Content analysis of oncology-related pharmaceutical advertising in a peer-reviewed medical journal

Background

The oncology market represents one of the largest pharmaceutical markets in any medical field, and printed advertising in medical journals is an important channel by which pharmaceutical companies communicate with healthcare professionals. The aim of the present study was to analyze the volume and content of and trends and changes in oncology-related advertising intended for healthcare professionals in a peer-reviewed medical journal. Information that could be included in advertisements to promote drug development and improve treatment strategies for cancer patients is discussed on the basis of the results of the analysis.

Methods/Principal Findings

Overall, 6,720 advertisements covering 13,039 pages in a leading oncology medical journal published (by the American Society of Clinical Oncology) between January 2005 and December 2009 were analyzed. The advertisements targeting pharmaceuticals and clinical trials, in particular, were reviewed. A total of 6,720 advertisements covering 13,039 pages were included in the analysis. For the years 2005–2009, the percentages of total journal pages dedicated to advertising were 24.0%, 45.7%, 49.8%, 46.8%, and 49.8%, respectively. Package insert information and efficacy and safety explanations appeared in more than 80% of advertisements intended for pharmaceutical promotion. From 2005 to 2009, the overall quantity of drug advertisements decreased by approximately 13%, whereas advertisements calling for the enrollment of patients into registration trials increased by approximately 11%.

Conclusion/Significance

Throughout the study period, oncology-related pharmaceutical advertisements occupied a considerable number of pages relative to other journal content. The proportion of advertisements on ongoing clinical trials increased progressively throughout the study period.     

General practitioner reported incidence of Lyme carditis in the Netherlands

Background

Between 1994 and 2009, incidence rates of general practitioner (GP) consultations for tick bites and erythema migrans, the most common early manifestation of Lyme borreliosis, have increased substantially in the Netherlands. The current article aims to estimate and validate the incidence of GP-reported Lyme carditis in the Netherlands.

Methods

We sent a questionnaire to all GPs in the Netherlands on clinical diagnoses of Lyme borreliosis in 2009 and 2010. To validate and adjust the obtained incidence rate, medical records of cases of Lyme carditis reported by GPs in this incidence survey were reviewed and categorised according to likelihood of the diagnosis of Lyme carditis.

Results

Lyme carditis occurred in 0.2 % of all patients with GP-reported Lyme borreliosis. The adjusted annual incidence was six GP-reported cases of Lyme carditis per 10 million inhabitants, i.e. approximately ten cases per year in 2009 and 2010.

Conclusions

We report the first incidence estimate for Lyme carditis in the Netherlands, validated by a systematic review of the medical records. Although Lyme carditis is an uncommon manifestation of Lyme borreliosis, physicians need to be aware of this diagnosis, in particular in countries where the incidence of Lyme borreliosis has increased during the past decades.     

Interactions between Medical Residents and Drug Companies: A National Survey after the Mediator? Affair

Background

The present study aimed to describe exposure and attitudes of French medical residents towards pharmaceutical industry. The study was performed shortly after the Mediator affair which revealed several serious conflicts of interest inside the French health system.

Methods and Findings

A cross-sectional study was implemented among residents from 6 French medical faculties. Independent education in pharmacology, attitudes towards the practices of pharmaceutical sales representatives, opinions concerning the pharmaceutical industry, quality of information provided by the pharmaceutical industry, and opinions about pharmaceutical company sponsorship were investigated through a web-based questionnaire. We also assessed potential changes in resident attitudes following the Mediator affair. The mean value of exposure to drug companies was 1.9 times per month. Global opinions towards drug company information were negative for 42.7% of the residents and positive for only 8.2%. Surprisingly, 81.6% of residents claimed that they had not changed their practices regarding drug information since the Mediator affair. Multivariate analyses found that residents in anesthesiology were less likely to be exposed than others (OR = 0.17 CI95% [0.05–0.61]), exposure was significantly higher at the beginning of residence (p<0.001) and residents who had a more positive opinion were more frequently exposed to drug companies (OR = 2.12 CI95% [1.07–4.22]).

Conclusions

Resident exposure to drug companies is around 1 contact every 2 weeks. Global opinion towards drug information provided by pharmaceutical companies was negative for around 1 out of 2 residents. In contrast, residents tend to consider the influences of the Mediator affair on their practice as relatively low. This survey enabled us to identify profiles of residents who are obviously less exposed to pharmaceutical industry. Current regulatory provisions are not sufficient, indicating that further efforts are necessary to develop a culture of disclosure of conflict of interest and of transparency in residents.     

Efficacy of Admission Screening for Extended-Spectrum Beta-Lactamase Producing Enterobacteriaceae

Objective

We hypothesized that admission screening for extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) reduces the incidence of hospital-acquired ESBL-E clinical isolates.

Design

Retrospective cohort study.

Setting

12 hospitals (6 screening and 6 non-screening) in Toronto, Canada.

Patients

All adult inpatients with an ESBL-E positive culture collected from 2005–2009.

Methods

Cases were defined as hospital-onset (HO) or community-onset (CO) if cultures were positive after or before 72 hours. Efficacy of screening in reducing HO-ESBL-E incidence was assessed with a negative binomial model adjusting for study year and CO-ESBL-E incidence. The accuracy of the HO-ESBL-E definition was assessed by re-classifying HO-ESBL-E cases as confirmed nosocomial (negative admission screen), probable nosocomial (no admission screen) or not nosocomial (positive admission screen) using data from the screening hospitals.

Results

There were 2,088 ESBL-E positive patients and incidence of ESBL-E rose from 0.11 to 0.42 per 1,000 inpatient days between 2005 and 2009. CO-ESBL-E incidence was similar at screening and non-screening hospitals but screening hospitals had a lower incidence of HO-ESBL-E in all years. In the negative binomial model, screening was associated with a 49.1% reduction in HO-ESBL-E (p<0.001). A similar reduction was seen in the incidence of HO-ESBL-E bacteremia. When HO-ESBL-E cases were re-classified based on their admission screen result, 46.5% were positive on admission, 32.5% were confirmed as nosocomial and 21.0% were probable nosocomial cases.

Conclusions

Admission screening for ESBL-E is associated with a reduced incidence of HO-ESBL-E. Controlled, prospective studies of admission screening for ESBL-E should be a priority.     

Impact of a New Reimbursement Program on Hepatitis B Antiviral Medication Cost and Utilization in Beijing,China

Background

Hepatitis B virus (HBV) infection is a significant clinical and financial burden for chronic hepatitis B (CHB) patients. In Beijing, China, partial reimbursement on antiviral agents was first implemented for the treatment of CHB patients in July 1, 2011.

Aims

In this study, we describe the medical cost and utilization rates of antiviral therapy for CHB patients to explore the impact of the new partial reimbursement policy on the medical care cost, the composition, and antivirals utilization.

Methods

Clinical and claims data of a retrospective cohort of 92,776 outpatients and 2,774 inpatients with non-cirrhotic CHB were retrieved and analyzed from You''an Hospital, Beijing between February 14, 2008 and December 31, 2012. The propensity score matching was used to adjust factors associated with the annual total cost, including age, gender, medical insurance type and treatment indicator.

Results

Compared to patients who paid out-of-pocket, medical cost, especially antiviral costs increased greater among patients with medical insurance after July 1, 2011, the start date of reimbursement policy. Outpatients with medical insurance had 16% more antiviral utilization; usage increased 3% among those who paid out-of-pocket after the new partial reimbursement policy was implemented.

Conclusions

Direct medical costs and antiviral utilization rates of CHB patients with medical insurance were higher than those from paid out-of-pocket payments, even after adjusting for inflation and other factors. Thus, a new partial reimbursement program may positively optimize the cost and standardization of antiviral treatment.     

Quality of pharmaceutical industry press releases based on original research

Background

Press releases are a popular vehicle to disseminate health information to the lay media. While the quality of press releases issued by scientific conferences and medical journals has been questioned, no efforts to assess pharmaceutical industry press releases have been made. Therefore, we sought to systematically examine pharmaceutical company press releases about original research for measures of quality.

Methodolgy/Principal Findings

Press releases issued by the ten top selling, international pharmaceutical companies in the year 2005 were selected for evaluation. A total of 1028 electronic press releases were issued and 235 were based on original research. More than half (59%) reported results presented at a scientific meeting. Twenty-one percent of releases were not explicit about the source of original data. While harms or adverse events were commonly cited (76%), study limitations were rarely noted (6%). Almost one-third (29%) of releases did not quantify study results. Studies presented in abstract form were subsequently published within at least 20 months in 53% of cases.

Conclusions

Pharmaceutical company press releases frequently report basic study details. However, readers should be cautioned by the preliminary nature of the data and lack of identified limitations. Methods to improve the reporting and interpretation of drug company press releases are desirable to prevent misleading media coverage.     

Control of (Multi)Drug Resistance and Tuberculosis Incidence over 23 Years in the Context of a Well-Supported Tuberculosis Programme in Rural Malawi

Background

The rise in tuberculosis (TB) incidence following generalized HIV epidemics can overwhelm TB control programmes in resource-limited settings, sometimes accompanied by rising rates of drug resistance. This has led to claims that DOTS-based TB control has failed in such settings. However, few studies have described the effect of a sustained and well-supported DOTS programme on TB incidence and drug resistance over a long period. We present long-term trends in incidence and drug resistance in rural Malawi.

Methods

Karonga District in northern Malawi has an adult HIV prevalence of ∼10%. A research group, the Karonga Prevention Study, collaborates with the National Tuberculosis Programme to support core TB control activities. Bacteriological, demographic and clinical (including HIV status) information from all patients starting TB treatment in the District have been recorded since 1988. During that period isolates from each culture-positive TB patient were exported for drug sensitivity testing. Antiretroviral therapy (ART) has been widely available since 2005.

Results

Incidence of new smear-positive adult TB peaked at 124/100,000/year in the mid-90s, but has since fallen to 87/100,000/year. Drug sensitivity information was available for 95% (3132/3307) of all culture-positive cases. Initial resistance to isoniazid was around 6% with no evidence of an increase. Fewer than 1% of episodes involved a multi-drug resistant strain.

Discussion

In this setting with a generalised HIV epidemic and medium TB burden, a well-supported DOTS programme enhanced by routine culture and drug sensitivity testing may well have reduced TB incidence and maintained drug resistance at low levels.     

Findings from the Peutz-Jeghers Syndrome Registry of Uruguay

Background

Peutz-Jeghers syndrome (PJS) is characterized by intestinal polyposis, mucocutaneous pigmentation and an increased cancer risk, usually caused by mutations of the STK11 gene. This study collected epidemiological, clinical and genetic data from all Uruguayan PJS patients.

Methods

Clinical data were obtained from public and private medical centers and updated annually. Sequencing of the STK11 gene in one member of each family was performed.

Results and discussion

25 cases in 11 unrelated families were registered (15 males, 10 females). The average age of diagnosis and death was 18 and 41 years respectively. All patients had characteristic PJS pigmentation and gastrointestinal polyps. 72% required urgent surgery due to intestinal obstruction. 3 families had multiple cases of seizure disorder, representing 20% of cases. 28% developed cancer and two patients had more than one cancer. An STK11 mutation was found in 8 of the 9 families analyzed. A unique M136K missense mutation was noted in one family. Comparing annual live births and PJS birth records from 1970 to 2009 yielded an incidence of 1 in 155,000.

Conclusion

The Uruguayan Registry for Peutz-Jeghers patients showed a high chance of emergent surgery, epilepsy, cancer and shortened life expectancy. The M136K missense mutation is a newly reported STK 11 mutation.     

The availability of references and the sponsorship of original research cited in pharmaceutical advertisements

Background

The primary goal of pharmaceutical advertisements is to convince physicians to prescribe the manufacturer''s product. We sought to determine what materials are cited in support of claims in pharmaceutical ads and medical research articles, and whether health care professionals seeking to verify the claims could obtain these references.

Methods

We reviewed 438 unique ads from the 1999 issues of 10 American medical journals, and a random sample of 400 references in medical research articles selected from the same journals. We classified references as journal article, data on file, meeting abstract or presentation, book or monograph, marketing report, prescribing information, government document or Internet site. We attempted to confirm or obtain each reference through library and Internet searches or by direct request from the manufacturer. The main outcome we sought to determine was the availability of the reference to a clinician. We also ascertained the source of funding for original research cited in the ads and the research articles.

Results

In the 438 ads with medical claims, 126 contained no references and 312 contained 721 unique references. Of these ad references, 55% (396/721) cited journal articles and 19% (135/721) cited data on file. In contrast, in the sample of research article references, 88% (351/400) cited journal articles and 8% (33/400) cited books. Overall, 84% of the citations from the ads were available: 98% of journal articles, 86% of books, 71% of meeting abstracts or presentations and 20% of data-on-file references. In all, 99% of the sample of research article references were available. We determined that 58% of the original research cited in the pharmaceutical ads was sponsored by or had an author affiliated with the product''s manufacturer, as compared with 8% of the articles cited in the research articles.

Interpretation

Many pharmaceutical ads contain no references for medical claims. Although references to journal articles were usually obtainable, other published sources were not as easily acquired. The majority of unpublished data-on-file references were not available, and the majority of original research cited to substantiate claims in the pharmaceutical ads was funded by or had authors affiliated with the product''s manufacturer.The primary goal of pharmaceutical advertisements is to convince clinicians to prescribe their product. These ads often cite external documents in support of their claims, but studies have shown that these claims may be misleading, distort the reporting of scientific data or fail to provide enough information to accurately interpret the data they present.^1,2,3,4,5,6 The transparency of pharmaceutical ads is important for 2 reasons. First, there is evidence that physician prescribing is influenced by pharmaceutical ads.^7,8,9 Second, the pharmaceutical industry views ads as one way in which they can educate physicians.^10,11 Given the potential for misrepresentation, health care professionals should be able to examine the cited references to determine whether the manufacturer''s claims are justified.In 2002, pharmaceutical companies submitted over 34 000 ads to the US Federal Drug Administration (FDA) (Thomas Abrams, Director, Division of Drug Marketing, Advertising, and Communications of the FDA, Rockville, Md.: personal communication, 2003). Most ads made several claims about the drug''s efficacy or effectiveness. The sheer volume makes it difficult for the FDA to adequately check the validity of many of the ads.¹² The absence of tight government oversight makes it particularly important that individual clinicians and groups (e.g., hospital pharmacy and therapeutics committees) can obtain cited documents to determine whether a claim is adequately substantiated. We performed this study to describe the kinds of documents cited in support of claims made in pharmaceutical ads, and to assess the availability of these documents to health care practitioners. We also examined whether original research cited by the pharmaceutical ads was sponsored or performed by the product''s manufacturer. To provide a standard for comparison, we repeated these investigations for randomly selected references in research articles published in the same journals in which we studied the ads.     

Concordance between Patient Self-Reports and Claims Data on Clinical Diagnoses,Medication Use,and Health System Utilization in Taiwan

Purpose

The aim of this study was to evaluate the concordance between claims records in the National Health Insurance Research Database and patient self-reports on clinical diagnoses, medication use, and health system utilization.

Methods

In this study, we used the data of 15,574 participants collected from the 2005 Taiwan National Health Interview Survey. We assessed positive agreement, negative agreement, and Cohen''s kappa statistics to examine the concordance between claims records and patient self-reports.

Results

Kappa values were 0.43, 0.64, and 0.61 for clinical diagnoses, medication use, and health system utilization, respectively. Using a strict algorithm to identify the clinical diagnoses recorded in claims records could improve the negative agreement; however, the effect on positive agreement and kappa was diverse across various conditions.

Conclusion

We found that the overall concordance between claims records in the National Health Insurance Research Database and patient self-reports in the Taiwan National Health Interview Survey was moderate for clinical diagnosis and substantial for both medication use and health system utilization.     

Clinical,Ethical and Financial Implications of Incidental Imaging Findings: Experience from a Phase I Trial in Healthy Elderly Volunteers

Background

The detection of incidental findings (IF) in magnetic resonance imaging (MRI) studies is common and increases as a function of age. Responsible handling of IF is required, with implications for the conduct of research and the provision of good clinical care.

Aim

To investigate the prevalence and clinical significance of IF in a prospective cohort of healthy elderly volunteers who underwent MRI of the torso as a baseline investigation for a phase I trial. We assessed the follow-up pathway with consequent cost implications and impact on trial outcomes.

Methods

A total of 29 elderly healthy volunteers (mean age 67, range 61–77, 59% female) were eligible at screening and underwent MRI for assessment of visceral and subcutaneous fat.

Results

IF were detected in 19 subjects (66%). Suspected IF of high and low clinical significance were found in 14% and 52% of participants, respectively. Follow up of IF was conducted in 18 individuals, confirming abnormalities in 13 subjects, 3 of whom were recommended for deferred clinical re-evaluation. The remaining 5 subjects had false positive IF based on second line imaging tests. Costs of follow-up medical care were considerable.

Conclusion

MRI abnormalities are common in elderly individuals, as a result of age and non-diagnostic quality of research scans. In the presence of IF in the context of clinical trials, immediate referrals and follow up assessments may be required to rule out suspected pathology prior to exposing trial participants to investigational medicine products (IMP). Unanticipated costs, ethical implication and the possible impact of IF on trial outcomes need to be taken into account when designing and conducting trials with an IMP.     

Incidental Findings on Brain MR Imaging in Older Community-Dwelling Subjects Are Common but Serious Medical Consequences Are Rare: A Cohort Study

Objectives

Incidental findings in neuroimaging occur in 3% of volunteers. Most data come from young subjects. Data on their occurrence in older subjects and their medical, lifestyle and financial consequences are lacking. We determined the prevalence and medical consequences of incidental findings found in community-dwelling older subjects on brain magnetic resonance imaging.

Design

Prospective cohort observational study.

Setting

Single centre study with input from secondary care.

Participants

Lothian Birth Cohort 1936, a study of cognitive ageing.

Main Outcome Measures

Incidental findings identified by two consultant neuroradiologists on structural brain magnetic resonance imaging at age 73 years; resulting medical referrals and interventions.

Primary and Secondary Outcome Measures

Prevalence of incidental findings by individual categories: neoplasms, cysts, vascular lesions, developmental, ear, nose or throat anomalies, by intra- and extracranial location; visual rating of white matter hyperintensities and brain atrophy.

Results

There were 281 incidental findings in 223 (32%) of 700 subjects, including 14 intra- or extracranial neoplasms (2%), 15 intracranial vascular anomalies (2%), and 137 infarcts or haemorrhages (20%). Additionally, 153 had moderate/severe deep white matter hyperintensities (22%) and 176 had cerebral atrophy at, or above, the upper limit of normal (25%) compared with a normative population template. The incidental findings were unrelated to white matter hyperintensities or atrophy; about a third of subjects had both incidental findings and moderate or severe WMH and a quarter had incidental findings and atrophy. The incidental findings resulted in one urgent and nine non-urgent referrals for further medical assessment, but ultimately in no new treatments.

Conclusions

In community-dwelling older subjects, incidental findings, including white matter hyperintensities and atrophy, were common. However, many findings were not of medical importance and, in this age group, most did not result in further assessment and none in change of treatment.     

Antibiotic Prescribing in DR Congo: A Knowledge,Attitude and Practice Survey among Medical Doctors and Students

Objectives

Antibiotic resistance (ABR) particularly hits resource poor countries, and is fuelled by irrational antibiotic (AB) prescribing. We surveyed knowledge, attitudes and practices of AB prescribing among medical students and doctors in Kisangani, DR Congo.

Methods

Self-administered questionnaires.

Results

A total of 184 questionnaires were completed (response rate 94.4%). Knowledge about AB was low (mean score 4.9/8 points), as was the estimation of local resistance rates of S. Typhi and Klebsiella spp.(correct by 42.5% and 6.9% of respondents respectively). ABR was recognized as a problem though less in their own practice (67.4%) than nation- or worldwide (92.9% and 85.5%, p<.0001). Confidence in AB prescribing was high (88.6%) and students consulted more frequently colleagues than medical doctors when prescribing (25.4% versus 11.6%, p  = 0.19). Sources of AB prescribing included pharmaceutical companies (73.9%), antibiotic guidelines (66.3%), university courses (63.6%), internet-sites (45.7%) and WHO guidelines (26.6%). Only 30.4% and 16.3% respondents perceived AB procured through the central procurement and local pharmacies as of good quality. Local AB guidelines and courses about AB prescribing are welcomed (73.4% and 98.8% respectively).

Conclusions

This data shows the need for interventions that support rational AB prescribing.     

Recruitment for Occupational Research: Using Injured Workers as the Point of Entry into Workplaces

Objective

To investigate the feasibility, costs and sample representativeness of a recruitment method that used workers with back injuries as the point of entry into diverse working environments.

Methods

Workers'' compensation claims were used to randomly sample workers from five heavy industries and to recruit their employers for ergonomic assessments of the injured worker and up to 2 co-workers.

Results

The final study sample included 54 workers from the workers’ compensation registry and 72 co-workers. This sample of 126 workers was based on an initial random sample of 822 workers with a compensation claim, or a ratio of 1 recruited worker to approximately 7 sampled workers. The average recruitment cost was CND$262/injured worker and CND$240/participating worksite including co-workers. The sample was representative of the heavy industry workforce, and was successful in recruiting the self-employed (8.2%), workers from small employers (<20 workers, 38.7%), and workers from diverse working environments (49 worksites, 29 worksite types, and 51 occupations).

Conclusions

The recruitment rate was low but the cost per participant reasonable and the sample representative of workers in small worksites. Small worksites represent a significant portion of the workforce but are typically underrepresented in occupational research despite having distinct working conditions, exposures and health risks worthy of investigation.     

Varicella Vaccination Alters the Chronological Trends of Herpes Zoster and Varicella

Background

Population studies on trends of varicella and herpes zoster (HZ) associated with varicella zoster vaccination and climate is limited.

Methods

This study used insurance claims data to investigate the chronological changes in incident varicella and HZ associated with varicella zoster vaccination. Poisson regression was used to estimate the occurrence of varicella associated with the occurrence of HZ and vice versa by year, season, sex, temperature, and sunny hours.

Results

The varicella incidence declined from 7.14 to 0.76 per 1,000 person-years in 2000–2009, whereas the HZ incidence increased from 4.04 to 6.24 per 1,000 person-years. Females tended to have a higher risk than men for HZ (p<0.0001) but not varicella. The monthly mean varicella incidence was the lowest in September (160 cases) and the highest in January (425 cases), while the mean HZ incidence was lower in February (370 cases) and higher in August (470 cases). HZ was negatively associated with the incidence of varicella before and after the varicella zoster vaccination (p<0.001), increased 1.6% within one week post-vaccination. The effect of temperature on HZ was attenuated by 18.5% (p<0.0001) in association with vaccination. The varicella risk was positively associated with sun exposure hours, but negatively associated with temperature only before vaccination.

Conclusions

The varicella vaccination is effective in varicella prevention, but the incidence of HZ increases after vaccination. HZ has a stronger association with temperature and UV than with seasonality while varicella risk associated with temperature and UV is diminished.     

Five Year Nationwide Incidence of Rhegmatogenous Retinal Detachment Requiring Surgery in Korea

Purpose

To define the incidence and demographic characteristics of rhegmatogenous retinal detachment (RRD) requiring surgery in Korea.

Design

Nationwide population-based retrospective study.

Methods

Patients who underwent surgery for RRD from 2007 to 2011 were retrospectively identified using the diagnostic code for RRD and the surgical codes for retinal detachment surgeries in the national claim database. The average incidence rate of RRD during the 5-year period was estimated using the population data of the 2010 Census in Korea.

Results

A total of 24,928 surgically treated RRD cases were identified. The average incidence of surgery requiring RRD was 10.39 cases per 100,000 person-years [95% confidence interval (CI), 10.26–10.52). The incidence in men (11.32 cases per 100,000 person-years; 95% CI: 11.13–11.51) was significantly higher than that in women (9.47 cases per 100,000 person-years; 95% CI: 9.29–9.64) (p<0.001). The incidence of surgery requiring RRD showed a bimodal distribution across age groups, with one peak (28.55 cases per 100,000 person-years; 95% CI: 27.46–29.67) representing patients between 65 and 69 years of age and the second peak (approximately 8.5 per 100,000 person-years) representing patients between 20 and 29 years of age. The male-to-female ratio was approximately 1.0 for the peak-incidence age groups, whereas the ratio was higher for the other age groups.

Conclusions

The incidence of RRD in the Korean population was similar to that reported previously, with the peak incidence being lower than that in the Caucasian population. The age-specific RRD incidence pattern in Korea followed a bimodal distribution.     

Quality of Pharmaceutical Care in Surgical Patients

Background

Surgical patients are at risk for preventable adverse drug events (ADEs) during hospitalization. Usually, preventable ADEs are measured as an outcome parameter of quality of pharmaceutical care. However, process measures such as QIs are more efficient to assess the quality of care and provide more information about potential quality improvements.

Objective

To assess the quality of pharmaceutical care of medication-related processes in surgical wards with quality indicators, in order to detect targets for quality improvements.

Methods

For this observational cohort study, quality indicators were composed, validated, tested, and applied on a surgical cohort. Three surgical wards of an academic hospital in the Netherlands (Academic Medical Centre, Amsterdam) participated. Consecutive elective surgical patients with a hospital stay longer than 48 hours were included from April until June 2009. To assess the quality of pharmaceutical care, the set of quality indicators was applied to 252 medical records of surgical patients.

Results

Thirty-four quality indicators were composed and tested on acceptability and content- and face-validity. The selected 28 candidate quality indicators were tested for feasibility and ‘sensitivity to change’. This resulted in a final set of 27 quality indicators, of which inter-rater agreements were calculated (kappa 0.92 for eligibility, 0.74 for pass-rate). The quality of pharmaceutical care was assessed in 252 surgical patients. Nearly half of the surgical patients passed the quality indicators for pharmaceutical care (overall pass rate 49.8%). Improvements should be predominantly targeted to medication care related processes in surgical patients with gastro-intestinal problems (domain pass rate 29.4%).

Conclusions

This quality indicator set can be used to measure quality of pharmaceutical care and detect targets for quality improvements. With these results medication safety in surgical patients can be enhanced.     

Surveillance of Candida spp Bloodstream Infections: Epidemiological Trends and Risk Factors of Death in Two Mexican Tertiary Care Hospitals

Introduction

Larger populations at risk, broader use of antibiotics and longer hospital stays have impacted on the incidence of Candida sp. bloodstream infections (CBSI).

Objective

To determine clinical and epidemiologic characteristics of patients with CBSI in two tertiary care reference medical institutions in Mexico City.

Design

Prospective and observational laboratory-based surveillance study conducted from 07/2008 to 06/2010.

Methods

All patients with CBSI were included. Identification and antifungal susceptibility were performed using CLSI M27-A3 standard procedures. Frequencies, Mann-Whitney U test or T test were used as needed. Risk factors were determined with multivariable analysis and binary logistic regression analysis.

Results

CBSI represented 3.8% of nosocomial bloodstream infections. Cumulative incidence was 2.8 per 1000 discharges (incidence rate: 0.38 per 1000 patient-days). C. albicans was the predominant species (46%), followed by C. tropicalis (26%). C. glabrata was isolated from patients with diabetes (50%), and elderly patients. Sixty-four patients (86%) received antifungals. Amphotericin-B deoxycholate (AmBD) was the most commonly used agent (66%). Overall mortality rate reached 46%, and risk factors for death were APACHE II score ≥16 (OR = 6.94, CI_95% = 2.34–20.58, p<0.0001), and liver disease (OR = 186.11, CI_95% = 7.61–4550.20, p = 0.001). Full susceptibility to fluconazole, AmBD and echinocandins among C. albicans, C. tropicalis, and C. parapsilosis was observed.

Conclusions

The cumulative incidence rate in these centers was higher than other reports from tertiary care hospitals from Latin America. Knowledge of local epidemiologic patterns permits the design of more specific strategies for prevention and preemptive therapy of CBSI.     

Consent for use of clinical leftover biosample: a survey among Chinese patients and the general public

Background

Storage of leftover biosamples generates rich biobanks for future studies, saving time and money and limiting physical impact to sample donors.

Objective

To investigate the attitudes of Chinese patients and the general public on providing consent for storage and use of leftover biosamples.

Design, Setting and Participants

Cross-sectional surveys were conducted among randomly selected patients admitted to a Shanghai city hospital (n = 648) and members of the general public (n = 492) from May 2010 to July 2010.

Main Outcome Measures

Face-to-face interviews collected respondents-report of their willingness to donate residual biosample, trust in medical institutions, motivation for donation, concerns of donated sample use, expectations for research results return, and so on.

Results

The response rate was 83.0%. Of the respondents, 89.1% stated that they completely understood or understood most of questions. Willingness to donate residual sample was stated by 64.7%, of which 16.7% desired the option to withdraw their donations anytime afterwards. Only 42.3% of respondents stated they “trust" or “strongly trust" medical institutions, the attitude of trusting or strongly trusting medical institutions were significantly associated with willingness to donate in the general public group.(p<0.05) The overall assent rate for future research without specific consents was also low (12.1%). Hepatitis B virus carriers were significantly less willing than non-carriers to donate biosamples (32.1% vs. 64.7%, p<0.001).

Conclusions

Low levels of public trust in medical institutions become serious obstacle for biosample donation and biobanking in China. Efforts to increase public understanding of human medical research and biosample usage and trust in the ethical purposes of biobanking are urgently needed. These efforts will be greatly advanced by the impending legislation on biobanking procedures and intent, and our results may help guide the structure of such law.