Significant Deterioration In Quality Of Life Research Articles

Prediction of Quality of Life by Helsinki CT Scoring System in Patients with Traumatic Brain Injury

Introduction: Traumatic brain injury (TBI) is an alteration in normally maintained homeostasis and function of the brain owing to any external forces. It is one of the major causes leading to increased disability and morbidity among patients suffering trauma. Hence, we aim to study the association between Helsinki computed tomography CT score on admission to patient’s Quality of Life (QoL) following traumatic brain injury in Dhulikhel Hospital, Nepal. Methods and Materials A prospective observational study was conducted among 44 patients who suffered traumatic brain injury. Eligible patients over 18 years of age diagnosed with traumatic brain injury which is confirmed with a computed tomography scan on admission were included. Outcomes were assessed using the quality of life scale “Project for the Epidemiological Analysis of Critical Care Patients scale (PAEEC)”. Results: Among 44 participants suffering from TBI owing to various modes of injury, male to female ratio was 2.3:1. The mean age among participants was 41.07 years with standard deviation of ± 20.13 (Range 18 – 90 years). Correlation analysis showed that QoL, up to 6 months post-TBI, was significantly associated with Helsinki CT classification. Group 1 and group 2 encompassed subjects who sustained TBI and are in their scheduled 3 monthly and 6 monthly follow up. And significant correlation was noted between two variables r1 = 0.536, p-value = 0.027 and r2 = 0.565, p-value = 0.001 respectively. Conclusion: The present study showed that patients with TBI experience significant quality of life deterioration up to 3-6 months post-TBI. And such deterioration can be predicted by use of Helsinki CT score on admission.

Эффективность амбулаторного лечения артериальной гипертензии через призму качества жизни и гемодинамический фенотип пациентов

Актуальность. Эффективность амбулаторного лечения артериальной гипертензии (АГ) как совокупный результат — достижение целевого уровня артериального давления (АДцел) и приемлемый уровень качества жизни (КЖ) пациентов, а также влияние на него гемодинамического фенотипа, определяемого оригинальным методом количественного анализа связей параметров артериального давления (КАСПАД), не исследованы, что явилось целью данной работы. Материалы и методы. Обследованы 175 амбулаторных пациентов с АГ, средний возраст 60,0 (52,0–70,0) года, получавших длительную (3–12 лет) стандартную терапию антигипертензивными препаратами из основных групп лекарственных средств (ЛС). Оценивалось КЖ по русскоязычной версии опросника RAND-36; для определения гемодинамического фенотипа по КАСПАД использованы индивидуальные ряды величин АД (не менее 25), полученные при ежедневных домашних измерениях за 2–4 недели; проведен статистический анализ клинических и демографических признаков, их связей с КЖ и фенотипами. Результаты. Значимое ухудшение КЖ (физический компонент и общий уровень) отмечено с увеличением возраста, степени и кардиоваскулярного риска АГ, особенно при наличии хронических форм ишемической болезни сердца. КЖ у пациентов, не достигших АДцел, значимо ниже по большинству параметров, чем у достигших его лиц. Увеличение количества принимаемых ЛС сопряжено со снижением КЖ у лиц, достигших АДцел. Пациенты с гемодинамическим фенотипом D, независимо от фармакологической группы принимаемых ЛС и их количества, значимо реже достигают АДцел по сравнению с лицами с фенотипом H, а также имеют более низкое КЖ, еще более снижающееся при интенсификации медикаментозной терапии. Ингибиторы ангиотензинпревращающего фермента (ИАПФ) и блокаторы кальциевых каналов (БКК) были эффективны для достижения АДцел, в основном у пациентов с фенотипом H, но негативно влияли на КЖ: ИАПФ — при фенотипе H, БКК — при D. Бета-адреноблокаторы и диуретики существенно не влияли на КЖ. Предложена статистическая модель прогноза низкого общего уровня КЖ у пациентов с достигнутым АДцел на основе 5 клинико-демографических факторов. Выводы. Эффективность лечения АГ целесообразно оценивать по совокупности достижения АДцел и общего уровня КЖ не менее 60 баллов (по RAND-36). При назначении лечения следует учитывать гемодинамический фенотип: медикаментозную терапию всех пациентов с фенотипом D, а также лиц с фенотипом H при низком КЖ и недостигнутом АДцел необходимо дополнять комплексной реабилитацией с использованием немедикаментозных методов.

The Impact of The Coronavirus Disease 2019 Outbreak on The Quality of Life of Patients with Epilepsy

Objectives: We aimed to investigate the effects of the coronavirus disease 2019 (COVID-19) outbreak on the quality of life (QOL) of patients with epilepsy. Methods: A total of 104 epilepsy patients admitted to our hospital during October and November of 2019 were evaluated for their QOL using the QOL in Epilepsy-31 questionnaire. These assessments were repeated in July 2020 and August 2020 to evaluate the impact of the epidemic on the QOL of epilepsy patients in the same group. The data of the patients were analyzed in SPSS. Results: During the pandemic period, overall score values decreased significantly compared to the pre-pandemic period (p=0.049). Although most of the subscores worsened with the pandemic, the most significant deterioration was observed in emotional well-being (p=0.021). There were six patients (5.8%) whose seizure frequency increased during the pandemic period. In the multivariate analysis, the only parameter that predicted an increase in seizure frequency during COVID-19 was the overall score. Overall score had a positive correlation with educational level. Disease duration, age, marital status, and number of drugs used were found to be negatively correlated with the overall score of the patients. Conclusion: The COVID-19 epidemic causes a significant deterioration in QOL in patients with epilepsy. During epidemics such as COVID-19, clinicians should consider psychosocial factors. In patients with epilepsy, measures should be taken not only to control seizures but also to prevent deterioration in mental health and QOL.

Prediction of quality of life by Helsinki computed tomography scoring system in patients with traumatic brain injury

ABSTRACT Purpose The aim of this study is to assess the association between the Computed Tomography (CT) findings on admission, according to the Helsinki computed tomography CT score, and patient’s Quality of Life (QoL) following traumatic brain injury (TBI) in Lebanon. Methods A retrospective study was performed on 49 males suffering from war induced TBI. Participants were stratified into two groups based on the date of injury. Helsinki CT score was calculated for CT scans of participants. Outcomes were assessed using QoL scales including the Project for the Epidemiological Analysis of Critical Care Patients scale (PAEEC). Results Correlation analysis showed that QoL, up to 4 years post-TBI, was significantly associated with Helsinki CT classification. Group 1 of subjects living with TBI for 1–2 years revealed a correlation coefficient r = 0.536, p-value = 0.027, whereas, group 2 including subjects who are injured since 3–4 years, had a correlation coefficient r = 0.565, p-value = 0.001. Conclusion The present study showed that patients with traumatic brain injury experienced significant quality of life deterioration up to 4 years post-TBI. Our findings propose the important role of Helsinki score in predicting the quality of life among patients with TBI.

1604P - Exposure to low energy amplitude modulated radiofrequency electromagnetic fields (EMF) is associated with rapid improvement in quality of life (QoL) status in patients with advanced hepatocellular carcinoma (HCC), using various analyses of EORTC-C30

BackgroundPatient-centered endpoints, overall survival (OS) and QoL (where the benefit is detectable by the patient as an improvement in symptoms or functional capacity), are considered valid “direct” endpoints by the FDA. While EORTC-C30 is an accepted indicator of QoL, there is no accepted standard for time to QoL status improvement, nor any accepted standard of analysis for EORTC-C30 data. MethodsA single-group, open-label, feasibility study was performed to assess QoL status in HCC patients exposed to modulated EMF at patient-specific frequencies. A 120-min outpatient EMF exposure procedure was performed every 30 days until significant QoL deterioration or death. An oral spoon-shaped RF antenna applicator was used to apply EMF while individuals were kept in supine position. EORTC-C30 v3.0 questionnaires were answered by individuals immediately prior to every EMF exposure. The 17 QoL parameters were divided into those measuring improvement (G+ functional scales and global health status/QOL) and those measuring deterioration (G- symptom scales). QoL index was calculated as (mean G+) – (mean G-). Different QoL index calculations were made using three groups of QoL parameters: all 17 QoL parameters, 15 QoL parameters (removing Functional scales and Symptom scales) and 3 QoL parameters (restricted to Functional scales, Symptom scales and Global health status/QOL). A change of +/-5% in QoL index was considered a clinically relevant improvement/deterioration in QoL status. Results42 HCC were exposed to 151 EMF procedures. 4,530 QoL data points were collected for analysis, with 0.1% missing data. QoL index was measured at baseline and 30 days after the baseline exposure procedure. Using the 3 QoL index calculation methods (17 QoL, 15 QoL and 3 QoL) measured 30 days from the baseline exposure, QoL status improved in 63%, 59% and 74% of HCC patients respectively. ConclusionsRapid and significant improvement in QoL status in HCC patients exposed to EMF was detected within 30 days of exposure regardless of the QoL index calculation methods used. Clinical trial identificationNCT 01686412. Editorial acknowledgementLuiz Fernando Reis PhD, Research Director Hospital Sírio Libanês, São Paulo, Brazil, Riad Younes MD and Bertram Wiedenmann PhD MD. Legal entity responsible for the studyHospital Sírio Libanês. FundingHas not received any funding. DisclosureF.P. Costa: Leadership role: Autem Medical. A. Iemma: Honoraria (institution): Autem Medical. F. Soares: Honoraria (institution): Autem Medical. J. Tuszynski: Advisory / Consultancy: Autem Medical. All other authors have declared no conflicts of interest.

Quality of life after switching to generic levetiracetam – A prospective comparative study

BackgroundImproved quality of life (QoL) is one of the most important objectives in the treatment of epilepsy. Recent prospective, clinical studies proved no significant differences between brand antiepileptic drugs (AEDs) and their generic equivalents in terms of seizure control, pharmacokinetics, or safety. In this study, we focused on possible changes in QoL and adverse events in connection with generic substitution of levetiracetam (LEV). MethodsThis was a prospective, naturalistic, two-cohort, twin-center study. After a baseline period of 10 weeks, outpatients with epilepsy on stable treatment with Keppra® either continued on this brand (reference group, n = 16) or switched to generic LEV (1A Pharma®) (study group, n = 16) for an eight-week study period. The Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and an adverse events' questionnaire were administered at inclusion, after baseline, and at the end of the study period. The study protocol included a close clinical follow-up with repeated LEV serum concentration measurements and nurse-led outpatient visits. ResultsClinically relevant improvements in overall QOLIE-31 scores according to minimally important change (MIC) estimates were seen in both groups. QOLIE-31 subscales in both groups showed significantly less worry about seizures at the end of the study compared to scores at inclusion (study group: p = 0.01; reference group: p = 0.02). No significant deterioration in QoL or adverse events were observed following generic substitution. No switchbacks occurred. ConclusionsWe found reduced seizure worries over time among people with epilepsy allocated to either generic switch or continued treatment with brand LEV. We hypothesize that the nurse-led structured follow-up had an impact on seizure worries and switchback rates because of reduced nocebo effects. Further studies on generic AED substitution, focusing on psychological outcome measures, are warranted to test this supposition.

Patient-reported severity of dry eye and quality of life in diabetes.

PurposeThe purpose of the study was to assess the relationship between patient-reported severity of dry eye disease (DED), quality of life (QoL), presence of diabetic retinopathy (DR) and length of disease duration in people with type 1 diabetes mellitus (DM1) and type 2 diabetes mellitus (DM2).Patients and methodsA survey of 152 people (110 with and 42 without diabetes). All participants completed the Ocular Surface Disease Index (OSDI) and Dry Eye-related Quality of Life Score (DEQS) questionnaires.ResultsForty-four percent of all diabetic subjects reported dry eye symptoms, compared to 29% in the control group. Patients with DM2 reported dry eye symptoms more frequently than those with DM1 (55% and 27% respectively, P=0.001). Dry eye severity was linked to a significant deterioration in QoL in both types of diabetes (DM1, r=0.609 and P=0.036; DM2, r=0.417 and P=0.011). Irrespective of DR, the presence of DED was significantly higher in DM2 compared to DM1 (with DR, P=0.011; without DR, P=0.018).ConclusionDry eye symptoms are associated with reduced QoL and are more common in people with DM2 than in DM1, irrespective of DR status. Routine clinical screening for severe DED could potentially allow for a timely and more effective treatment and could contribute to mitigating the dry eye-associated reduction in QoL in those with DM2.

Визначення показника якості життя як інтегральної ознаки фізичного та психічного здоров'я жінки після оперативного розродження за удосконаленою методикою

Purpose — to compare the quality of life (QoL) indicator in women undergoing Caesarean delivery performed traditionally and by using advanced technique. Materials and methods. According to the quality of life scale, we examined 80 women (I group) who underwent Caesarean delivery performed traditionally and 70 patients (group II) who were operated using the advanced Caesarean section technique. The survey was conducted on the first and fifth day after operative delivery with the estimation of quality of life indicator. Results. A significant decline in physical and social functioning on the first and fifth day, increasing pain syndrome, in comparison with the same criteria of the second group, showed a significant deterioration in QoL in women on the first and fifth day of postpartum period who underwent traditional Caesarean techniques. On the other hand, the high level of integrated QoL indicator in the second group proved the efficiency of the advanced Caesarean section technique by taking into account the significant reduction of pain syndrome. Conclusions. Quality of life indicator can be the leading criterion in decision making on the efficiency of different operative delivery techniques and no clear clinical, laboratory and instrumental markers. It should be noted that both general QoL indicator and all its constituents were significantly higher in the group of women who were operated using the advanced Caesarean section technique. Key words: Caesarean section, traditional technique, advanced technique, quality of life.

Key Cost Drivers Of Type 2 Diabetes Mellitus: an International Literature Review.

Type 2 Diabetes Mellitus (T2DM) is a worldwide chronic disease, related to high morbidity and mortality, and to significant quality of life deterioration. It is frequently associated not only with acute decompensations but also with chronic complications such as cardiovascular problems, renal disease, neuropathy, foot ulcer and loss of vision. The existence of comorbidities and complications not only increases mortality, but also the risk of hospitalizations, the average inpatient stay length, and the amount of illness related productivity losses. This, in turn, has an impact on direct and indirect costs associated to T2DM. Cost studies are relevant for policymakers, since they assess the impact of a disease in monetary terms and help budget allocation decision making. They are specially useful in the context of highly prevalent chronic diseases, such as DM. Many empirical studies have measured the magnitude of the cost of DM in different countries. However, results vary significantly, primarily because of methodological disparities.

Does neoadjuvant treatment before oncologic esophagectomy affect the postoperative quality of life? A prospective, longitudinal outcome study.

To evaluate the cancer patients' quality of life (QoL) following esophagectomy the focus was placed on the impact of neoadjuvant treatment before surgery. For patients undergoing oncologic surgery, the QoL is generally accepted as an important outcome parameter in addition to clinical parameters. This prospective nonrandomized study evaluated QoL in patients treated by preoperative chemo(radio)therapy followed by either surgery or surgery alone with special focus on the postoperative course. QoL was assessed in 131 consecutive patients who underwent surgery for esophageal cancer. The EORTC-QLQ-C30 and a tumor-specific module were administered before surgery, at discharge, 3, 6, 12, and 24 months after surgery. Clinical data were collected prospectively and a follow up was performed every 6 months. The histological type of cancer was squamous cell carcinoma in 49.6% and adenocarcinoma in 50.4%. There was no significant difference between patients that were treated neoadjuvantly and those that were first operated on with regard to morbidity, mortality, and survival rates (5-year survival rate of 34%). Most QoL scores dropped significantly below the baseline in the early postoperative period and recovered slowly during the follow-up period to almost preoperative levels in many scores. There was no statistically significant difference in any of the QoL scales between neoadjuvantly treated or primary operated patients. Esophageal resections are associated with significant deterioration of QoL, which slowly recovers during the follow-up period to an almost preoperative level. Neoadjuvant treatment seems to not further negatively affect the QoL deterioration.

Global quality of life during the acute toxicity phase of multimodality treatment for patients with head and neck cancer: Can we identify patients most at risk of profound quality of life decline?

Treatment intensification has improved outcomes for patients with head and neck cancer (HNC), but little has been reported on health-related quality of life (QoL) consequences. We investigated changes in QoL after (chemo)radiotherapy to identify patient characteristics that predict those whose QoL deteriorates most profoundly in the acute post-treatment period. Patients with locally advanced HNC treated with curative intent received intensity-modulated radiotherapy (60-70 Gy) in this prospective study. (Chemo)radiotherapy was either definitive or adjuvant. Induction chemotherapy consisted of three cycles of docetaxel, cisplatin, and 5-fluorouracil; responders received (chemo)radiotherapy; nonresponders underwent salvage surgery followed by (chemo)radiotherapy if appropriate. Patients completed the EORTC QLQ-C30 and HNC-specific HN35 module before and at the end of (chemo)radiotherapy and 6-8 weeks after therapy completion. Ninety-five patients participated. At baseline, patients reported significantly lower Global health status, functioning, and symptom scale scores than a reference German population (all p<0.001). At the end of (chemo)radiotherapy, patients had significantly lower QoL scores vs. baseline on all functioning scales (p<0.05). Most symptom and HN35 scores worsened during (chemo)radiotherapy but many recovered 6-8 weeks post-treatment. QoL deteriorated more in patients with high vs. low baseline QoL; no clinical or sociodemographic characteristics of patients most likely to experience a significant deterioration in QoL during treatment were identified. These standard QoL instruments did not predict patients at risk of profound global QoL impairments during acute treatment. Other than baseline QoL, no patient characteristics associated with significant QoL deterioration were identified.

Oral health-related quality of life following non-surgical (routine) tooth extraction: A pilot study

Aim:The study was designed to explore the changes in oral health-related quality of life (QoL) in the immediate postoperative period following routine (non-surgical) dental extraction.Setting and Design:A prospective study carried out at the Oral and Maxillofacial Surgery clinic of the Lagos University Teaching Hospital, Nigeria.Materials and Methods:Subjects attending who required non-surgical removal of one or two teeth under local anesthesia were included in the study. A baseline QoL questionnaire (oral health impact profile-14 [OHIP-14]) was filled by each patient just before surgery, and only those who were considered to have their QoL “not affected” (total score 14 or less) were included in the study. After the extraction, each subject was given a modified form of “health related QoL” [OHIP-14]-instrument to be completed by the 3rd day-after surgery, and were given the opportunity to review the questionnaire on the 7th day postoperative review.Results:Total OHIP-14 scores ranged between 14 and 48 (mean ± SD, 26.2 ± 8.3). Majority of the subjects (60%) reported, “a little affected.” Only few subjects (5.8%) reported, “not at all affected,” and about 32% reported, “quite a lot.” Summation of OHIP-14 scores revealed that QoL was “affected” in 41 subjects (34.2%) and “not affected” in 79 subjects (65.8%). More than 30% of subjects reported that their ability to chew, ability to open the mouth and enjoyment of food were affected following tooth extraction. Few subjects (14-34%) reported deterioration in their speech and less than 20% of subjects reported that change in their appearance was “affected.” Only few subjects (12.5-15.1%) reported sleep and duty impairment. Thirty-percent of subjects reported their inability to keep social activities, and 41% were not able to continue with their favorite sports and hobbies. Multiple regression analysis revealed no significant association between age, sex, indications for extraction, duration of extraction, intra-operative complications, and deterioration in QoL (P < 0.05). Consumption of analgesics beyond postoperative day 1 (POD1) was more common in subjects with socket healing complications than those without (P = 0.000). About 33% of subjects reported, “inability to work” (1-3 days).Conclusion:About a third of subjects experienced significant deterioration in QoL. The most affected domains were eating/diet variation and speech variation. Therefore, patients should be informed of possible deterioration in their QoL following non-surgical tooth extraction.

A phase II study of pemetrexed combined with cisplatin in patients (pts) with recurrent or metastatic nasopharyngeal carcinoma.

5538 Background: Nasopharyngeal carcinoma (NPC) is a chemo-sensitive disease but there is yet no consensus on the best regimen for recurrent or metastatic diseases. Pemetrexed is a new agent with good efficacy and toxicity profiles in other cancers. This phase II study aims to evaluate its use in combination with cisplatin for NPC. Methods: Patients (pts) with metastatic or extensive recurrence (unsuitable for radical surgery or re-irradiation) were included. All had prior treatment with platinum-based chemotherapy. The regimen consisted of pemetrexed 500mg/m2 (with vitamin B12 and folic acid support) and cisplatin 75mg/m2 every 3 weeks. Assessments of efficacy were based on both radiological and biochemical (DNA copies of Epstein-Barr virus) response. Toxicity profile was assessed by both acute toxicity rates and quality of life (QOL) scores (measured with FACT-H&N version 4). Patients with response/stable disease and good tolerance were given another 2-4 cycles. Results: Fourteen pts (5 with loco-regional recurrences and 9 with metastases) were treated with this regimen; their median age was 51 (range, 39-68) years. All except one pts had elevated EBV-DNA (median, 34,750 copies/ml; range, 42–17,500,000). A total of 4-8 (median, 6) cycles had been given. Reduction of EBV-DNA copies by >=50% was observed in 12/13 (92%) pts, 2/13 (15%) pts even achieved biochemical complete remission (CR). Radiological assessment showed that one (7%) pt achieved CR, 2 (14%) had partial remission and 7 (50%) had stable diseases. The median time to progression was 30 weeks (range, 11-119 weeks). Only one pt (7%) developed grade 4 toxicity (anemia). The most common grade 3 toxicities were neutropenia (29%) and anemia (21%). All 14 pts had QOL assessment at baseline and after the fourth cycle; 12 (86%) pts had further assessment after the sixth cycle. No significant deterioration in QOL was observed: the total QOL scores (mean) changed from 99 at baseline to 95 after the fourth cycle (p=0.35) and 90 after the sixth cycle (p=0.16). Conclusions: Cisplatin-pemetrexed was a well tolerated regimen and the efficacy for metastatic/recurrent NPC was encouraging. Further evaluation of its role in treatment of NPC is warranted.

Dose Escalation and Quality of Life in Patients With Localized Prostate Cancer Treated With Radiotherapy: Long-Term Results of the Dutch Randomized Dose-Escalation Trial (CKTO 96-10 Trial)

To assess the impact of dose escalation of radiotherapy on quality of life (QoL) in prostate cancer patients. Three hundred prostate cancer patients participating in the Dutch randomized trial (CKTO 69-10) comparing 68 Gy with 78 Gy were the subject of this analysis. These patients filled out the SF-36 QoL questionnaire before radiotherapy (baseline) and 6, 12, 24, and 36 months thereafter. Changes in QoL over time of ≥10 points were considered clinically relevant. Repeated-measures regression analyses were applied to estimate and test the QoL changes over time, the differences between the two arms, and for association with a number of covariates. At 3-year follow-up, the summary score physical health was 73.2 for the 68-Gy arm vs. 71.6 for the 78-Gy arm (p = 0.81), and the summary score mental health was 76.7 for the 68-Gy arm vs. 76.1 for the 78-Gy arm (p = 0.97). Statistically significant (p < 0.01) deterioration in QoL scores over time was registered in both arms in six scales. The deterioration over time was more pronounced in the high-dose arm for most scales. However, clinically relevant deterioration (>10 points) was seen for only two scales. None of the tested covariates were significantly correlated with QoL scores. Dose escalation did not result in significant deterioration of QoL in prostate cancer patients. In both randomization arms, statistically significant decreases in QoL scores over time were seen in six scales. The deterioration of QoL was more pronounced in the physical than in the mental health domain and in some scales more in the high- than in the low-dose arm, but the differences between arms were not statistically significant.

Impact of the Site of Anastomosis after Oncologic Esophagectomy on Quality of Life — A Prospective, Longitudinal Outcome Study

For patients undergoing oncologic surgery, the quality of life (QoL) is generally accepted as an important outcome parameter in addition to long-term survival, mortality, and complication rates. Our study focused on outcome in terms of QoL in patients with esophageal cancer, comparing the sites of anastomosis (cervical versus thoracic anastomosis). In a prospective longitudinal single-center study from 1998 to 2005, 105 patients underwent surgery for esophageal cancer. To assess QoL the EORTC-QLQ-C-30 and a tumor-specific module were administered before surgery, at discharge, and three, six, 12, and 24 months after surgery. Clinical data were collected prospectively and follow-up was performed every six months. The histological type was squamous cell carcinoma in 51.4% of the cases, adenocarcinoma in 41.9%, and some other type in 6.7%. There was no significant difference between cervical and thoracic anastomosis with regard to morbidity, mortality, and survival rates (30% five-year survival rate), whereas tumor stage was a significant (p < 0.001) prognostic factor. Most QoL scores dropped significantly below baseline in the early postoperative period. Even though they recovered slowly during the follow-up period, they never reached preoperative levels again. There was no statistically significant difference in any of the QoL scales between patients with a cervical or a thoracic anastomosis. Esophageal resections are associated with significant deterioration of QoL, which persists during the follow-up period. The surgical technique and position of the esophagogastrostomy did not affect QoL deterioration.

Health-Related Quality of Life in Patients With Locally Advanced Prostate Cancer After 76 Gy Intensity-Modulated Radiotherapy vs. 70 Gy Conformal Radiotherapy in a Prospective and Longitudinal Study

To compare quality of life (QoL) after 70 Gy conformal radiotherapy with QoL after 76 Gy intensity-modulated radiotherapy (IMRT) in patients with locally advanced prostate carcinoma. Seventy-eight patients with locally advanced prostate cancer were treated with 70 Gy three-field conformal radiotherapy, and 92 patients received 76 Gy IMRT with fiducial markers for position verification. Quality of life was measured by RAND-36, the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30(+3)), and the prostate-specific EORTC QLQ-PR25, before radiotherapy (baseline) and 1 month and 6 months after treatment. Quality of life changes in time (baseline vs. 1 month and baseline vs. 6 months) of > or =10 points were considered clinically relevant. Differences between the treatment groups for QoL changes over time occurred in several QoL domains. The 76-Gy group revealed no significant deterioration in QoL compared with the 70-Gy group. The IMRT 76-Gy group even demonstrated a significantly better change in QoL from baseline to 1 month in several domains. The conformal 70-Gy group revealed temporary deterioration in pain, role functioning, and urinary symptoms; for the IMRT 76-Gy group a better QoL in terms of change in health existed after 1 month, which persisted after 6 months. For both treatment groups temporary deterioration in physical role restriction occurred after 1 month, and an improvement in emotional role restriction occurred after 6 months. Sexual activity was reduced after treatment for both groups and remained decreased after 6 months. Intensity-modulated radiotherapy and accurate position verification seem to provide a possibility to increase the radiation dose for prostate cancer without deterioration in QoL.

Improved tolerability and quality of life with maintained efficacy using twice‐daily low‐dose interferon‐α‐2b

In vivo data have shown a more potent antiangiogenic effect and a higher antitumor activity of low-dose interferon (IFN) given twice daily. In a randomized Phase II trial, the authors tested the hypothesis that twice-daily low-dose IFN is more effective than daily intermediate-dose IFN in patients with metastatic renal cell cancer (MRCC). A total of 118 patients (59 per arm) were randomly assigned to receive IFN at a dose of 0.5 million units (MU) given subcutaneously twice daily (IFN1) or IFN at a dose of 5 MU given subcutaneously daily (IFN5). The primary endpoint was progression-free survival (PFS). Secondary endpoints included response rate (RR), overall survival (OS), toxicity, and quality of life (QOL). There were no significant differences in either PFS or OS between IFN1 and IFN5 (median of 3.7 months and median of 3.4 months PFS, respectively; median of 25.5 months and median of 17.5 months OS, respectively). The RRs were identical in the 2 arms (6.7%; 95% confidence interval [95% CI], 1.8-16.5%). Two patients, 1 in each arm, remained in complete remission at the time of last follow-up, at 45+ and 38+ months from treatment. Thirty-two patients receiving IFN5 and 19 patients receiving IFN1 experienced Grade 3 or higher adverse events (graded using the National Cancer Institute Common Toxicity Criteria [version 2.0]) (P = .025). Eighteen patients receiving IFN5 and 4 patients receiving IFN1 had dose reductions (P = .002). There was a significant deterioration in QOL and an increase in depression associated with IFN5 but no change was noted with IFN1. Compared with IFN5, IFN1 is neither more nor less effective but is less toxic, with a better reported QOL. These results may have implications for the design of combination regimens incorporating IFN with targeted agents.

The relationship between quality of life and perceived body weight and dieting history in Dutch men and women.

(1) To study the relationship between quality of life (QoL) and measured and perceived weight and dieting history in Dutch men and women; (2) to assess the effect of weight loss over a 5 y period on QoL. A cross-sectional study, in a sub-sample longitudinal over 5 y. A total of 2155 men and 2446 women, aged 20-59 and recruited from the general population from three towns in The Netherlands. Body weight, height, self-administered questionnaire including questions concerning demographic variables and weight loss practices as part of the Dutch Monitoring project on Risk Factors for Chronic Disease (MORGEN). The Rand-36 questionnaire was used as the QoL measure. In men, measured overweight (body mass index, BMI>25 kg/m(2)) was not associated with any dimension of QoL after adjustment for age, educational level and perceived overweight. Perceived overweight was related to reduced scores for general health and vitality. This relationship was independent of measured obesity. A history of repeated weight loss was associated with reduced scores for role functioning due to both physical and emotional problems. In women, measured overweight was significantly associated with lower scores for five out of eight QoL dimensions and perceived overweight with three: general health, vitality and physical functioning. A history of frequent weight loss was related to significantly reduced scores in six dimensions. However, only with history of frequent weight loss, and uniquely in women, was there a significant reduction in scores on mental health and limited emotional role functioning. Measured and perceived overweight and frequent weight loss were all related to reduced scores for physical functioning. Longitudinal data indicate that in older women weight gain of 10% body weight or more was associated with a significant deterioration in QoL. When looking at measures of QoL in relation to overweight it is important to separate the effects of perception of weight status and history of weight loss. We observed that the latter two factors were associated with reduced scores on several dimensions of QoL, particularly in women. These associations were observed to be independent of body weight.

A Prospective Longitudinal Study of Quality of Life After Resection of Hepatocellular Carcinoma

Hepatic resection improves quality of life (QOL) in patients with resectable hepatocellular carcinoma (HCC). A prospective longitudinal study. A university teaching hospital. Sixty-six consecutive patients undergoing resection of HCC, and 10 patients with unresectable HCC found after surgical exploration who were subsequently treated with transarterial chemoembolization (control group). Serial measurements of preoperative and postoperative QOL using the Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire for up to 2 years after surgery (at 3, 6, 9, 12, 18, and 24 months). Among the 66 patients with resectable HCC, the mean postoperative QOL scores at 3 months after surgery were significantly higher than the mean preoperative QOL scores in domains related to physical, social, and emotional well-being and relationship with physicians. The mean total QOL score increased from 83.5 (SD, 9.4) before surgery to 94.1 (SD, 7.7) at 3 months after surgery (P <.001). No significant change of QOL scores at 3 months after surgery was observed in the control group. Twenty patients in the resected group died of early recurrence within 2 years after surgery, but their mean postoperative QOL scores remained higher than the preoperative QOL scores for most assessment times. In contrast, in the control group, the mean total QOL scores became significantly lower than the preoperative scores, starting 9 months after surgery. Forty-six patients in the resected group completed all QOL assessments. At all postoperative assessments, their mean QOL scores were higher than preoperative scores. Recurrence developed in 13 of the 46 patients within the 2-year study, and there was significant deterioration of QOL over time among these 13 (P <.001), whereas no significant change in QOL over time was observed among the 33 recurrence-free patients. Of various clinicopathologic factors, only advanced pTNM stage was significantly predictive of deterioration of QOL over time after resection of HCC. Hepatic resection results in significant enhancement of QOL in patients with HCC. Development of recurrence is the main factor leading to deterioration in QOL over time after resection of HCC.