Parkinson's disease (PD) is the second most common neurodegenerative disorder in developed countries. There is an increasing interest in the use of mindfulness-related interventions in the management of patients with a chronic disease. In addition, interventions that promote personal control, stress-management and other lifestyle factors, such as diet and exercise, assist in reducing disability and improving quality of life in people with chronic illnesses. There has been little research in this area for people with PD.
A prospective mixed-method randomised clinical trial involving community living adults with PD aged <76 years and with moderate disease severity (Hoehn and Yahr stage 2) PD. Participants will be randomised into the ESSENCE 6-week programme or a matched wait list control group. ESSENCE is a multifaceted, healthy lifestyle and mindfulness programme designed to improve quality of life. We aim to determine whether participation in a mindfulness and lifestyle programme could improve PD-related function and explore self-management related experiences and changing attitudes towards self-management. The outcome measures will include 5 self-administered questionnaires: PD function and well-being questionnaire (PDQ39), Health Behaviours, Mental health, Multidimensional locus of control, and Freiburg mindfulness inventory. An embedded qualitative protocol will include in-depth interviews with 12 participants before and after participation in the 6-week programme and a researcher will observe the programme and take notes.
Repeated measures of Analysis of Variance (ANOVA) will examine the outcome measures for any significant effects from the group allocation, age, sex, adherence score and attendance. Qualitative data will be analysed thematically. We will outline the benefits of, and barriers to, the uptake of the intervention.
This protocol has received ethics approval from the Monash University Human Research Ethics Committee project number CF11/2662–2011001553.
This is the first research of its kind in Australia involving a comprehensive, lifestyle-based programme for people with PD and has the potential to involve a broader range of providers than standard care. The findings will be disseminated through peer reviewed journals, primary care conferences in Australia as well as abroad and through the Parkinson's community.
Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12612000440820.
PRIMARY CARE; COMPLEMENTARY MEDICINE
We examined the impact of functional limitations and functional decline during the first year following breast cancer diagnosis on the risk of mortality from breast cancer and other causes among African-American and white women, respectively.
The Health and Functioning in Women (HFW) cohort study.
Detroit, Michigan, USA.
A total of 162 African-American and 813 white women aged 40–84 years with newly diagnosed breast cancer identified through the Metropolitan Detroit Cancer Surveillance System over a 7-month period between 1984 and 1985 and followed for up to 28 years (median 11 years).
Risk of mortality from breast cancer and other causes.
Statistically significant increases in the risk of other-cause mortality were found for each unit increase in the number of self-reported functional limitations (HR=1.08, 95% CI 1.03 to 1.14), 0 vs ≥1 functional limitations (HR=1.47, 95% CI 1.13 to 1.91), difficulty in pushing or pulling large objects (HR=1.34, 95% CI 1.04 to 1.73), writing or handling small objects (HR=1.56, 95% CI 1.00 to 2.44), and walking half a mile (HR=1.60, 95% CI 1.19 to 2.14). Functional limitations and functional decline did not explain racial disparities in the survival of this cohort. Functional decline was associated with increased risk of other-cause mortality in women with regional and remote disease but not in women with localised disease. Whereas measures of functional limitation were not associated with breast cancer-specific mortality, each unit of functional decline (HR=1.17, 95% CI 1.05 to 1.31) and decline in the ability to sit ≥1 h (HR=2.06, 95% CI 1.13 to 3.76) were associated with increased risk of breast cancer-specific mortality. Measures of functional decline were associated with increased risk of breast cancer mortality in overweight and obese women, but not in women of normal weight.
Whereas functional limitations were associated with increased risk of other-cause mortality, functional decline was associated with increased risk of breast cancer mortality.
Mortality; Survival; Functional limitations; Functional decline
To determine prevalence of adverse drug events (ADEs) in patients aged 45 years or older presenting to Australian general practitioners (GPs) and identify drug groups related to ADEs, their severity and manifestation.
Substudy of the Bettering the Evaluation and Care of Health continuous survey of Australian GP clinical activity in which randomly selected GPs collected survey data from patients. Data are reported with 95% CIs.
General practice in Australia.
Main outcome measures
Prevalence in the preceding 6 months, type, implicated drugs, severity (including hospitalisation) and manifestation of ADEs.
From three survey samples, January–October 2007, and two samples, January–March 2010, responses were received from 482 GPs about 7561 patients aged 45 years or older.
Of a final sample of 7518 patients (after duplicate patients removed), 871 (11.6%) reported ADEs in the previous 6 months. The type of ADE was recognised side effect (75.8%, 95% CI 72.0 to 79.7), drug sensitivity (9.9%, 95% CI 7.2 to 12.7) and drug allergy (7.4%, 95% CI 4.7 to 10.1). Drug interaction (1.0%, 95% CI 0.1 to 1.8), overdose (0.8%, 95% CI 0.0 to 1.5) and contraindications (0.2%, 95% CI 0.0 to 0.6) were very infrequent. A severity rating was provided for 846 patients. Almost half (45.9%, 95% CI 42.0 to 49.7) were rated as ‘mild’ events, 42.2% (95% CI 38.8 to 45.6) ‘moderate’, 11.8% (95% CI 9.5 to 14.1) severe and 5.4% (95% CI 3.8 to 7.0) had been hospitalised as a result of the most recent ADE. Thirteen commonly prescribed drug groups accounted for 58% of all ADEs, opioids being the group most often implicated.
ADEs in patients aged 45 or older are frequent and are associated with significant morbidity. Most of ADEs result from commonly prescribed drugs at therapeutic dosage. The list of causative agents bears little relationship to published lists of ‘inappropriate medications’.
CLINICAL PHARMACOLOGY; EPIDEMIOLOGY; PRIMARY CARE
To assess if the Agency for Healthcare Research and Quality patient safety indictors (PSIs) could be used for case findings in the International Classification of Disease 10th revision (ICD-10) hospital discharge abstract data.
We identified and randomly selected 490 patients with a foreign body left during a procedure (PSI 5—foreign body), selected infections (IV site) due to medical care (PSI 7—infection), postoperative pulmonary embolism (PE) or deep vein thrombosis (DVT; PSI 12—PE/DVT), postoperative sepsis (PSI 13—sepsis)and accidental puncture or laceration (PSI 15—laceration) among patients discharged from three adult acute care hospitals in Calgary, Canada in 2007 and 2008. Their charts were reviewed for determining the presence of PSIs and used as the reference standard, positive predictive value (PPV) statistics were calculated to determine the proportion of positives in the administrative data representing ‘true positives’.
The PPV for PSI 5—foreign body was 62.5% (95% CI 35.4% to 84.8%), PSI 7—infection was 79.1% (67.4% to 88.1%), PSI 12—PE/DVT was 89.5% (66.9% to 98.7%), PSI 13—sepsis was 12.5% (1.6% to 38.4%) and PSI 15—laceration was 86.4% (75.0% to 94.0%) after excluding those who presented to the hospital with the condition.
Several PSIs had high PPV in the ICD administrative data and are thus powerful tools for true positive case finding. The tools could be used to identify potential cases from the large volume of admissions for verification through chart reviews. In contrast, their sensitivity has not been well characterised and users of PSIs should be cautious if using them for ‘quality of care reporting’ presenting the rate of PSIs because under-coded data would generate falsely low PSI rates.
To develop a classifier to predict the presence of visual field (VF) deterioration in glaucoma suspects based on optical coherence tomography (OCT) measurements using the machine learning method known as the ‘Random Forest’ algorithm.
293 eyes of 179 participants with open angle glaucoma (OAG) or suspected OAG.
Spectral domain OCT (Topcon 3D OCT-2000) and perimetry (Humphrey Field Analyser, 24-2 or 30-2 SITA standard) measurements were conducted in all of the participants. VF damage (Ocular Hypertension Treatment Study criteria (2002)) was used as a ‘gold-standard’ to classify glaucomatous eyes. The ‘Random Forest’ method was then used to analyse the relationship between the presence/absence of glaucomatous VF damage and the following variables: age, gender, right or left eye, axial length plus 237 different OCT measurements.
Main outcome measures
The area under the receiver operating characteristic curve (AROC) was then derived using the probability of glaucoma as suggested by the proportion of votes in the Random Forest classifier. For comparison, five AROCs were derived based on: (1) macular retinal nerve fibre layer (m-RNFL) alone; (2) circumpapillary (cp-RNFL) alone; (3) ganglion cell layer and inner plexiform layer (GCL+IPL) alone; (4) rim area alone and (5) a decision tree method using the same variables as the Random Forest algorithm.
The AROC from the combined Random Forest classifier (0.90) was significantly larger than the AROCs based on individual measurements of m-RNFL (0.86), cp-RNFL (0.77), GCL+IPL (0.80), rim area (0.78) and the decision tree method (0.75; p<0.05).
Evaluating OCT measurements using the Random Forest method provides an accurate prediction of the presence of perimetric deterioration in glaucoma suspects.
Optical Coherence Tomography; Visual Field; Random Forest
This study investigated and quantified risk factors of dose escalation, as an indication of drug misuse and dependency of benzodiazepines and congeners, among presumably drug naïve patients in the Norwegian drug prescription database, observed over 3 years.
Prescription database study.
We defined an excessive user as one redeeming more than two defined daily doses per day in 3 months.
Primary and secondary outcome measures
We examined the risk of excessive use over time and the effect of risk factors through multistate logistic regression and scenarios.
Most of the 81 945 patients had zopiclone or zolpidem as the initial drug (63.8%), followed by diazepam (25.3%), oxazepam (6.1%), nitrazepam/flunitrazepam (2.9%), hydroxyzine/buspirone (1.6%) and alprazolam (0.3%). At any time 23% redeemed prescriptions, about 34% did not redeem any prescriptions beyond any 3-month period and 0.9% ended up as excessive users. Patients previously using drugs, such as opioids, antialcohol or smoke cessation treatment, had a higher risk to become excessive users compared to patients who had not. Patients whose first prescription was for oxazepam or nitrazepam/flunitrazepam had a higher risk of becoming an excessive user compared to those who started with diazepam. A specialist in general practice as the first-time prescriber was associated with a lower risk compared to doctors without specialty.
Most benzodiazepine use occurred according to guidelines. Still, some experienced dose escalation over time, and risk factors were previous use of other psychotropic drugs, long time use, choice of first-time drug and prescriber's specialty. This could incite doctors to have a cessation plan when issuing first-time prescriptions.
PUBLIC HEALTH; Substance misuse < PSYCHIATRY
We assessed the situation of academic publications on access to and use of medicines (ATM) in low-income and middle-income countries (LMICs) of the Eastern Mediterranean Region (EMR). We aimed to inform priority setting for research on ATM in the region.
Bibliographic review of published studies.
LMICs in EMR.
Publications on ATM issues originating from or focusing on EMR LMICs covering the period 2000–2011. Publications involving multinational studies were included if at least one eligible country had been included in the study.
Information sources and data extraction
We conducted comprehensive searches of the PubMed, Social Science Citation Index and Science Citation Index. We used the WHO ATM framework for data extraction and synthesis. We analysed the data according to the ATM issues, health system levels, year of publication and the countries of origin or focus of the studies.
151 articles met the inclusion criteria. Most articles (77%) originated from LMICs in EMR, suggesting that the majority of evidence on ATM in the region is home-grown. Over 60% of articles were from Iran, Pakistan, Jordan and Lebanon (in order of volume), while we found no studies assessing ATM in Somalia, Djibouti and South Sudan, all low-income countries. Most studies focused on the rational use of medicines, while affordability and financing received limited attention. There was a steady growth over time in the number of ATM publications in the region (r=0.87).
There is a growing trend, over the years, of more studies from the region appearing in international journals. There is a need for further research on the financing and affordability aspects of ATM in the region. Cross-border issues and the roles of non-health sectors in access to medicines in the region have not been explored widely.
PUBLIC HEALTH; HEALTH SERVICES ADMINISTRATION & MANAGEMENT; EPIDEMIOLOGY
Asthmatics have increased risks of airway-related infections. Little is known about whether this is true for non-airway-related serious infections such as Escherichia coli bloodstream infection (BSI). We assessed whether asthma is associated with a risk of developing community-acquired E coli BSI.
The study was designed as a population-based retrospective case–control study.
This population-based study was conducted in Olmsted County, Minnesota.
The study included 259 all eligible community-acquired E coli BSI cases in Olmsted County, MN between 1998 and 2007 and 259 birthday-matched, gender-matched and residency-matched controls.
Primary and secondary outcome measures
Only community-acquired E coli BSI cases as the primary outcome was included. Asthma status as an exposure was ascertained by predetermined criteria. An adjusted OR and 95% CI for the association between asthma and risk of community-acquired E coli BSI was calculated using conditional logistic regression.
Of 259 eligible cases, 179 (69%) were women and mean age was 61±22 years. Of the 259 cases 37 (14%) and 16 (6%) of 259 controls had a prior history of asthma (adjusted OR 2.74; 95% CI 1.11 to 6.76; p=0.029). The population attributable risk of asthma for community-acquired E coli BSI was 9%. Although not statistically significant, there was a borderline association between having a history of food allergy and increased risk of community-acquired E coli BSI (6% vs 2%; adjusted OR 3.51; 95% CI 0.94 to 13.11; p=0.062).
Based on the findings of the current population-based, case–control investigation, a history of asthma may be associated with risk of community-acquired E coli BSI. The impact of asthma on risk of microbial infections may go beyond airways.
To compare the cost-effectiveness of PhysioDirect with usual physiotherapy care for patients with musculoskeletal problems.
(1) Cost-consequences comparing cost to the National Health Service (NHS), to patients, and the value of lost productivity with a range of outcomes. (2) Cost-utility analysis comparing cost to the NHS with Quality-Adjusted Life Years (QALYs).
Four physiotherapy services in England.
Adults (18+) referred by their general practitioner or self-referred for physiotherapy.
PhysioDirect involved telephone assessment and advice followed by face-to-face care if needed. Usual care patients were placed on a waiting list for face-to-face care.
Primary and secondary outcomes
Primary clinical outcome: physical component summary from the SF-36v2 at 6 months. Also included in the cost-consequences: Measure Yourself Medical Outcomes Profile; a Global Improvement Score; response to treatment; patient satisfaction; waiting time. Outcome for the cost-utility analysis: QALYs.
2249 patients took part (1506 PhysioDirect; 743 usual care). (1) Cost-consequences: there was no evidence of a difference between the two groups in the cost of physiotherapy, other NHS services, personal costs or value of time off work. Outcomes were also similar. (2) Cost-utility analysis based on complete cases (n=1272). Total NHS costs, including the cost of physiotherapy were higher in the PhysioDirect group by £19.30 (95% CI −£37.60 to £76.19) and there was a QALY gain of 0.007 (95% CI −0.003 to 0.016). The incremental cost-effectiveness ratio was £2889 and the net monetary benefit at λ=£20 000 was £117 (95% CI −£86 to £310).
PhysioDirect may be a cost-effective alternative to usual physiotherapy care, though only with careful management of staff time. Physiotherapists providing the service must be more fully occupied than was possible under trial conditions: consideration should be given to the scale of operation, opening times of the service and flexibility in the methods used to contact patients.
economic evaluation; physiotherapy; telehealth; PRIMARY CARE; costs & cost analysis
To examine cytomegalovirus (CMV) seroprevalence and associated risk factors for CMV seropositivity in pregnant Norwegian women.
The Norwegian Mother and Child Cohort Study (MoBa) in addition to two random samples of pregnant women from Sør-Trøndelag County in Norway.
Study group 1 were 1000 pregnant women, randomly selected among 46 127 pregnancies in the MoBa (1999–2006) at 17/18 week of gestation. Non-ethnic Norwegian women were excluded. Study groups 2 (n=1013 from 1995) and 3 (n=979 from 2009) were pregnant women at 12 weeks of gestation from Sør-Trøndelag County.
CMV seropositivity in blood samples from pregnant Norwegian women.
CMV-IgG antibodies were detected in 59.9% and CMV-IgM antibodies in 1.3% of pregnant Norwegian women in study group 1. Women from North Norway demonstrated a higher CMV-IgG seroprevalence (72.1%) than women from South Norway (58.5%) (OR 1.83, 95% CI 1.17 to 2.88). The CMV-IgG seroprevalence was higher among women with low education (70.5%) compared to women with higher education (OR 2.20, 95% CI 1.24 to 3.90). Between 1995 and 2009 the CMV-IgG seroprevalence increased from 63.1% to 71.4% in pregnant women from Sør-Trøndelag County (study groups 2 and 3; p<0.001). The highest CMV-IgG seroprevalence (79.0%) was observed among the youngest pregnant women (<25 years) from Sør-Trøndelag County in 2009 (study group 3).
The CMV-IgG seroprevalence of pregnant Norwegian women varies with geographic location and educational level. Additionally, the CMV-IgG seroprevalence appears to have increased over the last years, particularly among young pregnant women.
In clinical trials of dabigatran and rivaroxaban for stroke prevention in atrial fibrillation (AF), drug eligibility and dosing were determined using the Cockcroft-Gault equation to estimate creatine clearance as a measure of renal function. This cross-sectional study aimed to compare whether using estimated glomerular filtration rate (eGFR) by the widely available and widely used Modified Diet in Renal Disease (MDRD) equation would alter prescribing or dosing of the renally excreted new oral anticoagulants.
Of 4712 patients with known AF within a general practitioner-registered population of 930 079 in east London, data were available enabling renal function to be calculated by both Cockcroft-Gault and MDRD methods in 4120 (87.4%).
Of 4120 patients, 2706 were <80 years and 1414 were ≥80 years of age. Among those ≥80 years, 14.9% were ineligible for dabigatran according to Cockcroft-Gault equation but would have been judged eligible applying MDRD method. For those <80 years, 0.8% would have been incorrectly judged eligible for dabigatran and 5.3% would have received too high a dose. For rivaroxaban, 0.3% would have been incorrectly judged eligible for treatment and 13.5% would have received too high a dose.
Were the MDRD-derived eGFR to be used instead of Cockcroft-Gault in prescribing these new agents, many elderly patients with AF would either incorrectly become eligible for them or would receive too high a dose. Safety has not been established using the MDRD equation, a concern since the risk of major bleeding would be increased in patients with unsuspected renal impairment. Given the potentially widespread use of these agents, particularly in primary care, regulatory authorities and drug companies should alert UK doctors of the need to use the Cockcroft-Gault formula to calculate eligibility for and dosing of the new oral anticoagulants in elderly patients with AF and not rely on the MDRD-derived eGFR.
To determine the standard of reporting of harms-related data, in randomised controlled trials (RCTs) according to the Consolidated Standards of Reporting Trials (CONSORT) statement extension for harms.
The Cochrane library, Ovid MEDLINE, Scopus and ISI Web of Knowledge were searched for relevant literature.
Eligibility criteria for selecting studies
We included publications of studies that used the CONSORT harms extension to assess the reporting of harms in RCTs.
We identified 7 studies which included between 10 and 205 RCTs. The clinical areas of the 7 studies were: hypertension (1), urology (1), epilepsy (1), complimentary medicine (2) and two not restricted to a clinical topic. Quality of the 7 studies was assessed by a risk of bias tool and was found to be variable. Adherence to the CONSORT harms criteria reported in the 7 studies was inadequate and variable across the items in the checklist. Adverse events are poorly defined, with 6 studies failing to exceed 50% adherence to the items in the checklist.
Readers of RCT publications need to be able to balance the trade-offs between benefits and harms of interventions. This systematic review suggests that this is compromised due to poor reporting of harms which is evident across a range of clinical areas. Improvements in quality could be achieved by wider adoption of the CONSORT harms criteria by journals reporting RCTs.
General Medicine (see Internal Medicine); Clinical Trial Methodology; Biostatistics
To elucidate the experiences and perceptions of people living with primary frozen shoulder and their priorities for treatment.
Qualitative study design using semistructured interviews.
General practitioner (GP) and musculoskeletal clinics in primary and secondary care in one National Health Service Trust in England.
12 patients diagnosed with primary frozen shoulder were purposively recruited from a GP's surgery, community clinics and hospital clinics. Recruitment targeted the phases of frozen shoulder: pain predominant (n=5), stiffness predominant (n=4) and residual stiffness predominant following hospital treatment (n=2). One participant dropped out. Inclusion criteria: adult, male and female patients of any age, attending the clinics, who had been diagnosed with primary frozen shoulder.
The most important experiential themes identified by participants were: pain which was severe as well as inexplicable; inconvenience/disability arising from increasing restriction of movement (due to pain initially, gradually giving way to stiffness); confusion/anxiety associated with delay in diagnosis and uncertainty about the implications for the future; and treatment-related aspects. Participants not directly referred to a specialist (whether physiotherapist, physician or surgeon) wanted a faster, better-defined care pathway. Specialist consultation brought more definitive diagnosis, relief from anxiety and usually self-rated improvement. The main treatment priority was improved function, though there was recognition that this might be facilitated by relief of pain or stiffness. There was a general lack of information from clinicians about the condition with over-reliance on verbal communication and very little written information.
Awareness of frozen shoulder should be increased among non-specialists and the best available information made accessible for patients. Our results also highlight the importance of patient participation in frozen shoulder research.
To examine the relationship between blood pressure and depressive disorder in children and adolescents at high risk for depression.
Multisample longitudinal design including a prospective longitudinal three-wave high-risk study of offspring of parents with recurrent depression and an on-going birth cohort for replication.
High-risk sample includes 281 families where children were aged 9–17 years at baseline and 10–19 years at the final data point. Replication cohort includes 4830 families where children were aged 11–14 years at baseline and 14–17 years at follow-up and a high-risk subsample of 612 offspring with mothers that had reported recurrent depression.
Main outcome measures
The new-onset of Diagnostic and Statistical Manual of Mental Disorder, fourth edition defined depressive disorder in the offspring using established research diagnostic assessments—the Child and Adolescent Psychiatric Assessment in the high-risk sample and the Development and Wellbeing Assessment in the replication sample.
Blood pressure was standardised for age and gender to create SD scores and child's weight was statistically controlled in all analyses. In the high-risk sample, lower systolic blood pressure at wave 1 significantly predicted new-onset depressive disorder in children (OR=0.65, 95% CI 0.44 to 0.96; p=0.029) but diastolic blood pressure did not. Depressive disorder at wave 1 did not predict systolic blood pressure at wave 3. A significant association between lower systolic blood pressure and future depression was also found in the replication cohort in the second subset of high-risk children whose mothers had experienced recurrent depression in the past.
Lower systolic blood pressure predicts new-onset depressive disorder in the offspring of parents with depression. Further studies are needed to investigate how this association arises.
MENTAL HEALTH; EPIDEMIOLOGY
Psychosis, including hallucinations and delusions, is one of the important non-motor problems in patients with Parkinson's disease (PD) and is possibly associated with cholinergic neuronal degeneration. The EDAP (Efficacy of Donepezil against Psychosis in PD) study will evaluate the efficacy of donepezil, a brain acetylcholine esterase inhibitor, for prevention of psychosis in PD.
Methods and analysis
Psychosis is assessed every 4 weeks using the Parkinson Psychosis Questionnaire (PPQ) and patients with PD whose PPQ-B score (hallucinations) and PPQ-C score (delusions) have been zero for 8 weeks before enrolment are randomised to two arms: patients receiving donepezil hydrochloride or patients receiving placebo. The patients are then followed for 96 weeks. The primary outcome measure is the time to the event, defined as getting 2 points or more on the PPQ-B score or PPQ-C score, which is assessed using a survival time analysis. The hypothesis being tested is that donepezil prevents psychosis in patients with PD. Efficacy will be tested statistically using the intention-to-treat analysis including a log-rank test or Cox proportional hazard models. Secondary outcomes, such as changes of PPQ scores and Unified Parkinson's Disease Rating Scale scores from baseline will be assessed.
Ethics and dissemination
Ethics approval was received from the Central Review Board of the National Hospital Organization, Tokyo, Japan. The trial was declared and registered to the Pharmaceuticals and Medical Devices Agency(PMDA), Japan (No. 22-4018). All participants will receive a written informed consent that was approved by the Central Review. A completed written informed consent is required to enrol in the study. Severe adverse events will be monitored by investigators and in cases where a severe adverse event was previously unreported, it will be reported to the PMDA.
Clinical Trial Registration Number
To examine consumers’ confidence in their own, and also in other people's, over-the-counter (OTC) skills and to describe their attitude towards the availability of OTC painkillers. Moreover we examined the association between confidence in OTC skills and attitudes.
Cross-sectional survey. Mixed methods (postal and electronic) self-administered questionnaire.
Members of the Dutch Health Care Consumer Panel.
Main outcome measures
Consumers’ confidence in their own, and in other people's, OTC skills was examined. Confidence was measured by three questions regarding obtaining information on, choosing and using OTC medication. Consumers’ attitudes towards availability were assessed using six safety profiles, by asking which channel consumers prefer for each profile.
The response rate was 68% (n=972). Consumers feel confident about their own OTC skills (mean 3.74; 95% CI 3.69 to 3.79, on a 5-point Likert scale), but have less confidence in OTC skills of others (mean 2.92; 95% CI 2.88 to 2.96). Consumers are conservative in their attitudes towards the availability of OTC painkillers. Most consumers prefer painkillers to be available exclusively in pharmacies (41–71% per profile indicated pharmacy only). Moreover, there is an association between confidence in OTC skills and attitudes (p=0.005; β=−0.114). Consumers who are more confident about their own OTC skills prefer OTC painkillers to be more generally available.
Consumers feel confident about their own OTC skills. However, they would prefer painkillers with safety profiles resembling those currently available OTC, to be available as OTC in pharmacies exclusively. Consumers’ confidence in the OTC skills of others is more consistent with their attitudes towards availability of OTC painkillers. Until consumers themselves realise that they are also one of the others, they may overestimate their own OTC skills, which may entail health risks.
To assess the impact on cardiovascular risk factor management in primary care by the introduction of chronic kidney disease epidemiological collaboration (CKD-EPI) for estimated-glomerular filtration rate (eGFR) reporting.
Design and setting
Cross-sectional study of routine healthcare provision in 47 primary care practices in The Netherlands with Modification of Diet and Renal Disease Study eGFR reporting.
eGFR values were recalculated using CKD-EPI in patients with available creatine tests. Patients reclassified from CKD stage 3a to CKD stage 2 eGFR range were compared to those who remained in stage 3a for differences in demographic variables, blood pressure, comorbidity, medication usage and laboratory results.
Among the 60 673 adult patients (37% of adult population) with creatine values, applying the CKD-EPI equation resulted in a 16% net reduction in patients with CKD stage 3 or worse. Patients reclassified from stage 3a to 2 had lower systolic blood pressure (139.7 vs 143.3 mm Hg p<0.0001), higher diastolic blood pressure (81.5 vs 78.4 mm Hg p<0.0001) and higher cholesterol (5.4 vs 5.1 mmol/L p<0.0001) compared to those who remained in stage 3a. Of those reclassified out of a CKD diagnosis 463 (32%) had no comorbidities that would qualify for annual CVD risk factor assessment and 20 (12% of those with sufficient data) had a EuroSCORE CVD risk >20% within 10 years.
Use of the CKD-EPI equation will result in many patients being removed from CKD registers and the associated follow-up. Current risk factor assessment in this group may be lacking from routine data and some patients within this group are at an increased risk for cardiovascular events.
Primary Care; Chronic Renal Failure < Nephrology; Risk Management < Health Services Administration & Management
The long-term consequences of maternal physical activity during pregnancy for offspring cardiovascular health are unknown. We examined the association of maternal self-reported physical activity in pregnancy (18 weeks gestation) with offspring cardiovascular risk factors at age 15.
Prospective cohort study.
The Avon Longitudinal Study of Parents and Children (ALSPAC).
4665 maternal-offspring pairs (based on a sample with multiple imputation to deal with missing data) from the ALSPAC, a prospective cohort based in the South West of England with mothers recruited in pregnancy in 1991–1992.
Primary and secondary outcome measures
Offspring cardiovascular risk factors at age 15; body mass index (BMI), waist circumference, systolic blood pressure, diastolic blood pressure, glucose, insulin, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides.
Greater maternal physical activity was associated with lower BMI, waist circumference, glucose and insulin in unadjusted analyses. The magnitude of associations was generally small with wide CIs, and most associations attenuated towards the null after adjusting for confounders. The strongest evidence of association after adjustment for confounders was for glucose, although the 95% CI for this association includes the null; a one SD greater physical activity during pregnancy was associated with a −0.013 mmol/L difference in offspring glucose levels (equivalent to approximately one-third of a SD; 95% CI −0.027 to 0.001 mmol/L).
Our results suggest that maternal physical activity in pregnancy, measured at 18 weeks gestation, is unlikely to be an important determinant of later offspring cardiovascular health. There was some suggestion of association with offspring glucose, but given that all other associations (including insulin) were null after adjustment for confounders, this result should be interpreted with caution.
Paediatric cardiology < Paediatrics; Paediatrics; Epidemiology
The mechanisms through which ω-3 fatty acids reduce adverse cardiac events remain uncertain. We aimed to investigate the effect of ω-3 fatty acid supplementation on endothelial vasomotor function, endogenous fibrinolysis, and platelet and monocyte activation in patients with coronary heart disease.
Randomised, double-blind, placebo-controlled, cross-over trial.
Academic cardiac centre.
20 male patients with a previous myocardial infarction.
ω-3 Fatty acid supplementation (2 g/day for 6 weeks) versus olive oil placebo.
Peripheral blood was taken for analysis of platelet and monocyte activation, and forearm blood flow (FBF) was assessed in a subset of 12 patients during intrabrachial infusions of acetylcholine, substance P and sodium nitroprusside. Stimulated plasma tissue plasminogen activator (t-PA) concentrations were measured during substance P infusion.
All vasodilators caused dose-dependent increases in FBF (p<0.0001). ω-3 Fatty acid supplementation did not affect endothelium-dependent vasodilation with acetylcholine and substance P compared with placebo (p=0.5 and 0.9). Substance P caused a dose-dependent increase in plasma t-PA concentrations (p<0.0001), which was not affected by ω-3 fatty acid supplementation (p=0.9). ω-3 Fatty acids did not affect platelet–monocyte aggregation, platelet P-selectin or CD40L, or monocyte CD40.
We have demonstrated that dietary supplementation with ω-3 fatty acids does not affect endothelial vasomotor function, endothelial t-PA release, or platelet and monocyte activation in patients with coronary heart disease. Cardiac benefits conferred by ω-3 fatty acids in coronary heart disease are unlikely to be mediated through effects on these systems.
Nutrition & Dietetics; Vascular Medicine
To evaluate the impact of risk minimisation policies on the use of rosiglitazone-containing products and on glycaemic control among patients in Denmark and the UK.
Design, setting and participants
We used population-based data from the Aarhus University Prescription Database (AUPD) in northern Denmark and from the General Practice Research Database (GPRD) in the UK.
Main outcome measures
We examined the use of rosiglitazone during its entire period of availability on the European market (2000–2010) and evaluated changes in the glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) levels among patients discontinuing this drug.
During 2000–2010, 2321 patients with records in AUPD used rosiglitazone in northern Denmark and 25 428 patients with records in GPRD used it in the UK. The proportion of rosiglitazone users among all users of oral hypoglycaemic agents peaked at 4% in AUPD and at 15% in GPRD in May 2007, the month of publication of a meta-analysis showing increased cardiovascular morbidity associated with rosiglitazone use. 12 months after discontinuation of rosiglitazone-containing products, the mean change in HbA1c was −0.16% (95% CI −3.4% to 3.1%) in northern Denmark and −0.17% (95% CI −0.21% to 0.13%) in the UK. The corresponding mean changes in FPG were 0.01 mmol/L (95% CI −7.3 to 7.3 mmol/L) and 0.03 mmol/L (95% CI −0.22 to 0.28 mmol/L).
Publication of evidence concerning the potential cardiovascular risks of rosiglitazone was associated with an irreversible decline in the use of rosiglitazone-containing products in Denmark and the UK. The mean changes in HbA1c and FPG after drug discontinuation were slight.
diabetes mellitus; drug safety; glucose-lowering drugs; rosiglitazone; thiazolidinediones
The aim was to describe the strengths and weaknesses, from team member perspectives, of working with the Global Trigger Tool (GTT) method of retrospective record review to identify adverse events causing patient harm.
A qualitative, descriptive approach with focus group interviews using content analysis.
5 Swedish hospitals in 2011.
5 GTT teams, with 5 physicians and 11 registered nurses.
5 focus group interviews were carried out with the five teams. Interviews were taped and transcribed verbatim.
8 categories emerged relating to the strengths and weaknesses of the GTT method. The categories found were: Usefulness of the GTT, Application of the GTT, Triggers, Preventability of harm, Team composition, Team tasks, Team members’ knowledge development and Documentation. Gradually, changes in the methodology were made by the teams, for example, the teams reported how the registered nurses divided up the charts into two sets, each being read respectively. The teams described the method as important and well functioning. Not only the most important, but also the most difficult, was the task of bringing the results back to the clinic. The teams found it easier to discuss findings at their own clinics.
The GTT method functions well for identifying adverse events and is strengthened by its adaptability to different specialties. However, small, gradual methodological changes together with continuingly developed expertise and adaption to looking at harm from a patient's perspective may contribute to large differences in assessment over time.
To correlate motor deficit with involvement of corticofugal fibres in patients with subcortical stroke. The descending motor corticofugal fibres originate from the primary motor cortex (M1), dorsal and ventral premotor area (PMdv) and supplementary motor area (SMA).
Single tertiary teaching hospital.
57 patients (57% men) with subcortical infarcts on MRI (2009–2011) were included. The mean age was 64.3±14.4 years.
Primary and secondary outcome measures
National Institute of Health Stroke Scale subscores for arm and leg motor deficit at 90 days.
An area under the receiver operating characteristics curve (AUC) for the volume of overlap with infarct (and M1/PMdv/SMA fibres) and motor outcome was calculated. The AUC for the association with arm motor deficit from M1 fibres involvement was 0.80 (95% CI 0.66 to 0.94), PMdv was 0.76 (95% CI 0.61 to 0.91) and SMA was 0.73 (95% CI 0.58 to 0.88). The AUC for leg motor deficit from M1 fibres involvement was 0.69 (95% CI 0.52 to 0.85), PMdv was 0.67 (95% CI 0.50 to 0.85), SMA was 0.66 (95% CI 0.48 to 0.84).
Following subcortical stroke, the correlations between involvement of the corticofugal fibres for upper and lower limbs motor deficit were variable. A poor motor outcome was not universal following subcortical stroke.
Rehabilitation Medicine; Stroke Medicine
The purposes of this study were to (1) quantify dentists' practice patterns regarding caries prevention and (2) test the hypothesis that certain dentists' characteristics are associated with these practice patterns.
The study used a cross-sectional study design consisting of a questionnaire survey.
The study queried dentists who worked in outpatient dental practices who were affiliated with the Dental Practice-Based Research Network Japan, which seeks to engage dentists in investigating research questions and sharing experiences and expertise (n=282).
Dentists were asked about their practice patterns regarding caries preventive dentistry. Background data on patients, practice and dentist were also collected.
38% of dentists (n=72) provided individualised caries prevention to more than 50% of their patients. Overall, 10% of the time in daily practice was spent on caries preventive dentistry. Dentists who provided individualised caries prevention to more than 50% of their patients spent significantly more time on preventive care and less time on removable prosthetics treatment, compared to dentists who did not provide individualised caries prevention. Additionally, they provided oral hygiene instruction, patient education, fluoride recommendations, intraoral photographs taken and diet counselling to their patients significantly more often than dentists who did not provide individualised caries prevention. Multiple logistic regression analysis suggested that the percentage of patients interested in caries prevention and the percentage of patients who received hygiene instruction, were both associated with the percentage of patients who receive individualised caries prevention.
We identified substantial variation in dentists' practice patterns regarding preventive dentistry. Individualised caries prevention was significantly related to provision of other preventive services and to having a higher percentage of patients interested in caries prevention, but not to the dentist's belief about the effectiveness of caries risk assessment. (Clinicaltrials.gov registration number NCT01 680 848).
EPIDEMIOLOGY; ORAL MEDICINE; PREVENTIVE MEDICINE; PUBLIC HEALTH