How are we measuring health-related quality of life in patients with a Barrett Esophagus? A systematic review on patient-reported outcome measurements.

PURPOSE: Barrett esophagus (BE) is associated with a significant decrease of health-related quality of life (HRQoL). Too often, patient-reported outcome measures (PROMs) are applied without considering what they measure and for which purposes they are suitable. With this systematic review, we provide researchers and physicians with an overview of all the instruments previously used for measuring HRQoL in BE patients and which PROMs are most appropriate from the patient's perspective. METHODS: A comprehensive search was performed to identify all PROMs used for measuring HRQoL in BE patients, to identify factors influencing HRQoL according to BE patients, and to evaluate each PROM from a patients' perspective. RESULTS: Among the 27 studies, a total of 32 different HRQoL instruments were identified. None of these instruments were designed or validated for use in BE patients. Four qualitative studies were identified exploring factors influencing HRQoL in the perceptions of BE patients. These factors included fear of cancer, anxiety, trust in physician, sense of control, uncertainty, worry, burden of endoscopy, knowledge and understanding, gastrointestinal symptoms, sleeping difficulties, diet and lifestyle, use of medication, and support of family and friends. CONCLUSION: None of the quantitative studies measuring HRQoL in BE patients sufficiently reflected the perceptions of HRQoL in BE patients. Only gastrointestinal symptoms and anxiety were addressed in the majority of the studies. For the selection of PROMs, we encourage physicians and researchers measuring HRQoL to choose their PROMs from a patient perspective and not strictly based on health professionals' definitions of what is relevant.

Cognitive behavioral therapy or graded exercise therapy compared with usual care for severe fatigue in patients with advanced cancer during treatment: a randomized controlled trial.

BACKGROUND: Cancer-related fatigue remains a prevalent and burdensome symptom experienced by patients with advanced cancer. Our aim was to assess the effects of cognitive behavioral therapy (CBT) or graded exercise therapy (GET) on fatigue in patients with advanced cancer during treatment with palliative intent. PATIENTS AND METHODS: A randomized controlled trial was conducted from 1 January 2013 to 1 September 2017. Adult patients with locally advanced or metastatic cancer who reported severe fatigue during treatment [Checklist Individual Strength, subscale fatigue severity (CIS-fatigue) ≥35] were accrued across nine centers in The Netherlands. Patients were randomly assigned to either 12 weeks of CBT or GET, or usual care (1 : 1: 1, computer-generated sequence). Primary outcome was CIS-fatigue at 14 weeks. Secondary outcomes included fatigue measured with the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC-QLQ-C30), quality of life, emotional functioning, physical functioning, and functional impairments at baseline, 14, 18, and 26 weeks. RESULTS: Among 134 participants randomized, the mean age was 63 (standard deviation 9) years and 77 (57%) were women. Common diagnoses included: breast (41%), colorectal (28%), and prostate cancer (17%). A total of 126 participants completed assessment at 14 weeks. Compared with usual care, CBT significantly reduced fatigue [difference -7.2, 97.5% confidence interval (CI) -12.7 to -1.7; P = 0.003, d = 0.7], whereas GET did not (-4.7, 97.5% CI -10.2 to 0.9; P = 0.057, d = 0.4). CBT significantly reduced EORTC-QLQ-C30 fatigue (-13.1, 95% CI -22.1 to -4.0; P = 0.005) and improved quality of life (10.2, 95% CI 2.4 to 17.9; P = 0.011) and physical functioning (7.1, 95% CI 0.5 to 13.7; P = 0.036) compared with usual care. Improvement in emotional functioning and decrease in functional impairments failed to reach significance. GET did not improve secondary outcomes compared with usual care. CONCLUSIONS: Among advanced cancer patients with severe fatigue during treatment, a CBT intervention was more effective than usual care for reducing fatigue. Following GET, patients reported lower fatigue, but results were not significant, probably due to a smaller sample size and lower adherence than anticipated. TRIAL REGISTRATION: Netherlands National Trial Register, identifier: NTR3812.

A simplified combination antiretroviral therapy regimen enhances adherence, treatment satisfaction and quality of life: results of a randomized clinical trial.

OBJECTIVES: The aim of the study was to investigate the effect of a simplified regimen, in terms of reducing pill burden, dietary requirements and possible adverse effects, on patients' adherence, treatment satisfaction and quality of life (QoL). METHODS: Antiretroviral-naïve patients who achieved a viral load < 50 HIV-1 RNA copies/ml after induction therapy with twice-daily (bid) lopinavir/ritonavir (LPV/r) and fixed-dose zidovudine (ZDV)/lamivudine (3TC) (CBV) were randomly assigned to continue CBV/LPV/r or switch to fixed-dose ZDV/3TC/abacavir (TZV). Patients completed standardized questionnaires on adherence, treatment satisfaction and QoL at randomization (between weeks 12 and 24) and at weeks 48, 72 and 96. RESULTS: Patients on CBV/LPV/r were more likely to have skipped medicines in the last week (P = 0.035) and during the preceding weekend (P = 0.027) than patients on TZV. Patients on CBV/LPV/r were significantly less satisfied with the convenience of their treatment (P = 0.004) and tended to be less satisfied with the side effects of their treatment (P = 0.091) and continuation of their present treatment (P = 0.056) than patients on TZV. Patients on CBV/LPV/r reported significantly lower levels of role functioning (P = 0.013) than patients on TZV. CONCLUSIONS: In this randomized controlled trial, simplification of therapy to fixed-dose TZV among patients with suppressed HIV RNA was perceived to be more convenient, and resulted in improved adherence and better role functioning, than continuing treatment with CBV/LPV/r.

Statistical or clinical improvement? Determining the minimally important difference for the vascular quality of life questionnaire in patients with critical limb ischemia.

OBJECTIVE: Interpreting whether changes in quality of life (Qol) in patients with peripheral arterial disease (PAD) are not only statistically significant but also clinically relevant, may be difficult. This study introduces the concept of the minimally important difference (MID) to vascular surgeons using Qol outcomes of patients treated for chronic critical limb ischemia (CLI). METHODS: The Vascular Quality of Life (VascuQol) questionnaire was recorded at baseline before treatment and after 6 months follow-up in consecutive patients with CLI treated between May 2007 and May 2010. Statistical significance of change in VascuQol score was tested with the Wilcoxon Signed Rank test. The MID for the VascuQol score was determined using a clinical anchor-based method and a distribution-based method. RESULTS: A total of 127 patients with CLI completed the VascuQol after 6 months. The VascuQol sum scores improved from 3.0 (range 1.1-5.9) at baseline to 4.0 (range 1.2-6.7) at 6 months (p < .001). The MID on the VascuQol sumscore indicating a clinically important change determined with the anchor-based method was 0.36, and with the distribution-based method was 0.48. On an individual level, depending on the method of determining the MID, this resulted in 60% to 68% of the patients with an important benefit. CONCLUSIONS: Expression of changes in Qol by means of the MID provides better insight into clinically important changes than statistical significance.

Supportive care for women with recurrent miscarriage: a survey to quantify women's preferences.

BACKGROUND: Supportive care is regularly offered to women with recurrent miscarriages (RMs). Their preferences for supportive care in their next pregnancy have been identified by qualitative research. The aim of this study was to quantify these supportive care preferences and identify women's characteristics that are associated with a higher or lower need for supportive care in women with RM. METHODS: A questionnaire study was conducted in women with RMs (≥ 2 miscarriages) in three hospitals in the Netherlands. All women who received diagnostic work-up for RMs from January 2010 to December 2010 were sent a questionnaire. The questionnaire quantified supportive care options identified by a previous qualitative study. We next analysed associations between women's characteristics (age, ethnicity, education level, parity, pregnancy during questionnaire and time passed since last miscarriage) and their feelings about supportive care options to elucidate any differences between groups. RESULTS: Two hundred and sixty-six women were asked to participate in the study. In total, 174 women responded (response rate 65%) and 171 questionnaires were analysed. Women with RM preferred the following supportive care options for their next pregnancy: a plan with one doctor who shows understanding, takes them seriously, has knowledge of their obstetric history, listens to them, gives information about RM, shows empathy, informs on progress and enquires about emotional needs. Also, an ultrasound examination during symptoms, directly after a positive pregnancy test and every 2 weeks. Finally, if a miscarriage occurred, most women would prefer to talk to a medical or psychological professional afterwards. The majority of women expressed a low preference for admission to a hospital ward at the same gestational age as previous miscarriages and for bereavement therapy. The median preference, on a scale from 1 to 10, for supportive care was 8.0. Ethnicity, parity and pregnancy at the time of the survey were associated with different preferences, but female age, education level and time passed since the last miscarriage were not. CONCLUSIONS: Women with RM preferred a plan for the first trimester that involved one doctor, ultrasounds and the exercise of soft skills, like showing understanding, listening skills, awareness of obstetrical history and respect towards the patient and their miscarriage, by the health care professionals. In the event of a miscarriage, women prefer aftercare. Women from ethnic minorities and women who were not pregnant during the questionnaire investigation were the two patient groups who preferred the most supportive care options. Tailor-made supportive care can now be offered to women with RM.

Neurobiological basis and risk factors of persistent fatigue and concentration problems after COVID-19: study protocol for a prospective case-control study (VeCosCO).

INTRODUCTION: The risk factors for persistent fatigue and cognitive complaints after infection with SARS-CoV-2 and the underlying pathophysiology are largely unknown. Both clinical factors and cognitive-behavioural factors have been suggested to play a role in the perpetuation of complaints. A neurobiological aetiology, such as neuroinflammation, could be the underlying pathophysiological mechanism for persisting complaints.To unravel factors associated with persisting complaints, VeCosCO will compare individuals with and without persistent fatigue and cognitive complaints >3 months after infection with SARS-CoV-2. The study consists of two work packages. The first work package aims to (1) investigate the relation between persisting complaints and neuropsychological functioning; (2) determine risk factors and at-risk phenotypes for the development of persistent fatigue and cognitive complaints, including the presence of postexertional malaise and (3) describe consequences of persistent complaints on quality of life, healthcare consumption and physical functioning. The second work package aims to (1) determine the presence of neuroinflammation with [18F]DPA-714 whole-body positron emission tomography (PET) scans in patients with persisting complaints and (2) explore the relationship between (neuro)inflammation and brain structure and functioning measured with MRI. METHODS AND ANALYSIS: This is a prospective case-control study in participants with and without persistent fatigue and cognitive complaints, >3 months after laboratory-confirmed SARS-CoV-2 infection. Participants will be mainly included from existing COVID-19 cohorts in the Netherlands covering the full spectrum of COVID-19 acute disease severity. Primary outcomes are neuropsychological functioning, postexertional malaise, neuroinflammation measured using [18F]DPA-714 PET, and brain functioning and structure using (f)MRI. ETHICS AND DISSEMINATION: Work package 1 (NL79575.018.21) and 2 (NL77033.029.21) were approved by the medical ethical review board of the Amsterdam University Medical Centers (The Netherlands). Informed consent is required prior to participation in the study. Results of this study will be submitted for publication in peer-reviewed journals and shared with the key population.

Patient preferences in screening for recurrent disease after potentially curative esophagectomy.

BACKGROUND: Routine imaging (RI) as part of follow-up after potentially curative esophagectomy is currently not widely accepted. If detected recurrent disease could be adequately treated, it remains unclear whether patients would want to take part in a screening program. The aim of this study was to determine the extent to which patients who underwent esophagectomy prefer follow-up with or without RI. METHODS: Patients who underwent esophagectomy for carcinoma without evidence of recurrent disease were included. An interview-administered questionnaire was used to assess fear of recurrence and elicit patient preferences for the frequency and duration of follow-up and hypothetical changes of survival chances (1-10%). RESULTS: 45/54 eligible patients (83%) participated in this study. The majority of patients preferred follow-up with RI (67%) even if screening would not provide a survival benefit; this proportion increased up to 93% if the proposed chances of survival improved. Younger patients and patients with a lower histopathological tumor stage were more likely to desire follow-up with RI. CONCLUSION: Most patients who underwent esophagectomy preferred RI as part of follow-up over outpatient clinic visits only, even if such screening would not provide a survival benefit. Further research is needed to determine the most accurate screening modality and most efficient follow-up interval.

Patient preferences for clean intermittent catheterisation and transurethral indwelling catheterisation for treatment of abnormal post-void residual bladder volume after vaginal prolapse surgery.

OBJECTIVE: To determine patient preferences for clean intermittent catheterisation (CIC) relative to transurethral indwelling catheterisation (TIC) as the treatment of abnormal post-void residual bladder volume (PVR) following vaginal prolapse surgery. DESIGN: Scenario-based preference assessment during face-to-face interview. SETTING: Teaching hospital. POPULATION: A sample of consecutive patients scheduled for vaginal prolapse surgery. METHODS: Preference for CIC relative to TIC was assessed using written treatment scenarios. Initially, treatment duration was set at 3 days and the risk for urinary tract infection (UTI) was 30% for both interventions. Both treatment duration and UTI risk related to TIC were kept constant. Treatment duration and UTI risk after CIC were varied until patients altered their preference. In this way, the duration of catheterisation and level of UTI risk related to CIC at which patients would prefer CIC to TIC could be determined. MAIN OUTCOME MEASURES: Patients' preference for CIC relative to TIC. RESULTS: When both duration of treatment and UTI risk were identical for both interventions, 64% of patients prefer CIC. Ninety-two percent of patients prefer CIC when CIC lasts 3 days but results in a 15% lower risk of UTI. Assuming that CIC results in a 15% risk of UTI, a total of 98 and 99% of patients prefer CIC to TIC when catheterisation with CIC last 2 and 1 day, respectively. CONCLUSIONS: Most patients with abnormal PVR prefer CIC to TIC. The results of a recent randomised controlled trial showed that CIC resulted in a 2 days shorter catheterisation and more than 20% reduced risk of UTI. These conditions correspond to a preference of 99% of patients for CIC.

What women want and why. Women's preferences for induction of labour or expectant management in late-term pregnancy.

BACKGROUND: Both induction of labour at 41 weeks and expectant management until 42 weeks are common management strategies in low-risk pregnancy since there is no consensus on the optimal timing of induction in late-term pregnancy for the prevention of adverse outcomes. Our aim was to explore maternal preference for either strategy and the influence on quality of life and maternal anxiety on this preference. METHODS: Obstetrical low-risk women with an uncomplicated pregnancy were eligible when they reached a gestational age of 41 weeks. They were asked to fill in questionnaires on quality of life (EQ6D) and anxiety (STAI-state). Reasons of women's preferences for either induction or expectant management were explored in a semi-structured questionnaire containing open ended questions. RESULTS: Of 782 invited women 604 (77.2%) responded. Induction at 41 weeks was preferred by 44.7% (270/604) women, 42.1% (254/604) preferred expectant management until 42 weeks, while 12.2% (74/604) of women did not have a preference. Women preferring induction reported significantly more problems regarding quality of life and were more anxious than women preferring expectant management (p<0.001). Main reasons for preferring induction of labour were: "safe feeling" (41.2%), "pregnancy taking too long" (35.4%) and "knowing what to expect" (18.6%). For women preferring expectant management, the main reason was "wish to give birth as natural as possible" (80.3%). CONCLUSION: Women's preference for induction of labour or a policy of expectant management in late-term pregnancy is influenced by anxiety, quality of life problems (induction), the presence of a wish for natural birth (expectant management), and a variety of additional reasons. This variation in preferences and motivations suggests that there is room for shared decision making in the management of late-term pregnancy.

Improving disease knowledge of primary sclerosing cholangitis patients and their relatives with a 3-dimensional education video.

OBJECTIVE: Primary sclerosing cholangitis is a severe liver disease. Liver transplantation is the only curative therapeutic option. The unpredictable disease course causes much uncertainty and anxiety among patients and relatives. Improved disease knowledge may result in better health outcomes. In PSC, there is lack of high quality patient education materials. The aim of this study was to evaluate the ability of a 3-dimensional education video to improve PSC knowledge in patients and relatives. METHODS: A digital survey containing questions about PSC, anxiety and satisfaction was sent prior to, directly after, and one week after watching the video. Both European and American patients and relatives were included. RESULTS: A total of 278 participants (224 patients and 54 relatives) were included. PSC knowledge score increased from 53 % to 74 % directly after and 70 % one week after the video. The STAI anxiety score decreased after the video (-0,8, p = 0,007). Younger age and lower baseline knowledge were independent predictors of knowledge improvement. CONCLUSION: Disease knowledge improved after watching the video and this was sustained one week later. Generally, patients were very enthusiastic about the video. PRACTICE IMPLICATIONS: 3D education videos can be useful to increase disease knowledge in a severe disease such as PSC.

Mediation analysis shows that a decline in self-efficacy mediates the increase in fatigue severity following an initial positive response to cognitive behavioural therapy in Q fever fatigue syndrome.

OBJECTIVE: Q fever fatigue syndrome (QFS) is characterized by chronic fatigue following acute Q fever. Previously, it was shown that cognitive behavioural therapy (CBT), and not doxycycline, was significantly more effective than placebo in reducing fatigue severity in QFS patients. However, this effect was not maintained after one year. The aim of this study is to elucidate the cognitive and behavioural variables which mediate the positive effect of CBT on fatigue during the treatment and the relapse of fatigue after completion of CBT, by using multiple mediation analysis. METHODS: Additional analyses were performed on data of a randomized controlled trial that investigated the efficacy of CBT and antibiotics compared to placebo for QFS [1]. Only those patients in the CBT group who completed the allocated CBT treatment, and those patients in the medication group who did not follow additional CBT during follow-up, were included in this study. Two mediation models were tested, using respectively assessments at baseline and end-of-treatment (EOT), and EOT and follow-up, comparing the CBT group (n = 43) with the medication group (n = 89). RESULTS: During treatment, the decrease in fatigue brought on by CBT was completely mediated by an increase in self-efficacy with respect to fatigue. A reduction in self-efficacy partly mediated the increase in fatigue at follow-up in the CBT group. CONCLUSIONS: Given the decline in self efficacy, booster sessions focussing on restoration and maintenance of self-efficacy with respect to fatigue, may lead to elongation of the initial positive effects of CBT for QFS.

Patient-Reported Outcomes of Bleomycin Sclerotherapy for Low-Flow Vascular Malformations and Predictors of Improvement.

PURPOSE: There is paucity of data on patient-perceived outcomes of bleomycin sclerotherapy for low-flow vascular malformations. In this study, the long-term outcomes of bleomycin sclerotherapy were investigated in terms of quality of life (QoL) and patient-perceived changes in health. MATERIALS AND METHODS: A cohort of Dutch patients with vascular malformations treated with bleomycin sclerotherapy (June 2010-November 2015) completed a questionnaire evaluating disease symptoms, QoL (Short Form 36), patient-perceived change in health status (Global Rating of Change scales) and treatment satisfaction. QoL was assessed for the patient's status before and after treatment and was analyzed relative to an age and sex-matched Dutch reference population. Predictive factors associated with QoL and patient-perceived improvement in overall health status were assessed using multivariable linear and logistic regression analyses, respectively. RESULTS: Seventy-seven patients, with a median follow-up of 22 months, were enrolled. About half of the respondents (49.3%) indicated that they perceived (any form of) improvement in their overall health status. Most often improved were the specific health aspects 'pain' (54.5%) and 'overall severity of symptoms' (57.1%). No factors were significantly predictive for patient-perceived improvement in health with respect to the vascular malformation. Impairment in work- or study-related activities prior to sclerotherapy was found to negatively impact physical QoL at follow-up (p = 0.03). CONCLUSION: Approximately half of patients with low-flow vascular malformations indicate an improvement in overall health status following bleomycin sclerotherapy, particularly concerning pain and severity of symptoms. However, most patients only perceived little to moderate improvement to their health and desire further treatment.

Preference for direct oral anticoagulants in patients treated with vitamin K antagonists for venous thromboembolism.

BACKGROUND: Direct oral anticoagulants (DOACs) are an alternative for vitamin K antagonists (VKA) in the treatment and prevention of venous thromboembolism (VTE). Patient preferences for treatment options have not been extensively explored. METHODS: A random sample of 200 patients was obtained from those treated with VKA for deep vein thrombosis, pulmonary embolism or both at the Thrombosis Service Amsterdam. Preference for DOACs relative to VKA was assessed using a treatment trade-off technique administered as a questionnaire sent to all patients. The trade-off consisted of four consecutive scenarios: 1 (no need for laboratory control), 2 (decreased bleeding risk), 3 (less interactions with food and other drugs), 4 (higher efficacy). RESULTS: The response rate was 68%. In scenario 1, 36% of patients would switch to a DOAC. This proportion rises to 57% (odds ratio [OR] 2.3; 95% confidence interval [CI] 1.6-3.3) for scenario 2. Scenario 3 resulted in 64% of patients preferring a DOAC (OR 3.2; 95%CI 2.2-4.6). The advantage of greater efficacy did not result in a noteworthy change in the preference. Patients who were less satisfied with their current treatment, who were younger and those with higher education were more likely to prefer a DOAC over a VKA. The variables gender, treatment duration, and type of VKA were not significantly associated with DOAC preference. CONCLUSION: Almost two-thirds of patients preferred DOACs over VKA. Patients considered the lack of regular laboratory monitoring, the lower risk of serious bleeding and less interactions with food and other drugs the most important arguments to switch to a DOAC.

Limited patient adherence to highly active antiretroviral therapy for HIV-1 infection in an observational cohort study.

BACKGROUND: Adherence to highly active antiretroviral therapy (HAART) for human immunodeficiency syndrome type 1 (HIV-1) infection is essential to sustain viral suppression and prevent drug resistance. We investigated adherence to HAART among patients in a clinical cohort study. METHODS: Patients receiving HAART had their plasma concentrations of protease inhibitors or nevirapine measured and completed a questionnaire on adherence. We determined the percentage of patients who reported taking all antiretroviral medication on time and according to dietary instructions in the past week. Drug exposure was compared between patients reporting deviation from their regimen and fully adherent patients. Among patients who received HAART for at least 24 weeks, we assessed the association between adherence and virologic outcome. RESULTS: A total of 224 of 261 eligible patients completed a questionnaire. Forty-seven percent reported taking all antiretroviral medication on time and according to dietary instructions. Patients who reported deviation from their regimen showed lower drug exposure compared with fully adherent patients (median concentration ratio, 0.81 vs 1.07; P =.001). Among those receiving HAART for at least 24 weeks, patients reporting deviation from their regimen were less likely to have plasma HIV-1 RNA levels below 500 copies/mL (adjusted odds ratio, 4.0; 95% confidence interval, 1.4-11.6) compared with fully adherent patients. CONCLUSIONS: Only half of the patients took all antiretroviral medication in accordance with time and dietary instructions in the preceding week. Deviation from the antiretroviral regimen was associated with decreased drug exposure and a decreased likelihood of having suppressed plasma HIV-1 RNA loads. Patient adherence should remain a prime concern in the management of HIV-1 infection.

When do patients prefer a direct oral anticoagulant over a vitamin K antagonist?

BACKGROUND: The reasons for patients to change their usual vitamin K antagonist (VKA) treatment to a direct oral anticoagulant (DOAC) are unexplored. METHOD: A random sample of 200 patients treated with VKAs for the indication of atrial fibrillation from the Thrombosis Service in Amsterdam was selected. A survey, using the treatment trade-off technique, was sent to participants. The trade-off included four scenarios: 1 (no need for laboratory controls); 2 (less bleeding); 3 (less interactions); 4 (more effective). RESULTS: Under scenario 1, 57% of the patients would have made the switch, with a further increase to 65% with scenario 2 (trend value, p = 0.006, 95% CI 1.11-1.85). In addition, in each scenario patients who were less satisfied with their current treatment were more likely to switch to a DOAC compared with satisfied patients. The variables duration of treatment, gender, age and educational level did not affect the preference for a DOAC. CONCLUSION: Patients considered no requirement for regular laboratory control and a lower risk of bleeding the most important arguments to switch to a DOAC.

Long-term quality of life outcomes in three antiretroviral treatment strategies for HIV-1 infection.

OBJECTIVE: To compare changes in quality of life (QoL) over 96 weeks in patients enrolled in a triple-therapy protocol, a treatment-intensification protocol, or an induction-maintenance therapy protocol, and to compare QoL between patients who continued and discontinued their antiretroviral regimen. PATIENTS: Naive patients enrolled in a triple-therapy protocol (zidovudine/lamivudine or stavudine/didanosine or stavudine/lamivudine supplemented with protease inhibitor therapy of choice) (n = 35), a protocol of treatment intensification (ritonavir/saquinavir or ritonavir/saquinavir/stavudine) (n = 74) in which therapy was intensified with nucleoside analogue(s) in cases of insufficient viral suppression, and a protocol of induction (saquinavir/nelfinavir/lamivudine/ stavudine) maintenance (saquinavir/nelfinavir or stavudine/nelfinavir) therapy (n = 50). MAIN OUTCOME MEASURE: Changes from baseline in QoL assessed by the Medical Outcomes Study HIV Health Survey at weeks 0, 12, 24, 36, 48, 72 and 96. RESULTS: Patients in the triple-therapy and treatment-intensification protocols showed more favourable changes in physical function, social function, mental health, energy/fatigue, health distress and overall QoL compared to patients in the induction-maintenance protocol, with patients in the first two protocols showing improvements in QoL and those in the induction-maintenance protocol showing declining or unchanged QoL. Patients who discontinued study medication due to insufficient efficacy, toxicities or at their own request showed less favourable changes in QoL compared with patients who continued their regimen. The highest proportion of discontinuations was within the induction-maintenance protocol. CONCLUSION: Antiretroviral treatment strategies that are effective and tolerable have the potential to improve patients' QoL over 96 weeks.

Quality of life in asymptomatic- and symptomatic HIV infected patients in a trial of ritonavir/saquinavir therapy. The Prometheus Study Group.

OBJECTIVE: To compare the impact on quality of life (QoL) of treatment with ritonavir (RTV)/saquinavir (SQV) versus RTV/SQV/stavudine (d4T) in asymptomatic [Centers for Disease Control (CDC) class A] and symptomatic HIV-infected patients (CDC B and C) who did or did not receive antiretroviral therapy (ARVT) before entry into the study. DESIGN: A multicenter randomized clinical trial. PATIENTS: Protease inhibitor- and d4T-naive patients were allocated to RTV/SQV (n = 84) versus RTV/SQV/d4T (n = 83). MAIN OUTCOME MEASURE: Changes from baseline in QoL assessed by the Medical Outcomes Study Health Survey for HIV (MOS-HIV) and a symptom checklist administered at baseline and after 12, 24, 36 and 48 weeks. RESULTS: Changes in QoL were comparable in both treatments, although more neuropathy was reported in the RTV/SQV/d4T group. QoL improved significantly in both groups regarding health distress, energy/fatigue, mental health, health perceptions, physical function and overall QoL, despite an increase in reported symptoms. More favourable changes in cognitive and social function were observed in symptomatic compared with asymptomatic patients, with symptomatic patients showing an improvement and asymptomatic patients showing a decline in function after baseline. ARVT-naive patients showed more favourable changes in mental health, health distress and social function compared with patients with previous ARVT. CONCLUSION: RTV/SQV and RTV/SQV/d4T were equally effective in improving the QoL of patients over 48 weeks, despite an increase in reported symptoms. Symptomatic patients reported more QoL benefit than asymptomatic patients, and ARVT-naive patients benefitted more than those with previous ARVT. The impact on patients' QoL should be considered in the search for the optimal management of HIV infection.

Systemic methotrexate therapy versus laparoscopic salpingostomy in patients with tubal pregnancy. Part I. Impact on patients' health-related quality of life.

OBJECTIVE: To compare patients' health-related quality of life after systemic methotrexate therapy versus laparoscopic salpingostomy for tubal pregnancy. DESIGN: Multicenter randomized clinical trial. SETTING: Departments of obstetrics and gynecology of six Dutch hospitals. PATIENT(S): Hemodynamically stable patients with a laparoscopically confirmed unruptured tubal pregnancy without signs of active bleeding, who were randomly assigned to undergo either systemic methotrexate therapy or laparoscopic salpingostomy. INTERVENTION(S): Standard health-related quality of life questionnaires administered before and 2 days, 2 weeks, 4 weeks. and 16 weeks after confirmative laparoscopy. MAIN OUTCOME MEASURE(S): Health-related quality of life. RESULT(S): Health-related quality of life was impaired most severely 2 days after confirmative laparoscopy in both treatment groups and improved during follow-up. Health-related quality of life was impaired more severely after systemic methotrexate therapy than after laparoscopic salpingostomy. Medically treated patients had more limitations in physical functioning, role functioning, and social functioning; had worse health perceptions, less energy, more pain, more physical symptoms, and a worse overall quality of life; and were more depressed than surgically treated patients. CONCLUSION(S): Systemic methotrexate therapy had a more negative impact on patients' health-related quality of life than did laparoscopic salpingostomy. This negative impact on patients' health-related quality of life of systemic methotrexate therapy should be taken into account when deciding on the appropriate therapy for tubal pregnancy.

Systemic methotrexate therapy versus laparoscopic salpingostomy in tubal pregnancy. Part II. Patient preferences for systemic methotrexate.

OBJECTIVE: To investigate patient preferences for systemic methotrexate therapy relative to laparoscopic salpingostomy in the treatment of tubal pregnancy. DESIGN: Preference assessment in controlled clinical study. SETTING: Four hospitals and one infertility clinic. PATIENT(S): Forty patients who had been treated for tubal pregnancy and 40 nonpregnant controls. INTERVENTION(S): Preference for methotrexate therapy relative to salpingostomy was established during an interview. Two scenarios were offered for methotrexate therapy: one with and one without preceding diagnostic laparoscopy. Hypothetical tubal patency rates after methotrexate therapy were varied in both scenarios until patients switched in their initial preference. MAIN OUTCOME MEASURE(S): Preference for systemic methotrexate therapy. RESULT(S): Only a few patients switched in their initial preference when the tubal patency rate after systemic methotrexate therapy was varied. Most preferred methotrexate therapy without an increase in the tubal patency rate in a scenario without preceding diagnostic laparoscopy. A small group never opted for methotrexate therapy even when it would guarantee a 100% tubal patency rate. CONCLUSION(S): Systemic methotrexate therapy would be preferred by most patients as part of a completely nonsurgical management strategy. Tubal patency was a decisive factor for treatment preference in a minority of patients only.

[Treatment adherence amongst HIV-infected patients in Rotterdam: poorer prognosis independent of nationality in heterosexual infected patients, intravenous drug users, Negroid and Latin-American patients]. / Therapietrouw onder HIV-geïnfecteerden in Rotterdam: onafhankelijk van nationaliteit slechter bij heteroseksueel besmette patiënten, intraveneuzedruggebruikers, negroïde en Latijns-Amerikaanse patiënten.

OBJECTIVE: To assess adherence to antiretroviral therapy (ART) in Dutch and non-Dutch HIV-infected patients. DESIGN: Observational, cross-sectional study. METHODS: Consecutive HIV-infected patients taking ART and visiting the internal medicine outpatients' clinic at the Rotterdam Dijkzigt University Hospital between 1 February until 30 April 2001 were interviewed by a multilingual interviewer using a standard questionnaire. Classification of adherence was based on the interview data. Multivariate analysis was used to determine independent predictors of adherence. Nationality was defined as 'Dutch' if the person was born in the Netherlands, and otherwise as 'non-Dutch'. RESULTS: The 203 patients included in this study comprised 131 men and 69 women with an average age of 42 years. There were no data available on treatment adherence for 3 of the patients. Of the 81 Dutch patients, 60 (74%) adhered to the treatment compared with 68 (57%) of the 119 non-Dutch patients. However, after correction for sex, risk group, race and duration of treatment, there was no difference in treatment adherence between these two groups (OR: 0.6; 95% CI: 0.2-1.9). Failure to adhere to treatment was seen most frequently in the 109 heterosexually infected patients (OR: 2.6; 0.98-6.7), the 22 intravenous drug users (OR: 3.3; 1.04-10.1), as well as in the group of Negroid patients (OR: 3.5; 1.1-11.3) and Latin-American patients (OR: 8.5; 1.7-42.7).