Manipulation in treatment of low back pain: a multicentre study.

In a multicentre trial 456 selected patients with low back pain were randomly allocated to one of four treatments-manipulation, definitive physiotherapy, corset, or analgesic tablets. Patients were reassessed clinically after three weeks'' treatment and again after a further three weeks. Questionnaires were used to find out the patients'' condition three months and one year after admission to the trial. There were never any important differences among the four groups of patients. A few patients responded well and quickly to manipulation, but there was no way of identifying such patients in advance. The response to a corset was slow, but the long-tern effects were at least as good as those of the other treatments. Patients treated only with analgesics fared marginally worse than those on the other three treatments. There is no strong reason, however, for recommending manipulation over physiotherapy or corset.     

Computer aided diagnosis of acute abdominal pain: a multicentre study.

A multicentre study of computer aided diagnosis for patients with acute abdominal pain was performed in eight centres with over 250 participating doctors and 16,737 patients. Performance in diagnosis and decision making was compared over two periods: a test period (when a small computer system was provided to aid diagnosis) and a baseline period (before the system was installed). The two periods were well matched for type of case and rate of accrual. The system proved reliable and was used in 75.1% of possible cases. User reaction was broadly favourable. During the test period improvements were noted in diagnosis, decision making, and patient outcome. Initial diagnostic accuracy rose from 45.6% to 65.3%. The negative laparotomy rate fell by almost half, as did the perforation rate among patients with appendicitis (from 23.7% to 11.5%). The bad management error rate fell from 0.9% to 0.2%, and the observed mortality fell by 22.0%. The savings made were estimated as amounting to 278 laparotomies and 8,516 bed nights during the trial period--equivalent throughout the National Health Service to annual savings in resources worth over 20m pounds and direct cost savings of over 5m pounds. Computer aided diagnosis is a useful system for improving diagnosis and encouraging better clinical practice.     

HIV antibody assay that gave false negative results: multicentre collaborative study.

OBJECTIVE: To identify false negative results arising from the use of a commercial kit to detect antibody to HIV-1 and HIV-2 between July 1995 and March 1996. DESIGN: The 56 laboratories in the United Kingdom that were using the assay were asked to retrieve and retest specimens with an alternative assay for HIV-1 and HIV-2. Details of false negative results were obtained and these serum samples further investigated. SUBJECTS: 24,181 patients tested with the assay who were reported as being negative for HIV antibody. An additional 497 patients were confirmed as HIV positive with the assay. RESULTS: Serum samples of 20,973 of the patients were retested, and four patients were found to have had false negative results with the kit; three further patients were found to have had false negative results in the course of other laboratory testing. The seven patients with false negative results with the kit were of diverse risk group and HIV-1 subtype. Four had evidence of recent HIV infection. CONCLUSION: The commercial kit had a sensitivity of 99.2% (497/501), or less if the additional three patients with false negative results were taken into account.     

Impact of new antiretroviral combination therapies in HIV infected patients in Switzerland: prospective multicentre study. Swiss HIV Cohort Study.

OBJECTIVES: To examine trends in disease progression and survival among patients enrolled in the Swiss HIV cohort study during 1988-96 and to assess the influence of new antiretroviral combination therapies. DESIGN: Prospective multicentre study, with follow up visits planned at six monthly intervals. SETTING: Seven HIV units at university centres and cantonal hospitals in Switzerland. PATIENTS: 3785 men (mean age 35.0 years) and 1391 women (30.3 years) infected with HIV. 2023 participants had a history of intravenous drug misuse; 1764 were men who had sex with men; 1261 were infected heterosexually; and 164 had other or unknown modes of transmission. 601 participants had had an AIDS defining illness. RESULTS: During more than 15,000 years of follow up, there were 1456 first AIDS defining diagnoses and 1903 deaths. Compared with those enrolled during 1988-90, the risk of progression to a first AIDS diagnosis was reduced by 18% (relative risk 0.82 (95% confidence interval 0.73 to 0.93)) among participants enrolled in 1991-2, by 23% (0.77 (0.65 to 0.91)) among those enrolled in 1993-4, and by 73% (0.27 (0.18 to 0.39)) among those enrolled in 1995-6. Mortality was reduced by 19% (0.81 (0.73 to 0.90)), 26% (0.74 (0.63 to 0.87)), and 62% (0.38 (0.25 to 0.97)) respectively. Compared with no antiretroviral treatment, the risk of an initial AIDS diagnosis after CD4 lymphocyte counts fell to < 200 cells x 10(6)/1 was reduced by 16% (0.84 (0.73 to 0.97)) with monotherapy, 24% (0.76 (0.63 to 0.91)) with dual therapy, and 42% (0.58 (0.37 to 0.92)) with triple therapy. Mortality was reduced by 23% (0.77 (0.68 to 0.88)), 31% (0.69 (0.60 to 0.80)), and 65% (0.35 (0.20 to 0.60)) respectively. CONCLUSIONS: The introduction of antiretroviral combination therapies outside the selected patient groups included in clinical trials has led to comparable reductions in disease progression and mortality.     

Underdiagnosis and undertreatment of asthma in childhood.

A total of 179 Tyneside children who had suffered at least one episode of wheeze since school entry were seen at the age of 7. All but 14 had visited a doctor for chest symptoms, but a diagnosis of asthma had been offered to the parents of only 21 children, including three of the 56 children experiencing four to 12 wheezy episodes a year and 11 of the 31 children experiencing more than 12 episodes a year. Bronchodilator treatment was rarely offered in the absence of such a diagnosis, and two thirds of the children had never received a bronchodilator. Of the children experiencing four or more episodes a year, only a third had received bronchodilator drugs regularly, though half had lost more than 50 days from school because of wheeze. School absenteeism fell 10-fold in the 31 children finally offered continuous prophylactic treatment. Although many doctors had feared that use of the word "asthma" would cause anxiety, parents were uniformly relieved when given an explanation of their child''s recurrent wheeze. This study uncovered a disturbing amount of ill health in children that was easily rectified. Probably this same problem exists in other areas.     

Diagnosis of inflammatory bowel disease: an international multicentre scoring system.

Inflammatory bowel disease is being studied by the World Organisation of Gastroenterology (OMGE) Research Committee in a survey (currently) affecting 1696 patients presenting to 30 hospitals in 16 countries. A computer-aided diagnostic prediction system (when tested in 1056 patients) showed an accuracy of match between computer prediction and clinical diagnosis in 94% of these patients. Most centres, however, do not possess appropriate computing facilities. A simple diagnostic "scoring system", based on likelihood ratios, has therefore been developed, using a series of numbers set out on a single sheet of paper. The overall accuracy of the simple scoring system in the same 1056 patients was equivalent (93%) to the computer-aided system. In a further series of 510 "new" patients from eight fresh centres the diagnostic scoring system made a firm prediction in 490 cases (96%). Where made, the accuracy of match between the scoring system prediction and clinical diagnosis was 96%. It is suggested that this simple system, which requires no analytical resource and could be used by any gastroenterologist, might be of some value in clinical research and clinical practice.     

A Japanese cross-sectional multicentre study of biomarkers associated with cardiovascular disease in smokers and non-smokers

Abstract

We performed a cross-sectional, multicentre study in Japan to detect the differences in biomarkers of exposure and cardiovascular biomarkers between smokers and non-smokers. Several clinically relevant cardiovascular biomarkers differed significantly between smokers and non-smokers, including lipid metabolism (high-density lipoprotein cholesterol concentrations – lower in smokers), inflammation (fibrinogen and white blood cell count – both higher in smokers), oxidative stress (8-epi-prostaglandin F_2α – higher in smokers) and platelet activation (11-dehydro-thromboxane B₂ – higher in smokers) (p ≤ 0.0001). These results provide further evidence showing that cardiovascular biomarkers can discriminate smokers from non-smokers, and could be used to evaluate the risks associated with tobacco products.     

Prevalence of and risk factors for persistent postoperative nonanginal pain after cardiac surgery: a 2-year prospective multicentre study

Background:

Persistent postoperative pain continues to be an underrecognized complication. We examined the prevalence of and risk factors for this type of pain after cardiac surgery.

Methods:

We enrolled patients scheduled for coronary artery bypass grafting or valve replacement, or both, from Feb. 8, 2005, to Sept. 1, 2009. Validated measures were used to assess (a) preoperative anxiety and depression, tendency to catastrophize in the face of pain, health-related quality of life and presence of persistent pain; (b) pain intensity and interference in the first postoperative week; and (c) presence and intensity of persistent postoperative pain at 3, 6, 12 and 24 months after surgery. The primary outcome was the presence of persistent postoperative pain during 24 months of follow-up.

Results:

A total of 1247 patients completed the preoperative assessment. Follow-up retention rates at 3 and 24 months were 84% and 78%, respectively. The prevalence of persistent postoperative pain decreased significantly over time, from 40.1% at 3 months to 22.1% at 6 months, 16.5% at 12 months and 9.5% at 24 months; the pain was rated as moderate to severe in 3.6% at 24 months. Acute postoperative pain predicted both the presence and severity of persistent postoperative pain. The more intense the pain during the first week after surgery and the more it interfered with functioning, the more likely the patients were to report persistent postoperative pain. Pre-existing persistent pain and increased preoperative anxiety also predicted the presence of persistent postoperative pain.

Interpretation:

Persistent postoperative pain of nonanginal origin after cardiac surgery affected a substantial proportion of the study population. Future research is needed to determine whether interventions to modify certain risk factors, such as preoperative anxiety and the severity of pain before and immediately after surgery, may help to minimize or prevent persistent postoperative pain.Postoperative pain that persists beyond the normal time for tissue healing (> 3 mo) is increasingly recognized as an important complication after various types of surgery and can have serious consequences on patients’ daily living.^1–3 Cardiac surgeries, such as coronary artery bypass grafting (CABG) and valve replacement, rank among the most frequently performed interventions worldwide.⁴ They aim to improve survival and quality of life by reducing symptoms, including anginal pain. However, persistent postoperative pain of nonanginal origin has been reported in 7% to 60% of patients following these surgeries.^5–23 Such variability is common in other types of major surgery and is due mainly to differences in the definition of persistent postoperative pain, study design, data collection methods and duration of follow-up.^1–3,24Few prospective cohort studies have examined the exact time course of persistent postoperative pain after cardiac surgery, and follow-up has always been limited to a year or less.^9,14,25 Factors that put patients at risk of this type of problem are poorly understood.²⁶ Studies have reported inconsistent results regarding the contribution of age, sex, body mass index, preoperative angina, surgical technique, grafting site, postoperative complications or level of opioid consumption after surgery.^{5–7,9,13,14,16–19,21–23,25,27} Only 1 study investigated the role of chronic nonanginal pain before surgery as a contributing factor;²¹ 5 others prospectively assessed the association between persistent postoperative pain and acute pain intensity in the first postoperative week but reported conflicting results.^{13,14,21,22,25} All of the above studies were carried out in a single hospital and included relatively small samples. None of the studies examined the contribution of psychological factors such as levels of anxiety and depression before cardiac surgery, although these factors have been shown to influence acute or persistent postoperative pain in other types of surgery.^1,24,28,29We conducted a prospective multicentre cohort study (the CARD-PAIN study) to determine the prevalence of persistent postoperative pain of nonanginal origin up to 24 months after cardiac surgery and to identify risk factors for the presence and severity of the condition.     

Anastomotic integrity after operations for large-bowel cancer: a multicentre study.

Clinically evident anastomotic dehiscence was studied in 1466 patients who had undergone resection of a large-bowel adenocarcinoma. The overall incidence of anastomotic leakage was 13%, but the incidence varied between surgeons (range 0.5% to over 30%). Morbidity and mortality were significantly higher in those patients in whom the anastomosis failed to heal primarily. If these results are extrapolated to the national level, it should be possible by achieving results closer to those in patients without leakage to reduce overall post-operative mortality after resection of large-bowel cancer by 2% and to achieve an appreciable reduction in morbidity. Both factors are clinically important and, taken together, could result in appreciable saving of revenue.     

Pharmacological undertreatment of coronary risk factors in patients with psoriasis: observational study of the Danish nationwide registries

Background

Patients with psoriasis have increased prevalence of coronary risk factors and limited recent results have suggested that these risk factors are undertreated in patients with psoriasis. This may contribute to the increased risk of cardiovascular diseases observed in patients with psoriasis.

Objective

To examine the pharmacological treatment of coronary risk factors in patients with severe psoriasis treated with biologic agents in a real-world setting.

Methods and Findings

Medical history of patients with severe psoriasis treated with biologic agents in the time period 2007–09 was retrieved from a Danish nationwide registry (DERMBIO). Individual-level linkage of nationwide administrative registries of hospitalizations, concomitant medications, and socioeconomic status was performed to gain insights into the use of pharmacological treatment. A total of 693 patients (mean age 46.1±12.7 years, 65.7% male) with severe psoriasis treated with biologic agents were identified. Hypertension, hypercholesterolemia, and diabetes mellitus were identified in 16.6%, 9.2%, and 6.7% of cases, respectively. Patients with severe psoriasis were significantly less likely to receive cardiovascular pharmacotherapy compared to age, sex, and coronary risk factor matched controls. In psoriatic patients with hypertension 27.7% received no antihypertensive pharmacotherapy. Patients with dyslipidemia received cholesterol-lowering medications in 55.8% of cases and patients with diabetes mellitus received angiotensin converting enzyme inhibitors/angiotensin II receptor blockers and cholesterol-lowering medications in 42.1% and 23.7% of cases, respectively. Similar results were found for the subset of patients with >1 coronary risk factor and for high risk patients with established atherosclerotic disease.

Conclusion

This nationwide study of patients with severe psoriasis demonstrated substantial undertreatment of coronary risk factors. Increased focus on identifying cardiovascular risk factors and initiation of preventive cardiovascular pharmacotherapy in patients with psoriasis is warranted.     

Bacteriology of abscesses of the central nervous system: a multicentre prospective study.

Pus from 46 patients with abscesses of the central nervous system (CNS) was examined for bacteria; bacteria were found in all patients. Streptococci were isolated from 36 patients and most isolates were Streptococcus milleri, Lancefield Group F, Ottens and Winkler type O III. Staphylococci were isolated from nine patients, organisms of the bacteroides group from 11, Proteus spp from seven, Klebsiella aerogenes from one, and Haemophilus aphrophilus from one. Pure cultures predominated over mixed cultures. Streptococci were isolated from abscesses of all types, and at all sites, but members of the Enterobacteriaceae and of the bacteroides group were isolated, in mixed cultures, principally from abscesses of the temporal lobe secondary to infection of the middle ear. Staphylococci predominated in abscesses that followed accidental or surgical trauma. Compared with fully sensitive control organisms, microbes infecting half the patients were resistant to penicillin. The prognosis of abscess of the CNS is grave, and the microbiological findings have important consequences for treatment. Prompt inoculation of specimens to culture plates and prompt incubation are mandatory if bacteria are to be cultured. Inhibitors of antimicrobial agents should be added to culture media if antibiotics have been administered. Provided that the site of the abscess and the antecedent history are ascertainable, the neurosurgeon should be able to start appropriate treatment while awaiting the results of culture.     

Management of pain in sickle cell disease using biofeedback therapy: a preliminary study

Fifteen patients with a history of painful episodes of sickle cell disease were given training in progressive relaxation, thermal biofeedback, cognitive strategies, and self-hypnosis to help them develop self-management skills to relieve pain. Results show a 38.5% reduction in the number of emergency room visits, a 31% reduction in the number of hospitalizations, and a 50% reduction in the inpatient stay during the 6 months since the beginning of therapy compared to 6 months prior to therapy. Analgesic intake was reduced by 29% for those who were using it regularly. This is a preliminary study, and the results are considered only as suggestive of the potential use of biofeedback therapy and behavioral management in alleviating painful episodes in sickle cell disease.     

Management of pain in sickle cell disease using biofeedback therapy: A preliminary study

Fifteen patients with a history of painful episodes of sickle cell disease were given training in progressive relaxation, thermal biofeedback, cognitive strategies, and self-hypnosis to help them develop self-management skills to relieve pain. Results show a 38.5% reduction in the number of emergency room visits, a 31% reduction in the number of hospitalizations, and a 50% reduction in the inpatient stay during the 6 months since the beginning of therapy compared to 6 months prior to therapy. Analgesic intake was reduced by 29% for those who were using it regularly. This is a preliminary study, and the results are considered only as suggestive of the potential use of biofeedback therapy and behavioral management in alleviating painful episodes in sickle cell disease.An earlier version of this paper was presented at the 6th Annual Convention of the American Association of Biofeedback Clinicians, Chicago, November 5, 1982.     

Nosocomial meningitis caused by Staphylococcus other than S. aureus in children: multicentre study

Analysing 101 cases of nosocomial meningitis due to staphylococci other than S. aureus within last 15 years, coagulase negative staphylococci represented the commonest pathogen. Major risk factor for staphylococcal meningitis was prior neurosurgery, mainly ventriculoperitoneal shunt insertion. Ten of 101 cases were caused by glycopeptide intermediate resistant strains in patients pretreated with multiple combination of antibiotics including vancomycin and shunt exchanges: 76% of strains were also oxacillin resistant.     

Efficacy and safety of foscarnet for recurrent orolabial herpes: a multicentre randomized double-blind study.

Foscarnet sodium (trisodium phosphonoformate hexahydrate) has been shown to inhibit herpes simplex virus (HSV) in vitro and to be efficacious for topical treatment of experimental HSV infection in animals. To assess its clinical efficacy in the treatment of recurrent orolabial herpes a multicentre collaborative, double-blind, placebo-controlled trial was conducted. The study patients were randomly assigned to receive either 3% foscarnet cream (78 patients) or placebo (cream vehicle) (75 patients) and were asked to start treatment at the earliest indication of a recurrence. Efficacy was evaluated in 143 patients (74 in the foscarnet group and 69 in the placebo group). There was no significant difference in time to healing or duration of virus shedding between the two groups. However, in the subgroup of patients who started treatment before vesicles appeared, the duration of virus shedding was shorter in the foscarnet group than in the placebo group (p = 0.04), and the proportion of lesions that evolved to the vesicular stage was smaller (p = 0.03). No significant difference in the incidence of local or systemic adverse effects was noted between the two groups. We conclude that the beneficial effect of foscarnet was limited to a subgroup of patients who started treatment in the prevesicular stage.     

The optimized acupuncture treatment for neck pain caused by cervical spondylosis: a study protocol of a multicentre randomized controlled trial

ABSTRACT: BACKGROUND: Neck pain is one of the chief complains of patients with cervical spondylosis (CS). Both in China and worldwide, acupuncture is a well-accepted and widely used complementary therapy for the management of neck pain caused by CS. In this paper, we present a protocol designed for a multi-centre, randomised, controlled trial to evaluate the effects of optimised acupuncture treatment for CS neck pain. The study aims to evaluate the effects of the optimised acupuncture treatment in real practice compared with sham and shallow acupuncture therapy. Methods/design This trial uses a multicentre, three-group, randomised, sham acupuncture and shallow acupuncture, controlled single-blind design. Nine hospitals are involved as trial centres. The sample size is calculated based on the formula for a three-group parallel design with a 0.05 significance level and a power of 0.9. A total of 105 cases in a single centre, and a total of 315 cases per each arm are required across all 9 centres. Patients who meet inclusion criteria are randomly assigned to receive optimised acupuncture treatment, sham acupuncture or shallow acupuncture by a computerised central randomisation system. The interventions last for 4 weeks with 8 to 10 treatments. The group allocations and interventions are concealed to patients and statisticians. The Northwick Park Neck Pain Questionnaire (NPQ) is used as the primary outcome measure, and the McGill Pain Questionnaire (MPQ) and The Short Form (36) Health Survey (SF-36) are applied as secondary outcome measures. The evaluation is performed at baseline, at the end of the intervention, and at the end of the first month and the third month during follow-up. The statistical analyses will include baseline data comparison and repeated measures of analysis of variance (ANOVA) for primary and secondary outcomes of group and time differences. Adverse events (AEs) will be reported if they occur. DISCUSSION: This trial is a multicentre randomised control trial (RCT) on the efficacy of acupuncture for CS neck pain and has a large sample size and central randomisation in China. It will strictly follow the CONSORT statement and STRICTA extension guideline to report high-quality study results. By setting the control groups as sham and shallow acupuncture, this study attempts to reveal the effects of real acupuncture versus placebo or non-classic acupuncture therapy and evaluate whether classic Chinese medical acupuncture is effective on CS neck pain. This study will provide evidence for the effects of acupuncture on CS neck pain. Trial Registration: Chinese Clinical Trial Registry: ChiCTR-TRC-00000184.