Time Of Random Assignment Research Articles

Optimal duration of low molecular weight heparin for the treatment of cancer-related deep vein thrombosis: the Cancer-DACUS Study.

We evaluated the role of residual vein thrombosis (RVT) to assess the optimal duration of anticoagulants in patients with cancer who have deep vein thrombosis (DVT) of the lower limbs. Patients with active cancer and a first episode of DVT treated with low molecular weight heparin (LMWH) for 6 months were eligible. Patients were managed according to RVT findings: those with RVT were randomly assigned to continue LMWH for an additional 6 months (group A1) or to discontinue it (group A2), and patients without RVT stopped LMWH (group B). The primary end point was recurrent venous thromboembolism (VTE) during the 1 year after disconinuation of LMWH, and the secondary end point was major bleeding. Analyses are from the time of random assignment. Between October 2005 and April 2010, 347 patients were enrolled. RVT was detected in 242 patients (69.7%); recurrence occurred in 22 of the 119 patients in group A1compared with 27 of 123 patients in group A2. The adjusted hazard ratio (HR) for group A2 versus A1 was 1.37 (95% CI, 0.7 to 2.5; P = .311). Three of the 105 patients in group B developed recurrent VTE; adjusted HR for group A1 versus B was 6.0 (95% CI, 1.7 to 21.2; P = .005). Three major bleeding events occurred in group A1, and two events each occurred in groups A2 and B. The HR for major bleeding in group A1 versus group A2 was 3.78 (95% CI, 0.77 to 18.58; P = .102). Overall, 42 patients (12.1%) died during follow-up as a result of cancer progression. In patients with cancer with a first DVT, treated for 6 months with LMWH, absence of RVT identifies a population at low risk for recurrent thrombotic events. Continuation of LMWH in patients with RVT up to 1 year did not reduce recurrent VTE.

Adjunctive Psychotherapy for Bipolar Disorder: State of the Evidence

ObjectivePsychotherapy has long been recommended as adjunctive to pharmacotherapy for bipolar disorder, but it is unclear which interventions are effective for which patients, over what intervals, and for what domains of outcome. This article reviews randomized trials of adjunctive psychotherapy for bipolar disorder.MethodEighteen trials of individual and group psychoeducation, systematic care, family therapy, interpersonal therapy, and cognitive-behavioral therapy are described. Relevant outcome variables include time to recovery, recurrence, duration of episodes, symptom severity, and psychosocial functioning.ResultsThe effects of the treatment modalities varied according to the clinical condition of patients at the time of random assignment and the polarity of symptoms at follow-up. Family therapy, interpersonal therapy, and systematic care appeared to be most effective in preventing recurrences when initiated after an acute episode, whereas cognitive-behavioral therapy and group psychoeducation appear...

ATLAS: Randomized, Double-Blind, Placebo-Controlled, Phase IIIB Trial Comparing Bevacizumab Therapy With or Without Erlotinib, After Completion of Chemotherapy, With Bevacizumab for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer

This phase III trial was performed to assess the potential benefit of adding maintenance erlotinib to bevacizumab after a first-line chemotherapy regimen with bevacizumab for advanced non-small-cell lung cancer (NSCLC). One thousand one hundred forty-five patients with histologically or cytologically confirmed NSCLC (stage IIIB with malignant pleural effusion, stage IV, or recurrent) received four cycles of chemotherapy plus bevacizumab. Seven hundred forty-three patients without disease progression or significant toxicity were then randomly assigned (1:1) to bevacizumab (15 mg/kg, day 1, 21-day cycle) plus either placebo or erlotinib (150 mg per day). The primary end point was progression-free survival (PFS). Median PFS from time of random assignment was 3.7 months with bevacizumab/placebo and 4.8 months with bevacizumab/erlotinib (hazard ratio [HR], 0.71; 95% CI, 0.58 to 0.86; P < .001). Median overall survival (OS) times from random assignment were 13.3 and 14.4 months with bevacizumab/placebo and bevacizumab/erlotinib, respectively (HR, 0.92; 95% CI, 0.70 to 1.21; P = .5341). During the postchemotherapy phase, there were more adverse events (AEs) overall, more grade 3 and 4 AEs (mainly rash and diarrhea), more serious AEs, and more AEs leading to erlotinib/placebo discontinuation in the bevacizumab/erlotinib arm versus the bevacizumab/placebo arm. The incidence of AEs leading to bevacizumab discontinuation was similar in both treatment arms. The addition of erlotinib to bevacizumab significantly improved PFS but not OS. Although generally well tolerated, the modest impact on survival and increased toxicity associated with the addition of erlotinib to bevacizumab maintenance mean that this two-drug maintenance regimen will not lead to a new postchemotherapy standard of care.

Estimation of Progression-Free Survival in the Randomized Discontinuation Trial Design

TO THE EDITOR: Nosov et al recently published an article reporting on a study with a randomized discontinuation trial (RDT) design. Inthisdesign,allpatients initially receivedtivozanib for16weeks.After16 weeks, patients who responded (response was considered as 25% tumor shrinkage) continued on tivozanib, those with progressive disease were removed from the study, and those with stable disease were randomly assigned to either continue tivozanib or to be given a placebo. In Figure 4 of the article, a Kaplan-Meier curve is presented as an estimate of the progression-free survival (PFS) rate of all patients who were treated with tivozanib, measured from the time of initial dosing. However, this estimate may be biased, given that the method described was to simply censor patients who were assigned to the placebo at the time of random assignment. The reason for the bias is that the censoring is selectively performed only in the stable disease subgroup. If these patients have subsequent survival rates that are lower than those with initial tumor shrinkage (a likely possibility), the estimate will be positively biased. The solution is to combine the PFS estimate for the first 16 weeks (based on all patients) with a weighted average of the PFS rates beyond 16 weeks intherespondingandstabledisease/continually treatedsubgroups, asdescribedinthearticlebyRatainetal (seealsothearticlebyKarrisonet al). In the study by Nosov et al, 78 patients had an initial response and 118 had stable disease. The extent of the bias would depend on the magnitude of the difference in subsequent PFS in these two subgroups.

Flexible Sigmoidoscopy in the Randomized Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial: Added Yield from a Second Screening Examination

Among randomized trials evaluating flexible sigmoidoscopy (FSG) for its effect on colorectal cancer mortality, only the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial screened its participants more than one time. We report outcomes from the PLCO screening FSG program and evaluate the increased yield produced by a second FSG. Participants were screened by 60-cm FSG in 10 regional screening centers at study entry and 3 or 5 years later, depending on the time of random assignment. Results from subsequent diagnostic intervention were tracked and recorded in a standardized fashion, and outcomes were compared according to sex and age. The protocol discouraged repeat FSG in persons with colorectal cancer or adenoma diagnosed after the initial FSG. Of 77 447 enrollees, 67 073 (86.6%) had at least one FSG and 39 443 (50.9%) had two FSGs. Diagnostic intervention occurred in 74.9% after a positive first FSG and in 78.7% after a positive repeat FSG. The second FSG increased the screening yield by 32%: Colorectal cancer or advanced adenoma was detected in 37.8 per 1000 persons after first screening and in 49.8 per 1000 persons after all screenings. The second FSG increased the yield of cancer or advanced adenoma by 26% in women and by 34% in men. Of 223 subjects who received a diagnosis of colorectal carcinoma within 1 year of a positive FSG, 64.6% had stage I and 17.5% had stage II disease. Repeat FSG increased the detection of colorectal cancer or advanced adenoma in women by one-fourth and in men by one-third. Screen-detected carcinomas were early stage (stage I or II) in greater than 80% of screened persons. Colorectal cancer mortality data from the PLCO, as the definitive endpoint, will follow in later publications.

A family–school intervention for children with ADHD: Results of a randomized clinical trial.

Accumulating evidence highlights the importance of using psychosocial approaches to intervention for children with attention-deficit/hyperactivity disorder (ADHD) that target the family and school, as well as the intersection of family and school. This study evaluated the effectiveness of a family-school intervention, Family-School Success (FSS), designed to improve the family and educational functioning of students in Grades 2-6 who meet criteria for ADHD combined and inattentive types. Key components of FSS were conjoint behavioral consultation, daily report cards, and behavioral homework interventions. FSS was provided over 12 weekly sessions, which included 6 group sessions, 4 individualized family sessions, and 2 school-based consultations. Participating families were given the choice of placing their children on medication; 43% of children were on medication at the time of random assignment. Children (n = 199) were randomly assigned to FSS or a comparison group controlling for non-specific treatment effects (Coping With ADHD Through Relationships and Education [CARE]). Outcomes were assessed at post-intervention and 3-month follow-up. The analyses controlled for child medication status. FSS had a significant effect on the quality of the family-school relationship, homework performance, and parenting behavior. The superiority of FSS was demonstrated even though about 40% of the participants in FSS and CARE were on an optimal dose of medication and there were significant time effects on each measure. This relatively brief intervention produced effect sizes comparable to those of the more intensive Multimodal Treatment Study of Children With ADHD (MTA) behavioral intervention.

Duration of Chemotherapy for Metastatic Breast Cancer: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

To evaluate the effect of different first-line chemotherapy durations in patients with metastatic breast cancer (MBC) on overall survival (OS) and progression-free survival (PFS). We searched literature databases to identify randomized controlled trials that compared different chemotherapy durations in the first-line treatment of MBC. Only trials with unconfounded comparisons of additional cycles of chemotherapy were included. The main outcome measures for this analysis were OS and PFS. Published data from retrieved studies were analyzed according to standard meta-analytic techniques. We found 11 randomized clinical trials including 2,269 patients. Longer first-line chemotherapy duration resulted into a significantly improved OS (hazard ratio [HR], 0.91; 95% CI, 0.84 to 0.99; P = .046) and PFS (HR, 0.64; 95% CI, 0.55 to 0.76; P < .001). There were no differences in effects on either OS or PFS between subgroups defined by time of random assignment, study design, number of chemotherapy cycles in the control arm or concomitant endocrine therapy. Longer first-line chemotherapy duration is associated with marginally longer OS and a substantially longer PFS.

Linear and Ponderal Growth Trajectories in Well-Nourished, Iron-Sufficient Infants Are Unimpaired by Iron Supplementation

Iron deficiency remains the most common nutritional deficiency worldwide and supplementation is recommended during periods of high risk, including infancy. However, questions have been raised about possible adverse effects of iron on growth in iron-sufficient (IS) infants and the advisability of across-the-board iron supplementation. This study examined whether short- or long-term growth was impaired in IS infants who received iron supplementation. From a longitudinal study of healthy, breast-fed, low- to middle-income Chilean infants randomly assigned to iron supplementation or usual nutrition at 6 or 12 mo, we retrospectively identified infants meeting criteria for iron sufficiency at the time of random assignment (n = 273). Using multilevel analysis, ponderal and linear growth were modeled before, during, and after iron supplementation up to 10 y in 3 comparisons: 1) iron supplementation compared with usual nutrition from 6 to 12 mo; 2) iron supplementation compared with usual nutrition from 12 to 18 mo; and 3) 15 mg/d of iron as drops compared with iron-fortified formula (12 mg/L). Growth trajectories did not differ during or after supplementation indicating no adverse effect of iron in any comparison. These results suggest that, at least in some environments, iron does not impair growth in IS infants.

New Pharmacological Agents for Arrhythmias

Despite advances in catheter ablation techniques and device-based therapies for cardiac arrhythmias, antiarrhythmic drugs remain essential components of any comprehensive therapeutic strategy. Antiarrhythmic drug therapy, however, has been limited by both incomplete efficacy and a substantial potential for cardiac and extracardiac toxicity. As a result, only a few new antiarrhythmic agents have successfully completed clinical development programs and reached routine clinical usage over the past 20 years. Antiarrhythmic drugs may be indicated for ventricular tachycardia, sudden death prevention, or specific types of supraventricular arrhythmia. Implantable cardioverter-defibrillator (ICD) therapy has evolved as the primary treatment for most life-threatening ventricular arrhythmias, and antiarrhythmic drugs for these rhythms are currently mostly used either as acute interventions or as adjuncts to chronic ICD therapy. Although numerous trials have evaluated the effect of antiarrhythmic drugs to decrease ICD shocks or therapies, such data have yet to provide the sole basis for approval for any new agent. At the same time, drug therapy for atrial arrhythmias is often limited by the drug’s simultaneous effects on the ventricles, which has led to efforts to identify ionic channel targets specific to or preferentially located in the atria. The sustained outward K+ current (IKur, encoded by the Kv 1.5 subunit), the acetylcholine-activated outward K+ current (IKAch), and both peak and late atrial Na+ currents have therefore become potential targets for antiarrhythmic drug developers.1–4 Another approach has been to seek agents that synergistically affect multiple channels simultaneously, resulting in a net beneficial effect while minimizing toxicity. Other nontraditional targets for drug therapy that do not directly involve ion channels have also emerged as our understanding of the mechanisms of arrhythmias has improved. As a result, several new compounds are now at or near completion of phase 3 clinical trials, and other promising …

Immediate or Delayed Docetaxel: Does Progression-Free Survival Really Reflect Two Strategies?

TO THE EDITOR: We have read the article by Fidias et al with great interest. It made a valuable contribution from a clinical point of view. Their trial was designed to answer one question that clinicians come across frequently in everyday oncological management of patients with advanced non–small-cell lung cancer: should nonprogressing patients after a sufficient amount of first-line therapy proceed with immediate second-line chemotherapy, or should they defer it until documentation of first progression? The authors stated that progression-free survival (PFS) in the immediate docetaxel arm was significantly longer than that in the delayed docetaxel arm (5.7 v 2.7 months; P .0001) and that there was a trend of improved overall survival (OS) in the same arm (12.3 v 9.7 months; P .0853), probably owing to the greater number of patients who were able to receive treatment in the immediate docetaxel arm. OS was the primary end point.WehavesomecommentsonPFS,oneof thesecondaryendpoints. Rather than one PFS, the delayed arm has actually two PFS rates by definition, given that patients should wait until the documentation of progression before receiving chemotherapy: one from random assignment to documentation of first progression just before time of docetaxel institution (PFS1), and one from docetaxel institution to the documentation of progression while still receiving chemotherapy (PFS2). However, there is only one sort of PFS in the immediate docetaxel arm: the one from random assignment to progression on docetaxel chemotherapy. Although it is not clear from the article, the investigators probably reported a comparison of PFS1 in the delayed arm with PFS in the immediate arm. We think that this may be the reason why there was a strong statistical difference (2.7 v 5.7 months; P .0001). Such a comparison does not fully reflect the expected answer to the question of delayed versus immediate docetaxel after first-line therapy. Rather, it gives information concerning the question if docetaxel improves PFS after four cycles of gemcitabin-carboplatin in nonprogressing patients. It is highly probable that no PFS difference between delayed and immediate docetaxel would have been detected if the investigators had calculated PFS from the time of random assignment to progression during docetaxel chemotherapy for both arms.

Phase III Trial of Consolidation Therapy With Yttrium-90–Ibritumomab Tiuxetan Compared With No Additional Therapy After First Remission in Advanced Follicular Lymphoma

We conducted an international, randomized, phase III trial to evaluate the efficacy and safety of consolidation with yttrium-90 ((90)Y)-ibritumomab tiuxetan in patients with advanced-stage follicular lymphoma in first remission. Patients with CD20(+) stage III or IV follicular lymphoma, who achieved a complete response (CR)/unconfirmed CR (CRu) or partial response (PR) after first-line induction treatment, were randomly assigned to receive (90)Y-ibritumomab tiuxetan (rituximab 250 mg/m(2) on day -7 and day 0 followed on day 0 by (90)Y-ibritumomab tiuxetan 14.8 MBq/kg; maximum of 1,184 MBq) or no further treatment (control). The primary end point was progression-free survival (PFS), which was calculated from the time of random assignment. A total of 414 patients (consolidation, n = 208; control, n = 206) were enrolled at 77 centers. (90)Y-ibritumomab tiuxetan consolidation significantly prolonged median PFS (after a median observation time of 3.5 years) in all patients (36.5 v 13.3 months in control arm; hazard ratio [HR] = 0.465; P < .0001) and regardless of whether patients achieved PR (29.3 v 6.2 months in control arm; HR = 0.304; P < .0001) or CR/CRu (53.9 v 29.5 months in control arm; HR = 0.613; P = .0154) after induction treatment. Median PFS with consolidation was prolonged in all Follicular Lymphoma International Prognostic Index risk subgroups. After (90)Y-ibritumomab tiuxetan consolidation, 77% of patients in PR after induction converted to CR/CRu, resulting in a final CR rate of 87%. The most common toxicity with (90)Y-ibritumomab tiuxetan was hematologic, and grade 3 or 4 infections occurred in 8% of patients. Consolidation of first remission with (90)Y-ibritumomab tiuxetan in advanced-stage follicular lymphoma is highly effective with no unexpected toxicities, prolonging PFS by 2 years and resulting in high PR-to-CR conversion rates regardless of type of first-line induction treatment.

Adjunctive Psychotherapy for Bipolar Disorder: State of the Evidence

Psychotherapy has long been recommended as adjunctive to pharmacotherapy for bipolar disorder, but it is unclear which interventions are effective for which patients, over what intervals, and for what domains of outcome. This article reviews randomized trials of adjunctive psychotherapy for bipolar disorder. Eighteen trials of individual and group psychoeducation, systematic care, family therapy, interpersonal therapy, and cognitive-behavioral therapy are described. Relevant outcome variables include time to recovery, recurrence, duration of episodes, symptom severity, and psychosocial functioning. The effects of the treatment modalities varied according to the clinical condition of patients at the time of random assignment and the polarity of symptoms at follow-up. Family therapy, interpersonal therapy, and systematic care appeared to be most effective in preventing recurrences when initiated after an acute episode, whereas cognitive-behavioral therapy and group psychoeducation appeared to be most effective when initiated during a period of recovery. Individual psychoeducational and systematic care programs were more effective for manic than depressive symptoms, whereas family therapy and cognitive-behavioral therapy were more effective for depressive than manic symptoms. Adjunctive psychotherapy enhances the symptomatic and functional outcomes of bipolar disorder over 2-year periods. The various modalities differ in content, structure, and associated mediating mechanisms. Treatments that emphasize medication adherence and early recognition of mood symptoms have stronger effects on mania, whereas treatments that emphasize cognitive and interpersonal coping strategies have stronger effects on depression. The placement of psychotherapy within chronic care algorithms and its role as a preventative agent in the early stages of the disorder deserve investigation.

Cognitive and non‐cognitive predictors of success in adult education programs: Evidence from experimental data with low‐income welfare recipients

AbstractUsing data on approximately 2,000 low‐income welfare recipients in a three‐site random‐assignment intervention conducted in the early 1990s (the NEWWS), we examine the role of cognitive and non‐cognitive factors in moderating experimental impacts of an adult education training program for women who lacked a high school degree or GED at the time of random assignment. Both cognitive and noncognitive skills (in particular, locus of control) moderate treatment impacts. For the sample as a whole, assignment to an education‐focused program had a statistically significant (albeit modest) 8 percentage point impact on the probability of degree receipt. For those with low cognitive skills, virtually all of these program impacts were eliminated. However, non‐cognitive skills play a substantively important role such that women with high cognitive skills but low non‐cognitive skills are only half as likely to earn a degree as their counterparts with high skills of both types. © 2008 by the Association for Public Policy Analysis and Management.

Lessons to Take Home From CATIE

Lessons to Take Home From CATIE

Optimal Use of Aromatase Inhibitors: To Lead or to Follow?

Optimal Use of Aromatase Inhibitors: To Lead or to Follow?

Economic Analysis of NCIC CTG JBR.10: A Randomized Trial of Adjuvant Vinorelbine Plus Cisplatin Compared With Observation in Early Stage Non–Small-Cell Lung Cancer—A Report of the Working Group on Economic Analysis, and the Lung Disease Site Group, National Cancer Institute of Canada Clinical Trials Group

National Cancer Institute of Canada Clinical Trials Group JBR.10 study is among the landmark trials that have established third generation platinum-based adjuvant chemotherapy as the standard of care after resection of stages IB-II NSCLC, improving absolute 5-year survival by 15% and median survival by 21 months. This cost-effectiveness analysis of adjuvant chemotherapy from the perspective of Canada's public health care system was undertaken based on the JBR.10 study population. The primary outcome of the study was the incremental cost effectiveness ratio (ICER) expressed in dollars per life-year gained (LYG). Direct medical resource utilization data were collected retrospectively from trial data and medical records of patients enrolled in the JBR.10 study at the five largest accruing Canadian centers, from the time of random assignment until death or study closure (April 2004). Survival and available costs (2005 Canadian dollars [$CAD]) are presented both with and without discounting at 5% per year. Utilization data were collected from 172 Canadian patients (36% of the trial population), 85 randomly assigned to observation and 87 randomly assigned to chemotherapy. The mean costs of treatment per patient in the observation and adjuvant chemotherapy arms were $23,878 and $31,319, respectively, with an ICER of CAD$7,175/LYG discounted (95% CI, -$3,463 to $41,565), and $10,096/LYG undiscounted (95% CI, -$819 to $55,651). Adjuvant vinorelbine plus cisplatin is a highly cost effective treatment that compares very favorably with other standard health care interventions.

Time course of the regression of asymptomatic bacterial vaginosis in pregnancy with and without treatment

ObjectiveThe purpose of this study was to determine the effectiveness of treatment over time for bacterial vaginosis in pregnancy and the probability of spontaneous resolution with placebo. Study designWomen with asymptomatic bacterial vaginosis on Gram stain were assigned randomly at 16 to 23 weeks of gestation to receive two 2-g doses of metronidazole or placebo 48 hours apart and were re-evaluated for changes in Gram stain score on one occasion ≥2 weeks later. ResultsOf 658 women who underwent metronidazole therapy, treatment was successful (score, <7) in 78% of those women who were seen at 2 to 3.9 weeks of gestation, which was similar to women seen ≥10 weeks after treatment. In 683 women who underwent placebo therapy, spontaneous resolution increased significantly from 13% at 2 to 3.9 weeks of gestation to 36% at ≥10 weeks of gestation. Spontaneous resolution was more common with lower vaginal pH or lactobacilli on Gram stain at the time of random assignment. ConclusionThe effectiveness of metronidazole therapy of bacterial vaginosis persists for ≥10 weeks. Women who underwent placebo therapy had significant remission of bacterial vaginosis over ≥10 weeks. Remission was more common when the initial vaginal microbiologic disturbances were less severe.

Enalapril decreases the incidence of atrial fibrillation in patients with left ventricular dysfunction: insight from the Studies Of Left Ventricular Dysfunction (SOLVD) trials.

Atrial fibrillation (AF) is frequently encountered in patients with heart failure (HF) and is also a predictor of morbidity and mortality in this population. Recent experimental studies have shown electrical and structural atrial remodeling with increased fibrosis in animals with HF and have suggested a preventive effect of ACE inhibitors (ACEi) on the development of AF. To verify the hypothesis that ACEi prevent the development of AF in patients with HF, we conducted a retrospective analysis of the patients from the Montreal Heart Institute (MHI) included in the Studies Of Left Ventricular Dysfunction (SOLVD). Clinical charts were reviewed and serial ECGs interpreted by a single cardiologist blinded to drug allocation. Patients with AF or flutter on the baseline ECG were excluded. Baseline characteristics were obtained from the SOLVD databases. The mean follow-up was 2.9+/-1.0 years. Of the 391 patients randomly assigned at MHI, 374 were in sinus rhythm at the time of random assignment, with 186 taking enalapril and 188 taking placebo. Baseline characteristics were similar in the two groups except for a higher incidence of previous myocardial infarction in the enalapril group. Fifty-five patients had AF during the follow-up: 10 (5.4%) in the enalapril group and 45 (24%) in the placebo group (P<0.0001). By Cox multivariate analysis, enalapril was the most powerful predictor for risk reduction of AF (hazard ratio, 0.22; 95% CI, 0.11 to 0.44; P<0.0001). Treatment with the ACEi enalapril markedly reduces the risk of development of atrial fibrillation in patients with left ventricular dysfunction.

Evaluation of a Special Nursing Home Unit for Dementia Sufferers: A Randomised Controlled Comparison with Community Care

Applicants for a newly opened special unit for dementia sufferers were randomly allocated to full-time care in the unit or placed on a waiting list and offered periodic respite care in the meantime. All applicants were living in the community at the time of random assignment. Both groups were followed up for three months to assess the effects on the dementia sufferers and on their family care-givers. Care-givers initially had a high level of psychological symptoms, which was greatly reduced after admission of the dementia sufferer to full-time care. By contrast, the care-givers of the community care group of sufferers continued to have a high level of symptoms. Dementia sufferers continued to deteriorate with both forms of care, with little difference between the two groups. Admission of dementia sufferers to full-time care in a special unit appears to be of great benefit to the psychological health of their care-givers and has no adverse effects on the dementia sufferers themselves.