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PubMedDate not supplied

Reverse cholesterol transport in diabetes mellitus.

There are epidemiological data and experimental animal models relating the development of premature atherosclerosis with defects of the reverse cholesterol transport (RCT) system. In this regard, the plasma concentrations of the high density lipoprotein (HDL) subfractions, of cholesteryl ester transfer protein (CETP), as well as the activity of the enzyme lecithin-cholesterol acyl transferase (LCAT) play critical roles. However, there has been plenty of evidence that atherosclerosis in diabetes mellitus (DM) is ascribed to a greater arterial wall cell uptake of modified apoB-containing lipoproteins whereas a primary or predominant defect of the RCT system is still a subject of debate. In other words, in spite of the fact that in DM the composition and rates of metabolism of the HDL particles are greatly altered and display a diminished in vitro efficiency to remove cell cholesterol, definitive in vivo demonstration of the importance of this fact in atherogenesis is lacking. Furthermore, the roles played by LCAT and CETP in RCT in DM are difficult to interpret because the in vitro procedures of measurement utilized have either been inadequate, or inappropriately interpreted. Knock-out or transgenic mice are much needed models to investigate the roles of LCAT, CETP, phospholipid transfer protein (PLTP), and of a CETP inhibitor in the development of atherosclerosis of experimental DM.

Animals↗
PubMed2004

Subject retention and adherence in a randomized placebo-controlled trial of a disease-modifying osteoarthritis drug.

OBJECTIVE: To describe the methods by which remarkable levels of subject retention and adherence were achieved in a 30-month multicenter randomized placebo-controlled trial (RCT) of a disease-modifying osteoarthritis drug (DMOAD). METHODS: Subjects were obese 45-64-year-old women with unilateral knee osteoarthritis. Before randomization, each volunteer completed a 4-week "faintness-of-heart" (FOH) test, during which she was required to demonstrate reliable appointment keeping and > or =80% adherence to the dosing regimen. Subjects who passed the FOH test were randomized to treatment with doxycycline or placebo for 30 months. The double-blind phase entailed 15 bimonthly followup visits; intervisit adherence data were downloaded from the dosing monitor and used to estimate therapeutic coverage and to identify correctable patterns of nonadherence. Subjects received token incentives and a small cash payment at each followup visit. Measures to prevent or treat side effects of doxycycline were dispensed free of charge. Study coordinators monitored safety and reinforced participation through between-visit telephone calls. RESULTS: Of 463 eligible volunteers, 32 (7%) failed the FOH test and were excluded from the double-blind phase. Among the 431 subjects randomized to treatment groups, 307 (71%) completed the 30-month RCT and 124 discontinued the study drug prematurely. Nearly half of the dropouts returned for their 16- and 30-month radiographs, resulting in loss to followup of 14.8% of randomized subjects. The 2 treatment groups did not differ significantly with respect to rates of discontinuation or retention. Therapeutic coverage over 30 months was very high in both groups. CONCLUSION: The rate of discontinuation in this 30-month RCT (29%) was lower than that of any DMOAD trial of > or =2 years duration published to date. The proportion of subjects for whom 30-month radiographs were available (85%) and adherence to the dosing regimen (mean >80%) also were remarkably high.

Antirheumatic Agents↗
PubMed2005

Interventions for foot disease in rheumatoid arthritis: a systematic review.

OBJECTIVE: To systematically review medical and surgical foot intervention studies in rheumatoid arthritis (RA), focusing on clinical efficacy, study quality, and risk of harm. METHODS: We searched appropriate databases using a combination of the terms "rheumatoid arthritis" and "foot" against terms indicating treatment; we also hand-searched references. We selected articles in English (1968-2003) comprising randomized controlled trials (RCTs), controlled clinical trials (CCTs), prospective observational studies, and large retrospective observational surgical studies (> 50 cases). RCT quality was examined using Jadad scoring; other designs were assessed qualitatively. RESULTS: Inclusion criteria were met by 33 of 894 identified studies, comprising 5 RCTs and 1 CCT (all nonsurgical), 15 prospective observational studies (8 nonsurgical, 7 surgical), and 12 large retrospective studies (all surgical). Functional, custom-designed and semirigid orthoses and extra-depth shoes were effective in single RCTs of variable quality; no comparative studies have been conducted. This finding was supported by a CCT and prospective observational studies. There was no evidence of harm. There were no controlled trials of surgery. Prospective observational studies suggest that forefoot arthroplasty and first metatarsophalangeal joint implants, but not plantar callous debridement, are effective. Comparative retrospective analyses suggest that some procedure variants may be better, and surgery may relieve pain better than orthoses. Infection was the main risk. CONCLUSION: RCT evidence shows that orthoses and special shoes are likely to be beneficial in patients with RA. The only evidence of benefit from surgery comes from observational studies, because no RCTs have been conducted. Further RCT evidence is needed, although well-designed observational studies may be helpful.

Arthritis, Rheumatoid↗
PubMed2004

Hungarian cohort-controlled trial of periconceptional multivitamin supplementation shows a reduction in certain congenital abnormalities.

BACKGROUND: The 1984-1991 Hungarian randomized controlled trial (RCT) of periconceptional multivitamin supplementation containing folic acid (0.8 mg) showed a significant reduction in the first occurrence of neural tube defects (NTDs), and of urinary tract and cardiovascular abnormalities, but no reduction in orofacial clefts. A controlled cohort trial was designed to confirm or deny these results. METHODS: Supplemented women were recruited from the Hungarian Periconceptional Service using the same multivitamin as the Hungarian RCT. Unsupplemented pregnant women were recruited in the standard regional antenatal care clinics and were matched to each supplemented pregnant woman on the basis of age, socioeconomic status, place of residence, and year of pregnancy. RESULTS: A total of 3056 informative offspring were evaluated in each cohort. The occurrence of congenital cardiovascular malformations (31 vs. 50) was reduced (odds ratio [OR], 0.60; 95% confidence interval [CI], 0.38-0.96) in the supplemented cohort, accounted for mainly by ventricular septal defects (5 vs. 19; OR, 0.26; 95% CI, 0.09-0.72). There was no significant difference (14 vs. 19) in the occurrence of urinary tract defects between the two cohorts, but stenosis/atresia of pelvic-ureteric junction (2 vs. 13) showed a significant reduction (OR, 0.19; 95% CI, 0.04-0.86). The protective effect of the folic acid-containing multivitamin for NTDs (one offspring in the supplemented vs. nine in the unsupplemented cohort) was confirmed (OR, 0.11; 95% CI, 0.01-0.91). There was, however, no protective effect on orofacial clefts or on multiple congenital abnormalities. CONCLUSIONS: The results of this cohort-controlled trial support the findings of the previous Hungarian RCT. The primary prevention of some major structural birth defects by multivitamins containing folic acid or by folic acid has great public health importance.

Adult↗
PubMed2006

Randomized clinical trial and follow-up study of cost-effectiveness of laparoscopic versus conventional Nissen fundoplication.

BACKGROUND: Laparoscopic Nissen fundoplication (LNF) has essentially replaced its conventional open counterpart (CNF). An economic evaluation of LNF compared with CNF based on prospective data with adequate follow-up is lacking. METHODS: Data from two consecutive studies (a randomized clinical trial (RCT) of 57 patients undergoing LNF and 46 undergoing CNF that was terminated prematurely, and a follow-up study of 121 consecutive patients with LNF) were combined to determine incremental cost-effectiveness 1 year after surgery. RESULTS: Mean operating time, reoperation rate and hospital costs of LNF were lower in the second series. The mean overall hospital cost per patient was euro 9126 for LNF and euro 6989 for CNF at 1 year in the initial RCT, and euro 7782 in the second LNF series. The success rate of both LNF and CNF at 1 year was 91 per cent in the RCT, and LNF was successful in 90.1 per cent in the second series. A cost reduction of euro 998 for LNF would cancel out the cost advantage of CNF. Similarly, if the reoperation rate after LNF decreased from 0.05 to below 0.008 and/or if the mean duration of sick leave after LNF was reduced from 67.2 to less than 61.1 days, the procedure would become less expensive than CNF. Complications, reoperation rate and quality of life after both operations were similar. CONCLUSION: Including reinterventions, the outcome at 1 year after LNF and CNF was similar. In a well organized setting with appropriate expertise, the cost advantage of CNF may be neutralized.

Adult↗
PubMed2005

Does the non-randomized controlled study have a place in the systematic review? A pilot study.

BACKGROUND: A major issue in any systematic review is deciding which trials or studies to include and which to exclude. The Cochrane Collaboration and similar respected organizations have traditionally viewed the randomized trial (RCT) as the only acceptable evidence on treatment outcome. However, many systematic reviews are indeterminate because they include insufficient RCTs whilst they reject large numbers of non-randomized controlled studies. This is particularly true in forensic mental health, a domain where RCT methodology can be problematic. Systematic reviews could become more informative if reviewers knew when, and under what circumstances, non-randomized designs are acceptable for inclusion alongside RCTs. METHOD: This pilot study explores whether good-quality, controlled, non-randomized studies can be reliable surrogates for RCTs. We examined two published reviews from the Cochrane Schizophrenia Group. We compared outcomes between (a) randomized trials (that had been included) and non-randomized studies (that had been excluded), and (b) between high- and low-quality studies using an established quality checklist. RESULTS: In the first review, effect scores were similar for randomized and non-randomized studies and relatively insensitive to study quality. In the second review, the treatment effect was considerably lower for the RCT group - here, however, studies of high-quality showed much smaller effect scores than those of low-quality on two separate outcomes. CONCLUSIONS: Non-randomized controlled studies of high quality can produce outcomes that approximate to those found in RCTs. Trial quality may have a greater impact on treatment effect size than randomization alone, suggesting that randomization should not be seen as a reliable proxy for overall quality. The problems and issues still to be resolved are discussed with recommendations for future research.

Humans↗
PubMed2004

Light therapy for behavioural and psychological symptoms of dementia.

OBJECTIVES: To review literature concerning the efficacy, clinical practicability and safety of light treatment for behavioural and psychological symptoms of dementia (BPSD). METHOD: Data collection included computer literature searches (MEDLINE, PsycINFO and Cochrane) and checks of references, covering the period of January 1980-September 2003. Trials were searched for evidence for treatment efficacy and for their consideration of the treatment's clinical practicability and evidence of adverse effects. RESULTS: Results from randomised controlled trials (RCT) indicated some evidence of improvement in aspects of sleep disturbances and circadian activity rhythmicity. One RCT study indicated better response in patients with vascular dementia compared to Alzheimer's disease. By and large, non-RCT studies reported improvement in BPSD including sleep disturbances, agitation and activity rhythm disturbances. Few studies commented on the treatment's practicability and safety. CONCLUSION: Although there is some evidence for influence of light therapy on sleep and circadian activity rhythmicity, it is not possible to draw any conclusion about efficacy of light therapy for BPSD, or about practicability in clinical settings and safety. There are still too few well designed studies. Suggestions for further research are presented.

Aged↗
PubMed2006

Whither trial-based economic evaluation for health care decision making?

The randomised controlled trial (RCT) has developed a central role in applied cost-effectiveness studies in health care as the vehicle for analysis. This paper considers the role of trial-based economic evaluation in this era of explicit decision making. It is argued that any framework for economic analysis can only be judged insofar as it can inform two key decisions and be consistent with the objectives of a health care system subject to its resource constraints. The two decisions are, firstly, whether to adopt a health technology given existing evidence and, secondly, an assessment of whether more evidence is required to support this decision in the future. It is argued that a framework of economic analysis is needed which can estimate costs and effects, based on all the available evidence, relating to the full range of possible alternative interventions and clinical strategies, over an appropriate time horizon and for specific patient groups. It must also enable the accumulated evidence to be synthesised in an explicit and transparent way in order to fully represent the decision uncertainty. These requirements suggest that, in most circumstances, the use of a single RCT as a vehicle for economic analysis will be an inadequate and partial basis for decision making. It is argued that RCT evidence, with or without economic content, should be viewed as simply one of the sources of evidence, which must be placed in a broader framework of evidence synthesis and decision analysis.

Cost-Benefit Analysis↗
PubMed1998

Complementary and alternative medicine: evaluating its effectiveness in inflammatory bowel disease.

The use of complementary and alternative medicine (CAM) by patients with inflammatory bowel disease (IBD) is common. Physicians and scientists believe that the randomized controlled trial (RCT) provides the best evidence of an intervention's efficacy. However, there are only a few controlled trials that have assessed these therapies in IBD and all contain methodological problems. The RCT does not always fit well with the underlying principles of disease causation and treatment of CAM. Many forms of CAM take a holistic approach to the diagnosis and treatment of disease, where the patient plays an active and key role in healing and treatments are often highly individualized. Therefore, the use of placebos, blinding, and random allocation to structured treatment protocols in an RCT setting is often contradictory to the principles of CAM. We still know relatively little about the use of CAM in IBD. Prior to embarking upon a program of clinical trials to evaluate these therapies, a better understanding of the specific therapies being used, reasons for their use, and their potential side effects is required. We also need to understand how the CAM practitioners use their therapies, what they view as the appropriate indications, and how treatments are best administered.

Clinical Protocols↗
PubMed2002

Electrophysiological evaluation of conduction in the most proximal motor root segment.

Root conduction time (RCT), defined as the time difference between M-wave latency by cervical magnetic stimulation (CMS) and the total peripheral motor conduction time calculated from the shortest F-wave latency, was investigated in patients with inflammatory demyelinating neuropathies (IDP) and amyotrophic lateral sclerosis (ALS). The minimal threshold for CMS also was studied. In the IDP patients, conduction in the proximal motor root segment was considered abnormal in 52% by the RCT and in 47% by the minimal threshold for CMS, whereas both were normal in 85% of the ALS patients. These findings suggest that the RCT and minimal threshold for CMS might be additional parameters for evaluating motor nerve conduction in IDP.

Action Potentials↗
PubMed2007

Interval estimation of the risk difference in non-compliance randomized trials with repeated binary measurements.

In a randomized clinical trial (RCT), we often encounter non-compliance with the treatment protocol for a subset of patients. The intention-to-treat (ITT) analysis is probably the most commonly used method in a RCT with non-compliance. However, the ITT analysis estimates 'the programmatic effectiveness' rather than 'the biological efficacy'. In this paper, we focus attention on the latter index and consider use of the risk difference (RD) to measure the effect of a treatment. Based on a simple additive risk model proposed elsewhere, we develop four asymptotic interval estimators of the RD for repeated binary measurements in a RCT with non-compliance. We apply Monte Carlo simulation to evaluate and compare the finite-sample performance of these interval estimators in a variety of situations. We find that all interval estimators considered here can perform well with respect to the coverage probability. We further find that the interval estimator using a tanh(-1)(x) transformation is probably more precise than the others, while the interval estimator derived from a randomization-based approach may cause a slight loss of precision. When the number of patients per treatment is large and the probability of compliance to an assigned treatment is high, we find that all interval estimators discussed here are essentially equivalent. Finally, we illustrate use of these interval estimators with data simulated from a trial of using macrophage colony-stimulating factor to reduce febrile neutropenia incidence in acute myeloid leukaemia patients.

Humans↗
PubMedDate not supplied

Angiotensin II (AII) induced hypertension chemotherapy (IHC) for unresectable gastric cancer: with reference to resection after down staging.

Angiotensin II induced hypertension chemotherapy (IHC) is a drug delivery system for augmentation of anti-cancer effects on the experimental basis of the functional difference of microcirculation between tumor and normal tissue. Blood flow in tumor tissue increased selectively when the blood pressure was elevated by the infusion of angiotensin II. Two randomized controlled trials (RCT) for advanced gastric cancer using AFM regimen; a combination of adriamycin (ADM), 5-fluorouracil (5-FU), and mitomycin (MMC), showed increased response rate by IHC (response rate: IHC/non-IHC; 42.9% vs 10.5% in RCT-1, and 31.3% vs 6.7% in RCT-2, respectively). Toxicities were not different statistically between groups. In phase II for stage IVB gastric cancer patients (the criteria according to the General Rules of the Gastric Cancer Study of Japanese Research Society for Gastric Cancer), 5 complete response (CR) and 10 partial response (PR) (58%) were observed out of 26 unresectable cases without prior chemotherapy. Moreover, 5 of 15 responders could received curative gastrectomy and obtained conclusive down staging (19%). Here we discuss the role of enhancement of drug delivery for cancer chemotherapy on the basis of a series of clinical and experimental evidences.

Adult↗
PubMed1991

Augmentation of murine lymphokine-activated killer cell cytotoxicity by beta-cyclodextrin-benzaldehyde.

We investigated the effect of beta-cyclodextrin-benzaldehyde (CDBA) on lymphokine-activated killer (LAK) cell activity of spleen cells from normal or RCT(+)H-2(+)-sarcoma-bearing C3H/He mice. CDBA augmented the induction of LAK cytotoxicity in vitro against RCT(+)H-2+ tumor cells by IL-2, whereas the culture with CDBA alone did not. In a LAK cytotoxicity assay in vitro, the augmentative effect of CDBA was strongly exerted against spleen cells originating from 2-week-tumor-bearing mice, rather than those from normal mice or mice that had born tumors for 5 weeks. Such an augmentative effect was not observed against other tumor cells (YAC-1, D-6, Colon-26 and EL-4 cells) non-specifically. When the intravenous adoptive transfer of LAK cells was carried out in the mice, LAK cells from tumor-bearing mice induced by combined culture with interleukin-2 (IL-2) and CDBA markedly inhibited the pulmonary metastases of RCT(+)H-2+ tumor, while neither LAK cells from the same tumor-bearing mice induced by only IL-2 nor those from normal mice inhibited the pulmonary metastasis. The majority of LAK cells induced either by IL-2 plus CDBA or by IL-2 alone were found to be Thy1.2+ and asialoGM1+ cells by flow-cytometric analysis, but no obvious phenotypical difference was observed between them. However, the most significant effect of CDBA might be the maintenance of the Lyt-2+ cell level in the spleen cells from tumor-bearing mice. These results suggested that the costimulation of spleen cells with IL-2 and CDBA might induce cytotoxic T cells specific for syngeneic tumor cells.

Animals↗
PubMed1997

The ethical challenges of a randomized controlled trial of involuntary outpatient commitment.

Involuntary outpatient commitment (OPC) is a civil justice procedure intended to enhance compliance with community mental health treatment, to improve functioning, and to reduce recurrent dangerousness and hospital recidivism. The research literature on OPC indicates that it appears to improve outcomes in rates of rehospitalization and length of stay. However, all studies to date have serious methodological limitations because of selection bias; lack of specification of target populations; unclear operationalization of OPC; unmeasured variability in type, frequency, and intensity of treatment; as well as other confounding factors. To address limitations in these studies, the authors designed a randomized controlled trial (RCT) of OPC, combined with community-based case management, which is now under way in North Carolina. This article describes ethical dilemmas in designing and implementing an RCT of a legally coercive intervention in community-based settings. These ethical dilemmas challenge the experimental validity of an RCT but can be successfully addressed with careful planning and negotiation.

Ambulatory Care↗
PubMed1998

Radiotherapy alone or radiochemotherapy with platin derivatives following transurethral resection of the bladder. Organ preservation and survival after treatment of bladder cancer.

PURPOSE: Multivariate analysis of prognostic factors influencing survival and bladder preservation after radiochemotherapy for bladder cancer following transurethral resection of the bladder (TURB). PATIENTS AND METHODS: At the University Hospital of Erlangen 333 patients with bladder cancer were treated with either radiotherapy alone (RT, n = 128) or platin based radiochemotherapy (RCT, n = 205) after TURB between 5/1982 and 5/1996. Two-hundred and eighty-two curative patients, with either muscle invasive or T1-high risk cancer, were analyzed. Median age was 66 years, median follow-up is 7.5 years. Uni- and multivariate analysis was performed for age, grade, R-status after initial TURB, T-category and treatment modality relevant to the endpoints initial response, survival and bladder preservation. RESULTS: Treatment related mortality was below 1%. Complete remissions were achieved at 57%, 70%, and 85% after RT or RCT with carboplatin or cisplatin. This difference was multivariately significant. Further significant prognostic factors were pT-category and R-status. For all patients survival was 59% and 43% after 5 and 10 years. 79% of survivors could keep their own bladder. Five-year survival rates after RT alone, RCT with carboplatin or cisplatin were 47%, 57%, and 69%, respectively. This was univariately significant. The only multivariately significant factor for survival and bladder preservation was the R-status after initial TURB. CONCLUSIONS: Treatment of bladder cancer by TURB and RT/RCT is an alternative to primary cystectomy. The addition of chemotherapy leads to significantly more complete remissions and better survival. Initial TURB is recommended to be as radical as possible.

Adult↗
PubMed2003

Deficiency of choresteryl ester transfer protein and gene polymorphisms of lipoprotein lipase and hepatic lipase are not associated with longevity.

Cholesteryl ester transfer protein (CETP) is one of the key proteins in reverse cholesterol transport (RCT). The role of CETP in atherosclerosis remains controversial. In this study we investigated the associations between polymorphisms of CETP (mutations in intron 14 and exon 15, and Taq1B), hepatic lipase (C-514T), lipoprotein lipase ( PvuII and HindIII), and ATP-binding cassette transporter 1 (R219K) loci and longevity in 256 centenarians and 190 healthy younger controls. Although heterozygous CETP deficiency and the B2 allele of the Taq1B polymorphism was consistently associated with higher HDL-C concentrations both in centenarians and controls, the allelic frequencies of those polymorphisms did not differ between the two groups. The allelic frequencies of other gene polymorphisms in RCT were not different between the two groups. Centenarians with lipoprotein lipase P(-/-) genotype had significantly higher HDL-C concentration than those with P(-/+) or with P(+/+), in contrast, there was no such a relationship among controls. In stepwise multiple regression analysis, serum albumin, CETP deficiency and lipoprotein lipase PvuII genotype were independently associated with HDL-C in centenarians. Sex, CETP deficiency, and the Taq1B genotype were also independently associated with HDL-C; however, lipoprotein lipase PvuII genotype had no significant effect on their HDL-C in controls. In conclusion, we observed that CETP deficiency and other gene polymorphisms in RCT have no impact on longevity for Japanese centenarians.

Adult↗
PubMed2001

[Prospects in psychotherapy research].

The point of departure for this discussion is a critical review of the philosophy of randomized controlled trials (RCT) and their specific errors when applied to psychotherapeutic methods. There is a gap between the highly artificial settings of psychotherapy RCT and naturalistic psychotherapy procedures, which are grounded more in personality than in technique, less regulated, and mostly eclectic. Although RCT are necessary for general assessments of efficacy, they should be complemented by efficiency studies and evaluation of whole health care systems which include psychotherapy. We argue against overstretching the analogy of good clinical practice (GCP) research for the purpose of admitting new psychotropic drugs to psychotherapy research. A rational approach to psychotherapy for indication, quality ascertainment, and allocation of resources needs research which is methodologically explicable, replicable, and relevant to practice. The Cochrane Collaboration is a means of distributing such knowledge and making it work for practitioners. However, Cochrane also sheds light on psychological and practical obstacles which must be overcome before public health care systems can utilize new scientific results. The discussion of disorder-specific psychotherapy versus general psychotherapy ends by emphasizing the importance of more detailed psychopathology and pathopsychology of dysfunctions that cannot be sufficiently explained in manuals. Such dysfunctions--not necessarily specific for diagnoses or abnormality at all--can then be matched to specific psychotherapy tools. Further innovations can be expected from neurosciences, and some of the most promising paradigms are discussed. Finally, the lasting importance of hermeneutics is stressed not only with regard to the generation of new hypotheses but also to guiding the psychotherapeutic process.

Evidence-Based Medicine↗
PubMed2003

Day hospital vs. home treatment--a comparison of illness severity and costs.

BACKGROUND: Acute home treatment services, providing short-term intensive input as an alternative to in-patient admission, have been recommended by the Department of Health as part of a spectrum of care. The lack of research evidence for such services is in contrast to acute day hospital care which has been better researched, but not widely adopted. This paper compares the patients treated in a randomised controlled trial (RCT) of day hospital vs. in-patient care with patients treated several years later in the home treatment service which developed from the original acute day hospital. METHOD: In the original RCT, patients were randomised at the point of admission to day hospital or in-patient care. The home treatment sample consisted of a consecutive series of admissions. Severity of illness was assessed at admission using the Comprehensive Psychopathological Rating Scale (CPRS). Both samples were followed up for 12 months to monitor service use and costs. RESULTS: Symptom severity among the home treatment sample (n = 71) was greater than the day hospital sample (n = 94) (mean CPRS score 31.6 vs. 25.5, p < 0.0001). This difference remained significant following adjustment for other socio-demographic and illness variables. Secondary care costs for the home treatment sample (including in-patient, home treatment and out-patient costs) were intermediate between the costs for the day hospital and in-patient samples from the RCT, but the differences were not statistically significant. CONCLUSIONS: Extending the remit of an acute day hospital to provide 24-h care and a choice of treatment location is associated with an increase in the severity of illness treated. The impact on costs is unclear and the total cost of the new service may not be significantly less than in-patient care. The results need to be interpreted with caution because of differences in recruitment methods.

Adolescent↗