APPENDIX A

The Declaration of Helsinki

The Declaration of Helsinki (1964), revised in Tokyo in 1975, stated the following:

Basic Principles

1. Biomedical research involving human sub­jects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowl­edge of the scientific literature.

2. The design and performance of each exper­imental procedure involving human subjects should be clearly formulated in an experi­mental protocol which should be transmitted to a specially appointed independent com­mittee for consideration, comment and guidance.

3. Biomedical research involving human sub­jects should be conducted only by scientif­ically qualified persons and under the su­pervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the sub­ject of the research, even though the subject has given his or her consent.

4. Biomedical research involving human sub­jects cannot legitimately be carried out un­less the importance of the objective is in proportion to the inherent risk to the subject.

5. Every biomedical research project involving human subjects should be preceded by care­ful assessment of predictable risks in com­parison with foreseeable benefits to the sub­ject or to others. Concern for the interests of the subject must always prevail over the interests of science and society.

6. The right of the research subject to safeguard his or her integrity must always be respect­ed. Every precaution should be taken to re­spect the privacy of the subject to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject.

7. Doctors should abstain from engaging in re­search projects involving human subjects unless they are satisfied that the hazards in­volved are believed to be predictable. Doc­tors should cease any investigation if the hazards are found to outweigh the potential benefits.

8. In publication of the results of his or her re­search, the doctor is obliged to preserve the accuracy of the results. Reports of experi­mentation not in accordance with the prin­ciples laid down in this declaration should not be accepted for publication.

9. In any research on human beings, each po­tential subject must be adequately informed of the aims, methods, anticipated benefits, and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The doctor should then obtain the subject's freely given informed consent, preferably in writ­ing.

10. When obtaining informed consent for the research project the doctor should be par­ticularly cautious if the subject is in a de­pendent relationship to him or her or may consent under duress. In that case the in­formed consent should be obtained by a doctor who is not engaged in the investi-

370 Apppendix A The Declaration of Helsinki

gation and who is completely independent of this official relationship.

11. In cases of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legis­lation. Where physical or mental incapacity makes it impossible to obtain informed con­sent, or when the subject is a minor, per­mission from the responsible relative re­places that of the subject in accordance with national legislation.

12. The research protocol should always contain a statement of the ethical considerations in­volved and should indicate that the princi- • pies enunciated in the present declaration are complied with.

Medical Research Combined with Professional Care

(Clinical Research)

1. In the treatment of the sick person, the doctor must be free to use a new diagnostic and therapeutic measure if in his or her judgment

it offers hope of saving life, reestablishing health, or alleviating suffering.

2. The potential benefits, hazards and discom­fort of a new method should be weighed against the advantages of the best current di­agnostic and therapeutic methods.

3. In any medical study, every patient including those of a control group, if any, should be assured of the best proven diagnostic and therapeutic method.

4. The refusal of the patient to participate in a study must never interfere with the doctor­patient relationship.

S. If the doctor considers it essential not to ob­tain informed consent, the specific reasons for this proposal should be stated in the ex­perimental protocol for transmission to the independent committee (Section I, paragraph 2).

6. The doctor can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient.

APPENDIX B

Books on the Handling and Care of Animals

Title

Variolls Species: Small Animal Surgery

Current Techniques in Small Animal Surgery

Animal Physiologic Surgery

Experimental Surgery

Schmerzausschaltung in der experimentellen Chirurgie bei Hund, Katze, Schwein, Schaf

Grundlagen fur Zucht und Haltung der wichtigsten Versuchstiere

Biology Data Book

Rodents: Thymusaplastische Maus (nu/nu) Thymusaplastische Ratte (mu/mu)

The Laboratory Rat

Sheep and Pig: The Sheep as an Experimental Animal Das Goettinger Miniaturschwein

Cat and Dog: An Atlas of Surgical Approaches to the Bones of the

Dog and Cat Anatomy of the Dog

Source

Wingfeld WE, Rawlings CA, Philadelphia, London, Toronto, Saunders Co. 1979 Bojrab MJ, editor. Philadelphia: Lea & Febiger, 1975

Lang CM. New York-Heidelberg-Berlin: Springer Verlag, 1976 Markowitz J, Archibald J, Downie HG. Baltimore: Williams & Wilkins, 1964 Kupper W. In: Markenschlager M, Gartner K, editors. Schriftenreihe Versuchstierkunde, Berlin, Hamburg: Verlag P. Parey, 1984:11 Jung S, Fischer G. Stuttgart: Verlag, 1962

Altman PL, Dittmer DS. Federation of the American Society for Experimental Biology. Washington D.C.: 1964

Fortmeyer HP. In: Markenschlager M, Gartner K. Schriftereihe Versuchstierkunde, editors. Verlag P. Parey-Berlin-Hamburg Vol. 8, 1981 Baker HJ, Lindberg JR, Weisbroth SH, editors. New York: Academic Press, 1980

Hecker JF. New York: Academic Press, 1983 Gladek P, Oldigs B. In: Markenschlager M, Gartner K: Schriftenreihe Versuchstierkunde Pare-Berlin-Hamburg: Verlag P. Vol. 7, 1981

Piermattei DL, Greeleg RG, Philadelphia: Saunders Co., 1979 Evens HE, Christensen GL, Philadelphia: Saunders Co., 1978

Index

A Abstracts, writing of, 233-235, 236 Academic surgeons, 33-34, 138-139

in Canada, 285-287 in the United Kindgom, 330-332 in the United States, 341-342

ADL scales, 62-63 Administrators, 22 Adverse reactions

to anesthetics (Marburg experiment), 141-142 to plasma substitutes (Marburg experiment), 144-

145 Cl level, 74, 115 Analogies (in non-experimental methods), 226 Analysis of covariance, 81 Analysis of variance, 80 Analytic inference, 71 Anesthesiologists, 37 Anesthetics, adverse reactions to (Marburg experi­

ment), 141-142 Animal experimentation, 9, 26, 142-145, 149,291,

304, 311, 322, 333, 342 alternative to 151-152 benefits and necessity of, 149-150, 151 ethics of, 124-125 and experimental design, 155-156, 159 guidelines for, 152 and innovative surgery, 149-150 and randomization, 155 and surgical training, 150

Animal models, 152-155, 164 criteria for, 153 genetics of, 153-154 and toxicity, 153

Animals care of, 155-158, 159-160 diseased, 158 killing of, 157 optimal use of, 155 producers of, 158-159

quality of, 158-159 surgery on, 156-157

Appearance, personal, at presentations, 237 Applicability (of measuring instruments), 60 Archibald, Edward, 281 Artificial organs, 360-361 Association (in non-experimental methods), 225-

227 Attitude, in presentations, 237-239 Audio-visual aids, 254-267 Audio-visual presentations, 257-258 Average effect, and literature reviews, 47, 49

B Banting, Frederick G., 30 Baseline comparability, 114 Baseline investigations, 171 Basic sciences and scientists, 19,40-42, 137-140,

361-363, 365-366 Bayes' Theorem, 202 Before-and-after studies, 113, 227 Bernard principle, 123 Bernoulli, Jacob, 9 Bias, 14,91,115, 172, 181, 182,227

volunteer, 113-114 Bigelow, William, 281 Billroth, Theodor, 27 Binomial distribution, 83 Biological plausibility (in non-experimental meth­

ods) 226 Biomechanically activated cardiac assist device

project (case study) 162-165 Biostatisticians, 176 Blalock, Alfred, 28-29 Blindness (in research studies), 113, 125, 173,205 Brevity

in data collection, 90 in research proposals, 109

"Bridge tender" investigators, 21, 137

374

Budgets, 94-95, 110, 179 and multi-centre trials, 189-190

Buxton Brown Farm, 327

C Canterbury v. Spence, 13

Index

Cardiac assist devices project (case study), 162-165 Case referent studies, 225 Case series, 113 Case studies, 134 Causality (in non-experimental methods), 225-227 Cell frequency (four-fold table), 81-82, 83 Central Limit Theorem, 77, 79 Central tendency, 72 Chalmers, Thomas C, 126-127 X2 test, 82-83 Clarity

and data collection, 90 in research proposals, 109

Clerical support, 41 Clinical

characteristics, 53-54 significance, 75, 116 studies, scope of, 88-89

Coding (data), 94 Coefficient of variation, 72 Coherence of evidence (in non-experimental meth-

ods), 226 Cohort analytic studies, 224 Cohorts, 134, 223-224 Co-intervention (in research studies), 114 Coisogenic strains (animal strains), 154 Collaboration, and surgical research, 162-165, 363-

364 Color, in audio-visual presentation, 257-258 Combined significance tests, 50-51 Compatibility, 102, 104 Compliance, and research studies, 114-115 Computer networks, 103, 105 Computer searches, 48 Computer-to-computer exchange, 103 Computers, 96-105

and audio-visual aids, 256 mainframe, 101-102, 104 minicomputers, 102, 104 personal, 102-104 and photography, 101 and research, 96-97 types of, 101-103

Conceptual definition, 89 Confidence.intervals, 70 Confidentiality (of data), 95 Confounding factors, 167, 172,227-228

control for, 80-81, 83-84 Congenic strain (animal strains), 154 Conscience, professional, 124

Consensus conference, 253 Consistency (in non-experimental methods) 225-

226 Constructs, 59 Consultants, 108 Contamination (in research studies), 93, 114 Content, in audio-visual presentations, 225 Continuity correction, 82 Control, in research studies, 49-167 Controlled clinical trials, 113, 119

reasons for failures of, 141 Correlation, linear, 84-86 Cost analyses, 215-216 Creativity, 23 Criticism, 7-9, 112-117 Cross-over trial, 78, 114-115, 173-174, 177 Cross-sectional designs, 224-225

D Data

confidentiality of, 95 data, "hard". 55-56 data preparation of, for presentation, 236 data security of, 95 data "soft", 55-56

Data analysis, 46, 175-176 Data collection, 89-92 Data collectors, 94-95 Data-gathering instruments, 90-92 Data management, 191-192 Data managers, 37-38, 92, 192 Database programs, 97-98, 104 Databases, 104 Davy, Humphry, 29 Death (as outcome variable), 54 Decision-making, 144-146 Degrees of freedom, 72, 78, 82 Departmental chairmen, 38-40, 293-294, 332 Descriptive studies, 228 Diagnosis, 203 Diagnostic tests

assessment of, 202-206 assessment methodology, 204-205 evaluation of, 195-206 practicality, 198-202 validity of, 195-198

Disability (as outcome variable), 55 Discomfort (as outcome variable), 54-55 Discriminant function analysis, 84 Discussion-periods, 246, 248-250, 252 Disease (as outcome variable), 54 Dissatisfaction (as outcome variables), 55 Documentation (of research proposals), 110 Dose-response curve (in non-experimental meth-

ods) 226 Double coding, 94

Drop-outs (research studies), 114-115 Duodenal ulcer pathogenesis (Marburg experi­

ment), 142-143

E Editing

data, 93-94 word-processing, 98-99

Editorials, 274 Effect size, 50 Effectiveness, 122-133, 213 Efficacy, 112-113,213 Electronic mail, 103 Emergency services, 218-219 Epidemiology, 134, 207, 228, 287 Error, 8, 166-167 Ethics, 95, 108-109, 118-129

conditional, 119-120 in Japan, 304

Euthanasia (animals), 157 Exclusion criteria, 114-115, 170, 182 Experiment, definition of, 222 Experimental design, 23, 39, 73, 108, 112, 167,

169-177, 190 and animal experimentation 155-159 and ethics, 125-126

Explained variance, 85 Explanatory trials, 168, 173 Explicatory trials, 124

F FI hybrids (animal strains), 154 False negative rate, 197 False negatives error, 196,205-206 False positive rate, 197 False positives error, 196, 205-206 Fatality rates, 217 Feinstein, A., 123-124 Fincke, Martin, 15 Fisher exact probability test, 83 Fisher, Ronald Aylmer, 11 Format in audio-visual aids, 255 Formatting (word processing), 99 Forssmann, Werner, 30-31 Free paper sessions, 246 Free Standing Ambulatory Surgery Centers, 216-

217 Frequency distribution, 71 Fried, Charles, 121-122 Funding, non-research, 108

G Gastrointestinal tract haemorrhage (Marburg exper­

iment), 145-146

Index

Generalizability (of research studies), 116, 134 Genetics of animal models, 153-154 Gold standard, 195-196, 204-205 Gossett, William S., 77 Grammar checking programs, 100 Graphics programs, 100-101

resolution, 105 Groups (in research studies), 70, 74-75

and literature reviews, 47, 49

H Health maintenance organizations, 217 Health policy research, 366-367 Health services research

definition of, 207-208 in Canada, 208 and epidemiology, 207 in the United Kingdom, 208 in the United States, 208

375

Haemaccel-35 (Marburg experiment), 144-145 Haemorrhage, gastrointestinal tract (Marburg ex-

periment, 144-146 Halsted, William Stewart, 27-28, 182-183 Hardware, 105 Harm-benefit ratio, 123, 128 Helsinki Declaration, 13, 120, 369-370 Hill, Sir Austin Bradford, 12, 225-227 Histamine (Marburg experiment), 141-145 Histograms, 71, 73

in audio-visual aids, 256, 265 Historical controls, 10, 181-182, 228 Holmes, Oliver Wendell, 226 Human resources, in surgical research, 364-365 Hunter, John, 18, 26-27 Hypothesis, 7, 24, 43, 46-47, 73, 75, 89, 112, 162-

163 in abstracts, 234 alternative, 76 directional, 75 multiple, 74-75 non-directional, 75 in research papers, 271

Hypothesis generation, 222, 228

I Illogical values, 94 In vitro studies, 151-152, 159 In vivo studies, 151-152, 159 Inbred strains (animal models), 153 Inclusion criteria, 114-115, 169-170, 182 Inferential statistics

of means, 77-81 of Rates and Proportion, 81-84

Information needs of surgical research, 218

376

Informed consent, 12-14, 122-123 in Germany, 294 in Japan, 304 and randomization, 127-128 in Spain, 311 in Sweden, 322 as two-way transaction, 122 in the United Kingdom, 333 in the United States, 342

Innovative treatments, 119, 12~127 Interactions, and literature reviews, 47, 49 Interim analysis, 14-15, 176, 178 Internal consistency (in measuring instruments),

57-58 International meetings, 238, 24~248, 250 Interventional trials, 124 Investment in research, 345-348

J Jenner, Edward, 26, 152

K Karnofsky Performance Status, 63-64 Katz Index of ADL, 62, 64 Keypunching, 94 Key terms, 89 Keywords, 273 Knee scale, 62-64 Koch, Robert, 153 Kocher, Theodor, 27 Kuhn, Thomas, 7, 8

L Langenbeck, Bernhard von, 26-27 Langerhans, Paul, 30 Languages and language barriers, 246-248, 291,

296,303,312,321-322,341 Language interface, 87-98, 105 Lead-time bias, 181 Length bias, 181 Lettering in audio-visual aids, 255, 262-263 Letters-to-the-Editor, 274-275 Libraries, 48, 286, 303 Line graphs, in audio-visual aids, 256, 265 List processing programs, 100 Lister, Joseph, 2~27 Literature

reviews, 43-51, 107-108, 163-164 searches, 48

Litigation, 366 Living matter, differentiation of, 150-151 Local area networks, 103-105 Louis, Pierre-Charles-Alexander, 10

Index

M McGill Pain Questionnaire, 59, 61-62 McGill University, 281, 286 McGill University project on cardiac arrest devices

(case study), 162-165 MacLean, Jay, 30 McNemar test, 84 Magnitudes, 80 Malpractice, 366 Management trials, 168-173 Mann-Whitney U Test, 80, 83 Mante1-Haensze1 l test, 84 Manuscripts, 23, 237, 243

preparation of, 277 Marburg experiment, 40, 137-146, 162, 297-298 Mathematical modelling, 229 mean, 70, 72-73, 77 Means, difference in, 78-79 Measuring instruments, 57-64 Median, 72 Medical records, 91 Medical Research Council of Canada, 282-284, 287 Medical Research Council of Sweden, 320 Medical students, 29-31, 34 Medicine and the sciences, 29, 33 Melzack, R., 61-62 Meta-analysis, 4~47, 49, 51 Methodology, 113, 120-121 Milan Group (multi-center trial), 186, 188 Mode, 72 Models, in audio-visual presentations, 259 Modem, 103 Moderators, 249-253 Monitoring, 203 Monographs, 270

preparing manuscripts for, 27~278 Morton, William T.G., 30 Muench, Hugo, 49 Multi-centre trials, 92, 180-193

and ethics, 120, 193 Multiple comparisons problem, 115 Multiple linear regression, 86 Multiple logistic regression, 84 Myocardial assist devices project (case study) 162-

165

N National Health Services (UK), 328, 333 National Institutes of Health (US), 33~339 Nausea, measuring instruments for, 62 Nausea Questionnaire, 62, 64 National Surgical Adjuvant Breast Project, 183-

189, 213-214 Negative findings, 109, 115 Negative predictive value, 198-199, 201-202

Non-experimental methods, 222-229 Non-parametric testing, 79-80 Non-random control trials, II Normal distribution, 72, 77-78 Nuclear magnetic resonance, 363-364 Null hypothesis, 73-77, 80-82 Nuremberg Code, 120

o Observation, 7, 10,29,91-92,223

and error, 115, 166-167

p

Pain, measuring instruments for, 61-62 Paired t-test, 164, 177 Panel discussion, 251-252 PAP test, diagnostic evaluation of, 197-202 Paradigms, 7, 8 Parameters, 70 Parametric estimation, 70 Parametric testing, 80 Pare, Ambroise, 26-27 Pathological specimens, in audio-visual presenta­

tions, 256-257, 264 Patient compliance (and measuring instruments),

60-61 Patient variables, 53-54 Pearson correlation coefficient, 84-86 Peer review, 22-23 Penfield, Wilder, 281 Percentile ranges, 72 Perfusionists, 37 Pharmaceutical companies, 285, 321, 325 Photography and computers, 101 Physical function, measuring instruments for, 62-63 Physiologic characteristics, 55 Placebo effect, 166-167

and ethics, 125-126 Plasma substitutes, adverse reactions to (Marburg

experiment), 144-145 "Play-the-winner" randomization, 15 Plotters, 100-10 1, 105 Poisson, Simon-Denis, 10 Popper, Karl, 7-9 Positive predictive value, 198-199, 201-202 Positron emission tomography, 363-364 Post-test probability

of a negative result, 199, 201-202 of a positive result, 198-199, 201-202

Poster sessions, 260 Practicality (of measuring instruments), 60-61, 90 Pre-analysis (of data), 94 Precision (of measuring instruments), 59, 60, 177 Pre-coding (in data collection), 90

Index

Presentation, at international meetings, 246-248 techniques of, 237

Presentations longer, 240-245 shorter, 236-239

Pre-tests, 93, 178 Prevalence, 198 Printers, 99-100, 105 Printing (word processing), 99-100 Prognostic stratification, 113-114, 172, 185 Programs, 96, 101 Proof-reading, 278 Proportion of variance, 85, 86 Proportional spacing, 105 Proportionality ethics, 123 Proportions, 81 Protocols, 39, 168-171, 173, 177-178, 190 Public opinion and surgical research, 352-353

in Canada, 284 in Germany, 294 in Japan, 304 in Sweden, 322 in the United Kingdom, 333 in the United States, 336-337

Publication, 22-23, 74, 76, 178, 193, 326 writing for, 268-275, 276-278

Publication bias, 49 p value, 50, 74-77, 80

Q Quality control, 191

in multi-center trials, 185 Quality of life measuring instruments for, 63-64 Quality of Life Index, 63, 64 Quasi-random allocation, 113 Questionnaires, 91

R

377

Random control clinical trials, 12-16, 134, 180-181, 213-214

Random sampling, 70 Randomization, 113, 126-127, 171-173,222-223

and animal experimentation, 155 central, 12 and ethics, 119, 121, 123-124, 126 and informed consent, 14, 127-128 and therapeutic relationships, 123-124 timing of, 173

Randomly-mating populations (animal models), 153 Range, 72 Rate, 70, 73

in cohort studies, 223-224 Reference management programs, 101

378

Reference centers, 41 Regression, linear, 85, 86 Regression coefficient, 85-86 Regression of variables, 85

Index

Regression toward the mean, and clinical practice, 167

Reibl versus Hughes, 122 Relational database systems, 97 Relationships

dependent (between variables), 84-85 non-dependent (between variables), 84-85

Relative odds, 227 Relative risk, 227 Reliability (of measuring instruments), 56-58, 90-92 Repeated measures (data collection), 92 Repetitive sampling, 77 Research, philosophy of, 7-9, 118 Research advisors, 303, 320, 341-342 Research funding, 20-23, 106, 108, 345-348, 353

applications, 23, 41, 43, 106-111 in Canada, 284-285 in France, 292 in Germany, 295 in Japan, 303-304 in Spain, 308-310 in Sweden, 320-321 in Switzerland, 325 in the United Kingdom, 333-335 in the United States, 337-339

Research laboratories, 38 Research proposals, 106-111

criteria for success of, 109 Research questions, 89, 106-107 Research staff

evaluation of, 93 training of, 93

Research teams, 92 Resources (outlined in research proposals), 110 Response rate (questionnaires), 91 Response time, 101, 102, 105 Reversible association (in non-experimental meth­

ods),226 Review articles

and literature reviews, 273-274 and readers, 274 and research papers, 271

Review committees, 23 for abstracts, 234

"Revolutions" in science, 8 Risk ratio, 227 Rutstein, David R., 121

S Salary supplements (for technicians assisting in re­

search), 38 Sample mean, 77

Sample size, 50, 70, 76-86, 115, 164, 185 calculation of, 79, 83, 176-177

Sample variation, 47 Samples, selection of, 169-171 Sampling, 10

convenience, 70 distribution, 77 systematic, 70 variation, 70

Sandstrom, Ivar, 30 Scientific method, 7

and practice of surgery, 36 Scientific statement, definition of, 7 Scientific writing, 268-275

and abstracts, 233-235, 273 and monographs, 270 and reader, 268 and research papers, 270-273 and review articles, 273-274 styie in, 269

Scoring, 89 Screening, 199, 201-204 Second opinions, and surgical services, 216 Security

and computers, 103 and data, 95

Seminars, 252 Sensitivity, 195, 196-198 Sensitivity

and construct validity, 59 and precision, distinction between, 60

Sequential measurements (in non-experimental methods), 227

Sickness Impact Profile, 63-64 Side effects, 114 Significance testing, 70, 78, 79 Simultaneous translation, 248, 250 Skeletal muscles, synchronously stimulated, for

myocardial assist device (case study), 162-165

Slides, 254-258, 262-267 preparation of, 237, 238

Sociodemographic characteristics, 53-54 Sociopersonal characteristics, 53-54 Software, 105 Speakers, at panel discussions, etc. 250, 251 Spearman rank correlation coefficient, 86 Specialization, 19, 138, 354

in Canada, 283, 286 in France, 290 in Spain, 313-314

Specificity, 195, 197-198 Specificity of association (in non-experimental

methods), 226 Spelling-checking programs, 100 Spread,72 Stage fright, 244

Staging, 181-182, 203 Standard deviation, 72 Standard error of the mean, 72-73 Standards, and surgical research, 125 Statistical analysis programs, 98, 105 Statistical, power, 50, 76--77, 79, 115 Statistical significance, 74-76, 86, 115-116

and clinical importance, 75 and meta-analysis, 47, 50, 51

Statistics descriptive, 70-73 development of, 9-10 inferential, 70-71 in research papers, 272 and the surgical investigator, 69, 86--87

Stipends, 31 Strength of association (in non-experimental meth-

ods), 225 Student's t-test, 78, 79 Study base (non-experimental method), 227 Study manuals, 178 Study objectives, 106--107, 112, 167-169 Study on Surgical Services for the United States,

207,209 Style, in oral presentations, 237-239 Surgeons

and confirmation of diagnoses, 36 and the sciences, 19, 29, 33 as surgical investigators, justification for, 167 and surgical research, 284, 337 theoretical, 139-141

Surgical assistants, and surgical research, 37-38 Surgical care

and ethics, 119 levels of, 216--217 quality of, 55

Surgical departments, 24, 29 Surgical education, 19, 23, 24, 138, 140,

348-352 and animal experimentation, 150 in Canada, 285-287 in Germany, 295-296 history of, 26--34 in Japan, 301-302 in Spain, 312-315 in Sweden, 318-321 in Switzerland, 325-326 in the United Kingdom, 329-330 in the United States, 339-341

Surgical investigation, definition of, 21 Surgical investigators

and basic science and scientists, 19,22,38,137-148 and biostatisticians, 39 ideals of, 24 and integrity, 24-25 and peers, 22-23 problems of, 19-21

Index

and research funding, 20-23 and surgery departments, 24, 29 and surgical education, 23 types of, 21-22

Surgical problems, 1-2 Surgical research 28-29, 137-145

attitudes toward, 352-353 and basic science, 361-363, 365-366 in Canada, American influences on 281-282

attitudes toward, 284 funding for, 284-285 problems of 282-283

case study of, 162-165 and collaboration, 36, 39-40, 42, 363-364 in France, 289-292

achievements of, 289 in Germany, 137-148,293-298

attitudes towards, 294 history of, 9-10, 26--32 human relationship aspect of, 121-122 and individual scholar, 34, 36, 39-40, 42 in Japan, 299-305

attitude towards, 304 history of, 299-300

justification for, 18-19, 120, 166 levels of, 293 new procedures in, 360 and patient care, 37 and practice of surgery, 31-33 in Spain, 306--316

achievements of, 310-311 funding for, 308-310 history of, 306--308

and standards, 125 and surgical education, 23-24, 40-41, 348-352 in Sweden, 318-323

achievements of, 322-323 attitudes toward, 322 funding for, 320-321

in Switzerland, 324-326 achievements of, 324-325

and team work, 37 therapeutic relationship aspect of, 13, 123-124 in the United Kingdom, 327-335

American influences on, 328 attitudes toward, 333 funding for, 333-335 history of, 327-329

in the United States, 336--343 achievements of, 337 attitudes toward, 336--337 funding for, 337-339

Surgical residents, 329-330, 339-341 in France, 289-290 in Germany, 294 in Switzerland, 326 in Canada, 281-287

379

380

Surgical services accessibility of, 209-210 availability of, 209 in Canada, 209, 211-212 costs of, 216-217 effects of, 212-214 fatality rates of, 217 information needs of, 218 monitoring of, 217 quality control, 217-218 patient satisfaction and, 210 utilization of, 210-212

Index

Surgical students, and international meetings, 41, 287 Surgical techniques

and animal experimentation, 149-150 and multi-centre trials, 189

Swammerdam, Jan, 29 Symptoms, measuring instruments for, 61-62

T Target disease, 195, 204-205 Target populations, 70, 77, 114 Team leaders, 22, 165, 190-191 Terminals, 105 Theoretical surgeons, 138-139 Time management, 344-345 Toulmin, Stephen, 119 Toxicity, and animal models, 153 Transformations (on statistical analysis programs),

98 Transparencies, 258 Transplantation, 360-361 Trauma services, 218-219 Treatment impact (in studies), 50 Triage, 203 Trials, aborting of, 176, 192 True negatives, 196 True positives, 196 2 x 2 tables, 81-82 Type I error, 74-76, 79, 176-177 Type II error, 76-77, 79,115,176-177

V Validity

in measuring instruments, 58-59, 90-91 of research studies, 112-115

Variability of data, 76 Variables, 53, 69-73

categorical, 69, 73 continuous, 69, 71-73, 76, 84-85 dependent, 84-85 dichotomous, 69 independent, 54, 84-85 nominal, 69 ordinal, 69, 86 outcome, 54-57, 60 polychotomous, 69 treatment, 53-54

Variance, 72, 80, 85 Vesalius, Andreas, 29-30 Video display units, 100-101, 105 Videodiscs, 259 Video-tape and film, 258-259 Visick scale, 62, 64

W Wangensteen, Owen H., 28 Wilcoxon Signed Rank Test, 80 Wellcome Foundation, 328, 334 Withdrawals (and research studies), 114-115, 174-

175 Word processing programs, 98-100

X X-ray films (in audio-visual presentations) 256, 267

Z Z-scores, 50-51 Zelen, M. 14

Invitation to Critique

The editors and authors hope that revisions of this book will be justified by the interest it stimulates and its usefulness to colleagues. Further editions will be enriched beyond what our efforts alone could accomplish with critique from the readers. Accordingly, we ask that you write to us with constructive feedback under any or all of the following headings or questions:

Does the plan of the book incorporate most issues in research of im­portance to surgeons?

Strong chapters Chapters that could benefit with change (specifics are important)

New chapter titles suggested

Errors of fact, interpretation, spelling, or style

Existing sections, chapters, or passages which are particularly well done and deserving expansion or emulation in other parts of the book

Other topics

All suggestions will be carefully considered by the editors. Please mail them to:

Dr. David S. Mulder Professor of Surgery McGill University Montreal General Hospital 1650 Cedar Avenue Montreal, Canada H3G lA4