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This thesis has used qualitative methodology, with the three studies underlying the five published

works all employing qualitative study designs (semi-structured interviews, case studies and narrative

literature review) and thematic analysis (method of analysis to report patterns within data; Merriam,

2002). The below describes the procedures employed and justification for their selection.

1.5.1 Qualitative methodology

A distinction is often made between qualitative and quantitative methodology. Qualitative

methodology is largely born out of social sciences (e.g., anthropology, sociology and clinical

psychology; Merriam, 2002) and associated with an interpretive/constructionist approach that accepts

the subjective acquisition of knowledge. In contrast, quantitative methodology is largely practiced in

the natural sciences and associated with a scientific/positivist approach that seeks to acquire objective

knowledge. There has however, been an increasing value placed upon employing qualitative methods

to study phenomena in the natural sciences (particularly in the medical and health care setting;

Greenhalgh 1997; Maleterud 2001a). In addition, that less emphasis should be placed on performing

scientific investigation from one or either paradigm; instead to accept that science, in practice, can

draw on multiple paradigms as illustrated by the below quote:

“…[a scientist] must appear to the systematic epistemologist as a type of unscrupulous

opportunist: he appears as realist insofar as he seeks to describe a world independent of the

acts of perception; as idealist insofar as he looks upon the concepts and theories as free

inventions of the human spirit (not logically derivable from what is empirically given); as

positivist insofar as he considers his concepts and theories justified only to the extent to

which they furnish a logical representation of relations among sensory experiences. He may

even appear a Platonist or Pythagorean insofar as he considers the viewpoint of logical

simplicity as an indispensable and effective tool of his research.”

Einstein, 1949.

A qualitative approach was considered appropriate in this thesis due to the complexity of the

phenomenon under study (micronutrient recommendation setting process) i.e., the number of

stakeholders, activities and contextual factors involved that were outside the control of the researcher

(Yin, 2003). Qualitative methods have been criticised for a lack of objectivity and reliability;

however, all of the available research methods to conduct qualitative or quantitative research have

limitations and if done correctly qualitative research is no less rigorous than correctly conducted

quantitative research (Black, 1994; Malterud, 2001a; Malterud, 2001b). Taking this into account, the

qualitative methodology and methods used in this thesis were considered appropriate to answer the

research questions in this thesis; the recognised strengths and weaknesses of this decision (including

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disclosure of how bias has been minimised or might influence the validity of findings) are discussed

in section 3.2 (Black, 1994; Breakwell, 1995; Mays, 1995).

1.5.2 Qualitative methods

The process of setting micronutrient recommendations has been a relatively inaccessible and under

researched area of study (Aggett, 2010). Consequently, qualitative case study, interview and narrative

review methods were utilised to study the multiple perceptions of the micronutrient risk analysis

process and understand the meaning of those perceptions that could help to answer the thesis research

questions. Bias in the form of subjectivity - from both the researchers and the participants of study -

was accepted as intrinsic to the research process, apparent throughout sampling, data collection and

analyses. This bias was minimised by acknowledgement that the thesis author’s perspective (personal

characteristics, ability to reflect on assumptions and view findings from alternative perspectives)

would be a component of the research; by detailed provision of the study method (context, sampling

strategies, ethical concerns, data collection/ processing/ analysis/ interpretation/synthesis); and by the

credible use of interview/text quotes when presenting results (Greenhalgh, 1997; O’Brien, 2014;

Tong, 2007). These principles were consistently applied via the use of thesis author designed

protocols to ensure the research was as robust as possible. This was particularly important due to the

collaborative nature of the data collected during study 1 and study 3 of this thesis. A number of

international partners, with varying degrees of qualitative or nutrition research experience, were

involved in collecting data relevant to their respective country/region’s micronutrient

recommendations. The above principles were enforced by regular communication to clarify research

questions and objectives (via a minimum of twice yearly face-to-face meetings; a face-to-face

qualitative training session; monthly phone meetings; and weekly e-mail contact, all organised, run

and led by the thesis author). Furthermore, sample selection for the interviews conducted in studies 1

and 3 was led by the thesis author. Information on the risk experts and stakeholders

responsible/involved in the micronutrient recommendation setting process across Europe was

gathered from previous research (de Wit, 2008; Dhonukshe-Rutten, 2013; Doets, 2008; Timotijevic,

2011; table 3) and collated to provide, for each country/ region, both a starting point and a suggested

boundary for sampling/interview recruitment. Any changes from the initial sampling strategy, such as

institutional changes in those responsible for setting recommendations were discussed and captured in

reporting. Stakeholders were originally classified into groups; however, the meaning of these different

stakeholder groups and their responsibility/involvement in micronutrient risk analysis varied across

countries (e.g., health professionals represented academics in countries which had less food/nutrition

academic representation). It was therefore, decided unsuitable to conduct analysis by stakeholder

group. Protocols also detailed the methods to be employed for data collection and analysis. Semi-

structure interviews were used in study 1 and 3 and these schedules were created by the thesis author

based upon preparatory research (Timotijevic, 2010; Timotijevic, 2011); literature reviews (both grey

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and white) and the specific research questions under study, in line with guidelines for establishing

interview schedules (Breakwell, 1996; Mays, 1995). The pre-set interview questions were developed

to encourage an in-depth exploration in areas of micronutrient risk analysis considered non-

transparent (e.g., ambiguity surrounding stakeholder involvement or how uncertain evidence is

considered).

Study 2 employed a narrative review method to explore the impact of recommendations regarding the

efficacy of FBDG. A systematic, meta-analysis literature review was not deemed appropriate for the

various quantitative, qualitative and mixed methodology research expected to be reviewed; due to the

variety of methods, study designs and potential few common variables to align analyses (Baumeister,

1997). Instead a narrative review was conducted using a theoretical framework of awareness,

understanding and use to capture and categorise findings (Grunert, 2007). In addition, the

methodological quality of the papers (and studies) reviewed were based on guidelines from

Greenhalgh et al. on assessing methodological quality of published papers, including judgement of

the study aim, purpose, method, design, theoretical framework, analysis, findings, discussion,

presentation and references (Greenhalgh, 1997).

Study 3 employed a case study method: collating a range of data from multiple sources, including

semi-structure interviews, desk research and direct observation (the latter, most relevant to the UK).

Case study research is often employed when conducting “empirical enquiry that investigates a

contemporary phenomenon within its real-life context” (Yin, 2003). This was therefore a suitable

method to study the challenge of transparently handling uncertain evidence during the development of

micronutrient recommendations. Three a priori areas were the focus of the case studies: i) the request

to develop DRV, e.g., the source of the request, scope the request and reasons for the request; ii) the

process of DRV evidence evaluation e.g., selection and evaluation of evidence; and iii) the integration

of evidence to develop final DRV e.g., formation of quantitative numbers and advisory committee

report. These areas were selected as relevant to the specific research question and were based upon

previous and preparatory research (Doets, 2008; Timotijevic, 2010; Timotijevic, 2011). The

advantage of using this case study method was the ability to use multiple sources to dispute or

corroborate findings and increase the validity of final interpretations (Yin, 2003). Interview

participants were selected using the recruitment strategy of study 1; however, only the risk experts

and stakeholders who had direct involvement in the micronutrient recommendation setting process

were targeted (as opposed to stakeholders involved to a lesser degree). Desk research was led by the

thesis author with suggested key word searches produced in English and amended by researchers in

each country/region. These case studies were used to describe and explore this area of nutrition

recommendation setting in different countries/regions where previously it had been demonstrated that

knowledge was limited (Aggett, 2010; Darke, 1998; Doets, 2008).

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1.5.3 Thematic analysis

The aim of thematic analysis is to categorise data and identify patterns/themes from which a

description can be derived to understand a situation (Joffe, 2004). This method of analysis was

selected as the most appropriate for the team of researchers who collected the data in each individual

country/region, whom had varying degrees of qualitative research experience. Thematic analysis is

not necessarily attached to any particular theory and this allowed the diverse research team an

accessible and flexible research tool that could “provide a rich and detailed, yet complex account of

data” (Boyatzis, 1998; Braun, 2006; Braun, 2012; Joffe, 2004). Alternative analysis approaches were

not deemed appropriate for this thesis, such as Interpretative Phenomenological Analysis (IPA),

which represents an individual perception of a situation (Smith, 2009) or discourse analysis, which

looks at a dialectic relationship between a producer and reader of text i.e., reconciling the difference

between these different perceptions (Wodak, 2008). IPA and discourse analysis would have required a

greater level of researcher qualitative experience, and potentially more time, than was available.

Furthermore, the idiosyncratic nature of IPA and the detailed attention to language required in

discourse analysis would have limited the ability to collate data and consider themes across the

multiple languages in the countries/regions and cases sampled.

The thematic analysis conducted in study 1 and 2 followed protocols developed by the thesis author.

This protocol, included a step by step approach to data analysis, emphasising the principles of

qualitative thematic research e.g., becoming familiar with the data; iteratively generating codes and

searching for themes; reflecting upon and challenging interpretations of the data (Boyatzis, 1998;

Braun, 2006; Braun, 2012; Joffe, 2004). The thesis author led the analysis strategy for both study 1

and 2, producing initial skeleton coding templates based upon the research questions under study

(similarly reflecting semi-structure interview schedules and desk-research literature searches) and

initial reviews of the data from the UK, Netherlands or Denmark/Nordic countries. Templates were

later modified by researchers in each country. Initial coding and theme development was conducted

by the researchers who collected the data, in their native language, to maintain the authenticity of data

interpretation. These, largely descriptive reports with initial themes and illustrative quotes in English

were then collated by the thesis author, who endeavoured to answer the research questions and

interpret, as well as, synthesise the data across interviews/cases from different countries/regions.

Ethical procedures were followed for all of the research underlying this thesis. The sample

participants were not considered to be from vulnerable populations; however, research was still

conducted in compliance with country specific data protection and ethical requirements. This included

the use of anonymous quotes and at times the removable of identifiable data, such as in study 3

(Brown, 2015) where stakeholder groups have not been disclosed to protect the anonymity of the

participants involved.

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Table 3 Type and nature of the body responsible for setting micronutrient recommendations

Country

Body responsible

Type of body

Inception

Australia & New

Zealand

Australian National Health and Medical Research Council (NHMRC); Australian

Department of Health and Aging (DOHA); New Zealand Ministry of Health (NZ

MOH)

Expert advisory committee and

governmental

*

Czech Republic

Ministry of Health, Department of Public Health; Scientific Committee for Food Governmental and working group

*

DA-CH countries

German Nutrition Society (DGE); Austrian Nutrition Society (OGE); Swiss

Society for Nutrition Research (SGE) and Swiss Nutrition Association (SVE)

Nutrition society

1992

Italy

Italian Society of Human Nutrition (SINU); National Research Institute on Food

& Nutrition (INRAN)

Nutrition society (scientific with

links to governmental bodies)

1977

Netherlands

Ministry of Health; Health Council of the Netherlands (HCN)

Governmental and independent

scientific advisory body

1992

Nordic countries

Nordic Committee of Senior Officials on Food Issues, EK-Livs.; Working Group

on Diet & Nutrition (NKE)

Project group nominated by NKE

2000

Poland

Ministry of Health; National Food & Nutrition Institute, Warsaw

Governmental

1963

Serbia

Ministry of Labour and Social Policy

Governmental and expert group

*

Spain

Madrid University; Spanish Society of Community Nutrition (SENC)

Expert group and nutrition society *

UK (Department of

Health devolved to each

region)

Department of Health; Scientific Advisory Committee on Nutrition (SACN)

(previously Committee on Medical Aspects of Food & Nutrition Policy, COMA)

Governmental and advisory

committee of independent experts

1991

*: information was not provided; DA-CH countries: Germany, Austria, Switzerland; Nordic countries: Denmark, Finland, Iceland, Norway, Sweden

Adapted from de Wit et al. Inventory of currently used methods for defining and applying micronutrient recommendations in Europe. A EURRECA report for

RA1.3-2, 2008

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2 SUMMARY OF PUBLISHED WORKS FORMING THESIS

In document PROPUESTA DE MEJORAMIENTO PRODUCTIVO PARA UNA EMPRESA DE LA INDUSTRIA PANIFICADORA WHANDA SCHENEIDER BOLAÑOS PADILLA VANESSA ORDOÑEZ REBOLLEDO (página 25-0)