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The aim of the present study was to assess the effect of lung transplantation (LgTX) on health-related quality of life (HRQL) in a group of patients with cystic fibrosis (CF), compared to patients with other diagnoses (non-CF). HRQL was assessed before transplantation in a group of 32 CIF patients and 183 non-CF patients. After LgTX, we conducted a prospective longitudinal study among 10 CF patients and 35 non-CIF patients who survived at least 31 months after LgTX. Measures were the Nottingham Health Profile (NHP), the State-Trait Anxiety Inventory (STAI), the Self-Rating Depression Scale (ZUNG), the Index of Well-Being (IWB), and the Karnofsky Performance Index. Patients in the CIF group were younger, spent more days on the waiting list, and were more likely to be working or going to school than patients with other indications. Before transplantation, CIF patients and non-CF patients experienced restrictions on almost all HRQL measures, compared to the general population. On the NHP dimensions of mobility and energy, CF patients had significantly better scores than non-CF patients. Between 1-4 months after transplantation, scores on the NHP, ZUNG, and Karnofsky performance indices improved, and STAI and IWB scores even occurred within the reference value in both groups. Significantly better scores in the CIF group compared to the non-CIF group were found on the NHP dimension of mobility 4 months after transplantation, and on the dimension of sleep 7 and 13 months after transplantation. Scores remained more or less stable overtime in both groups. It may be concluded that patients in both groups experience major restrictions in HRQL before transplantation. However, pretransplant non-CF patients experience more restrictions than CIF patients. After LgTX, both groups of patients showed substantial improvement in HRQL, and this improvement was maintained until 31 months after LgTX. (C) 2004 Wiley-Liss, Inc.

This study investigated the psychometric adequacy of the (modified) Amsterdam Inventory for Auditory Disability and Handicap ((m)AIAD). The original version of the AIAD was developed by Kramer et al in 1995. Special emphasis was placed on the statistical aspects of the scores, because these properties place limits on the clinical utility of the instrument. The AIAD is a self-assessment questionnaire that consists of 30 questions covering all the relevant factors of disability in individual hearing functioning in daily life. This paper reports data from 94 subjects, aged 17-65 years, with different hearing abilities, who completed a modified version of the AIAD and the Hearing Disability Questionnaire (HDQ), on two occasions 1 month apart. The psychometric adequacy of the AIAD was determined by measuring its reliability and validity. Factor analysis was performed, and the reliability was tested by measuring, internal consistency, split-half correlation, and test-retest reproducibility. The validity was tested by measuring construct and criterion validity. The results showed that the reliability of the (m)AIAD was highly satisfactory, with good internal consistency, high split-half correlations, and high test-retest correlations. Construct validity showed a high correlation between scores on the (m)AIAD and scores on the HDQ. Criterion validity showed a moderate but significant correlation between scores on the (m)AIAD and hearing thresholds in dB HL.

Objective: To examine the cost-effectiveness of Hallucination focused Integrative Treatment (HIT) in patients with schizophrenia and a history of persistent auditory hallucinations. Method: Costs, in and outside the health care sector, and outcomes were registered prospectively during a period of 18 months for patients who received the HIT programme and for patients in the care as usual (CAU) condition. The Positive and Negative Syndrome Scale (PANSS) was used as main outcome measure in the cost-effectiveness analysis. Bootstrap analyses provided additional information on the skewly distributed costs. Results: Mean costs per patient in the HIT group ($18 237) were lower than the mean costs per patient in the CAU group ($21 436). Results of the PANSS were slightly in favour of the HIT group. Conclusion: There appears to be no significant cost-effectiveness advantage of the HIT programme over CAU. Additional analyses indicated that future application of the HIT programme will, in most cases, lead to a reduction of (non) medical costs.

This study was performed to assess the main reasons for the unfavorable cost effectiveness of lung transplantation compared with that of heart and liver transplantation. Costs, effects, and cost-effectiveness ratios of Dutch lung, heart, and liver transplantation programs were compared. The data are based on three Dutch technology assessments of transplantation, with minor adjustments for time and methods. In result, mainly follow-up costs of lung transplantation are higher than costs of heart and liver transplantation - US $150,300, US $121,500, and US $95,300, respectively - in the first 3 years after transplantation. The survival gain realized by lung transplantation is small (4.4 years) compared with heart (8.8 years) and liver (14.7years) transplantation. Costs per life-year gained were US $77,000, US $38,000, and US $26,000 for lung, heart, and liver transplantation, respectively. The unfavorable cost effectiveness of lung transplantation is largely related to a relatively small survival gain and high follow-up costs.

The aim of this study was to examine the long-term effect of lung transplantation on Health Related Quality of Life by studying 28 patients who survived at least 55 months after lung transplantation. Measures included the Nottingham Health Profile, questions concerning lung-specific problems, the State-Trait Anxiety Inventory, the Self-rating Depression Scale, the Index of Well-Being, the Karnofsky performance index, and questions concerning activities of daily life. Furthermore, comorbid conditions were measured. Before transplantation patients reported restrictions on almost all quality of life measures. Until approximately 43 months after transplantation there were significant improvements on most dimensions of the Nottingham Health Profile and more patients could walk without dyspnea. Significant improvements occurred with regard to the levels of anxiety, depression, and well being, and the scores on the Karnofsky performance index improved. Activities of daily life could be performed without help by most patients. After approximately 43 months patients experienced more dyspnea, anxiety, depression, and a lower level of well being. The number of patients suffering from a decrease of kidney function, drug treated hyperlipidemia, insulin dependent diabetes mellitus and bronchiolitis obliterans syndrome increased. It may be concluded that patients experience a stable and better overall quality of life after transplantation. Long-term after lung transplantation patients experience a decline on several dimensions of quality of life, which may be explained by an increase of comorbid conditions and Bronchiolitis Obliterans Syndrome. 2003 Elsevier Science Inc. All rights reserved.

Background: In lung transplantation (LTx), allocation of donor lungs is usually based on blood group, height and waiting time. Long waiting times favor patients with a slowly progressive end-stage lung disease and make the current allocation system the subject of discussion. In an attempt to equalize the chances for transplantation for every patient, irrespective of diagnosis, we investigated the effect of diagnosis-dependent prioritization on the waiting list, using a simulation model. Methods: For the main disease categories on the waiting list, the relative risks of dying while on the waiting list were calculated using empirical data from the Dutch LTx program gathered over a period of 10 years. In a microsimulation model of the Dutch LTx program based on data from the actual situation, patients with diagnoses associated with a statistically significant increased risk of death while on the waiting list were prioritized by multiplying the time on the waiting list by the relative risk. Results: Relative risks of death on the waiting list were increased significantly in patients with cystic fibrosis, primary pulmonary hypertension and pulmonary fibrosis. Prioritization resulted in an increased chance of transplantation for the prioritized diagnoses and a decreased chance for the non-prioritized diagnoses. The distribution of diagnoses after LTx was almost equal to the distribution of diagnoses on the waiting list. Conclusion: The simulated method of prioritization on the waiting list is a step forward to a more equitable allocation of donor lungs. Moreover, this method is clinically feasible, as long as the waiting list is updated frequently.

Objective., To determine the efficacy of selective decontamination of the digestive tract (SDD) in patients undergoing elective transplantation of the liver. Design: Randomized, double-blind, placebo-controlled study. Setting. Two academic teaching hospitals. Patients. Adult patients undergoing elective liver transplantation: 26 patients receiving SDD and 29 patients receiving a placebo. Interventions: Patients undergoing SDD were administered 400 mg of norfloxacin once daily as soon as they were accepted for transplantation, Postoperative treatment for this group consisted of 2 mg of colistin, 1.8 mg of tobramycin, and 10 mg of amphotericin B, four times daily, combined with an oral paste containing a 2% solution of the same drugs until postoperative day 30. Prophylactic Intravenous administration of antibiotics was not part of the SDD regimen in this study. Control patients were given a similar regimen with placebo drugs. Measurements: The mean number of postoperative bacterial and fungal infections in the first 30 days after transplantation was the primary efficacy end point. Days on a ventilator, days spent in the intensive care unit, and medical costs were registered as secondary outcome variables. Main Results. Of the 26 patients undergoing SOD, 22 (84.5%) developed an infection in the postoperative study period; In the placebo group (n = 29), these numbers were not significantly different (25 patients, 86%). The mean number of postoperative infectious episodes per patient was also not significantly different: 1.77 (SDD) vs. 1.93 (placebo), Infections Involving Gram-negative aerobic bacteria and Candida species were significantly less frequent in patients receiving SOD (p Conclusions. Selective decontamination of the digestive tract does not prevent Infection in patients undergoing elective liver transplantation and increases the cost of their care. It does, however, affect the type of infection. Infections with Gram-negative bacilli and with Candida species are replaced by infections with Gram-positive cocci.

Objective To describe the epidemiology and causes of graft loss after pediatric liver transplantation and to identify risk factors. Summary Background Data Graft failure after transplantation remains an important problem. It results in patient death or retransplantation, resulting in lower survival rates. Methods A series of 157 transplantations in 120 children was analyzed. Graft loss was categorized as early (within 1 month) and late (after 1 month). Risk factors were identified by analyzing recipient, donor, and transplantation variables. Results Kaplan-Meier 1-month and 1 -, 3-, and 5-year patient survival rates were 85%, 82%, 77%, and 71%, respectively, Graft survival rates were 71%, 64%, 59%, and 53%, respectively. Seventy-one of 157 grafts (45%) were lost 18 (25%) by death of patients with functioning grafts and 53 (75%) by graft-related complications. Forty-five grafts (63%) were lost early after transplantation. Main causes of early loss were vascular complications, primary nonfunction, and patient death. Main cause of late graft loss was fibrosis/cirrhosis, mainly as a result of biliary complications or unknown causes, Child-Pugh score, anhepatic phase, and urgent transplantation were risk factors for early loss, Donor age, clonor/recipient weight ratio, blood loss, and technical-variant liver grafts were risk factors for late loss, Conclusions To prevent graft loss after pediatric liver transplantation, potential recipients should be referred early so they can be transplanted in an earlier phase of their disease, Technical-variant liver grafts are risk factors for graft survival. The logistics of the operation need to be optimized to minimize the length of the anhepatic phase.

Whether lung transplantation improves Health-related Quality of Life in patients with emphysema and other end-stage lung diseases before and after lung transplantation was examined. Between 1992 and 1999, 23 patients with emphysema and 19 patients with other indications completed self-administered questionnaires before lung transplantation, and at 4, 7, 13, and 25 mo. after transplantation. The questionnaire included the Nottingham Health Profile, the State-Trait Anxiety Inventory, the Self-rating Depression Scale, the Index of Well-being, the Self-report Karnofsky Index, and four respiratory-specific questions. Neither before nor after transplantation were significant differences found on most dimensions of Health-related Quality of Life between patients with emphysema and other indications. Before transplantation, both groups report major restrictions on the dimensions Energy and Mobility of the Nottingham Health Profile, low experienced well-being, depressive symptoms, and high dyspnea, About 4 mo. after transplantation, most Health-related Quality of Life measures improved significantly in both groups. These improvements were maintained in the following 21 mo.

Objective: To assess the cost effectiveness of selective decontamination of the digestive tract (SDD) in liver transplant patients. Design: Randomised, placebo-controlled, double-blind trial with an integrated economic evaluation. Setting: Two university hospitals in The Netherlands. Cost effectiveness was assessed from a societal perspective. Patients and participants: 58 patients who underwent liver transplantation and received SDD (n = 29) or placebo (n = 29) pre- and postoperatively. Interventions: SDD medication and placebo. Main outcome measures: Infection episodes, days of infection, costs of SDD and routine cultures, mean other direct medical costs per patient and additional costs of severe infection. Results: Costs of SDD medicine and routine cultures were on average 3100 US dollars ($US; 1997 values) per patient who underwent SDD. Both preoperatively and postoperatively, costs other than SDD and cultures did not significantly differ between the SDD and the placebo groups (preoperative, $US2370 vs $US2590; postoperative, $US25 455 vs $US24 915). Additional postoperative costs of severe infections were $US250 per day per patient. There were no significant differences in the mean number of infection episodes between groups. Conclusions: SDD leads to the additional costs of SDD medication and routine cultures, whereas no savings in other costs and no improvement in infection episodes are realised. Consequently, SDD may be considered as a nonefficient approach in patients undergoing liver transplantation. The additional costs of severe infection are considerable.

Background To alleviate the shortage of size-matched whole-donor organs, too-large-for-size cadaveric donor grafts are modified by liver resection techniques. These modifications result in technical-variant liver transplantation (TVLTx). Patient and graft survival rates after TVLTx are considered comparable to those after full-size liver transplantation (FSLTx). However, morbidity after TVLTx is often underexposed. The aim of this study was to analyze the results of FSLTk and TVLTx in terms of patient and graft survival rates and morbidity. Methods. A consecutive series of 97 primary and elective pediatric liver transplantations performed in a single center was retrospectively analyzed. Forty-seven children had a FSLTx and 50 a TVLTx (38 reduced-size liver grafts and 12 split-liver grafts). The overall median follow-up period was 3.5 years. Results. There were no differences in patient and graft survival rates between FSLTx and TVLTx. However, after TVLTx there was a significantly higher complication rate (1.42 vs. 0.81 after FSLTx). TVLTx is more hampered by biliary complications (30% vs. 17%), expressed by a higher incidence of cholangitis and leakage of bile. These complications led to a significantly higher incidence of sepsis (44% vs. 19%) and a significantly higher intervention rate (0.40 vs. 1.28) after TVLTx, There was no difference in the incidence of retransplantations between FSLTx and TVLTx. Conclusions. Both FSLTx and TVLTx offer the same prognosis in terms of patient and graft survival rates for children after a primary and elective liver transplantation. However, TVLTx has a higher morbidity.

Background: Because of the assumed beneficial effect of lung transplantation on survival, controlled trials to assess the therapeutic benefit of lung transplantation are considered to be unethical. Therefore other methods must be used to provide control data. In this study the effect of lung transplantation on survival for patients with end-stage pulmonary disease was analyzed, with waiting list survival rates used as control data. Methods: The analysis was based on 157 consecutive patients who were put on the waiting list of the Dutch lung transplantation program during the period November 1990 to January 31, 1996, of whom 76 underwent transplantation. Following the principles of control group estimation as set out in the context of heart transplantation, a stepwise approach was used to arrive at a multivariate time-dependent Cox regression model. The following prognostic variables were included in the analyses: age, forced expiratory volume in 1 second, partial pressure of carbon dioxide, partial pressure of oxygen, and diagnosis. Results: The 1- and 2-year waiting list survival rates were 78% and 58%, respectively. The 1- and 2-year transplantation survival rates (i.e., survival from placement on the waiting list, including posttransplantation survival) were 79% and 64%, respectively. The multivariate time-dependent Cox analysis showed that lung transplantation reduced the risk of dying by 55% (95% confidence interval, 3% to 79%). For patients with emphysema the risk of dying was estimated to be 77% lower than for patients with other diagnoses (96% confidence interval, 50% to 89%). Conclusions: With COX regression, adjusting for age, forced expiratory volume in 1 second, partial pressure of carbon dioxide, partial pressure of oxygen, and diagnosis, lung transplantation showed a statistically significant effect on survival in selected patients with end-stage pulmonary disease.

Study objectives: To calculate cost-effectiveness of scenarios concerning lung transplantation in the Netherlands. Design: Microsimulation model predicting survival, quality of life, and costs with and without transplantation program, based on data of the Dutch lung transplantation program of 1990 to 1995. Setting: Netherlands, University Hospital Groningen. Patients: Included were 425 patients referred for lung transplantation, of whom 57 underwent transplantation. Intervention: Lung transplantation. Results: For the baseline scenario, the costs per life-year gained are G 194,000 (G=Netherlands guilders) and the costs per quality-adjusted life-year (QALY) gained are G 167,000. Restricting patient inflow ("policy scenario") lowers the costs per life-year gained: G 172,000 (costs per QALY gained: G 144,000). The supply of more donor lungs could reduce the costs per life-year gained to G 159,000 (G 135,000 per QALY gained; G1=US$0.6, based on exchange rate at the time of the study). Conclusions: Lung transplantation is an expensive but effective intervention: survival and quality of life improve substantially after transplantation, The costs per life-year gained are relatively high, compared with other interventions and other types of transplantation. Restricting the patient inflow and/or raising donor supply improves cast-effectiveness to some degree. Limiting the extent of inpatient screening or lower future costs of immunosuppressives may slightly improve the cost-effectiveness of the program.

The costs, effects, and cost-effectiveness of the Dutch Lung Transplantation program were assessed. The results show that lung transplantation is a very costly intervention that improves survival and quality of life. Costs per life-year and per QALY gained were, respectively, US $90,000 and US $71,000.

Donor liver shortage is a persistent problem in liver transplantation. A more liberal donor acceptance policy may be a possible solution. However, this might put recipients at risk for initial poor function or even non-function of the graft. Therefore risk factors for initial graft dysfunction should be identified, preferably by using an uniform definition of primary graft dysfunction or non-function. We retrospectively analysed 125 adult liver transplantations in order to identify risk factors for initial poor function and primary non-function. Donor, recipient pretransplant and surgical parameters were evaluated. Since there is no consensus on the criteria of dysfunction we used two definitions known from literature. No risk factors for postoperative dysfunction could be identified for either of the two definition sets. Furthermore, the definition set that included ALAT, prothrombin time and bile production in the first 72 h to identify poor graft function showed no relation with graft or recipient outcome. The other set, using ASAT and prothrombin time, determined from day 2 to day 7, showed that patients with a primary dysfunction had significantly higher morbidity and mortality compared to patients with a well functioning graft. We conclude that initial poor function after liver transplantation remains unpredictable, irrespective of the way it is defined. Moreover, our analysis shows that initial poor function can also develop in recipients that receive 'non-marginal' grafts without prolonged ischemia times. These results may support a more liberal selection of donor livers.

Despite an expanding number of centres which provide lung transplantation, information about the incremental costs of lung transplantation is scarce. From 1991 until 1995, in The Netherlands a technology assessment was performed which provided information about the incremental costs of lung transplantation. Costs in the situation with and without a transplantation programme were compared from a Lifetime perspective. Because randomization was ethically inadmissible, only costs in the situation with the programme were observed. Both conventional treatment costs and costs of the transplantation programme were registered. Costs in the situation without the programme were based on the conventional treatment costs in the situation with the programme. Due to the study period of four years, long term follow-up costs were estimated. The total incremental costs per transplanted patient were estimated at Dfl 466 767 (5% discounted costs). The main part of these costs was caused by the high costs during the Lifetime follow-up of the patients. (C) 1997 by John Wiley & Sons, Ltd.

Background - Pulmonary rehabilitation has been shown to have short term subjective and objective benefits for patients with chronic obstructive pulmonary disease (COPD). However, appropriately controlled studies have not previously been performed, nor have the benefits of different types of continuation programme for rehabilitation been investigated. Both these problems have been addressed in a single study of the long term effects of once monthly physiotherapy versus once weekly physiotherapy at home after a comprehensive home rehabilitation programme on quality of life and exercise tolerance in patients with COPD. Methods - Thirty six patients with severe airways obstruction (mean (SD) forced expiratory volume in one second (FEV(1)) 1.3(0.4)1, FEV(1)/inspiratory vital capacity (IVC) 37.2(7.9)%) were studied. Twenty three patients followed a rehabilitation programme at home for 18 months consisting of physiotherapy and supervision by a nurse and general practitioner. During the first three months all 23 patients visited the physiotherapist twice a week for a 0.5 hour session, Thereafter, 11 patients (group A) received a session of physiotherapy once weekly while 12 patients (group B) received a session of physiotherapy once a month. The control group C (13 patients) received no rehabilitation at all. Quality of life was assessed by the Chronic Respiratory Questionnaire, exercise tolerance by the six minute walking distance, and lung function by FEV(1) and IVC. Outcome measures were assessed at baseline and at three, six, 12, and 18 months. Results - Long term improvements in quality of life were found in patients in groups A and B, but not in those in group C compared with baseline, but these only reached significance in group B at all time points. Patients in group B had a higher quality of life than those in group C only at three and 12 months. There was a decrease in both six minute walking distance (at 12 and 18 months) and IVC (at three, 12, and 18 months) in patients in group C compared with the baseline measurement. Between groups analysis showed no differences for six minute walking distance, FEV(1), and IVC. Conclusions - This study is the first to show that rehabilitation at home for three months followed by once monthly physiotherapy sessions improves quality of life over 18 months. The change in quality of life was not associated with a change in exercise tolerance.

Background - Several studies have shown that both objective and subjective measurements are related to exercise capacity in patients with chronic obstructive pulmonary disease (COPD). In this study the relative contribution of lung function, maximal inspiratory pressure, dyspnoea, and quality of life to the performance in a walking distance test and a bicycle ergometer test was investigated. Methods - Static lung volumes, forced expiratory volume in one second (FEV(1)), inspiratory slow vital capacity (IVC), transfer factor for carbon monoxide (TLCO) divided by the alveolar volume (TLCO/VA), static compliance (Cst), and maximal inspiratory peak pressure (PImaxPOES) were measured in 40 patients with COPD with severe airways obstruction (mean FEV(1) 44% predicted, mean FEV(1)/IVC 37% predicted). Quality of life was assessed by the Chronic Respiratory Questionnaire (CRQ) and dyspnoea by the Borg category scale. Exercise capacity was measured by both a six minute walking distance (test) and a maximal work load of the bicycle ergometer test (Wmax). Results - Spirometric values and maximal inspiratory pressure were modestly correlated with both the six minute walking test and Wmax, r values ranging from 0.50 to 0.58. The TLCO was strongly correlated with the six minute walking test (r = 0.62) and with Wmax (r = 0.78). Quality of Life showed no correlation with exercise capacity, while there was a correlation between dyspnoea and the six minute walking test (r = -0.41). Backward linear regression analysis selected TLCO and PImaxPOES as the most significant determinants for exercise performance. They explained 54% and 69% of the variance in the six minute walking test and Wmax, respectively. Conclusions - The results show that exercise capacity in patients with COPD with severe airways obstruction is more strongly related to inspiratory muscle strength and lung function than to dyspnoea and quality of life. The significant correlation between dyspnoea and the six minute walking test suggests that subjective variables are more strongly related to walking tests than to bicycle ergometer tests.

The study investigated the effects of Obuchova's (1966, 1972) method of teaching children how to measure. The subjects were 30 kindergarten children who showed no pretest knowledge of either conservation or seriation. Children from the training condition (n = 15) received 3 1/2 weeks of training. Training appeared to be highly effective. A broad near-far transfer was observed; that is, skills were transferred to conservation tasks not taught in training. Far-far transfer (i.e., transfer to concepts not included in training) was also observed, because the children were able to solve a broad range of seriation tasks for which they had received no training. This is a noteworthy result, because far-far transfer has rarely been reported in training research. These effects persisted for 4 months. The educational importance of this result is that by means of a broadly designed course of training, strong and long-lasting near-far and far-far transfer effects may be induced. Training did not, however, evoke sleeper effects, because trained and untrained children performed at the same level 2 years after training.

In a clinical setting, the effect of Eurocollins (EC) and University of Wisconsin solution (UW) on liver grafts were studied in the early reperfusion phase of liver transplantation. Blood samples were drawn before and after declamping of the portal vein in a group of 11 transplants with EC-perfused livers, and a group of 12 transplants with UW-perfused livers. Parenchymal damage was assessed by the LDH, AST, and ALT, and purine degradation by measuring the uric acid levels. Metabolic function was determined by the serum bile acids and the plasma amino acids, i.e. (valine + leucine + isoleucine)/(phenylalanine + tyrosine) ratio. Donor and pretransplant recipient parameters were almost identical. The cold ischemia time of both groups differed significantly. The results show the following: a significant difference between both the LDH and the uric acid levels in the two groups was revealed, with a smaller increase of the LDH levels and no increase of the uric acid levels in the UW group. Metabolic activity, as measured from the bile acids and the amino acid profile in the peripheral blood, was identical in both groups. We conclude that both EC-stored and UW-stored liver grafts show immediate metabolic function after reperfusion. The amount of metabolic function was equal in both groups, notwithstanding longer cold ischemia time in the UW group. In addition, more parenchymal damage occurred in the EC group.