Randomised controlled trial of routine hospital clinic care versus routine general practice care for type II diabetics.

Two hundred patients with type II diabetes were entered into a randomised controlled trial lasting five years to compare routine care of this condition by a hospital diabetic clinic with routine care in general practice. Fewer patients in the group being cared for by their general practitioner (general practice group) were regularly reviewed or had regular estimations of blood glucose concentration. More patients in the general practice group than in the hospital group were admitted to hospital for medical reasons during the study (25 (24%) compared with 17 (18%] and more patients in the general practice group died (18) than did in the hospital group (6). At the end of the study mean concentrations of haemoglobin A1 were higher in the general practice group (10.4%) than in the hospital group (9.5%). Routine care in general practice for patients with type II diabetes was less satisfactory than care by the hospital diabetic clinic.     

Randomised controlled trial for evaluation of fitness programme for patients with chronic low back pain.

OBJECTIVE--To evaluate a progressive fitness programme for patients with chronic low back pain. DESIGN--Single blind randomised controlled trial. Assessments were carried out before and after treatment by an observer blinded to the study and included a battery of validated measures. All patients were followed up by postal questionnaire six months after treatment. SETTING--Physiotherapy department of orthopaedic hospital. SUBJECTS--81 patients with chronic low back pain referred from orthopaedic consultants for physiotherapy. The patients were randomly allocated to a fitness programme or control group. INTERVENTION--Both groups were taught specific exercises to carry out at home and referred to a back-school for education in back care. Patients allocated to the fitness class attended eight exercise classes over four weeks in addition to the home programme and backschool. RESULTS--Significant differences between the groups were shown in the changes before and after treatment in scores on the Oswestry low back pain disability index (P < 0.005), pain reports (sensory P < 0.05 and affective P < 0.005), self efficacy reports (P < 0.05), and walking distance (P < 0.005). No significant differences between the groups were found by the general health questionnaire or questionnaire on pain locus of control. A benefit of about 6 percentage points on the disability index was maintained by patients in the fitness group at six months. CONCLUSION--There is a role for supervised fitness programmes in the management of moderately disabled patients with chronic low back pain. Further clinical trials, however, need to be established in other centres to confirm these findings.     

Randomised trial of a mobile coronary care unit for emergency calls.

A randomised trial was conducted to assess the value of sending a mobile coronary care unit (MCCU) to all emergency calls other than those for children or for patients injured in road-traffic accidents or brawls. Over 15 months 6223 calls for emergency ambulances were considered for the study, but a routine ambulance had to be dispatched on 2583 occasions because the MCCU was not available. A group of 1664 patients was randomly allocated to transport by the MCCU and 1676 patients to routine transport. In these groups the prehospital mortality among patients with heart attacks was 45% and 47%, and no patient survived resuscitation attempts long enough to leave hospital. During the same period general practitioners sent 190 patients with heart attacks to hospital in routine ambulances and none of them died during the interval between the call for the ambulance and arrival at hospital. Although it may be worth equipping all emergency ambulances with a defibrillator, MCCUs as at present envisaged will not appreciably affect mortality from heart attacks.     

Randomised controlled trial of intravenous antibiotic treatment for cellulitis at home compared with hospital

Objectives To compare the efficacy, safety, and acceptability of treatment with intravenous antibiotics for cellulitis at home and in hospital.Design Prospective randomised controlled trial.Setting Christchurch, New Zealand.Participants 200 patients presenting or referred to the only emergency department in Christchurch who were thought to require intravenous antibiotic treatment for cellulitis and who did not have any contraindications to home care were randomly assigned to receive treatment either at home or in hospital.Main outcome measures Days to no advancement of cellulitis was the primary outcome measure. Days on intravenous and oral antibiotics, days in hospital or in the home care programme, complications, degree of functioning and pain, and satisfaction with site of care were also recorded.Results The two treatment groups did not differ significantly for the primary outcome of days to no advancement of cellulitis, with a mean of 1.50 days (SD 0.11) for the group receiving treatment at home and 1.49 days (SD 0.10) for the group receiving treatment in hospital (mean difference 0.01 days, 95% confidence interval -0.3 to 0.28). None of the other outcome measures differed significantly except for patients'' satisfaction, which was greater in patients treated at home.Conclusions Treatment of cellulitis requiring intravenous antibiotics can be safely delivered at home. Patients prefer home treatment, but in this study only about one third of patients presenting at hospital for intravenous treatment of cellulitis were considered suitable for home treatment.     

Effectiveness and economic evaluation of a nurse delivered home exercise programme to prevent falls. 1: Randomised controlled trial

ObjectivesTo assess the effectiveness of a trained district nurse individually prescribing a home based exercise programme to reduce falls and injuries in elderly people and to estimate the cost effectiveness of the programme.DesignRandomised controlled trial with one year''s follow up.SettingCommunity health service at a New Zealand hospital.Participants240 women and men aged 75 years and older.Intervention121 participants received the exercise programme (exercise group) and 119 received usual care (control group); 90% (211 of 233) completed the trial.ResultsFalls were reduced by 46% (incidence rate ratio 0.54, 95% confidence interval 0.32 to 0.90). Five hospital admissions were due to injuries caused by falls in the control group and none in the exercise group. The programme cost $NZ1803 (£523) (at 1998 prices) per fall prevented for delivering the programme and $NZ155 per fall prevented when hospital costs averted were considered.ConclusionA home exercise programme, previously shown to be successful when delivered by a physiotherapist, was also effective in reducing falls when delivered by a trained nurse from within a home health service. Serious injuries and hospital admissions due to falls were also reduced. The programme was cost effective in participants aged 80 years and older compared with younger participants.

What is already known on this topic

Falls are the costliest type of injury among elderly people, and the healthcare costs increase with frequency of falls and severity of injuriesAn exercise programme delivered by a physiotherapist was successful in reducing falls and moderate injuries in elderly people

What this study adds

An exercise programme to prevent falls in elderly people worked well when delivered by a district nurse from a home health service in the suburbs of a large cityResearchers, public health administrators, and health practitioners can work together to benefit elderly people in the community     

Acute pain therapy in postanesthesia care unit directed by skin conductance: a randomized controlled trial

Background

After surgery, effective and well-directed acute pain therapy is a necessary and integral part of the overall treatment plan. Generally, the assessment of pain intensity depends on a patient’s self-evaluation using scoring systems such as numeric rating scales (NRS, 0 to 10). Recently, a “Pain Monitor” was commercially provided which is based on measurements of fluctuations of skin conductance (NFSC). In this randomized, controlled, single-blind trial, possible benefits of this certain device were studied.

Methods

Postoperative patients (n = 44) were randomly assigned to a test or a control group during their stay in the postanesthesia care unit (PACU). All patients were treated and monitored according to internal hospital standards. Whereas all patients systematically evaluated their pain each 15 min, test group patients were additionally addressed when NFSC exceeded a predefined level. In cases of NRS≥5 during a routine elevation or in between, pain relief was achieved by standard procedures irrespective of group allocation.

Results

During their stay in PACU, both test and control groups experienced a significant decrease in NRS as a consequence of pain therapy. No significant differences in mean NRS or in NFSC values were found between the test and control groups. No correlation was observed between NRS and NFSC.

Conclusion

Postoperative patients experience diverse stressors, such as anxiety, disorientation, shivering, sickness and pain. Although the application of continuous pain monitoring would be meaningful in this clinical setting, the tested device failed to distinguish pain from other stressors in postoperative adult patients.

Trial Registration

German Clinical Trials Register DRKS00000755.     

A randomised controlled trial and economic evaluation of a referrals facilitator between primary care and the voluntary sector

ObjectivesTo compare outcome and resource utilisation among patients referred to the Amalthea Project, a liaison organisation that facilitates contact between voluntary organisations and patients in primary care, with patients receiving routine general practitioner care.DesignRandomised controlled trial with follow up at one and four months.Setting26 general practices in Avon.Participants161 patients identified by their general practitioner as having psychosocial problems.ResultsThe Amalthea group showed significantly greater improvements in anxiety (average difference between groups after adjustment for baseline −1.9, 95% confidence interval −3.0 to −0.7), other emotional feelings (average adjusted difference −0.5, −0.8 to −0.2), ability to carry out everyday activities (−0.5, −0.8 to −0.2), feelings about general health (−0.4, −0.7 to −0.1), and quality of life (−0.5, −0.9 to −0.1). No difference was detected in depression or perceived social support. The mean cost was significantly greater in the Amalthea arm than the general practitioner care arm (£153 v £133, P=0.025).ConclusionReferral to the Amalthea Project and subsequent contact with the voluntary sector results in clinically important benefits compared with usual general practitioner care in managing psychosocial problems, but at a higher cost.     

Randomised controlled trial of structured personal care of type 2 diabetes mellitus

ObjectiveTo assess the effect of a multifaceted intervention directed at general practitioners on six year mortality, morbidity, and risk factors of patients with newly diagnosed type 2 diabetes.DesignPragmatic, open, controlled trial with randomisation of practices to structured personal care or routine care; analysis after 6 years.Setting311 Danish practices with 474 general practitioners (243 in intervention group and 231 in comparison group).Participants874 (90.1%) of 970 patients aged ⩾40 years who had diabetes diagnosed in 1989-91 and survived until six year follow up.InterventionRegular follow up and individualised goal setting supported by prompting of doctors, clinical guidelines, feedback, and continuing medical education.ResultsPredefined non-fatal outcomes and mortality were the same in both groups. The following risk factor levels were lower for intervention patients than for comparison patients (median values): fasting plasma glucose concentration (7.9 v 8.7 mmol/l, P=0.0007), glycated haemoglobin (8.5% v 9.0%, P<0.0001; reference range 5.4-7.4%), systolic blood pressure (145 v 150 mm Hg, P=0.0004), and cholesterol concentration (6.0 v 6.1 mmol/l, P=0.029, adjusted for baseline concentration). Both groups had lost weight since diagnosis (2.6 v 2.0 kg). Metformin was the only drug used more frequently in the intervention group (24% (110/459) v 15% (61/415)).Intervention doctors arranged more follow up consultations, referred fewer patients to diabetes clinics, and set more optimistic goals.ConclusionsIn primary care, individualised goals with educational and surveillance support may for at least six years bring risk factors of patients with type 2 diabetes to a level that has been shown to reduce diabetic complications but without weight gain.

What is already known on this topic

Evidence is increasing that control of hyperglycaemia, hypertension, and dyslipidaemia may postpone the development of diabetic complications in patients with type 2 diabetesMaintaining good control over a long period can be difficult

What this study adds

Structured individualised personal care with educational and surveillance support for general practitioners reduced levels of risk factors in type 2 diabetic patients after six yearsRisk factors were reduced to a level that has been shown to have a beneficial effect on diabetic complicationsParticipants also showed modest weight loss     

Use of standardized brief geriatric evaluation compared with routine care in general practice for preventing functional decline: a pragmatic cluster-randomized trial

Background:Although assessment of geriatric syndromes is increasingly encouraged in older adults, little evidence exists to support its systematic use by general practitioners (GPs). The aim of this study was to determine whether a systematic geriatric evaluation performed by GPs can prevent functional decline.Methods:We conducted a controlled, open-label, pragmatic cluster-randomized trial in 42 general practices in Switzerland. Participating GPs were expected to enrol an average of 10 community-dwelling adults (aged ≥ 75 yr) who understood French, and had visited their GP at least twice in the previous year. The intervention consisted of yearly assessment by the GP of 8 geriatric syndromes with an associated tailored management plan according to assessment results, compared with routine care. Our primary outcomes were the proportion of patients who lost at least 1 instrumental activity of daily living (ADL) and the proportion who lost at least 1 basic ADL, over 2 years. Our secondary outcomes were quality-of-life scores, measured using the older adult module of the World Health Organization Quality of Life Instrument, and health care use.Results:Forty-two GPs recruited 429 participants (63% women) with a mean age of 82.5 years (standard deviation 4.8 yr) at time of recruitment. Of these, we randomly assigned 217 participants to the intervention and 212 to the control arm. The proportion of patients who lost at least 1 instrumental ADL in the intervention and control arms during the course of the study was 43.6% and 47.6%, respectively (risk difference −4.0%, 95% confidence interval [CI] −14.9% to 6.7%, p = 0.5). The proportion of patients who lost at least 1 basic ADL was 12.4% in the intervention arm and 16.9% in the control arm (risk difference −5.1%, 95% CI −14.3% to 4.1%, p = 0.3).Interpretation:A yearly geriatric evaluation with an associated management plan, conducted systematically in GP practices, does not significantly lessen functional decline among community-dwelling, older adult patients, compared with routine care.Trial registration:ClinicalTrials.gov, {"type":"clinical-trial","attrs":{"text":"NCT02618291","term_id":"NCT02618291"}}NCT02618291.

The World Health Organization has defined healthy aging as the process of developing and maintaining functional ability that enables well-being in older age.¹ Functional ability is often measured by an individual’s ability to perform activities of daily living (ADLs) without assistance. Geriatric syndromes, corresponding to multifactorial, chronic conditions, can impair physical and mental capacities,^2–4 and are directly associated with functional decline.⁵ If recognized early, adapted preventive measures and management strategies can be started to limit functional decline.^6–8 Interventions that have been shown to delay functional decline include comprehensive geriatric assessment, regular home visits and physical therapy.^6,8,9 Comprehensive geriatric assessment consists of a “multidisciplinary diagnostic and treatment process that identifies medical, psychosocial, and functional capabilities of older adults to develop a coordinated plan to maximize overall health with ageing.”¹⁰ These assessments are usually performed by specialized geriatric teams for patients who have already been identified as frail or in the context of rehabilitation. However, most older patients see only their general practitioner (GP) and are not provided a comprehensive geriatric assessment, considering that this is a lengthy process that is often beyond the scope of a usual primary care consultation. A recent systematic review of comprehensive geriatric assessment in primary care found only 4 studies conducted in this setting,¹¹ showing mixed effects on clinical outcomes. Only 1 study assessed functional ability, and it showed no impact in this context.¹²In primary care, it may be more beneficial to use shorter screening tools.^13–19 Previous studies using shorter tools adapted for primary care have failed to show a difference for patients compared with routine care.^17,18 These interventions usually targeted patients who were already identified as frail or with a predefined number of problems.^17,18,20In contrast, our Active Geriatric Evaluation (AGE) tool targets all patients aged 75 and older. This clinical tool can be easily integrated to clinical encounters in GP practices, without the need for additional organizational changes. For this study, we aimed to determine whether the AGE tool, specifically designed for GPs and consisting of a brief assessment of the most relevant geriatric syndromes combined with management plans, could slow functional decline in older patients.     

Randomised controlled trial of computer assisted management of hypertension in primary care.

The hypothesis that general practitioners would obtain better outcomes for patients with hypertension using a computer than doctors not using a computer was tested. Sixty family physicians were randomised to two treatment strategies. "Test" physicians completed a data collection form after each visit from a patient with hypertension and mailed the forms to the test centre for processing. Computer feedback on management was mailed to the doctors. This encouraged doctors to apply the "stepped care" protocol, supplied charts of diastolic blood pressure v time, and ranked patients'' diastolic blood pressures by percentile. Letters were mailed to patients to remind them of appointments. "Control" doctors filled out the same data collection forms as test physicians, but neither doctors nor patients received computer feedback. Physicians who used the computer saw more patients per practice than control doctors (test 50 patients, control 40). For all patients the length of follow up was significantly longer in test practices (test 199 days, control 167), and a smaller percentage dropped out of active treatment in test practices (test 37.5%, control 42.1%). For patients with "moderate" hypertension of a baseline diastolic pressure of greater than 104 mm Hg the mean score of the last recorded pressure was below the goal of 90 mm Hg in test practices (88.5 mm Hg), but it failed to reach this goal in control practices (93.3 mm Hg). A greater average reduction of diastolic pressure was achieved in test practices (test 21.7 mm Hg, control 16.7 mm Hg). Though patients with "moderate" hypertension were better controlled in test practices than in control practices, the patients in test practices visited their doctors less often (test 13.3 visits per patient-year, control 17.4 visits). Among patients with newly detected hypertension test practices achieved a greater reduction in diastolic pressure than control practices (test 15.1 mm Hg v control 11.3 mm Hg) and more sustained control of hypertension (test 323 days per patient-year with a diastolic pressure of 90 mm Hg or less v control 259 days).     

Randomised controlled trial of Helicobacter pylori testing and endoscopy for dyspepsia in primary care

ObjectiveTo determine the cost effectiveness of a strategy of near patient Helicobacter pylori testing and endoscopy for managing dyspepsia.DesignRandomised controlled trial.Setting31 UK primary care centres.Participants478 patients under 50 years old presenting with dyspepsia of longer than four weeks duration.InterventionsNear patient testing for H pylori and open access endoscopy for patients with positive results. Control patients received acid suppressing drugs or specialist referral at general practitioner''s discretion.Results40% of the study group tested positive for H pylori. 45% of study patients had endoscopy compared with 25% of controls. More peptic ulcers were diagnosed in the study group (7.4% v 2.1%, P=0.011). Paired comparison of symptom scores and quality of life showed that all patients improved over time with no difference between study and control groups. No significant differences were observed in rates of prescribing, consultation, or referral. Costs were higher in the study group (£367.85 v £253.16 per patient).ConclusionsThe test and endoscopy strategy increases endoscopy rates over usual practice in primary care. The additional cost is not offset by benefits in symptom relief or quality of life.

What is already known on this topic

Patients younger than 50 without H pylori infection are unlikely to have treatable disease detected at endoscopySuch patients can be managed by acid suppression and reassurance aloneTest and endoscopy (referral of patients testing positive for H pylori in primary care) has been recommended as a way to reduce endoscopic workload

What this paper adds

Applying a test and endoscopy strategy increased the endoscopy referral rate from 25% to 40%The strategy produced no significant differences in symptoms or quality of life compared with usual managementThe increased costs of this strategy cannot be justified     

Randomised controlled trial of nicotine chewing-gum.

The effectiveness of 2 mg nicotine chewing-gum as an aid to stopping smoking was compared with a placebo containing 1 mg nicotine, but unbuffered, in a double-blind randomised trial. Of 58 subjects given the active gum, 27 (47%) were not smoking at one-year follow-up compared with 12 (21%) of the 58 subjects treated with placebo (p less than 0.025). By the most stringent criterion of outcome, 18 (31%) subjects in the active treatment group and eight (14%) in the placebo group had not smoked at all from the start of treatment to follow-up at one year (p less than 0.05). Subjects receiving the active gum experienced less severe withdrawal symptoms and rated their gum as more helpful than did the placebo group. Minor side effects were common but only gastric symptoms were more frequent with the active gum. Subjects receiving active gum used it for longer than those receiving placebo but most stopped using it within six months and only four (7%) developed longer-term dependence. The number of gums used daily correlated significantly with pretreatment blood nicotine concentrations in the active treatment group and with pretreatment cigarette consumption in the placebo group. A lower pretreatment blood nicotine value was the best predictor of success at one year (p less than 0.001) but there was no significant relation to cigarette consumption, sex, and social class. The results clearly confirm the usefulness of nicotine chewing-gum as an aid to stopping smoking and imply a definite role for nicotine in cigarette dependence and withdrawal. Successful use of the gum requires careful attention to subjects'' expectations and clear instructions on how to use it.     

Randomised controlled trial of effects of coordinating care for terminally ill cancer patients.

OBJECTIVES--To measure effects on terminally ill cancer patients and their families of coordinating the services available within the NHS and from local authorities and the voluntary sector. DESIGN--Randomised controlled trial. SETTING--Inner London health district. PATIENTS--Cancer patients were routinely notified from 1987 to 1990. 554 patients expected to survive less than one year entered the trial and were randomly allocated to a coordination or a control group. INTERVENTION--All patients received routinely available services. Coordination group patients received the assistance of two nurse coordinators, whose role was to ensure that patients received appropriate and well coordinated services, tailored to their individual needs and circumstances. MAIN OUTCOME MEASURES--Patients and carers were interviewed at home on entry to the trial and at intervals until death. Interviews after bereavement were also conducted. Outcome measures included the presence and severity of physical symptoms, psychiatric morbidity, use of and satisfaction with services, and carers'' problems. Results from the baseline interview, the interview closest to death, and the interview after bereavement were analysed. RESULTS--Few differences between groups were significant. Coordination group patients were less likely to suffer from vomiting, were more likely to report effective treatment for it, and less likely to be concerned about having an itchy skin. Their carers were more likely to report that in the last week of life the patient had had a cough and had had effective treatment for constipation, and they were less likely to rate the patient''s difficulty swallowing as severe or to report effective treatment for anxiety. Coordination group patients were more likely to have seen a chiropodist and their carers were more likely to contact a specialist nurse in a night time emergency. These carers were less likely to feel angry about the death of the patient. CONCLUSIONS--This coordinating service made little difference to patient or family outcomes, perhaps because the service did not have a budget with which it could obtain services or because the professional skills of the nurse-coordinators may have conflicted with the requirements of the coordinating role.     

Should obstetricians see women with normal pregnancies? A multicentre randomised controlled trial of routine antenatal care by general practitioners and midwives compared with shared care led by obstetricians.

OBJECTIVE--To compare routine antenatal care provided by general practitioners and midwives with obstetrician led shared care. DESIGN--Multicentre randomised controlled trial. SETTING--51 general practices linked to nine Scottish maternity hospitals. SUBJECTS--1765 women at low risk of antenatal complications. INTERVENTION--Routine antenatal care by general practitioners and midwives according to a care plan and protocols for managing complications. MAIN OUTCOME MEASURES--Comparisons of health service use, indicators of quality of care, and women''s satisfaction. RESULTS--Continuity of care was improved for the general practitioner and midwife group as the number of carers was less (median 5 carers v 7 for shared care group, P<0.0001) and the number of routine visits reduced (10.9 v 11.7, P<0.0001). Fewer women in the general practitioner and midwife group had antenatal admissions (27% (222/834) v 32% (266/840), P<0.05), non-attendances (7% (57) v 11% (89), P<0.01) and daycare (12% (102) v 7% (139), P<0.05) but more were referred (49% (406) v 36% (305), P<0.0001). Rates of antenatal diagnoses did not differ except that fewer women in the general practitioner and midwife group had hypertensive disorders (pregnancy induced hypertension, 5% (37) v 8% (70), P<0.01) and fewer had labour induced (18% (149) v 24% (201), P<0.01). Few failures to comply with the care protocol occurred, but more Rhesus negative women in the general practitioner and midwife group did not have an appropriate antibody check (2.5% (20) v 0.4% (3), P<0.0001). Both groups expressed high satisfaction with care (68% (453/663) v 65% (430/656), P=0.5) and acceptability of allocated style of care (93% (618) v 94% (624), P=0.6). Access to hospital support before labour was similar (45% (302) v 48% (312) visited labour rooms before giving birth, P=0.6). CONCLUSION--Routine specialist visits for women initially at low risk of pregnancy complications offer little or no clinical or consumer benefit.     

Randomised controlled trial comparing problem solving treatment with amitriptyline and placebo for major depression in primary care.

OBJECTIVE--To determine whether, in the treatment of major depression in primary care, a brief psychological treatment (problem solving) was (a) as effective as antidepressant drugs and more effective than placebo; (b) feasible in practice; and (c) acceptable to patients. DESIGN--Randomised controlled trial of problem solving treatment, amitriptyline plus standard clinical management, and drug placebo plus standard clinical management. Each treatment was delivered in six sessions over 12 weeks. SETTING--Primary care in Oxfordshire. SUBJECTS--91 patients in primary care who had major depression. MAIN OUTCOME MEASURES--Observer and self reported measures of severity of depression, self reported measure of social outcome, and observer measure of psychological symptoms at six and 12 weeks; self reported measure of patient satisfaction at 12 weeks. Numbers of patients recovered at six and 12 weeks. RESULTS--At six and 12 weeks the difference in score on the Hamilton rating scale for depression between problem solving and placebo treatments was significant (5.3 (95% confidence interval 1.6 to 9.0) and 4.7 (0.4 to 9.0) respectively), but the difference between problem solving and amitriptyline was not significant (1.8 (-1.8 to 5.5) and 0.9 (-3.3 to 5.2) respectively). At 12 weeks 60% (18/30) of patients given problem solving treatment had recovered on the Hamilton scale compared with 52% (16/31) given amitriptyline and 27% (8/30) given placebo. Patients were satisfied with problem solving treatment; all patients who completed treatment (28/30) rated the treatment as helpful or very helpful. The six sessions of problem solving treatment totalled a mean therapy time of 3 1/2 hours. CONCLUSIONS--As a treatment for major depression in primary care, problem solving treatment is effective, feasible, and acceptable to patients.