WHO Regional Publications Eastern Mediterranean Series 30
A Practical Guide
for
Health Researchers
Mahmoud F. Fathalla 3URIHVVRURI2EVWHWULFVDQG*\QDHFRORJ\ $VVLXW8QLYHUVLW\(J\SW &KDLUPDQ:+2*OREDO$GYLVRU\&RPPLWWHHRQ+HDOWK5HVHDUFK )RUPHU'LUHFWRU81'381)3$:+2:RUOG%DQN6SHFLDO3URJUDPPHRI5HVHDUFK'HYHORSPHQWDQG 5HVHDUFK7UDLQLQJLQ+XPDQ5HSURGXFWLRQ
Mohamed M. F. Fathalla 'HSDUWPHQWRI2EVWHWULFVDQG*\QDHFRORJ\ $VVLXW8QLYHUVLW\(J\SW
World Health Organization Regional Office for the Eastern Mediterranean Cairo, 2004 :+2/LEUDU\&DWDORJXLQJLQ3XEOLFDWLRQ'DWD )DWKDOOD0DKPRXG) $SUDFWLFDOJXLGHIRUKHDOWKUHVHDUFKHUVE\0DKPRXG))DWKDOODDQG0RKDPHG0))DWKDOOD S :+25HJLRQDO3XEOLFDWLRQV(DVWHUQ0HGLWHUUDQHDQ6HULHV ,6%1 5HVHDUFK±6FLHQWLILF:ULWLQJ±*XLGHOLQHV3XEOLVKLQJ±*XLGHOLQHV:+25HJLRQDO2IILFHIRUWKH(DVWHUQ 0HGLWHUUDQHDQ ,)DWKDOOD0RKDPHG0) ,,7LWOH >1/0&ODVVLILFDWLRQ4@
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Foreword ...... 7
Preface ...... 9
Acknowledgements ...... 10
Chapter 1. Introduction and overview ...... 11 References and additional sources of information ...... 19
Chapter 2. Ethics in health research ...... 20 2.1 Introduction...... 20 2.2 General ethical principles...... 21 2.3 Responsibility for ethics in health research ...... 22 2.4 Ethics committees ...... 22 2.5 Ethical considerations throughout the research process...... 23 References and additional sources of information ...... 24
Chapter 3. What research to do? ...... 25 3.1 Introduction...... 25 3.2 Selection of a field for research...... 26 3.3 Drivers for health research ...... 29 3.4 Participation in collaborative international research...... 32 3.5 Participation in pharmaceutical company research...... 34 3.6 Where do research ideas come from? ...... 36 3.7 Criteria for a good research topic...... 39 References and additional sources of information ...... 41
Chapter 4. Planning the research...... 43 4.1 Introduction ...... 43 4.2 Types of research design ...... 44 4.3 Selecting a research design...... 47 4.4 Defining and refining the research question...... 49 4.5 Generating the research hypothesis ...... 50 4.6 Study sample...... 50 4.7 Sample size...... 52 4.8 Measurement ...... 54 4.9 Planning qualitative research ...... 55 4.10 A note on questionnaire design...... 57 4.11 A note on research in health economics ...... 58 4.12 Ethics in research design ...... 59 References and additional sources of information ...... 62 Chapter 5. Writing the research protocol ...... 65 5.1 Introduction...... 65 5.2 Format for the protocol ...... 66 References and additional sources of information ...... 71
Chapter 6. Submitting a research proposal ...... 72 6.1 Introduction...... 72 6.2 How to get your research project funded ...... 72 6.3 Components of a research proposal ...... 75 References and additional sources of information ...... 78
Chapter 7. Implementing the research project ...... 79 7.1 Introduction...... 79 7.2 Scientific rigour...... 79 7.3 Pre-testing the protocol ...... 80 7.4 Monitoring of the study...... 80 7.5 Periodic tabulations and reports...... 82 7.6 Validation of results in qualitative research ...... 82 7.7 Good clinical practice ...... 82 7.8 Research on new pharmaceutical products ...... 83 7.9 Termination of the study ...... 84 7.10 Changes in the protocol ...... 84 7.11 Ethical issues in the implementation of the study ...... 85 References and additional sources of information ...... 86
Chapter 8. Describing and analysing research results ...... 87 8.1 Introduction ...... 87 8.2 Descriptive statistics...... 87 8.3 Tabulation ...... 88 8.4 Calculations ...... 89 8.5 Graphs/figures...... 91 8.6 Correlation...... 91 8.7 Inferential statistics ...... 93 8.8 What statistical tests tell us ...... 95 8.9 Selection of statistical test ...... 98 8.10 Examples of some common statistical tests...... 101 8.11 Description and analysis of results of qualitative research...... 102 References and additional sources of information ...... 105
Chapter 9. Interpreting research results ...... 106 9.1 Introduction...... 106 9.2 Interpreting descriptive statistics ...... 106 9.3 Interpreting “statistical significance” ...... 107 9.4 Bias ...... 107 9.5 Confounding ...... 109 9.6 Making the case for causation...... 110 9.7 Interpreting end points to measure the outcome ...... 112 9.8 Interpreting studies of risk factors ...... 112 9.9 Interpreting studies of diagnostic tests...... 114 9.10 Interpreting studies that report the results of interventions ...... 116 9.11 Interpreting results of qualitative research ...... 116 References and additional sources of information ...... 117
Chapter 10. Communicating research...... 119 10.1 Introduction...... 119 10.2 Communicating to scientists ...... 120 10.3 Communicating to funding agencies ...... 123 10.4 Communicating to health professionals ...... 124 10.5 Communicating to policy-makers ...... 125 10.6 Communicating to patients...... 127 10.7 Communicating to the community ...... 127 10.8 Communicating to the public ...... 127 10.9 Communicating to the public media ...... 128 References and additional sources of information ...... 129
Chapter 11. Writing a scientific paper...... 130 11.1 Introduction...... 130 11.2 Selecting a title for the paper...... 131 11.3 Writing the abstract and key words ...... 131 11.4 Article structure ...... 132 11.5 Writing the Introduction ...... 132 11.6 Writing the Methods section ...... 132 11.7 Writing the Results ...... 134 11.8 Writing the Discussion and Conclusions ...... 137 11.9 Acknowledgements ...... 138 11.10 Citation of references ...... 139 11.11 Steps in the process of writing a paper ...... 140 11.12 Revision of the manuscript for scientific content ...... 141 11.13 Revision of the manuscript for style ...... 142 11.14 Writing a case report ...... 144 11.15 Writing a secondary scientific paper ...... 145 11.16 Writing a paper on qualitative research...... 147 11.17 The dissertation or thesis ...... 147 References and additional sources of information ...... 149
Chapter 12. Publishing a scientific paper ...... 151 12.1 Introduction...... 151 12.2 How to get your paper published...... 151 12.3 Uniform requirements for manuscripts submitted to biomedical journals...... 153 12.4 Summary of technical instructions for submission of papers ...... 154 12.5 Sending the manuscript to the journal...... 155 12.6 After submitting the manuscript ...... 155 12.7 Authorship in scientific papers...... 156 12.8 Patents and publication ...... 157 12.9 Ethics in scientific publication...... 157 References and additional sources of information ...... 161
Chapter 13. Making a scientific presentation...... 162 13.1 Introduction...... 162 13.2 Planning of the presentation ...... 162 13.3 Preparation...... 163 13.4 Presentation ...... 167 13.5 Guide to how to give a “bad” presentation...... 169 References and additional sources of information ...... 170
Chapter 14. Assessment and evaluation of research ...... 172 14.1 Introduction...... 172 14.2 Assessment and evaluation by researchers...... 173 14.3 Assessment and evaluation by health professionals...... 175 14.4 Assessment and evaluation by policy-makers...... 177 14.5 Assessment and evaluation by investors in research...... 180 References and additional sources of information ...... 183
Annex 1. World Medical Association Declaration of Helsinki Ethical principles for medical research involving human subjects ...... 185
Annex 2. International ethical guidelines for biomedical research involving human subjects...... 191
Annex 3. Searching the literature...... 201
Annex 4. Guidelines on how to write references for scientific papers ...... 210
Annex 5. Bangkok Declaration on Health Research for Development ...... 214
Glossary of terms in health research ...... 216 Foreword
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0DKPRXG))DWKDOOD 0RKDPHG0))DWKDOOD Acknowledgements
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References and additional sources of information
Commission on Health Research for Development. Health research: essential link to equity in development. Oxford, Oxford University Press, 1990. Einstein A. http://www.memorablequotations.com/einstein.htm (accessed 30/3/2004). Global Forum for Health Research. The 10/90 report on health research 2000. Geneva, Global Forum for Health research, 2000. Medawar PB. Advice to a young scientist. New York, Basic Books, 1979. Investing in health research and development: Report of the Ad Hoc Committee on Health Research Relating to Future Intervention Options. Geneva, World Health Organization, 1996. Sustaining the strength of the UK in healthcare and life sciences R&D: competition, cooperation and cultural change. A report on the third SmithKline Beecham R&D Policy Symposium. Oxted, ScienceBridge, 1996: 17. Salam A. Notes on science, technology and science education in the development of the south. Prepared for the fifth meeting of the South Commission, May 27–30, 1989, Maputo, Mozambique. Trieste, The Third World Academy of Sciences. Chapter 2 Ethics in health research
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2.2 General ethical principles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practical guide for health researchers
2.3 Responsibility for ethics in health research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¶SHHUVDQGRWKHUVWRSURYLGH DGYLFHRQHWKLFDODVSHFWVRIWKHVWXG\DQGWRDSSURYHLWRUGLVDSSURYHLWRQEHKDOIRI WKHLQVWLWXWLRQ7KHPHPEHUVKLSPD\LQFOXGHRWKHUKHDOWKSURIHVVLRQDOVSDUWLFXODUO\ QXUVHVDVZHOODVOD\PHQTXDOLILHGWRUHSUHVHQWWKHFRPPXQLW\¶VFXOWXUDODQGPRUDO YDOXHV7KHFRPPLWWHHVKRXOGEHFRPSOHWHO\LQGHSHQGHQWIURPWKHLQYHVWLJDWRUV$Q\ PHPEHUZLWKDGLUHFWLQWHUHVWLQDSURSRVDOVKRXOGQRWSDUWLFLSDWHLQLWVDVVHVVPHQW 7KHQH[WVHFWLRQSURYLGHVPRUHLQIRUPDWLRQRQHWKLFVFRPPLWWHHV 1DWLRQDO'UXJ5HJXODWRU\$JHQF\1HZGUXJVRUGHYLFHVWKDWDUHQRW\HWDSSURYHGLQ WKHFRXQWU\VKRXOGQRWEHXVHGRQKXPDQVXEMHFWVZLWKRXWDSSURYDOEHLQJREWDLQHG IRUWKHLUXVHXQGHUWKHFRQGLWLRQVRIWKHVWXG\ (GLWRUVRIPHGLFDOMRXUQDOV5HSRUWVRIUHVHDUFKQRWFRPSO\LQJZLWKHWKLFDOVWDQGDUGV VKRXOGQRWEHDFFHSWHGIRUSXEOLFDWLRQ )XQGLQJDJHQFLHVDQGRUJDQL]DWLRQV1RUHVHDUFKSURSRVDOVKRXOGEHIXQGHGE\ DQDWLRQDORULQWHUQDWLRQDODJHQF\XQOHVVLWKDVFOHDUO\RXWOLQHGWKHHWKLFDODVSHFWV RIWKHVWXG\DQGKDVSURYLGHGDVVXUDQFHVWKDWHWKLFDOSULQFLSOHVZLOOEHREVHUYHG LQFOXGLQJDVDSSURSULDWHWKHDSSURYDORIDQLQVWLWXWLRQDOUHYLHZFRPPLWWHH
2.4 Ethics committees &RXQWULHVDQGLQVWLWXWLRQVVKRXOGHVWDEOLVKHWKLFDOUHYLHZV\VWHPVWRHQVXUHWKH SURWHFWLRQRISRWHQWLDOUHVHDUFKSDUWLFLSDQWVDQGFRQWULEXWHWRWKHKLJKHVWDWWDLQDEOH TXDOLW\LQWKHVFLHQFHDQGHWKLFVRIKHDOWKUHVHDUFK(WKLFVFRPPLWWHHVVKRXOGEH HVWDEOLVKHGDVDSSURSULDWHDWWKHQDWLRQDOUHJLRQDODQGLQVWLWXWLRQDOOHYHOV Ethics in health research 23
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2.5 Ethical considerations throughout the research process 7KHUHVHDUFKSURFHVVEHJLQVZLWKWKHFKRLFHRIWKHUHVHDUFKWRSLFIROORZHGE\ VHOHFWLRQRIWKHDSSURSULDWHUHVHDUFKGHVLJQGHYHORSPHQWRIWKHUHVHDUFKSURWRFRO ZULWLQJDQGVXEPLWWLQJDUHVHDUFKSURSRVDOIRUIXQGLQJLPSOHPHQWLQJWKHVWXG\ GHVFULSWLRQDQGDQDO\VLVRIWKHUHVHDUFKUHVXOWVLQWHUSUHWDWLRQRIWKHUHVHDUFKUHVXOWV DQGILQDOO\FRPPXQLFDWLQJWKHUHVHDUFKLQFOXGLQJLWVSXEOLFDWLRQ(WKLFDOFRQVLGHUDWLRQV DSSO\WKURXJKRXWWKHUHVHDUFKSURFHVVDQGZLOOEHGLVFXVVHGLQWKHUHOHYDQWFKDSWHUV 7KHREMHFWLYHRIWKLVDSSURDFKLVWRGHPRQVWUDWHWKDWHWKLFDOFRQVLGHUDWLRQVDUHLQWHJUDO FRPSRQHQWVRIWKHUHVHDUFKSURFHVVDQGDUHQRWDVXEMHFWWREHGLVFXVVHGVHSDUDWHO\ ,QIDFWVFLHQWLILFDVVHVVPHQWRIWKHSODQQHGUHVHDUFKLVDQLPSRUWDQWSDUWRIWKHHWKLFDO 24 A practical guide for health researchers
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References and additional sources of information
Angell M. The ethics of clinical research in the Third World. New England Journal of Medicine, (editorial). 1997, 337, 847–849. International ethical guidelines for biomedical research involving human subjects. Geneva, Council for International Organizations of Medical Sciences (CIOMS), 2002. International guiding principles for biomedical research involving animals. Geneva, Council for International Organizations of Medical Sciences (CIOMS), 1985. Research ethics training curriculum. [CD-ROM teaching aid appropriate for international biomedical and social science researchers]. Family Health International, 2001. (E-mail: [email protected]). Fluss S.S. International guidelines on bioethics: informal listing of selected international codes, declarations, guidelines, etc. on medical ethics/ bioethics/ health care ethics/ human rights aspects of health. Geneva, Council for International Organizations of Medical Sciences, 2000. Lansang MA, Crawley FP. The ethics of international biomedical research (editorial). British Medical Journal, 2000, 321: 777–778. Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. New England Journal of Medicine, 1997, 337: 853–855. Resnik DB. The ethics of science: an introduction. London and New York, Routledge, 1999. Singer PA, Benatar SR. Beyond Helsinki: a vision for global health ethics (editorial). British Medical Journal, 2001, 322: 747–748. Operational guidelines for ethics committees that review biomedical research. Geneva, World Health Organization, 2000 (TDR/PRD/Ethics/2000/1 available from http: //www.who.int/tdr/publications/publications/pdf/ethics.pdf accessed 22/7/2004). World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. World Medical Association, 2000 (http://www.wma.net/e/policy/ b3.htm accessed 22/7/2004). Chapter 3 What research to do?
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3.2 Selection of a field for research 3.2.1 Categories of health research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
3.2.2 Multidisciplinary research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hat research to do? 27
3.2.3 Basic versus applied research )UDQFLV%DFRQLQWKHWKFHQWXU\PDGHWKHGLVWLQFWLRQEHWZHHQVFLHQWLILFH[SHULPHQWV IRUOLJKW LHNQRZOHGJH DQGH[SHULPHQWVIRUIUXLW LHUHVXOWV 0HGDZDU :HFDQ DGGWRWKLVVWDWHPHQWWKDWZHQHHGWRKDYH³OLJKW´LQRUGHUWREHDEOHWRVHDUFKIRU³IUXLW´ +RZHYHULQWKHILHOGRIKHDOWKUHVHDUFKDQGVFLHQFHLQJHQHUDOWKH³SXUH´ EDVLF YHUVXV ³DSSOLHG´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³DSSOLHG´VFLHQFHDQG³QRW\HWDSSOLHG´VFLHQFH
3.2.4 Quantitative versus qualitative research &OLQLFLDQVDUHWUDLQHGWRWKLQNPHFKDQLVWLFDOO\DQGFOLQLFLDQVDUHWKHUHIRUHPRVW IDPLOLDUZLWKTXDQWLWDWLYHUHVHDUFK+RZHYHUPHGLFLQHLVQRWRQO\DPHFKDQLVWLFDQG TXDQWLWDWLYHVFLHQFH3DWLHQWVDUHQRWEURNHQGRZQPDFKLQHVRUPDOIXQFWLRQLQJELRORJLFDO V\VWHPV'RFWRUVGRQRWWUHDWGLVHDVHVGRFWRUVWUHDWSDWLHQWV+HDOWKLVPRUHLQWKHKDQGV RISHRSOHWKDQLQWKHKDQGVRIKHDOWKSURIHVVLRQDOV4XDOLWDWLYHUHVHDUFKLVQHHGHGWR SURYLGHLQVLJKWVLQWRSHRSOH¶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practical guide for health researchers
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3.2.5 Action research $FWLRQUHVHDUFKLVDVW\OHRIUHVHDUFKUDWKHUWKDQDVSHFLILFPHWKRGRORJ\,QDFWLRQ UHVHDUFKWKHUHVHDUFKHUVZRUNZLWKWKHSHRSOHDQGIRUWKHSHRSOHUDWKHUWKDQXQGHUWDNH UHVHDUFKRQWKHP7KHIRFXVRIDFWLRQUHVHDUFKLVRQJHQHUDWLQJVROXWLRQVWRSUREOHPV LGHQWLILHGE\WKHSHRSOHZKRDUHJRLQJWRXVHWKHUHVXOWVRIUHVHDUFK$FWLRQUHVHDUFKLV QRWV\QRQ\PRXVZLWKTXDOLWDWLYHUHVHDUFK%XWLWW\SLFDOO\GUDZVRQTXDOLWDWLYHPHWKRGV VXFKDVLQWHUYLHZVDQGREVHUYDWLRQV
3.2.6 Research in health economics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
3.2.7 Big science 7KHQDWXUHRIKHDOWKUHVHDUFKKDVEHHQHYROYLQJ5HODWLYHO\VPDOOSURMHFWVLQLWLDWHG E\VLQJOHRUVPDOOJURXSVRILQYHVWLJDWRUVKDYHWUDGLWLRQDOO\EHHQDQGFRQWLQXHWREH DPDLQVWD\RIVFLHQFH5HFHQWWHFKQRORJLFDODGYDQFHVQRZDOORZWKHH[SORUDWLRQRIELJ TXHVWLRQVZKLFKFDQQRWEHDQVZHUHGE\VPDOOVFDOHUHVHDUFK7KHKXPDQJHQRPHSURMHFW LVWKHELJJHVWDQGEHVWNQRZQODUJHVFDOHELRPHGLFDOUHVHDUFKSURMHFWXQGHUWDNHQWRGDWH 7KHLPSOLFDWLRQVRI³ELJVFLHQFH´IRUIXWXUHKHDOWKUHVHDUFKZHUHH[SORUHGLQDUHSRUWE\ What research to do? 29
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3.3 Drivers for health research 3.3.1 Curiosity-driven research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³.HHSRQJRLQJDQGWKHFKDQFHVDUHWKDW\RXZLOO VWXPEOHRQVRPHWKLQJSHUKDSVZKHQ\RXDUHOHDVWH[SHFWLQJLW,KDYHQHYHUKHDUGRI DQ\RQHVWXPEOLQJRQVRPHWKLQJVLWWLQJGRZQ´ +HDWK 3DVWHXUVDLG³,QWKHILHOGVRIREVHUYDWLRQFKDQFHIDYRXUVRQO\WKHSUHSDUHGPLQG´ 5REHUWV ,WKDVEHHQVDLGWKDWWKHVHHGVRIJUHDWGLVFRYHU\DUHFRQVWDQWO\IORDWLQJ DURXQGXVEXWWKDWWKH\RQO\WDNHURRWLQPLQGVZHOOSUHSDUHGWRUHFHLYHWKHP$OH[DQGHU )OHPLQJLQWKHVXPPHURIZRUNLQJLQ6W0DU\¶V+RVSLWDOLQ/RQGRQZDVQRW ORRNLQJIRUDQDQWLEDFWHULDODJHQWDWWKHWLPHDVSRUHIORDWHGLQWRKLV3HWULGLVK%XWKH ZDVH[WUHPHO\ZHOOUHDGDQGWUDLQHGLQPLFURELRORJ\DQGFRXOGHDVLO\UHFRJQL]HWKH 30 A practical guide for health researchers
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³VDIDULUHVHDUFK´VKRXOGEHGLVFRXUDJHG 62 A practical guide for health researchers 4.12.4 Ethics in research designs involving experimentation on animals 7KHDQLPDOPRGHOFKRVHQPXVWEHUHOHYDQWWRWKHKXPDQ7KHLQIRUPDWLRQPXVWEH DSSOLFDEOHWRWKHKXPDQ 7KHPLQLPXPQXPEHURIDQLPDOVVKRXOGEHXVHG([SHULPHQWVVKRXOGEHGHVLJQHG ZLWKSURSHUFDOFXODWLRQRIWKHVL]HRIWKHDQLPDOVDPSOHQHHGHGWRDQVZHUWKHUHVHDUFK TXHVWLRQRUWHVWWKHUHVHDUFKK\SRWKHVLV1RPRUHWKDQWKHPLQLPDOQXPEHURI DQLPDOVVKRXOGEHXVHGEXWDVXIILFLHQWQXPEHURIDQLPDOVVKRXOGEHXVHGWRSURYLGHD VFLHQWLILFDOO\YDOLGFRQFOXVLRQ References and additional sources of information Browner WS, et al. Getting ready to estimate sample size: hypotheses and underlying principles. In: Hulley SB, Cummings SR, eds. Designing clinical research: an epidemiologic approach, 2nd edition. Philadelphia, Lippincott Williams & Wilkins, 2001: 51–62. Byrne DW. Publishing your medical research paper. Baltimore, Lippincott Williams & Wilkins, 1998: 5–44. Carey SS. A beginner’s guide to scientific method, 2nd edition. New York, Wadsworth Publishing Company, 1998. Coppleson L, Factor R, Strums S, Graff P, Rappaport H. Observer disagreement in the classification and histology of Hodgkin’s disease. Journal of the National Cancer Institute, 1970, 45: 731–740. International guidelines for ethical review of epidemiological studies. Geneva, Council for International Organizations of Medical Sciences, 1991. International guiding principles for biomedical research involving animals. Geneva, Council for International Organizations of Medical Sciences, 1985. Hulley SB, Martin JN, Cummings SR. Planning the measurements: precision and accuracy. In: Hulley SB, Cummings SR. eds. Designing clinical research: an epidemiologic approach, 2nd edition. Philadelphia, Lippincott Williams & Wilkins, 2001: 37–49. Devers KJ, Sofaer S, Rundall TG, eds. Qualitative methods in health services research: a special supplement to HSR. Health Services Research, 1999, 34 (5) Part II: 1083– 1263. Doll R, Hill AB. Mortality in relation to smoking: ten years’ observation of British doctors. British Medical Journal, 1964, 1:1399–1414; 1460–1467. Doll R, Peto R. Mortality in relation to smoking: 20 years’ observation on British doctors. British Medical Journal, 1976, 2: 1525–1536. Planning the research 63 Doll R, Peto R, Wheatley K et al. Mortality in relation to smoking: 40 years’ observations on male British doctors. British Medical Journal, 1994, 309: 901–911. Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet 2002, 359: 57–61. Grimes DA, Schulz KF. Descriptive studies: what they can and cannot do. Lancet, 2002, 359: 145–49. Grimes DA, Schulz KF. Bias and causal associations in observational research. Lancet, 2002, 359: 248–52. Grimes DA, Schulz KF. Cohort studies: marching towards outcomes. Lancet, 2002, 359: 341–45. Jefferson T, Demicheli V, Mugford M. Elementary economic evaluation in health care, 2nd edition. London, British Medical Journal Books, 2000. Neame R, Kluge E-H. The impact of informatics. Computerisation and health care: some worries behind the promises. British Medical Journal, 1999, 319:1295. O’Brien PMS, Pipkin FB. eds. Introduction to research methodology for specialists and trainees. London, Royal College of Obstetricians and Gynaecologists Press, 1999. Polgar S, Thomas SA. Introduction to research in the health sciences, 4th edition. London, New York, Churchill Livingstone, 2000: 62; 63; 107–114. Schulz KF, Grimes DA. Case-control studies: research in reverse. Lancet, 2002, 359: 431–34. Schulz KF, Grimes DA. 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Designing and conducting health systems research projects. Volume 1: Proposal development and field work. Volume 2: Data analysis and report writing. Ottawa, International Development Research Centre, 1995. Wingo PA, Higgins JA, Rubin GL, Zahniser SC. An epidemiologic approach to reproductive health. Geneva, World Health Organization, 1994 (WHO/HRP/EPI/1994). Health research methodology. A guide for training in research methods. 2nd edition. Manila, World Health Organization Regional Office for the Western Pacific, 2001. 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'UXJVDQGGHYLFHVLQWHQGHGIRUXVHE\ZRPHQRQO\ZHUHVRPHWLPHVWHVWHGRQWKHP ZLWKRXWWKHLUSURSHULQIRUPHGFRQVHQWSDUWLFXODUO\LQSRRUUHVRXUFHVHWWLQJV :KHQZRPHQZHUHLQFOXGHGZLWKPHQDVUHVHDUFKVXEMHFWVJHQGHUZDVQRWDOZD\V WDNHQLQWRFRQVLGHUDWLRQZKHQUHVXOWVZHUHDQDO\VHG ,WLVZHOONQRZQWKDWJHQHWLFDQGKRUPRQDOIDFWRUVPRGLI\WKHSUHYDOHQFHEHKDYLRXU DQGWUHDWPHQWRIGLVHDVHVRIERG\V\VWHPVLQPHQDQGZRPHQ%XWZKDWLVOHVVNQRZQLV WKDWFXOWXUDOO\HYROYHGJHQGHUUHODWHGGLIIHUHQFHVLQOLIHVW\OHEHKDYLRXUDUHDOVRSRZHUIXO GHWHUPLQDQWVRIZRPHQ¶VKHDOWKDQGDFFRXQWIRUPDMRUGLIIHUHQFHVLQWKHGLVHDVHEXUGHQ EHWZHHQPDOHVDQGIHPDOHVSUREDEO\PRUHWKDQJHQHWLFRUKRUPRQDOIDFWRUV%RWK ELRORJLFDODQGJHQGHUUHODWHGGLIIHUHQFHVFDQLQIOXHQFHWKHRXWFRPHRIWKHUHVHDUFKIRU PHQDQGZRPHQ Writing the research protocol 71 References 7KHSURWRFROVKRXOGHQGZLWKUHOHYDQWUHIHUHQFHVRQWKHVXEMHFW References and additional sources of information Commission on the Status of Women Forty-third session. Revised draft agreed conclusions on women and health submitted by the Chairperson of the Commission. New York, United Nations Economic and Social Council, 1999 (E/CN.6/1999/L.2/Rev.1). Fathalla MF. Gender matters in health research. In: International Conference on Health Research for Development, Bangkok 10-13 October 2000. Conference report. Geneva, Global Forum for Health Research, 2001: 105–108. Kendall MJ and Hawkins C. Planning and protocol writing. In: Hawkins C, Sorgi M, eds. Research: How to plan, speak and write about it. Berlin, Springer-Verlag, 1985: 12–28. UNDP/UNFPA/WHO/World Bank Special Programme of Research, development and research training in human reproduction. Preparing a research project proposal. Guidelines and forms. 3rd edition. Geneva, World Health Organization, 2000 (WHO/ HRP/PP/2000). 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7KHEXGJHWUHTXHVWVKRXOGEHLWHPL]HGDQGHDFKLWHPVKRXOGEHMXVWLILHG Budget itemization 7KHIROORZLQJDUHH[DPSOHVRIFDWHJRULHVRIH[SHQVHV 3HUVRQQHO QDPHVSRVLWLRQVSHUFHQWDJHRIWLPHVSHQWRQWKHSURMHFWVDODU\IULQJH EHQHILWV (TXLSPHQW 6XSSOLHV 3DWLHQWFDUHFRVWV 7UDYHO 'DWDSURFHVVLQJ &RPPXQLFDWLRQV 6HFUHWDULDOH[SHQVHV 3XEOLFDWLRQGLVVHPLQDWLRQRILQIRUPDWLRQDERXWWKHRXWFRPHRIWKHSURMHFW Budget justification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practical guide for health researchers UHOHDVHGRQD\HDUO\EDVLVVXEMHFWWRWKHVXEPLVVLRQRIDFFHSWDEOHSURJUHVVDQGILQDQFLDO UHSRUWV $JHQFLHVQRUPDOO\ZLOODOORZVRPHIOH[LELOLW\LQWKHXVHRIWKHEXGJHWSURYLGHGWKH WRWDOEXGJHWLVQRWH[FHHGHG)RUVKLIWVEHWZHHQEXGJHWLWHPVKRZHYHULWLVH[SHFWHG WKDWWKHDJHQF\¶VDSSURYDOEHVRXJKWEHIRUHKDQG $QXQUHDOLVWLFEXGJHWLVOLNHO\WROHDGWRUHMHFWLRQRIWKHSURSRVDO7KHEXGJHWPD\ EHXQUHDOLVWLFLQRQHRIWZRZD\V,WPD\DVNIRUPRUHWKDQLVQHHGHGWRXQGHUWDNHWKH SURMHFWRULWPD\DVNIRUPXFKOHVVWKDQLVUHDOLVWLFDOO\QHHGHGWRXQGHUWDNHWKHSURMHFW VXFFHVVIXOO\7KHLQYHVWLJDWRUVPD\ZDQWWROLPLWWKHEXGJHWWRWKHIXQGLQJFHLOLQJRIWKH DJHQF\EXWNHHSWKHODUJHSURMHFWDVLWLV,QVWHDGWKH\VKRXOGOLPLWWKHSURMHFWREMHFWLYHV WRZKDWFDQUHDOLVWLFDOO\EHDFKLHYHGZLWKWKHUHTXHVWHGIXQGV References $QXPEHURIUHFHQWUHIHUHQFHVRQWKHVXEMHFWVKRXOGEHFLWHGLQVXSSRUWRIWKH SURSRVDO Curriculum vitae (CVs) of the investigator(s) 7KHDELOLW\RIWKHLQYHVWLJDWRUVWRFDUU\RXWWKHSURMHFWLVDQLPSRUWDQWFRQVLGHUDWLRQ %LRJUDSKLFDOVNHWFKHVRIWKHLQYHVWLJDWRUVRU&9VVKRXOGEHDWWDFKHG7KHWUDFNUHFRUGRI WKHLQYHVWLJDWRUVLVLPSRUWDQW3UHOLPLQDU\VWXGLHVRURWKHUZRUNGRQHE\WKHLQYHVWLJDWRUV RQWKHVXEMHFWVKRXOGEHLQFOXGHG References and additional sources of information Cummings SR, Holly EA, Hulley SB. Writing and funding a research proposal. In: Hulley SB, Cummings SR. eds. Designing clinical research: an epidemiologic approach, 2nd edition. Philadelphia, Lippincott Williams & Wilkins, 2001: 285–298. Wingo PA, Higgins JA, Rubin GL, Zahniser SC. An epidemiologic approach to reproductive health. Geneva. World Health Organization, 1994: 15–67 (WHO/HRP/EPI/1994). Health research methodology: A guide for training in research methods. 2nd edition. Manila, World Health Organization Regional office for the Western Pacific, 2001: 147–161. UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction. Preparing a research project proposal. Guidelines and forms. 3rd edition. Geneva, World Health Organization, 2000 (WHO/ HRP/PP/2000). Wyatt KM, Dimmock PW. Applying for a grant. In: O’Brien PMS, Pipkin FB. Introduction to research methodology for specialists and trainees. London, Royal College of Obstetricians and Gynaecologists Press, 1999: 201–209. Chapter 7 Implementing the research project 7.1 Introduction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cientific rigour 7KH(QJOLVKZRUG³ULJRXU´OLWHUDOO\PHDQV³VWULFWQHVV´,QVFLHQWLILFUHVHDUFKWKH WHUPULJRXULVXVHGWRLPSO\WKDW WKHVWXG\SURWRFROLVEHLQJDGKHUHGWR WKHUHVHDUFKLVFRQGXFWHGLQDFFRUGDQFHZLWKHVWDEOLVKHGHWKLFDOVWDQGDUGV PHWLFXORXVDQGGHWDLOHGUHFRUGVRIDOOREVHUYDWLRQVDUHPDLQWDLQHG PHWKRGVRIPHDVXUHPHQWDUHXVHGLQDQREMHFWLYHZD\WRSURYLGHYDOLGDQGUHOLDEOH UHVXOWV 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ILQDOILQDQFLDOUHSRUWVDUHUHTXLUHGDQGVKRXOGEHVXEPLWWHG References and additional sources of information Hulley SB, Cummings SR. Implementing the study: Pre-testing, quality control, and protocol revisions. In: Hulley SB, Cumming SR, eds. Designing clinical research: an epidemiologic approach, 2nd edition. Philadelphia, Lippincott Williams & Wilkins, 2001: 259–271. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. Geneva, World Health Organization, 1995: 97–137 (WHO Technical Report Series, No. 850). 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FDQEHGRQHZLWKTXDOLWDWLYHGDWDDQDO\VLVVRIWZDUH$IWHUH[WUDFWLQJDQGFRPELQLQJDOO WKHLQIRUPDWLRQRQDWKHPHLQDFRGLQJVRUWWKHLQYHVWLJDWRUZLOOEHUHDG\IRUDFORVH H[DPLQDWLRQRIWKHGDWD 3XWWLQJTXDOLWDWLYHGDWDLQWDEOHVDQGILJXUHVLVRIWHQFDOOHG³GDWDUHGXFWLRQ´$ WDEOHWKDWFRQWDLQVZRUGV QRWQXPEHUVDVLQTXDQWLWDWLYHUHVHDUFK LVFDOOHGD³PDWUL[´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escribing and analysing research results 105 References and additional sources of information Briscoe MH. A researcher’s guide to scientific and medical illustrations. New York, Springer-Verlag, 1990. Browner WS et al. Getting ready to estimate sample size: hypotheses and underlying principles. In: Hulley SB, Cummings SR, eds. Designing clinical research: an epidemiologic approach, 2nd edition. Philadelphia, Lippincott Williams & Wilkins, 2001: 51–62. Gardner MJ, Altman DG. Statistics with confidence: confidence intervals and statistical guidelines. London, BMJ Books, 1997. Gehlbach SH. Interpreting the medical literature. 3rd edition. New York, McGraw-Hill Inc., 1993: 138. Hill AB. Principles of medical statistics, 9th edition. New York, Oxford University Press, 1971. Malterad K. Qualitative research: standards, challenges, and guidelines. Lancet, 2001, 358: 483–88. Medawar PB. Advice to a young scientist. New York, Basic Books, 1979: 39. Pope C, Ziebland S, Mays V. Qualitative research in health care: Analysing qualitative data. British Medical Journal, 2000, 320:114–116. Swinscow TDV, Campbell MJ. Statistics at square one. 10th edition. London, BMJ Books, 2002. Weaver JH. Conquering statistics: numbers without the crunch. Cambridge, Massachusetts, Perseus Publishing, 2000: 5–12. 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³DXGLWWUDLO´HQDEOHVRWKHUVRQWKHEDVLVRIWKH FROOHFWHGGDWDWRUHYLHZWKHDQDO\VLVGHFLVLRQVDQGYHULI\WKHLQWHUSUHWDWLRQV 7UDQVIHUDELOLW\PHDQVWKHXVHRIWKHILQGLQJVWRPDNHLQIHUHQFHVWRRWKHUSRSXODWLRQV 7KLVPD\QRWEHSRVVLEOHEHFDXVHTXDOLWDWLYHUHVHDUFKLVRIWHQFRQWH[WVSHFLILF4XDOLWDWLYH UHVHDUFKHPSKDVL]HVGHSWKPRUHWKDQEUHDGWKDQGLQVLJKWUDWKHUWKDQJHQHUDOL]DWLRQ,Q VXFKFDVHVKRZHYHUWKHUHDUHOHVVRQVOHDUQWWKDWPD\KHOSLQXQGHUVWDQGLQJWKHVLWXDWLRQ LQRWKHUSRSXODWLRQV References and additional sources of information Altman DG, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Annals of Internal Medicine, 2001, 134: 663–694. Bossuyut PM, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. British Medical Journal, 2003, 326: 41–44. 118 A practical guide for health researchers Newman B, Browner WS, Cummings SR. Designing studies of medical tests. In: Hulley SB, Cumming SR, eds. Designing clinical research: an eidemiologic approach, 2nd edition. Philadelphia, Lippincott Williams & Wilkins, 2001: 175–192. Byrne DW. Publishing your medical research paper. Baltimore, Lippincott Williams & Wilkins, 1998. Devers KJ, Sofaer S, Rundall TG, eds. Qualitative methods in health services research: A special supplement to HSR. Health Services Research 1999, 34 (5) Part II: 1083– 1263. Doll R, Hill AB, Mortality in relation to smoking: ten years’ observation of British doctors. British Medical Journal, 1964, 1:1399–1460. Einstein A. http://www.memorable quotations.com/einstein.htm (accessed 30/04/2004). Gehlbach SH. Interpreting the medical literature, 3rd edition. New York, McGraw-Hill Inc., 1993. Greenhalgh T. How to read a paper: the basics of evidence-based medicine. London, BMJ Books, 1997. Hill BA. The environment and disease: association or causation? Proceedings of the Royal Society of Medicine, 1965, 58: 295–300. Huff D. How to lie with statistics. London, Penguin Books, 1991. Malterad K. Qualitative research: standards, challenges, and guidelines. Lancet, 2001, 358: 483–88. Schulz KF, Grimes DA. Uses and abuses of screening tests. Lancet, 2002, 359: 881– 884. Steering Committee of the Physicians’ Health Study Research Group: Final report on the aspirin component of the ongoing physicians’ health study. New England Journal of Medicine, 1989, 321:129. Writing group for the Women’s Health Initiative investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. Journal of the American Medical Association, 2002, 288: 312–333. 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ommunicating research 129 WKHLUSUHVHQWDWLRQVZLWKPHGLDUHSRUWHUVEXWWKH\VKRXOGQRWJREH\RQGZKDWWKH\KDYH SUHVHQWHG References and additional sources of information Reading the medical literature. Applying evidence to practice. Washington, DC, American College of Obstetricians and Gynaecologists, 1998. Byrne DW. Publishing your medical research paper. Baltimore, Williams & Wilkins, 1998: 210–217. Delamothe T, Smith R. PubMed Central: creating an Aladdin’s cave of ideas (editorial). British Medical Journal, 2001, 322:1–2. Delamothe T, Godlee F, Smith R. Scientific literature’s open sesame? British Medical Journal, 2003, 326: 945–946. Davidoff F, Haynes B, Sackett D, Smith R.. Evidence based medicine (editorial). British Medical Journal, 1995, 310: 1085–1086. Eysenbach G, Sa ER, Diepgen TL. Shopping around the Internet today and tomorrow: towards the millenium of cybermedicine. British Medical Journal, 1999, 319: 1294. Gigerenzen G, Edward A. Simple tools for understanding risks: from innumeracy to insight. British Medical Journal, 2003, 327: 741–744. Grimes DA. Communicating research: working with the media. In: O’Brien PMS, Pipkin FB, eds. Introduction to research methodology for specialists and trainees. London, Royal College of Obstetricians and Gynaecologists Press, 1999: 210–217. Kiley R, Graham E. The patient’s Internet handbook. London, Royal Society of Medicine Press Ltd., 2002. Lock S. Foreword. In: Hawkins C, Sorgi M, eds. Research: How to plan, speak and write about it. Berlin, Springer-Verlag, 1985: vii. Long M. The future of electronic publishing. In: Hall GM, ed. How to write a paper, 2nd edition. London, BMJ Books, 1998: 132–138. Shiffman RN et al. Standardized reporting of clinical practice guidelines: a proposal from the Conference on Guideline Standardization. Annals of Internal Medicine, 2003, 139: 493–498. Smith R. Closing the digital divide (editorial). British Medical Journal, 2003, 326: 328. Smith R. Do patients need to read research? British Medical Journal, 2003, 326: 1304. Tamber PS, Fiona F, Newmark P. Open access to peer-reviewed research: making it happen. Lancet, 2003, 362: 1575–77. 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,WLVQRWWKHQXPEHURIUHIHUHQFHVWKDWPDWWHUVEXWWKHLUUHOHYDQFH7KH\VKRXOG LQFOXGHRULJLQDODUWLFOHVDQGQRWEHODUJHO\EDVHGRQUHYLHZV7KH\VKRXOGEHXSWRGDWH LQGLFDWLQJWKDWWKHFDQGLGDWHZDVIROORZLQJWKHOLWHUDWXUHGXULQJDQGDIWHUWKHVWXG\ 5HIHUHQFHVIURPQDWLRQDOVRXUFHVRUUHJLRQDOVRXUFHVVKRXOGEHLQFOXGHGWRJHWKHUZLWK WKRVHIURPWKHLQWHUQDWLRQDOOLWHUDWXUH,WLVDVVXPHGWKDWWKHFDQGLGDWHKDVUHDGDOOWKH UHIHUHQFHV7KHUHIHUHQFHVVKRXOGEHFDUHIXOO\FKHFNHGDJDLQVWRULJLQDOGRFXPHQWV Writing a scientific paper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eferences and additional sources of information Baker P.N. How to set about writing your first paper. In: O’Brien PMS, Pipkin FB, eds. Introduction to research methodology for specialists and trainees. London, Royal College of Obstetricians and Gynaecologists Press, 1999: 225–230. Byrne DW. Publishing your medical research paper. Baltimore, Lippincott Williams & Wilkins, 1998. Crowley P. Corticosteroids prior to pre-term delivery, (updated January 1996). Cochrane Database of Systemic Reviews. London, BMJ Books, 1996. DeLacey G, Record C, Wade J. How accurate are quotations and references in medical journals. British Medical Journal, 1985, 291: 884–886. Docherty M, Smith R.. The case for structuring the discussion of scientific papers (editorial). British Medical Journal, 1999, 318:1224–1225. Forgacs J. How to write a review. In: Hall GM, ed. How to write a paper, 2nd edition. London, BMJ Books, 1998: 77–82. Greenhalgh T. How to read a paper: the basics of evidence-based medicine. London, BMJ Books, 1997:122; 119–123. Hall GM, ed. How to write a paper, 2nd edition. London, BMJ Books, 1998. Halsy MJ. Revising prose structure and style. In: Hall GM, ed. How to write a paper. 2nd edition. London, BMJ Books, 1998: 109–136. Herod JJO. How to prepare a thesis. In: O’Brien PMS, Pipkin FB, eds. Introduction to research methodology for specialists and trainees. London, Royal College of Obstetricians and Gynaecologists Press, 1999: 241–247. Hill B. The reason for writing. British Medical Journal, 1965, 2:870. Huth EJ. How to write and publish papers in the medical sciences. 2nd edition. Baltimore, Williams & Wilkins, 1990. 150 A practical guide for health researchers Hymes KB, Cheung T et al. Kaposi’s sarcoma in homosexual men: A report of eight cases. Lancet 1981, 2: 598–600. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Updated November 2003. (http://www.icmje.org accessed 24/2/2004) Malterad K. Qualitative research: standards, challenges, and guidelines. Lancet, 2001, 358: 483–88. Lester JD, Lester JD, Jr. Writing research papers: a complete guide, 10th edition. New York, Longman, 2002. Pearce N. Style: What is it and does it matter? In: Hall GM, ed. How to write a paper, 2nd edition. London, BMJ Books, 1998: 116–121. Pipkin FB. How a thesis or dissertation is assessed or examined. In: O’Brien PMS, Pipkin FB, eds. Introduction to research methodology for specialists and trainees. London, Royal College of Obstetricians and Gynaecologists Press, 1999: 248–253. Skelton JR, Edwards SJL. The function of the discussion section in academic medical writing. British Medical Journal, 2000, 320: 1269–1270. Strunk W Jr. The elements of style. 4th edition. New York, Longman, 2000. Wildsmith JAW. How to write a case report. In: Hall GM, ed. How to write a paper. 2nd edition. London, BMJ Books, 1998: 70–76. 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References and additional sources of information Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials. Journal of the American Medical Association, 2003, 290: 921–928. Byrne DW. Publishing Your Medical Research Paper. What they don’t teach in medical school. New York, London, Lippincott Williams & Wilkins, 1998. Delamothe T. Is that it? How online articles have changed over the past five years. British Medical Journal, 2002, 325: 1475–1478. Farthing MJG. Ethics of publication. In: Hall GM, ed. How to write a paper. 2nd edition. London, BMJ Books,1998: 122–131. Grant JM and Laird A. How a paper is reviewed and why it might be turned down. In: O’Brien PMS, Pipkin FB, eds. Introduction to research methodology for specialists and trainees. London, Royal College of Obstetricians and Gynaecologists Press, 1999: 231–240. Huth EJ. How to write and publish papers in the medical sciences, 2nd edition. Baltimore, Williams & Wilkins, 1990. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Updated November 2003. (http://www.icmje.org accessed 24/2/2004) Jones J. UK watchdog issues guidelines to combat medical research fraud. British Medical Journal, 1999, 319:660. Weeks WB, Wallace AE. Readability of British and American medical prose at the start of the 21st century. British Medical Journal, 2002, 325: 1451–1452. 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8VH³ILOOHU´VOLGHVLIQHHGHGWRDYRLGKDYLQJOLJKWVRQDQGRIIGXULQJWKHSUHVHQWDWLRQ %XWLWPD\EHJRRGWRFRQFOXGHZKLOHWKHOLJKWVDUHRQWRPDNHDVWURQJILQLVK 'RQRWUHDGWKHVOLGHV Keeping to time 7KHVSHDNHUZKRH[FHHGVKLVDOORWWHGWLPHLVJXLOW\RIJURVVEDGPDQQHUV+H LPSRVHVQRWRQO\RQKLVDXGLHQFHEXWDOVRRQDOOWKHVSHDNHUVZKRFRPHDIWHUKLP,WLV DVLJQRISRRUSUHSDUDWLRQ Answering questions $QVZHUSROLWHO\'RQRWDQVZHUTXHVWLRQVLQDGLVPLVVLYHRUFRQIURQWDWLRQDOPDQQHU $QVZHUNQRZOHGJHDEO\5HPHPEHUWKDW³,GRQRWNQRZ´LVDJRRGDQVZHU 13.5 Guide to how to give a “bad” presentation %DVHGRQDKXPRURXVSLHFHE\5LFKDUG6PLWKHGLWRURIWKH%ULWLVK0HGLFDO-RXUQDO )RUJHWWLQJDOWRJHWKHUWKDW\RXDJUHHGWRVSHDNLVDJRRGZD\WRPDNHDPHVVRI \RXUSUHVHQWDWLRQ$YDULDQWLVWRDUULYHODWH'RQ¶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practical guide for health researchers %HVXUHWRSUHSDUHDSUHVHQWDWLRQWKDWLVWKHZURQJOHQJWK7RRORQJLVPXFKWKHEHVW 0RVWRIWKHDXGLHQFHZLOOEHGHOLJKWHGLI\RXUWDONLVWRRVKRUW%XWVRPHWKLQJWKDW LVWRRORQJDOZD\VGHSUHVVHVDQDXGLHQFHHYHQLIZKDW\RXDUHVD\LQJLVIXOORIZLW DQGZLVGRP $QRWKHUWULFNLVWRLJQRUHWKHWRSLF\RXDUHJLYHQDQGVSHDNRQDFRPSOHWHO\GLIIHUHQW VXEMHFW References and additional sources of information Harvey RF, Schullinger MB, Stassinopoulus A, Winkle E. Dreaming during scientific papers. British Medical Journal, 1983, 2: 1916–1919. Hawkins C. Speaking at meetings. In: Hawkins C, Sorgi M, eds. Research: How to plan, speak and write about it. Berlin, Springer-Verlag, 1985: 60–84. Hextall A, Cardozo L. Presenting a paper. In: O’Brien PMS, Pipkin FB, eds. Introduction to research methodology for specialists and trainees. London, Royal College of Obstetricians and Gynaecologists Press, 1999: 218–224. Lashford LS. Presenting a scientific paper, including the pitfalls. Archives of Disease in Childhood, 1995, 73: 168–169. Making a scientific presentation 171 Smith R. How not to give a presentation. British Medical Journal, 2000, 321:1570– 1571. Sorgi M, Hawkins C. Illustrating talks and articles. In: Hawkins C, Sorgi M, eds. Research: How to plan, speak and write about it. Berlin, Springer-Verlag, 1985: 110–135. Thompson WA et al. Scientific presentations. What to do and what not to do. Investigative Radiology, 1987, 22: 224–45. 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$PLQLVWHULDOVXPPLWRQKHDOWKUHVHDUFKLVSODQQHGE\ :+2IRU1RYHPEHULQ0H[LFR References and additional sources of information Reading the medical literature. 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Putting NHS research on the map: an analysis of scientific publications in England 1990–1997. London, The Wellcome Trust, 2001. (http://www.wellcome.ac.uk. accessed 30/3/2004). World Health Organization Department of Reproductive Health and Research, 2002. The WHO Reproductive Health Library, No. 5 [CD-ROM]. Geneva (WHO/RHR/02.1). Annex 1 World Medical Association Declaration of Helsinki Ethical principles for medical research involving human subjects $GRSWHGE\WKHWK:RUOG0HGLFDO$VVRFLDWLRQ :0$ *HQHUDO$VVHPEO\ +HOVLQNL)LQODQG-XQH DQGDPHQGHGE\WKH WK:0$*HQHUDO$VVHPEO\7RN\R-DSDQ2FWREHU WK:0$*HQHUDO$VVHPEO\9HQLFH,WDO\2FWREHU VW:0$*HQHUDO$VVHPEO\+RQJ.RQJ6HSWHPEHU WK:0$*HQHUDO$VVHPEO\6RPHUVHW:HVW5HSXEOLFRI6RXWK$IULFD 2FWREHU DQGWKH QG:0$*HQHUDO$VVHPEO\(GLQEXUJK6FRWODQG2FWREHU 1RWHRIFODULILFDWLRQRQSDUDJUDSKDGGHGE\WKH:0$*HQHUDO$VVHPEO\ :DVKLQJWRQ A. 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