OBJECTIVE-To test Web-based care management of glycemic control using a shared electronic medical record with patients who have type 2 diabetes. RESEARCH DESIGN AND METHODS-We conducted a trial of 83 adults with type 2 diabetes randomized to receive usual care plus Web-based care management or usual care alone between August 2002 and May 2004. All patients had GHb Ն7.0%, had Web access from home, and could use a computer with English language-based programs. Intervention patients received 12 months of Web-based care management. The Web-based program included patient access to electronic medical records, secure e-mail with providers, feedback on blood glucose readings, an educational Web site, and an interactive online diary for entering information about exercise, diet, and medication. The primary outcome was change in GHb. RESULTS-GHb levels declined by 0.7% (95% CI 0.2Ϫ1.3) on average among intervention patients compared with usual-care patients. Systolic blood pressure, diastolic blood pressure, total cholesterol levels, and use of in-person health care services did not differ between the two groups. CONCLUSIONS-Care management delivered through secure patient Web communications improved glycemic control in type 2 diabetes.
Background: Patient-reported outcome (PRO) measures historically used in inflammatory bowel disease have been considered inadequate to support future drug labelling claims by regulatory agencies. Aims: To develop PRO tools for use in Crohn's disease (CD) and ulcerative colitis (UC) following guidance issued by the US FDA and the ISPOR (International Society for Pharmacoeconomics and Outcomes Research). Methods: Concept elicitation and cognitive interviews were conducted in adult patients (≥18 years) across the United States and Canada. Semi-structured interview guides were used to collect data, and interview transcripts were coded and analysed. Concept elicitation results were considered alongside existing literature and clinical expert opinion to identify candidate PRO items. Cognitive interviews evaluated concept relevance, interpretability and structure, and facilitated instrument refinement.Concept elicitation participants, except those with an ostomy, underwent centrally read endoscopy to assess inflammatory status.
Results:In all, 54 participants (mean age: 46.2 years; 66.7% female) were included in the CD concept elicitation interviews. In total, 80 symptom concepts and 61 impact concepts were identified. After three waves of cognitive interviews, the 31-item Symptoms and Impacts Questionnaire for CD (SIQ-CD) was developed. In the UC concept elicitation phase, 53 participants were interviewed (mean age: 41.4 years; 49.1% female). In total, 79 symptoms concepts and 49 impact concepts were identified. Following two waves of cognitive interviews, the 29-item Symptoms and Impacts Questionnaire for UC (SIQ-UC) was developed. Both instruments include four symptom and six impact domains.
Conclusions:We developed PROs to support CD and UC drug labelling claims.Psychometric validation studies to evaluate instrument reliability and responsiveness are ongoing.
Higher minimum wages may be associated with a reduced likelihood of experiencing unmet medical need among low-skilled workers, and do not appear to be associated with uninsurance. These findings appear to refute the suggestion that minimum wage laws have detrimental effects on access to health care, as opponents of the policies have suggested.
PURPOSE
To describe the process and results of the preliminary qualitative development of a new symptom-based PRO measure intended to assess treatment benefit in advanced non-small cell lung cancer (NSCLC) clinical trials.
METHODS
Individual qualitative interviews were conducted with adult NSCLC (Stage I–IV) patients in the US. Experienced interviewers conducted concept elicitation (CE) and cognitive interviews using semi-structured interview guides. The CE interview guide was used to elicit spontaneous reports of symptom experiences along with probing to further explore and confirm concepts. Interview transcripts were coded and analyzed by professional qualitative coders using Atlas.ti software, and were summarized by like-content using an iterative coding framework.
Data from the CE interviews were considered alongside existing literature and clinical expert opinion during an item-generation process, leading to development of a preliminary version of the NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ). Three waves of cognitive interviews were conducted to evaluate concept relevance, item interpretability, and structure of the draft items to facilitate further instrument refinement.
FINDINGS
Fifty-one patients (mean age 64.9 [SD=11.2]; 51.0% female) participated in the CE interviews. A total of 1,897 expressions of NSCLC-related symptoms were identified and coded in interview transcripts, representing approximately 42 distinct symptom concepts. A 9-item initial draft instrument was developed for testing in three waves of cognitive interviews with additional NSCLC patients (n=20), during which both paper and electronic versions of the instrument were evaluated and refined. Participant responses and feedback during cognitive interviews led to the removal of 2 items and substantial modifications to others.
IMPLICATIONS
The NSCLC-SAQ is a 7-item PRO measure intended for use in advanced NSCLC clinical trials to support medical product labelling. The NSCLC-SAQ uses a 7-day recall period and verbal rating scales. It was developed in accordance with the FDA’s PRO Guidance and scientific best practices, and the resulting qualitative interview data provide evidence of content validity. The NSCLC-SAQ has been prepared in both paper and electronic administration formats and a tablet computer-based version is currently undergoing quantitative testing to confirm its measurement properties and support FDA qualification.
Survey results identified constitutional symptoms of CLL included in existing PRO instruments and the literature. Although the findings suggest that qualitative data obtained through social media applications can be potentially useful in supporting concept identification for newly developed PRO instruments, they also indicate that online approaches alone may not be sufficient to achieve efficient and exhaustive concept elicitation. Further research is needed to identify whether the results can support content validity in the same way as established qualitative research methods.
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