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Chapter 3 Methodology
Introduction
The three studies comprising this research project reside in the domain of health research within the medical branch of SLP. Health research focuses on resources necessary to provide evidence-based health services (Shi, 2007). A novel clinical assessment instrument in neonatal dysphagia would be considered a resource that can potentially contribute to evidence-based services to neonates. The project also linked to applied research (Meline, 2010) conducted for the purpose of improved understanding of the clinical process of assessment and reliable diagnosis of neonatal dysphagia. Applied research may contribute more than basic research to the medical SLP community involved in evidence-based practice in neonatal health services (Meline, 2010).
Aims of the study
Main aim
The main aim of the study was to develop and test the psychometric performance of a clinical assessment scale for the identification and diagnosis of OPD in the high-risk neonatal population in South Africa.
Aims and objectives
To meet the main aim the research project was divided in three separate studies:
Study 1: The aim was to develop and validate the content of a novel clinical feeding assessment scale to identify and diagnose OPD in neonates. The objectives to support the aim were, a) to determine if the panel of experts agreed about the need for a validated clinical feeding assessment scale, to b) select appropriate items for inclusion in the NFAS, and to lastly c) establish face and content validity of the NFAS based on expert input.
Study 2: The aim for the second study was to determine the preliminary psychometric performance of the NFAS to identify OPD in a small sample of neonates. The objectives were to determine the sensitivity, specificity, accuracy and predictive values of the NFAS, in comparison to the MBSS and to verify inter-rater reliability.
Study 3: Based on the promising performance of the NFAS on a small sample, the aim of the third study was to determine the validity and reliability of the NFAS in comparison to the MBSS in a larger sample. To achieve this aim, the objectives were to, a) describe the diagnostic outcomes of the participants on the MBSS and the NFAS, and b) to determine the specificity, sensitivity, accuracy and predictive values of the NFAS to establish criterion validity. The final objective was, c) to determine the inter-rater reliability of the NFAS.
Research design
The research design consolidating the three studies was an exploratory sequential mixed method design (Creswell, 2014). Although Creswell (2014) initially developed the exploratory sequential mixed method design as a two phase model from a social research perspective, it was considered useful for the purpose of combining a qualitative and quantitative phase of research in the domain of health research. Such cross-field application of a social research design used in health research can add value to a study (Shi, 2007).
An exploratory sequential approach starts with a qualitative phase followed by a quantitative phase and has also been referred to as an ‗instrument development design‘ (Creswell, 2014; Creswell & Plano Clark, 2011). The instrument is mainly developed based on the results of the qualitative phase and then administered to a sample of participants to obtain quantitative data, as was done in this study. The main benefit of this design is that it is suitable for developing and testing a new instrument if no other instrument to investigate or measure phenomena is currently available.
Study 1: Delphi method design
In study 1 the Delphi method (Okoli & Pawlowski, 2004) represented the qualitative phase used to develop the NFAS. The Delphi review process considered systematically obtained expert judgements of whether the newly developed assessment instrument represented all facets of the concept under consideration, in this case neonatal feeding skills. The primary strength of the Delphi method was the independent exploration of the content and scoring of the instrument that required external judgment (Du Plessis & Human, 2007).
The Delphi method is a survey technique consisting of more than one stage to facilitate a group‘s communication about the review of a complex construct (De Villiers, De Villiers, & Kent, 2005; Du Plessis & Human, 2007; Hassan, Keeney, & McKenna, 2008; Okoli & Pawlowski, 2004). The Delphi method‘s scientific merit has also been established in the South African research context in the field of nursing practice (De Villiers et al., 2005) and in the international arena of health research (Hassan et al., 2008).
Study 2 and 3: Cross-sectional comparative within-subject design
Study 2 and 3 represented the quantitative phase utilizing a cross-sectional comparative within-subject design (Irwin, Pannbacker, & Lass, 2008) to determine the psychometric performance of the NFAS in comparison to the MBSS, and establish the reliability and validity of the NFAS. The NFAS and MBSS results were compared specifically regarding outcome for diagnosis of OPD. In a comparative within-subject design all participants undergo all research procedures and statistical analysis for determining reliability and validity can be used (Irwin et al., 2008).
Ethical considerations
The approval of the Research and Ethics Committee of the Faculty of Humanities, University of Pretoria and the approval of the Medical Research Ethics Committee of the Gauteng Department of Health, was obtained prior to the commencement of the study – see Appendix A. The chief executive officer of the academic hospital serving as research site in Gauteng granted permission to conduct the study.
In health research the Declaration of Helsinki (World Medical Association [WMA] Declaration of Helsinki Working Group, 2013) and ethical research guidelines (De Vos, Delport, Fouche & Strydom, 2011) provided principles for the researcher to conduct ethical research involving human participants. Neonates with OPD are considered a vulnerable population since the most severe consequence of OPD may be death, therefore ethical decision making and consideration in the research process should be strictly implemented.
The following ethical principles were adhered to:
Malfescence and beneficence (WMA Declaration of Helsinki Working Group,2013):
This ethical principle ensured protection against harm for participants guiding the researcher to act in the best interest of the participants (De Vos et al., 2011). Due to the advancement of life-saving medical technology in the NICU context more high-risk neonates are surviving, but problems such as OPD are now emphasized. It is thus the researcher‘s responsibility to adhere to research ethics when developing new tools for practice to improve quality of life.
Study 1: Participation in this study was not harmful to the expert panel members. Their ideas were not judged by others, thereby lessening possible intimidation to participate.
Study 2 and 3: During the clinical assessment of the neonate due precautions for safety had been taken to prevent any harm to the participants. The participant‘s treating physician gave consent that the neonate was medically stable to undergo a clinical and instrumental feeding assessment. Participants were assessed in a developmentally supportive position in the cot/incubator and on the parent‘s lap to prevent undue discomfort and distress during clinical assessment. The risk of radiation exposure during instrumental assessment was explained to the parents together with the safety of the MBSS procedure (Brenner & Hall, 2007; Hiorns & Ryan, 2006). Relevant feeding treatment options were discussed with the parents after clinical and instrumental assessment was completed. The discussion was non-discriminatory to refer the neonate and family to appropriate professional services such as speech-language therapy, occupational therapy and gastroenterology in the hospital.
Confidentiality (WMA Declaration of Helsinki Working Group, 2013):
The researcher had an obligation to the participants to maintain confidentiality to protect personal information (De Vos, et al., 2011). The identities of the participants were known to the researcher. The researcher respected the participants by also informing them of their right to withdraw from the study without any negative consequences.
Study 1: The panel members were blinded to each other‘s identities and their identities were only known to the researcher. Participants provided opinions to the researcher only, who integrated responses as that of the group and not of individual participants, to allow open participation.
Study 2 and 3: No personal information of the mothers or the neonates was disclosed. A number was allocated to each infant participant‘s documentation to allow anonymity throughout the research process. Information was kept confidential at all times during the research process. Data are securely stored in the Department of Speech-Language Pathology and Audiology at the University of Pretoria, where it will remain for 15 years.
Informed consent (WMA Declaration of Helsinki Working Group, 2013):
To enable participants to provide informed consent all relevant information regarding the aims and objectives of the research, the procedures that the participants would have undergone, the possible advantages and disadvantages and safety issues, as well as the credibility and competence of the persons performing the research were disclosed (De Vos et al., 2011).
Study 1: The expert panel member participants provided informed consent to form part of the panel – see Appendix B for Information leaflet.
Study 2 and 3: The mothers of the high-risk neonates were approached in the NICU to give informed consent to participate in the study. A Parent information leaflet – see Appendix C – was provided in English, Afrikaans and Setswana (the three major languages spoken in the city where the study was conducted) to explain the purpose and nature of the study. An interpreter was used with four mothers who were illiterate and verbal consent was obtained from each.
Justice (WMA Declaration of Helsinki Working Group, 2013):
Just treatment of participants during the research process should be implemented at all times (WMA Declaration of Helsinki Working Group, 2013).
Study 1: The researcher only selected expert panel members who were recognized as experts in the field of paediatric dysphagia, as evidenced by peer-reviewed publications, post-graduate qualifications and a minimum of five years clinical experience.
Study 2 and 3: All parents of neonates in the NICU at the research site were approached to participate in the study if the treating physician declared their infant to be stable to undergo the research procedures. All neonates meeting the inclusion criteria were enrolled in the study. The clinical feeding assessment was within the scope of practice of the researcher and data collectors, who were all registered with the Health Professions Council of South Africa (HPCSA). The researcher ensured that the data collectors were skilled in clinical and instrumental assessment of high-risk neonates.
Truthful (WMA Declaration of Helsinki Working Group, 2013):
A researcher is expected to act truthfully in disclosing results and when acknowledging resources and persons who consulted and collaborated on the project (De Vos et al., 2011).
The research results were disclosed in the format of a dissertation and two published and one submitted articles in accredited, peer-reviewed scientific journals. All references and sources were acknowledged through the appropriate citation method required for the dissertation and the individual journals. Acknowledgement of contribution to the research study was done by granting co-author status and special acknowledgement in Article 3 for consultation (study 3). A plagiarism declaration was included in the dissertation stating that the study contained original work by the researcher to fulfil doctoral degree purposes at the University of Pretoria.
Acknowledgements
Research outputs and awards
Abstract
Keywords
List of abbreviations
List of figures
List of tables
Declaration
PART I: Introduction, theoretical perspectives and methodology
Chapter 1 Introduction
1.1. Introduction
1.2. Neonatal dysphagia assessment in the South African context – problem statement, rationale and research questions
1.3. Roadmap for the thesis
1.3.1. Terminology as used in the thesis
1.3.2. Outline of the chapters for the thesis
1.4. Summary
Chapter 2 Theoretical perspectives on neonatal dysphagia and clinical assessment of OPD
2.1. Introduction
2.2. Typical development of feeding skills
2.3. The complexity of neonatal dysphagia
2.4. The influence of OPD on neonatal physiology and development
2.5. Theoretical framework underpinning the Neonatal Feeding Assessment Scale
2.6. A speech-language pathology perspective on the assessment of neonatal dysphagia in South Africa
2.7. Summary
Chapter 3 Methodology
3.1. Introduction
3.2. Aims of the study
3.2.1. Main aim
3.2.2. Aims and objectives
3.3. Research design
3.3.1. Study 1: Delphi method design
3.3.2. Study 2 and 3: Cross-sectional comparative within-subject design
3.4. Ethical considerations
3.5. Participants
3.5.1. Sampling method
3.5.2. Sample size
3.5.3. Participant selection criteria
3.5.4. Participant description
3.6. Material and apparatus
3.7. Procedures
3.7.1. Overview of the procedures followed in the development of the NFAS
3.7.2 Specified procedures followed in each study
3.8. Data analysis
3.9. Reliability and validity
3.10. Summary
PART II: Published and submitted papers
Chapter 4 Development of a clinical feeding assessment scale for neonates in South Africa
Abstract
Introduction
Method
Aims
Design
Participants
Materials
Procedures
Data analysis
Results
Objective A: Determining agreement on the need for a validated feeding assessment instrument
Objective B: Content and item selection for the NFAS
Objective C: Face and content validity of the final version of the NFAS
Discussion
Need for the NFAS
Development, face- and content validity of the NFAS
Outcome of the Delphi-process
Conclusion
Reference list
Chapter 5 Preliminary psychometric performance of the Neonatal Feeding Assessment Scale
Abstract
Introduction
Methods
Aims and objectives 13
Design
Participants
Materials
Procedures
Data analysis
Results
NFAS results
Criterion validity
Sensitivity and specificity
Predictive diagnostic ability of the NFAS
Diagnostic accuracy of the NFAS compared to MBSS
Inter-rater reliability
Discussion
Criterion validity
Inter-rater reliability
Scoring criteria
Conclusion
References
Chapter 6 Validity and reliability of the Neonatal Feeding Assessment Scale
Abstract
Introduction
Methods
Objectives
Design
Participants
Material
NFAS structure, rationale for inclusion of sections and scoring
MBSS material and apparatus
Procedures
Data analysis
Results
MBSS results
NFAS results
Comparative results of the NFAS and the MBSS
Validity
Reliability
Discussion
Validity and reliability of the NFAS in comparison to MBSS
Clinical use of NFAS
Conclusion
Appendix A Examples of items from the NFAS
References
PART III: Conclusion and future perspectives
Chapter 7 General conclusions, implications and future perspectives
7.1. Introduction
7.2. Study 1 Development of a clinical feeding assessment scale for neonates in South Africa – Implications for theory and practice
7.3. Study 2 Preliminary psychometric performance of the Neonatal Feeding Assessment Scale – Implications for theory and practice
7.4. Study 3 Validity and reliability of the Neonatal Feeding Assessment Scale – Implications for theory and practice
7.5. Critical review of the study
7.6. Recommendations for research
7.7. Future perspectives on neonatal dysphagia in South Africa
7.8. Conclusion
References
Appendices
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