Intraaortic administration of protamine: Method for heparin neutralization after cardiopulmonary bypass

In neutralizing heparin with intravenous protamine sulfate, hypotension may be prevented by administering the drug intraarterially. Forty patients underwent cardiac surgery with extracorporeal circulation in our hospital; each received a rapid injection of nondiluted protamine sulfate in the aortic root to reverse the effects of heparin. To maintain the blood volume at a constant level, volume expanders and inotropic drugs were avoided. The intraaortic injections ranged in duration from 0.2 min to 2.8 min, with a mean of 1.1 min. The mean systolic pressure only dropped from 92 mm Hg (SD +/- 21) before protamine injection to 85 mm Hg (SD +/- 23) after injection (p < 0.0001). In seven patients (18%), no hypotension was evident; in the remaining patients, the systolic pressure returned to preinjection values within a mean of 2.2 min. Coagulation was observed within 3 to 4 min (mean = 2.2 min) after the initiation of injection. This study indicates that intraaortic administration of protamine is a rapid and safe technique for heparin reversal after cardiopulmonary bypass.     

Remedial therapy after stroke: a randomised controlled trial.

Of 1094 patients with a confirmed stroke admitted to Northwick Park, a district general hospital, 364 (33%) died while in hospital, 215 (20%) were fully recovered when discharged, and 329 (30%) were too frail or too ill from diseases other than stroke to be considered for active rehabilitation. Only 121 (11%) were suitable for intensive treatment. They and 12 patients referred direct to outpatients were allocated at random to one of three different courses of rehabilitation. Intensive was compared with conventional rehabilitation and with a third regimen which included no routine rehabilitation, but under which patients were encouraged to continue with exercises taught while in hospital and were regularly seen at home by a health visitor. Progress at three months and 12 months was measured by an index of activities of daily living. Improvement was greatest in those receiving intensive treatment, intermediate in those receiving conventional treatment, and least in those receiving no routine treatment. Decreasing intensity of treatment was associated with a significant increase in the proportions of patients who deteriorated and in the extent to which they deteriorated. Probably only a few stroke patients, mostly men, are suitable for intensive outpatient rehabilitation, but for those patients the treatment is effective and realistic.     

Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial.

OBJECTIVE: To evaluate rehabilitation after myocardial infarction. DESIGN: Randomised controlled trial of rehabilitation in unselected myocardial infarction patients in six centres, baseline data being collected on admission and by structured interview (of patients and spouses) shortly after discharge and outcome being assessed by structured interview at six months and clinical examination at 12 months. SETTING: Six district general hospitals. SUBJECTS: All 2328 eligible patients admitted over two years with confirmed myocardial infarction and discharged home within 28 days. INTERVENTIONS: Rehabilitation programmes comprising psychological therapy, counselling, relaxation training, and stress management training over seven weekly group outpatient sessions for patients and spouses. MAIN OUTCOME MEASURES: Anxiety, depression, quality of life, morbidity, use of medication, and mortality. RESULTS: At six months there were no significant differences between rehabilitation patients and controls in reported anxiety (prevalence 33%) or depression (19%). Rehabilitation patients reported a lower frequency of angina (median three versus four episodes a week), medication, and physical activity. At 12 months there were no differences in clinical complications, clinical sequelae, or mortality. CONCLUSIONS: Rehabilitation programmes based on psychological therapy, counselling, relaxation training, and stress management seem to offer little objective benefit to patients who have experienced myocardial infarction compared with previous reports of smaller trials.     

"Right" stay in hospital after sugery: randomised controlled trial.

A randomised controlled trial was carried out on 100 patients to compare the effects of discharge after certain pre-specified clinical criteria had been fulfilled--"right" stay--with those of discharge at an arbitrary 10 days after surgery--"fixed" stay. The operations concerned (cholecystectomy and vagotomy) were more hazardous than those previously included in studies of early discharge. Patients in the right-stay group were discharged, on average, 7-6 days after operation--that is, two days earlier than those in the fixed-stay group. In terms of clinical progress, social factors such as return to work, and the acceptability to patients and relatives of the implications of right stay, patients in this group fared as well as those in the fixed-stay group, and in some respects slightly better. Right stay entailed the transfer of some work from hospital to community medical and nursing staff, but this also was acceptable. The concept and use of the right-stay principle is of value in planning the postoperative discharge of suitable patients.     

Cimetidine for recurrent ulcer after vagotomy or gastrectomy: a randomised controlled trial.

In a randomised controlled trial cimetidine 1 g daily for six weeks was compared with placebo in the treatment of recurrent ulcers after gastrectomy or vagotomy for duodenal ulcer. Healing, assessed endoscopically, was seen in seven out of 12 patients given cimetidine and in five out of 12 controls. Four of the controls whose ulcers did not heal were subsequently treated with cimetidine, and in two the ulcers healed after six weeks. Pain recorded by the patient and consumption of alkalis were each slightly but not significantly less in the cimetidine-treated patients. When cimetidine is to be used for recurrent ulceration probably the dosage and duration of treatment should be increased.     

Design and protocol for the Dialysis Optimal Health Program (DOHP) randomised controlled trial

BackgroundChronic kidney disease (CKD) and end-stage kidney disease (ESKD) are serious and growing health problems with enormous impact on psychological and social functioning. Despite high rates of comorbid depression and anxiety in these patient populations, and the adverse impact these have upon treatment adherence, quality of life, social connectedness and healthcare costs there has been little attention focused on the prevention or management of these problems. Thus, our aim was to evaluate the Dialysis Optimal Health Program (DOHP) that adopts a person-centred approach and engages collaborative therapy to educate and support those diagnosed with ESKD who are commencing dialysis.MethodsThe study design is a randomised controlled trial. Ninety-six adult patients initiating haemodialysis or peritoneal dialysis will be randomly allocated to either the intervention (DOHP) or usual care group. Participants receiving the intervention will receive nine (8 + 1 booster session) sequential sessions based on a structured information/workbook, psychosocial and educational supports and skills building. The primary outcome measures are depression and anxiety (assessed by the Hospital Anxiety and Depression Scale; HADS). Secondary outcomes include health-related quality of life (assessed by the Kidney Disease Quality of Life instrument; KDQOL), self-efficacy (assessed by General Self-Efficacy Scale) and clinical indices (e.g. albumin and haemoglobin levels). Cost-effectiveness analysis and process evaluation will also be performed to assess the economic value and efficacy of the DOHP. Primary and secondary measures will be collected at baseline and at 3-, 6-, and 12-month follow-up time points.DiscussionWe believe that this innovative trial will enhance knowledge of interventions aimed at supporting patients in the process of starting dialysis, and will broaden the focus from physical symptoms to include psychosocial factors such as depression, anxiety, self-efficacy, wellbeing and community support. The outcomes associated with this study are significant in terms of enhancing an at-risk population’s psychosocial health and reducing treatment-related costs and associated pressures on the healthcare system.

Trial registration

ANZCTR no. 12615000810516. Registered on 5 August 2015.

Electronic supplementary material

The online version of this article (doi:10.1186/s13063-016-1558-z) contains supplementary material, which is available to authorized users.     

The FLASSH study: protocol for a randomised controlled trial evaluating falls prevention after stroke and two sub-studies

Background  

Falls are common in stroke survivors returning home after rehabilitation, however there is currently a lack of evidence about preventing falls in this population. This paper describes the study protocol for the FLASSH (FaLls prevention After Stroke Survivors return Home) project.     

Befriending carers of people with dementia: randomised controlled trial

Objective To evaluate the effectiveness of a voluntary sector based befriending scheme in improving psychological wellbeing and quality of life for family carers of people with dementia.Design Single blind randomised controlled trial.Setting Community settings in East Anglia and London.Participants 236 family carers of people with primary progressive dementia.Intervention Contact with a befriender facilitator and offer of match with a trained lay volunteer befriender compared with no befriender facilitator contact; all participants continued to receive “usual care.”Main outcome measures Carers’ mood (hospital anxiety and depression scale—depression) and health related quality of life (EuroQoL) at 15 months post-randomisation.Results The intention to treat analysis showed no benefit for the intervention “access to a befriender facilitator” on the primary outcome measure or on any of the secondary outcome measures.Conclusions In common with many carers’ services, befriending schemes are not taken up by all carers, and providing access to a befriending scheme is not effective in improving wellbeing.Trial registration Current Controlled Trials ISRCTN08130075.     

Compliance therapy in psychotic patients: randomised controlled trial.

OBJECTIVE--To determine whether compliance therapy, a cognitive-behavioural intervention, could improve compliance with treatment and hence social adjustment in acutely psychotic inpatients, and if so, whether the effect persisted six months later. DESIGN--Randomised controlled trial of compliance therapy and non-specific counselling, each comprising 4-6 sessions lasting 10-60 minutes. SETTING--Acute psychiatric admissions ward serving an inner London catchment area. SUBJECTS--47 patients with psychosis. MAIN OUTCOME MEASURES--Informant and observer reported measure of compliance; observer assessed global functioning after intervention and three and six months later; self-rated attitudes to drug treatment after the intervention and one month later; symptom scores after intervention and six months later. RESULTS--25 patients received compliance therapy and showed significantly greater improvements in their attitudes to drug treatment and in their insight into illness and compliance with treatment compared with the control group. These gains persisted for six months. The intervention group was 5.2 times more likely than the control group to reach a criterion level of compliance (95% confidence interval 1.5 to 18.3). Global functioning showed a tendency to improve more in the intervention group after a delay (odds ratio 3.0 (0.8 to 11.5) to reach the criterion level at six months). Four subjects given compliance therapy and six in the control group were readmitted during follow up (odds ratio 2.0 (0.48 to 8.2)). CONCLUSIONS--Compliance therapy is a pragmatic method for improving compliance with drug treatment in psychotic inpatients and its gains persist for at least six months. Overall functioning may also be enhanced.     

Vitamin E supplementation and macular degeneration: randomised controlled trial

ObjectiveTo determine whether vitamin E supplementation influences the incidence or rate of progression of age related maculopathy (AMD).DesignProspective randomised placebo controlled clinical trial.SettingAn urban study centre in a residential area supervised by university research staff.Participants1193 healthy volunteers aged between 55 and 80 years; 73% completed the trial on full protocol.InterventionsVitamin E 500 IU or placebo daily for four years.ResultsThe incidence of early age related macular degeneration (early AMD 3) was 8.6% in those receiving vitamin E versus 8.1% in those on placebo (relative risk 1.05, 95% confidence interval 0.69 to 1.61). For late disease the incidence was 0.8% versus 0.6% (1.36, 0.67 to 2.77). Further analysis showed no consistent differences in secondary outcomes.ConclusionDaily supplement with vitamin E supplement does not prevent the development or progression of early or later stages of age related macular degeneration.

What is already known on this topic

Age related macular degeneration is the leading cause of loss of vision and blindness in elderly people; for people aged ⩾90 years, two out of every three will be affected and one in four will become blindCurrently, there are no methods of prevention or treatment in most cases, though a third of cases are due to cigarette smokingAntioxidant vitamins have been suggested as a possible prevention

What this study adds

Daily supplementation with 500 mg vitamin E for four years did not alter the incidence or progression of AMD     

Benefits of supplementary tube feeding after fractured neck of femur: a randomised controlled trial.

A total of 744 elderly women with fractured neck of femur were classified into three groups according to anthropometric measurements on admission: group 1, well nourished; group 2, thin; group 3, very thin. Group 1 ate well and had a low mortality and a short rehabilitation time. The thinner the patients the lower their voluntary food intake, the higher their mortality and the longer their rehabilitation time. A series of 122 patients from groups 2 and 3 were entered postoperatively into a randomised controlled trial of overnight supplementary nasogastric tube feeding (4.2 MJ (1000 kcal), including 28 g protein) in addition to their normal ward diet. This treatment was associated with improvements not only in anthropometric and plasma protein measurements but also in clinical outcome, especially in the very thin group 3 patients. Rehabilitation time and hospital stay were shortened. Mortality in group 3 was less in the tube fed patients (8%) than in the controls (22%) but this difference did not reach statistical significance. One in five patients could not tolerate the nasogastric tube, but in the remainder the treatment caused no side effects and did not seriously diminish voluntary oral food intake by day.     

A randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study

BackgroundWater, sanitation and hygiene (WASH) interventions should support infant growth but trial results are inconsistent. Frequently, interventions do not consider behaviours or transmission pathways specific to age. A household playspace (HPS) is one intervention component which may block faecal-oral transmission. This study was a two-armed, parallel-group, randomised, controlled feasibility trial of a HPS in rural Ethiopia. It aimed to recommend proceeding to a definitive trial. Secondary outcomes included effects on infant health, injury prevention and women’s time.MethodsNovember 2019−January 2020 106 households were identified and assessed for eligibility. Recruited households (N = 100) were randomised (blinded prior to the trial start) to intervention or control (both n = 50). Outcomes included recruitment, attrition, adherence, and acceptability. Data were collected at baseline, two and four weeks.FindingsRecruitment met a priori criteria (≥80%). There was no loss to follow-up, and no non-use, meeting adherence criteria (both ≤10%). Further, 48.0% (95% CI 33.7−62.6; n = 24) of households appropriately used and 56.0% (41.3−70.0; n = 28) cleaned the HPS over four weeks, partly meeting adherence criteria (≥50%). For acceptability, 41.0% (31.3−51.3; n = 41) of infants were in the HPS during random visits, failing criteria (≥50%). Further, the proportion of HPS use decreased during some activities, failing criteria (no decrease in use). A modified Barrier Analysis described good acceptability and multiple secondary benefits, including on women’s time burden and infant injury prevention.InterpretationDespite failing some a priori criteria, the trial demonstrated mixed adherence and good acceptability among intervention households. A definitive trial to determine efficacy is warranted if recommended adjustments are made.FundingPeople In Need; Czech Development Agency.Trial registrationRIDIE-ID-5de0b6938afb8.     

Cost effectiveness of community leg ulcer clinics: randomised controlled trial

Objectives: To establish the relative cost effectiveness of community leg ulcer clinics that use four layer compression bandaging versus usual care provided by district nurses. Design: Randomised controlled trial with 1 year of follow up. Setting: Eight community based research clinics in four trusts in Trent. Subjects: 233 patients with venous leg ulcers allocated at random to intervention (120) or control (113) group. Interventions: Weekly treatment with four layer bandaging in a leg ulcer clinic (clinic group) or usual care at home by the district nursing service (control group). Main outcome measures: Time to complete ulcer healing, patient health status, and recurrence of ulcers. Satisfaction with care, use of services, and personal costs were also monitored. Results: The ulcers of patients in the clinic group tended to heal sooner than those in the control group over the whole 12 month follow up (log rank P=0.03). At 12 weeks, 34% of patients in the clinic group were healed compared with 24% in the control. The crude initial healing rate of ulcers in intervention compared with control patients was 1.45 (95% confidence interval 1.04 to 2.03). No significant differences were found between the groups in health status. Mean total NHS costs were £878.06 per year for the clinic group and £859.34 for the control (P=0.89). Conclusions: Community based leg ulcer clinics with trained nurses using four layer bandaging is more effective than traditional home based treatment. This benefit is achieved at a small additional cost and could be delivered at reduced cost if certain service configurations were used.

Key messages

• Leg ulcer clinics based in the community using four layer compression bandaging can be more clinically effective than usual care provided by the district nursing service
• Community based leg ulcer clinics could be provided more cost effectively than usual home based care for venous leg ulcers
• Recurrence of venous leg ulcers is an important variable that should be measured in future trials of venous leg ulcer care
• It is difficult to measure improvements in health related quality of life among people with venous leg ulcers

     

Screening for abdominal aortic aneurysms: single centre randomised controlled trial

Objective To determine whether screening Danish men aged 65 or more for abdominal aortic aneurysms reduces mortality.Design Single centre randomised controlled trial.Setting All five hospitals in Viborg County, Denmark.Participants All 12 639 men born during 1921-33 and living in Viborg County. In 1994 we included men born 1921-9 (64-73 years). We also included men who became 65 during 1995-8.Interventions Men were randomised to the intervention group (screening by abdominal ultrasonography) or control group. Participants with an abdominal aortic aneurysm > 5 cm were referred for surgical evaluation, and those with smaller aneurysms were offered annual scans.Outcome measures Specific mortality due to abdominal aortic aneurysm, overall mortality, and number of planned and emergency operations for abdominal aortic aneurysms.Results 4860 of 6333 men were screened (attendance rate 76.6%). 191 (4.0% of those screened) had abdominal aortic aneurysms. The mean follow-up time was 52 months. The screened group underwent 75% (95% confidence interval 51% to 91%) fewer emergency operations than the control group. Deaths due to abdominal aortic aneurysms occurred in nine patients in the screened group and 27 in the control group. The number needed to screen to save one life was 352. Specific mortality was significantly reduced by 67% (29% to 84%). Mortality due to non-abdominal aortic aneurysms was non-significantly reduced by 8%. The benefits of screening may increase with time.Conclusion Mass screening for abdominal aortic aneurysms in Danish men aged 65 or more reduces mortality.     

Analgesic effect of breast feeding in term neonates: randomised controlled trial

ObjectivesTo investigate whether breast feeding is effective for pain relief during venepuncture in term neonates and compare any effect with that of oral glucose combined with a pacifier.DesignRandomised controlled trial.Participants180 term newborn infants undergoing venepuncture; 45 in each group.InterventionsDuring venepuncture infants were either breast fed (group 1), held in their mother''s arms without breast feeding (group 2), given 1 ml of sterile water as placebo (group 3), or given 1 ml of 30% glucose followed by pacifier (group 4). Video recordings of the procedure were assessed by two observers blinded to the purpose of the study.ResultsMedian pain scores (interquartile range) for breast feeding, held in mother''s arms, placebo, and 30% glucose plus pacifier groups were 1 (0-3), 10 (8.5-10), 10 (7.5-10), and 3 (0-5) with the Douleur Aiguë Nouveau-né scale and 4.5 (2.25-8), 13 (10.5-15), 12 (9-13), and 4 (1-6) with the premature infant pain profile scale. Analysis of variance showed significantly different median pain scores (P<0.0001) among the groups. There were significant reductions in both scores for the breast feeding and glucose plus pacifier groups compared with the other two groups (P<0.0001, two tailed Mann-Whitney U tests between groups). The difference in Douleur Aiguë Nouveau-né scores between breast feeding and glucose plus pacifier groups was not significant (P=0.16).ConclusionsBreast feeding effectively reduces response to pain during minor invasive procedure in term neonates.

What is already known on this topic

Current pharmacological treatments are not appropriate for pain relief during minor procedures like venepuncture or heel prick in newborn infantsOral sweet solutions, non-nutritive sucking, and skin to skin contact reduce procedural pain in newborn infants

What this study adds

Breast feeding during a painful procedure effectively reduces the response to pain in newborn infantsThe analgesic properties of breast feeding are at least as potent as the combination of sweet solutions and a pacifier     

Zinc supplementation in children with cholera in Bangladesh: randomised controlled trial

Objective To investigate the impact of zinc supplementation in children with cholera.Design Double blind, randomised, placebo controlled trial.Setting Dhaka Hospital, Bangladesh.Participants 179 children aged 3-14 years with watery diarrhoea and stool dark field examination positive for Vibrio cholerae and confirmed by stool culture.Intervention Children were randomised to receive 30 mg elemental zinc per day (n=90) or placebo (n=89) until recovery. All children received erythromycin suspension orally in a dose of 12.5 mg/kg every six hours for three days.Main outcome measures Duration of diarrhoea and stool output.Results 82 children in each group completed the study. More patients in the zinc group than in the control group recovered by two days (49% v 32%, P=0.032) and by three days (81% v 68%, P=0.03). Zinc supplemented patients had 12% shorter duration of diarrhoea than control patients (64.1 v 72.8 h, P=0.028) and 11% less stool output (1.6 v 1.8 kg/day, P=0.039).Conclusion Zinc supplementation significantly reduced the duration of diarrhoea and stool output in children with cholera. Children with cholera should be supplemented with zinc to reduce its duration and severity.Trial registration Clinical trials {"type":"clinical-trial","attrs":{"text":"NCT00226616","term_id":"NCT00226616"}}NCT00226616.     

Bezafibrate in men with lower extremity arterial disease: randomised controlled trial

ObjectiveTo assess the effect of bezafibrate on the risk of coronary heart disease and stroke in men with lower extremity arterial disease.DesignDouble blind placebo controlled randomised trial.Setting85 general practices and nine hospital vascular clinics.Participants1568 men, mean age 68.2 years (range 35 to 92) at recruitment.InterventionsBezafibrate 400 mg daily (783 men) or placebo (785 men).ResultsBezafibrate did not reduce the incidence of coronary heart disease and stroke. There were 150 and 160 events in the active and placebo groups respectively (relative risk 0.96, 95% confidence interval 0.76 to 1.21). There were 90 and 111 major coronary events in the active and placebo groups respectively (0.81, 0.60 to 1.08), of which 64 and 65 were fatal (0.95, 0.66 to 1.37) and 26 and 46 non-fatal (0.60, 0.36 to 0.99). Beneficial effects on non-fatal events were greatest in men aged <65 years at entry, in whom benefit was also seen for all coronary events (0.38, 0.20 to 0.72). There were no significant effects in older men. There were 60 strokes in those on active treatment and 49 in those on placebo (1.34, 0.80 to 2.01). There were 204 and 195 deaths from all causes in the two groups respectively (1.03, 0.83 to 1.26). Bezafibrate reduced the severity of intermittent claudication for up to three years.ConclusionsBezafibrate has no effect on the incidence of coronary heart disease and of stroke combined but may reduce the incidence of non-fatal coronary events, particularly in those aged <65 years at entry, in whom all coronary events may also be reduced.

What is already known on this topic

The beneficial effects of bezafibrate on blood lipids and fibrinogen concentrations should reduce the incidence of heart attacks and strokesSo far, however, there is only limited evidence on clinical outcomes from randomised controlled trials

What this study adds

Treatment with bezafibrate was not associated with a reduction in the combined incidence of heart attacks and strokes, though there were substantially fewer non-fatal heart attacks in those taking bezafibrateBezafibrate was associated with a reduction in the incidence of all heart attacks, especially non-fatal, in men aged <65 yearsBezafibrate seems to reduce the severity of intermittent claudication for two or three years     

Preventing injuries in children: cluster randomised controlled trial in primary care

ObjectiveTo assess the effectiveness of safety advice at child health surveillance consultations, provision of low cost safety equipment to families receiving means tested state benefits, home safety checks, and first aid training on frequency and severity of unintentional injuries in children at home.DesignCluster randomised controlled trial.Setting36 general practices in Nottingham.SubjectsAll children aged 3-12 months registered with participating practices.InterventionsA package of safety advice at child health surveillance consultations at 6-9, 12-15, and 18-24 months; provision of low cost safety equipment to families on means tested state benefits; and home safety checks and first aid training by health visitors.ResultsAt baseline, both groups had similar risk factors for injury, sociodemographic characteristics, safety practices, possession and use of safety equipment, knowledge and confidence in dealing with first aid, and perceptions of risk. No significant difference was found in frequency of at least one medically attended injury (odds ratio 0.97, 95% confidence interval 0.72 to 1.30), at least one attendance at an accident and emergency department for injury (1.02, 0.76 to 1.37), at least one primary care attendance for injury (0.75, 0.48 to 1.17), or at least one hospital admission for injury (0.69, 0.42 to 1.12). No significant difference in the secondary outcome measures was found between the intervention and control groups. ConclusionsThe intervention package was not effective in reducing the frequency of minor unintentional injuries in children at home, and larger trials are required to assess the effect on more severe injuries.

Key messages

• A package of activities for preventing injuries, as suggested by the Health of the Nation, delivered to families with children aged under 3 in primary care did not reduce the frequency of minor injuries
• The findings were consistent with a reduction in the frequency of more severe injuries, and larger primary care based studies are required to test this hypothesis
• The effectiveness of each of the interventions, delivered singly, is not known