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Objectives: This study explored the decision-making experiences of patients and their partners or primary caregiver who opted for experimental active surveillance (instead of standard surgery) for the treatment of esophageal cancer., Methods: Seventeen couples participated. Semi-structured interviews were conducted on couples' joint experiences as well as their individual experiences. Preferred and perceived role in the treatment decision-making process was assessed using the adjusted version of the Control Preferences Scale, and perceived influence on the treatment decision was measured using a visual analog scale., Results: Couples reflected on the decision-making process as a positive collaboration, where patients retain their autonomy by making the final decision, and partners offer emotional support. Couples reported about an overwhelming amount and sometimes conflicting information about treatments among different hospitals and healthcare providers., Conclusions: Patients often involve their partner in decision-making, which they report to have enhanced their ability to cope with the disease. The amount and sometimes conflicting information during the decision-making process provide opportunities for improvement., Practice Implications: Couples can benefit from an overview of what they can expect during treatment course. If active surveillance becomes an established treatment option in the future, provision of such overviews and consistent information should become more streamlined., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

The transition from in-person to digital preoperative patient education requires effective methods for evaluating patients' understanding of the perioperative process, risks, and instructions to ensure informed consent. A knowledge questionnaire covering different anaesthesia techniques and instructions could fulfil this need. We constructed a set of items covering common anaesthesia techniques requiring informed consent and developed the Rotterdam Anaesthesia Knowledge Questionnaire (RAKQ) using a structured approach and Item Response Theory. A team of anaesthetists and educational experts developed the initial set of 60 multiple-choice items, ensuring content and face validity. Next, based on exploratory factor analysis, we identified seven domains: General Anaesthesia-I (regarding what to expect), General Anaesthesia-II (regarding the risks), Spinal Anaesthesia, Epidural Anaesthesia, Regional Anaesthesia, Procedural sedation and analgesia, and Generic Items. This itemset was filled out by 577 patients in the Erasmus MC, Rotterdam, and Albert Schweitzer Hospital, Dordrecht, the Netherlands. Based on factor loadings (≥0.25) and considering clinical relevance this initial item set was reduced to 50 items, distributed over the seven domains. Each domain was processed to produce a separate questionnaire. Through an iterative process of item selection to ensure that the questionnaires met the criteria for Item Response Theory modelling, 40 items remained in the definitive set of seven questionnaires. Finally, we developed an Item Response Theory model for each questionnaire and evaluated its reliability. 1-PL and 2-PL models were chosen based on best model fit. No item misfit (S-χ2, p<0.001 = misfit) was detected in the final models. The newly developed RAKQ allows practitioners to assess their patients' knowledge before consultation to better address knowledge gaps during consultation. Moreover, they can decide whether the level of knowledge is sufficient to obtain digital informed consent without face-to-face education. Researchers can use the RAKQ to compare new methods of patient education with traditional methods., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: JK was an unpaid medical adviser for NovaCair B.V., a developer of digital preoperative screening software. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 van den Heuvel et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Purpose: Clear information and supportive care are necessary for patients with cancer to effectively manage their condition. Traditionally, healthcare professionals offer information and support via the so-called formal care route. In addition, research has found favorable effects of informal care provided by volunteer programs and informal "walk-in support centers." Less research has been done on initiatives that combine formal and complementary informal supportive care for patients with cancer. This systematic literature study aimed to discover (1) which types of initiatives are described in the literature, (2) what type of care they offer, and (3). how they are evaluated in terms of outcome measures., Methods: We performed a systematic literature search of MEDLINE, Embase, PsycINFO, and CINAHL. Studies were included if the collaboration between one type of formal care together with one type of informal care was explicitly mentioned in the article. The search was not restricted to a specific cancer type., Results: A total of 4869 records were retrieved and 18 studies were included. In most studies, the care provided consisted of emotional support for, and/or providing information to, patients and their families. Initiatives were evaluated with interviews and questionnaires. Patients with cancer reported that they were satisfied with the care offered, including information, social and emotional support, help with activities of daily living, and family-related issues. Volunteers reported that visits they made were experienced positive and rewarding and the volunteers were confident about their contribution to general healthcare. Some negative experiences were reported by volunteers, e.g., interference of their own cancer diagnosis with volunteer work. The importance of proper training was stressed., Conclusions: Initiatives combining formal and informal supportive care hold the potential of added value in terms of providing emotional support for, and providing information to, patients with cancer. Support and specific training for volunteers can be viewed as success factors in the involvement of volunteers in formal care practices., (© 2022. The Author(s).)

Integrated inpatient medical and psychiatric care units (IMPUs) are hospital wards that care for inpatients with both acute general medical and psychiatric disorders. IMPU development has stalled, and wide variation in IMPU designs may reflect the fact that IMPUs are still in an early evolutionary stage. High-quality evidence concerning the costs and effectiveness of IMPUs is sparse, because IMPUs do not lend themselves well to traditional evidence-based medicine methods. As a result, most studies of IMPUs have been only observational. Therefore, it is time for a different approach, in which goals for IMPUs are explicitly formulated and IMPU research is incorporated into evidence-based practice (EBP) instead of evidence-based medicine. EBP can be viewed as integrating best available evidence into organizational practices by using four pillars of evidence: organizational, experiential, stakeholder, and scientific. Such types of evidence require an investment in describing the field more precisely. When pragmatic reasoning, where clinical expertise and organizational needs determine IMPU designs, is replaced with EBP, researchers can more effectively perform studies that may convince health care policy makers that IMPUs represent a cost-effective way to improve patients' health and that they increase the well-being of both patients and hospital staff.

Research has shown that a home-based educational intervention for patients with chronic kidney disease results in better knowledge and communication, and more living donor kidney transplantations (LDKT). Implementation research in the field of renal care is almost nonexistent. The aims of this study were (1) to demonstrate generalizability, (2) evaluate the implementation process, and (3) to assess the relationship of intervention effects on LDKT-activity. Eight hospitals participated in the project. Patients eligible for all kidney replacement therapies (KRT) were invited to participate. Effect outcomes were KRT-knowledge and KRT-communication, and treatment choice. Feasibility, fidelity, and intervention costs were assessed as part of the process evaluation. Three hundred and thirty-two patients completed the intervention. There was a significant increase in KRT-knowledge and KRT-communication among participants. One hundred and twenty-nine out of 332 patients (39%) had LDKT-activity, which was in line with the results of the clinical trials. Protocol adherence, knowledge, and age were correlated with LDKT-activity. This unique implementation study shows that the results in practice are comparable to the previous trials, and show that the intervention can be implemented, while maintaining quality. Results from the project resulted in the uptake of the intervention in standard care. We urge other countries to investigate the uptake of the intervention., (© 2021 The Authors. Transplant International published by John Wiley & Sons Ltd on behalf of Steunstichting ESOT.)

Objective: The treatment of critical limb ischemia (CLI), with the intention to prevent limb loss, is often an intensive and expensive therapy. The aim of this study was to examine the cost-effectiveness of endovascular and conservative treatment of elderly CLI patients unsuitable for surgery., Methods: In this prospective observational cohort study, data were gathered in two Dutch peripheral hospitals. CLI patients aged 70 years or older were included in the outpatient clinic. Exclusion criteria were malignant disease, lack of language skills, and cognitive impairment; 195 patients were included and 192 patients were excluded. After a multidisciplinary vascular conference, patients were divided into three treatment groups (endovascular revascularization, surgical revascularization, or conservative therapy). Subanalyses based on age were made (70-79 years and ≥80 years). The follow-up period was 2 years. Cost-effectiveness of endovascular and conservative treatment was quantified using incremental cost-effectiveness ratios (ICERs) in euros per quality-adjusted life-years (QALYs)., Results: At baseline, patients allocated to surgical revascularization had better health states, but the health states of endovascular revascularization and conservative therapy patients were comparable. With an ICER of €38,247.41/QALY (∼$50,869/QALY), endovascular revascularization was cost-effective compared with conservative therapy. This is favorable compared with the Dutch applicable threshold of €80,000/QALY (∼$106,400/QALY). The subanalyses also established that endovascular revascularization is a cost-effective alternative for conservative treatment both in patients aged 70 to 79 years (ICER €29,898.36/QALY; ∼$39,765/QALY) and in octogenarians (ICER €56,810.14/QALY; ∼$75,557/QALY)., Conclusions: Our study has shown that endovascular revascularization is cost-effective compared with conservative treatment of CLI patients older than 70 years and also in octogenarians. Given the small absolute differences in costs and effects, physicians should also consider individual circumstances that can alter the outcome of the intervention. Cost-effectiveness remains one of the aspects to take into consideration in making a clinical decision., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The study aims were: to estimate the proportion of patients with an indication for admission to a new high acuity Medical Psychiatric Unit (MPU), to explore the reasons for MPU-admission according to different health disciplines, and to check for differences in patient characteristics. The results of this study are to be utilized in the proposed establishment of a high-acuity MPU in a University Medical Center. Such a unit currently does not exist at Erasmus MC., Methods: Hospital in-patients were included if they received psychiatric consultation from the Psychiatric Consultative Service (PCS). As part of the study protocol, psychiatrists, other medical specialists, and nurses determined the need for admission to the proposed MPU. Patient groups were compared with respect to diagnoses, socio-demographic characteristics and patient routing., Results: One hundred and fifty-one patients were included, 43% had an indication for MPU-admission, for the other patients PCS involvement was sufficient. There was agreement on suicide attempts as a reason for MPU-admission. For psychiatrists, the need for further diagnostic evaluation was a common reason for MPU admission, while other medical specialists more often emphasized the need for safety measures. Patients with an unplanned hospital admission had a higher chance of MPU eligibility (OR = 2.72, 95% CI 1.10-6.70). The main psychiatric diagnoses of MPU-eligible patients were organic disorders (including delirium), mood disorders, and disorders related to substance abuse. The most common diagnoses found were similar to those in previous research on MPU populations., Conclusion: Different medical disciplines have different views on the advantages of MPUs, while all see the need for such facilities. The proposed MPU should be able to accommodate patients directly from the Emergency Unit, and the MPU should provide specialized diagnostic care in an extra safe environment.

Objective: One of the spearheads of psychiatric healthcare in the Netherlands is hospital care for patients with a psychiatric comorbidity. In 2014, the Netherlands Psychiatric Association published ten field standards for Medical Psychiatric Units (MPUs). We catalogued healthcare in the Netherlands on the basis of these field standards., Design: Telephone screening, followed by a questionnaire investigation., Method: In the period May-August 2015, psychiatrists in 90 hospitals in the Netherlands were approached by telephone with 4 screening questions. If the department complied with the screening criteria for an MPU, a structured interview comprising 51 questions followed. The interview script was tested against the field standards using the Delphi method., Results: The screening identified 40 potential MPUs; 37 (92.5%) wards participated in the complete interview., Conclusion: MPUs are unevenly distributed across the country; care content is adequate, but education, tighter multidisciplinary cooperation and availability of somatic nursing expertise on every shift could improve care on MPUs. The departments should also pay more attention to care chain arrangements. The field standards are too stringent; these could be improved by defining 'essential care' and application of differentiated assessment of subcriteria.

Background: Literature is scarce on the palliative care experiences of patients with head and neck cancer. We report our experience in this patient population after the establishment of our Expert Center., Methods: We administered a questionnaire to 40 surviving relatives of patients with head and neck cancer after the establishment of our Expert Center and compared the results to a similar group of patients with head and neck cancer before the establishment of our Expert Center., Results: Since the establishment of our Expert Center, we found: an improved evaluation of the psychosocial support offered; better contact between head and neck surgeons, the patients, and families; and improvement in the quantity of information in the palliative phase. Some relatives, however, reported that patients received treatment against their wishes and life was not made as comfortable as possible., Conclusion: Important aspects of palliative care, such as psychosocial support and contact between patient and surgeon, have been improved since the establishment of our Expert Center., (© 2013 Wiley Periodicals, Inc.)

The field of clinical personality assessment is lacking in published empirical evidence regarding its treatment and clinical utility. This article reports on a randomized controlled clinical trial (N = 74) allocating patients awaiting treatment in a specialized clinic for personality disorders to either 4 sessions of (a) therapeutic assessment (TA) or (b) a structured goal-focused pretreatment intervention (GFPTI). In terms of short-term outcome, TA demonstrated superior ability to raise outcome expectancies and patient perceptions of progress toward treatment (Cohen's d = 0.65 and 0.56, respectively) and yielded higher satisfaction (d = 0.68). Moreover, patients reported marginally stronger alliance to the TA clinicians than to GFPT clinicians (d = 0.46), even though therapists perceived the alliance as equally positive in both groups. No differences in symptomatic ratings were observed. Results are discussed with reference to treatment utility in this particular patient group.

Objective: To assess the effectiveness of solution-focused therapy (SFT) on fatigue and quality of life (QoL) in patients with fatigued inflammatory bowel disease (IBD)., Design: Randomised controlled trial in two Dutch hospitals. Patients with IBD with quiescent IBD and with a Checklist Individual Strength--Fatigue (CIS--fatigue) score of ≥ 35 were enrolled. Patients were 1:1 randomised to receive SFT or care as usual (CAU) for 3 months. Patients were followed for a further 6 months after the SFT. Primary endpoint was defined as changes in fatigue and QoL during follow-up. Secondary endpoints included change in anxiety and depression, medication use, side effects to medication, disease activity, laboratory parameters (C-reactive protein, leucocytes and haemoglobin) and sleep quality., Results: Ninety-eight patients were included, of whom 63% were women, mean age was 40.1 years. After the SFT course, 17 (39%) patients in the SFT group had a CIS-fatigue score below 35 compared with eight (18%) of patients in the CAU group (p=0.03). The SFT group also showed a greater reduction in fatigue across the first 6 months compared with the CAU group (CIS-fatigue: p=<0.001 and CIS-total: p=0.001). SFT was associated with a significant higher mean IBD questionnaire change at 3 months (p=0.020). At 9 months, no significant differences between the two groups were observed., Conclusions: SFT has a significant beneficial effect on the severity of fatigue and QoL in patients with quiescent IBD. However, this effect diminished during follow-up.

Objective: To determine the reliability and internal validity of the Hypospadias Objective Penile Evaluation (HOPE)-score, a newly developed scoring system assessing the cosmetic outcome in hypospadias., Patients and Methods: The HOPE scoring system incorporates all surgically-correctable items: position of meatus, shape of meatus, shape of glans, shape of penile skin and penile axis. Objectivity was established with standardized photographs, anonymously coded patients, independent assessment by a panel, standards for a "normal" penile appearance, reference pictures and assessment of the degree of abnormality. A panel of 13 pediatric urologists completed 2 questionnaires, each consisting of 45 series of photographs, at an interval of at least 1 week. The inter-observer reliability, intra-observer reliability and internal validity were analyzed., Results: The correlation coefficients for the HOPE-score were as follows: intra-observer reliability 0.817, inter-observer reliability 0.790, "non-parametric" internal validity 0.849 and "parametric" internal validity 0.842. These values reflect good reproducibility, sufficient agreement among observers and a valid measurement of differences and similarities in cosmetic appearance., Conclusions: The HOPE-score is the first scoring system that fulfills the criteria of a valid measurement tool: objectivity, reliability and validity. These favorable properties support its use as an objective outcome measure of the cosmetic result after hypospadias surgery., (Copyright © 2013 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.)

Background: There has been discussion regarding the psychologic functioning of living donors who donate their kidney to an unrelated and unknown patient ("unspecified living donors"). This is the first prospective study to investigate group- and individual-level changes in psychologic functioning among a large group of unspecified donors., Methods: Forty-nine medically and psychologically screened unspecified living kidney donors completed the Symptom Checklist before and after donation., Results: Group-level analysis showed that overall psychologic symptoms increased after donation (P=0.007); the means remained within the average range of the normal population. Individual-level analysis showed that 33 donors showed no statistically significant change, 3 donors showed a statistically significant decrease, and 13 donors showed a statistically significant increase in psychologic symptoms. Two of the latter donors showed a clinically significant increase., Conclusions: We found more increases in psychologic symptoms than decreases, particularly if follow-up time was longer. However, for almost all donors, these increases were not clinically significant and the clinically significant changes found are comparable with natural fluctuations in psychologic symptoms in the general population. Possibly, the donors underreported their psychologic symptoms before donation to pass the screening. Due to the low level of predonation symptoms reported, regression to the mean could also explain the results. Although we found that changes were not associated with donation-related factors, it is possible that other donation-related factors or other life events not measured have an influence on psychologic functioning. Therefore, further research is needed to investigate whether the fluctuations are related to the donation process.

Background: Recent guidelines concerning the treatment of personality disorders (PDs) recommend diagnosing PDs in adolescents. However, it remains unclear whether these guidelines influence the current opinions and practices of mental health care professionals., Methods: Five hundred sixty-six psychologists completed an online survey concerning PDs in adolescents, of whom 367 professionals reported working with adolescents. The survey contained demographical questions (age, gender, profession, work setting) and specific questions related to PD in adolescence., Results: Although a majority of psychologists working with adolescents acknowledged the existence of PDs in adolescents (57.8%), only a small minority diagnoses PDs in adolescence (8.7%) and offers a treatment specifically aimed at targeting PD pathology (6.5%). Reasons for not diagnosing PDs in adolescence mainly concerned the belief that adolescent personality problems are transient (41.2%) and that the DSM-IV-TR does not allow diagnosing PDs in adolescence (25.9%)., Conclusions: Although practice guidelines might have influenced clinicians' opinions about PDs in adolescence, they have had little impact so far on routine clinical practice.

Background: Crohn's disease patients have a decreased Quality of Life (QoL) which is in part due to extreme fatigue. In a pilot study we prospectively assessed the feasibility and effect of psychological interventions in the management of fatigue., Methods: Patients with quiescent Crohn's disease and a high fatigue score according to the Checklist Individual Strength were randomized to Problem Solving Therapy (PST), Solution Focused Therapy (SFT) or to a control group (treatment as usual, TAU). Patients completed the Inflammatory Bowel Disease Questionnaire, the EuroQol-5D, and the Trimbos questionnaire for Costs., Results: Twenty-nine patients were included (12 TAU, 9 PST, 8 SFT), of these 72% were female, mean age was 31 years (range 20-50). The SFT group improved on the fatigue scale in 85.7% of the patients, in the PST group 60% showed improved fatigue scores and in the TAU group 45.5%. Although not significant, in both intervention groups the QoL increased. Medical costs lowered in 57.1% of the patients in the SFT group, in the TAU 45.5% and the in PST group 20%. The drop out rate was highest in the PST group (44%; SFT 12.5%; TAU 8.3%)., Conclusions: PST and SFT both positively affect the fatigue and QoL scores in patients with Crohn's disease. SFT seems most feasible with fewer dropouts and is therefore a promising new tool in the management of fatigue in Crohn's disease patients., (Copyright © 2011 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.)

Background: In primary care, up to 74% of physical symptoms is classified as unexplained. These symptoms can cause high levels of distress and healthcare utilization. Cognitive behavioral therapy has shown to be effective, but does not seem to be attractive to patients. An exception herein is a therapy based on the consequences model, which distinguishes itself by its labeling of psychosocial distress in terms of consequences rather than as causes of physical symptoms. In secondary care, 81% of the patients accepts this therapy, but in primary care the outcome is poor. We assume that positive outcome can also be reached in primary care, when the consequences model is modified and used bottom-up in an easily accessible group training, in which patients are relieved of being blamed for their symptoms. Our aim is to investigate the (cost-)effectiveness of this training., Methods and Design: A randomized controlled trial is designed. One hundred patients are randomized to either the group training or the waiting list. Physicians in general practices and outpatients clinics of general hospitals refer patients. Referral leads to inclusion if patients are between 18 and 65 years old, understand Dutch, have no handicaps impeding participation and the principal DSM-IV-TR classification is undifferentiated somatoform disorder or chronic pain disorder. In contrast to other treatment effect studies, the co-morbidity of a personality disorder does not lead to exclusion. By this, we optimize the comparability between the study population and patients in daily practice enlarging the generalization possibilities. Also in contrast to other effect studies, we chose quality of life (SF-36) instead of physical symptoms as the primary outcome measure. The SF-6D is used to estimate Quality Adjusted Life Years (QALYs). Costs are measured with the Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness. Measurements are scheduled at baseline, after the training or waiting list, three and twelve months after the training. The differences between measurements are analyzed according to the intention-to-treat principle. The cost-effectiveness is expressed as costs per QALY, using multiple sensitivity analyses on the basis of a probabilistic model of the trial., Discussion: If we show that our group training is (cost-)effective, more patients could be served, their quality of life could be improved while costs might be reduced. As the training is investigated in a heterogeneous patient group in the daily practice of a mental healthcare institution, its transfer to practice should be relatively easy., Trial Registration: Nederlands Trial Register, NTR1609.

Objective: To value EQ-5D health states by a general Dutch public. EQ-5D is a standardised questionnaire that is used to calculate quality-adjusted life-years for cost-utility analysis., Design: Descriptive., Method: A sample of 309 Dutch adults from Rotterdam and surroundings was asked to value 17 EQ-5D health states using the time trade-off method. Regression analysis was applied to the valuations of these 17 health states. By means of the estimated regression coefficients, which together constitute the so-called Dutch tariff, valuations can be determined for all possible EQ-5D health states. These values reflect the relative desirability of health states on a scale where 1 refers to full health and 0 refers to death. Societal valuations are necessary in order to correct life-years for the quality of life., Results: Complete data were obtained from 298 persons. Theywere representative for the Dutch population as far as age, gender and subjective health were concerned, but had a somewhat higher educational level. The estimated Dutch EQ-5D tariff revealed that the respondents assigned the most weight to (preventing) pain and anxiety or depression, followed by mobility, self-care and the activities of daily living. The Dutch tariff differed from the UK ('Measurement and Valuation of Health') tariff, which is currently used in Dutch cost-utility analyses. Compared to UK respondents, Dutch respondents assigned more weight to anxiety and depression and less weight to the other dimensions. Conclusion. The valuation of health states by this representative Dutch study group differed from the valuation that is currently used in Dutch cost-utility analyses.

In the Netherlands, cross-over kidney transplantation has been introduced as an extra option in the living kidney donation programme. In cross-over transplantation, patients who cannot be given their own partner's kidney for immunological reasons are given a kidney from the partner of another patient in exchange for a kidney from their own partner. There is no difference in the medical indications and contraindications between direct and indirect living donation. There are no ethical obstacles since the net gain for the two couples is no different from that of direct living kidney donation and because the exchange takes place on the basis of equality. One should be aware that the extra possibilities may result in more psychological pressure on potential donors. It is important that the donation procedures start at the same moment and that the wishes of patients and donors for anonymity be preserved. A successful cross-over kidney transplantation programme requires a large pool of donors and patients. Therefore, this has been organised in a national programme. The Dutch Transplantation Foundation is responsible for the allocation of cross-over kidneys. Organ trade will thus be impossible. The seven Dutch centres for kidney transplantation have developed a protocol.

In the Netherlands, the Priorities in Healthcare [Keuzen in de Zorg] Committee proposed that the prioritisation of healthcare interventions should in part be based on the criterion 'necessity'. However, this criterion has hardly ever been used. It was proposed that 'necessity' should be defined in terms of disease severity. This concept examines the fraction of expected quality-adjusted life years (QALY) that a patient will lose if the condition concerned is not treated. The following two possible applications for healthcare policy were studied. Firstly, relatively necessary care could be fully reimbursed, whereas less necessary care would only be reimbursed in part. Secondly, for relatively necessary interventions a lower cost-effectiveness threshold (relatively high costs per QALY for necessary care) could be accepted. In these cases the concept of disease severity provides a new feasible interpretation of the criterion 'necessity'.

Purpose: The purpose of this study was to compare quality of life in patients with and without various ischemic complications after infrainguinal bypass grafting surgery for occlusive vascular disease., Methods: A sample of patients (n = 746) randomized in the Dutch BOA study (n = 2645), a multicenter trial that compared the effectiveness of oral anticoagulant therapy with aspirin in the prevention of infrainguinal bypass graft occlusions, was entered in this study. On the basis of clinical outcomes of the trial, the patients were grouped as follows: patients with patent grafts (n = 409); patients with nontreated graft occlusions, subdivided into an asymptomatic group (n = 32) and a symptomatic group (n = 65); patients with subsequent revascularizations (n = 194); patients with amputations (n = 36); and patients with failed secondary revascularizations followed by secondary amputation (n = 38). In case an outcome event occurred, the patients were regrouped accordingly. Every half year, the patients completed a Short Form-36 and a EuroQol questionnaire. A multilevel model was used for repeated measure analysis., Results: The mean follow-up time was 21 months. The quality of life in patients with nontreated asymptomatic occlusions was roughly similar to the quality of life in patients with patent grafts. Patients with symptomatic nontreated occlusions had the lowest outcome with regard to pain as compared with the other groups. Furthermore, physical and social functioning was lower for these patients than for patients with patent grafts. Revascularizations, successful or not, negatively affected pain, social functioning, and physical and emotional role. After successful revascularization, some improvement was observed in pain, physical and social functioning, and general and mental health as compared with the group with nontreated symptomatic occlusions. Amputation deteriorated physical functioning strikingly, especially after failed secondary revascularization. These patients also had the lowest scores of all the groups in the dimensions of social functioning, physical and emotional role, and mental health. EuroQol score showed deterioration of quality of life after all events, except for asymptomatic occlusions. The same patterns emerged if we stratified our analysis according to the indication for the initial operation: claudication or limb salvage. Quality of life was constant over time in all the groups in the observed period., Conclusion: Quality of life in patients with asymptomatic occluded grafts is similar to quality of life in patients with patent grafts. Revascularization of symptomatic occluded grafts improves quality of life to a certain extent. Amputation, in particular after failed secondary revascularization, seemed to be the lowest possible outcome. The results of the Short Form-36 and EuroQol measurements were in line with the clinical expectations. The association of disease severity with scores on the instruments supports the construct validity of these outcome measures for an objective assessment of quality of life in controlled studies.