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A
s next-generation technology ratchets the price of
sequencing lower and lower, users from aca-
demic labs to Big Pharma are fi nding themselves
drowning in data. What used to be gigabytes
worth of information has become terabytes or
petabytes. At the same time, the cost crunch
brought on by the global recession has made
researchers leery of unnecessary capital spending.
The result is more and more users moving their data
management
to the cloud or outsourcing it entirely.
Whereas large pharma companies may have the funds and
infrastructure to maintain dedicated servers for storage and
analysis
of sequencing data, small companies—especially those that
don’t
sequence continuously—are leading the migration to the cloud,
and
service providers are springing up to meet the demand. Cost,
secu-
rity, and convenience top the list of concerns for researchers
looking
for a place to unload reams of data. However, once that
transition is
made, features like collaborative data sharing, access to third-
party
analysis apps, and patient privacy become more important.
Expression Analysis, a Quintiles Co., Durham, N.C., provides
genomic services to the pharma and biotech industry, as well as
academic, government, and foundation laboratories doing
research
in molecular biology and genetics. It provides cloud computing
services through a partnership with Golden Helix Inc.,
Bozeman,
Mont. Its clients require computation-intensive services for
gener-
ating the initial RNA or DNA sequence and also for cleaning
up,
aligning, and analyzing the sequence.
According to Expression Analysis, a typical sequencing project
for 100 RNA samples would generate 300 to 400 GB worth of
com-
pressed data, or 700 GB to 1 TB worth of data in total; and
that’s
just for one experiment. For multiple experiments, the amount
of
data can add up to astronomical quantities quite quickly.
Some applications, such as analyzing cancer samples, are even
more data intensive, because of the depth of coverage and the
need
to sample multiple cells in the tumor.
“The cloud offers a full environment in order to do analysis on
a large number of samples simultaneously,” said Wendell Jones,
PhD, vice president of statistics and bioinformatics for
Expression
Analysis.
That computing power becomes a commodity for the customer,
replacing expensive, on-site, server infrastructure. The data is
instead accessed through a browser, and there is no need to
upload
or download huge fi les. “You can leave them on the cloud and
access in a streaming fashion via the cloud,” Jones said.
For small companies, the cloud-based service offers additional
advantages beyond saving on hardware and real estate. Startup
companies may not have the structure in place to operate Linux-
based genome software applications. A cloud-based storage and
analysis service allows those companies to use their own local
Windows or Macintosh desktop operating systems.
There are some advantages to maintaining a physical server.
“You have the option of having lower redundancy ... and faster
data access times. You can choose to take your old data and
unplug it. You don’t have to pay for power,” explained Jonathan
Bingham, product manager for informatics and software for
Menlo Park, Calif.-based Pacifi c Biosciences, a provider of
genom-
ics services through its SMRT platform technology and hosted
cloud-based storage and analysis service.
10 � September/October 2012 www.dddmag.com
Exploding sequencing data volumes push researchers to
the cloud and into partnerships.
� COVER STORY
� Catherine Shaffer, Contributing Editor
Managing
Data in the
Cloud Age
dd29_10_COS.indd 10dd29_10_COS.indd 10 10/1/2012
11:41:49 AM10/1/2012 11:41:49 AM
On the other hand, that means taking
responsibility for managing the hardware,
Bingham added, such as replacing failed
drives. That burden of ownership and main-
tenance is not right for every company.
Jones explained that cloud comput-
ing is ideal for research groups that have
“bursty” computing needs, meaning that
generating and analyzing sequence data is
an intermittent need.
“The cloud in some sense is cheap, in
the sense that it’s cheaper to rent a vacation
home than buy it and only use it two or three
weeks a year. If you’re constantly at your
vacation home, it’s just better to buy it.”
Cost is a major concern at Illumina (San
Diego, Calif.) as well. A giant in the sequenc-
ing industry, Illumina controls 70% of the
market share for sequencing. Illumina can
sequence an entire human genome in a day,
and it offers its cloud-computing solution,
BaseSpace, through Amazon Web Services
(Seattle), the world’s largest cloud hosting
service. Recently, Amazon announced a ser-
vice providing reliable data storage starting at
$0.01 per gigabyte per month.
Although that is a very economical rate
for data storage by any standard, for long-
term storage of hundreds or thousands of
complete genomes, many experts agree it is
better to store the data in the original tissue.
In other words, if the raw data is needed
again in the future, it is cheaper to regener-
ate the sequence from an archived sample.
Illumina offers an even better deal to
its customers. “We’ve picked the ultimate
pricing strategy which is free,” said Alex
Dickinson, senior vice president of cloud
DRUG Discovery & Development September/October 2012 �
11
genomics for the company. “Customers get
a free terabyte of data storage, enough for
10 years of typical usage of MiSeq. We do
the secondary processing, alignment, and
variant calling. We also do that for free,”
Dickinson said.
MiSeq is Illumina’s “personal
sequencer,” a next-generation sequenc-
ing system suitable for applications such
as multiplexed PCR amplicon sequenc-
ing, targeted resequencing, small RNA
sequencing, and so forth.
Illumina’s choice to offer free service
is based on concerns of researchers, who
may be comparing the company’s offerings
to use of infrastructure in their facil-
ity. Although in an absolute sense, that
infrastructure is never “free,” because of
the cost of housing it in the facility, its use
often doesn’t come out of an individual
laboratory budget. “If you try to charge
for basic service, they try to compare that
to free,” Dickinson said.
Instead of charging customers directly,
Illumina instead channels revenue through
third-party service providers, who will be
offering genomic analysis apps within the
sequencing environment. The application
interface (API) for BaseSpace will be open
to partner companies to offer applications
that will be available in an app store. An
initial block of 14 companies are already
signed up to offer those apps.
Although Amazon cloud services
provide an ideal solution for research,
the rapidly emerging market for clinical
sequencing comes with tougher regulatory
requirements, chief among them compli-
ance with the Health Insurance Portability
and Accountability Act of 1996 (HIPAA).
Amazon cloud services are not cur-
rently HIPAA compliant, and according to
Richard Resnick, CEO of GenomeQuest Inc.
(Westborough, Mass.), it is very unlikely to
become compliant any time soon. Resnick
said that the cloud is comprised of three
components: application, platform, and
hardware. Achieving HIPAA compliance
requires control of all three of those com-
ponents. A service that is designed around
coordination of many third-party providers
such as Amazon would have a hard time ever
validating full compliance for the entirety of
its applications, platform, and hardware.
“What we’re doing is thinking about
how to connect different parts of the
health care ecosystem through next-gener-
ation sequencing and cloud-based genom-
ics,” said Resnick.
GenomeQuest offers a secure HIPAA-
compliant cloud designed for large scale
analysis of whole genomes and gene panel
samples from clinical laboratories.
Resnick said that unlike research labs,
clinical laboratories can’t tolerate problems
like noise and false positives in their data.
“You can’t do that because there’s a real
patient at the end of the day.”
So in addition to security and data pri-
vacy standards, cloud services for clinical
sequencing applications have a higher bar
to achieve for quality.
“There are still many uncertainties
around the regulatory requirements for
using cloud and hosted IT services in
genomic medicine trials, so it was impor-
tant for us to work with a company that
really understands the healthcare IT
space,” said Spyro Mousses, PhD, director
of the Center for BioIntelligence at The
Translational Genomics Research Institute
(TGen) in Phoenix, Ariz.
BaseSpace enables users to perform interactive
genetic analysis from any location using a web
browser.
Sequence data analysis results depicted in the DNANexus
genome browser.
dd29_10_COS.indd 11dd29_10_COS.indd 11 9/28/2012
3:00:59 PM9/28/2012 3:00:59 PM
www.dddmag.com
� COVER STORY
In November 2011, TGen partnered
with Dell to support the world’s fi rst
personalized medicine trial for pediatric
cancer, and to leverage cloud comput-
ing resources donated by Dell. The Dell
Giving commitment includes multi-year
grant funding to support the clinical trial,
as well as major hardware, software, and
services contributions.
Focusing initially on neuroblastoma,
the trials will leverage high-performance
computing to dramatically accelerate the
processing of sequencing information from
patient tumors to predicting the optimal
treatment for each patient. As would be
required of any trial under U.S. Food and
Drug Administration (FDA) regulations, the
cloud solution will be compatible with both
FDA and HIPAA compliance requirements.
The KIDS Cloud, as TGen terms it,
“will provide a hybrid-cloud platform for
securely storing and exchanging genomic
data and clinical information across mul-
tiple collaborating organizations,” accord-
ing to Mousses.
TGen is also participating in several
other large personalized medicine trials
and hopes that the kind of cloud-enabled
computational infrastructure can serve as
a national model for collaborative person-
alized medicine. “It takes a village to cure
a kid with cancer,” Mousses said.
With the advent of next-generation
sequencing technology, the emphasis has
shifted from bringing the cost of sequenc-
ing down to addressing the cost of analy-
sis. “The bottleneck now is being able to
effectively analyze the data,” said Marc
Olsen, president and COO of DNANexus
(Mountain View, Calif.), a provider of
cloud-based data management and analy-
sis. Those challenges include not only the
cost of storage and management of quanti-
ties of data that could fi ll thousands and
thousands of PCs, but questions of how
to transfer data, and how to share and
collaborate while still maintaining security
and privacy. The industry is currently seek-
ing answers to those emerging problems,
and in some cases already moving towards
some degree of standardization. �
Catherine Shaffer is a freelance science writer
specializing in biotechnology and related
disciplines with a background in laboratory
research in the pharmaceutical industry.
Expression Analysis’ cloud computing pipeline,
powered by Golden Helix, can access virtually
infi nite storage capacity on the fl y and distribute
large jobs across hundreds of servers in parallel. A
dashboard showing computing progress for a 15
sample RNA-Seq project is shown above.
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244
Article
Management of a Large Qualitative Data Set: Establishing
Trustworthiness of the Data
Debbie Elizabeth White, RN, PhD
Associate Professor, Associate Dean of Research
Faculty of Nursing
University of Calgary
Calgary, Alberta, Canada
Nelly D. Oelke, RN, PhD
Assistant Professor
School of Nursing
Faculty of Health and Social Development
University of British Columbia, Okanagan Campus
Kelowna, British Columbia, Canada
Steven Friesen, BSc
Quality Practice Leader
Bethany Care Society
Calgary, Alberta, Canada
© 2012 White, Oelke, and Friesen.
Abstract
Health services research is multifaceted and impacted by the
multiple contexts and
stakeholders involved. Hence, large data sets are necessary to
fully understand the complex
phenomena (e.g., scope of nursing practice) being studied. The
management of these large
data sets can lead to numerous challenges in establishing
trustworthiness of the study. This
article reports on strategies utilized in data collection and
analysis of a large qualitative study
to establish trustworthiness. Specific strategies undertaken by
the research team included
training of interviewers and coders, variation in participant
recruitment, consistency in data
collection, completion of data cleaning, development of a
conceptual framework for analysis,
consistency in coding through regular communication and
meetings between coders and key
research team members, use of N6
TM
software to organize data, and creation of a
comprehensive audit trail with internal and external audits.
Finally, we make eight
recommendations that will help ensure rigour for studies with
large qualitative data sets:
organization of the study by a single person; thorough
documentation of the data collection
and analysis process; attention to timelines; the use of an
iterative process for data collection
and analysis; internal and external audits; regular
communication among the research team;
adequate resources for timely completion; and time for
reflection and diversion. Following
these steps will enable researchers to complete a rigorous,
qualitative research study when
faced with large data sets to answer complex health services
research questions.
245
Keywords: qualitative research, data management, large data
sets, rigour, nursing, scope of
practice
Acknowledgements: We want to thank all the participants for
their valuable contributions to
this study. In addition, we would like to thank our funders:
Canadian Health Services
Research Foundation, Calgary Health Region (now Alberta
Health Services, Calgary),
Capital Health Region (now Alberta Health Services,
Edmonton), Saskatoon Health Region,
and the University of Calgary, Faculty of Nursing.
International Journal of Qualitative Methods 2012, 11(3)
246
Introduction
Healthcare systems are very complex, multi component systems
that are continually evolving.
Given the complexity of these systems, health services research
is multifaceted and impacted by
the multiple contexts and stakeholders involved. Even when
researchers study only a particular
component of the healthcare system (e.g., scope of nursing
practice in acute care), multiple
contexts are encountered and many participants are included to
better understand the complex
phenomena being studied. Health services research on scope of
practice is not well established
and, given the research questions, qualitative research is often
the focus of such exploratory
research. Because data collection may occur across a number of
sites by more than one research
assistant, research teams encounter logistical issues and have
difficulties maintaining
predetermined timelines. The end result can be a very large
amount of qualitative data that must
be analyzed and interpreted appropriately to ensure that an
accurate synopsis of the results will be
presented. Organization of data and attention to rigour are
essential when working with such large
qualitative data sets. This article describes the management of a
large qualitative data set
generated from the research study entitled “A Systematic
Approach to Maximizing Nurses’ Scope
of Practice.” More specifically, the purpose of this article is to
reflect upon and describe the
processes through which the research team managed a large
qualitative data set to ensure that the
final product would be judged as rigorous. One of the authors,
Nelly D. Oelke, has considerable
experience in qualitative research. This expertise and the
application of the literature on
qualitative data analysis guided the structures and processes
used to collect and analyze our data.
This article contributes to the literature about managing large
qualitative data sets by providing
concrete steps for ensuring rigour in data collection, analysis,
and interpretation.
Background
Trustworthiness and data management are vital to the success of
qualitative studies. Although
literature on maintaining rigour in qualitative research is
abundant, few articles have tackled
doing so with large qualitative data sets (Knafl & Ayres, 1996)
and few researchers have
documented their process. A search of the literature was
conducted and confirmed these findings.
Search terms used for our literature search included qualitative
research, data management, large
data sets, and rigor, with coverage of the following databases:
MEDLINE, CINAHL, and
PsycINFO. Guba (1981) and others (Johnson & Waterfield,
2004; Whittemore, Chase, & Mandle,
2001) recommend general methodologies to ensure rigour in
qualitative research. Although the
descriptions of methodologies in the literature vary, most
involve steps to maintain credibility,
dependability, transferability, and confirmability (Guba, 1981).
To maintain credibility (Guba, 1981) or authenticity
(Whittemore et al., 2001), researchers must
adhere to methods accepted as scientifically sound in the
qualitative and informational sciences.
While transparency of methodology is important, Sandelowski
(1997) cautions against focusing
only on methods. Rather, researchers should maximize data
utility to answer the research
questions. The researcher must have a satisfactory cultural
familiarity with the participating
institution and use a comfortable approach in recruiting
participants so that the sampling process
is random and unbiased (Guba, 1981). Moreover, participants’
input must be honest, clearly
recorded, and accurately presented (Whittemore et al., 2001).
Dependability and transferability are related in that both ensure
all research design and operations
are clearly identified (Guba, 1981). These steps also allow for
replication of the methodology
with a larger population or by future researchers. However, it is
important to differentiate
between the dependability of a method in producing similar
interpretations and the reliability of a
method in producing identical results. Qualitative research
focuses on describing participants’
International Journal of Qualitative Methods 2012, 11(3)
247
experience as accurately as possible (Sandelowski, 1997), rather
than using numbers to describe
the phenomena of interest. According to Sandelowski (1997),
interpreting the results, providing
valid applications of the findings, and accumulating knowledge
as a foundation for other studies
are essential for validating data from a qualitative study.
Johnson and Waterfield (2004) explain:
Qualitative data are descriptive, unique to a particular context
and therefore cannot be
reproduced time and again to demonstrate ‘reliability’(Bloor,
1997). Instead of trying to
control extraneous variables, qualitative research takes the view
that reality is socially
constructed by each individual and should be interpreted rather
than measured; that
understanding cannot be separated from context. (p. 122-123)
Whittemore et al.’s (2001) framework for enhancing rigour
includes criticality and integrity
components, which for Guba (1981) and Johnson and Waterfield
(2004), are included as
components of confirmability or an audit trail. It is
recommended that researchers keep an
accurate, comprehensive record of the approaches and activities
employed in the study, both in
data collection and analysis. This record includes highlighting
shortcomings of the study in the
research report and providing transparent links between study
results and actual experiences of
the participants in the study (Guba, 1981). Such audit trails not
only provide a solid
methodological reference for the reader, but also provide an
opportunity for reflective reasoning
(on themes or categories chosen, interpretations, etc.) and
criticism for the researchers as the
study progresses (Guba, 1981; Johnson & Waterfield, 2004;
Whittemore et al., 2001). For
example, if methodology changes at some point in the study, an
audit trail would keep a record of
when, why, and what changes were implemented. Such audit
trails become especially useful in
the management of large databases and for placing data points,
methodology, and interpretation
within the particular context in which they belong.
Knafl and Ayres (1996) offer researchers two data management
steps for handling larger
qualitative data sets. First, case summaries can save researchers
great time and logistical
resources while decreasing error. Core study researchers would
summarize focus group or
interview transcripts to a fraction of their original length, and
also include relevant data organized
into themes agreed upon beforehand as part of a summary
guideline. This step not only allows
core researchers, who will be interpreting the data, to work
closely with the data, but also allows
for critical insight. As a complement to the case summaries, it
is recommended that researchers
tackling a large data set create matrices using database
management systems. Guided by themes
and questions identified in the study, matrices provide a visual
display of the data, including
extracted themes. Such matrices simplify the data for
researchers’ discussions, while the case
summaries provide more details on the data. Moreover, data can
be reorganized quickly using
electronic matrices, allowing for various perspectives and
discussions on study outcomes (Knafl
& Ayres, 1996).
Ensuring rigour in qualitative research is a priority when
collecting, presenting, and interpreting
data. Larger qualitative data sets can present a critical challenge
for researchers in maintaining
study trustworthiness and, therefore, special guidelines must be
strictly followed to ensure
transparency, logical reasoning, and criticality. As few sources
in the literature have suggested
methodology for managing large qualitative data sets, this
article aims to outline the methods
followed by our research team to maintain rigour in such
circumstances.
Description of the Study
Numerous reports have highlighted the need to address the
under-utilization of health human
resources by maximizing professional scopes of practice
(Advisory Committee on Health Human
International Journal of Qualitative Methods 2012, 11(3)
248
Resources, 2002; Fyke, 2001). The need to clarify and define
the nursing scope of practice was
recognized in Canada as well as internationally. However, there
was a void in the research
literature in terms of describing scope of practice (being able to
practice to the full extent of one’s
education, knowledge, and experience) and examining barriers
to the enactment of full scope of
practice. This research study was unique in that it examined
scope and boundaries in the practice
of various categories of nursing personnel simultaneously, for
example, registered nurses (RNs),
registered psychiatric nurses (RPNs), and licensed practical
nurses (LPNs). The overall goal of
this research was to make rich and robust conclusions about the
scope of practice of nurses, the
barriers to and facilitators of scope, and the impact of
contextual factors on scope of practice.
Research findings have been reported elsewhere (Oelke, White,
Besner, Doran, McGillis-Hall, &
Giovannetti, 2008; White, Oelke, Besner, Doran, McGillis-Hall,
& Giovannetti, 2008).
Study Methodology
This research study used a descriptive exploratory design with
mixed methods (Creswall, 2009)
to explain enactment of scope of practice among all categories
of regulated nurses (e.g., RNs,
LPNs, RPNs). Both quantitative (e.g., questionnaires) and
qualitative (e.g., interviews with a
variety of stakeholders) data were collected, and one informed
the other in the data analysis and
interpretation. This article focuses on the qualitative data set.
To make our experience of
managing this large qualitative data set truly transparent,
underlying foundational components of
the study will be discussed. According to Sandelowski’s (2000)
classifications, our study was a
qualitative descriptive study. The methodological underpinnings
of this study were eclectic. The
qualitative component drew on tenets (e.g., importance of the
setting and context, purposive
sampling, and inductive analysis) situated within the
naturalistic paradigm espoused by Lincoln
and Guba (1985) and Miles and Huberman (1994). A
subcomponent of the study (quantitative
data from surveys and regional corporate databases) was
positioned within a positivist paradigm.
This latter component will not be addressed in this article.
Research questions focused on nurses’ and other healthcare
providers’ perceptions of nurses
working to their full scope of practice. Participants were also
asked to identify personal,
professional, and organizational barriers or facilitators that
enabled or hindered their ability to
work to their full scope of practice. These types of questions are
typically associated with
qualitative descriptive studies (Sandelowski, 2000). Data were
collected on 14 acute care nursing
units located within three western Canadian Health Regions. To
ensure variability in sampling,
patient care units from hospitals of various intensities and
representing variability in provider and
organizational characteristics were selected across the health
regions to participate in the study.
Types of units included in the study were intensive care,
medicine, surgery, and psychiatry.
Individual, face-to-face, semi-structured interviews were
conducted to gather information on
enactment of nursing roles and perceived facilitators and
barriers to maximizing scope of
practice. A purposive volunteer sample of nursing personnel
(e.g., RNs, LPNs, RPNs, and Patient
Care Managers) and inter-professional healthcare team members
were recruited on the study
units. Patient interviews were also conducted with a small
sample of volunteer patients from each
health region to validate the extent to which patient experience
reflected the expected focus of
nursing defined in scope of practice documents. A total of 236
interviews were audio-recorded
and transcribed. There were 167 interviews conducted with
nursing staff: 85 RNs, 31 LPNs, 11
RPNs, 19 patient care managers and assistant patient care
managers, and 21 nurses in specialized
roles (e.g., nurse educators and nurse clinicians). The remainder
of the interviews were completed
with other healthcare providers (e.g., physicians, social
workers, and physiotherapists) and
patients. The establishment of rigour in this study became a
daunting task when a large number of
nurses and other healthcare providers were interviewed to
discuss enactment of scope of practice
International Journal of Qualitative Methods 2012, 11(3)
249
of nurses and the influence of the work environment and other
structures and processes on role
enactment.
Ensuring Trustworthiness of the Data
Our study presented a myriad of challenges to ensure
trustworthiness of the data. These
challenges included collecting data from multiple sites using
different research assistants,
developing a process for analyzing the data, recruiting and
retaining qualified individuals to
complete coding and initial analysis, and completing in-depth
analysis of the data. Despite the
many challenges encountered while managing this large
qualitative data set, we succeeded in
reporting research results that met the criteria for data
trustworthiness. The following sections of
this article will outline the challenges and how they were
addressed in handling the large amount
of data collected in this study.
Credibility or Authenticity
First, participant recruitment was an important aspect to ensure
credibility of research results.
Participant selection required the incorporation of multiple
perspectives (e.g., RNs, LPNs,
managers, and interdisciplinary team members) to provide a
clear and broad understanding of
nurses’ and other healthcare providers’ perceptions of nursing
scope of practice. Although
participants volunteered to be interviewed, researchers
facilitated a diverse range of perspectives
by presenting in both posters and unit presentations the
importance of capturing varied perception
of scope of practice. Maximum variation (Polit & Hungler,
1999) was sought when recruiting
units for the study. Variability in organizational characteristics,
hospital intensity, and a variety of
patient care units was desired (Aita & McIlvain, 1999; Morse &
Richards, 2002). Once hospital
units were selected, participants were recruited for interviews
with attention to maximum
variability in representing the various perspectives of nursing
scope of practice. Given the
geographical nature of the study, as well as the nature of the
clinical environment, it was not
possible to limit interviews to one unit with one group of
providers at a single point in time.
Rather, interviews were completed on various patient care units
with a variety of providers in the
same time frame, depending on their work schedules. Initially,
both research assistants and
several research team members were concerned that this process
would result in more interviews
being conducted because of the uncertainty about data
saturation. However, bi-weekly
discussions with interviewers confirmed that while they were
hearing similar elements, data
saturation had not been reached. The variability in units, desired
variability in participants, and
lack of data saturation until later in the study all led to the
recruitment of a very large sample of
participants for the study, which created a situation requiring
the management of a large
qualitative data set.
Second, the consistency of data collection was important to
ensure credibility of research results.
Data collection was conducted across three health regions with
multiple research assistants. Semi-
structured interview questions focused on components of the
overarching research questions and
guided the interview process with nurses and interdisciplinary
team members (Sandelowski,
2000). These interviews were conducted by three different
research assistants. To standardize
interview tracking and scheduling and the entry of demographic
data, an Access
TM
database,
along with a user manual detailing the process and technical
applications, were provided to each
study site. To further establish consistency in data collection
(Aita & McIlvain, 1999; Morse &
Richards, 2002), a two day training session was conducted by
the project manager with the
research assistants to discuss the interview protocol, review
interview questions and cues, address
the concept of data saturation, and discuss the purpose of
writing brief field notes following
interviews. A second component of the training session was the
completion and review of several
International Journal of Qualitative Methods 2012, 11(3)
250
interviews with each of the research assistants. Feedback about
interviewing techniques (e.g.,
paraphrasing, clarity, utilization of cues for questions, and
getting the interviewee to elaborate on
their responses) was provided to each of the research assistants.
At this time, research assistants
also shared their experiences in completing the interview and
provided valuable feedback
contributing to the clarity of the interview questions and
additional prompts for the questions. A
training manual was also provided as a resource for the
interviewers to complement training
sessions. Given the magnitude of the study, research assistants
were reminded to limit the number
of interviews (3-4) completed in one day to avoid interviewer
burden. Despite the focus on
consistency of data collection, opportunity was provided
through the field notes to co-author
results as noted in Kvale (1996).
Finally, presentations were made to participants to ensure the
credibility and authenticity of the
research results. Ten to fifteen presentations were made to
various groups of participants (e.g.,
nurses, allied healthcare professionals, Patient Care Managers,
senior health leaders, and Chief
Nursing Officers) wherein results were validated by
participants.
Dependability and Transferability
Data Processing and Cleaning
Consistency between transcribers was ensured by utilizing a
consistent template, which permitted
easy transfer of documents into N6
TM
,
a computer program designed for qualitative data storage,
indexing, and theorizing. Transcription guidelines to
standardize expressions and formatting were
provided to each transcriptionist. To ensure the accuracy of the
transcription, each of the research
assistants reviewed the transcripts while comparing them to
audio files. Minor discrepancies, such
as spelling errors and clarification of acronyms, were made in
the transcripts following review by
the research assistants.
Data Analysis
Preparation for the data analysis component of the study was
intense, time consuming, and multi-
focused. A phased approach (Gaskell & Bauer, 2000) was used
in data analysis, with the
completion of coding and initial analysis prior to in-depth
analysis of the data. A conceptual
framework was developed by the research team to begin a
content analysis process. As an initial
step in the development of the framework, two research team
members and one research assistant
independently reviewed four interviews to identify preliminary
themes. The second step in the
development of the framework was to have two of the original
research team members and two
new research team members independently analyze four new
interviews utilizing the existing
framework. With the analysis of this second set of interviews,
consistencies were found in the
themes identified between the team members. However, new
themes also emerged resulting in an
expansion of the conceptual framework. Miller and Crabtree
(1992) have described this approach
to content analysis as a “template” style (p.18). The conceptual
framework served as the initial
tree node structure to begin coding interviews in the N6
TM
software program.
As consistent with qualitative methods, the categories and nodes
identified were not considered
static. Several iterations of this conceptual framework and tree
node structure evolved,
particularly in the early stages of coding and analysis by the
coders and the research team
(Gaskell & Bauer, 2000). In developing the evolving tree,
particular attention was paid to the
semantic relationships of the parent and child nodes. A
reference document defining each node
and indicating placement in the hierarchy of the tree structure
was developed and modified to
reflect coding team discussions. This process assisted the
dependability of the analysis of the
International Journal of Qualitative Methods 2012, 11(3)
251
large data set, which occurred across multiple coders.
Documentation of the changes and the
rationale for changes were maintained to establish an audit trail
(Lincoln & Guba, 1985).
Recruiting and retaining qualified individuals to do coding and
initial analysis was both an
important and difficult task (Richards, 2005). Coders were
recruited through the university and
connections with other qualitative researchers. Coding was
accomplished through collaboration
and strengthened by the varying perspectives of
multidisciplinary team members with
backgrounds in clinical and academic nursing, psychology,
social work, occupational therapy,
and health services research. Most team members had previous
qualitative research experience. A
half day of training was provided to all coders with ongoing
consultation and assistance provided
by various members of the research team. Binders describing
the technical aspects of N6
TM
were
developed for each coder. Initially the coders completed the
coding of the same two interviews.
Coding was compared and the coding tree was discussed. Early
in the coding process weekly
meetings were held with the coders; as the study progressed
meetings were decreased to every
two weeks. These meetings provided an excellent opportunity
both to discuss the development of
new themes and to question and confirm saturation of themes.
In-depth analysis was completed by two experienced qualitative
research team members with
different healthcare backgrounds (nursing and occupational
therapy). Analysis was completed by
provider group; each researcher examined the data for specific
groups of providers (e.g., RNs,
LPNs, etc.). While each of the researchers examined
descriptions of nursing scope of practice and
barriers and facilitators to enactment of scope of practice,
patterns across the data were also
examined (Richards, 2005). Assigning data sets to different
researchers (Gaskell & Bauer, 2000)
was seen as an appropriate and manageable approach to in-depth
data analysis of this large data
set. Data overload, fatigue, and the potential for the researcher
to “get lost in the data” posed real
challenges for the analysis of the large amount of data collected
for this study. Dedicating two
researchers, who met and discussed regularly, to the process of
in-depth analysis assisted in
managing these challenges. Researchers frequently documented
their processes and
interpretations as memos directly in the software program.
Summary analysis documents were
also created for each of the data sets analyzed. Meeting
regularly was also important in making
meaningful sense of all the data in this study.
Although N6
TM
was an excellent program for organizing the qualitative data,
challenges were
encountered in merging projects between coders (initial
analysis) and again between researchers
once the in-depth analysis was completed. QSR Merge
TM
is designed to merge one project with
another project, but with the coders and researchers each
developing separate N6
TM
projects (five
different projects in total) merging was not seamless.
Duplication of transcripts and codes
required that one individual be associated with one transcript to
prevent duplication in the final
N6
TM
for the complete analysis of all the data for the study. Although
challenges were
encountered in merging the projects, we were successful in
creating one complete N6
TM
project.
Confirmability
Confirmability (Guba, 1981; Johnson & Waterfield, 2004) of
research results was ensured via
four key processes: the creation of an audit trail; an internal
audit; an external audit; and the
writing of the final research report.
Audit Trail
A detailed, comprehensive accounting of all data collection and
data analysis activities was
completed. Changes were documented as they were made, along
with rationale for the change.
International Journal of Qualitative Methods 2012, 11(3)
252
Accurate and comprehensive records of the methods employed
in data collection and analysis by
researchers in the study were recommended by qualitative
research experts (Lincoln & Guba,
1985; Sandelowski, 2000). Such audit trails provided not only a
solid methodological reference
for the reader, but also provided an opportunity for reflective
reasoning (on the themes or
categories chosen, interpretations, etc.) for the researchers as
the study progressed (Guba, 1981;
Johnson & Waterfield, 2004; Whittemore et al., 2001). For
example, if methodology changed at
some point in the study, an audit trail would keep a record of
when, why, and what changes were
implemented. Such audit trails became especially useful for
managing large data sets and placing
data, methodology, and interpretation within the particular
context in which they belonged.
Internal audit
Internal audits of coding and themes for the study were
completed at three different intervals
(after 10, 25, and 45 interviews were coded) during the analysis
of the study. The purposes of
these audits were to assess inter-rater reliability and to
determine similarities and differences in
key themes identified by coders and auditors. Audits were
conducted by three auditors, each
members of the research team. The audit included interviews of
nurses (RNs, RPNs, and LPNs),
nurse managers, interdisciplinary team members, and patients.
The sample of interviews was
based on a stratified selection by profession, education, unit,
and health region …
Assignment:
Final Project is on Netflix but you will incorporate Netflix
company in this week learning. I will attach a couple articles on
things learned this week, and you will answer questions below
about this Assignment. Assignment should be 1.5-3 pages.
***This week you will continue to work on your Final Project,
you will submit a business memo, written to your Instructor,
that explains how you plan to incorporate your learning from
the week into your Final Project. This will not be a "perfect"
synopsis at this point, but it should capture the main themes and
important ideas from the week. Your memo should include the
following:
· Your preliminary summary of how you are planning to
incorporate this week’s learning into your Final Project
· Your ideas and recommendations for how your organization
can mitigate the short-term and long-term issues that can arise
when selecting and using data resources and systems
· Brief descriptions of the types of data resources, data
processing, and storage systems chosen
· An explanation of how the organization might manage the
potential implications of those selections, while taking
advantage of the opportunities they afford to sustain the
business or gain a competitive advantage
· Other relevant recommendations or issues that you identified,
with a brief analysis of why they are important
Note: If you are unable to find relevant information, you may
want to look for similar information at /for other similar
publically traded companies. You may find relevant information
that will enable you to make appropriate inferences about your
organization and make reasonable assumptions so you can
proceed with your project.
If you have questions about how to apply what you are learning
or how to find the most relevant information for your
organization’s needs, please discuss your choice with your
Instructor using the Contact the Instructor link in the classroom.
General Guidance on Assignment Length: Your Week 3
Assignment will typically be 1.5–3 pages (0.75–1 page(s) if
single spaced), excluding a title page (not required for this
Assignment) and references.
As a best practice for this course, as you engage and complete
your weekly activities, you will capture notes on your learning
for each week and add them to your Final Project Portfolio,
which you will use to formulate your Final Project. By the time
you turn in your Final Project in Week 7, your working Final
Project Portfolio document will contain your notes on the
resources you found relevant in each week, as well as your
ideas for how your organization can improve its business
information systems management with respect to each week’s
main themes. You should also include your analyses of the
implications of your recommendations, as well as reasons why
your recommendations are important. You will update
your Final Project Portfolio each week.
This week you are encouraged to begin setting up your
presentation in PowerPoint. You should complete a title slide
and 1–2 slides with your preliminary recommendations for your
organization as they relate to this week’s learning.
Note: Neither your Final Project Portfolio nor your preliminary
slides will be submitted for grading this week.
Final Project is on Netflix but you will incorporate Netflix
company in this week learning. I will post a couple articles
below on things learned this week, and you will answer
questions above about this Assignment.

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As next-generation technology ratchets the price of sequen.docx

  • 1. A s next-generation technology ratchets the price of sequencing lower and lower, users from aca- demic labs to Big Pharma are fi nding themselves drowning in data. What used to be gigabytes worth of information has become terabytes or petabytes. At the same time, the cost crunch brought on by the global recession has made researchers leery of unnecessary capital spending. The result is more and more users moving their data management to the cloud or outsourcing it entirely. Whereas large pharma companies may have the funds and infrastructure to maintain dedicated servers for storage and analysis of sequencing data, small companies—especially those that don’t sequence continuously—are leading the migration to the cloud, and service providers are springing up to meet the demand. Cost, secu- rity, and convenience top the list of concerns for researchers looking for a place to unload reams of data. However, once that transition is made, features like collaborative data sharing, access to third- party analysis apps, and patient privacy become more important. Expression Analysis, a Quintiles Co., Durham, N.C., provides
  • 2. genomic services to the pharma and biotech industry, as well as academic, government, and foundation laboratories doing research in molecular biology and genetics. It provides cloud computing services through a partnership with Golden Helix Inc., Bozeman, Mont. Its clients require computation-intensive services for gener- ating the initial RNA or DNA sequence and also for cleaning up, aligning, and analyzing the sequence. According to Expression Analysis, a typical sequencing project for 100 RNA samples would generate 300 to 400 GB worth of com- pressed data, or 700 GB to 1 TB worth of data in total; and that’s just for one experiment. For multiple experiments, the amount of data can add up to astronomical quantities quite quickly. Some applications, such as analyzing cancer samples, are even more data intensive, because of the depth of coverage and the need to sample multiple cells in the tumor. “The cloud offers a full environment in order to do analysis on a large number of samples simultaneously,” said Wendell Jones, PhD, vice president of statistics and bioinformatics for Expression Analysis. That computing power becomes a commodity for the customer, replacing expensive, on-site, server infrastructure. The data is instead accessed through a browser, and there is no need to
  • 3. upload or download huge fi les. “You can leave them on the cloud and access in a streaming fashion via the cloud,” Jones said. For small companies, the cloud-based service offers additional advantages beyond saving on hardware and real estate. Startup companies may not have the structure in place to operate Linux- based genome software applications. A cloud-based storage and analysis service allows those companies to use their own local Windows or Macintosh desktop operating systems. There are some advantages to maintaining a physical server. “You have the option of having lower redundancy ... and faster data access times. You can choose to take your old data and unplug it. You don’t have to pay for power,” explained Jonathan Bingham, product manager for informatics and software for Menlo Park, Calif.-based Pacifi c Biosciences, a provider of genom- ics services through its SMRT platform technology and hosted cloud-based storage and analysis service. 10 � September/October 2012 www.dddmag.com Exploding sequencing data volumes push researchers to the cloud and into partnerships. � COVER STORY � Catherine Shaffer, Contributing Editor Managing Data in the Cloud Age dd29_10_COS.indd 10dd29_10_COS.indd 10 10/1/2012 11:41:49 AM10/1/2012 11:41:49 AM
  • 4. On the other hand, that means taking responsibility for managing the hardware, Bingham added, such as replacing failed drives. That burden of ownership and main- tenance is not right for every company. Jones explained that cloud comput- ing is ideal for research groups that have “bursty” computing needs, meaning that generating and analyzing sequence data is an intermittent need. “The cloud in some sense is cheap, in the sense that it’s cheaper to rent a vacation home than buy it and only use it two or three weeks a year. If you’re constantly at your vacation home, it’s just better to buy it.” Cost is a major concern at Illumina (San Diego, Calif.) as well. A giant in the sequenc- ing industry, Illumina controls 70% of the market share for sequencing. Illumina can sequence an entire human genome in a day, and it offers its cloud-computing solution, BaseSpace, through Amazon Web Services (Seattle), the world’s largest cloud hosting service. Recently, Amazon announced a ser- vice providing reliable data storage starting at $0.01 per gigabyte per month. Although that is a very economical rate for data storage by any standard, for long- term storage of hundreds or thousands of
  • 5. complete genomes, many experts agree it is better to store the data in the original tissue. In other words, if the raw data is needed again in the future, it is cheaper to regener- ate the sequence from an archived sample. Illumina offers an even better deal to its customers. “We’ve picked the ultimate pricing strategy which is free,” said Alex Dickinson, senior vice president of cloud DRUG Discovery & Development September/October 2012 � 11 genomics for the company. “Customers get a free terabyte of data storage, enough for 10 years of typical usage of MiSeq. We do the secondary processing, alignment, and variant calling. We also do that for free,” Dickinson said. MiSeq is Illumina’s “personal sequencer,” a next-generation sequenc- ing system suitable for applications such as multiplexed PCR amplicon sequenc- ing, targeted resequencing, small RNA sequencing, and so forth. Illumina’s choice to offer free service is based on concerns of researchers, who may be comparing the company’s offerings to use of infrastructure in their facil- ity. Although in an absolute sense, that infrastructure is never “free,” because of the cost of housing it in the facility, its use often doesn’t come out of an individual
  • 6. laboratory budget. “If you try to charge for basic service, they try to compare that to free,” Dickinson said. Instead of charging customers directly, Illumina instead channels revenue through third-party service providers, who will be offering genomic analysis apps within the sequencing environment. The application interface (API) for BaseSpace will be open to partner companies to offer applications that will be available in an app store. An initial block of 14 companies are already signed up to offer those apps. Although Amazon cloud services provide an ideal solution for research, the rapidly emerging market for clinical sequencing comes with tougher regulatory requirements, chief among them compli- ance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Amazon cloud services are not cur- rently HIPAA compliant, and according to Richard Resnick, CEO of GenomeQuest Inc. (Westborough, Mass.), it is very unlikely to become compliant any time soon. Resnick said that the cloud is comprised of three components: application, platform, and hardware. Achieving HIPAA compliance requires control of all three of those com- ponents. A service that is designed around coordination of many third-party providers such as Amazon would have a hard time ever
  • 7. validating full compliance for the entirety of its applications, platform, and hardware. “What we’re doing is thinking about how to connect different parts of the health care ecosystem through next-gener- ation sequencing and cloud-based genom- ics,” said Resnick. GenomeQuest offers a secure HIPAA- compliant cloud designed for large scale analysis of whole genomes and gene panel samples from clinical laboratories. Resnick said that unlike research labs, clinical laboratories can’t tolerate problems like noise and false positives in their data. “You can’t do that because there’s a real patient at the end of the day.” So in addition to security and data pri- vacy standards, cloud services for clinical sequencing applications have a higher bar to achieve for quality. “There are still many uncertainties around the regulatory requirements for using cloud and hosted IT services in genomic medicine trials, so it was impor- tant for us to work with a company that really understands the healthcare IT space,” said Spyro Mousses, PhD, director of the Center for BioIntelligence at The Translational Genomics Research Institute (TGen) in Phoenix, Ariz.
  • 8. BaseSpace enables users to perform interactive genetic analysis from any location using a web browser. Sequence data analysis results depicted in the DNANexus genome browser. dd29_10_COS.indd 11dd29_10_COS.indd 11 9/28/2012 3:00:59 PM9/28/2012 3:00:59 PM www.dddmag.com � COVER STORY In November 2011, TGen partnered with Dell to support the world’s fi rst personalized medicine trial for pediatric cancer, and to leverage cloud comput- ing resources donated by Dell. The Dell Giving commitment includes multi-year grant funding to support the clinical trial, as well as major hardware, software, and services contributions. Focusing initially on neuroblastoma, the trials will leverage high-performance computing to dramatically accelerate the processing of sequencing information from patient tumors to predicting the optimal treatment for each patient. As would be required of any trial under U.S. Food and Drug Administration (FDA) regulations, the cloud solution will be compatible with both
  • 9. FDA and HIPAA compliance requirements. The KIDS Cloud, as TGen terms it, “will provide a hybrid-cloud platform for securely storing and exchanging genomic data and clinical information across mul- tiple collaborating organizations,” accord- ing to Mousses. TGen is also participating in several other large personalized medicine trials and hopes that the kind of cloud-enabled computational infrastructure can serve as a national model for collaborative person- alized medicine. “It takes a village to cure a kid with cancer,” Mousses said. With the advent of next-generation sequencing technology, the emphasis has shifted from bringing the cost of sequenc- ing down to addressing the cost of analy- sis. “The bottleneck now is being able to effectively analyze the data,” said Marc Olsen, president and COO of DNANexus (Mountain View, Calif.), a provider of cloud-based data management and analy- sis. Those challenges include not only the cost of storage and management of quanti- ties of data that could fi ll thousands and thousands of PCs, but questions of how to transfer data, and how to share and collaborate while still maintaining security and privacy. The industry is currently seek- ing answers to those emerging problems, and in some cases already moving towards
  • 10. some degree of standardization. � Catherine Shaffer is a freelance science writer specializing in biotechnology and related disciplines with a background in laboratory research in the pharmaceutical industry. Expression Analysis’ cloud computing pipeline, powered by Golden Helix, can access virtually infi nite storage capacity on the fl y and distribute large jobs across hundreds of servers in parallel. A dashboard showing computing progress for a 15 sample RNA-Seq project is shown above. ANTIBODY PROBLEMS? Have difficult targets to develop effective antibodies? What if an antibody doesn't exist for your target/antigen? Aptagen develops and manufactures aptamers which are ligands of RNA/DNA and peptide oligos that bind to a variety of target antigens. Aptamers are sometimes referred to as “chemical antibodies or DNA antibodies.” …AND MUCH MORE ONLINE For Example: Aptamers have been generated that exhibit greater than 10,000-fold binding affinity for theophylline over caffeine, which differ from one another in structure by only a single methyl group. dd29_10_COS.indd 12dd29_10_COS.indd 12 9/28/2012 3:01:50 PM9/28/2012 3:01:50 PM
  • 11. Copyright of Drug Discovery & Development is the property of Advantage Business Media and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. 244 Article Management of a Large Qualitative Data Set: Establishing Trustworthiness of the Data Debbie Elizabeth White, RN, PhD Associate Professor, Associate Dean of Research Faculty of Nursing University of Calgary Calgary, Alberta, Canada
  • 12. Nelly D. Oelke, RN, PhD Assistant Professor School of Nursing Faculty of Health and Social Development University of British Columbia, Okanagan Campus Kelowna, British Columbia, Canada Steven Friesen, BSc Quality Practice Leader Bethany Care Society Calgary, Alberta, Canada © 2012 White, Oelke, and Friesen. Abstract Health services research is multifaceted and impacted by the multiple contexts and stakeholders involved. Hence, large data sets are necessary to
  • 13. fully understand the complex phenomena (e.g., scope of nursing practice) being studied. The management of these large data sets can lead to numerous challenges in establishing trustworthiness of the study. This article reports on strategies utilized in data collection and analysis of a large qualitative study to establish trustworthiness. Specific strategies undertaken by the research team included training of interviewers and coders, variation in participant recruitment, consistency in data collection, completion of data cleaning, development of a conceptual framework for analysis, consistency in coding through regular communication and meetings between coders and key research team members, use of N6 TM software to organize data, and creation of a comprehensive audit trail with internal and external audits. Finally, we make eight recommendations that will help ensure rigour for studies with large qualitative data sets: organization of the study by a single person; thorough documentation of the data collection
  • 14. and analysis process; attention to timelines; the use of an iterative process for data collection and analysis; internal and external audits; regular communication among the research team; adequate resources for timely completion; and time for reflection and diversion. Following these steps will enable researchers to complete a rigorous, qualitative research study when faced with large data sets to answer complex health services research questions. 245 Keywords: qualitative research, data management, large data sets, rigour, nursing, scope of practice Acknowledgements: We want to thank all the participants for their valuable contributions to this study. In addition, we would like to thank our funders: Canadian Health Services Research Foundation, Calgary Health Region (now Alberta
  • 15. Health Services, Calgary), Capital Health Region (now Alberta Health Services, Edmonton), Saskatoon Health Region, and the University of Calgary, Faculty of Nursing. International Journal of Qualitative Methods 2012, 11(3) 246 Introduction Healthcare systems are very complex, multi component systems that are continually evolving. Given the complexity of these systems, health services research is multifaceted and impacted by the multiple contexts and stakeholders involved. Even when researchers study only a particular component of the healthcare system (e.g., scope of nursing practice in acute care), multiple contexts are encountered and many participants are included to better understand the complex
  • 16. phenomena being studied. Health services research on scope of practice is not well established and, given the research questions, qualitative research is often the focus of such exploratory research. Because data collection may occur across a number of sites by more than one research assistant, research teams encounter logistical issues and have difficulties maintaining predetermined timelines. The end result can be a very large amount of qualitative data that must be analyzed and interpreted appropriately to ensure that an accurate synopsis of the results will be presented. Organization of data and attention to rigour are essential when working with such large qualitative data sets. This article describes the management of a large qualitative data set generated from the research study entitled “A Systematic Approach to Maximizing Nurses’ Scope of Practice.” More specifically, the purpose of this article is to reflect upon and describe the processes through which the research team managed a large qualitative data set to ensure that the final product would be judged as rigorous. One of the authors, Nelly D. Oelke, has considerable
  • 17. experience in qualitative research. This expertise and the application of the literature on qualitative data analysis guided the structures and processes used to collect and analyze our data. This article contributes to the literature about managing large qualitative data sets by providing concrete steps for ensuring rigour in data collection, analysis, and interpretation. Background Trustworthiness and data management are vital to the success of qualitative studies. Although literature on maintaining rigour in qualitative research is abundant, few articles have tackled doing so with large qualitative data sets (Knafl & Ayres, 1996) and few researchers have documented their process. A search of the literature was conducted and confirmed these findings. Search terms used for our literature search included qualitative research, data management, large data sets, and rigor, with coverage of the following databases: MEDLINE, CINAHL, and PsycINFO. Guba (1981) and others (Johnson & Waterfield,
  • 18. 2004; Whittemore, Chase, & Mandle, 2001) recommend general methodologies to ensure rigour in qualitative research. Although the descriptions of methodologies in the literature vary, most involve steps to maintain credibility, dependability, transferability, and confirmability (Guba, 1981). To maintain credibility (Guba, 1981) or authenticity (Whittemore et al., 2001), researchers must adhere to methods accepted as scientifically sound in the qualitative and informational sciences. While transparency of methodology is important, Sandelowski (1997) cautions against focusing only on methods. Rather, researchers should maximize data utility to answer the research questions. The researcher must have a satisfactory cultural familiarity with the participating institution and use a comfortable approach in recruiting participants so that the sampling process is random and unbiased (Guba, 1981). Moreover, participants’ input must be honest, clearly recorded, and accurately presented (Whittemore et al., 2001). Dependability and transferability are related in that both ensure
  • 19. all research design and operations are clearly identified (Guba, 1981). These steps also allow for replication of the methodology with a larger population or by future researchers. However, it is important to differentiate between the dependability of a method in producing similar interpretations and the reliability of a method in producing identical results. Qualitative research focuses on describing participants’ International Journal of Qualitative Methods 2012, 11(3) 247 experience as accurately as possible (Sandelowski, 1997), rather than using numbers to describe the phenomena of interest. According to Sandelowski (1997), interpreting the results, providing valid applications of the findings, and accumulating knowledge as a foundation for other studies are essential for validating data from a qualitative study. Johnson and Waterfield (2004) explain: Qualitative data are descriptive, unique to a particular context and therefore cannot be
  • 20. reproduced time and again to demonstrate ‘reliability’(Bloor, 1997). Instead of trying to control extraneous variables, qualitative research takes the view that reality is socially constructed by each individual and should be interpreted rather than measured; that understanding cannot be separated from context. (p. 122-123) Whittemore et al.’s (2001) framework for enhancing rigour includes criticality and integrity components, which for Guba (1981) and Johnson and Waterfield (2004), are included as components of confirmability or an audit trail. It is recommended that researchers keep an accurate, comprehensive record of the approaches and activities employed in the study, both in data collection and analysis. This record includes highlighting shortcomings of the study in the research report and providing transparent links between study results and actual experiences of the participants in the study (Guba, 1981). Such audit trails not only provide a solid methodological reference for the reader, but also provide an opportunity for reflective reasoning
  • 21. (on themes or categories chosen, interpretations, etc.) and criticism for the researchers as the study progresses (Guba, 1981; Johnson & Waterfield, 2004; Whittemore et al., 2001). For example, if methodology changes at some point in the study, an audit trail would keep a record of when, why, and what changes were implemented. Such audit trails become especially useful in the management of large databases and for placing data points, methodology, and interpretation within the particular context in which they belong. Knafl and Ayres (1996) offer researchers two data management steps for handling larger qualitative data sets. First, case summaries can save researchers great time and logistical resources while decreasing error. Core study researchers would summarize focus group or interview transcripts to a fraction of their original length, and also include relevant data organized into themes agreed upon beforehand as part of a summary guideline. This step not only allows core researchers, who will be interpreting the data, to work closely with the data, but also allows
  • 22. for critical insight. As a complement to the case summaries, it is recommended that researchers tackling a large data set create matrices using database management systems. Guided by themes and questions identified in the study, matrices provide a visual display of the data, including extracted themes. Such matrices simplify the data for researchers’ discussions, while the case summaries provide more details on the data. Moreover, data can be reorganized quickly using electronic matrices, allowing for various perspectives and discussions on study outcomes (Knafl & Ayres, 1996). Ensuring rigour in qualitative research is a priority when collecting, presenting, and interpreting data. Larger qualitative data sets can present a critical challenge for researchers in maintaining study trustworthiness and, therefore, special guidelines must be strictly followed to ensure transparency, logical reasoning, and criticality. As few sources in the literature have suggested methodology for managing large qualitative data sets, this article aims to outline the methods
  • 23. followed by our research team to maintain rigour in such circumstances. Description of the Study Numerous reports have highlighted the need to address the under-utilization of health human resources by maximizing professional scopes of practice (Advisory Committee on Health Human International Journal of Qualitative Methods 2012, 11(3) 248 Resources, 2002; Fyke, 2001). The need to clarify and define the nursing scope of practice was recognized in Canada as well as internationally. However, there was a void in the research literature in terms of describing scope of practice (being able to practice to the full extent of one’s education, knowledge, and experience) and examining barriers to the enactment of full scope of practice. This research study was unique in that it examined scope and boundaries in the practice
  • 24. of various categories of nursing personnel simultaneously, for example, registered nurses (RNs), registered psychiatric nurses (RPNs), and licensed practical nurses (LPNs). The overall goal of this research was to make rich and robust conclusions about the scope of practice of nurses, the barriers to and facilitators of scope, and the impact of contextual factors on scope of practice. Research findings have been reported elsewhere (Oelke, White, Besner, Doran, McGillis-Hall, & Giovannetti, 2008; White, Oelke, Besner, Doran, McGillis-Hall, & Giovannetti, 2008). Study Methodology This research study used a descriptive exploratory design with mixed methods (Creswall, 2009) to explain enactment of scope of practice among all categories of regulated nurses (e.g., RNs, LPNs, RPNs). Both quantitative (e.g., questionnaires) and qualitative (e.g., interviews with a variety of stakeholders) data were collected, and one informed the other in the data analysis and interpretation. This article focuses on the qualitative data set. To make our experience of
  • 25. managing this large qualitative data set truly transparent, underlying foundational components of the study will be discussed. According to Sandelowski’s (2000) classifications, our study was a qualitative descriptive study. The methodological underpinnings of this study were eclectic. The qualitative component drew on tenets (e.g., importance of the setting and context, purposive sampling, and inductive analysis) situated within the naturalistic paradigm espoused by Lincoln and Guba (1985) and Miles and Huberman (1994). A subcomponent of the study (quantitative data from surveys and regional corporate databases) was positioned within a positivist paradigm. This latter component will not be addressed in this article. Research questions focused on nurses’ and other healthcare providers’ perceptions of nurses working to their full scope of practice. Participants were also asked to identify personal, professional, and organizational barriers or facilitators that enabled or hindered their ability to work to their full scope of practice. These types of questions are typically associated with
  • 26. qualitative descriptive studies (Sandelowski, 2000). Data were collected on 14 acute care nursing units located within three western Canadian Health Regions. To ensure variability in sampling, patient care units from hospitals of various intensities and representing variability in provider and organizational characteristics were selected across the health regions to participate in the study. Types of units included in the study were intensive care, medicine, surgery, and psychiatry. Individual, face-to-face, semi-structured interviews were conducted to gather information on enactment of nursing roles and perceived facilitators and barriers to maximizing scope of practice. A purposive volunteer sample of nursing personnel (e.g., RNs, LPNs, RPNs, and Patient Care Managers) and inter-professional healthcare team members were recruited on the study units. Patient interviews were also conducted with a small sample of volunteer patients from each health region to validate the extent to which patient experience reflected the expected focus of nursing defined in scope of practice documents. A total of 236
  • 27. interviews were audio-recorded and transcribed. There were 167 interviews conducted with nursing staff: 85 RNs, 31 LPNs, 11 RPNs, 19 patient care managers and assistant patient care managers, and 21 nurses in specialized roles (e.g., nurse educators and nurse clinicians). The remainder of the interviews were completed with other healthcare providers (e.g., physicians, social workers, and physiotherapists) and patients. The establishment of rigour in this study became a daunting task when a large number of nurses and other healthcare providers were interviewed to discuss enactment of scope of practice International Journal of Qualitative Methods 2012, 11(3) 249 of nurses and the influence of the work environment and other structures and processes on role enactment. Ensuring Trustworthiness of the Data
  • 28. Our study presented a myriad of challenges to ensure trustworthiness of the data. These challenges included collecting data from multiple sites using different research assistants, developing a process for analyzing the data, recruiting and retaining qualified individuals to complete coding and initial analysis, and completing in-depth analysis of the data. Despite the many challenges encountered while managing this large qualitative data set, we succeeded in reporting research results that met the criteria for data trustworthiness. The following sections of this article will outline the challenges and how they were addressed in handling the large amount of data collected in this study. Credibility or Authenticity First, participant recruitment was an important aspect to ensure credibility of research results. Participant selection required the incorporation of multiple perspectives (e.g., RNs, LPNs, managers, and interdisciplinary team members) to provide a clear and broad understanding of
  • 29. nurses’ and other healthcare providers’ perceptions of nursing scope of practice. Although participants volunteered to be interviewed, researchers facilitated a diverse range of perspectives by presenting in both posters and unit presentations the importance of capturing varied perception of scope of practice. Maximum variation (Polit & Hungler, 1999) was sought when recruiting units for the study. Variability in organizational characteristics, hospital intensity, and a variety of patient care units was desired (Aita & McIlvain, 1999; Morse & Richards, 2002). Once hospital units were selected, participants were recruited for interviews with attention to maximum variability in representing the various perspectives of nursing scope of practice. Given the geographical nature of the study, as well as the nature of the clinical environment, it was not possible to limit interviews to one unit with one group of providers at a single point in time. Rather, interviews were completed on various patient care units with a variety of providers in the same time frame, depending on their work schedules. Initially, both research assistants and
  • 30. several research team members were concerned that this process would result in more interviews being conducted because of the uncertainty about data saturation. However, bi-weekly discussions with interviewers confirmed that while they were hearing similar elements, data saturation had not been reached. The variability in units, desired variability in participants, and lack of data saturation until later in the study all led to the recruitment of a very large sample of participants for the study, which created a situation requiring the management of a large qualitative data set. Second, the consistency of data collection was important to ensure credibility of research results. Data collection was conducted across three health regions with multiple research assistants. Semi- structured interview questions focused on components of the overarching research questions and guided the interview process with nurses and interdisciplinary team members (Sandelowski, 2000). These interviews were conducted by three different research assistants. To standardize
  • 31. interview tracking and scheduling and the entry of demographic data, an Access TM database, along with a user manual detailing the process and technical applications, were provided to each study site. To further establish consistency in data collection (Aita & McIlvain, 1999; Morse & Richards, 2002), a two day training session was conducted by the project manager with the research assistants to discuss the interview protocol, review interview questions and cues, address the concept of data saturation, and discuss the purpose of writing brief field notes following interviews. A second component of the training session was the completion and review of several International Journal of Qualitative Methods 2012, 11(3) 250 interviews with each of the research assistants. Feedback about interviewing techniques (e.g., paraphrasing, clarity, utilization of cues for questions, and getting the interviewee to elaborate on
  • 32. their responses) was provided to each of the research assistants. At this time, research assistants also shared their experiences in completing the interview and provided valuable feedback contributing to the clarity of the interview questions and additional prompts for the questions. A training manual was also provided as a resource for the interviewers to complement training sessions. Given the magnitude of the study, research assistants were reminded to limit the number of interviews (3-4) completed in one day to avoid interviewer burden. Despite the focus on consistency of data collection, opportunity was provided through the field notes to co-author results as noted in Kvale (1996). Finally, presentations were made to participants to ensure the credibility and authenticity of the research results. Ten to fifteen presentations were made to various groups of participants (e.g., nurses, allied healthcare professionals, Patient Care Managers, senior health leaders, and Chief Nursing Officers) wherein results were validated by participants.
  • 33. Dependability and Transferability Data Processing and Cleaning Consistency between transcribers was ensured by utilizing a consistent template, which permitted easy transfer of documents into N6 TM , a computer program designed for qualitative data storage, indexing, and theorizing. Transcription guidelines to standardize expressions and formatting were provided to each transcriptionist. To ensure the accuracy of the transcription, each of the research assistants reviewed the transcripts while comparing them to audio files. Minor discrepancies, such as spelling errors and clarification of acronyms, were made in the transcripts following review by the research assistants. Data Analysis
  • 34. Preparation for the data analysis component of the study was intense, time consuming, and multi- focused. A phased approach (Gaskell & Bauer, 2000) was used in data analysis, with the completion of coding and initial analysis prior to in-depth analysis of the data. A conceptual framework was developed by the research team to begin a content analysis process. As an initial step in the development of the framework, two research team members and one research assistant independently reviewed four interviews to identify preliminary themes. The second step in the development of the framework was to have two of the original research team members and two new research team members independently analyze four new interviews utilizing the existing framework. With the analysis of this second set of interviews, consistencies were found in the themes identified between the team members. However, new themes also emerged resulting in an expansion of the conceptual framework. Miller and Crabtree (1992) have described this approach to content analysis as a “template” style (p.18). The conceptual framework served as the initial
  • 35. tree node structure to begin coding interviews in the N6 TM software program. As consistent with qualitative methods, the categories and nodes identified were not considered static. Several iterations of this conceptual framework and tree node structure evolved, particularly in the early stages of coding and analysis by the coders and the research team (Gaskell & Bauer, 2000). In developing the evolving tree, particular attention was paid to the semantic relationships of the parent and child nodes. A reference document defining each node and indicating placement in the hierarchy of the tree structure was developed and modified to reflect coding team discussions. This process assisted the dependability of the analysis of the International Journal of Qualitative Methods 2012, 11(3) 251 large data set, which occurred across multiple coders.
  • 36. Documentation of the changes and the rationale for changes were maintained to establish an audit trail (Lincoln & Guba, 1985). Recruiting and retaining qualified individuals to do coding and initial analysis was both an important and difficult task (Richards, 2005). Coders were recruited through the university and connections with other qualitative researchers. Coding was accomplished through collaboration and strengthened by the varying perspectives of multidisciplinary team members with backgrounds in clinical and academic nursing, psychology, social work, occupational therapy, and health services research. Most team members had previous qualitative research experience. A half day of training was provided to all coders with ongoing consultation and assistance provided by various members of the research team. Binders describing the technical aspects of N6 TM were developed for each coder. Initially the coders completed the coding of the same two interviews.
  • 37. Coding was compared and the coding tree was discussed. Early in the coding process weekly meetings were held with the coders; as the study progressed meetings were decreased to every two weeks. These meetings provided an excellent opportunity both to discuss the development of new themes and to question and confirm saturation of themes. In-depth analysis was completed by two experienced qualitative research team members with different healthcare backgrounds (nursing and occupational therapy). Analysis was completed by provider group; each researcher examined the data for specific groups of providers (e.g., RNs, LPNs, etc.). While each of the researchers examined descriptions of nursing scope of practice and barriers and facilitators to enactment of scope of practice, patterns across the data were also examined (Richards, 2005). Assigning data sets to different researchers (Gaskell & Bauer, 2000) was seen as an appropriate and manageable approach to in-depth data analysis of this large data set. Data overload, fatigue, and the potential for the researcher to “get lost in the data” posed real
  • 38. challenges for the analysis of the large amount of data collected for this study. Dedicating two researchers, who met and discussed regularly, to the process of in-depth analysis assisted in managing these challenges. Researchers frequently documented their processes and interpretations as memos directly in the software program. Summary analysis documents were also created for each of the data sets analyzed. Meeting regularly was also important in making meaningful sense of all the data in this study. Although N6 TM was an excellent program for organizing the qualitative data, challenges were encountered in merging projects between coders (initial analysis) and again between researchers once the in-depth analysis was completed. QSR Merge TM is designed to merge one project with another project, but with the coders and researchers each developing separate N6 TM
  • 39. projects (five different projects in total) merging was not seamless. Duplication of transcripts and codes required that one individual be associated with one transcript to prevent duplication in the final N6 TM for the complete analysis of all the data for the study. Although challenges were encountered in merging the projects, we were successful in creating one complete N6 TM project. Confirmability Confirmability (Guba, 1981; Johnson & Waterfield, 2004) of research results was ensured via four key processes: the creation of an audit trail; an internal audit; an external audit; and the writing of the final research report. Audit Trail
  • 40. A detailed, comprehensive accounting of all data collection and data analysis activities was completed. Changes were documented as they were made, along with rationale for the change. International Journal of Qualitative Methods 2012, 11(3) 252 Accurate and comprehensive records of the methods employed in data collection and analysis by researchers in the study were recommended by qualitative research experts (Lincoln & Guba, 1985; Sandelowski, 2000). Such audit trails provided not only a solid methodological reference for the reader, but also provided an opportunity for reflective reasoning (on the themes or categories chosen, interpretations, etc.) for the researchers as the study progressed (Guba, 1981; Johnson & Waterfield, 2004; Whittemore et al., 2001). For example, if methodology changed at some point in the study, an audit trail would keep a record of when, why, and what changes were implemented. Such audit trails became especially useful for managing large data sets and placing
  • 41. data, methodology, and interpretation within the particular context in which they belonged. Internal audit Internal audits of coding and themes for the study were completed at three different intervals (after 10, 25, and 45 interviews were coded) during the analysis of the study. The purposes of these audits were to assess inter-rater reliability and to determine similarities and differences in key themes identified by coders and auditors. Audits were conducted by three auditors, each members of the research team. The audit included interviews of nurses (RNs, RPNs, and LPNs), nurse managers, interdisciplinary team members, and patients. The sample of interviews was based on a stratified selection by profession, education, unit, and health region … Assignment: Final Project is on Netflix but you will incorporate Netflix company in this week learning. I will attach a couple articles on things learned this week, and you will answer questions below about this Assignment. Assignment should be 1.5-3 pages. ***This week you will continue to work on your Final Project,
  • 42. you will submit a business memo, written to your Instructor, that explains how you plan to incorporate your learning from the week into your Final Project. This will not be a "perfect" synopsis at this point, but it should capture the main themes and important ideas from the week. Your memo should include the following: · Your preliminary summary of how you are planning to incorporate this week’s learning into your Final Project · Your ideas and recommendations for how your organization can mitigate the short-term and long-term issues that can arise when selecting and using data resources and systems · Brief descriptions of the types of data resources, data processing, and storage systems chosen · An explanation of how the organization might manage the potential implications of those selections, while taking advantage of the opportunities they afford to sustain the business or gain a competitive advantage · Other relevant recommendations or issues that you identified, with a brief analysis of why they are important Note: If you are unable to find relevant information, you may want to look for similar information at /for other similar publically traded companies. You may find relevant information that will enable you to make appropriate inferences about your organization and make reasonable assumptions so you can proceed with your project. If you have questions about how to apply what you are learning or how to find the most relevant information for your organization’s needs, please discuss your choice with your Instructor using the Contact the Instructor link in the classroom. General Guidance on Assignment Length: Your Week 3 Assignment will typically be 1.5–3 pages (0.75–1 page(s) if single spaced), excluding a title page (not required for this Assignment) and references. As a best practice for this course, as you engage and complete your weekly activities, you will capture notes on your learning for each week and add them to your Final Project Portfolio,
  • 43. which you will use to formulate your Final Project. By the time you turn in your Final Project in Week 7, your working Final Project Portfolio document will contain your notes on the resources you found relevant in each week, as well as your ideas for how your organization can improve its business information systems management with respect to each week’s main themes. You should also include your analyses of the implications of your recommendations, as well as reasons why your recommendations are important. You will update your Final Project Portfolio each week. This week you are encouraged to begin setting up your presentation in PowerPoint. You should complete a title slide and 1–2 slides with your preliminary recommendations for your organization as they relate to this week’s learning. Note: Neither your Final Project Portfolio nor your preliminary slides will be submitted for grading this week. Final Project is on Netflix but you will incorporate Netflix company in this week learning. I will post a couple articles below on things learned this week, and you will answer questions above about this Assignment.