Design and Analysis of Clinical Nursing Research Studies
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Routledge Essentials for Nurses
Series editors: Robert Newell, University of Leeds, and
David Thompson, University of York
Routledge Essentials for Nurses cover four key areas of nursing:
• core theoretical studies
• psychological and physical care
• nurse education
• new directions in nursing and health care.
Written by experienced practitioners and teachers, books in the series
encourage a critical approach to nursing concepts and show how research
findings are relevant to nursing practice.
Nursing Theories and Models
Hugh McKenna
Nursing Perspectives on Quality of Life
Peter Draper
Education for Patients and Clients
Vivien Coates
Caring for People in Pain
Bryn D.Davis
Body Image and Disfigurement Care
Robert Newell
Design and Analysis of Clinical Nursing Research Studies
Colin R.Martin and David R.Thompson
Sociology and Nursing
Peter Morrall
Design and Analysis
of Clinical Nursing
Research Studies
Colin R.Martin and
David R.Thompson
London and New York
First published 2000
by Routledge
11 New Fetter Lane, London EC4P 4EE
Simultaneously published in the USA and Canada
by Routledge
29 West 35th Street, New York, NY 10001
Routledge is an imprint of the Taylor & Francis Group
This edition published in the Taylor & Francis e-Library, 2002.
© 2000 Colin R.Martin & David R.Thompson
All rights reserved. No part of this book may be reprinted or
reproduced or utilised in any form or by any electronic, mechanical,
or other means, now known or hereafter invented, including
photocopying and recording, or in any information storage or
retrieval system, without permission in writing from the publishers.
British Library Cataloguing in Publication Data
A catalogue record for this book is available from the British Library
Library of Congress Cataloging in Publication Data
Martin Colin R., 1964–
Design and analysis of clinical nursing research studies/Colin
R.Martin & David R.Thompson.
p. cm. —(Routledge essentials for nurses)
Includes bibliographical references and index.
ISBN 0-415-22598-1 (hb)—ISBN 0-415-22599-X (pb)
1. Nursing—Research—Methodology. 2. Nursing—Research—
Statistical methods. 3. Clinical medicine—Research—
Methodology.
I. Thompson, David R. II. Title. III. Series.
[DNLM: 1. Clinical Nursing Research—methods. 2. Research
Design—Nurses’ Instruction. 3. Statistics—Nurses’ Instruction.
WY 20.5 m379bd 2000]
RT81.5 .M27 2000
610.73‘07‘2–dc21 00–034485
ISBN 0-203-13498-2 Master e-book ISBN
ISBN 0-203-17991-9 (Glassbook Format)
This book is dedicated to Caragh Brien-Martin,
Eloise Lily Robbins and Luke and Jack Thompson
Contents
List of illustrations ix
Acknowledgements xi
Foreword xii
1 Clinical research in nursing 1
2 Designing a clinical study 8
3 The qualities and power of data 16
4 Study sample size calculation 27
5 Choice of statistical tests 30
6 Between-subjects design and tests 34
7 Within-subjects design and tests 50
8 Mixed-group design and tests 60
9 Correlation and association between variables 71
10 Single-sample studies and analysis 83
11 Confidence intervals 95
12 Graphical presentation of data 103
viii Contents
13 The use of computers for statistical analysis 109
14 Considerations when designing a clinical study 115
Appendix: Statistical tables 123
Index 137
Illustrations
Figures
3.1 The normal distribution 23
8.1 Interaction of group type by time 61
9.1 Highly positive correlation 73
9.2 Positive correlation 73
9.3 Highly negative correlation 74
9.4 Negative correlation 74
9.5 No correlation 75
9.6 Non-linear correlation 75
12.1 Pie chart 105
12.2 Bar chart 106
Tables
3.1 A dataset of patients’ systolic blood pressure observations 20
3.2 Patients’ blood pressure variances I 21
3.3 Patients’ blood pressure variances II 22
6.1 Control and treatment group blood lipid levels 36
6.2 Individual and squared control and treatment group lipid
values 37
6.3 Control and treatment group pain rating scores 41
6.4 2×2 contingency table 45
6.5 Cell number substitution of cell frequencies 46
7.1 Post-MI self-report anxiety scores 52
7.2 Post-MI self-report anxiety difference scores 52
7.3 Self-report depression scores as a function of breakfast type 56
7.4 Self-report depression score ranking procedure 56
8.1 Anxiety score as a function of gender and admission time 64
x Illustrations
8.2 Anxiety score as a function of gender and admission
time mean score calculation 65
8.3 Anxiety score as a function of gender and admission
time deviation calculation 66
8.4 Between-subjects component calculation 66
8.5 Within-subjects component calculation 67
8.6 Interaction component calculation 67
8.7 ANOVA summary table 68
9.1 Creatinine clearance and depression score data 77
9.2 Creatinine clearance and depression score data and
ranking procedure 80
11.1 Lipid level as a function of group type 98
11.2 Data required to calculate a confidence interval 98
11.3 Anxiety score at admission and day 5 post MI and
difference score calculation 100
12.1 Demographic and clinical data 107
12.2 Mean scores and standard deviations (SD) of patients’
scores on psychometric measures 107
12.3 Affective state measures as a function of dietary
manipulation, associated F- and P-values 108
A.1 The t-distribution 123
A.2 The Mann-Whitney test 125
A.3 Z-test table 126
A.4 Chi-square (c2) test 128
A.5 Wilcoxon test 129
A.6 F-values for analysis of variance (ANOVA) at 0.05 level of
significance (one-tailed) 130
A.7 Product-moment correlation coefficient for parametric
correlations 132
A.8 Spearman’s rs non-parametric correlation test 133
Acknowledgements
We would like to thank the following friends and colleagues for their
support and understanding in the writing of this volume and for their
contribution to our ongoing research programmes: Dr Adrian Bonner,
Pamela Canbaz, Sarah Ford, Mairwen Gale, Caroline Hollins, Corinna
Petre and Rose Webster.
Foreword
The development of an evidence-based NHS is essential to improve and
sustain high-quality clinical care and the appropriate organisation of
health services. Nurses are vital to this effort, and nursing research must
play its part in developing that evidence base.
Although there is a long research tradition in nursing, competing career
options, lack of opportunity to develop research skills and the complex
nature of institutional relationships between the service and higher
education have constrained the development of nursing capacity and
capability, particularly in clinical research. Making a Difference, the new
national strategy for nurses, health visitors and midwives, signals a
commitment to ‘develop a strategy to influence the research and
development agenda, to strengthen research capacity to undertake
nursing, midwifery and health visiting research, and to use research to
support nursing, midwifery and health visiting practice’.
There is clearly a need to develop expertise in clinical research, which
will underpin the evidence base of the discipline and enhance the nursing
contribution to both nursing and multidisciplinary research.
This text provides a step-by-step approach to the design of good-
quality clinical nursing research and, using relevant examples, considers
how this should be applied at both the design and analysis stages of all
good studies. It demystifies the choice and application of statistical tests
that give appropriate answers to important questions.
Poor research design and inappropriate methodology are far from
uncommon in health-related research undertaken by any discipline. I
certainly recommend this text to the nursing community, but also believe
that it has relevance to many others about to embark on clinical research.
Finally, David Thompson and Colin Martin are to be congratulated for
producing a thoroughly readable and informative text.
Professor Sir John Pattison
Director of Research & Development
Department of Health
Chapter 1
Clinical research in nursing
Introduction
Developments in nursing as a research-based profession have continued
apace over recent years. A key issue in terms of developing an evidence
base in any discipline is the nature of the dominant philosophy
underpinning the particular profession. The philosophy underlying the
discipline must inevitably inform the direction and style of knowledge
seeking undertaken and the accompanying methodology to execute this
pursuit of evidence. In many areas of research, this does not present any
real practical difficulties. In physics research, for example, a fundamental
tenet underlying the accumulation of evidence is to adopt a scientific
approach to the research enterprise, the methodology for which is clearly
circumscribed within established design parameters. Nursing, on the other
hand, presents us with a special case. The philosophy underlying nursing
in terms of developing a research identity is not at all clear. This is due,
in part, to the lack of clarity about what nursing represents regarding a
dominant ideology; put simply, there is no clear consensus as to whether
nursing is an ‘art’ or a ‘science’ (Thompson, 1998). Inevitably, this has
led to the adoption of a wide variety of research methodologies applied
to nursing research, all of which are legitimised by the presence of an
ambiguous nursing ideology. Methodologies used in nursing research
can be grouped into two distinctive camps, these being qualitative and
quantitative.
Qualitative and quantitative approaches to
nursing research
The distinction between qualitative and quantitative research in nursing
is representative of a complex issue which will be simplified for the
purposes of clarity and brevity. Broadly speaking, qualitative research
2 Design and analysis of clinical nursing research studies
takes the view that attempting to quantify the salient aspects of human
experience in relation to health and disease represents a reductionist
approach that cannot encapsulate the real matter of experience. As an
example, a qualitative approach to understanding the process of recovery
from surgery would focus on the context within which the individuals
find themselves, the personal qualities of significant contacts during the
period of treatment and the individuals’ prior life experiences. It can be
seen that these concepts would be difficult to measure numerically and
to enter into a data analysis. This leads us then to a fundamental limitation
of qualitative research in nursing, a lack of generality, replication and
knowledge generation in terms of new theory.
Quantitative methodology addresses the criticisms of qualitative
methodology by conducting studies that provide data in numerical form
that can be entered into data analysis. Quantitative studies attempt to
investigate a research question or ‘hypothesis’ by focusing on discrete
and measurable aspects of an area of clinical and theoretical interest.
The research question is therefore quantified. So, using the earlier
example, in a quantitative study of recovery after surgery, we would be
interested in measurable factors such as length of time in hospital, amount
of anaesthetic given, type of anaesthetic given and number of previous
procedures incurred by the patient. Further, we would want to be able to
generalise the findings; so, using quantitative methodology, we may wish
to compare different groups of patients defined by a particular
characteristic such as diagnostic criteria and to compare the groups to
investigate the differential effects of a treatment intervention. As the
methodology used would be well circumscribed, replication of the study
would be relatively simple.
A quantitative focus
It could be argued that an emphasis on the more qualitative aspects of
nursing research in an era of evidence-based practice has led to an
underrepresentation of quantitative methodology in present research
endeavours. It is therefore crucial that nurses involved in quantitative
research have available a text that covers experimental design and statistics
in a context-sensitive manner. The following chapters will describe the
design and statistical analysis of clinical nursing research studies using
data from actual studies that have been conducted in the field. The breadth
of the studies described will cover both general and mental health nursing
research paradigms including data from multidisciplinary studies with a
strong nursing contribution in the design and execution of the study.
Clinical research in nursing 3
Although most statistical analyses are these days carried out on computer
packages, these packages being discussed in Chapter 13, the emphasis
within this text will be on the rationale for the tests used and their working
out with reference to standard statistical tables included in the appendices.
It is hoped that this approach will give the reader a more in-depth
understanding of the philosophy and cerebral mechanics underpinning
the tests, as well as providing the researcher with statistical independence
when computer-based statistical packages are not available. The applied
nature of the statistical tests described in this volume has been emphasised
to indicate the ready applicability of the testing techniques to other
appropriate clinical domains. The scope of the study designs and the
associated statistical techniques covered has been intended to allow both
the novice nurse researcher and the more seasoned professional nurse
investigator to approach the design, execution and analysis of a study
with confidence and optimism.
A common research language
An extremely useful by-product of nurses becoming familiar and proficient
in the design, execution and analysis of quantitatively biased research
projects is that it facilitates more readily collaborative ventures with other
health disciplines such as medicine, clinical psychology, physiotherapy,
etc. The reason for this salience is twofold. First, health disciplines other
than nursing, and in particular medicine, have traditionally focused on
quantitative approaches to the analysis of clinical material, this being
dichotomous to the qualitative research approach which has been a
traditional strength of the nursing profession. There is then a methodological
issue involved in the failure to communicate between the two most
influential professions involved in evidence-based patient care. Second,
and more importantly for the future development of nursing as a research-
based profession, the launch of the National Health Service (NHS) research
and development (R&D) strategy Research for Health (Department of
Health, 1991) stimulated increased interest in health-related research.
The NHS R&D strategy
This created new demands on the research community within and beyond
the NHS and new opportunities for NHS staff to become involved in
R&D. The importance of a sound research basis for nursing has been
reemphasised in the new strategy for nursing Making a Difference
(Department of Health, 1999).
4 Design and analysis of clinical nursing research studies
The aim of the NHS R&D strategy is to improve the health of the
nation by promoting a knowledge-based health service in which clinical,
managerial and policy decisions are based on sound research evidence.
Although nursing needs to generate and extend its own body of knowledge
through research, it is important that nursing research is seen as part of
the broader scientific research community. The NHS R&D initiative offers
nurses an ideal opportunity to engage in truly collaborative
multidisciplinary and multiagency research, to demonstrate to others their
own unique skills and distinct approach to research and to learn about
the methods and approaches of others (Thompson, 1999). Further, the
cross-fertilisation of skills from complementary disciplines allows
freedom to develop more sophisticated research studies to address
complex clinical questions previously occluded to single-discipline
scientific enquiry (Martin et al., 1998).
The research question
The key to the design of a good quantitative nursing study is to ask the
right research question. Although this intrinsically crucial aspect of the
research process may seem intuitively simple, a review of published
literature across all disciplines will demonstrate that even seasoned
researchers have not consistently formulated an appropriate research
question and, consequently, have produced a flawed and lacklustre piece
of work. Key identifying clues are often the use of ‘esoteric’, and usually
inappropriate statistical tests to attempt to save a poorly conceived and/
or executed study and a discussion section that bears no line of continuity
to the introduction. Time spent thinking and discussing the question that
we wish to address will lead the researcher to the correct methodology
to implement the study. Essentially then, all quantitative research must
begin with an appraisal of two key questions: ‘I wonder if…’ and ‘I
wonder why…’. These fundamental questions represent the skeleton of
research design, the flesh being the hypotheses (formal research
questions) and the skin being the methodology. Hopefully, this analogy
illustrates the relative importance of formulating the research question;
attempting to clothe a body of work with abstract statistics will in no
way present a boneless and meatless study in a positive light. Time
invested in considering the research question will pay dividends in getting
work published and disseminated to the wider academic and clinical
community.
