PINCER trial: a cluster randomised trial comparing the effectiveness and cost-effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices

Background: Medication errors in general practice are an important source of potentially preventable morbidity and mortality. Building on previous descriptive, qualitative and pilot work, we sought to investigate the effectiveness, cost-effectiveness and likely generalisability of a complex pharm acist-led IT-based intervention aiming to improve prescribing safety in general practice. Objectives: We sought to: • Test the hypothesis that a pharmacist-led IT-based complex intervention using educational outreach and practical support is more effective than simple feedback in reducing the proportion of patients at risk from errors in prescribing and medicines management in general practice. • Conduct an economic evaluation of the cost per error avoided, from the perspective of the National Health Service (NHS). • Analyse data recorded by pharmacists, summarising the proportions of patients judged to be at clinical risk, the actions recommended by pharmacists, and actions completed in the practices. • Explore the views and experiences of healthcare professionals and NHS managers concerning the intervention; investigate potential explanations for the observed effects, and inform decisions on the future roll-out of the pharmacist-led intervention • Examine secular trends in the outcome measures of interest allowing for informal comparison between trial practices and practices that did not participate in the trial contributing to the QRESEARCH database. Methods Two-arm cluster randomised controlled trial of 72 English general practices with embedded economic analysis and longitudinal descriptive and qualitative analysis. Informal comparison of the trial findings with a national descriptive study investigating secular trends undertaken using data from practices contributing to the QRESEARCH database. The main outcomes of interest were prescribing errors and medication monitoring errors at six- and 12-months following the intervention. Results: Participants in the pharmacist intervention arm practices were significantly less likely to have been prescribed a non-selective NSAID without a proton pump inhibitor (PPI) if they had a history of peptic ulcer (OR 0.58, 95%CI 0.38, 0.89), to have been prescribed a beta-blocker if they had asthma (OR 0.73, 95% CI 0.58, 0.91) or (in those aged 75 years and older) to have been prescribed an ACE inhibitor or diuretic without a measurement of urea and electrolytes in the last 15 months (OR 0.51, 95% CI 0.34, 0.78). The economic analysis suggests that the PINCER pharmacist intervention has 95% probability of being cost effective if the decision-maker’s ceiling willingness to pay reaches £75 (6 months) or £85 (12 months) per error avoided. The intervention addressed an issue that was important to professionals and their teams and was delivered in a way that was acceptable to practices with minimum disruption of normal work processes. Comparison of the trial findings with changes seen in QRESEARCH practices indicated that any reductions achieved in the simple feedback arm were likely, in the main, to have been related to secular trends rather than the intervention. Conclusions Compared with simple feedback, the pharmacist-led intervention resulted in reductions in proportions of patients at risk of prescribing and monitoring errors for the primary outcome measures and the composite secondary outcome measures at six-months and (with the exception of the NSAID/peptic ulcer outcome measure) 12-months post-intervention. The intervention is acceptable to pharmacists and practices, and is likely to be seen as costeffective by decision makers.

A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis

Background: Medication errors are common in primary care and are associated with considerable risk of patient harm. We tested whether a pharmacist-led, information technology-based intervention was more effective than simple feedback in reducing the number of patients at risk of measures related to hazardous prescribing and inadequate blood-test monitoring of medicines 6 months after the intervention. Methods: In this pragmatic, cluster randomised trial general practices in the UK were stratified by research site and list size, and randomly assigned by a web-based randomisation service in block sizes of two or four to one of two groups. The practices were allocated to either computer-generated simple feedback for at-risk patients (control) or a pharmacist-led information technology intervention (PINCER), composed of feedback, educational outreach, and dedicated support. The allocation was masked to general practices, patients, pharmacists, researchers, and statisticians. Primary outcomes were the proportions of patients at 6 months after the intervention who had had any of three clinically important errors: non-selective non-steroidal anti-inflammatory drugs (NSAIDs) prescribed to those with a history of peptic ulcer without co-prescription of a proton-pump inhibitor; β blockers prescribed to those with a history of asthma; long-term prescription of angiotensin converting enzyme (ACE) inhibitor or loop diuretics to those 75 years or older without assessment of urea and electrolytes in the preceding 15 months. The cost per error avoided was estimated by incremental cost-eff ectiveness analysis. This study is registered with Controlled-Trials.com, number ISRCTN21785299. Findings: 72 general practices with a combined list size of 480 942 patients were randomised. At 6 months’ follow-up, patients in the PINCER group were significantly less likely to have been prescribed a non-selective NSAID if they had a history of peptic ulcer without gastroprotection (OR 0∙58, 95% CI 0∙38–0∙89); a β blocker if they had asthma (0∙73, 0∙58–0∙91); or an ACE inhibitor or loop diuretic without appropriate monitoring (0∙51, 0∙34–0∙78). PINCER has a 95% probability of being cost eff ective if the decision-maker’s ceiling willingness to pay reaches £75 per error avoided at 6 months. Interpretation: The PINCER intervention is an effective method for reducing a range of medication errors in general practices with computerised clinical records. Funding: Patient Safety Research Portfolio, Department of Health, England.

Neurotrophic gene polymorphisms and response to psychological therapy

Therapygenetics, the study of genetic determinants of response to psychological therapies, is in its infancy. Here, we investigate whether single-nucleotide polymorphisms in nerve growth factor (NGF) (rs6330) and brain-derived neutrotrophic factor (BDNF) (rs6265) genes predict the response to cognitive behaviour therapy (CBT). Neurotrophic genes represent plausible candidate genes: they are implicated in synaptic plasticity, response to stress, and are widely expressed in brain areas involved in mood and cognition. Allelic variation at both loci has shown associations with anxiety-related phenotypes. A sample of 374 anxiety-disordered children with white European ancestry was recruited from clinics in Reading, UK, and in Sydney, Australia. Participants received manualised CBT treatment and DNA was collected from buccal cells using cheek swabs. Treatment response was assessed at post-treatment and follow-up time points. We report first evidence that children with one or more copies of the T allele of NGF rs6330 were significantly more likely to be free of their primary anxiety diagnosis at follow-up (OR=0.60 (0.42–0.85), P=0.005). These effects remained even when other clinically relevant covariates were accounted for (OR=0.62 (0.41–0.92), P=0.019). No significant associations were observed between BDNF rs6265 and response to psychological therapy. These findings demonstrate that knowledge of genetic markers has the potential to inform clinical treatment decisions for psychotherapeutic interventions.

Magnetic resonance imaging of a randomized controlled trial investigating predictors of recovery following psychological treatment in adolescents with moderate to severe unipolar depression: study protocol for Magnetic Resonance - Improving Mood with Psychoanalytic and Cognitive Therapies (MR-IMPACT)

Background Major depressive disorders (MDD) are a debilitating and pervasive group of mental illnesses afflicting many millions of people resulting in the loss of 110 million working days and more than 2,500 suicides per annum. Adolescent MDD patients attending NHS clinics show high rates of recurrence into adult life. A meta-analysis of recent research shows that psychological treatments are not as efficacious as previously thought. Modest treatment outcomes of approximately 65% of cases responding suggest that aetiological and clinical heterogeneity may hamper the better use of existing therapies and discovery of more effective treatments. Information with respect to optimal treatment choice for individuals is lacking, with no validated biomarkers to aid therapeutic decision-making. Methods/Design Magnetic resonance-Improving Mood with Psychoanalytic and Cognitive Therapies, the MR-IMPACT study, plans to identify brain regions implicated in the pathophysiology of depressions and examine whether there are specific behavioural or neural markers predicting remission and/or subsequent relapse in a subsample of depressed adolescents recruited to the IMPACT randomised controlled trial (Registration # ISRCTN83033550). Discussion MR-IMPACT is an investigative biomarker component of the IMPACT pragmatic effectiveness trial. The aim of this investigation is to identify neural markers and regional indicators of the pathophysiology of and treatment response for MDD in adolescents. We anticipate that these data may enable more targeted treatment delivery by identifying those patients who may be optimal candidates for therapeutic response.

Information architecture for healthcare organizations: the case of a NHS Hospital in UK

Healthcare organizations are known for their complex and intense information environment. Healthcare information is facilitated via heterogeneous information systems or paper-based sources. Access to the right information under increasing time pressure is extremely challenging. This paper proposes an information architecture for healthcare organizations. It facilitates the provision of the right information to the right person in the right place and time tailored to their requirements. It adapts an abductive reasoning research approach. Organizational semiotics serves as its theoretical underpinning, guiding the data collection process through direct observation in the ophthalmology outpatient clinics of a UK hospital. It results the norm and information objects that form the information architecture. This is modeled by Archimate. The contribution of the information architecture can be seen from organizational, social and technical perspective. It clearly shows how information is facilitated within a healthcare organization, reducing duplicated data entry, and guiding the future technological implementation.

Health surveys and use of maternal and child health care services in three municipalities within the Sao Paulo metropolitan area

Objectives. To describe the changes in the use of maternal and child health care services by residents of three municipalities-Embu, Itapecerica da Serra, and Taboao da Serra-in the Sao Paulo metropolitan area, 12 years after the implementation of the Unified Health System (SUS) in Brazil, and to analyze the potential of population-based health care surveys as sources of data to evaluate these changes. Methods. Two population-based, cross-sectional surveys were carried out in 1990 and 2002 in municipalities located within the Sao Paulo metropolitan area. For children under 1 year of age, the two periods were compared in terms of outpatient services utilization and hospital admission; for the mothers, the periods were compared in terms of prenatal care and deliveries. In both surveys, stratified and multiple-stage conglomerate sampling was employed, with standardization of interview questions. Results. The most important changes observed were regarding the location of services used for prenatal care, deliveries, and hospitalization of children less than 1 year of age. There was a significant increase in the use of services in the surrounding region or hometown, and decrease in the utilization of services in the city of Sao Paulo (in 1990, 80% of deliveries and almost all admissions for children less than 1 year versus 32% and 46%, respectively, in 2002). The use of primary care units and 24-hour walk-in clinics also increased. All these changes reflect care provided by public resources. In the private sector, there was a decrease in direct payments and payments through company-paid health insurance and an increase in payments through self-paid health insurance. Conclusions. The major changes observed in the second survey occurred simultaneous to the changes that resulted from the implementation of the SUS. Population-based health surveys are adequate for analyzing and comparing the utilization of health care services at different times.

Diet and serum micronutrients in relation to cervical neoplasia and cancer among low-income Brazilian women

Cervical cancer is a leading cancer among women in developing countries. Infection with oncogenic human papillomavirus (HPV) types has been recognized as a necessary cause of this disease. Serum carotenoids and tocopherols have also been associated with risk for cervical neoplasia, but results from previous studies were not consistent. We evaluated the association of serum total carotene and tocopherols, and dietary intakes with the risk of newly diagnosed, histologically confirmed cervical intraepithelial neoplasia (CIN) grades 1, 2, 3 and invasive cancer in a hospital-based case-control study in Sao Paulo, Brazil. The investigation included 453 controls and 4 groups of cases (CIN1, n = 140; CIN2, n = 126; CIN3, n = 231; invasive cancer, n = 108) recruited from two major public clinics between 2003 and 2005. Increasing concentrations of serum lycopene were negatively associated with CIN1, CIN3 and cancer, with odds ratios (OR) (95% CI) for the highest compared to the lowest tertile of 0.53 (0.27-1.00, p for trend = 0.05), 0.48 (0.22-1.04, p for trend = 0.05) and 0.18 (0.06-0.52, p for trend = 0.002), respectively, after adjusting for confounding variables and HPV status. Increasing concentrations of serum alpha- and gamma-tocopherols, and higher dietary intakes of dark green and deep yellow vegetables/fruit were associated with nearly 50% decreased risk of CIN3. These results support the evidence that a healthy and balanced diet leading to provide high serum levels of antioxidants may reduce cervical neoplasia risk in low-income women.

Vasectomy within the public health services in Campinas, Sao Paulo, Brazil

Objective: To describe some of the characteristics of men who underwent a vasectomy in the public health network of Campinas, Sao Paulo, Brazil. Methods: A descriptive study including 202 men randomly selected from a list of all the men vasectomized between 1998 and 2004 in the public health network. Results: Most of the men were 30 years of age or older when vasectomized, had completed elementary school and had two or more children of both sexes. Most of the men came from the lowest income segment of the population: 47.6% in 1998-1999 and 61.3% in 2003-2004. Although the men knew various contraceptive methods, 51.2% reported that their partners were using combined oral contraceptives at the time of surgery. Most men initially sought information on vasectomy at health-care clinics where care was provided by a multidisciplinary team; most received counselling, however, 47.9% of the men waited more than 4 months for the vasectomy. Conclusions: The profile of the vasectomized men in this study appears to indicate that the low-income population from Campinas, Sao Paulo, Brazil has access to vasectomy; however, the waiting time for vasectomy reveals that difficulties exist in obtaining this contraceptive method in the public health service.

The variability of baroreflex sensitivity in juvenile, spontaneously hypertensive rats

In this study the baroreflex sensitivity of conscious, juvenile, spontaneously hypertensive rats (SHRs) was compared. The study population consisted of 19 eight-week-old male SHRs. The baroreflex sensitivity was quantified as the derivative of the variation in heart rate (HR) and the variation of mean arterial pressure (baroreflex sensitivity = Delta HR/Delta MAP). MAP was manipulated with sodium nitroprusside (SNP) and phenylephrine (PHE), administered via an inserted cannula in the right femoral vein. The SHRs were divided into four groups: (1) low bradycardic baroreflex (LB) where the baroreflex gain (BG) was between 0 and 1 bpm/mmHg with PHE; (2) high bradycardic baroreflex (HB), where the BG was < -1 bpm/mmHg with PHE; (3) low tachycardic baroreflex (LT) where the BC was between 0 and 3 bpm/mmHg with SNP; (4) high tachycardic baroreflex (HT) where the BG was > 3 bpm/mmHg with SNP. We noted that 36.8% of the rats presented with an increased bradycardic reflex, while 27.8% demonstrated an attenuated tachycardic reflex. No significant alterations were noted regarding the basal MAP and HR. There were significant differences in the baroreflex sensitivity between SHRs in the same laboratory. One should be careful when interpreting studies employing the SHR as a research model.

Association between particulate matter from biomass burning and respiratory diseases in the southern region of the Brazilian Amazon

Objective. To investigate the short-term effects of exposure to particulate matter from biomass burning in the Amazon on the daily demand for outpatient care due to respiratory diseases in children and the elderly. Methods. Epidemiologic study with ecologic time series design. Daily consultation records were obtained from the 14 primary health care clinics in the municipality of Alta Floresta, state of Mato Grosso, in the southern region of the Brazilian Amazon, between January 2004 and December 2005. Information on the daily levels of fine particulate matter was made available by the Brazilian National Institute for Spatial Research. To control for confounding factors ( situations in which a non-causal association between exposure and disease is observed due to a third variable), variables related to time trends, seasonality, temperature, relative humidity, rainfall, and calendar effects ( such as occurrence of holidays and weekends) were included in the model. Poisson regression with generalized additive models was used. Results. A 10 mu g/m(3) increase in the level of exposure to particulate matter was associated with increases of 2.9% and 2.6% in outpatient consultations due to respiratory diseases in children on the 6th and 7th days following exposure. Significant associations were not observed for elderly individuals. Conclusions. The results suggest that the levels of particulate matter from biomass burning in the Amazon are associated with adverse effects on the respiratory health of children.

Riskfaktorer och prevention vid trycksårsamt sjuksköterskans roll i omvårdnaden : En systematisk litteraturstudie

Syftet med denna litteraturstudie var att beskriva riskfaktorer som påverkade uppkomsten av trycksår samt de vanligaste förekommande preventiva åtgärderna. Vidare var syftet att beskriva sjuksköterskans roll vid förebyggandet samt behandlingen av trycksår. De vetenskapliga artiklar (n=21) som ingick i studien söktes manuellt samt datoriserat via databaserna Blackwell Synergy, CHINAL, Elin@Dalarna och Elsiever. Inklusionskriterierna var att de skulle vara vetenskapliga samt av kvalitativ och kvantitativ design. Även litteraturstudier inkluderades. Artiklarna skulle vara publicerade 1990 eller senare och vara svensk eller engelskspråkiga. Resultatet visade att patienter med lågt nutritionsstatus och låga serum albuminvärden riskerade att utveckla trycksår. En annan stor riskgrupp var patienter i peri- och postoperativa skeden där operationstiden kraftigt inverkade på uppkomsten av sår. Även anestesiformen spelade roll. Trycksåren uppkom vanligen på hälarna och korsbenet. I preventativt syfte var evidensbaserade mätskalor viktiga. Även trycksårsreducerande madrasser visade sig vara betydelsefulla. Vidare framkom att hälso- och sjukvårdspersonalen visade ett svalt intresse för trycksår och att kvalitetssäkringen var bristfällig. Sjuksköterskan hade främst en informerande roll inom trycksårspreventionen. Såren rengjordes lämpligast med fysiologisk koksaltlösning och omlades med våt omläggning. Resultatet visade även att smärtanalyser i högre grad borde involveras i trycksårsbehandlingen.

Trycksår : Omvårdnadsåtgärder vid trycksårsprevention och sårläkning

Syftet med denna systematiska litteraturstudie var att ta reda på vilka mätinstrument som används för att identifiera patienter med risk att utveckla trycksår samt beskriva vilka omvårdnadsåtgärder som har betydelse för trycksårsprevention och sårläkning. De vetenskapliga artiklarna (n=16) som ingick i denna studie söktes i databasen Elin@dalarna. Sökorden som användes var pressure ulcer i olika kombinationer med nutrition, activity, skin, Norton, treatment och hydrocolloid. Inklusionskriterierna var att artiklarna skulle vara publicerade mellan åren 1999-2006 och vara i fulltext samt svensk och/eller engelskspråkig. Resultatet visade att patienter borde riskbedömas för trycksår så snart som möjligt efter att de anlänt till vårdinrättningen. Bedömningen kunde göras med ett flertal olika evidensbaserade mätinstrument såsom Norton, modifierad Norton, Braden, modifierad Braden, och RAPS skalorna samt bedömning av BMI, serum albuminvärde och hudtemperatur. Sjuksköterskans omvårdnadsåtgärder gällande prevention och sårläkning var att snabbt mobilisera patienter. Hos immobiliserade patienter var det viktigt att dessa vändes varannan timme samt att sjuksköterskan använde kuddar, fårskinn eller anti- decubitus madrasser för att tryckavlasta huden i denna patientgrupp. Resultatet visade även att kosttillägg hade stor betydelse för trycksårsprevention och sårläkning. Det var viktigt att sjuksköterskan rengjorde såret med tvål/vatten eller natriumklorid och använde hydrocolloida förband för att få en optimal sårläkning.

Evidensbaserade omvårdnadsåtgärder vid trycksår : En systematisk litteraturstudie

I föreliggande systematiska litteraturstudie var syftet att samla information om och belysa sjuksköterskans evidensbaserade omvårdnadsåtgärder för att förebygga och bedöma trycksår. Artiklar söktes via Högskolan Dalarnas bibliotek och sökmotorn Electronic Library Information Navigator (ELIN). Sökorden pressure, ulcer och nurs* användes. De vetenskapliga artiklarna (n= 15) kvalitetsbedömdes enligt granskningsmallar som bestod av 28 kvalitetskriterier. Därefter evidensgraderades artiklarna. Resultatet i föreliggande studie visade att sjuksköterskan använde sig av tre evidensbaserade omvårdnadsåtgärder i omsorgen om patienter med risk för trycksår. Den första omvårdnadsåtgärden omfattade tryckavlastande omvårdnadsåtgärder, vilka insatser befanns vila på stark vetenskaplig grund. Den andra omvårdnadsåtgärden inbegrep användning av riskbedömningsinstrument och den tredje bestod av klinisk bedömning som båda befanns vila på måttlig vetenskapligt underlag. I resultatet framkom att riskbedömningsinstrument hjälpte sjuksköterskan att reducera uppkomsten av trycksår och därmed minskade ett onödigt lidande för patienten. Resultatet diskuterades utifrån Florence Nightingales omvårdnadsteori, där miljön var en av grundstenarna i omsorgen och att sjuksköterskan hade ansvaret för att anpassa miljön efter patientens behov. Medvetenheten om detta tillsammans med de evidensbaserade omvårdnadsåtgärderna som framkom i föreliggande studie kunde minska risken för trycksår hos patienter och i förlängningen reducera sjukvårds- kostnaderna.

Handläggning av intrauterin fosterdöd : En kartläggning av vårdprogram vid Sveriges kvinnokliniker

Background: Parents that loose a child in connection to labour are in great need of support.Health care provider treatment and support is of great importance to how the parents will experience something that is doomed from the beginning to be one of the most tragic events the parents will ever experience. For care givers to live up to this it is incredibly important that there are worked out guidelines to follow at these situations.Aim: To chart and describe Swedish maternity wards care program with reference to “IUFD”.Method: All clinics in Sweden have been questioned regarding care program for handling of “IUFD”. Care programs has been gathered, charted and described.Results: 87% (29 of 33) off the maternity wards has a plan for treatment and guidelines for “IUFD”. Care programs are more or less explanatory and a number of variables are present in different extents.Conclusion: That ones children die is the most tragic thing that can happen to a parent.The writer is of the opinion that it is of outmost importance that these parents get the best thinkable nursing and care.There are good guidelines regarding “IUFD” at the majority of the clinics, but to safeguard the quality the writer is of the opinion that it would be good if there where national guidelines for the shaping of these care programs.

Unsupervised learning to cluster the disease stages in parkinson's disease

Parkinson's disease (PD) is the second most common neurodegenerative disorder (after Alzheimer's disease) and directly affects upto 5 million people worldwide. The stages (Hoehn and Yaar) of disease has been predicted by many methods which will be helpful for the doctors to give the dosage according to it. So these methods were brought up based on the data set which includes about seventy patients at nine clinics in Sweden. The purpose of the work is to analyze unsupervised technique with supervised neural network techniques in order to make sure the collected data sets are reliable to make decisions. The data which is available was preprocessed before calculating the features of it. One of the complex and efficient feature called wavelets has been calculated to present the data set to the network. The dimension of the final feature set has been reduced using principle component analysis. For unsupervised learning k-means gives the closer result around 76% while comparing with supervised techniques. Back propagation and J4 has been used as supervised model to classify the stages of Parkinson's disease where back propagation gives the variance percentage of 76-82%. The results of both these models have been analyzed. This proves that the data which are collected are reliable to predict the disease stages in Parkinson's disease.