A Patient Reported Experience Measure (PREM) for use by older people in community services.

BACKGROUND: intermediate care (IC) services operate between health and social care and are an essential component of integrated care for older people. Patient Reported Experience Measures (PREMs) offer an objective measure of user experience and a practical way to measure person-centred, integrated care in IC settings. OBJECTIVE: to describe the development of PREMs suitable for use in IC services and to examine their feasibility, acceptability and scaling properties. SETTING: 131 bed-based and 143 home-based or re-ablement IC services in England. METHODS: PREMs for each of home- and bed-based IC services were developed through consensus. These were incorporated into the 2013 NAIC and distributed to 50 consecutive users of each bed-based and 250 users of each home-based service. Return rates and patterns of missing data were examined. Scaling properties of the PREMs were examined with Mokken analysis. RESULTS: 1,832 responses were received from users of bed-based and 4,627 from home-based services (return rates 28 and 13%, respectively). Missing data were infrequent. Mokken analysis of completed bed-based PREMs (1,398) revealed 8 items measuring the same construct and forming a medium strength (Loevinger H 0.44) scale with acceptable reliability (ρ = 0.76). Analysis of completed home-based PREMs (3,392 records) revealed a medium-strength scale of 12 items (Loevinger H 0.41) with acceptable reliability (ρ = 0.81). CONCLUSIONS: the two PREMs offer a method to evaluate user experience of both bed- and home-based IC services. Each scale measures a single construct with moderate scaling properties, allowing summation of scores to give an overall measure of experience.

Comparison of dobutamine-based and milrinone-based therapy for advanced decompensated congestive heart failure: Hemodynamic efficacy, clinical outcome, and economic impact.

BACKGROUND: The use of parenteral positive inotropic agents still remains a major component of therapy for patients with advanced decompensated congestive heart failure (CHF). However, no consensus guidelines have been developed for the appropriate selection of a first-line inotropic therapy. We sought to compare the clinical outcome and economic cost of dobutamine-based and milrinone-based therapy in patients with acute exacerbation of CHF. METHODS AND RESULTS: We retrospectively analyzed the outcome of 329 patients admitted to the heart failure unit with acute exacerbation of CHF. More patients were treated with dobutamine-based therapy (269/329, 81.7%) than with milrinone-based therapy (60/329, 18.3%). Both groups had similar baseline characteristics and similar hemodynamic profiles at baseline, with the exception of higher mean pulmonary arterial pressure in the milrinone group (47 mm Hg vs 42 mm Hg, P <.001). One hundred nine patients (40%) of the dobutamine group required parenteral nitroprusside for hemodynamic optimization compared with 11 patients (18%) in the milrinone group (P <.001). The use of parenteral nitroglycerin and dopamine was similar in both groups. There was no significant difference in the in-hospital mortality rate (dobutamine 7.8% vs milrinone 10%) or clinical outcome between the 2 groups. However, the average direct drug cost per patient was significantly reduced in the dobutamine group compared with the milrinone group ($45 +/- $10 vs $1855 +/- $350, P <.0001). CONCLUSION: Dobutamine-based therapy is an attractive approach for the treatment of decompensated advanced heart failure, achieving comparable clinical efficacy to milrinone with a significantly reduced economic cost.

Oral steroid pulse without taper for the treatment of asymptomatic moderate cardiac allograft rejection.

BACKGROUND: The most frequently administered treatment for asymptomatic ISHLT Grade 3A cardiac allograft rejection is intravenous steroids or oral steroid pulse with a taper. This study analyzes the efficacy of 3-day 100-mg course of prednisone without a tapered regimen for the treatment of asymptomatic moderate cardiac allograft rejection. METHODS: All new episodes of asymptomatic ISHLT Grade 3A rejections were treated with oral steroid pulse without taper, consisting of 100 mg of prednisone for 3 consecutive days followed by resuming the pre-rejection steroid dose on the fourth day. We retrospectively reviewed the histologic response of all treated episodes among all cardiac transplant recipients transplanted between January 1995 through December 1997 who were treated with triple therapy consisting of cyclosporine, azathioprine and steroids. Patients receiving additional or alternative immunosuppressives were excluded from the study. The treated episodes were analyzed as responders if the follow-up biopsy were Grade 0, 1A, 1B, or 2; treatment was counted as non-responders if the follow-up biopsy showed Grade 3A or higher. RESULTS: Of 230 cardiac transplant recipients, 100 patients received a 3-day 100 mg course of prednisone without taper for 174 new episodes of asymptomatic ISHLT Grade 3A rejection. The overall response rate was 75% (130/174 rejection episodes). A significant difference in the response rate was observed depending on the number of days post transplant. A comparison of the success rates among rejections which occurred > 90 days post transplant versus < 30 days revealed responses to be 88% versus 70% (p = 0.02); for rejections treated > 60 days post transplant versus < 30 days showed success rates of 84% versus 70% (p = 0.04). The mean age of the recipient revealed a trend to be lower among the non-responder group (49+/-12 years versus 53+/-9 years, p = 0.07). Having left ventricular assist device as a bridge to transplant did not significantly affect the treatment outcome. The response rates were 69% for the patients who required the assist device versus 77% for those not bridged (p = ns). There was no significant difference in the gender or the baseline immunosuppressive doses between the responders and non-responders. The cost of a 3-day outpatient, visiting nurse supervised intravenous steroid therapy versus 3 days of oral prednisone was $861 vs $6.88. CONCLUSION: Oral steroid pulse without taper is an effective and economical way to treat asymptomatic moderate grade cardiac allograft rejection. A 3-day course of 100 mg of prednisone without taper should be considered as first line of therapy for clinically stable form of moderate cardiac allograft rejection occurring > 60 days post transplant.

Cardiac transplantation at the Cleveland Clinic Foundation.

The past 15 years has seen a significant evolution of heart transplant patient selection criteria, definition of suitable donors, immunosuppressive strategies, infection prophylaxis and treatment, and post-transplant patient surveillance. Primarily important has been broadening of the donor suitability definition and an evolution toward transplanting more ill and hemodynamically unstable patients. Despite "pushing the envelope" with both patient and donor selection and with transplanted patients generally being more ill, we believe our outcomes at the Cleveland Clinic Foundation are exemplary. The one- and 3-year survival rates for 265 heart transplants performed during 1996-1998 were 88% and 81%, respectively. Key to the success of our program has been close interdisciplinary working relationships and respect, broad and expert consultative support services, a desire to investigate clinical challenges, and dedication to excellence. Of additional importance is the realization that no matter how difficult we believe our difficulties are, we realize that those of our patients are vastly greater.

Superiority of "triple" drug therapy in heart failure: insights from the PROVED and RADIANCE trials. Prospective Randomized Study of Ventricular Function and Efficacy of Digoxin. Randomized Assessment of Digoxin and Inhibitors of Angiotensin-Converting Enzyme.

OBJECTIVES: We sought to study the efficacy of "triple" therapy with digoxin, diuretic and angiotensin-converting enzyme inhibitor (ACEI) compared to other combinations of these drugs in patients with symptomatic left ventricular systolic dysfunction. BACKGROUND: Controversy continues concerning the role of combining digoxin with diuretic and ACEI in the initial management of patients with heart failure. METHODS: The study utilized data from two studies of digoxin efficacy: Prospective Randomized Study of Ventricular Function and Efficacy of Digoxin (PROVED) and Randomized Assessment of Digoxin and Inhibitors of Angiotensin-Converting Enzyme (RADIANCE). Worsening heart failure defined as augmentation of heart failure therapy or an emergency room visit or hospitalization for increased heart failure was the main outcome measure. RESULTS: A total of 266 patients comprising the four treatment groups of the combined PROVED (diuretic alone or digoxin and diuretic) and RADIANCE (ACEI and diuretic, or digoxin, diuretic and ACEI) trials were analyzed. Worsening heart failure occurred in only 4 of the 85 patients who continued digoxin, diuretic and ACEI therapy (4.7%) compared to 18 of the 42 patients (19%) on digoxin and diuretic therapy (p=0.009), to 23 of the 93 patients (25%) on ACEI and diuretic therapy (p=0.001) and to 18 of the 46 patients (39%) on diuretic alone (p < 0.001). Life table and multivariate analysis also demonstrated that worsening heart failure was least likely in patients treated with triple therapy (p < 0.01 vs. all other groups). CONCLUSION: Pending definitive, prospective clinical trials, our results argue for triple therapy as the initial management of patients with symptomatic heart failure due to systolic dysfunction.

Assessment of myocardial viability with 99mTc sestamibi in patients undergoing cardiac transplantation. A scintigraphic/pathological study.

BACKGROUND: 99mTc sestamibi and 201 Tl are tracers that allow equivalent detection of myocardial infarction. However, because sestamibi does not undergo as much time-dependent redistribution as does 201Tl, it has been considered suboptimal for the detection of myocardial viability. METHODS AND RESULTS: Fifteen consecutive patients with ischemic cardiomyopathy who underwent orthotopic cardiac transplantation received an intravenous injection of 99mTc sestamibi at 1 to 6 hours before transplantation. Rotational tomography of the excised, intact, native hearts was performed to quantify the extent of myocardial hypoperfusion. The hearts were then sliced and reimaged on a gamma camera, followed by pathological quantification of the extent and severity of scarred and normal myocardium. Samples of normally and abnormally perfused myocardium underwent gamma well counting to determine tissue radioactivity and were examined under light microscopy for delineation of myocardial structure after trichrome staining. The mean extent of scintigraphic scar quantified through the use of rotational tomography was 45 +/- 14% of the left ventricle and correlated closely with pathological scar size (r = .89), despite a slight overestimation. Scintigraphic scar size determined with planar imaging of the individual myocardial slices also correlated closely with pathological scar size (r = .88). A good correlation existed between tissue 99mTc sestamibi activity determined through well counting and histological evidence of myocardial viability (r = .89). Most hypokinetic and 40% of akinetic/dyskinetic myocardial segments contained scintigraphically and histologically normal myocardium. CONCLUSIONS: 99mTc sestamibi scintigraphy can be used to accurately quantify the extent of myocardial scarring. Furthermore, the relative sestamibi activity in perfusion defects, measured several hours after administration, is a good indicator of myocardial viability determined with microscopy.

Economic outcomes of withdrawal of digoxin therapy in adult patients with stable congestive heart failure.

OBJECTIVES: This study sought to analyze the health and economic outcomes of withdrawal of digoxin therapy among U.S. adult patients with stable congestive heart failure. BACKGROUND: New information regarding the outcomes of digoxin withdrawal has been provided by the Prospective Randomized Study of Ventricular Failure and Efficacy of Digoxin (PROVED) and Randomized Assessment of Digoxin and Inhibitors of Angiotensin-Converting Enzyme (RADIANCE) trials. We interpreted and extrapolated the results of these trials to describe implications on a national level. METHODS: We used a decision-analytic model to estimate the outcomes of two alternative strategies to 1) continue and 2) withdraw digoxin in patients with congestive heart failure with normal sinus rhythm, New York Heart Association functional class II or III and left ventricular ejection fraction < or = 35%. Epidemiologic assumptions were derived from published reports and expert opinion. Assumptions regarding the effectiveness of digoxin therapy were derived from the RADIANCE and PROVED digoxin withdrawal trials. Hospital and Medicare data were used for economic assumptions. Calculated outcomes included treatment failures, cases of digoxin toxicity and health care costs. RESULTS: The continuation of digoxin therapy in these patients with congestive heart failure nationally would avoid an estimated 185,000 clinic visits, 27,000 emergency visits and 137,000 hospital admissions for congestive heart failure. After accounting for an estimated 12,500 cases of digoxin toxicity, the net annual savings would be $406 million, with a 90% range of uncertainty of $106 to $822 million. One-way sensitivity analysis indicated that digoxin therapy is cost-saving when the assumed annual incidence of digoxin toxicity is < or = 33%. CONCLUSIONS: The continuation of digoxin therapy in patients with stable congestive heart failure should be strongly considered, because this strategy is likely to lead to both lower costs and greater health benefits on the basis of available information.

Magnetic resonance imaging for assessment of tissue rejection after heterotopic heart transplantation.

Detection of myocardial rejection is difficult in patients with heterotopic heart transplantation because of the complex vascular anatomy present after transplant surgery. To determine whether magnetic resonance imaging might be useful for the assessment of heart rejection, eight patients with heterotopic heart transplantation were serially studied on 27 occasions. One patient had two donor hearts implanted, which allowed the study of 33 donor hearts. Data acquisition was gated to the ECG signal of the donor heart. Heavily T2-weighted (TE = 90 ms) velocity compensated spin-echo images were obtained through the midportion of the donor heart to assess tissue rejection. Donor heart function was qualitatively measured by acquiring multiphasic gradient echo images at the same level. A myocardial/skeletal muscle signal intensity ratio was calculated for the donor heart and compared to results of right ventricular biopsy obtained within 24 hours of imaging. A change in signal intensity ratio of 0.14 or more exceeded normal signal variation. All three episodes of rejection detected by biopsy were detected by magnetic resonance imaging. In three instances a significant change in the signal intensity ratio was associated with clinical evidence of rejection and a negative biopsy. Two instances were treated with a steroid bolus, and the signal returned to baseline. In three other instances a significant change in the magnetic resonance imaging signal occurred without clinical or biopsy evidence of rejection. Cardiac toxoplasmosis was present in one of these cases, and signal intensity returned to baseline after treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Pressure sores. Epidemiology and current management concepts.

Pressure sores remain common, with a prevalence of 5 to 9% and more than 70% occurring in patients over 70 years of age. They are often falsely ascribed to poor nursing care, but can more usefully be regarded as a potentially preventable complication of an acute immobility illness. Prevention involves identification of patients at risk, appropriate nursing care measures and the use of special equipment. Much of the special equipment is excessively complex and not validated by clinical trial work. The airwave system, polystyrene bead bed system and Vaperm mattress have been best studied and are effective. Management of the established sore involves treatment of the underlying medical condition(s), attention to hydration and nutrition, prevention of further tissue trauma and the use of special dressings and procedures which facilitate the inflammatory repair response. There is considerable doubt about the use of 'traditional' wound applications such as gauze or chlorinated lime and boric acid solution ('Eusol'). An extensive range of newer products is now available but these have not yet been subjected to controlled clinical trials. A useful starting point is to classify pressure sores into 4 clinical types depending on amount of tissue damage and depth of ulcer. The least severe sore (type 1) can be protected using polyurethane film dressings. Deeper ulcers (types 2 and 3) can be easily and quickly treated by hydrocolloid or alginate dressings which optimise the local wound environment, thus facilitating tissue repair. However, there may be no satisfactory dressing for sacral (near-anal) sores which are more difficult to treat than those at other body sites because of dressing detachment. Cavity ulcers (type 4) can be managed with silastic foam or hydrocolloid or alginate dressings. Debridement of necrotic material is best done manually by scalpel/scissors, although streptokinase/streptodornase (Varidase Topical) may also help if used correctly. Antiseptics have little part to play and ulcers are best cleaned with warm normal saline. Systemic antibiotics are indicated only when surrounding cellulitis is present, although metronidazole is useful for malodorous sores.

Ethnic differences in sympathetic nervous system-mediated energy expenditure.

The impact of sympathetic nervous system (SNS) activity on energy expenditure (EE) was evaluated in nondiabetic Caucasian and Pima Indian men while on a weight-maintenance diet using two approaches as follows. 1) The relationship between 24-h EE, measured in a respiratory chamber, and 24-h urinary norepinephrine was studied in 36 Caucasians [32 +/- 8 (SD) yr, 95 +/- 41 kg, 22 +/- 13% fat] and 33 Pimas (29 +/- 6 yr, 103 +/- 28 kg, 30 +/- 9% fat). There was no difference between the two groups in 24-h EE (2,422 vs. 2,523 kcal/24 h) and in urinary norepinephrine (28 vs. 31 micrograms/24 h), even after adjusting for body size and composition. Twenty-four-hour EE correlated significantly with 24-h urinary norepinephrine in Caucasians (r = 0.78, P less than 0.001) but not in Pimas (r = 0.03), independent of fat-free mass (FFM), fat mass, and age. 2) The effect of beta-adrenoceptor blockade with propranolol (120 micrograms/kg FFM bolus and 1.2 micrograms.kg FFM-1.min-1 for 45 min) on the resting metabolic rate (RMR) was evaluated in 36 Caucasians (30 +/- 6 yr, 103 +/- 36 kg, 25 +/- 11% fat) and 32 Pimas (28 +/- 6 yr, 100 +/- 34 kg, 27 +/- 10% fat). The RMR was similar in the two groups (2,052 vs. 1,973 kcal/24 h) even after adjustment for FFM, fat mass, and age and dropped significantly after propranolol infusion in Caucasians (-3.9%, P less than 0.001) but not in Pimas (-0.8%, P = 0.07).(ABSTRACT TRUNCATED AT 250 WORDS)

Protein-induced changes in energy expenditure in young and old individuals.

Resting energy expenditure (EE) has recently been shown to be reduced in elderly human subjects even after adjustment for body size and composition. The present study extended this examination of EE in relation to age by comparing the thermic effect of a protein meal in young men (YM 20-26 yr, n = 9), old men (OM 70-89 yr, n = 9), and old women (OW 67-75 yr, n = 6). EE was measured before and from 1 to 6 h after presentation of 60 g protein and of a control noncaloric meal on separate occasions. Despite substantial differences in body size and composition, the protein-induced increment in EE was similar in all groups [maximum increase: YM 0.21 +/- 0.05, OM 0.17 +/- 0.12, and OW 0.17 +/- 0.04 (SE) kcal/min]. Although fasting plasma norepinephrine (NE) levels differed among all three groups (YM less than OM less than OW), NE concentrations were not affected by protein ingestion. Because protein administration acutely promotes synthesis of dopamine (DA) and serotonin (5-HT), which are both capable of stimulating EE, blockade of extraneuronal synthesis of DA and 5-HT with carbidopa, a competitive inhibitor of aromatic-L-amino acid decarboxylase, failed to suppress (and actually increased) postprandial EE. These data demonstrate that not all mechanisms responsible for EE decline with age and that protein-induced changes in EE are more a function of the oral load itself than of the size, age, or antecedent diet of the individual ingesting the protein.

Effect of diet on energy expenditure and plasma norepinephrine in lean and obese Pima Indians.

To assess whether thermogenesis or sympathetic nervous system (SNS) function might differ between lean and obese human subjects, studies of thermic and sympathetic responses to standard stimuli were undertaken in Pima Indians, an ethnic group with a high prevalence of obesity. Plasma levels of norepinephrine (NE) and energy expenditure at rest and in response to feeding, exercise, and graded infusions of NE were compared in five lean and five obese Indians during a period of weight maintenance (WM), after 3 weeks of overfeeding (OF) and, in the obese, also after 6 weeks of underfeeding (UF). Basal energy expenditure, when adjusted for fat free mass, was equivalent during WM and increased 3% with OF (P less than 0.01) in both groups. Thermic responses to exercise or a test meal did not differ in lean and obese and did not change with OF, while thermic responses to NE infusion fell during OF to a greater degree in obese than lean (P less than 0.05). A similar pattern (decreased effect in obese with OF) was also noted in the glycemic response to infused NE (P less than 0.05). Although not quantitatively different in lean and obese, the plasma NE concentration appeared to vary more in response to feeding or dietary alteration in the obese than lean, a finding that may reflect lower plasma clearance of NE in the obese. These studies, therefore, raise the possibility that overfeeding in obese Pima Indians may limit the contribution of sympathetically mediated thermogenesis to energy expenditure, though the implications of this for body weight regulation are speculative.

Left ventricular diastolic performance at rest and during exercise in patients with coronary artery disease. Assessment with first-pass radionuclide angiography.

We used first-pass radionuclide angiocardiography to assess filling fraction during the first third of diastole, peak filling rate and peak filling rate during the first third of diastole as indexes of left ventricular diastolic performance at rest and after upright bicycle exercise in 32 normal patients and 68 patients with coronary artery disease. The mean filling fraction was unchanged from rest to exercise in normal patients (47+/- 15% vs 46 +/- 13%; NS). Even in 49 coronary patients with normal (greater than or equal to 50%) ejection fraction at rest, filling fraction was less than that in normal patients at rest (35 +/- 11% vs 47 +/- 15%, p less than 0.001). Despite similar resting heart rates, patients with coronary disease had lower (p less than 0.001) peak filling rate and peak filling rate during the first third of diastole than normal patients. With exercise, filling fraction decreased (p less than 0.001) from the resting value in coronary patients. These data suggest that (1) indexes of diastolic performance can be noninvasively assessed at rest and during exercise using first-pass radionuclide angiocardiography, (2) abnormalities in early diastolic performance are often present at rest in patients with coronary artery disease despite normal systolic performance, and (3) exercise-induced ischemia results in increased early diastolic dysfunction in patients with coronary disease.

Assessment of pulsed Doppler echocardiography in detection and quantification of aortic and mitral regurgitation.

Pulsed Doppler echocardiography was employed to detect disturbed or turbulent flow diagnostic of aortic or mitral regurgitation. Sensitivity, specificity, diagnostic accuracy, and predictive value were assessed by the independent interpretation and comparison of aortic root angiograms (91 patients) and left ventriculograms (94 patients) to the time interval histogram display of the pulsed Doppler. Sensitivity of Doppler in detecting mitral regurgitation was 94 per cent, with specificity 89 per cent, predictive value 81 per cent, and diagnostic accuracy 90 per cent (32 patients with, 62 without regurgitation). In aortic regurgitation, sensitivity was also 94 per cent, specificity 82 per cent, predictive value 94 per cent, and the diagnostic accuracy was 91 per cent (69 patients with, 22 without aortic regurgitation). Additionally, no Doppler evidence of mitral or aortic regurgitation was present in 20 normal subjects. The aetiology of left-sided valvular regurgitation varied widely, with prosthetic valvular insufficiency being the cause of mitral and aortic regurgitation in seven and 10 patients, respectively. Sixteen of 17 (94%) paraprosthetic leaks were correctly identified by pulsed Doppler. In patients with aortic regurgitation the flow-velocity curve recorded in the ascending aorta frequently showed a negative (or reversed) diastolic component, the magnitude of which (expressed as percentage negative area) correlated significantly with angiographic severity of regurgitation. Thus, pulsed Doppler echocardiography is a highly accurate and objective non-invasive technique for detecting mitral and aortic regurgitation. In aortic regurgitation, estimation of severity is possible from inspection of the Doppler ascending aortic flow velocity curve.