Effect of Testosterone Solution 2% on Testosterone Concentration, Sex Drive and Energy in Hypogonadal Men: Results of a Placebo Controlled Study.

PURPOSE: We determined the effect of testosterone solution 2% on total testosterone level and the 2 symptoms of hypogonadism, sex drive and energy level. MATERIALS AND METHODS: This was a randomized, multicenter, double-blind, placebo controlled, 16-week study to compare the effect of testosterone and placebo on the proportion of men with a testosterone level within the normal range (300 to 1,050 ng/dl) upon treatment completion. We also assessed the impact of testosterone on sex drive and energy level measured using SAID (Sexual Arousal, Interest and Drive scale) and HED (Hypogonadism Energy Diary), respectively. A total of 715 males 18 years old or older with total testosterone less than 300 ng/dl and at least 1 symptom of testosterone deficiency (decreased energy and/or decreased sexual drive) were randomized to 60 mg topical testosterone solution 2% or placebo once daily. RESULTS: Of study completers 73% in the testosterone vs 15% in the placebo group had a testosterone level within the normal range at study end point (p <0.001). Participants assigned to testosterone showed greater baseline to end point improvement in SAID scores (low sex drive subset p <0.001 vs placebo) and HED scores (low energy subset p = 0.02 vs placebo, not significant at prespecified p <0.01). No major adverse cardiovascular or venous thrombotic events were reported in the testosterone group. The incidence of increased hematocrit was higher with testosterone vs placebo (p = 0.04). CONCLUSIONS: Once daily testosterone solution 2% for 12 weeks was efficacious in restoring normal testosterone levels and improving sexual drive in hypogonadal men. Improvement was also seen in energy levels on HED though not at the prespecified p <0.01. No new safety signals were identified.

Exploration of oncologists' attitudes toward and perceived value of patient-reported outcomes.

PURPOSE: To understand oncologists' attitudes toward patient-reported outcome (PRO) measures and to learn how PRO data influence their clinical decision-making. METHODS: Twenty practicing oncologists participated in 1 of 4 semi-structured focus groups. RESULTS: Most oncologists had no experience with PRO measures, but were able to identify several concepts appropriate for patient-reported assessment. Participants agreed that clinical measures such as performance status were more meaningful to them, but acknowledged that PRO measures were more appropriate for assessing patient symptoms and treatment response. All oncologists believed that clinical efficacy and toxicity data were of primary importance, but that PROs become increasingly important when multiple treatments are available, in advanced or incurable disease, and in palliative care. Several issues prevented oncologists from being able to draw meaningful conclusions from PRO data: lack of familiarity with PRO measures, being presented with too much data to process, lack of clarity around a meaningful change in PRO measure scores, and lack of standardization in the use of PRO measures. CONCLUSIONS: Oncologists indicated that PRO data are most influential in advanced or incurable disease and in palliative care. Improving the interpretability of PRO measures could increase the usefulness of PRO data in treatment decision-making.

Construct validation of patient global impression of severity (PGI-S) and improvement (PGI-I) questionnaires in the treatment of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia.

BACKGROUND: Lower urinary tract symptoms (LUTS) in aging men are often associated with benign prostatic hyperplasia (BPH). While regulatory evaluations of treatment benefit require an assessment of specific symptoms, a simpler approach to measuring patients' perceptions of severity and symptom change may be particularly useful for clinical practice. The aim of this study was to provide evidence of the validity of the 1-item Patient Global Impression of Severity (PGI-S) and Improvement (PGI-I) questionnaires for use as outcome measures in the treatment of BPH-LUTS. METHODS: This was a secondary analysis of data from 4 randomized placebo-controlled 12-week trials evaluating tadalafil for the treatment of BPH-LUTS (N=1694). Visit 2 (V2 [beginning of a 4-week placebo lead-in period]) and endpoint assessments included International Prostate Symptom Score (IPSS), IPSS Quality of Life Index (IPSS-QoL), BPH Impact Index (BII), and peak urine flow (Qmax). PGI-S was only administered at V2 and PGI-I only at endpoint. Associations between the PGI-S or the PGI-I and the other assessments were analyzed by calculating Spearman rank correlation coefficients and performing analysis of variance (ANOVA). RESULTS: Spearman correlation coefficients were 0.43, 0.43, 0.53, and -0.09, between the PGI-S and IPSS, IPSS-QoL, BII, and Qmax baseline results (all P<0.001). Similar results were seen across race, ethnicity, and baseline severity (moderate LUTS versus severe LUTS). IPSS, IPSS-QoL, BII baseline scores (P <0.001) and Qmax values (P=0.003) were significantly different among the 4 PGI-S severity levels. Spearman correlation coefficients were 0.56, 0.53, 0.47 and -0.15 between the PGI-I and change in IPSS, IPSS-QoL, BII scores, and Qmax values from baseline to endpoint (all P<0.001). Similar results were seen across race, ethnicity, and baseline severity. Change in IPSS, IPSS-QoL, BII scores, and Qmax values (P<0.001) were significantly different among the PGI-I levels (i.e., patient perception of change in urinary symptoms). CONCLUSIONS: This study demonstrated patients' overall perceptions of their severity and change in BPH-LUTS can be captured in a way that is simple, valid, and easily administered in a research setting or clinical practice. Clinical parameters are weakly associated with patients' perception of urinary symptoms, emphasizing the importance of a patient-reported assessment in the evaluation of BPH-LUTS treatment benefit.

Measurement properties of the benign prostatic hyperplasia impact index in tadalafil studies.

BACKGROUND: To assess the measurement properties of the Benign Prostatic Hyperplasia Impact Index (BII) for use in men with Lower Urinary Tract Symptoms (LUTS) secondary to Benign Prostatic Hyperplasia (BPH) treated with tadalafil. METHODS: Data from a dose-titration (Study 1) and a dose-finding placebo-controlled (Study 2) tadalafil studies of men 45 years of age or older with moderate to severe LUTS (N = 281; N = 1053) were included in this post-hoc analysis. Measures included the BII, International Prostate Symptom Score (IPSS), IPSS Quality of Life Index (IPSS-QoL), LUTS Global Assessment Question, uroflowmetry measure peak flow rate (Qmax) and postvoid residual volume (PVR). Spearman rank and Pearson correlation coefficients were computed between the BII score and the other measures at each visit. Wilcoxin two-sample tests, t-tests and general linear modeling compared BII scores of subjects with global ratings of improvement versus no improvement, and subjects taking tadalafil versus placebo. Effect size, standardized response mean and Guyatt's responsiveness statistic were calculated for BII and IPSS change scores. RESULTS: There were high correlations between BII and IPSS & IPSS-QoL and low correlations between BII and Qmax & PVR at each visit. There were significant differences in BII at the End-of-Study Visit between subjects reporting improvement versus subjects reporting no improvement (Studies 1 and 2, P < .0001) and subjects taking tadalafil versus subjects taking placebo (Study 1, P = .0045; Study 2, P = .0064). The BII and IPSS were both responsive to change. CONCLUSIONS: Results show that the BII is reliable, shows responsiveness to change in patients with BPH-LUTS, and demonstrates construct validity.

Diabetes in Japan: a review of disease burden and approaches to treatment.

In recent years there has been rapid growth in diabetes in Japan which now is one of the nations most affected by the worldwide diabetes epidemic. Diabetes has been identified as a healthcare priority by the Ministry of Health, Labour and Welfare (MHLW). Type 1 diabetes is rare in Japan, and type 2 diabetes predominates in both adults and children. The growth in diabetes is due to increases in the number of people with type 2 diabetes associated with increased longevity and lifestyle changes. Approximately 13.5% of the Japanese population now has either type 2 diabetes or impaired glucose tolerance. This high prevalence of type 2 diabetes is associated with a significant economic burden, with diabetes accounting for up to 6% of the total healthcare budget. The costs of diabetes are increased in patients with co-morbidities such as hypertension and hyperlipidaemia and in patients who develop complications, of which retinopathy has the highest cost. Costs increase with increasing number of complications. Current guidelines from the Japan Diabetes Society (JDS) recommend a target HbA(1c) of 6.5% for glycaemic control. This is achieved in approximately one third of patients with type 2 diabetes, and Japanese patients typically have lower HbA(1c) than patients in Western countries (e.g. US, UK). Japanese patients with type 2 diabetes have better adherence with diet and exercise recommendations than their peers in Western countries. Sulfonylureas have been the most widely prescribed first-line treatment for type 2 diabetes, although there is increasing use of combination therapy and of insulin.

Perceptions and attitudes are primary contributors to insulin delivery system satisfaction in people with type 2 diabetes.

BACKGROUND: This study identifies factors that influence satisfaction with an insulin delivery system (IDS). Knowledge of such factors could help identify individuals who would benefit from innovative IDS. METHODS: Individuals with type 2 diabetes who use insulin, recruited from a general and chronic illness panel, participated in a web-based survey that included questions about demographics, self-reported diagnoses and hemoglobin A1c (HbA1c), current IDS used, insulin therapy attitudes, current IDS features, and satisfaction with IDS. Univariate analyses identified variables associated with IDS satisfaction (P < 0.05); those variables were entered into stepwise linear regression analyses with IDS satisfaction as the dependent variable. RESULTS: Six hundred sixty-seven individuals with type 2 diabetes participated (mean age, 57 years; 52% female; 88% Caucasian; 73% vial/syringe users, 27% insulin pen users). IDS satisfaction was associated (P < 0.05) with gender, health status, HbA1c, self-reported comorbidity, insulin therapy attitudes, IDS type, and evaluation of IDS features. Among individuals who reported their HbA1c (n = 438), the best predictors of IDS satisfaction were perceived effectiveness and value of insulin therapy, evaluation of IDS activity interference, and commitment to insulin therapy (R2 = 0.49, P < 0.001). Among all participants (n = 667), a second regression analysis that employed a variable representing report of HbA1c found the best predictors of IDS satisfaction included those in the first analysis with the addition of gender, report of HbA1c, and evaluation of IDS ease of use. These variables provided additional variance (R2 = 0.56, P < 0.001). CONCLUSIONS: In people with type 2 diabetes, positive perceptions and attitudes about insulin therapy have greater influence than the type of IDS used on IDS satisfaction.

Reliability and validity of an instrument for assessing patients' perceptions about medications for diabetes: the PAM-D.

PURPOSE: To evaluate the reliability and validity of the Perceptions About Medications for Diabetes (PAM-D) instrument. METHODS: The item pool was generated from a literature review and 18 focus groups of Type 2 diabetes patients. Surveys were mailed to 1,000 low-income diabetes patients; 362 were returned; 65 of 100 re-test surveys were returned. RESULTS: This paper uses data from 343 Type 2 respondents. Mean age and age diagnosed were 59 and 48, respectively; 72% female; 52% African American; 51% were taking oral antihyperglycemic agents [OHA] monotherapy, 18% insulin monotherapy, and 28% insulin plus OHA. The initial 66 items were reduced to 37 across nine scales: scheduling flexibility, portability convenience, regimen inconvenience, medication effectiveness, difficulty remembering medications, gastrointestinal, hypoglycemia-related, and weight/edema physical side effects, and emotional side effects. Scale reliabilities ranged from 0.71 to 0.92 (coefficient alpha) and from 0.54 to 0.83 (test-retest coefficient, 37-81-day interval); factor loadings ranged from 0.35 to 0.86 (median, 0.67); significant scale differences across medication groups (insulin, OHA, insulin plus OHA) were consistent with a priori hypotheses. CONCLUSIONS: The PAM-D has substantial reliability and validity in a low-income, inner-city population of Type 2 diabetes patients and may be valuable for understanding multidimensional perceptions driving patients' treatment preferences.

Effect of standard (self-directed) training versus intensive training for Lilly/Alkermes human insulin inhalation powder delivery system on patient-reported outcomes and patient evaluation of the system.

BACKGROUND: Inhaled insulin may provide patients with diabetes a safe, efficacious method of insulin delivery without the burden of injection, but complexity of and time required for training in proper use of delivery systems have not been evaluated. METHODS: This 4-week, multicenter, single-blind, randomized parallel-group study compared the effect of self-directed [written text-graphic directions for use (DFU) with patient-assistance phone number] or intensive (same DFU, personal training by study personnel, inspiratory flow rate coaching) training for the Lilly/Alkermes human insulin inhalation powder (HIIP) delivery system on patient-reported outcomes (PROs). Patients with type 2 diabetes poorly controlled on oral therapy (n = 102, mean hemoglobin A1C = 9.3%) were administered measures of vitality, diabetes-associated symptoms, fear of hypoglycemia, insulin-delivery system satisfaction, and a delivery system-specific evaluation questionnaire. Analysis of covariance models were used to compare the effect on PROs of treatment of diabetes for 1 month following the two training methods. Paired t tests were used to determine change in PROs after treatment with HIIP. RESULTS: PROs did not differ significantly between training groups. Patients in both groups positively evaluated the delivery system, but the intensive group agreed significantly (P < 0.05) more strongly that the DFU was easy to follow. Improvements in vitality and symptoms of fatigue and increases in fear of hypoglycemia were detected among all patients after using HIIP (P < 0.05). CONCLUSION: Training for this HIIP delivery system can be self-directed without detrimental effects on PROs, making it potentially a more patient-friendly insulin-delivery method that should appeal to both clinicians and patients.

Patient-reported outcomes in a trial of exenatide and insulin glargine for the treatment of type 2 diabetes.

BACKGROUND: Patient-reported measures can be used to examine whether drug differences other than clinical efficacy have an impact on outcomes that may be important to patients. Although exenatide and insulin glargine appear to have similar efficacy for treatment of type 2 diabetes, there are several differences between the two treatments that could influence outcomes from the patient's perspective. The purpose of the current study was to examine whether the two drugs were comparable as assessed by patient-reported outcomes using data from a clinical trial in which these injectable medications were added to pre-existing oral treatment regimens. METHODS: Patients were randomized to either twice daily exenatide or once daily insulin glargine during a 26-week international trial. At baseline and endpoint, five patient-reported outcome measures were administered: the Vitality Scale of the SF-36, The Diabetes Symptom Checklist - Revised (DSC-R), the EuroQol EQ-5D, the Treatment Flexibility Scale (TFS), and the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Change from baseline to endpoint was analyzed within each treatment group. Group differences were examined with General linear models (GLMs), controlling for country and baseline scores. RESULTS: A total of 549 patients with type 2 diabetes were enrolled in the trial, and current analyses were conducted with data from the 455 per protocol patients (228 exenatide and 227 insulin glargine). The sample was primarily Caucasian (79.6%), with slightly more men (55.2%) than women, and with a mean age of 58.5 years. Paired t-tests found that both treatment groups demonstrated statistically significant baseline to endpoint change on several of the health outcomes instruments including the DSC-R, DTSQ, and the SF-36 Vitality subscale. GLMs found no statistically significant differences between groups in change on the health outcomes instruments. CONCLUSION: This analysis found that both exenatide and insulin glargine were associated with significant improvements in patient-reported outcomes when added to oral medications among patients with type 2 diabetes. Despite an additional daily injection and a higher rate of gastrointestinal adverse events, treatment satisfaction in the exenatide group was comparable to that of the glargine group, possibly because of weight reduction observed in patients treated with exenatide.

Understanding diabetes medications from the perspective of patients with type 2 diabetes: prerequisite to medication concordance.

PURPOSE: The purpose of this qualitative study was to explore diabetes medication experiences of patients with type 2 diabetes. METHODS: Study participants were recruited through newspaper advertisements and letters from primary and specialty clinics in Indianapolis, Indiana. The same professional facilitator conducted 18 focus groups (7 male, 11 female) at a Veteran Affairs facility in Indianapolis, Indiana. Participants were 138 socioeconomically diverse individuals with type 2 diabetes (68% female, 74% > or = 50 years old, 61% non-Hispanic Caucasian). Participants were on a variety of diabetes medication regimens (61% injectable insulin monotherapy or in combination with orals). Content analysis of focus group transcripts was used to establish themes. RESULTS: Three major themes emerged across the focus groups: (1) the inconvenience and inflexibility of the timing and frequency of administration of many diabetes treatments on participants' lives, (2) the desire to avoid injections and/or insulin therapy, and (3) the physical and emotional side effects of diabetes medications. Assuming equivalent effectiveness of 2 medications, participants would weigh the convenience and flexibility, route of administration, side effects, and cost of the medications to arrive at a treatment preference. Participants believed they currently had no opportunity to express their treatment preference to their health care provider. CONCLUSIONS: The best therapeutic option for a patient with type 2 diabetes will be one that is clinically effective and consistent with the patient's needs and preferences. The challenge for diabetes educators is to support patients in articulating and incorporating their needs and preferences into the treatment decision-making process.

An endocrinologist-supported intervention aimed at providers improves diabetes management in a primary care site: improving primary care of African Americans with diabetes (IPCAAD) 7.

OBJECTIVE: Management of diabetes is frequently suboptimal in primary care settings, where providers often fail to intensify therapy when glucose levels are high, a problem known as clinical inertia. We asked whether interventions targeting clinical inertia can improve outcomes. RESEARCH DESIGN AND METHODS: A controlled trial over a 3-year period was conducted in a municipal hospital primary care clinic in a large academic medical center. We studied all patients (4,138) with type 2 diabetes who were seen in continuity clinics by 345 internal medicine residents and were randomized to be control subjects or to receive one of three interventions. Instead of consultative advice, the interventions were hard copy computerized reminders that provided patient-specific recommendations for management at the time of each patient's visit, individual face-to-face feedback on performance for 5 min every 2 weeks, or both. RESULTS: Over an average patient follow-up of 15 months within the intervention site, improvements in and final HbA1c (A1C) with feedback + reminders (deltaA1C 0.6%, final A1C 7.46%) were significantly better than control (deltaA1C 0.2%, final A1C 7.84%, P < 0.02); changes were smaller with feedback only and reminders only (P = NS vs. control). Trends were similar but not significant with systolic blood pressure (sBP) and LDL cholesterol. Multivariable analysis showed that the feedback intervention independently facilitated attainment of American Diabetes Association goals for both A1C and sBP. Over a 2-year period, overall glycemic control improved in the intervention site but did not change in other primary care sites (final A1C 7.5 vs. 8.2%, P < 0.001). CONCLUSIONS: Feedback on performance aimed at overcoming clinical inertia and given to internal medicine resident primary care providers improves glycemic control. Partnering generalists with diabetes specialists may be important to enhance diabetes management in other primary care settings.

The development and validation of the Norfolk QOL-DN, a new measure of patients' perception of the effects of diabetes and diabetic neuropathy.

BACKGROUND: This study was designed to develop and validate a patient-reported outcomes measure, sensitive to the different features of diabetic neuropathy (DN)-small fiber, large fiber, and autonomic nerve function. METHODS: The review of 1,000 structured patient interviews guided the development of 28 items pertaining specifically to the symptoms and impact of large fiber, small fiber, and autonomic nerve function. These items, in addition to 14 generic health status items and five general information items formed the 47-item Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (QOL-DN). Items were grouped according to small fiber, large fiber, and autonomic nerve function, symptoms, and activities of daily living (ADL). Scores in individual domains were aggregated to provide a total score. Item groupings were tested for their ability to distinguish between the effects of specific nerve fiber deficits in 262 subjects-81 healthy controls (C), 86 controls with diabetes (DC), and 95 patients with DN-using one-way analysis of variance (ANOVA). Internal consistency was estimated using Cronbach's alpha coefficient. Test-retest reliability over a 4-6-week period was estimated by intra-class correlation coefficients and ANOVA on data of a subset of patients and controls. RESULTS: Differences between DN subjects and both DC and C subjects were significant (P < 0.05) for all item groupings. Total quality of life (QOL) scores correlated with total neuropathy scores. The ADL, total QOL, and autonomic scores were greater in DC than C subjects (P < 0.05). Intra-class correlation coefficients were > 0.9 for most domains. Internal consistency of the fiberspecific domains using Cronbach's alpha was > 0.6 and up to 0.8. CONCLUSIONS: The fiber-specific domains of the QOL-DN demonstrated acceptable reliability and ability to discriminate between subjects with and without neuropathy. Not surprisingly, the DN group scored significantly (P < 0.05) higher than either of the two control groups (i.e., greater impairment). The positive scores for the DC group in the ADL and autonomic domains suggest that diabetes per se impacts these aspects of QOL.

Reliability, validity, and responsiveness of the Impact of Weight on Self-Perceptions Questionnaire (IW-SP) in individuals with type 2 diabetes and obesity.

BACKGROUND: The Impact of Weight on Self-Perceptions Questionnaire (IW-SP) assesses an individual's self-perception related to his or her weight. The primary objective of this study was to provide evidence of the reliability, validity, and responsiveness of the IW-SP. MATERIALS AND METHODS: Study participants were individuals with type 2 diabetes mellitus (T2DM) and obesity enrolled in clinical weight-loss programs in the United States. Data were obtained for clinical measures, IW-SP, and other patient-reported outcome measures. An intraclass correlation coefficient (ICC) and Cronbach's α were calculated for test-retest reliability and internal consistency, respectively. For validity, correlations and t tests were performed. For responsiveness, baseline and 6-month data for a subgroup of patients were analyzed using the paired t test and calculation of effect size (ES). RESULTS: Reliability data for 106 study participants (mean age, 52 years; 69% female; 31% white; mean body mass index, 38 kg/m(2)) yielded an ICC of 0.85 and Cronbach's α values of >0.89. IW-SP scores were associated with obesity-related quality of life, mental health, and vitality (r>0.50, P<0.001). In the subgroup (n=40) used to estimate responsiveness, weight was significantly less at end point than at baseline (mean, baseline=231.9 vs. end point=222.0 pounds; P<0.001; ES=0.23), and IW-SP scores were significantly better than at baseline (mean, baseline=61.0 vs. end point=72.1 [on a scale of 0-100]; P=0.01; ES=0.34). Mean IW-SP change scores significantly discriminated between those achieving >5% body weight loss and those who achieved <5% (mean change, 23.6 vs. 5.7; P=0.03). CONCLUSIONS: The IW-SP has demonstrated reliability, validity, and responsiveness in individuals with T2DM and obesity, thereby making it a potentially valuable tool in the evaluation of weight-loss interventions targeted toward patients with T2DM.

The Patient-Reported Outcome (PRO) Consortium: Lessons Learned Along the Path to PRO Instrument Qualification.

Established in 2008, the Patient-Reported Outcome (PRO) Consortium is a collaboration among the US Food and Drug Administration's Center for Drug Evaluation and Research, the Critical Path Institute, the pharmaceutical/biotechnology industry, and other stakeholders. The purpose of the consortium is to qualify PRO instruments through the Center for Drug Evaluation and Research's drug development tool qualification process for use as clinical trial endpoints to support drug approval and product labeling claims. The PRO Consortium has made notable progress toward collaborative development of PRO instruments in the following areas: asthma, mild cognitive impairment, depression, functional dyspepsia, irritable bowel syndrome, non-small cell lung cancer, and rheumatoid arthritis. This progress has come with considerable challenges, including navigating a new and evolving regulatory initiative, gaining consensus on key issues, and maintaining communication and engagement in a precompetitive environment. The purpose of this paper is to describe some of the challenges and lessons learned since the creation of the PRO Consortium in hopes that this information may provide direction and insight for similar collaborations.

Clinical Global Impression of Change in Physical Frailty: development of a measure based on clinical judgment.

OBJECTIVES: To expand the ability to assess physical frailty by developing a Clinical Global Impression of Change in Physical Frailty (CGIC-PF) instrument. DESIGN: Qualitative and quantitative instrument development. SETTING: Academic centers. PARTICIPANT: s Six expert panel members, 46 clinicians, 24 patients, and 12 caregivers. MEASUREMENTS: Literature review and structured group processes with experts, clinicians, and consumers were used to generate an initial list of domains and indicators. Structured interviews with clinical experts in the area of frailty were used to establish relevance and feasibility of measurement of domains. Interrater reliability was assessed through a Web-based study. Geriatricians pilot tested the feasibility of the baseline CGIC-PF with 10 patients. RESULTS: The CGIC-PF includes six intrinsic domains (mobility, balance, strength, endurance, nutrition, and neuromotor performance) and seven consequences domains (medical complexity, healthcare utilization, appearance, self-perceived health, activities of daily living, emotional status, and social status). Each domain has two to four clinical indicators. Change is scored on a 7-point scale from markedly worse to markedly improved. Average interrater reliability of the CGIC-PF for the Web-based cases was 0.97. Geriatricians completed a baseline CGIC-PF on their own patients in 10 minutes or less. CONCLUSION: The CGIC-PF is a structured assessment of change in physical frailty with defined content and process. It has strong face validity, reliability, and feasibility for use in clinical research. It may be useful as one criterion of change and as an anchor for change in other measures.

Refining the categorization of physical functional status: the added value of combining self-reported and performance-based measures.

BACKGROUND: When considered individually, self-reported functional status and performance-based functional status predict functional status decline and mortality. However, what additional prognostic information is gained by combining these approaches remains unknown. METHODS: The authors used three waves of three sites (5138 participants) of the Established Populations for Epidemiologic Studies of the Elderly to determine the prognostic value of individual and combined approaches. Baseline self-reported (mobility and activities of daily living [ADL] items) and performance-based (Physical Performance Score) functional status information was classified into three and four hierarchical categories, respectively. RESULTS: Based on self-reported information alone, at 1 year, 73% participants had not changed, 15% declined, 6% improved, and 6% died. At 4 years, 53% had not changed, 24% declined, 2% improved, and 22% died. Based on performance-based assessment alone, at 4 years, 33% of the sample remained stable, 37% declined, 6% improved, and 24% died. In the top two self-reported categories, functioning on the performance-based assessment varied widely. Among those who were independent in all self-reported functioning, approximately 40% scored in each of the top two performance-based categories. Among persons in the top two self-reported categories, poorer performance was associated with progressively higher 1-year and 4-year mortality rates. Among persons with impaired mobility and at least 1 ADL dependency, the mortality rate was high and was not influenced by performance-based score. CONCLUSIONS: Combining self-reported and performance-based measurements can refine prognostic information, particularly among older persons with high self-reported functioning. However, if ADL dependency is present, performance-based measures do not add prognostic value regarding mortality.

Preference and compliance in postoperative thromboembolism prophylaxis among gynecologic oncology patients.

OBJECTIVE: To compare low molecular weight heparin and external pneumatic compression in terms of patient preference and compliance to determine if either of these two methods is superior in postoperative thromboembolism prophylaxis of gynecologic oncology patients. METHODS: A total of 211 patients undergoing major surgery for a suspected gynecologic malignancy were randomized to receive thromboembolism prophylaxis with either external pneumatic compression or low molecular weight heparin. Surveys regarding thromboembolism prophylaxis were completed by patients before surgery and approximately 7 days postoperatively. Patient preferences as well as reasons for patient dissatisfaction with prophylactic methods were elicited in the questionnaires. In addition, patient compliance with prophylaxis was recorded twice a day during hospitalization. Patients were not considered to be compliant with prophylaxis if the external pneumatic compression device was not functioning properly or if the administration of low molecular weight heparin was not given in a timely manner. RESULTS: The majority of patients were satisfied with the prophylactic method that they received to the extent that they would prefer the treatment they received to one they had not necessarily experienced. The postoperative preferences of 78% of patients receiving low molecular weight heparin and 74% of those wearing external pneumatic compression corresponded to what the patients actually received as a method of thromboembolism prevention. Patient compliance with prophylaxis was noted to be inadequate in ten of 104 (9.6%) patients receiving external pneumatic compression and seven of 103 (6.8%) patients receiving low molecular weight heparin. CONCLUSION: Pneumatic compression and low molecular weight heparin are similar both in terms of patient preference and compliance among gynecologic oncology patients receiving postoperative thromboembolism prophylaxis.

The effect of self-reported and performance-based functional impairment on future hospital costs of community-dwelling older persons.

PURPOSE: We determined the prognostic value of self-reported and performance-based measurement of function, including functional transitions and combining different measurement approaches, on utilization. DESIGN AND METHODS: Our cohort study used the 6th, 7th, and 10th waves of three sites of the Established Populations for Epidemiologic Studies of the Elderly, linked to 1- and 4-year Medicare Part A hospital costs. We examined mean hospital expenditures based on (a) 1- and 4-year transitions in self-reported functional status; (b) 4-year transitions in performance-based functional status; (c) combined baseline self-reported and performance-based functional status; and (d) poorest self-reported and performance-based functional status during a 4-year period. RESULTS: Even modest declines in self-reported or performance-based functional status were associated with increased expenditures. When baseline self-reported and performance-based assessments were combined, mean 1- and 4-year adjusted costs were higher with progressively worse performance-based scores, even among those who were independent in self-reported function. When the poorest 4-year self-reported and performance-based functions were examined, self-reported functioning was the most important determinant of hospital costs, but within each self-reported functional level, poorer performance-based function was associated with progressively higher costs. IMPLICATIONS: The costs associated with even modest functional decline are high. Combining self-reported and performance-based measurements can provide more precise estimates of future hospital costs.

The effect of external feedback on the management of medicare inpatients with congestive heart failure.

The purpose of this study was to compare the effect of 2 feedback strategies on the adherence to congestive heart failure (CHF) guidelines. Thirty-two hospitals in 4 states were randomized to receive either a written feedback intervention (low-intensity intervention [LII]) or an intervention involving feedback, a physician liaison, and quality improvement tools (high-intensity intervention [HII]). CHF quality indicators were assessed, and quality managers were interviewed at baseline and remeasurement. No significant changes in quality indicators were found as a result of either intervention. Seventy-eight percent of quality managers indicated that hospital project implementation had not begun until shortly before remeasurement. HII quality managers perceived the CHF project as significantly more successful compared with LII quality managers (63% versus 13%, P < .01). Evaluation of the effects of external feedback on practice behavior requires sufficient time for organizational and individual clinician change to occur. Physician liaisons may play a role in facilitating this change.

Expectations about insulin therapy, perceived insulin-delivery system social acceptability, and insulin treatment satisfaction contribute to decreases in insulin therapy self-efficacy in patients with type 2 diabetes after 36 weeks insulin therapy.

BACKGROUND: Self-efficacy plays a critical role in diabetes self-care. Herein we explore factors contributing to decreased insulin therapy self-efficacy in insulin-naïve patients with type 2 diabetes mellitus (T2DM) initiating and managing insulin therapy over 36 weeks. METHODS: The study was conducted within an international, randomized clinical trial comparing two insulin therapies administered by insulin pen in patients with T2DM inadequately controlled with oral antihyperglycemic medications. Patients completed the Self-Efficacy about Insulin Therapy Questionnaire (SEITQ) at baseline and endpoint. Patients also completed patient-reported measures assessing expectations about insulin therapy at baseline and perceptions about insulin therapy and insulin-delivery system (IDS) satisfaction at endpoint. Baseline and endpoint SEITQ scores were compared. Using prespecified criteria, patients were classified as having "decreased" or "no change/improved" insulin self-efficacy. Demographic, clinical, and patient-reported variables were entered into a logistic regression model with decreased insulin self-efficacy (yes or no) as the dependent variable. RESULTS: Baseline and endpoint SEITQ data were available for 450 insulin-naïve T2DM patients (mean age 59 years; 53% female; 57% Caucasian; mean baseline HbA1c 9.4%; 80.0 mmol/mol). Insulin therapy self-efficacy improved from baseline to endpoint (74.0 vs 77.5; P<0.001). Logistic regression analysis indicated that lower IDS satisfaction (P<0.0001), lower IDS social acceptability (P=0.004), and more positive expectations of insulin therapy (P<0.0001) were associated with decreased insulin self-efficacy. CONCLUSIONS: A candid discussion between clinicians and their insulin-naïve T2DM patients about the benefits and challenges of insulin therapy may prevent unrealistic expectations that could potentially undermine insulin self-efficacy.