The Role of Philosophical Tools in Nursing Research.

The objective of this article is to illustrate the importance of the role philosophy and its tools play in the designing and undertaking of nursing research and its importance to be understood by the practicing researcher to ensure the selected methodology and the tools used provide the framework for obtaining reliable and valid answers to their research questions. The article discusses the three major paradigms (Positivism, Interpretivism, and Pragmatism) which have characterized much of health-related research together with a set of essential and practical tools with no metaphysical assumptions that will hopefully provide an explicit framework and a nomenclature which can be applied as we proceed through the research process.

Phenomenology: A Method for the Interpretation of Patient-Reported Outcomes.

Patient-reported outcome measures (PROMs) play a central role in clinical research and patient care resulting in a plethora of standardized PROMs to measure a range of constructs, including disease symptoms, health-related quality of life, and health status (Meadows/Reaney) used in a range of settings, including the nursing environment. However, the use of PROMs in drug development and their use in healthcare evaluation do not easily marry together. In drug development, standardization of measurement is key to the interpretation of the formation at a population level with minimal biases. However, in health care, the individual patient perspective, priority, and needs should be taken into account whereas, in the clinical encounter, one has to also deal with what is particular and unique. The purpose of this paper is to describe the characteristics of the phenomenological method as a means within a mixed-method framework, to supplement participants' patient-reported outcome numeric scores with a more in-depth commentary on the essence of the lived health experiences.

Story completion (SC) - an epistemological approach to the interpretation of patient-reported outcomes?

INTRODUCTION: Patient-reported outcome measures (PROMs) quantitative data are increasingly accompanied by qualitative narrative data, which does not always provide the insights required to inform healthcare. AREAS COVERED: This perspective considers how story completion (SC) may be used to gain a deeper insight on people's experiences and guide interpretation of the meaning of PROM responses. EXPERT OPINION: Story completion (SC) is an epistemological approach involving participants telling a story in response to a pre-determined 'stem' they have been presented with.

A patient-centred conceptual model of nocturnal scratch and its impact in atopic dermatitis: A mixed-methods study supporting the development of novel digital measurements.

Background: Emerging digital measures and clinical outcome assessments (COAs) leveraging digital health technologies (DHTs) could address the need for objective, quantitative measures of symptoms of atopic dermatitis (AD), such as nocturnal scratching. Development of such measures needs to be supported by evidence reflecting meaningfulness to patients. Objectives: To assess nocturnal scratching as a concept of interest associated with meaningful aspects of health of patients with AD (adults and children); and to explore patient-centred considerations for novel COAs measuring nocturnal scratch using DHTs. Methods: Phase 1 evaluated disease impacts on everyday life and the lived experience with nocturnal scratching through qualitative interviews of AD patients and caregivers. Phase 2 deployed a quantitative survey to a sample of AD patients as well as caregivers. Results: Four cohorts with various AD severity levels participated in Phase 1: (1) adults with AD (n = 15), (2) their caregivers/spouses/partners (n = 6), (3) children with AD (n = 14), and (4) their adult caregivers (n = 14). Findings were used to develop a conceptual model for nocturnal scratching as a potential concept of interest. The Phase 2 survey was completed by 1349 of 27640 invited adults with AD and caregivers of children with AD. The most burdensome aspects of AD reported were itchy skin and scratching. Overall, ∼65% of participants reported nocturnal scratching ≥1 day/week, resulting in ∼1-1.4 h of sleep lost per night. In all, 85%-91% of respondents considered it at least somewhat valuable that a treatment reduces night-time scratching. About 50% reported willingness to use technology to this end and ∼25% were unsure. Conclusion: Our results represented by the conceptual model confirm that nocturnal scratch is a concept of interest related to meaningful aspects of health for patients with AD and therefore is worth being captured as a distinct outcome for clinical and research purposes. DHTs are suitable tools presenting an important measurement opportunity to assess and evaluate occurrence, frequency, and other parameters of nocturnal scratching as a disease biomarker or COA of treatment efficacy.

A philosophical perspective on the development and application of patient-reported outcomes measures (PROMs).

Questionnaires are a common method in healthcare and clinical research to collect self-reported data on patients' behaviour and outcomes rather than the clinician's perspective. As a consequence there is a plethora of questionnaires and rating forms developed to measure a range of concepts such as health-related quality of life and health status. Given that these measures have been developed within a nomothetic paradigm to enhance our understanding of peoples self-perceived health status by translating complex personal feelings and experiences into a simple numeric score, the patient's illness narrative is lost along the way. This commentary discusses the limitations of the nomothetic approach as completion of a questionnaire is a social and contextually orientated activity and that their development is best viewed within the philosophical tradition of pragmatism, based on sound qualitative methods and rigorous psychometric testing. The commentary discusses the philosophical orientation underpinning PROM development and argues the case for a pragmatic epistemology based on a mixed methods research paradigm which goes beyond the current practice of informing the content validity of a PROM in the early phase of its development but to work towards developing a more composite and holistic picture through mixed methods in the interpretation of a patient's PROM score. Therefore, it is argued that the quality of data obtained will be enhanced but, also importantly and rightly places the participant at the centre of the research.

Patient-reported Outcome Measures - A Call for More Narrative Evidence.

This article puts forward the need to reconsider the current underlying quantitative approach underpinning the application of patient reported outcomes, to a mixed methods approach through the tandem use of patients' narrative that enables informants in addition to their scores to express the reality of the ways in which their lives are physically and mentally impacted by their health status.

The construct validity and responsiveness of the EQ-5D, SF-6D and Diabetes Health Profile-18 in type 2 diabetes.

BACKGROUND: Interest in the measurement of health related quality of life and psychosocial functioning from the patient's perspective in diabetes mellitus has grown in recent years. The aim of this study is to investigate the psychometric performance of and agreement between the generic EQ-5D and SF-6D and diabetes specific DHP-18 in Type 2 diabetes. This will support the future use of the measures by providing further evidence regarding their psychometric properties and the conceptual overlap between the instruments. The results will inform whether the measures can be used with confidence alongside each other to provide a more holistic profile of people with Type 2 diabetes. METHODS: A large longitudinal dataset (n = 1,184) of people with Type 2 diabetes was used for the analysis. Convergent validity was tested by examining correlations between the measures. Known group validity was tested across a range of clinical and diabetes severity indicators using ANOVA and effect size statistics. Agreement was examined using Bland-Altman plots. Responsiveness was tested by examining floor and ceiling effects and standardised response means. RESULTS: Correlations between the measures indicates that there is overlap in the constructs assessed (with correlations between 0.1 and 0.7 reported), but there is some level of divergence between the generic and condition specific instruments. Known group validity was generally good but was not consistent across all indicators included (with effect sizes from 0 to 0.74 reported). The EQ-5D and SF-6D displayed a high level of agreement, but there was some disagreement between the generic measures and the DHP-18 dimensions across the severity range. Responsiveness was higher in those who self-reported change in health (SRMs between 0.06 and 0.25). CONCLUSIONS: The psychometric assessment of the relationship between the EQ-5D, SF-6D and DHP-18 shows that all have a level of validity for use in Type 2 diabetes. This suggests that the measures can be used alongside each other to provide a more holistic assessment of with the quality of life impacts of Type 2 diabetes.

Patient-reported outcome measures: an overview.

With the increasing prominence of the patients' involvement in the care they receive, the assessment of outcomes based on the patient's perspective using patient-reported outcome measures (PROMs), are increasingly accompanying the traditional clinical ways of measuring health and the effects of treatment on the patient. This article provides an overview as to what PROMs are and the different health constructs they are purported to measure. Differences between generic and disease-specific, multidimensional and index scored PROMs are also described. Factors relating to the choice of a PROM are discussed with a particular focus on the importance of developing a measurement strategy and endpoint model to ensure the appropriate PROM is selected to measure the desired outcome. Examples of the application of PROMs are given together with some of the methodological approaches to interpreting PROM data. Finally, issues on maximizing the benefits of using PROMs are briefly discussed.

Factors associated with psychological and behavioral functioning in people with type 2 diabetes living in France.

BACKGROUND: To identify demographic and clinical factors associated with psychological and behavioral functioning (PBF) in people with type 2 diabetes living in France. METHODS: In March 2002, approximately 10,000 adults, who had been reimbursed for at least one hypoglycemic treatment or insulin dose during the last quarter of 2001, received a questionnaire about their health status and PBF (3,646 responders). For this analysis, the 3,090 persons with type 2 diabetes, aged 18-85 years old were selected.PBF was measured with the adapted version of the Diabetes Health Profile for people with type 2 diabetes. This permitted the calculation of three functional scores - psychological distress (PD), barriers to activity (BA), and disinhibited eating (DE) - from 0 (worst) to 100 (best). RESULTS: Major negative associations were observed with PBF for microvascular complications (a difference of 6.7 in the BA score between persons with and without microvascular complications) and severe hypoglycemia (difference of 7.9 in the BA score), insulin treatment (-8.5 & -9.5 in the PD & BA scores respectively, as compared to treatment with oral hypoglycemic agents), non-adherence to treatment (-12.3 in the DE score for persons forgetting their weekly treatment), increasing weight (-8.5 & -9.7 in the PD & DE scores respectively, as compared to stable weight), at least one psychiatrist visit in 2001 (-8.9 in the DE score), and universal medical insurance coverage (-7.9 in the PD score) (due to low income). CONCLUSION: Prevention and management of microvascular complications or adherence to treatment (modifiable factors) could be essential to preserving or improving PBF among people with type 2 diabetes. A specific approach to type 2 diabetes management may be required in groups with a low socioeconomic profile (particularly people with universal medical insurance coverage), or other non modifiable factors.

Development and validation of the insulin treatment satisfaction questionnaire.

BACKGROUND: Treatment of diabetes mellitus (DM) is complex, requiring multifaceted lifestyle change or regulation and, for many, self-regulation of insulin levels in the blood. Historically, daily insulin treatment has been viewed as burdensome to patients, prompting newer formulations and improved delivery methods. OBJECTIVE: This multicenter, clinical study was designed to develop a conceptually sound, clinically meaningful, and psychometrically valid measure of insulin treatment satisfaction, applicable to a wide range of insulin therapies. METHODS: A 3-phase iterative process was employed to develop and validate the Insulin Treatment Satisfaction Questionnaire (ITSQ): (1) conceptual development of items, (2) preliminary validation among patients with DM, and (3) confirmatory validation among patients with DM. RESULTS: The ITSQ was validated with 170 patients in phase 2 and 402 patients in phase 3. Confirmatory factor analysis produced a 5-factor, 22-item instrument assessing regimen inconvenience, lifestyle flexibility, glycemic control, hypoglycemic control, and satisfaction with the insulin delivery device. Results for reliability and construct validity of the final version were consistent in both samples of patients treated with insulin, with different data collection methods. Internal consistency (using Cronbach alpha coefficient) of the subscales ranged from 0.79 to 0.91. Test-retest reliability (using Spearman rank correlation coefficients) ranged from 0.63 to 0.94. ITSQ scores showed moderate to high correlation with related measures of treatment burden. The ITSQ differentiated among insulin delivery methods, glycosylated hemoglobin values, the number of times the patient required assistance administering insulin, and insulin adherence. CONCLUSION: In our study samples, the ITSQ appeared to be conceptually and psychometrically sound and applicable to a wide range of insulin therapies.

So you want to do research? 6: Reporting research.

This last article of the series reviews some of the key issues that need to be considered when preparing your research findings for dissemination. Dissemination is an integral part of the research process and this article outlines some of the initial steps that need to be taken, including the establishment of agreements between authors. The importance of writing for a specific audience and how this determines the content of the report is then discussed. An overview together with guidelines on how to report qualitative and quantitative research is presented. General guidance on the choice of title, writing an abstract, listing references and acknowledgements are discussed. The article concludes with an outline of some of the key criteria editors use when reviewing a paper for publication.

So you want to do research? 4: An introduction to quantitative methods.

This fourth article of a series of six focuses on some of the key aspects of quantitative research methods. Starting with a review of what quantitative research is, the distinguishing characteristics of experimental and non-experimental research strategies, the different approaches for collecting data including self-completion questionnaires, interviews and scales, together with their respective strength and weaknesses are discussed. The differences between probability and non-probability sampling and the different methods for selecting a sample are described. Aspects of quantitative data analysis are briefly reviewed and the concepts of reliability and validity are described in the context of ensuring rigour in the research design. Finally, some guidance on the reporting the findings from quantitative research is provided.

So you want to do research? 5: Questionnaire design.

This article describes the key aspects in the design, construction and adaptation of survey questionnaires. There are different types of questionnaire, each of which has its advantages and disadvantages. Aspects of constructing the questionnaire are discussed in detail; choosing the mode of administration; the objectives of the survey; availability of resources; characteristics of the target population; and quality of data. Issues concerning the identification of the questionnaire's content, wording and sequencing of the questions through to the overall appearance and layout of the questionnaire are also considered. Differences in the role of open-ended and closed questions, together with their strengths and weaknesses, are outlined, and the need to undertake pre-testing and piloting as an integral part of questionnaire development is highlighted. Finally, issues around the adaptation of existing questionnaires are discussed with particular emphasis on their use in different language and cultural groups, and the need to achieve conceptual, content, semantic, operational and functional equivalence is described. An overview of the translation process is provided.

So you want to do research? 3. An introduction to qualitative methods.

This article describes some of the key issues in the use of qualitative research methods. Starting with a description of what qualitative research is and outlining some of the distinguishing features between quantitative and qualitative research, examples of the type of setting where qualitative research can be applied are provided. Methods of collecting information through in-depth interviews and group discussions are discussed in some detail, including issues around sampling and recruitment, the use of topic guides and techniques to encourage participants to talk openly. An overview on the analysis of qualitative data discusses aspects on data reduction, display and drawing conclusions from the data. Approaches to ensuring rigour in the collection, analysis and reporting of qualitative research are discussed and the concepts of credibility, transferability, dependability and confirmability are described. Finally, guidelines for the reporting of qualitative research are outlined and the need to write for a particular audience is discussed.

So you want to do research? 2: developing the research question.

The development of the research question for a study can be where a lot of research fails. Without a well-defined and specific research question or hypothesis, findings from the research are unlikely to tell us very much. Developing a tightly focused research question or hypothesis defines how and what data is collected and analysed and provides a context for the results. This article, the second in a series of six, focuses on the process of developing a research question or hypothesis from the initial idea through to the final research question, using examples to illustrate the key principles. Approaches to reviewing the literature, including hand searching and the use of electronic sources, are described together with their different strengths and weaknesses. An overview of the deductive and inductive approaches to research are described, as well as the underlying rationale of the null hypothesis and one and two-tailed tests. Finally, issues around the feasibility of the study, including cost, time and relevance, are discussed in relationship to developing the research question or hypothesis.

So you want to do research? 1: an overview of the research process.

Relative to some other health care professionals, nursing has an immature research tradition as well as a limited body of research-based knowledge to draw on. Nevertheless, research is important to the nursing profession which over the past 15 years has increasingly had pressure placed on it to be more accountable for its actions. Research is also important so as to answer specific and broader clinical questions. This article, the first in series of seven, is aimed to provide novice researchers with an overview of the research process, with a specific focus on developing the research question, undertaking a review of the literature, describing the different research methodologies, sample size, data collection methods and analysis. Different approaches for ensuring more effective dissemination of research findings to different audiences are also briefly discussed.