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PubMed2025

Whole-genome sequencing, strain composition, and predicted antimicrobial resistance of Streptococcus pneumoniae causing invasive disease in England in 2017-20: a prospective national surveillance study.

BACKGROUND: Surveillance of the invasive disease burden caused by Streptococcus pneumoniae in England is performed by the UK Health Security Agency (UKHSA). In 2017, UKHSA switched from phenotypic methods to whole-genome sequencing (WGS) approaches for pneumococcal surveillance. Here, we present the first results of national WGS surveillance, up to the start of the COVID-19 pandemic, with the aim of describing the population genomics of this important pathogen. METHODS: We examined prospective national surveillance data from England, using bacterial isolates from cases of invasive pneumococcal disease (IPD) submitted to the national reference laboratory at UKHSA. A bioinformatic pipeline was developed to quality control WGS data and routinely report species and serotype. We assembled isolate data, assigned global pneumococcal sequencing clusters (GPSCs), and predicted antimicrobial resistance (AMR) profiles for isolates that passed further quality control. We collected additional data on patient outcomes and characteristics using enhanced surveillance questionnaires completed by patients' general practitioners. We used logistic regression analysis to assess the effects of various genomic and patient characteristics on the outcomes of IPD. FINDINGS: In England, between July 1, 2017, and Feb 29, 2020, there were 15 400 cases of IPD. From these cases, 13 749 (89·3%) isolates were sequenced, passed quality control, and were included in analyses. Serotype diversity was high during the study period, with 2751 (20%) isolates serotyped as 13-valent pneumococcal conjugate vaccine (PCV13) types, whereas serotype 8 was the most prevalent serotype (n=3074 [22·4%]) overall. There were 157 GPSCs within the collection, with GSPC3 the most common, encompassing 98·7% (3033 of 3074) of serotype 8 isolates. Most isolates (n=10 198 [74·2%]) did not contain AMR-associated genes. Resistance to co-trimoxazole was the most frequently predicted resistance (n=2331 [17%]), followed by resistance to tetracycline (n=1199 [8·7%]) and β-lactams (n=1149 [8·4%]). Logistic regression analysis found the presence of AMR-associated genes significantly increased the odds of patient death (odds ratio 1·18, 95% CI 1·01-1·38). Some GPSCs were also associated with a significant increase in the odds of patient death, such as GPSC12 (1·88, 1·48-2·38). Isolates from 2018 were associated with a significant increase in the odds of patient death (1·12, 1·00-1·25), whereas younger patient age was significantly associated with a reduction in the odds of patient death compared with being aged 85 years or older. INTERPRETATION: WGS-based surveillance has allowed us to interrogate country-wide population dynamics driving changes in pneumococcal serotype frequency. Here, we observe a stable but diverse population before the COVID-19 pandemic restrictions were enforced in England, with low rates of AMR. These findings will provide the baseline for pandemic and post-pandemic data, to collectively inform implementation and development of the vaccination programme within the country. FUNDING: None.

Streptococcus pneumoniae↗
PubMed1995

A prospective, randomized surveillance study of postoperative wound infections after plastic surgery: a study of incidence and surveillance methods.

In a postoperative wound infection study in plastic surgery, 315 patients were randomized to either outpatient wound control after 30 days (group I) or self-control by questionnaire (group II). We present a new definition of wound infection based on physiologic wound healing. The surveillance of postoperative wound infection showed follow-up rates of 95 and 68 percent and infection rates of 16.3 and 17.1 percent for groups I and II, respectively. Of the 43 patients (16.7 percent) with postoperative wound infections, 31 (72 percent) were diagnosed after leaving the hospital, and only 12 (28 percent) were diagnosed during hospital stay. The monthly wound infection rate declined from 23.5 percent when the registration started to 12.2 percent at the end of the surveillance. The wound infection rate nearly tripled when duration of surgery was more than 120 minutes compared with less than 60 minutes. Postoperative wound infection was significantly related to preoperative contamination class, with an increase from 10.2 percent wound infections in class "clean" to 37.5 percent in class "dirty." We conclude that postoperative wound infection also crops up in the plastic surgical department, and this situation has not, to date, been documented sufficiently. A simple questionnaire gives a useful survey of postoperative wound infections. An active follow-up for at least 30 days is essential to register the rate of surgical infections.

Adolescent↗
PubMed1993

Comparing the strengths and weaknesses of observational and experimental studies using a postmarketing surveillance study as a protypic example.

A recent prospective, observational study in rheumatoid arthritis patients indicated that the addition of hydroxychloroquine to either aspirin or methotrexate therapy decreased the incidence of hepatic enzyme abnormalities. This interesting finding is of potential clinical importance, but its validity needs to be examined in terms of the potential confounders inherent in observational studies. Although one of the study's strengths is its derivation from "real-life" data, some potential confounders that might weaken the data include a need to examine whether any scientific rationale can be discerned for the observation; examination of control-case matching (issues of randomization and baseline disease characteristics); the potential for attribution bias; data-collection methods (prospective versus retrospective, uniform versus chart review); and equivalency of treatment protocols, dosing regimens, and concomitant medications. Potential scientific rationale exists for the observed interaction, and data collection is both uniform and prospective. These strengths are confounded by the inevitable lack of randomization in observational studies, the potential for differences in baseline disease characteristics, attribution bias, a lack of controlled dosing regimens and treatment protocols, and an assumption that all nonsteroid antiinflammatory drugs are alike (which is not true). On balance, the hypothesis generated by these data is compelling enough to deserve further testing in both observational and experimental settings.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1997

Chromosome aberrations in hospital workers: evidence from surveillance studies in Italy (1963-1993).

Hospital workers are occupationally exposed to various agents known or suspected to induce chromosome damage, the most studied being ionizing radiation. To determine the extent of chromosome damage in peripheral blood lymphocytes in this population, taking into account temporal changes and job titles, a re-analysis of cytogenetic studies performed in four Italian laboratories in the period 1965-1993 was carried out. A total of 871 hospital workers and 617 controls, mainly coming from ad hoc studies or surveillance programs in occupational groups potentially exposed to ionizing radiation, were examined. The exposed to controls frequency ratio of chromosome aberrations was evaluated as the measure of effect within each dataset by job title, using multivariate Poisson regression analysis, which allowed an efficient control of confounding. Increased frequency of chromosome-type aberrations among exposed subjects was found in all datasets, especially in those dealing with older data. Significantly higher frequencies are reported for various job titles, particularly for orthopedists, radiologists, anesthesists, and nurses among paramedical occupations. Decrease in exposure to ionizing radiation in hospital workers was documented through a targeted study in the critical group of radiologists. A similar time-related reduction in the frequency of chromosome-type aberrations also has been reported by the surveillance studies carried out over the most recent decades. These data substantiate the use of chromosome-type aberrations as biomarkers of exposure in this occupational setting in the period evaluated. However, the increases observed also in workers with doubtful exposure to ionizing radiation indicate that other chromosome-damaging agents may be involved and, in turn, suggest the extension of surveillance to a larger number of occupations.

Adult↗
PubMed1998

Efficacy and safety of acarbose in the treatment of type 2 diabetes: data from a 2-year surveillance study.

This 2-year surveillance study assessed the tolerability and safety of acarbose in patients with diabetes. A total of 2035 patients were enrolled; approximately 95% were classified as having Type 2 diabetes. The study was open with no control groups. Physicians had sole control of the acarbose doses prescribed. Doses of acarbose were generally low, and hence well-tolerated. The incidence of acarbose-associated adverse effects and withdrawals was 7.5 and 2.5%, respectively. No sustained adverse changes in laboratory parameters occurred. Fasting blood glucose levels, 1- and 2-h postprandial glucose levels, HbA1c or HbA1, and other clinical parameters, such as blood cell counts and liver enzyme levels were also assessed as measures of efficacy and safety. Over the 2 years the mean fasting blood glucose level decreased by 2.39 mmol/l in patients with Type 2 diabetes, while mean 1- and 2-h postprandial blood glucose levels both decreased by 3.56 mmol/l. HbA1 and HbA1c decreased by 2.0 and 1.1 percentage points, respectively. These results suggest that when used in long-term day-to-day management of diabetes, acarbose is well tolerated and can improve glycaemic control.

Acarbose↗
PubMed2001

Safety and efficacy of acarbose in the treatment of Type 2 diabetes: data from a 5-year surveillance study.

This 5-year surveillance study assessed the tolerability and safety of acarbose in patients with diabetes. A total of 2035 patients were enrolled of whom 1954 were classified as having Type 2 diabetes. The study was open with no control group. Physicians had sole control of the acarbose doses prescribed. Fasting blood glucose levels, 2-h postprandial glucose levels, HbA(1) or HbA(1c) and other clinical parameters, such as lipids and liver enzyme levels, were also assessed as measures of efficacy and safety. One-third of the patients received acarbose as monotherapy and two-thirds in combination with other glucose-lowering treatment. The concomitant diseases were also assessed. Doses of acarbose were low in the majority of the patients and well tolerated. The incidence of acarbose-associated side effects was 4.7%. No sustained adverse changes in laboratory measures occurred. Over the 5 years, HbA(1) and glycated haemoglobin (HbA(1c)) decreased by 2.4 and 1.8% points, respectively, and the mean fasting glucose and 2-h postprandial glucose decreased by 2.7 and 3.4 mmol/l. Mean body weight was reduced by 0.9 kg. The results suggest that when used in long-term day-to-day management of diabetes, acarbose is well tolerated and can improve glycaemic control as monotherapy, as well as in combination therapy. In a high-risk patient group acarbose proved to be a safe drug.

Acarbose↗
PubMed1988

Adverse reactions to atracurium and alcuronium. A prospective surveillance study.

A multicentre prospective surveillance study was undertaken to compare the incidence and severity of adverse reactions attributed to atracurium and alcuronium. Clinical manifestations were used by the anaesthetist to diagnose an adverse reaction (a cutaneous reaction, a greater than 20% change in arterial pressure or heart rate, and bronchospasm). Of the 1956 patients receiving atracurium, 10.1% had adverse reactions compared with 17.9% of the 1425 patients receiving alcuronium (P less than 0.001). There were no longterm sequelae. The atracurium group had a markedly lower incidence of hypotension (3.4% v. 13.7%; P less than 0.0001), but a higher incidence of cutaneous reactions (4.6% v. 2.3%; P less than 0.005) which were not associated with other adverse reactions. There was a low incidence of bronchospasm in both groups (0.2% v. 0.1%).

Adult↗
PubMed2004

Nosocomial bloodstream infections in US hospitals: analysis of 24,179 cases from a prospective nationwide surveillance study.

BACKGROUND: Nosocomial bloodstream infections (BSIs) are important causes of morbidity and mortality in the United States. METHODS: Data from a nationwide, concurrent surveillance study (Surveillance and Control of Pathogens of Epidemiological Importance [SCOPE]) were used to examine the secular trends in the epidemiology and microbiology of nosocomial BSIs. RESULTS: Our study detected 24,179 cases of nosocomial BSI in 49 US hospitals over a 7-year period from March 1995 through September 2002 (60 cases per 10,000 hospital admissions). Eighty-seven percent of BSIs were monomicrobial. Gram-positive organisms caused 65% of these BSIs, gram-negative organisms caused 25%, and fungi caused 9.5%. The crude mortality rate was 27%. The most-common organisms causing BSIs were coagulase-negative staphylococci (CoNS) (31% of isolates), Staphylococcus aureus (20%), enterococci (9%), and Candida species (9%). The mean interval between admission and infection was 13 days for infection with Escherichia coli, 16 days for S. aureus, 22 days for Candida species and Klebsiella species, 23 days for enterococci, and 26 days for Acinetobacter species. CoNS, Pseudomonas species, Enterobacter species, Serratia species, and Acinetobacter species were more likely to cause infections in patients in intensive care units (P<.001). In neutropenic patients, infections with Candida species, enterococci, and viridans group streptococci were significantly more common. The proportion of S. aureus isolates with methicillin resistance increased from 22% in 1995 to 57% in 2001 (P<.001, trend analysis). Vancomycin resistance was seen in 2% of Enterococcus faecalis isolates and in 60% of Enterococcus faecium isolates. CONCLUSION: In this study, one of the largest multicenter studies performed to date, we found that the proportion of nosocomial BSIs due to antibiotic-resistant organisms is increasing in US hospitals.

Adolescent↗
PubMed2005

Making the most of surveillance studies: summary of the OPTAMA Program.

Antibiotic surveillance studies lack consideration of pharmacodynamics and provide little information about optimal dosing. By using minimum inhibitory concentration (MIC) data derived from a global surveillance study and Monte Carlo simulation, the Optimizing Pharmacodynamic Target Attainment using the MYSTIC Antibiogram (OPTAMA) Program was established to impart greater understanding of the ability to attain pharmacodynamic exposure for specific dosing regimens and their relationship with percent susceptibility. Early OPTAMA studies focused on determining the cumulative fraction of response (CFR) for various antibiotics against Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii, and Pseudomonas aeruginosa regionally in Europe and the Americas. Later reports considered the prevalence of specific bacteria causing infections to estimate the CFR for empiric therapy of pneumonia, bloodstream, complicated skin/skin structure, and intra-abdominal infections. Collectively, the approach of the OPTAMA Program provides a novel tool that complements susceptibility data to help in the selection of appropriate empirical antibiotic therapy at the national, regional, and institutional level.

Anti-Bacterial Agents↗
PubMed1994

[A national surveillance study on alcoholic liver disease in Japan (1986-1991)].

National surveillance studies on alcoholic liver disease (ALD) in Japan were performed in 1978 and 1985, by a previous Japanese study group for ALD (Takeuchi group). In the present study, a subsequent nationwide surveillance study was performed from 1986 to 1991 and the results were compared with the previous two studies. In order to clarify the etiological relationships between hepatitis C virus (HCV) infection and ALD, an analysis was also done according to the new diagnostic criteria of ALD which was proposed by this group (Takada group). By the criteria of the Takeuchi group, the incidence of ALD was not significantly different during 1986 to 1991. However, the incidence of hepatocellular carcinoma (HCC) in alcoholic cirrhosis (AL-LC) clearly increased during this period. The analysis including the results of the previous study indicate that incidence of ALD reached a plateau in 1980 and then features of ALD in Japan entered a stable stage. However, HCC in AL-LC continued to show a linear increase from 1976 to 1991. Analysis with the new criteria of the Takada group was done in cases of 1990 and 1991. Approximately 2 out of 3 cases of ALD were caused by alcohol alone, and the remaining cases were caused by a combination of alcohol and HCV. Cases caused only by HCV were very rare. The main etiology in patients with alcoholic hepatitis and fibrosis was alcohol alone and that in chronic hepatitis of heavy drinkers was a combination of alcohol and HCV. In half of the patients with AL-LC, the etiology was alcohol alone and in the other half patients, it was a combination of both factors. In most patients with HCC, the etiology was a combination of alcohol and HCV, indicating that HCV infection may be important for the development of HCC in alcoholics.

Carcinoma, Hepatocellular↗
PubMed2006

Using multiple sources to improve and measure case ascertainment in surveillance studies: 20 years of the British Paediatric Surveillance Unit.

BACKGROUND: The British Paediatric Surveillance Unit (BPSU) was established in 1986 to facilitate national surveillance of uncommon paediatric disorders. This study investigated the effectiveness of using multiple source reporting and capture-recapture analysis to maximize case ascertainment in studies undertaken through the BPSU. METHODS: Structured review of all surveillance studies completed through the BPSU. Quantitative and qualitative analysis of the effectiveness of multiple reporting sources and capture-recapture methods was made. RESULTS: Of 71 studies undertaken through the BPSU, 59 were included in this review and 38 used additional data sources. Established national sources were most readily adapted for use as secondary data sources, including routine health data, communicable disease and specialty-specific surveillance units, whilst the involvement of parent groups and the media was less successful. Six studies employed capture-recapture techniques to estimate the completeness of case ascertainment. CONCLUSIONS: Active surveillance through the BPSU remains a timely and reliable primary source of cases, but employing additional reporting sources is effective in enhancing case ascertainment. When the assumptions for its valid use are met, capture-recapture analysis allows the estimation of completeness of ascertainment. It is essential to define the purpose of an additional source at the outset of a study and to ensure that subsequent analysis is appropriate.

Data Collection↗
PubMed1997

[Planning, realization and evaluation of post-marketing surveillance studies. Recommendations of the Society for Phytotherapy].

Post-marketing-surveillance studies with herbal drugs usually are prospective prescription-epidemiological studies, which should allow statements on quality, efficacy and safety. Until now neither laws nor concrete normative guidelines for the methodology and the evaluation of post-marketing-surveillance studies are existing which could be used for pharmacovigilance. In the present paper guidelines for planning, realisation and evaluation are presented which should allow studies of high quality. The essential components required for the investigational plan are focussed. Also recommendations on the obligatory, optional and special components of the study protocols are made. Additionally statistical methods which allow the evaluation of the therapeutic efficacy are presented.

Humans↗
PubMed2005

Efficacy and tolerability of almotriptan in postmarketing surveillance studies.

While randomized, double-blind, placebo-controlled trials are considered the gold standard of clinical evidence, they are limited by patient numbers, duration of patient exposure, and restricted patient populations. Data from controlled trials may not be generalizable to all individuals likely to take the drug under investigation. Postmarketing surveillance studies are designed to measure efficacy and safety in larger and more diverse populations, allowing them to detect less common and delayed adverse events. However, postmarketing surveillance studies are limited by their lack of randomization, open-label design that can result in patient and physician bias, incomplete follow-up, less than rigorous outcome measurement, and lack of a contemporaneous control group. With regard to acute treatment of migraine, clinical trials using per protocol primary endpoints do not reflect the more favorable experience with triptans in general practice. Postmarketing surveillance studies have been performed to determine whether the high levels of efficacy and tolerability of almotriptan reported in controlled clinical trials can been reproduced in routine practice. An observational study conducted in Spain with 2,074 migraine sufferers (4,183 attacks) reported a 2-hour pain-relief rate of 86.9%, a 2-hour pain-free rate of 51.5%, and a sustained pain-free rate of 46.0%; 1.1% of patients reported adverse reactions. A German postmarketing study in 899 patients (2,131 attacks) with acute migraine treated with almotriptan 12.5 mg reported 2-hour pain relief in 84.5% of attacks and 2-hour pain free in 41.4%; 1.1% of patients reported adverse reactions. The consistency of response (at least two out of three attacks successfully treated) with almotriptan 12.5 mg was 87.3%. Regarding satisfaction, 88.5% of patients were satisfied or very satisfied and 80.3% of patients stated that almotriptan was better compared to their prior therapy; 92% of physicians indicated that they would continue treating their patients' migraines with almotriptan. The results of these studies demonstrate that the high levels of efficacy and tolerability seen with almotriptan in controlled clinical trials are achieved in real-world clinical settings. In conclusion, a combination of controlled clinical trials, postmarketing surveillance studies, and physician's experience in the general population can give us a better understanding of the efficacy and tolerability of acute migraine agents.

Germany↗
PubMed2001

The microbiology of chronic rhinosinusitis: results of a community surveillance study.

In view of the rapidly changing patterns of antibiotic resistance, community surveillance studies are providing important information to help guide practitioners in making their choice of antibiotics. For this community surveillance study, we performed a retrospective chart review of nasal and sinus culture data obtained from 83 patients with typical symptoms of chronic rhinosinusitis who visited a community otolaryngologist in Rochester, New York. Pathogens were isolated in 59 of these patients (71%). The most common were coagulase-negative staphylococci (31% of isolates). Among the other isolated pathogens were Hemophilus influenzae (25%), Streptococcus pneumoniae (12%), Moraxella catarrhalis (10%), Pseudomonas aeruginosa (7%), alpha-hemolytic streptococci (5%), and Staphylococcus aureus (3%). Approximately 39% of the coagulase-negative staphylococci isolates were resistant to penicillin. Some 20% of the H influenzae isolates were beta-lactamase-positive, and 14% of all isolates were resistant to multiple antibiotics. Approximately 12% of the 83 patients cultured positive for multiple organisms. Our findings provide important surveillance information about the resistance patterns of pathogens in our area. Although the prevalence of beta-lactamase-positive H influenzae that we observed was consistent with those of other reports, we found a lower prevalence of polymicrobial flora. Our findings suggest that culture- and sensitivity-directed therapy should be effective in the treatment of chronic rhinosinusitis.

Bacterial Infections↗
PubMed1999

Relationship between upper gastrointestinal symptoms and lifestyle, psychosocial factors and comorbidity in the general population: results from the Domestic/International Gastroenterology Surveillance Study (DIGEST).

BACKGROUND: The Domestic/International Gastroenterology Surveillance Study (DIGEST) investigated the prevalence and economic/quality-of-life impact of upper gastrointestinal (GI) symptoms over 3 months among the general population of seven international sites (n = 5581). METHODS: Respondents were classified as having relevant or non-relevant symptoms, and were further classified as having gastro-oesophageal reflux disease (GORD)-, ulcer-, or dysmotility-like symptoms, based on their most bothersome symptom. Associations were investigated between the prevalence of relevant upper GI symptoms and these subtypes, and the following potential risk factors: psychosocial variables (income, educational level, marital status, having children, occupation, any significant life event during previous year); lifestyle variables (tobacco use, levels of alcohol and caffeine consumption); comorbidity variables (illnesses or symptoms experienced in the previous 3 months, concurrent conditions diagnosed by a doctor, prescriptions and over-the-counter (OTC) medications taken in the previous 3 months for health problems other than upper GI symptoms). RESULTS AND CONCLUSIONS: The most notable risk factors for the occurrence of upper GI symptoms, including symptoms indicative of GORD, were found to be various indicators of psychological stress (particularly recent life events) and psychiatric disease. A wide range of other non-psychiatric illnesses and their treatments was also clearly associated with the occurrence of upper GI symptoms, consistent with these symptoms occurring in many organic illnesses or as adverse effects of their treatments. Smoking was also found to be associated with GORD-like symptoms.

Adult↗
PubMed1999

The health economic impact of upper gastrointestinal symptoms in the general population: results from the Domestic/International Gastroenterology Surveillance Study (DIGEST).

BACKGROUND: The Domestic/International Gastroenterology Surveillance Study (DIGEST) is the first large, multinational, population-based survey to assess the 3-month prevalence and economic/quality-of-life impact of upper gastrointestinal symptoms (UGIS). METHODS: A total of 5581 subjects were interviewed in 10 countries (grouped into seven regions). Respondents were classified as having relevant or non-relevant upper gastrointestinal symptoms, and questioned about consumption of healthcare resources in terms of doctor consultations, prescribed and non-prescribed medications, hospital stays and investigations for both gastrointestinal and other health problems. The impact of symptoms in terms of time lost and reduced effectiveness at work or social activities was also recorded. RESULTS AND CONCLUSIONS: Twenty-eight percent of the total sample was defined as having clinically relevant UGIS (UGIS of at least moderate severity and with a frequency of at least once per week in the previous 3 months). During the period studied, 20% of these subjects had consulted a family practitioner (16.2%) and/ or a specialist (6.3%), primarily for UGIS. Of those with clinically relevant UGIS, 49% had taken over-the-counter medication, and 27% prescription medication for gastrointestinal (GI) symptoms. Two percent reported a hospital stay and 27% reported days of reduced or no work, school or domestic productivity due to UGIS. Four percent of all study subjects underwent investigations for UGIS during this period. Variations between countries in these parameters may be due to differences in healthcare systems and cultural attitudes towards UGIS, influencing both the healthcare-seeking behaviour of subjects with UGIS and their management.

Adult↗
PubMed2000

Invasive disease due to group B streptococcal infection in adults: results from a Canadian, population-based, active laboratory surveillance study--1996. Sentinel Health Unit Surveillance System Site Coordinators.

In 1996, a population-based surveillance program for invasive adult group B streptococcal (GBS) diseases in Canada was undertaken, to define the epidemiologic and microbiologic characteristics of the disease. Nine public health units across Canada, representing 9.6% of the population, participated in the program. In total, 106 culture-positive cases of invasive adult GBS disease were reported, which represented an incidence rate 4.6 per 100,000 adults (41/100, 000 for pregnant and 4.1/100,000 for nonpregnant adults). Sixty-two (58.5%) of the 106 cases occurred in females, and, of these, 15 (14. 2%) were associated with pregnancy. Serotype V was the most common, accounting for 31% of the 90 GBS isolates typed (26.7% of nonpregnant and 4.4% of pregnant cases). This was followed by serotypes III (19%), Ia (17%), Ib (10%), II (9%), and VII (1%). Thirteen percent were nontypeable. All isolates were susceptible to penicillin, ampicillin, and vancomycin. Resistance to erythromycin and clindamycin was 6.7% and 4.4%, respectively.

Adolescent↗