Psychometric testing of two new patient-reported outcome instruments for the evaluation of treatment for hypogonadism.

AIM: The aim of this study was to perform psychometric testing and estimate minimal important change (MIC) of two new patient-reported outcome (PRO) instruments - Sexual Arousal, Interest and Drive Scale (SAID) and Hypogonadism Energy Diary (HED). METHODS: New PRO instruments were administered immediately after screening (Time 1, test-retest subset only) and immediately prior to both randomisation (Time 2) and end-point (Time 3) to men participating in a randomised clinical trial comparing the effect of testosterone solution 2% (TS) and placebo on serum total testosterone. Psychometric analyses included reliability, validity and responsiveness. Total scores for both PRO instruments were transformed to a 0-100 scale. RESULTS: Study participants (n = 694) were 80% age ≤ 65 years, 79% White, with mean baseline testosterone = 202 ng/dl. Clinicians identified 86% subjects as having low sex drive, 86% with low energy and 76% with both symptoms. Reliability analyses for SAID and HED yielded reliability coefficients > 0.70. SAID scores discriminated between men having low sex drive (n = 553) and those who did not (n = 80) (34.5 vs. 42.8, p < 0.001). HED scores discriminated between men having low energy (n = 541) and those who did not (n = 64) (48.9 vs. 60.2, p < 0.001). In the men randomised to TS (vs. placebo), SAID and HED detected effect sizes of 0.61 (vs. 0.39) and 0.68 (vs. 0.48), respectively. MIC estimates for SAID and HED were approximately 10 and 8, respectively. CONCLUSIONS: This study provided evidence of the reliability, validity and responsiveness of SAID and HED as measures of sex drive and energy, respectively, making them potentially useful for evaluation of hypogonadal treatment.

Establishing the content validity of the Sexual Arousal, Interest, and Drive Scale and the Hypogonadism Energy Diary.

AIM: The aim of this qualitative analysis was to establish the content validity of two new patient-reported outcome (PRO) measures: Sexual Arousal, Interest, and Drive Scale (SAID) and Hypogonadism Energy Diary (HED). METHODS: Four separate qualitative studies were conducted with 125 men with hypogonadism (mean age: 53 years, 85% adult onset). Study 1 used focus groups/interviews to identify important and relevant concepts related to the experience of hypogonadism and its treatment in men primarily with adult-onset hypogonadism. Study 2 tested items generated for assessments of low sex drive and low energy. Study 3 used interviews to confirm in men with early-onset hypogonadism that low sex drive and low energy were also important and relevant symptoms. Study 4 tested final versions of the two PROs and determined equivalency of paper-based and electronic versions of the two PROs. RESULTS: Of the concepts emerging in Studies 1 and 3, low sex drive and low energy were the symptoms most often spontaneously mentioned. Coding of transcripts from Studies 1 and 3 led to the generation of items for the SAID and HED. After item testing (Studies 2 and 4), the final SAID included five items pertaining to arousal, interest in sex and sex drive with a 7-day recall period and the final HED included two items (energy, tired/exhausted) to be administered three times per day. CONCLUSION: The SAID and HED have content validity established according to regulatory guidance and, therefore, the potential to provide the patient perspective of treatments for hypogonadism.

Effect of once-daily tadalafil on confidence and perceived difficulty in performing sexual intercourse in men who were incomplete responders to as-needed PDE5 inhibitor treatment.

INTRODUCTION: For men with erectile dysfunction (ED), the expectation of difficulty and level of confidence in achieving and maintaining an erection have an impact on sexual performance. OBJECTIVE AND METHODS: This 12-week, double-blind study investigated once-daily tadalafil (2.5 mg titrated to 5 mg or 5 mg) (n = 176) or placebo (n = 79) on confidence and perceived difficulty in performing sexual intercourse in men with ED who were incomplete responders to as-needed phosphodiesterase-5 inhibitor therapy. The Confidence in Performing Sexual Intercourse Questionnaire (CPSIQ) and Difficulty in Performing Sexual Intercourse Questionnaire (DPSIQ) were administered at baseline and 12 weeks. RESULTS: The mean change in CPSIQ for the tadalafil group was 1.8, which represents a shift from 'very low' to 'moderate' sexual confidence vs. a mean change of 0.5 in the placebo group (p < 0.0001). The mean change in DPSIQ for tadalafil was 1.6, which represents a shift from 'very difficult' to 'moderately' or 'slightly difficult' sexual performance vs. a mean change of 0.4 in the placebo group (p < 0.0001). Among men receiving tadalafil with an International Index of Erectile Function-Erectile Function (IIEF-EF) end-point score of ≥ 26 or who achieved a minimal clinically important difference in IIEF-EF score at end-point, the mean changes in CPSIQ were 3.0 and 2.4, respectively (both p < 0.0001). CONCLUSION: Once-daily tadalafil vs. placebo improves confidence and decreases difficulty in performing sexual intercourse for men with ED who were incomplete responders to as-needed PDE5 inhibitor therapy.

Psychometric validation of the Confidence in Performing Sexual Intercourse Questionnaire and Difficulty in Performing Sexual Intercourse Questionnaire.

The objective of this study was to perform psychometric testing of two new patient-reported outcome instruments (PROs), the Confidence in Performing Sexual Intercourse Questionnaire (CPSIQ) and the Difficulty in Performing Sexual Intercourse Questionnaire (DPSIQ). The new PROs were administered at non-drug, run-in, baseline and end point in men with erectile dysfunction (ED) participating in a randomized clinical trial of ED treatment (Study 1, n=291) and two times within 2 weeks to men with ED participating in a web-based survey (Study 2, n=71). Psychometric tests included factor analysis, internal consistency and test-retest reliability, construct validity and responsiveness. Analysis of data from Study 1 participants (74% ≤65 years, 83% Caucasian and 75% with moderate ED) suggested one-factor solutions for both PROs with Cronbach's α >0.88. CPSIQ and DPSIQ total scores discriminated between ED severity groups showed worsening after a 4-week non-drug, run-in period, and showed improvement after 12 weeks of ED treatment (all, P<0.05). Intraclass correlation coefficients calculated for the CPSIQ and DPSIQ, using data from Study 2 participants (82% ≤65 years, 90% Caucasian and 66% with mild ED), were 0.56 and 0.83, respectively. The CPSIQ and DPSIQ show potential for augmenting existing treatment outcome measures used in the evaluation of ED treatment.

Establishing the content validity of the confidence in performing sexual intercourse and difficulty in performing sexual intercourse questionnaires.

The aim of this qualitative analysis was to establish the content validity of two new patient-reported outcome (PRO) measures, Confidence in Performing Sexual Intercourse Questionnaire (CPSIQ) and Difficulty in Performing Sexual Intercourse Questionnaire (DPSIQ). Six separate qualitative studies (interviews/focus groups) were conducted from December 2009 to August 2010 by a single moderator and included 227 men with erectile dysfunction (ED; mean age: 54 years, 58% Caucasian). In the first three studies, concepts about ED and its treatment that were important and relevant to men with ED were identified. They included: getting and controlling erection; erection hardness; maintaining erection for desired duration; achieving and controlling ejaculation; satisfying partner; changing sexual positions; and frequency and spontaneity of sexual intercourse. In the subsequent two studies, concepts were confirmed and transformed into CPSIQ and DPSIQ items. The last study entailed a cognitive interview of the CPSIQ and DPSIQ to ensure that respondents' interpretation of the PRO items were consistent with their intended meaning and that both recall periods and response sets were acceptable. After psychometric testing, the CPSIQ and DPSIQ could serve as complementary tools to existing PROs used in ED clinical trials.

Expectations about and experiences with insulin therapy contribute to diabetes treatment satisfaction in insulin-naïve patients with type 2 diabetes.

AIM: The aim of this study was to investigate how patients' expectations about and experiences with insulin therapy contribute to diabetes treatment satisfaction. METHODS: The Expectations about Insulin Therapy (EAITQ) and the Experience with Insulin Therapy Questionnaires (EWITQ) were administered at baseline and end-point, respectively to insulin-naïve patients with type 2 diabetes in a randomised trial comparing treatment algorithms for inhaled insulin. Pearson correlation coefficients were calculated between EAITQ and EWITQ scores, patient characteristics and patient-reported outcomes measures. Wilcoxon Signed Rank test compared EAITQ and EWITQ item score distributions. Differences between EAITQ and EWITQ scores were calculated to categorize patients according to the extent to which their expectations were met by experiences (i.e. unmet, met, exceeded). RESULTS: EAITQ and EWITQ data were available for 240 patients (61% male, mean age 58 years, mean diabetes duration 10 years, mean baseline HbA(1c) 8.4%). Increasingly positive expectations were significantly associated with greater self-efficacy; greater levels of positive experiences were significantly associated with greater positive expectations, shorter diabetes duration, less symptom distress, greater well-being, self-efficacy and diabetes treatment satisfaction. Overall, patients' experiences with inhaled insulin therapy were significantly more positive than their expectations: 58% patients' experiences exceeded expectations, 29% patients' experiences met expectations and 13% patients' experiences did not meet expectations. Post hoc tests indicated that treatment satisfaction scores differed among these groups (all p < 0.01). CONCLUSION: Expectations may not independently impact treatment satisfaction, but the relationship with experiences significantly contributes to it. The EAITQ and EWITQ may be useful tools for clinicians to better understand patients' expectations about and experiences with insulin therapy.

Primary care physician beliefs about insulin initiation in patients with type 2 diabetes.

BACKGROUND: Insulin is the most effective drug available to achieve glycaemic goals in patients with type 2 diabetes. Yet, there is reluctance among physicians, specifically primary care physicians (PCPs) in the USA, to initiate insulin therapy in these patients. AIMS: To describe PCPs' attitudes about the initiation of insulin in patients with type 2 diabetes and identify areas in which there is a clear lack of consensus. METHODS: Primary care physicians practicing in the USA, seeing 10 or more patients with type 2 diabetes per week, and having > 3 years of clinical practice were surveyed via an internet site. The survey was developed through literature review, qualitative study and expert panel. RESULTS: Primary care physicians (n = 505, mean age = 46 years, 81% male, 62% with > 10 years practice; 52% internal medicine) showed greatest consensus on attitudes regarding risk/benefits of insulin therapy, positive experiences of patients on insulin and patient fears or concerns about initiating insulin. Clear lack of consensus was seen in attitudes about the metabolic effects of insulin, need for insulin therapy, adequacy of self-monitoring blood glucose, time needed for training and potential for hypoglycaemia in elderly patients. CONCLUSIONS: The beliefs of some PCPs are inconsistent with their diabetes treatment goals (HbA1c < or = 7%). Continuing medical education programmes that focus on increasing primary care physician knowledge about the progression of diabetes, the physiological effects of insulin, and tools for successfully initiating insulin in patients with type 2 diabetes are needed.

Physician assistant students and diabetes: evaluation of attitudes and beliefs.

PURPOSE: Physician assistants are assuming a greater role in patient care in the US health system. The objective of this study was to examine attitudes and beliefs about diabetes among physician assistant trainees. METHODS: A survey of 3 currently enrolled classes of physician assistant students was conducted using the Diabetes Attitude Survey (DAS, version 3). An additional question was presented to gather information about the level of hyperglycemia at which students would intensify diabetes therapy. RESULTS: On average, students scored high on all subscales, indicating general agreement with the attitudes examined by the DAS. For 3 subscales (seriousness of type 2 diabetes, value of tight glucose control, and patient autonomy), significant differences were seen across year of training. When asked about the level of glucose control at which they would advance therapy, a wide range of responses occurred, with some being out of target. CONCLUSIONS: Physician assistant students had favorable attitudes regarding type 2 diabetes. However, deficits appear to exist in understanding when to advance therapy. More studies on physician assistant students' knowledge of diabetes standards of care are required.

Diabetes in urban African Americans: assessment of diabetes-specific locus of control in patients with type 2 diabetes.

PURPOSE: This study was conducted to examine the applicability and relationship to glycemic control of the Diabetes Locus of Control (DLC) Scales in a low-literacy, economically deprived, African American population with type 2 diabetes. METHODS: The DLC Scales were administered orally to African American patients with type 2 diabetes who had been referred to the diabetes unit of a large urban public hospital. Reliability, interscale correlations, and associations with patient characteristics were compared with those originally obtained for a better educated, predominately Caucasian population. RESULTS: The structure and correlates of the DLC Scales in the African American population were more similar than different from those originally obtained from a primarily well-educated, Caucasian population. However, comprehension of some items was difficult for up to 10% of the low-literacy population. A significant relationship was found between belief in chance and both glycemic control at the 6-month follow-up and the change in glycemic control over time. CONCLUSIONS: Although the DLC Scales operate similarly in an urban African American population with limited education, further modification is needed to enhance the prediction of glycemic control and provide direction for developing targeted interventions.

Qualitative outcome assessment of a medical ethics program for clinical clerkships: a pilot study.

This study assessed the usefulness of an open-ended case analysis test instrument for evaluating the effects of a 1-year ethics course on medical students' decision-making skills. Through case-oriented seminars in gynecology, internal medicine, obstetrics, pediatrics, psychiatry, and surgery, third-year medical students were taught a structured analytic framework for analyzing clinical ethical problems stressing the interactive relationships among medical indications, patient preferences, quality of life, and contextual (social, legal, economic) matters. At precourse, the students were given a test case and asked to provide a line of reasoning for their clinical decisions. At postcourse, the students were given the same case. Content analysis of pre- and postcourse responses of a random student sample revealed increases in student awareness in the following areas: 1) consideration of informed consent, 2) professional liability, 3) physician-assisted suicide, and 4) resource utilization. With some modifications, open-ended case analysis holds promise for evaluating medical ethics courses. The authors make recommendations for future research in evaluating the true impact of clinical ethics courses in medical education.

Variations in family physicians' and cardiologists' care for patients with heart failure.

BACKGROUND: Improved understanding of the reasons for underuse of diagnostic tests and treatments for congestive heart failure (CHF) may be helpful for designing future interventions to improve quality of care. METHODS: To determine differences between family physicians' and cardiologists' practice styles for diagnosis and treatment of CHF, a random sample of family physicians and cardiologists were surveyed with standardized case scenarios. RESULTS: Survey respondents were 182 family physicians and 163 cardiologists. Family physicians were less likely than cardiologists to rate measurement of left ventricular ejection fraction as "very important" for patients with new CHF, less likely to order an echocardiogram or test for ischemia, and much less likely to identify diastolic dysfunction as a cause of CHF. Family physicians were more likely to prescribe digoxin when it was not indicated (diastolic dysfunction) and less likely to prescribe digoxin and an angiotensin-converting enzyme (ACE) inhibitor when they were indicated (moderately to severely reduced left ventricular ejection fraction). Family physicians expressed more concern over the risks of ACE inhibitors in patients with blood pressure of 100/70 mm Hg or serum creatinine of 2.0 mg/dL and were less likely to prescribe an ACE inhibitor in these settings. Family physicians overestimated the risks of warfarin use for atrial fibrillation and were therefore less likely to prescribe warfarin. CONCLUSIONS: Family physicians appear to have less understanding of CHF pathophysiology (ie, systolic versus diastolic dysfunction) and how treatment differs according to the underlying disease process. Overestimation of the risk of ACE inhibitor and warfarin use may result in underprescribing these medications.

Changing attitudes about end-of-life decision making of medical students during third-year clinical clerkships.

To better define the learning objectives of ethics curricula and evaluate changes in medical students' attitudes about end-of-life decision making, enrolled students (N = 96) of a pilot medical ethics program were surveyed at the beginning and end of their third-year clinical clerkship about their experiences and attitudes about end-of-life decision making. At the end of their clinical clerkship year, the majority of students had participated in end-of-life decisions, prioritized patient autonomy and quality-of-life issues, were concerned about legal liability, were polarized over issues such as physician-assisted suicide, and gained confidence in their ethical decision-making ability. To train future physicians such that clinical practice is consistent with ethical guidelines and legislation on end-of-life care, medical ethics curricula should focus on symptom relief, clarification of legal issues, and resolution of conflicts between personal beliefs and public opinion about such issues as physician-assisted suicide. Appropriate role-modeling and mentoring by residents and attending physicians should also be emphasized.

Staff perceptions of emergency and home-care telemedicine.

The utilization of a low-bandwidth telemedicine system for emergency and for home-care was studied in a pilot trial. The emergency setting was the emergency department of a small urban hospital and its emergency medical service (EMS); the home-care setting was the home-health agency affiliated to the hospital. Utilization data were obtained through baseline and follow-up interviews with EMS technicians, emergency department and home-health nurses, and the project coordinator. The results indicated that initial enthusiasm for the use of the telemedicine system was not followed by a commitment to the system's utilization during the trial by the relevant administrations. Barriers to optimum utilization were identified, but the actual value of the system to patient care could not be determined. We conclude that the value of a telemedicine system to patient care cannot be realized unless there is an organizational commitment from the top to system utilization.

The impact of Gaucher disease and its treatment on quality of life.

To obtain information about how Gaucher disease and its treatment, specifically enzyme replacement therapy, affect patients' health-related quality of life (HRQoL), we interviewed 16 patients with type I Gaucher disease (range 8-67 years). All but three patients had been receiving enzyme replacement therapy for at least 6 months. The quality of life factors examined for these patients included physical health, social life, emotional health, financial burden, future plans and satisfaction with health care. The results indicated that bone pain and chronic fatigue interfered with school, job and social activities and were the most debilitating symptoms of Gaucher disease. Most patients experienced a significant increase in energy level from therapy and reported significant improvements in quality of life. Most patients did not perceive an effect of Gaucher disease on their overall emotional health, but some patients expressed anxieties about the discomfort, inconvenience and high costs of therapy. We conclude that a measure of HRQoL for Gaucher patients should include a generic core of items supplemented by disease-specific items designed to assess the changes in symptoms and in the occupational, recreational, social and emotional aspects of patients' lives that occur as a result of disease progression and/or management.

Methodological problems in comparing English-speaking and Spanish-speaking patients' satisfaction with interpersonal aspects of care.

OBJECTIVES: The authors examine the reliability and validity of English and Spanish versions of a patient satisfaction measure, the Interpersonal Aspects of Care (IAC) Examiner Scale. METHODS: The examiner scale was administered to 234 Spanish-speaking and 250 English-speaking patients seen in the emergency department of a large public hospital. Reliability and validity coefficients were calculated for both administrations. Differences in item and scale response distributions were compared using two methods of response dichotomization. RESULTS: In general, the examiner scale was reliable and valid. However, the Spanish version of the scale was significantly less reliable and valid. Depending on the method of item response dichotomization, significant differences between Spanish-speaking and English-speaking patients were found for the majority of the individual scale items. This was due primarily to a tendency for Spanish-speaking patients to respond "good" to items more frequently than did English-speaking patients. CONCLUSIONS: The results bring into question the use of certain types of response formats and the practice of dichotomizing responses when evaluating patient satisfaction in Spanish-speaking patients.

Informatics, imaging, and healthcare quality management: imaging quality improvement opportunities and lessons learned form HCFA's Health Care Quality Improvement Program.

This article examines the use of population-based healthcare data at the interface among radiology, healthcare informatics, and health services research for the purposes of healthcare quality management. To illustrate these concepts, we draw on experience with Health Care Financing Administration's Medicare Health Care Quality Improvement Program (HCQIP). We present two HCQIP efforts that have identified opportunities to improve the delivery of imaging services, specifically studies of the diagnosis and management of congestive heart failure and cerebrovascular disease. The examples demonstrate from a population-level perspective that there are opportunities to enhance the quality of imaging practice by reducing the magnitude of imaging practice variability, implementing evidence-based guidelines, and optimizing the communication of imaging study findings to physicians who are responsible for subsequent diagnostic and therapeutic decisions. Additional research is required in specific clinical domains of radiology to determine if implementation of evidence-based imaging guidelines and enhanced clarity in the interpretation and communication of diagnostic imaging will improve health outcomes.

Linking health services research to education at an academic health center.

Academic health centers (AHCs) face numerous challenges as they prepare students, housestaff, and faculty for the rapidly changing health care environment. An already overburdened curriculum makes it difficult to provide medical students with skills in outcomes assessment, health economics, clinical decision making, epidemiology, and basic statistics. Practicing physicians may find it difficult to expend the time and resources needed for degree programs in public health or the evaluative clinical sciences. AHCs may need to tap into existing resources in the health evaluation sciences, as Emory University (Atlanta, Georgia) has done by establishing the Emory University Center for Clinical Evaluation Sciences. Although the Center's primary missions are to be an analytical resource for Emory's health care delivery system and to promote health services research across the university, the authors illustrate its potential as a resource for training medical students, housestaff, and faculty in the evaluative clinical sciences.

HCFA's health care quality improvement program: the medical informatics challenge.

The peer-review organizations (PROs) were created by Congress in 1984 to monitor the cost and quality of care received by Medicare beneficiaries. In order to do this, the Health Care Financing Administration (HCFA) contracted with the PROs through a series of contracts referred to as "Scopes of Work." Under the Fourth Scope of Work, the HCFA initiated the Health Care Quality Improvement Program (HCQIP) in 1990, as an application of the principles of continuous quality improvement. Since then, the PROs have participated with health care providers in cooperative projects to improve the quality of primarily inpatient care provided to Medicare beneficiaries. Through HCFA-supplied administrative data and clinical data abstracted from patient records, the PROs have been able to identify opportunities for improvements in patient care. In May 1995, the HCFA proposed a new Fifth Scope of Work, which will shift the focus of HCQIP from inpatient care projects to projects in outpatient and managed care settings. This article describes the HCQIP process, the types of data used by the PROs to conduct cooperative projects with health care providers, and the informatics challenges in improving the quality of care received by Medicare beneficiaries.

Emory University Center for Clinical Evaluation Sciences: a model for clinical practice evaluation in the changing environment of the academic health center.

Changes in the health care marketplace have had a profound effect on academic health centers and their traditional missions: teaching, patient care, and research. Many academic health centers have recognized the need to develop a capability for evaluating clinical practices and organizational restructuring. The Center for Clinical Evaluation Sciences at Emory University represents a model for the integration of evaluative capabilities into academic clinical practices.