s) details 6.Research & Development Office 7.History of the Application 8.Patient and public involvement 9.Case For Support – Part 1 10.Case for Support – Part Case For Support – Part Management and Governance 13. Intellectual Property and Innovation 14. NIHR Infrastructure 15. Finances 16. Monitoring information 17. Suggested reviewers 18. Supporting Documentation 19. Declarations and signatures

48 (1) Research details Title Host organisation Region Duration Proposed start date (Application type) – Pilot, Feasibility, or Main Study* (Theme Call Name) – Only fill this in if you are applying for a specific theme call, e.g. dementia *For definitions, see:

49 Research Title Descriptive, yet concise Contains keywords relevant to the research Study question and main outcome measure to be included If a trial, also include intervention and population State if pilot/ feasibility Clear from title that study is in scope – e.g. for RfPB, has short- medium term patient benefit

50 Whilst you may think some titles are genuinely funny: Parasites as weapons of mouse destruction. Journal Animal Ecology Mar;77(2): They may be viewed by some as inappropriate: Targeting promiscuous signaling pathways in cancer: another notch in the bedpost Trends in Molecular Medicine Dec;10 (12): Title: What can go wrong

51 And some can appear very strange indeed: Who Moved My Cheese by Dr Spencer Morgan Putnam Adult (1998) Image from Office Online A bestseller!

52 Lead applicant Current Research Commitments and how this application will fit within current research activities Lead applicant’s C.V. Joint lead, Co-applicants. N.B. There is now a system for co-applicants to formally confirm involvement, add C.V.s, and approve the final application. The latter must be done before submission. Consider: Kudos associated with being lead Not necessarily a big-wig but need proper support if junior Tends to be person initiating the research Contract duration (especially universities), i.e. if your contract expires before project, can you be lead? (2-5) Applicants Q. What is the difference between ‘co-applicants’ and ‘research team’? A. A research team may consist of more people than simply the applicants, but N.B. the application will be judged primarily by those appearing on the form

53 Host must be an NHS organisation Host R&D office contact details (6) Research and Development Office Image from Office Online

54 (7) History of This Application If previous RfPB, NIHR may well look to see what the initial feedback was and how the current application has changed, BUT always viewed as a NEW application (no resubmission policy) If previously submitted elsewhere, just for their information Details of related applications Details of concurrent applications are not asked for, but RfPB would obviously want to know if a submitted project gets funded from another source

55 (8) Patient and Public Involvement Image courtesy of healthcaregovernancereview.wordpress.com

56 What is Patient and Public Involvement? An active partnership between the patient/public and researchers, NOT the use of patients/public as ‘subjects’ to be studied (e.g. to be interviewed or assessed) by researchers For example: Working together with patients to develop a good research proposal Commenting on the methods or processes of the research, being actively involved in the research process Image from Office Online

57 Examples of PPI Being part of the research team Helping design the research Being a member of project reference group Writing lay summaries and patient information sheets Carrying out questionnaires with the participants More power in the decision making process of the research Image from Office Online

58 Nature of PPI in Research Consultation:Asking people who use your services for their views on your research to help inform decision making E.g. Commenting on the ability to understand lay summaries Collaboration:Ongoing partnership with members of the public throughout the course of the research project. E.g. A member of public on the project steering group. User-Led/ User Controlled: Members of the public lead the research and are in control of the research. This is often, through a community or voluntary organisation E.g. Service users may decide on the research question; or manage the research itself

59 Proper PPI in Research IS NOT: Asking the patient or the public to answer research questions and provide data, i.e. asking them to be a ‘guinea pig’ in your research – enrolling them into the study Listening to patients to design your service better – to elicit service design suggestions Asking for feedback about a web based intervention – to evaluate an intervention Image from Office Online X

60 Why Involvement? To prevent researchers making mistakes that are obvious to patients To guide finances For greater transparency, making research with patients, for patients, that is more relevant to patients. Obligation to the tax payer To meet the requirements of the NHS Constitution To meets the requirements of funders

61 Can you spot Involvement? The following are all extracts taken from National Institute of Health Research grant proposals Which are Involvement and which are not? Image from Office Online

62 "We plan a steering group for the project with four patient representatives as equal members of the research team." 1. Involvement 2. Participation 3. None of these 4. Unsure

63 "Individual service users who have been referred... via this and other routes will be interviewed regarding their experiences." 1. Involvement 2. Participation 3. None of these 4. Unsure

64 "Our patients agreed with us that the study would deliver important information and that the research was timely and important." 1. Involvement 2. Participation 3. None of these 4. Unsure

65 What can the RDS Offer? We provide a lay review service as part of our pre-submission review panel and as a separate activity We can advertise your project through our PPI network and help to identify patients to work with you We can provide financial support to patients or members of the public working on projects supported by the RDS up until the point of submission. We can provide PPI advice from our staff on the PPI team.

66 What can the RDS do? Give guidance on payment structures. Provide assistance in writing lay summaries usually by getting lay members to write them either with you or for you. We have useful guidance helping you consider what involvement to use to get the best out of involvement in your project. David Castillo Dominici

67 How can we work together? Maybe you are part of, or know of, a group that wants to get involved in research, if so register the group via the RDS website Researchers can advertise their projects through our systems If you would like to get involved individually as a patient or a member of the public register with us via the RDS website Image from Office Online

68 What reviewers expect to see: Patient & Public Involvement (PPI) Have the needs of the service users been considered? Have you made any assumptions about service users or the co- operation of other involved parties which may not actually be met? Are there lay co-applicants? Are there lay people on the project steering group? Have the relevant national / local organisations been contacted for their input? Are there plans to involve them in the study design / study management / in dissemination of the results? Is there evidence of consulting the INVOLVE guidelines on PPI? State if PPI input at study design stage was not undertaken and say why this was the case (N.B. all efforts must be made...) Is the PPI element ‘tokenistic’, or has real thought and planning been put into it?

69 (9) Case for Support - Part 1 Aims and objectives Plain English (Lay) and Scientific Summaries Background and rationale Why research is needed now

70 Aims and Objectives Need absolute clarity of objectives / primary outcome / secondary outcomes, and ensure that these relate to RfPB scope and are not contradicting the title Is this definitive / exploratory / preliminary work? What would the upshot be if it is successful in the case of the latter? If there is a null hypothesis, is it clear and appropriate? Do any qualitative aspects of the research have clearly stated objectives / questions / intentions? If a pilot or feasibility study, make this clear, and also how it would lead on to full trial

71 Q. What is the difference between a feasibility study and a pilot study? A.Feasibility Studies “Can this study be done?” Used to estimate important parameters needed to design the main study, e.g. standard deviation of the outcome measure; willingness of participants to be randomised and clinicians to recruit them; number of eligible patients; characteristics / design of proposed outcome measure; follow-up rates, response rates, adherence/compliance rates Pilot studies are a version of the main study that is run in miniature to test whether the components of the main study can all work together, e.g. to test recruitment, randomisation, treatment, and follow-up assessments (http://www.netscc.ac.uk/glossary/#glos6)

72 Abstract in plain English (Lay Summary) Concise, convincing summary of: Problem (e.g. disease burden) Research question and rationale Design and method Expected outcomes Expected impact BUT absolutely understandable to the lay person: No clinical or research jargon No difficult words Involve a PPI representative!

73 (Scientific) Summary Concise, convincing summary of: Problem (e.g. disease burden) Research question and rationale Design and method Expected outcomes Expected impact A ‘Mini-Me’ of the main protocol!

74 Background / Rationale This section needs to PACK a PUNCH !!! Using the literature: Image from Wikimedia Commons (Public Domain). Define the research issue Justify WHY the research is necessary – clear case for clinical importance and impact - E.g. Disease / condition burden (local / national figures) Back up logic of aims and objectives Provide evidence of best design approach Highlight if study fits into a desired but under-represented area in the funding stream - E.g. social care, minority groups

75 Relevance of proposal to RfPB Look at RfPB scope in Guidance Think of the: Likely benefits to patients Implications for health services Potential impact on policy / service delivery Make sure you are showing how your work fits in with the RfPB remit Image from Office Online

76 Why is this research needed now? What evidence is available to justify the study at this time: make a case Is the research addressing the right questions in the subject area at the right time in relation to, for example, the availability of knowledge, or the development of technology, Government priorities? Are you presenting a convincing argument? Don’t forget this is a competitive process!

77 (10) Case for Support Part 2: Research Plan & Methodology Image: NASA

78 You should include: Study design – appropriate to meet aims and objectives Setting (location, population) Sample – sampling frame, eligibility criteria Sample size Intervention (if relevant) Details of randomisation if RCT Appropriate data types and sources Outcomes/ other measures – validated/appropriate for the population Procedures Data analysis methods Consider: How will potential sources of bias be avoided/ taken care of? Who is blinded and how will this be achieved? Feasibility Bear in mind what will be reported (e.g. CONSORT, STARD etc)

79 Study population Image by Xedos4, freedigital photos.net w_photog.php?photogid=1539

80 Intervention (i) Clear description of intervention ?product / technology/therapy ?timing ?dose ?length of exposure ?number of sessions/treatments ?staff administering treatment (training, quality assurance, experience, preferences) Allocation - randomisation method – blocks / stratification / matching Blinding – who, how and why? Balance between standardisation and tailoring to the patient Will it be affected by patient/ carer adherence?

81 Intervention (ii) Why was it chosen? Evidence of piloting / testing or feasibility/ effectiveness from the literature Clear description and evidence-base for control / comparison group(s) For Example, Why placebo / alternative treatment chosen? Why 3 weeks treatment rather than 6?

82 Intervention (iii) Feasibility and other benefits Provision for gathering information on the patients / staff view of the research, whether it works or not Patient benefit of intervention – Recovery – Empowerment – Independence – Increased confidence in their outlook – Benefits added on existing standard of care

83 Outcomes Measurements must accurately reflect the impact of the intervention If surrogate / proxy measures are used, give evidence that these can accurately predict long-term outcomes WHO? HOW? WHEN? WHY? Follow-up: Appropriate length of follow-up to see the effect on outcome measures Motivation of patients to complete study! Image in Public domain, courtesy of Wikimedia

84 Statistical Considerations Statisticians are useful for much more than just a sample size calculation!!! Prof. David Spiegelhalter playing with Arco Iris samba band, by Tamara K. This file is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported license (http://creativecommons.org/licenses/by- sa/3.0/deed.en)Creative CommonsAttribution-Share Alike 3.0 Unported

85  Type of outcome o Continuous o Binary  Clinically relevant and relevant to patients  Measurable  Accurate  Cohort study  Cross sectional study  Case-control study  Randomised controlled trial  Effect size o Clinically significant o Results in a change in practice  Based on pilot study/previous evidence  Correct and appropriate for the study design chosen  Account for loss to follow-up  Which patients to include in the analysis o E.g. principle of intention to treat in randomised controlled trials  Account for confounding  Missing data  Subgroup analysis  Multiplicity  Sensitivity analysis

86 Sample size State null hypothesis and choice of statistical test Is the detectable effect size likely to be clinically significant and result in a change in practice? Is the sample size based on previous evidence / pilot results? Are the sample size calculations correct and appropriate for the study design chosen? Has loss to follow-up been accounted for in the sample size?

87 Common statistical errors in applications Statistical analysis does not meet objectives or type of data collected Section is too ‘general’ ‘continuous data will be analysed using t- tests’ Copied from other/ previous grant application without tailoring No costing for statistical support

88 Outcomes / Analysis Measurements accurately reflect the impact of the intervention or are surrogate / proxy measures (and if so, evidence that these can accurately predict long-term outcomes) Appropriate length of follow-up to see the effect on outcome measures If there is a long period of follow-up, how will the patients be motivated to complete the study? Protection of outcome measurement from bias Sub-analysis clear and documented – rationale and design Listing of confounding factors – measured / factors for stratification with rationale Set out analysis plan logically – descriptive tabulations, approach to analyzing associations among variables, qualitative analytic methods

89 What is Health Economics? The NHS operates in a world of scarce resources (e.g. MONEY, labour, medicines, hospital beds) Health economics informs how scarce resources may be allocated among treatment, prevention & diagnosis of different diseases. At the extreme: Karl Marx: State allocates resources Adam Smith (man in £20 note): Free market Images in Public Domain. Courtesy of Wikimedia.

90 How do we prioritise resources to treat & prevent disease? Need (how do you measure it / competing needs) Discrimination (e.g. by age, smokers …) Personal merit and social esteem Lottery Ability to pay (free market approach) Do you think any of these methods would work in the NHS consistently?

91 In the NHS, new interventions prioritised if: they can be shown to be effective and fit for purpose AND GOOD VALUE FOR MONEY – i.e. the intervention is likely to be cost-effective (mainly through NICE) Image from Office Online

92 Health economics can help us understand the costs and benefits of different interventions: For example: If the health benefit generated by a new intervention is worth the additional cost If an intervention is more effective than its alternative, but its related costs are exorbitant, this intervention will represent poor value for money and not a good use of NHS resources If one intervention provides more health outcomes for the same level of cost this intervention should be adopted UK research funders increasingly value applications that answer health economic questions

93 “ Beagle 2 could have crashed into Mars because the atmosphere on the planet was less dense than expected”, explained Professor Pillinger. “The probe may have been going too fast for its parachute and airbags to bring about a soft landing.” But contrary to belief, the mission was not a failure. The technology used for the project could play a major part in managing the tuberculosis pandemic. (Open University WebSite, March 2010) Photograph: ESA Planning a project

94 The people you need The materials, equipment and space you need The time you need How you organise the above Who? What? When? Where? For how long? Think about what will need to be done on a day to day basis Think about maximising benefits to all involved

95 The people you need Photograph: NASA

96 Various roles, for example: Collaborators Steering committee Day to day project manager/ co-ordinator Research assistants Administrative staff Support staff Consultants Data Safety Monitoring Board Patients/ public

97 Collaborators Bring the right skill mix to the research team Varying degrees of involvement Steering committee Overseeing the work, ensuring that the study happens as intended Day to day project manager/ co-ordinator Managing the study on a day to day basis Research assistants Data collection Collection and processing of samples Administrative staff Administrative support

98 Support staff People external to the study, but whose help may be needed. E.g. staff on wards, library, ethics committee, local data protection officer Consultants For specialist help and advice E.g. statisticians, economists, computing Data Safety Monitoring Board Independent ; periodically check on data being collected for patient safety purposes; broad-ranging monitoring of data quality and integrity Patients/ public Different levels of involvement E.g. Consultation, collaboration, user control

99 Organising the personnel Who is in charge of what? Must be clearly designated at the start Everyone involved must be committed in terms of interest and time Staff management: very important

100 Logistical issues in recruitment Photograph: NASA

101 Staff Liaison with personnel Development of job descriptions Advertisements Interviewing Getting proper references Sites Liaison with management Liaison with health professionals Information about the study, what it will entail for the study site, the information being collected etc. Participants Look at throughput/ numbers to give you an idea about how long it will take First contact, informed consent Give yourself time!

102 Recruiting Participants Clear recruitment plan and sampling strategy (note any key groups of patients likely to be excluded) Realistic timing - use local data and apply eligibility criteria, refusals, variation in caseload etc Make effort to ensure inclusion of minority / disadvantaged groups / range of patients across all socioeconomic groups – describe provision for overcoming poor literacy and language barriers Image from Office Online Image: ddpavumba freedigitalphotos.net /view_photog.php?photogid=2888

103 Photograph: NASA The importance of communication

104 Before the start of the study Who should know about the study? Who should be involved? Formal agreements (e.g. sponsorship, financial arrangements, data ownership and authorship) External communication (e.g. Websites, Press Office) Examples of who needs to know: Trust R&D offices Other senior managers Ethics committee(s) Clinicians caring for patients involved Nursing staff if wards involved Comprehensive Local Research Networks Medical records officer Clinic/ward clerks GPs

105 On-going communication Clearly defined roles between researchers – ‘chain of command’, appropriate support To ensure data quality, reaching of project milestones With ethics committee (any change in protocol, methods, dilemmas etc.) With participants: contact person for everyone, whenever required (e.g. everyday, or ‘on-call’, as necessary) Back-up information With study sites and personnel: politics and facilitation Clearly identified researchers on wards etc. General information exchange Query-answering Trouble-shooting Feedback and acknowledgement

106 Photograph: NASA The other resources you need

107 Stationery Printing Postage Travel Tests Equipment Telephones Miscellaneous, e.g. staff training Photos: Wikimedia

108 Logistical considerations in study design Photograph: NASA

109 Can your protocol be operationalised as a guidance document for staff? Sample selection and monitoring recruitment If applicable: Randomisation Arranging an intervention Assigning responsibility and ensuring time for these

110 Logistical considerations in data collection & data management Data collection on Mars Photograph: NASA

111 Types of tools Measuring outcomes – tools need finding (N.B. permissions) or developing (N.B. validity, reliability) Lay and Non-English speaking issues Collecting other information, e.g. process, administrative, contextual Coding for the computer, development of database Only collect what you need to answer the question Logistics How will the data be collected: By whom? Where? When? Holidays, bank holidays (postage) Data checking and quality control Confidentiality/ data protection issues Procedures for reporting adverse events Data management and storage (e.g. double blind entry, restricted access, back- up, encryption etc) Computing – coding and data entry Data cleaning

112 Piloting Photograph: NASA

113 The importance of piloting Always pilot! It checks that everything works: Management and personnel Methods Feasibility – technically, politically, logistically, methodologically Training of fieldworkers Sample Timing and content of questionnaires/ interviews Validity of tools and data sources (feedback from participants) Overall time-scale Data entry, cleaning and analysis

114 Logistical issues in data analysis Cray 2 Supercomputer, NASA Photograph: NASA

115 Planned before the study has started: Equipment (hardware, software) Statistical methods Statistics and computing support Other analysis issues (e.g. qualitative, health economic) TIME

116 Pigeon post Source: Wikipedia (Public Domain) (11) Case for Support – Part 3 Dissemination, Outputs & Expertise

117 Routes for Outputs/ Dissemination Via: Involved patients / lay members & local interest groups Research network meetings Targeted conferences for presentations / posters Targeted peer-reviewed journals - maximum readership within field Other media, as appropriate Use of workshops / training packages Guidelines which could be altered by the results Targeted groups of specialist / professional bodies Inclusion of results in existing meta-analyses / Cochrane reviews Members of the team involved in teaching

118 Not forgetting… Participant patients and staff Report for funding body Any reports for Ethics Committee And logistically… Time Personnel And importantly… How will findings be translated into health care to produce patient benefits

119 Expertise: have you got your A-team? 1 ) Mad Scientist drawn by JJ, Image provided courtesy of Wikipedia. Permission is granted to copy, distribute and/or modify this document under the terms of the GNU Free Documentation License, Version 1.2 2) The School of Athens - fresco by Raffaello Sanzio. Image in the public domain supplied courtesy of Wikipedia. 3) Marie Currie ca Image in the public domain supplied courtesy of Wikipedia.http://www.mlahanas.de/Physics/Bios/MarieCurie.html 4) This image is available from the United States Library of Congress's Prints and Photographs Division under the digital ID cph.3b Image in the public domain supplied courtesy of Wikipedia Hypatia ( Ὑ πατία)

120 Questions a funder will ask: What are the specific roles of members of the research team? Does the team: Have appropriate track records in research? Demonstrate appropriate skills mix - clinical and research experience? Include, where appropriate, a statistician, health economist? Include a PPI representative? Have genuine interest and time to commit to your research Overall, why is this group of people best placed to do the work?

121 (12) Management and Governance Research timetable: milestones and deliverables Management arrangements Previous relevant work Measures of success, risks and how to manage them Ethical issues

122 Ethics Does the research involve specific areas with particular ethical implications? Ethics committee approval required? Has the proposal already been granted a favourable opinion from relevant regulatory authorities? Image from Office Online

123 (13) Intellectual Property and Innovation Current IPR held by applicants and relevance to current application Has a search for existing IPR been undertaken? Related/ similar IPR which may affect freedom to operate? Will IPR be produced or improved through the research? Management of any IPR Competitive devices, practices and technologies and advantages over these of any likely to be produced through the research? Benefits of any likely IPR Regulatory considerations and risks to be considered for any new technology to reach the market?

124 (14) NIHR Infrastructure Links to NIHR networks - look at RDS input Involvement with other NIHR partners Image from Office Online

125 Source: nuttakit, freedigitalphotos.net php?photogid=1556 (15) Finances

126 Value for money Justification for major sources of expenditure, e.g. staff Justification for how research costs have been allocated Justification for how NHS Support and Treatment costs will be allocated.

127 The people you will need to involve The local NHS R&D Finance Officer of your employer If you are collaborating with other organisations, the appropriate Finance Officer in each one Your local Comprehensive Local Research Network (for any NHS Support Costs required) Photo: renjith krishnan,

128 Always: Consult your Finance Office at an early stage Be aware: That costs are broken down by project year Of timings for university/ trust/ CLRN approval Of which organisation is taking responsibility for the project – their authorised signatory will have to sign off the form. That if the study is a collaboration between organisations, a ‘system’ will not necessarily exist to sort out respective costs That the participation/ costs of other collaborators will also have to be signed off by them That, if successful, formal collaboration agreements will need to be in place before funds are distributed The RfPB Finance Form Photo: renjith krishnan,

129 Directly Incurred Costs Q. What is a directly incurred cost? A.Costs of people/ other things that are being employed/ used exclusively for the project Research, technical and other staff Travel and subsistence Equipment Consumables PPI Other, e.g: Conference fees, room hire, publication, training Photo: renjith krishnan,

130 HEI Indirect Costs –Estates Charges Q.What are HEI Indirect Costs – Estates Charges? For universities only, the estate costs for staff, i.e. physical environment required for general staff support. E.g. For Oxford University, for 2010/11, the estate charges, per full time member of staff per year, regardless of grade, are £3,367 (£12,020 for lab. (scientific) departments) Photo: renjith krishnan,

131 HEI Indirect Costs – Other Indirect Costs Q.What are HEI indirect Costs –Other Indirect Costs? For universities only, (i) the overheads associated with employing someone, (ii) the costs of people already employed taking ‘time out’ for the purposes of the study (e.g. supervision), & (iii) university-based technical support (e.g. laboratory costs) E.g. For Oxford University, for 2010/11, the additional costs (or ‘overheads’) associated with employing a full time member of staff, regardless of grade, is £44,124. Photo: renjith krishnan,

132 Seek advice from Finance Department Commercial/ Other Partner Organisation Indirect Costs Q. What are ‘Commercial/ Other partner Organisation Indirect Costs’? A.The costs of resources used by the research that are shared by other activities. Photo: renjith krishnan,

133 NHS Overheads E.g. Estates charges Telephone rental etc. Q. What are ‘NHS Overheads’? A.Costs of resources used by a project, but shared by other activities Photo: renjith krishnan,

134 NHS Support Costs Q. What are ‘NHS support costs’? A.The additional patient care costs that result from the research being run in an NHS organisation. These costs would end when the project ends. Extra patient tests Extra in-patient days Extra staff time, e.g. consultants or nurses taking consent, extra attention due to the research This funding would usually come via the Comprehensive Local Research Network, and is not included in the total of the grant application figure Photo: renjith krishnan,

135 NHS Estimated Treatment Costs Q. What are ‘estimated treatment costs’? A.The treatment costs that relate to the research intervention. You are asked for information on the research treatment (intervention), and the normal standard treatment, so the additional costs for running the research intervention can be calculated. These costs would normally come from the NHS as part of normal patient care commissioning Different treatment, or treatment administered in a new way, or a new place. Photo: renjith krishnan,

136 Costing people Researchers involved with the study (but already in post) Researchers employed exclusively for the study, e.g. experienced day to day study/ clinical trial manager/ co- ordinator/ primary researcher, research assistants Collaborators Steering committee Administrative staff Support staff Consultants Data Safety Monitoring Board (DSMB) Patients and public involved with research (PPI) Photo: renjith krishnan,

137 Salaries: Regular staff (internal)Consultancy (external) Basic salary (check scales) National insurance Superannuation Increments/ pay rises Indirect costs (including Estate costs) Daily rate Rate per sample etc Have you considered dates for each major phase of the study, with staff responsible Photo: renjith krishnan,

138 Stationery E.g. How many questionnaires, how long, how many times; invitations; letters, information sheets, how to represent study to public/ patients Printing E.g. How many questionnaires, how long, how many times; invitations; letters, information sheets Postage E.g. How many mailings, follow-ups and reminders Travel E.g. researcher to participant, participant to researcher, meetings to sites to set up and run project, dissemination, PPI, Steering Committee meetings Costing other resources Photo: renjith krishnan,

139 Tests E.g. Clinical tests, laboratory tests Equipment E.g. monitoring instruments, computing equipment (including software), desks, chairs Telephones E.g. Office and mobile; standard rates for institutions? Miscellaneous E.g. Staff training, running costs of equipment, advertisements for staff, incentives (within ethics guidance) Photo: renjith krishnan,

140 How the resources requested will be used How realistic and accurate the costings are Whether the ‘best price’ has been found for tests etc? Whether anything appears ‘over-budgeted’? Whether the requested resources are justified? Does the proposal represent the most efficient use of resources? Is the research good value for money? Give yourself some leeway Overall budget Have you considered: Photo: renjith krishnan,

141 (16) Monitoring information Suggest three potential peer reviewers who have relevant expertise May or may not be used (17) Suggested Reviewers Information used by DoH and NIHR to monitor and categorise applications RDS use and satisfaction with service Carbon guidelines

142 (18) Supporting Documentation E.g. Flow diagram Gantt Chart Bibliography - ensure that all papers cited are listed clearly and logically Letters of support

143 Image in public domain courtesy of Wikimedia The inclusion of a Gantt Chart is mandatory 31st FW Balkan Operations Gantt chart. United States Air Force, 2000

144 (19) Declarations and Signatures Lead Applicant Host Organisation (finances) Host Organisation (Head of Department/ Senior Manager) Give yourself TIME to get these! renjith krishnan, freedigitalphotos.net hotogid=721

145 Part 4 Top Tips: Optimising your chances of success (Inspired by RfPB feedback)

146 Make sure: Your study is in scope You submit your proposal on time It is complete! It is a ‘well-crafted’ proposal Your proposal is understandable to a diverse audience You have shown the relevance of the study to the NHS You have had adequate lay involvement You have the right skill mix You have made the necessary research partnerships

147 Make sure: You have demonstrated a need for the study, and your knowledge of the area Any necessary pilot work is undertaken or planned appropriately Interventions (e.g. for RCTs) are clearly described You have an appropriate study design Other aspects of the methods and procedures are clear You have consulted appropriate experts and incorporated their suggestions You have given yourself a realistic timetable Your study is sensibly funded Don’t be over-ambitious!

148 Any questions? MANY THANKS! Photo: Simon Howden, FreeDigitalPhotos.net hotog.php?photogid=404 FreeDigitalPhotos.net staff FreeDigitalPhotos.net Evaluation


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