A brief intervention for weight control based on habit-formation theory delivered through primary care: results from a randomised controlled trial.

BACKGROUND: Primary care is the 'first port of call' for weight control advice, creating a need for simple, effective interventions that can be delivered without specialist skills. Ten Top Tips (10TT) is a leaflet based on habit-formation theory that could fill this gap. The aim of the current study was to test the hypothesis that 10TT can achieve significantly greater weight loss over 3 months than 'usual care'. METHODS: A two-arm, individually randomised, controlled trial in primary care. Adults with obesity were identified from 14 primary care providers across England. Patients were randomised to either 10TT or 'usual care' and followed up at 3, 6, 12, 18 and 24 months. The primary outcome was weight loss at 3 months, assessed by a health professional blinded to group allocation. Difference between arms was assessed using a mixed-effect linear model taking into account the health professionals delivering 10TT, and adjusted for baseline weight. Secondary outcomes included body mass index, waist circumference, the number achieving a 5% weight reduction, clinical markers for potential comorbidities, weight loss over 24 months and basic costs. RESULTS: Five-hundred and thirty-seven participants were randomised to 10TT (n=267) or to 'usual care' (n=270). Data were available for 389 (72%) participants at 3 months and for 312 (58%) at 24 months. Participants receiving 10TT lost significantly more weight over 3 months than those receiving usual care (mean difference =-0.87kg; 95% confidence interval: -1.47 to -0.27; P=0.004). At 24 months, the 10TT group had maintained their weight loss, but the 'usual care' group had lost a similar amount. The basic cost of 10TT was low, that is, around £23 ($32) per participant. CONCLUSIONS: The 10TT leaflet delivered through primary care is effective in the short-term and a low-cost option over the longer term. It is the first habit-based intervention to be used in a health service setting and offers a low-intensity alternative to 'usual care'.

The association between C-reactive protein and delirium in 710 acute elderly hospital admissions.

BACKGROUND: Delirium is a common neuropsychiatric syndrome associated with poor outcomes. Evidence supports a neuroinflammatory etiology, but the role of the inflammatory marker C-reactive protein (C-RP) remains unclear. We investigated the relationship between C-RP and delirium and its severity as well as interaction with medical diagnosis. METHODS: From an existing database (710 patients over 70 years old admitted to a Medical Acute Admissions Unit) we analyzed data which included C-RP levels, delirium (using the Confusion Assessment Method), and other clinical and demographic factors. Primary diagnoses were grouped (cardiovascular, musculoskeletal, infection, metabolic, and other). RESULTS: There was a strong association between elevated C-RP and delirium (t = 5.09; p < 0.001), independent of other potential risk factors for delirium (odds ratio (OR) = 1.32 (95% CI: 1.10-1.58) p = 0.003). There was no significant association between C-RP and delirium severity, and between C-RP and delirium in the populations with cardiovascular disease, infection upon admission, or from the metabolic group despite an OR of 2.24 (95% CI: 0.92-5.45). There was an association in the musculoskeletal group (OR 2.19 (95% CI: 1.19-4.02)). CONCLUSIONS: There is an association between elevated C-RP and delirium. This is strongest in patients admitted with musculoskeletal disease but not in others, implying that C-RP is involved in the genesis of delirium in musculoskeletal disease, but that other factors or processes may be more important in those with cardiovascular disease or infection.

Spiritual and religious beliefs as risk factors for the onset of major depression: an international cohort study.

BACKGROUND: Several studies have reported weak associations between religious or spiritual belief and psychological health. However, most have been cross-sectional surveys in the U.S.A., limiting inference about generalizability. An international longitudinal study of incidence of major depression gave us the opportunity to investigate this relationship further. METHOD: Data were collected in a prospective cohort study of adult general practice attendees across seven countries. Participants were followed at 6 and 12 months. Spiritual and religious beliefs were assessed using a standardized questionnaire, and DSM-IV diagnosis of major depression was made using the Composite International Diagnostic Interview (CIDI). Logistic regression was used to estimate incidence rates and odds ratios (ORs), after multiple imputation of missing data. RESULTS: The analyses included 8318 attendees. Of participants reporting a spiritual understanding of life at baseline, 10.5% had an episode of depression in the following year compared to 10.3% of religious participants and 7.0% of the secular group (p<0.001). However, the findings varied significantly across countries, with the difference being significant only in the U.K., where spiritual participants were nearly three times more likely to experience an episode of depression than the secular group [OR 2.73, 95% confidence interval (CI) 1.59­4.68]. The strength of belief also had an effect, with participants with strong belief having twice the risk of participants with weak belief. There was no evidence of religion acting as a buffer to prevent depression after a serious life event. CONCLUSIONS: These results do not support the notion that religious and spiritual life views enhance psychological well-being.

Characteristics of a population-wide sample of smokers recruited proactively for the ESCAPE trial.

OBJECTIVES: To describe the characteristics of a sample of smokers recruited proactively into a smoking cessation trial, and to compare these characteristics with the wider population using data from the General Household Survey (GHS) and National Statistics Omnibus Survey. STUDY DESIGN: Sample recruited for a randomized controlled trial. METHODS: Between August 2007 and October 2008, 123 general practices mailed questionnaires to smokers in the U.K. identified from computer records. Smokers willing to participate in a trial of personalized computer-tailored feedback returned the questionnaires to the research team. The characteristics of the sample were compared with the wider population using data from the GHS and National Statistics Omnibus Survey, and Index of Material Deprivation scores. RESULTS: A response rate of 11.4% (n = 6697) was achieved. The sample was demographically similar to the population sample, with an even distribution of participants from areas of both high and low deprivation. The sample was more dependent than the GHS sample, but less dependent than clinic samples. Distribution by motivation and readiness to quit was similar to population estimates. CONCLUSIONS: Public health strategies targeting the entire population of smokers are needed to counter the low recruitment rates resulting from the traditional reactive methods of recruitment to smoking cessation studies. Using computerized records to identify and contact patients who are smokers is a simple method of recruiting a larger, more representative sample of smokers.

Group art therapy as an adjunctive treatment for people with schizophrenia: a randomised controlled trial (MATISSE).

OBJECTIVE: To examine the clinical effectiveness and cost-effectiveness of referral to group art therapy plus standard care, compared with referral to an activity group plus standard care and standard care alone, among people with schizophrenia. DESIGN: A three-arm, parallel group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by study centre. SETTING: Study participants were recruited from secondary care mental health and social services in four UK centres. PARTICIPANTS: Potential participants were aged 18 years or over, had a clinical diagnosis of schizophrenia, confirmed by an examination of case notes, and provided written informed consent. We excluded those who were unable to speak sufficient English to complete the baseline assessment, those with severe cognitive impairment and those already receiving arts therapy. INTERVENTIONS: Group art therapy was delivered by registered art therapists according to nationally agreed standards. Groups had up to eight members, lasted for 90 minutes and ran for 12 months. Members were given access to a range of art materials and encouraged to use these to express themselves freely. Activity groups were designed to control for the non-specific effects of group art therapy. Group facilitators offered various activities and encouraged participants to collectively select those they wanted to pursue. Standard care involved follow-up from secondary care mental health services and the option of referral to other services, except arts therapies, as required. MAIN OUTCOME MEASURES: Our co-primary outcomes were global functioning (measured using the Global Assessment of Functioning Scale - GAF) and mental health symptoms (measured using the Positive and Negative Syndrome Scale - PANSS) at 24 months. The main secondary outcomes were level of group attendance, social functioning, well-being, health-related quality of life, service utilisation and other costs measured 12 and 24 months after randomisation. RESULTS: Four hundred and seventeen people were recruited, of whom 355 (85%) were followed up at 2 years. Eighty-six (61%) of those randomised to art therapy and 73 (52%) of those randomised to activity groups attended at least one group. No differences in primary outcomes were found between the three study arms. The adjusted mean difference between art therapy and standard care at 24 months was -0.9 [95% confidence interval (CI) -3.8 to 2.1] on the GAF Scale and 0.7 (95% CI -3.1 to 4.6) on the PANSS Scale. Differences in secondary outcomes were not found, except that those referred to an activity group had fewer positive symptoms of schizophrenia at 24 months than those randomised to art therapy. Secondary analysis indicated that attendance at art therapy groups was not associated with improvements in global functioning or mental health. Although the total cost of the art therapy group was lower than the cost of the two comparison groups, referral to group art therapy did not appear to provide a cost-effective use of resources. CONCLUSIONS: Referring people with established schizophrenia to group art therapy as delivered in this randomised trial does not appear to improve global functioning or mental health of patients or provide a more cost-effective use of resources than standard care alone. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 46150447. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 8. See the HTA programme website for further project information.

Cardiovascular risk assessment of South Asians in a religious setting: a feasibility study.

AIMS: South Asians in the UK have high cardiovascular disease (CVD) mortality. Therefore, this population is likely to benefit from screening programmes. To address this issue, an initiative was set up between the Royal Free Hampstead NHS Trust, H.E.A.R.T. UK and two Hindu temples in North London to provide screening for CVD risk factors in the community. METHODS: A total of 434 individuals of Gujarati Indian origin were screened. Measurements included anthropometry, blood pressure and lipid profiles. Three different scoring systems: Framingham, Joint British Societies' 2 and QRISK2 were used to estimate CVD risk. RESULTS: At least one modifiable CVD risk factor was present in 92% of the individuals screened; 52% were hypertensive, 40% were obese, 75% had central adiposity and 10% had total cholesterol/high density lipoprotein cholesterol ratio > 6. In addition, 37% of a subset of 104 individuals with a fasting sample fulfilled the diagnostic criteria for metabolic syndrome. Overall, 15% of participants screened had a 10-year CV risk score > 20% using QRISK2. The three risk score calculators showed moderate agreement: QRISK2 and JBS2 (kappa 0.61, 95% CI 0.54-0.67), QRISK2 and Framingham (kappa 0.63, 95% CI 0.57-0.70) and JBS2 and Framingham (kappa 0.70, 95% CI 0.64-0.75). CONCLUSIONS: A high prevalence of modifiable risk factors for CVD was detected in the population screened.

Hospice care delivered at home, in nursing homes and in dedicated hospice facilities: A systematic review of quantitative and qualitative evidence.

BACKGROUND: Hospice care supports patients and their families physically and emotionally through the dying phase. In many countries a substantial portion of specialised end-of-life care is provided through hospices. Such care has developed outside of general healthcare and is commonly provided in a patient's home or in dedicated facilities. Hospice provision may need to increase in the future due to an ageing population with a greater need for access to end-of-life care. OBJECTIVES: In this systematic review we sought to identify the current evidence on (1) the effectiveness, including cost-effectiveness, of hospices, and hospice care in a patient's home and in nursing homes and (2) the experiences of those who use and of those who provide such services. METHODS: We included quantitative and qualitative studies on hospice care that was provided in a patient's home, nursing home or hospice. We did not include studies on end-of-life care that was provided as part of general healthcare provision, such as by general practitioners in primary care, community nurses or within general hospitals. For quantitative evaluations we included only those that compared hospice care with usual generalist healthcare. The databases CINAHL, MEDLINE, EMBASE, and The Cochrane Library were searched from 2003 to 2009. Evidence was assessed for quality and data extractions double-checked. For quantitative studies we present the outcome data comparing hospice versus usual care. For qualitative evaluations we organise findings thematically. FINDINGS: Eighteen comparative evaluations and four thematic papers were identified. Quantitative evidence, mostly of limited quality in design, showed that hospice care at home reduced general health care use and increased family and patient satisfaction with care. Main themes in the qualitative literature revealed that home hospice services support families to sustain patient care at home and hospice day care services generate for the patient a renewed sense of meaning and purpose. CONCLUSIONS: Although studies had methodological limitations, in this review we found much evidence to support the benefits of hospice care. There were limited evaluations found on the impact of hospice care on psychological well-being, such as symptoms of depression, and on inpatient hospice care and non-hospital related costs.

Treatment of refractory congestive heart failure by cardiac resynchronization.

The contributions of long-term cardiac resynchronization as a supplemental treatment of refractory congestive heart failure have recently been reported. Several completed studies support the validity of this new therapy, capable of improving quality of life as well as increasing exercise capacity. These gains hinge on a careful patient selection, on the proper placement of the leads, particularly that responsible for left ventricular stimulation, and on an individualized patient follow-up. The results obtained thus fat fully justify considering cardiac resynchronization as an additional option in the treatment management of patients refractory to conventional measures. Ongoing studies should help to further defining its impact on morbidity and overall mortality, as well as the potential role for back up defribillator.

Plasma treatment effects on the tantalum Strecker stent implanted in femoral arteries of sheep.

PURPOSE: To evaluate the effects of plasma treatment, a cleaning process for removal of organic contaminants from the knit-wire surface of tantalum Strecker stents, on biocompatibility and thrombogenicity. METHODS: A treated or untreated stent was randomly implanted in both femoral arteries of 15 sheep studied for periods of 4 (group 1), 15 (group 2), or 42 (group 3) days. Patency, histological changes, and mechanical effects were compared by means of radiologic and pathologic controls. RESULTS: Plasma treatment did not influence overall patency (93.3% vs 86.7%), maximal neointimal hyperplasia in groups 2 and 3 (801 +/- 123 vs 733 +/- 179 microns), or media thinning in any group (254 +/- 92 vs 285 +/- 72 microns), but modified the elastic properties of the stents by limiting (p = 0.01) shortening at implantation. CONCLUSION: Plasma treatment does not affect the biocompatibility and thrombogenicity of Strecker stents implanted in normal femoral arteries of sheep but modifies their elastic properties. Further studies are needed to account for this effect.

Vena Tech-LGM filter: long-term results of a prospective study.

Efficiency and tolerance of the Vena Tech-LGM filter were assessed in 142 patients prospectively studied during a 2-6-year follow-up period. No patients were lost to follow-up, and 137 (91.3%) scheduled control examinations were performed. Fifty-three patients died of causes unrelated to thromboembolic disease. Pulmonary embolism was suspected in five surviving patients (3.5%). Sixteen retractions (18.4%), 16 intracaval migrations (18.4%), and one tilt were observed. Filter patency studied at Doppler ultrasonography, with or without phlebocavography, gave the following results according to the Kaplan-Meier actuarial method: 92% patency after 2 years of follow-up, 80% after 4 years, and 70% after 6 years. Vena Tech-LGM filter obstruction was related to retraction (P < 10(-6)) or distal migration (P < .004). Occurrence of trophic disease in the lower limbs during the follow-up period was related to the initial level of deep venous thrombosis (P = .03) and had no relation to the patency of the filter. The filter was effective in preventing pulmonary embolism, with 70% demonstrating long-term patency, and no deleterious effects were imputed to obstructions observed during follow-up.

[Percutaneous aortic valvuloplasty. Long-term outcome apropos of 85 patients with successful dilatation]. / Valvuloplastie aortique percutanée. Evolution à long terme à propos de 85 patients dilatés avec succès.

The outcome at 2, 6, 12, 18 and 24 months in terms of clinical status and Doppler echocardiographic parameters of 85 patients successfully dilated out of 116 patients undergoing percutaneous aortic valvuloplasty is reported. The objectives were to determine the survival rate, degree of clinical remission, the restenosis rate and its predictive factors. The 31 patients considered to be primary failures were excluded from the study. The global survival rates were 90 +/- 2% at 2 months, 84 +/- 4% at 6 months, 78 +/- 5% at 12 months, 69 +/- 6% at 18 months and 60 +/- 8% at 2 years. Patients in clinical remission and with clinical relapse were compared at the 6th month: relapse was significantly, related to prevalvuloplathy, low cardiac output (p = 0.05), low ejection fraction (p less than 0.03) and low fractional shortening (p less than 0.01), but the clinical relapse was independent of aortic valve surface area before and dilatation. In the relapse group, 14 patients (12%) were operated without complications in the first month of follow up, 6 patients underwent repeat valvuloplasty with 4 immediate failures and 2 improvements. The other patients were treated medically. The restenosis rate (loss of greater than 50% of initial gain in surface area or return of pre-valvuloplasty maximal pressure gradient +/- 25%) increased up to the 12th month in both groups (remission and relapse) and reached 78% at 12 +/- 3 months and seemed more pronounced in the less severe aortic stenosis. The incidence of restenosis was independent of gain in surface area after valvuloplasty.(ABSTRACT TRUNCATED AT 250 WORDS)

[Coronary aneurysm after transluminal angioplasty. Report of 13 cases]. / Anévrysmes coronaires après angioplastie transluminale. A propos de 13 observations.

The aim of this study was to determine the incidence, angiographic characteristics, clinical consequences, therapeutic implications and evolution of coronary arterial aneurysms after percutaneous transluminal coronary angioplasty (PTCA) based on a series of 13 cases out of a total population of 752 patients undergoing balloon dilatation. Before BTCA, 10 patients had unstable angina and 3 had stable angina. The stenoses were of type A in 6 cases and, more complex, type B, in 7 cases. The results of PTCA were good except in 1 case in which the procedure was complicated by a rudimentary infarct due to an extensive intra mural rupture. The frequency of coronary aneurysms evaluated in a series of 150 patients dilated and controlled systematically was 4 p. 100. This complication was observed relatively late, 2 to 13 months after PTCA. The length of aneurysm ranged from 2 to 13 mm (3.9 +/- 2.9 mm). Nine aneurysms were sacciform and 4 were fusiform. They were isolated in 6 cases and associated with restenosis in 7 cases. The predisposing role of an oversized angioplasty balloon was a probable etiological factor; the balloon/artery ratio was over 1.1 in 4 cases and over 1.2 in 3 cases. Intramural rupture observed at the time of PTCA (8/13 cases) did not seem to be a predisposing factor as the incidence of coronary aneurysm was not significantly different in patients without this complication in the group of 150 patients dilated and controlled systematically by angiography (5.8% vs 3%; NS). In the 6 cases of isolated coronary aneurysm the patients were asymptomatic and were followed up with medical treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

[Comparative results of coronary angioplasty performed at the time of coronarography and at a later time]. / Résultats comparés de l'angioplastie coronaire pratiquée dans le même temps ou à distance de la coronarographie.

Between January 1986 and December 1988, 558 patients underwent percutaneous transluminal coronary angioplasty (PTCA) of whom 40 per cent were dilated at the time of diagnostic coronary arteriography. In order to assess the value of this therapeutic strategy we compared the results of 221 patients dilated at the time of diagnostic coronary arteriography (Group 1) with those of 337 patients who underwent deferred PTCA. In Group 1, the incidence of stable angina was lower (26.7% vs 46.3%, p less than 10-5), that of thrombolysed myocardial infarction was higher (24% vs 2.7%, p less than 10-9) and a higher proportion of patients had previously undergone PTCA (29.4% vs 3.2%, p less than 10-9). The proportion of patients with single vessel disease was higher in Group 1 (84.6% vs 74.7%, p less than 0.01) as was that of angioplasty of a single lesion (97.7% vs 88.1%, p less than 10-4). There were fewer dilations of the left circumflex artery in Group 1 (17.2% vs 27.3%, p less than 0.05) which was compensated by a higher number involving the right coronary artery (26.1% vs 15.5%, p less than 0.01). The immediate results were comparable in the two groups with 87.8 per cent primary successes, 3.6 per cent of myocardial infarcts and 1.3 per cent of coronary bypass operations with no fatalities in Group 1. These favorable results encourage the development of PTCA at the time of diagnostic coronary arteriography in the following indications: unstable angina, thrombolysed myocardial infarction and restenosis irrespective of the patient's symptomatology.(ABSTRACT TRUNCATED AT 250 WORDS)

[Aortic valvuloplasty in the elderly. Immediate and medium-term results]. / La valvuloplastie aortique du sujet âgé. Résultats immédiats et à moyen terme.

Between January 86 and February 88 we attempted percutaneous aortic valvuloplasty in 100 patients. 68 patients could be dilated with hemodynamic success: the aortic valve area increased from 0.52 +/- 0.17 cm2 to 0.78 +/- 0.27 cm2 (p less than 0.001). Cardiac output did not change significantly (4 +/- 1.1 l/mn). In the remaining 32 patients: 8 patients (8%) died in hospital and the morbidity rate was 11%: arterial injury (9), stroke (1) and major cardiac event (1). Sixty patients regarded as initial success were followed for 6 months: 3 patients (5%) died without cardiac events, functional improvement persisted in 41 patients (68%) and clinical failure was observed in 16 patients (27%): 4 patients died and in the remaining 12 patients, the recurrence of symptoms required medical treatment (5), surgery (5) or repeat percutaneous valvuloplasty (2). Echo-Doppler maximum aortic valve gradient was significantly less in improved patients (55 +/- 21 mmHg) than in deteriorated patients (78 +/- 36 mmHg) (p less than 0.02). One year after valvuloplasty: actuarial survival was 74 +/- 6%, clinical improvement was 53 +/- 7% and clinical recurrence was 41 +/- 7%. Thus percutaneous aortic valvuloplasty may be proposed only to non surgical patients.

[Transluminal coronary angioplasty at the same time as or separate from coronarography. Comparative results]. / Angioplastie transluminale coronaire dans le même temps ou à distance de la coronarographie. Résultats comparatifs.

Frequency of PTCA performed at the time of initial coronary angiography has increased to 47% of all PTCA performed in 1988. The aim of this study is to assess the efficacy and safety of this strategy by comparing the results in 2 groups of patients: in group 1 (179 patients), PTCA was performed at the time of initial coronary angiography and in group 2 (549 patients) PTCA was performed, 15 to 30 days after initial coronary angiography. Clinical differences between the two groups concerned: stable angina (25.1% vs 41%; p less than 0.001) and myocardial infarction treated with thrombolytic therapy (23.7% vs 7.7%; p less than 10(-9)). The extent of coronary artery disease was similar in the two groups but the incidence of single vessel PTCA was higher in group 1 (96% vs 90%; p less than 0.01). The immediate results of PTCA were similar and led us to develop this strategy for unstable angina, myocardial infarction treated with thrombolytic therapy, as well as total coronary obstruction and restenosis whatever their symptoms and signs. This strategy requires high quality fluoroscopic and video replay images, and allows a reduction in hospital costs.

Congenital valvular aortic stenosis in adults.

Based on a study of 20 patients operated on between the ages of 21 and 38 for congenital valvular aortic stenosis, the distinguishing features of congenital aortic valvular stenosis in adults are reviewed: valvular calcification (75%), valvular dome rarely present (10%), usually moderate cardiac disability (70%), diminished or inaudible second heart sound (50%), associated diastolic murmur (75%), electrocardiographic left ventricular hypertrophy (70%), and an infrequent protosystolic click (30%). Surgery is necessary for symptomatic patients. If patients are asymptomatic, surgery is decided after measuring the left ventricle-aortic pressure gradient by continuous Doppler wave study, or by cardiac catheterization. If surgery is not performed, a regular follow-up is necessary because stenosis can evolve. Valvular replacement by a mechanical valve is preferable. Even if the aortic valve is not calcified and a simple commissurotomy is technically possible, it is only a palliative method with unsatisfactory results and an annual mortality rate after surgery of 1%.

[Aortic insufficiency and Takayasu disease]. / Insuffisance aortique et maladie de Takayasu.

Six cases of this rare association (7 to 10 p. 100 of Takayasu's disease) are reported. The authors also review 73 previously reported cases. The valvular lesion is usually detected secondarily during follow-up (2/3 of cases), but is observed at the same time as the arterial disease in about 1 out of 5 cases. In rare cases, it may be the presenting feature before the vascular disease becomes clinically apparent. Quantification of the regurgitation may be difficult because of stenosis of the thoracic aorta and the supra aortic vessels. In some cases it is severe and poorly tolerated but has no particular distinguishing features apart from the incidence of aortic wall calcification (ascending aorta to all of the aortic arch). Twenty five anatomical observations (operative or autopsy) are sufficiently well documented to show the mechanism of the aortic incompetence. It is caused by an inflammatory aortitis: valvular lesions were found in 2/3 of cases but other causes may be observed, dilatation of the aortic ring (1 out of 4 cases), disunion of the commissures (1 out of 4 cases) and changes in aortic compliance causing systolic hypertension. Aortic valve replacement is rare (11 cases including 3 personal cases) and sometimes completed by resection of an aneurysmal ascending aorta.