Randomised trial of endoscopy with testing for Helicobacter pylori compared with non-invasive H pylori testing alone in the management of dyspepsia

ObjectiveTo compare the efficacy of non-invasive testing for Helicobacter pylori with that of endoscopy (plus H pylori testing) in the management of patients referred for endoscopic investigation of upper gastrointestinal symptoms.DesignRandomised controlled trial with follow up at 12 months.SettingHospital gastroenterology unit.Participants708 patients aged under 55 referred for endoscopic investigation of dyspepsia, randomised to non-invasive breath test for H pylori or endoscopy plus H pylori testing.ResultsIn 586 patients followed up at 12 months the mean change in dyspepsia score was 4.8 in the non-invasive H pylori test group and 4.6 in the endoscopy group (95% confidence interval for difference –0.7 to 0.5, P=0.69). Only 8.2% of patients followed up who were randomised to breath test alone were referred for subsequent endoscopy. The use of non-endoscopic resources was similar in the two groups. Reassurance value, concern about missed pathology, overall patient satisfaction, and quality of life were similar in the two groups. The patients found the non-invasive breath test procedure less uncomfortable and distressing than endoscopy with or without sedation. No potentially serious pathology requiring treatment other than eradication of H pylori was missed.ConclusionIn this patient group, non-invasive testing for H pylori is as effective and safe as endoscopy and less uncomfortable and distressing for the patient. Non-invasive H pylori testing should be the preferred mode of investigation.

What is already known on this topic

Endoscopy is a commonly used investigation for upper gastrointestinal symptoms, but its effectiveness has been questionedNon-invasive testing for Helicobacter pylori has been shown to predict endoscopic diagnosis in patients with dyspepsia

What this study adds

In patients less than 55 years of age with uncomplicated dyspepsia, non-invasive testing for H pylori is as effective and as safe as endoscopyNon-invasive H pylori testing is as reassuring to the patient as endoscopy and is less uncomfortable and distressing     

Testing for Helicobacter pylori infection: validation and diagnostic yield of a near patient test in primary care

ObjectiveTo evaluate the performance of a near patient test for Helicobacter pylori infection in primary care.DesignValidation study performed within a randomised trial of four management strategies for dyspepsia.Setting43 general practices around Nottingham.Subjects394 patients aged 18-70 years presenting with recent onset dyspepsia.ResultsWhen used in primary care FlexSure test had a sensitivity and specificity of 67% (95% confidence interval 59% to 75%) and 98% (95% to 99%) compared with a sensitivity and specificity of 92% (87% to 97%) and 90% (83% to 97%) when used previously in secondary care. Of the H pylori test and refer group 14% (28/199) were found to have conditions for which H pylori eradication was appropriate compared with 23% (39/170) of the group referred directly for endoscopy.ConclusionsWhen used in primary care the sensitivity of the FlexSure test was significantly poorer than in secondary care. About a third of patients who would have benefited from H pylori eradication were not detected. Near patient tests need to be validated in primary care before they are incorporated into management policies for dyspepsia.

Key messages

• Near patient tests for H pylori infection have been recommended in the management of dyspepsia in primary care without proper evaluation
• Such tests should have a high sensitivity to avoid missing treatable illness related to infection
• The FlexSure near patient test had a lower sensitivity than previously reported in validation studies performed in secondary care
• Fewer than expected numbers of patients with H pylori related pathology were identified with the FlexSure in primary care

     

Mixed infection with cagA positive and cagA negative strains of Helicobacter pylori lowers disease burden in The Gambia

Background

The prevalence of Helicobacter pylori including strains with putatively virulent genotypes is high, whereas the H. pylori-associated disease burden is low, in Africa compared to developed countries. In this study, we investigated the prevalence of virulence-related H. pylori genotypes and their association with gastroduodenal diseases in The Gambia.

Methods and Findings

DNA extracted from biopsies and H. pylori cultures from 169 subjects with abdominal pain, dyspepsia or other gastroduodenal diseases were tested by PCR for H. pylori. The H. pylori positive samples were further tested for the cagA oncogene and vacA toxin gene.One hundred and twenty one subjects (71.6%) were H. pylori positive. The cagA gene and more toxigenic s1 and m1 alleles of the vacA gene were found in 61.2%, 76.9% and 45.5% respectively of Gambian patients harbouring H. pylori. There was a high prevalence of cagA positive strains in patients with overt gastric diseases than those with non-ulcerative dyspepsia (NUD) (p = 0.05); however, mixed infection by cagA positive and cagA negative strains was more common in patients with NUD compared to patients with gastric disease (24.5% versus 0%; p = 0.002).

Conclusion

This study shows that the prevalence of H. pylori is high in dyspeptic patients in The Gambia and that many strains are of the putatively more virulent cagA⁺, vacAs1 and vacAm1 genotypes. This study has also shown significantly lower disease burden in Gambians infected with a mixture of cag-positive and cag-negative strains, relative to those containing only cag-positive or only cag-negative strains, which suggests that harbouring both cag-positive and cag-negative strains is protective.     

Accuracy and cut-off values of pepsinogens I, II and gastrin 17 for diagnosis of gastric fundic atrophy: influence of gastritis

Background

To establish optimal cutoff values for serologic diagnosis of fundic atrophy in a high-risk area for oesophageal squamous cell carcinoma and gastric cancer with high prevalence of Helicobacter pylori (H. pylori) in Northern Iran, we performed an endoscopy-room-based validation study.

Methods

We measured serum pepsinogens I (PGI) and II (PGII), gastrin 17 (G-17), and antibodies against whole H. pylori, or cytotoxin-associated gene A (CagA) antigen among 309 consecutive patients in two major endoscopy clinics in northeastern Iran. Updated Sydney System was used as histology gold standard. Areas under curves (AUCs), optimal cutoff and predictive values were calculated for serum biomarkers against the histology.

Results

309 persons were recruited (mean age: 63.5 years old, 59.5% female). 84.5% were H. pylori positive and 77.5% were CagA positive. 21 fundic atrophy and 101 nonatrophic pangastritis were diagnosed. The best cutoff values in fundic atrophy assessment were calculated at PGI<56 µg/l (sensitivity: 61.9%, specificity: 94.8%) and PGI/PGII ratio<5 (sensitivity: 75.0%, specificity: 91.0%). A serum G-17<2.6 pmol/l or G-17>40 pmol/l was 81% sensitive and 73.3% specific for diagnosing fundic atrophy. At cutoff concentration of 11.8 µg/l, PGII showed 84.2% sensitivity and 45.4% specificity to distinguish nonatrophic pangastritis. Exclusion of nonatrophic pangastritis enhanced diagnostic ability of PGI/PGII ratio (from AUC = 0.66 to 0.90) but did not affect AUC of PGI. After restricting study samples to those with PGII<11.8, the sensitivity of using PGI<56 to define fundic atrophy increased to 83.3% (95%CI 51.6–97.9) and its specificity decreased to 88.8% (95%CI 80.8–94.3).

Conclusions

Among endoscopy clinic patients, PGII is a sensitive marker for extension of nonatrophic gastritis toward the corpus. PGI is a stable biomarker in assessment of fundic atrophy and has similar accuracy to PGI/PGII ratio among populations with prevalent nonatrophic pangastritis.     

Images of the good doctor in Western medicine: The doctor-patient relationship

ObjectiveTo determine whether the management of head injuries differs between patients aged ⩾65 years and those <65.DesignProspective observational national study over four years.Setting25 Scottish hospitals that admit trauma patients.Participants527 trauma patients with extradural or acute subdural haematomas.ResultsPatients aged ⩾65 years had lower survival rates than patients <65 years. Rates were 15/18 (83%) v 165/167 (99%) for extradural haematoma (P=0.007) and 61/93 (66%) v 229/249 (92%) for acute subdural haematoma (P<0.001). Older patients were less likely to be transferred to specialist neurosurgical care (10 (56%) v 142 (85%) for extradural haematoma (P=0.005) and 56 (60%) v 192 (77%) for subdural haematoma (P=0.004)). There was no significant difference between age groups in the incidence of neurosurgical interventions in patients who were transferred. Logistic regression analysis showed that age had a significant independent effect on transfer and on survival. Older patients had higher rates of coexisting medical conditions than younger patients, but when severity of injury, initial physiological status at presentation, or previous health were controlled for in a log linear analysis, transfer rates were still lower in older patients than in younger patients (P<0.001).ConclusionsCompared with those aged under 65 years, people aged 65 and over have a worse prognosis after head injury complicated by intracranial haematoma. The decision to transfer such patients to neurosurgical care seems to be biased against older patients.

What is already known on this topic

Older patients with acute intracranial haematomas have significantly higher mortality and poorer functional outcome than younger patients with similar injuriesIntracranial haematomas are larger and more common in older patients with head injury than in younger patientsEarly diagnosis and surgical intervention for operable lesions is a crucial factor in determining patients'' outcomes

What this study adds

Older patients with acute intracranial haematomas were less likely to be transferred for specialist neurosurgical care than younger patients with similar severities of injuries, extracranial injuries, and physiological status at presentationSignificant differences in transfer rates related to age were still seen after pre-existing medical conditions were controlled for     

Exposure to foodborne and orofecal microbes versus airborne viruses in relation to atopy and allergic asthma: epidemiological study

ObjectiveTo investigate if markers of exposure to foodborne and orofecal microbes versus airborne viruses are associated with atopy and respiratory allergies.DesignRetrospective case-control study.Participants240 atopic cases and 240 non-atopic controls from a population sample of 1659 participants, all Italian male cadets aged 17-24.SettingAir force school in Caserta, Italy.ResultsCompared with controls there was a lower prevalence of T gondii (26% v 18%, P=0.027), hepatitis A virus (30% v 16%, P=0.004), and H pylori (18% v 15%, P=0.325) in atopic participants. Adjusted odds ratios of atopy decreased with a gradient of exposure to H pylori, T gondii, and hepatitis A virus (none, odds ratio 1; one, 0.70; two or three, 0.37; P for trend=0.000045) but not with cumulative exposure to the other viruses. Conversely, total IgE concentration was not independently associated with any infection. Allergic asthma was rare (1/245, 0.4%) and allergic rhinitis infrequent (16/245, 7%) among the participants (245/1659) exposed to at least two orofecal and foodborne infections (H pylori, T gondii, hepatitis A virus).ConclusionRespiratory allergy is less frequent in people heavily exposed to orofecal and foodborne microbes. Hygiene and a westernised, semisterile diet may facilitate atopy by influencing the overall pattern of commensals and pathogens that stimulate the gut associated lymphoid tissue thus contributing to the epidemic of allergic asthma and rhinitis in developed countries.     

Is Helicobacter pylori associated with non-ulcer dyspepsia and will eradication improve symptoms? A meta-analysis

ObjectivesTo examine the association between Helicobacter pylori infection and non-ulcer dyspepsia, and to assess the effect of eradicating H pylori on dyspeptic symptoms in patients with non-ulcer dyspepsia.DesignSystematic review and meta-analysis of (a) observational studies examining the association between Helicobacter pylori infection and non-ulcer dyspepsia (association studies), and (b) therapeutic trials examining the association between eradication of H pylori and dyspeptic symptoms in patients with non-ulcer dyspepsia (eradication trials).Results23 association studies and 5 eradication trials met the inclusion criteria. In the association studies the summary odds ratio for H pylori infection in patients with non-ulcer dyspepsia was 1.6 (95% confidence interval 1.4 to 1.8). In the eradication trials the summary odds ratio for improvement in dyspeptic symptoms in patients with non-ulcer dyspepsia in whom H pylori was eradicated was 1.9 (1.3 to 2.6).ConclusionsSome evidence shows an association between H pylori infection and dyspeptic symptoms in patients referred to gastroenterologists. An improvement in dyspeptic symptoms occurred among patients with non-ulcer dyspepsia in whom H pylori was eradicated.     

Effects of interleukin-10 polymorphisms, Helicobacter pylori infection, and smoking on the risk of noncardia gastric cancer

Objective

Both variations in the interleukin-10 (IL10) gene and environmental factors are thought to influence inflammation and gastric carcinogenesis. Therefore, we investigated the associations between IL10 polymorphisms, Helicobacter pylori (H. pylori) infection, and smoking in noncardia gastric carcinogenesis in Koreans.

Methods

We genotyped three promoter polymorphisms (-1082A>G, -819T>C, and -592 A>C) of IL10 in a case-control study of 495 noncardia gastric cancer patients and 495 sex- and age-matched healthy controls. Multiple logistic regression models were used to detect the effects of IL10 polymorphisms, H. pylori infection, and smoking on the risk of gastric cancer, which was stratified by the histological type of gastric cancer.

Results

The IL10-819C and -592C alleles were found to have complete linkage disequilibrium, and all three IL10 polymorphisms were associated with an increased risk of intestinal-type noncardia gastric cancer. These associations were observed only in H. pylori-positive subjects and current smokers. A statistically significant interaction between the IL10-592 genotype and H. pylori infection on the risk of intestinal-type gastric cancer was observed (P for interaction  = 0.047). In addition, H. pylori-positive smokers who were carriers of either the IL10-1082G (OR [95% CI]  = 17.76 [6.17−51.06]) or the -592C (OR [95% CI]  = 8.37 [2.79−25.16]) allele had an increased risk of intestinal-type gastric cancer compared to H. pylori-negative nonsmokers homozygous for IL10-1082A and -592A, respectively. The interaction between the IL10-1082 polymorphism and the combined effects of H. pylori infection and smoking tended towards significance (P for interaction  = 0.080).

Conclusions

Inflammation-related genetic variants may interact with H. pylori infection and smoking to increase the risk of noncardia gastric cancer, particularly the intestinal-type. These findings may be helpful in identifying individuals at an increased risk for developing noncardia gastric cancer.     

Real-time PCR improves Helicobacter pylori detection in patients with peptic ulcer bleeding

Background and Aims

Histological and rapid urease tests to detect H. pylori in biopsy specimens obtained during peptic ulcer bleeding episodes (PUB) often produce false-negative results. We aimed to examine whether immunohistochemistry and real-time PCR can improve the sensitivity of these biopsies.

Patients and Methods

We selected 52 histology-negative formalin-fixed paraffin-embedded biopsy specimens obtained during PUB episodes. Additional tests showed 10 were true negatives and 42 were false negatives. We also selected 17 histology-positive biopsy specimens obtained during PUB to use as controls. We performed immunohistochemistry staining and real-time PCR for 16S rRNA, ureA, and 23S rRNA for H. pylori genes on all specimens.

Results

All controls were positive for H. pylori on all PCR assays and immunohistochemical staining. Regarding the 52 initially negative biopsies, all PCR tests were significantly more sensitive than immunohistochemical staining (p<0.01). Sensitivity and specificity were 55% and 80% for 16S rRNA PCR, 43% and 90% for ureA PCR, 41% and 80% for 23S rRNA PCR, and 7% and 100% for immunohistochemical staining, respectively. Combined analysis of PCR assays for two genes were significantly more sensitive than ureA or 23S rRNA PCR tests alone (p<0.05) and marginally better than 16S rRNA PCR alone. The best combination was 16S rRNA+ureA, with a sensitivity of 64% and a specificity of 80%.

Conclusions

Real-time PCR improves the detection of H. pylori infection in histology-negative formalin-fixed paraffin-embedded biopsy samples obtained during PUB episodes. The low reported prevalence of H. pylori in PUB may be due to the failure of conventional tests to detect infection.     

Prevalence of dysfunctional breathing in patients treated for asthma in primary care: cross sectional survey

ObjectivesTo estimate the prevalence of dysfunctional breathing in adults with asthma treated in the community.DesignPostal questionnaire survey using Nijmegen questionnaire.SettingOne general practice with 7033 patients.ParticipantsAll adult patients aged 17-65 with diagnosed asthma who were receiving treatment.Results227/307 patients returned completed questionnaires; 219 (71.3%) questionnaires were suitable for analysis. 63 participants scored ⩾23. Those scoring ⩾23 were more likely to be female than male (46/132 (35%) v 17/87 (20%), P=0.016) and were younger (mean (SD) age 44.8 (14.7) v 49.0 (13.8, (P=0.05). Patients at different treatment steps of the British Thoracic Society asthma guidelines were affected equally.ConclusionsAbout a third of women and a fifth of men had scores suggestive of dysfunctional breathing. Although further studies are needed to confirm the validity of this screening tool and these findings, these prevalences suggest scope for therapeutic intervention and may explain the anecdotal success of the Buteyko method of treating asthma.

What is already known on this topic

Abnormal breathing patterns may cause characteristic symptoms and impair quality of lifeEffective interventions exist for dysfunctional breathingDysfunctional breathing has been described in patients attending hospital respiratory clinics

What this study adds

29% of adults treated for asthma in primary care had symptoms suggestive of dysfunctional breathingAffected patients were more likely to be female and younger, but no differences were found with severity of asthmaSome patients with asthma may benefit from breathing therapy     

Provider-initiated HIV testing and counseling: increased uptake in two public community health centers in South Africa and implications for scale-up

Background

International guidance recommends the scale up of routinely recommended, offered, and delivered health care provider-initiated HIV testing and counseling (PITC) to increase the proportion of persons who know their HIV status. We compared HIV test uptake under PITC to provider-referral to voluntary counseling and testing (VCT referral) in two primary health centers in South Africa.

Methods

Prior to introducing PITC, clinical providers were instructed to refer systematically selected study participants to VCT. After PITC and HIV rapid test training, providers were asked to recommend, offer and provide HIV testing to study participants during the clinical consultation. Participants were interviewed before and after their consultation to assess their HIV testing experiences.

Results

HIV test uptake increased under PITC (OR 2.85, 95% CI 1.71, 4.76), and more patients felt providers answered their questions on HIV (104/141 [74%] versus 73/118 [62%] for VCT referral; p 0.04). After three months, only 4/106 (3.8%) HIV-positive patients had registered for onsite HIV treatment. Providers found PITC useful, but tested very few patients (range 0–15).

Conclusion

PITC increased the uptake of HIV testing compared with referral to onsite VCT, and patients reported a positive response to PITC. However, providing universal PITC will require strong leadership to train and motivate providers, and interventions to link HIV-positive persons to HIV treatment centers.     

Helicobacter pylori test and treat versus proton pump inhibitor in initial management of dyspepsia in primary care: multicentre randomised controlled trial (MRC-CUBE trial)

Objective To determine the cost effectiveness of Helicobacter pylori “test and treat” compared with empirical acid suppression in the initial management of patients with dyspepsia in primary care.Design Randomised controlled trial.Setting 80 general practices in the United Kingdom.Participants 699 patients aged 18-65 who presented to their general practitioner with epigastric pain, heartburn, or both without “alarm symptoms” for malignancy.Intervention H pylori ¹³C urea breath test plus one week of eradication treatment if positive or proton pump inhibitor alone; subsequent management at general practitioner’s discretion.Main outcome measures Cost effectiveness in cost per quality adjusted life year (QALY) (EQ-5D) and effect on dyspeptic symptoms at one year measured with short form Leeds dyspepsia questionnaire.Results 343 patients were randomised to testing for H pylori, and 100 were positive. The successful eradication rate was 78%. 356 patients received proton pump inhibitor for 28 days. At 12 months no significant differences existed between the two groups in QALYs, costs, or dyspeptic symptoms. Minor reductions in costly resource use over the year in the test and treat group “paid back” the initial cost of the intervention.Conclusions Test and treat and acid suppression are equally cost effective in the initial management of dyspepsia. Empirical acid suppression is an appropriate initial strategy. As costs are similar overall, general practitioners should discuss with patients at which point to consider H pylori testing.Trial registration Current Controlled Trials ISRCTN87644265.     

Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial

Background

Cutaneous leishmaniasis (CL) is treated with parenteral drugs for decades with decreasing rate cures. Miltefosine is an oral medication with anti-leishmania activity and may increase the cure rates and improve compliance.

Methodology/Principal Findings

This study is a randomized, open-label, controlled clinical trial aimed to evaluate the efficacy and safety of miltefosine versus pentavalent antimony (Sb^v) in the treatment of patients with CL caused by Leishmania braziliensis in Bahia, Brazil. A total of 90 patients were enrolled in the trial; 60 were assigned to receive miltefosine and 30 to receive Sb^v. Six months after treatment, in the intention-to-treat analyses, the definitive cure rate was 53.3% in the Sb^v group and 75% in the miltefosine group (difference of 21.7%, 95% CI 0.08% to 42.7%, p = 0.04). Miltefosine was more effective than Sb^v in the age group of 13–65 years-old compared to 2–12 years-old group (78.9% versus 45% p = 0.02; 68.2% versus 70% p = 1.0, respectively). The incidence of adverse events was similar in the Sb^v and miltefosine groups (76.7% vs. 78.3%). Vomiting (41.7%), nausea (40%), and abdominal pain (23.3%) were significantly more frequent in the miltefosine group while arthralgias (20.7%), mialgias (20.7%) and fever (23.3%) were significantly more frequent in the Sb^v group.

Conclusions

This study demonstrates that miltefosine therapy is more effective than standard Sb^v and safe for the treatment of CL caused by Leishmania braziliensis in Bahia, Brazil.

Trial Registration

Clinicaltrials.gov Identifier {"type":"clinical-trial","attrs":{"text":"NCT00600548","term_id":"NCT00600548"}}NCT00600548     

One hundred years ago: A medical minister in Russia

ObjectivesTo evaluate cardiovascular fitness exercise in people with fibromyalgia.DesignRandomised controlled trial.SettingHospital rheumatology outpatients. Group based classes took place at a “healthy living centre.”Participants132 patients with fibromyalgia.InterventionsPrescribed graded aerobic exercise (active treatment) and relaxation and flexibility (control treatment).ResultsCompared with relaxation exercise led to significantly more participants rating themselves as much or very much better at three months: 24/69 (35%) v 12/67 (18%), P=0.03. Benefits were maintained or improved at one year follow up when fewer participants in the exercise group fulfilled the criteria for fibromyalgia (31/69 v 44/67, P=0.01). People in the exercise group also had greater reductions in tender point counts (4.2 v 2.0, P=0.02) and in scores on the fibromyalgia impact questionnaire (4.0 v 0.6, P=0.07).ConclusionsPrescribed graded aerobic exercise is a simple, cheap, effective, and potentially widely available treatment for fibromyalgia.

What is already known on this topic

Fibromyalgia is common debilitating medically unexplained condition affecting around 1% of the populationCurrent treatments are unsatisfactory and most people remain the same after several years of treatmentExercise as a treatment given by healthcare professionals in highly specialised centres is of some short term benefit

What this study adds

For people with fibromyalgia prescribed graded aerobic exercise is an effective treatment that leads to improvements in self reported health statusPrescribed exercise can be undertaken effectively in the community by personal trainers previously inexperienced in management of people with ill health     

Cost-Effectiveness of HIV Testing Referral Strategies among Tuberculosis Patients in India

Background

Indian guidelines recommend routine referral for HIV testing of all tuberculosis (TB) patients in the nine states with the highest HIV prevalence, and selective referral for testing elsewhere. We assessed the clinical impact and cost-effectiveness of alternative HIV testing referral strategies among TB patients in India.

Methods and Findings

We utilized a computer model of HIV and TB disease to project outcomes for patients with active TB in India. We compared life expectancy, cost, and cost-effectiveness for three HIV testing referral strategies: 1) selective referral for HIV testing of those with increased HIV risk, 2) routine referral of patients in the nine highest HIV prevalence states with selective referral elsewhere (current standard), and 3) routine referral of all patients for HIV testing. TB-related data were from the World Health Organization. HIV prevalence among TB patients was 9.0% in the highest prevalence states, 2.9% in the other states, and 4.9% overall. The selective referral strategy, beginning from age 33.50 years, had a projected discounted life expectancy of 16.88 years and a mean lifetime HIV/TB treatment cost of US$100. The current standard increased mean life expectancy to 16.90 years with additional per-person cost of US$10; the incremental cost-effectiveness ratio was US$650/year of life saved (YLS) compared to selective referral. Routine referral of all patients for HIV testing increased life expectancy to 16.91 years, with an incremental cost-effectiveness ratio of US$730/YLS compared to the current standard. For HIV-infected patients cured of TB, receiving antiretroviral therapy increased survival from 4.71 to 13.87 years. Results were most sensitive to the HIV prevalence and the cost of second-line antiretroviral therapy.

Conclusions

Referral of all patients with active TB in India for HIV testing will be both effective and cost-effective. While effective implementation of this strategy would require investment, routine, voluntary HIV testing of TB patients in India should be recommended.     

Reduction in mortality after inappropriate early discharge from intensive care unit: logistic regression triage model

ObjectiveTo develop a predictive model to triage patients for discharge from intensive care units to reduce mortality after discharge.DesignLogistic regression analyses and modelling of data from patients who were discharged from intensive care units.SettingGuy''s hospital intensive care unit and 19 other UK intensive care units from 1989 to 1998.Participants5475 patients for the development of the model and 8449 for validation.ResultsMortality after discharge from intensive care was up to 12.4%. The triage model identified patients at risk from death on the ward with a sensitivity of 65.5% and specificity of 87.6%, and an area under the receiver operating curve of 0.86. Variables in the model were age, end stage disease, length of stay in unit, cardiothoracic surgery, and physiology. In the validation dataset the 34% of the patients identified as at risk had a discharge mortality of 25% compared with a 4% mortality among those not at risk.ConclusionsThe discharge mortality of at risk patients may be reduced by 39% if they remain in intensive care units for another 48 hours. The discharge triage model to identify patients at risk from too early and inappropriate discharge from intensive care may help doctors to make the difficult clinical decision of whom to discharge to make room for a patient requiring urgent admission to the unit. If confirmed, this study has implications on the provision of resources.

What is already known on this topic

In the United Kingdom, the mortality of patients who die on the ward after discharge from intensive care is unacceptably high (9% to 27%)Indirect evidence has shown that this is due to too early and inappropriate discharge from intensive care that has increased over the past 10 years

What this study adds

A triage model identifies patients at risk from inappropriate discharge from intensive careMortality after discharge from intensive care may be reduced by 39% if these patients were to stay in intensive care for another 48 hoursAn estimated 16% more beds are required if mortality after discharge from intensive care is to be reduced     

Treatment outcomes and cost-effectiveness of shifting management of stable ART patients to nurses in South Africa: an observational cohort

Background

To address human resource and infrastructure shortages, resource-constrained countries are being encouraged to shift HIV care to lesser trained care providers and lower level health care facilities. This study evaluated the cost-effectiveness of down-referring stable antiretroviral therapy (ART) patients from a doctor-managed, hospital-based ART clinic to a nurse-managed primary health care facility in Johannesburg, South Africa.

Methods and Findings

Criteria for down-referral were stable ART (≥11 mo), undetectable viral load within the previous 10 mo, CD4>200 cells/mm³, <5% weight loss over the last three visits, and no opportunistic infections. All patients down-referred from the treatment-initiation site to the down-referral site between 1 February 2008 and 1 January 2009 were compared to a matched sample of patients eligible for down-referral but not down-referred. Outcomes were assigned based on vital and health status 12 mo after down-referral eligibility and the average cost per outcome estimated from patient medical record data.The down-referral site (n = 712) experienced less death and loss to follow up than the treatment-initiation site (n = 2,136) (1.7% versus 6.2%, relative risk = 0.27, 95% CI 0.15–0.49). The average cost per patient-year for those in care and responding at 12 mo was US$492 for down-referred patients and US$551 for patients remaining at the treatment-initiation site (p<0.0001), a savings of 11%. Down-referral was the cost-effective strategy for eligible patients.

Conclusions

Twelve-month outcomes of stable ART patients who are down-referred to a primary health clinic are as good as, or better than, the outcomes of similar patients who are maintained at a hospital-based ART clinic. The cost of treatment with down-referral is lower across all outcomes and would save 11% for patients who remain in care and respond to treatment. These results suggest that this strategy would increase treatment capacity and conserve resources without compromising patient outcomes. Please see later in the article for the Editors'' Summary     

Computer assisted self interviewing in a sexual health clinic as part of routine clinical care; impact on service and patient and clinician views

Background

Computer assisted self interviewing (CASI) has been used at the Melbourne Sexual Health Centre (MSHC) since 2008 for obtaining sexual history and identifying patients'' risk factors for sexually transmitted infections (STIs). We aimed to evaluate the impact of CASI operating at MSHC.

Methodology/Principal Findings

The proportion of patients who decline to answer questions using CASI was determined. We then compared consultation times and STI-testing rates during comparable CASI and non-CASI operating periods. Patients and staff completed anonymous questionnaires about their experience with CASI. 14,190 patients completed CASI during the audit period. Men were more likely than women to decline questions about the number of partners they had of the opposite sex (4.4% v 3.6%, p = 0.05) and same sex (8.9% v 0%, p<0.001). One third (34%) of HIV-positive men declined the number of partners they had and 11–17% declined questions about condom use. Women were more likely than men to decline to answer questions about condom use (2.9% v 2.3%, p = 0.05). There was no difference in the mean consultation times during CASI and non-CASI operating periods (p≥0.17). Only the proportion of women tested for chlamydia differed between the CASI and non-CASI period (84% v 88% respectively, p<0.01). 267 patients completed the survey about CASI. Most (72% men and 69% women) were comfortable using the computer and reported that all their answers were accurate (76% men and 71% women). Half preferred CASI but 18% would have preferred a clinician to have asked the questions. 39 clinicians completed the staff survey. Clinicians felt that for some STI risk factors (range 11%–44%), face-to-face questioning was more accurate than CASI. Only 5% were unsatisfied with CASI.

Conclusions

We have demonstrated that CASI is acceptable to both patients and clinicians in a sexual health setting and does not adversely affect various measures of clinical output.     

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     

Submitting articles to the BMJ

ObjectiveTo measure the effect of giving out free smoke alarms on rates of fires and rates of fire related injury in a deprived multiethnic urban population.DesignCluster randomised controlled trial.SettingForty electoral wards in two boroughs of inner London, United Kingdom.ParticipantsPrimarily households including elderly people or children and households that are in housing rented from the borough council.Intervention20 050 smoke alarms, fittings, and educational brochures distributed free and installed on request.ResultsGiving out free smoke alarms did not reduce injuries related to fire (rate ratio 1.3; 95% confidence interval 0.9 to 1.9), admissions to hospital and deaths (1.3; 0.7 to 2.3), or fires attended by the fire brigade (1.1; 0.96 to 1.3). Similar proportions of intervention and control households had installed alarms (36/119 (30%) v 35/109 (32%); odds ratio 0.9; 95% confidence interval 0.5 to 1.7) and working alarms (19/118 (16%) v 18/108 (17%); 0.9; 0.4 to 1.8).ConclusionsGiving out free smoke alarms in a deprived, multiethnic, urban community did not reduce injuries related to fire, mostly because few alarms had been installed or were maintained.

What is already known on this topic

In the United Kingdom, residential fires caused 466 deaths and 14 600 non-fatal injuries in 1999The risk of death from fire is associated with socioeconomic classOne study reported an 80% decline in hospitalisations and deaths from residential fires after free smoke alarms were distributed in an area at high risk, but these results may not apply in other settings, and evidence from randomised controlled trials is lacking

What this study adds

Giving out free smoke alarms in a multiethnic poor urban population did not reduce injuries related to fire or firesGiving smoke alarms away may be a waste of resources and of little benefit unless alarm installation and maintenance is assured