Torsten Christensen

Qualitative research and content validity: developing best practices based on science and experience.

PurposeEstablishing content validity for both new and existing patient-reported outcome (PRO) measures is central to a scientifically sound instrument development process. Methodological and logistical issues present a challenge in regard to determining the best practices for establishing content validity.MethodsThis paper provides an overview of the current state of knowledge regarding qualitative research to establish content validity based on the scientific methodological literature and authors’ experience.ResultsConceptual issues and frameworks for qualitative interview research, developing the interview discussion guide, reaching saturation, analysis of data, developing a theoretical model, item generation and cognitive debriefing are presented. Suggestions are offered for dealing with logistical issues regarding facilitator qualifications, ethics approval, sample recruitment, group logistics, taping and transcribing interviews, honoraria and documenting content validity.ConclusionsIt is hoped this paper will stimulate further discussion regarding best practices for establishing content validity so that, as the PRO field moves forward, qualitative research can be evaluated for quality and acceptability according to scientifically established principles.

The Impact of Non-Severe Hypoglycemic Events on Work Productivity and Diabetes Management

OBJECTIVES Hypoglycemia is a common complication of treatment with certain diabetes drugs. Non-severe hypoglycemic events (NSHEs) occur more frequently than severe events and account for the majority of total events. The objective of this multi-country study was to identify how NSHEs in a working population affect productivity, costs, and self-management behaviors. METHODS A 20-minute survey assessing the impact of NSHEs was administered via the Internet to individuals (≥ 18 years of age) with self-reported diabetes in the United States, United Kingdom, Germany, and France. The analysis sample consisted of all respondents who reported an NSHE in the past month. Topics included: reasons for, duration of, and impact of NSHE(s) on productivity and diabetes self-management. RESULTS A total of 1404 respondents were included in this analysis. Lost productivity was estimated to range from

Psychological insulin resistance: patient beliefs and implications for diabetes management

15.26 to

Impact of nocturnal hypoglycemic events on diabetes management, sleep quality, and next-day function: results from a four-country survey.

93.47 (USD) per NSHE, representing 8.3 to 15.9 hours of lost work time per month. Among individuals reporting an NSHE at work (n = 972), 18.3% missed work for an average of 9.9 hours (SD 8.4). Among respondents experiencing an NSHE outside working hours (including nocturnal), 22.7% arrived late for work or missed a full day. Productivity loss was highest for NSHEs occurring during sleep, with an average of 14.7 (SD 11.6) working hours lost. In the week following the NSHE, respondents required an average of 5.6 extra blood glucose test strips. Among respondents using insulin, 25% decreased their insulin dose following the NSHE. CONCLUSIONS NSHEs are associated with substantial economic consequences for employers and patients. Greater attention to treatments that reduce NSHEs could have a major, positive impact on lost work productivity and overall diabetes management.

Utility values for symptomatic non-severe hypoglycaemia elicited from persons with and without diabetes in Canada and the United Kingdom

PurposeTo define and understand patient psychological insulin resistance (PIR) and its impact on diabetes management.MethodsSystematic literature review of peer-refereed journals using the MEDLINE database, including all articles in English from 1985 to 2007. The population included patients with type 1 and type 2 diabetes, insulin naïve, and those currently using insulin. A total of 116 articles were reviewed.ResultsPIR is impacted by patients’ beliefs and knowledge about diabetes and insulin, negative self-perceptions and attitudinal barriers, the fear of side effects and complications from insulin use, as well as lifestyle adaptations, restrictions required by insulin use, and social stigma. These etiological influences, both independently and in combination, constitute a patient’s PIR and may result in the reluctance of patients to both initiate and intensify treatment, leading to delayed treatment initiation and compromised glucose control.ConclusionsPIR is complex and multifaceted. It plays an important, although often ignored, role in diabetes management. Assisting health care professionals in better understanding PIR from the patient’s perspective should result in improved treatment outcomes. By tailoring treatments to patients’ PIR, clinicians may be better able to help their patients begin insulin treatment sooner and improve compliance, thus facilitating target glycemic control.

A nine country study of the burden of non-severe nocturnal hypoglycaemic events on diabetes management and daily function

Abstract Objectives: Non-severe nocturnal hypoglycemic events (NSNHEs) may have a major impact on patients. The objective was to determine how NSNHEs affect diabetes management, sleep quality, functioning, and to assess if these impacts differ by diabetes type or country. Methods: An internet survey to adults with diabetes in the US, UK, Germany, and France. Results: Of 6756 screened respondents, 1086 reported an NSNHE in the past month. For this last event, respondents with type 2 required significantly more time than type 1 to recognize and respond to the event (1.5 vs 1.1 hours), 25.7% (T1) and 18.5% (T2) decreased their normal insulin dose due to their most recent NSNHE. All respondents were likely to take 1–2 additional self-monitored blood glucose measurements on the day following. NSNHEs were associated with a high proportion of respondents contacting a healthcare professional (18.6% T1, 27.8% T2) reporting they could not return to sleep at night (13.3% T1, 13.4% T2), and tiredness on the day following the event (71.2% for both). Of the respondents working for pay, 18.4% T1 and 28.1% T2 reported being absent from work due to the NSNHE, and a substantial proportion of respondents (8.7% T1, 14.4% T2) also reported missing a meeting or work appointment or not finishing a task on time. Compared with other countries, respondents from France may experience a more substantial impact on diabetes management and daily functioning following an NSNHE. Potential limitations in this study include recall and selection bias; however, these biases are not believed to have impacted findings in any meaningful way. Conclusions: NSNHEs are associated with a substantial impact on diabetes management, sleep quality, and next-day functioning.

Understanding and assessing the impact of treatment in diabetes: the Treatment-Related Impact Measures for Diabetes and Devices (TRIM-Diabetes and TRIM-Diabetes Device)

ObjectiveTo elicit societal and patient utilities associated with diabetic symptomatic non-severe hypoglycaemia for three health states: 1) rare (quarterly), 2) intermittent (monthly), 3) and frequent (weekly) hypoglycaemia episodes.MethodsUsing validated health states, time trade-off utilities were elicited from 51 Canadian respondents with diabetes, and 79 respondents in Canada and 75 respondents in the United Kingdom (UK) without diabetes.Results and discussionEach hypoglycaemic episode was associated with a reduction in utility and persons with diabetes consistently reported slightly higher utility values than respondents without diabetes. The utility for diabetes without hypoglycaemia ranged from 0.88 to 0.97, the mean utility for rare hypoglycaemic events (quarterly) ranged between 0.85 and 0.94. The utility for the intermittent state (monthly) ranged from 0.77 to 0.90 and from 0.66 to 0.0.83 for the frequent state (weekly). Differences were observed between respondents without diabetes in Canada and the UK. Using a multivariate linear OLS regression, the estimated utilities associated with a single hypoglycaemic event were -0.0033 and -0.0032 for respondents with diabetes and without diabetes, respectively.ConclusionAmong respondents with and without diabetes, there was a demonstrable utility loss associated with hypoglycaemia. Considering a utility loss of 0.03 as a minimum clinically important difference for persons with diabetes, the evidence from this study indicates that as low as ten symptomatic non-severe hypoglycaemic episodes per year may be of clinical importance and that the importance increases with frequency of episodes. Integrating directly elicited utility values such as those reported here will improve the quality and applicability of economic evaluations of diabetes treatment.

Cost‐effectiveness of insulin degludec compared with insulin glargine for patients with type 2 diabetes treated with basal insulin – from the UK health care cost perspective

The purpose of this study was to explore the burden and impact of non‐severe nocturnal hypoglycaemic events (NSNHEs) on diabetes management, patient functioning and well‐being in order to better understand the role that NSNHEs play in caring for persons with diabetes and facilitate optimal diabetes treatment management strategies.

A comparison of health-related quality of life (health utility) between insulin degludec and insulin glargine: a meta-analysis of phase 3 trials.

PurposeDiabetes is a debilitating illness requiring lifelong management. Treatments can be varied in terms of mode of administration as well as type of agent. Unfortunately, most patient reported outcome measures currently available to assess the impact of treatment are specific to diabetes type, treatment modality or delivery systems and are designed to be either a HRQoL or treatment satisfaction measure. To address these gaps, the Treatment Related Impact Measure-Diabetes and Device measures were developed. This paper presents the item development and validation of the TRIM Diabetes/Device.MethodsPatient interviews were conducted to collect the patient perspective and ensure high content validity. Interviews were hand coded and qualitatively analyzed to identify common themes. A conceptual model of the impact of diabetes medication was developed and preliminary items for the TRIM-Diabetes/Device were generated and cognitively debriefed. Validation data was collected via an on-line survey and analyzed according to an a priori statistical analysis plan to validate the overall score as well as each domain. Item level criteria were used to reduce the preliminary item pool. Next, factor analysis to identify structural domains was performed. Reliability and validity testing was then performed.ResultsOne hundred and five patients were interviewed in focus groups, individual interviews and for cognitive debriefing. Five hundred seven patients participated in the validation study. Factor analysis identified seven domains: Treatment Burden, Daily Life; Diabetes Management; Psychological Health; Compliance and Device Function and Bother. Internal consistency reliability coefficients of the TRIM-Diabetes/Device ranged from 0.80 and 0.94. Test-retest reliability of the TRIM-Diabetes/Device ranged from 0.71 to 0.89. All convergent and known groups validity hypotheses were met for the TRIM-Diabetes/Device total scores and sub-scales.ConclusionValidation is an ongoing and iterative process. These findings are the first step in that process and have shown that both the TRIM-Diabetes and the TRIM-Diabetes Device have acceptable psychometric properties. Future research is needed to continue the validation process and examine responsiveness and the validity of the TRIM-Diabetes/Device in a clinical trial population.

Cost of Self-Monitoring of Blood Glucose in Canada among Patients on an Insulin Regimen for Diabetes

The aim of this analysis was to evaluate the cost‐effectiveness of insulin degludec (IDeg) versus insulin glargine (IGlar) in adults with type 2 diabetes mellitus (T2DM) who are considered appropriate for treatment with a basal insulin analogue, using a short‐term economic model.