Iatrogenic risk factors associated with hospital readmission of elderly patients: A matched case-control study using a clinical data warehouse.

WHAT IS KNOWN: Hospital readmission within 30 days of patient discharge has become a standard to judge the quality of hospitalizations. It is estimated that 14% of the elderly, people over 75 years old or those over 65 with comorbidities, are at risk of readmission, of which 23% are avoidable. It may be possible to identify elderly patients at risk of readmission and implement steps to reduce avoidable readmissions. OBJECTIVE: The aim of this study was to identify iatrogenic risk factors for readmission. The secondary objective was to evaluate the rate of drug-related readmissions (DRRs) among all readmissions and compare it to the rate of readmissions for other reasons. METHODS: We conducted a retrospective, matched, case-control study to identify non-demographic risk factors for avoidable readmission, specifically DRRs. The study included patients hospitalized between 1 September 2014 and 31 October 2015 in an 800-bed university hospital. We included patients aged 75 and over. Cases consisted of patients readmitted to the emergency department within 30 days of initial discharge. Controls did not return to the emergency department within 30 days. Cases and controls were matched on sex and age because they are known as readmissions risk factors. After comparison of the mean or percentage between cases and controls for each variable, we conducted a conditional logistic regression. RESULTS: The risk factors identified were an emergency admission at the index hospitalization, returning home after discharge, a history of unplanned readmissions and prescription of nervous system drugs. Otherwise, 11.4% of the readmissions were DRRs, of which 30% were caused by an overdose of antihypertensive. The number of drugs at readmission was higher, and potentially inappropriate medications were more widely prescribed for DRRs than for readmissions for other reasons. WHAT IS NEW AND CONCLUSION: In this matched case-control retrospective study, after controlling for gender and age, we identified the typical profile of elderly patients at risk of readmission. These patients had an unplanned admission at the index hospitalization and prescribed nervous system drugs at discharge from the index admission; they have a history of unplanned readmission within 30 days and return home after discharge.

Reproducibility of clinical events adjudications in a trial of venous thromboembolism prevention.

Essentials The reproducibility of Clinical Events Committee (CEC) adjudications is almost unexplored. A random selection of events from a venous thromboembolism trial was blindly re-adjudicated. 'Unexplained sudden deaths' (possible fatal embolism) explained most discordant adjudications. A precise definition for CEC adjudication of this type of events is needed and proposed. SUMMARY: Background When clinical trials use clinical endpoints, establishing independent Clinical Events Committees (CECs) is recommended to homogenize the interpretation of investigators' data. However, the reproducibility of CEC adjudications is almost unexplored. Objectives To assess the reproducibility of CEC adjudications in a trial of venous thromboembolism (VTE) prevention. Methods The PREVENU trial, a multicenter trial of VTE prevention, included 15 351 hospitalized medical patients. The primary endpoint was the composite of symptomatic VTE, major bleeding or unexplained sudden death (interpreted as possible fatal pulmonary embolism [PE]) at 3 months. The CEC comprised a chairman and four pairs of adjudicators. Of 2970 adjudicated clinical events, a random selection of 179 events (121 deaths, 40 bleeding events, and 18 VTE events) was blindly resubmitted to the CEC. Kappa values and their 95% confidence intervals (CIs) were calculated to measure adjudication agreement. Results Overall, 18 of 179 (10.1%, 95% CI 6.5-15.3%) adjudications proved discordant. Agreement for the PREVENU composite primary endpoint was good (kappa = 0.73, 95% CI 0.61-0.85). When analyzed separately, agreements were very good for non-fatal VTE events (1, 95% CI not applicable), moderate for all (fatal and non-fatal) VTE events (0.58, 95% CI 0.34-0.82), good for fatal and non-fatal major bleeding events (0.71, 95% CI 0.55-0.88), and moderate for all fatal events (0.60, 95% CI 0.40-0.81). Unexplained sudden death interpreted as possible fatal PE was responsible for nine of 18 (50%) discordant adjudications. Conclusion The reproducibility of CEC adjudications was good or very good for non-fatal VTE and bleeding events, but insufficient for VTE-related deaths, for which more precise and widely accepted definitions are needed.

Tumor necrosis factor-alpha concentration in the aqueous humor of healthy and diseased dogs: a preliminary pilot study.

OBJECTIVES: To determine reference values of tumor necrosis factor-alpha (TNF-α) concentrations in the aqueous humor of control dogs. To show whether these values are significantly different from those obtained in dogs affected with intraocular pathology: acute anterior uveitis (AAU) or chronic primary angle closure glaucoma (PACG). METHODS: Forty-four dogs were included in the study and were divided into two groups: a control group and a group with intraocular disease. Twenty-seven dogs (9 males and 18 females) were examined and found to be normal after a complete ophthalmological examination (control group), 7 (6 females and 1 male) presented with PACG, and 10 (7 females and 3 males) presented with AAU secondary to corneal perforation. One aqueous humor sample (volume ≥ 0.2 mL) was collected from one eye of all dogs. The aqueous TNF-α concentration was determined with an Elisa kit. RESULTS: TNF-α levels were detectable in all dogs. TNF-α levels were significantly higher in the group with intraocular disease compared to the normal control group (P=0.001). In the group with intraocular disease, TNF-α levels were significantly higher in the aqueous humor of the AAU group compared with the PACG group (P=0.001). CONCLUSIONS: In the dog, it is possible to measure the concentration of TNF-α in the aqueous humor. The level of TNF-α was significantly higher in the case of AAU. TNF-α is an interesting biomarker for longitudinal follow-up studies of comparative ophthalmology.

Clinical trial registration in oral health journals.

Prospective registration of randomized controlled trials (RCTs) represents the best solution to reporting bias. The extent to which oral health journals have endorsed and complied with RCT registration is unknown. We identified journals publishing RCTs in dentistry, oral surgery, and medicine in the Journal Citation Reports. We classified journals into 3 groups: journals requiring or recommending trial registration, journals referring indirectly to registration, and journals providing no reference to registration. For the 5 journals with the highest 2012 impact factors in each group, we assessed whether RCTs with results published in 2013 had been registered. Of 78 journals examined, 32 (41%) required or recommended trial registration, 19 (24%) referred indirectly to registration, and 27 (35%) provided no reference to registration. We identified 317 RCTs with results published in the 15 selected journals in 2013. Overall, 73 (23%) were registered in a trial registry. Among those, 91% were registered retrospectively and 32% did not report trial registration in the published article. The proportion of trials registered was not significantly associated with editorial policies: 29% with results in journals that required or recommended registration, 15% in those that referred indirectly to registration, and 21% in those providing no reference to registration (P = 0.05). Less than one-quarter of RCTs with results published in a sample of oral health journals were registered with a public registry. Improvements are needed with respect to how journals inform and require their authors to register their trials.

Validity of a clinical decision rule-based alert system for drug dose adjustment in patients with renal failure intended to improve pharmacists' analysis of medication orders in hospitals.

OBJECTIVE: The main objective of this study was to assess the diagnostic performances of an alert system integrated into the CPOE/EMR system for renally cleared drug dosing control. The generated alerts were compared with the daily routine practice of pharmacists as part of the analysis of medication orders. MATERIALS AND METHODS: The pharmacists performed their analysis of medication orders as usual and were not aware of the alert system interventions that were not displayed for the purpose of the study neither to the physician nor to the pharmacist but kept with associate recommendations in a log file. A senior pharmacist analyzed the results of medication order analysis with and without the alert system. The unit of analysis was the drug prescription line. The primary study endpoints were the detection of drug dose prescription errors and inter-rater reliability (Kappa coefficient) between the alert system and the pharmacists in the detection of drug dose error. RESULTS: The alert system fired alerts in 8.41% (421/5006) of cases: 5.65% (283/5006) "exceeds max daily dose" alerts and 2.76% (138/5006) "under-dose" alerts. The alert system and the pharmacists showed a relatively poor concordance: 0.106 (CI 95% [0.068-0.144]). According to the senior pharmacist review, the alert system fired more appropriate alerts than pharmacists, and made fewer errors than pharmacists in analyzing drug dose prescriptions: 143 for the alert system and 261 for the pharmacists. Unlike the alert system, most diagnostic errors made by the pharmacists were 'false negatives'. The pharmacists were not able to analyze a significant number (2097; 25.42%) of drug prescription lines because understaffing. CONCLUSION: This study strongly suggests that an alert system would be complementary to the pharmacists' activity and contribute to drug prescription safety.

A business rules design framework for a pharmaceutical validation and alert system.

OBJECTIVES: Several alert systems have been developed to improve the patient safety aspects of clinical information systems (CIS). Most studies have focused on the evaluation of these systems, with little information provided about the methodology leading to system implementation. We propose here an 'agile' business rule design framework (BRDF) supporting both the design of alerts for the validation of drug prescriptions and the incorporation of the end user into the design process. METHODS: We analyzed the unified process (UP) design life cycle and defined the activities, subactivities, actors and UML artifacts that could be used to enhance the agility of the proposed framework. We then applied the proposed framework to two different sets of data in the context of the Georges Pompidou University Hospital (HEGP) CIS. RESULTS: We introduced two new subactivities into UP: business rule specification and business rule instantiation activity. The pharmacist made an effective contribution to five of the eight BRDF design activities. Validation of the two new subactivities was effected in the context of drug dosage adaption to the patients' clinical and biological contexts. Pilot experiment shows that business rules modeled with BRDF and implemented as an alert system triggered an alert for 5824 of the 71,413 prescriptions considered (8.16%). CONCLUSION: A business rule design framework approach meets one of the strategic objectives for decision support design by taking into account three important criteria posing a particular challenge to system designers: 1) business processes, 2) knowledge modeling of the context of application, and 3) the agility of the various design steps.

Non-adherence with drug treatment after heart or lung transplantation in adults: a systematic review.

OBJECTIVE: Heart or lung transplantation is a complex intervention requiring medication adherence. The objective of this systematic review is to estimate the prevalence of non-adherence (NA) with post-transplantation medication in heart or lung recipients and to assess its clinical impact. We examined in the selected studies if the authors considered the patient's perspective in their evaluations. METHODS: The electronic database MEDLINE, EMBASE and The Cochrane Central Register were searched. Only studies that reported the number of non-adhere subjects were eligible. The different methods of measurement, the ways in which authors defined NA and if authors had integrated patient's perspective in their secondary objectives were also assessed. RESULTS: The range frequency of NA was 1-42.9% for all drugs. Non-adherent patients tend to experience worse outcomes compared to adherent patients. The patient's perception of drug side-effects is the most reported patient-related factor for impairing adherence. CONCLUSION: NA after heart or lung transplantation is an important issue and concerns not only immunosuppressant treatments. The main striking point of the selected studies is the lack of patient perspective and the omission of patients-healthcare providers' relationship. PRACTICE IMPLICATIONS: Future research must focus on patients' motivation for the medication-taking behaviour.

[From clinical observation to assessment of practices: guidelines for hypertension management]. / De l'observation clinique à l'évaluation des pratiques : les recommandations pour la prise en charge de l'hypertension artérielle.

Arterial hypertension is highly prevalent and one of the main risk factors for cardiovascular diseases. It has been demonstrated that antihypertensive treatment is effective to prevent cardiovascular events. Advances have been made in this field for 50 years and the knowledge and management of hypertension has been modified continuously with increase of related costs. Therefore hypertension is one of the favorite themes for guidelines and indeed several guidelines have been published on this theme regularly. Despite this, a high percentage of treated hypertensive patients remains uncontrolled. Several reasons have been raised for not implementing guidelines: these guidelines are often little-known because of their large number and their bad distribution. A systematic analysis of the last guidelines showed also they were structurally different with a small percentage of identical references and they provided sometimes different practical conclusions. Finally, clinical inertia is partly responsible for these insufficient results. As the current form of the guidelines has a limited impact on the medical practice, we should find other methods to improve their implementation.

Long-term effects of a multifaceted intervention to encourage the choice of the oral route for proton pump inhibitors: an interrupted time-series analysis.

PROBLEM: Drugs are often given intravenously even when the patient is able to swallow and when an oral form would be more cost-effective. DESIGN: Evaluation of the impact of a multifaceted intervention on the early switch from intravenous to oral administration of proton pump inhibitors (PPI) in a hospital setting. The interrupted time series of intravenous PPI consumption was analysed. BACKGROUND AND SETTING: At a French University Hospital, the Drug Committee, composed of multidisciplinary pharmacy and medical staff, addressed the issue of increasing consumption of intravenous PPI drugs (May 2003). STRATEGY FOR CHANGE: Letters to department heads, academic analyses from members of the Drug Committee, paper reminders at the point of care and audit-feedbacks by pharmacists. Monitoring of consumption and repeated reminder letters were planned. EFFECT OF CHANGE: The consumption of PPI was stable before the first intervention (mean level: 954 units/month). An immediate decrease occurred after the first Drug Committee letter (30% relative reduction, 95% CI -16% to -46%; p<0.001) with a significant trend change during the first multifaceted intervention (-24 units/month, 95% CI -42 to -7; p = 0.007). After the end of the outreach visits (July 2004), the consumptions increased (+32 units/month, 95% CI: 14 to 50, p<0.001). The second intervention had no significant impact. LESSONS LEARNT: A complex intervention (audit, feedbacks, outreach visits) had an effect on practice. It was not sustained even after a less resource-intensive intervention. Other types of interventions are needed that could be continuously implemented to improve ordering practices long term.

Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception.

BACKGROUND: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment. AIM: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials (parent studies). PATIENTS AND METHODS: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient subjects based on this questionnaire. RESULTS: A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good (69-97%), and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease. CONCLUSION: The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators.

A comparative analysis of four clinical guidelines for hypertension management.

We compared the structure and content of guidelines for hypertension management across countries to gain an understanding of where differences between them originate from. Four guidelines published between 2003 and 2006 were selected. Two were issued by national agencies in the United Kingdom and France, and two were issued by working groups or national medical societies in the United States and in Europe. The structure of guidelines, the content of each section and their underlying bibliographic references were compared between authoring bodies. If differences were found between guidelines in terms of content, we analysed the rationales. The guidelines were sufficiently similar in structure, showing common sections such as lifestyle interventions, cardiovascular risk assessment and drug therapies. However, contentwise, major differences were observed across the four hypertension guidelines in virtually every section of the document. The definition of hypertension was consistent, whereas the grade stratification was not. Information concerning the blood pressure self-measurement, the estimation of cardiovascular risk and the antihypertensive drugs proposed for initial treatment also varied. Most of the differences were present in both guidelines and their rationales, but some were only found in the guidelines. The bibliographic references for the rationales differed significantly, with only 1.2, 2.2 and 8.8% of the total number of references were common to four, three and two authoring bodies, accounting for the variability. We conclude that improving the selection process of bibliographic references and the extraction process of guidelines from the rationales might be the first step to harmonize guidelines' development.

Lack of validity of a French adaptation of a scale measuring attitudes towards clinical practice guidelines.

BACKGROUND: Valid instruments to measure practitioners' attitudes towards clinical practice guidelines need to be developed. However, few of the available instruments have been thoroughly validated. OBJECTIVE: To adapt into French and to test the reliability and validity of a scale for measurement of attitudes towards guidelines developed by Elovainio et al. METHODS: A 27-item scale (divided into six dimensions) measuring attitudes towards guidelines was translated into French by two English native translators, reviewed and finalized by expert committee and administered to 314 practitioners who agreed to participate. Main practitioners' characteristics were collected. Item and dimension reproducibility were assessed for 62 practitioners by calculation of intraclass correlation coefficients. Internal construct validity was assessed by principal components analyses. Convergent and discriminant validity were analysed. RESULTS: Item response rates ranged from 82 to 100%. In the test-retest procedure, intraclass correlation coefficients for separate items ranged from 0.1 to 0.7 and those for dimensions were 0.7 [95% confidence interval (CI): 0.5-0.8] for usefulness, 0.5 (0.3-0.6) for reliability, 0.4 (0.2-0.5) for individual competence, 0.5 (0.3-0.6) for organizational competence, 0.7 (0.5-0.8) for impracticality and 0.4 (0.3-0.6) for availability. The factorial structure after Varimax rotation showed that none of the different solutions obtained had a strictly comparable structure to that of the original scale. External construct validity was satisfactory. CONCLUSION: This scale does not have satisfactory psychometric properties and therefore cannot confidently be used in future research assessing whether attitudes towards guidelines are a determining factor in physicians' compliance with guidelines. More research is needed to develop valid scales in a more rigorous procedure, involving qualitative and quantitative steps.

[Pleural effusion revealing non-Hodgkin lymphoma. Diagnose performed by videothoracoscopy]. / [In Process Citation]

We report the case of a 67-year-old man with an history of pneumopathy with pleural effusion and weight loss. Exsudative lymphocytic pleural effusion was found. Thoracoscopy gave diagnosis of widespread diffuse large B-cell NHL. Talc pleurodesis and CHOP-Rituximab regimen were performed with a favorable clinical and radiological response. We discuss about lymphocytic pleural effusion, especially associated with NHL and primary pleural lymphoma.

Comparison of health care professionals' self-assessments of standards of care and patients' opinions on the care they received in hospital: observational study.

OBJECTIVES: To compare the views of healthcare professionals and patients regarding compliance with standards of care concerning patient information. DESIGN: Self-rated questionnaire survey. SETTING: Nine wards in short stay French hospitals. PARTICIPANTS: 939 patients and 359 healthcare professionals (physicians, nurses, assistants and other professionals). MAIN OUTCOME MEASURE: Patients' and healthcare professionals' views of compliance with 20 standards of patient care described in the French accreditation manual. Comparison of the rank order of the standards within the two samples. RESULTS: The response rate was 61.5% in the patient group and 85.8% in the healthcare professionals. The rank orders for the 20 items were similar in both groups (Spearman rank order correlation 0.6, p = 0.004). The two items ranked highest by healthcare professionals ("consent request for a surgical procedure" and "the doctors ask the visitors to leave the room before examining a patient") were also the two ranked highest by the patients. Three items were ranked low by both groups: "consent request for students to be present", "health education given to patients", and "possibility to express satisfaction during discharge". Patients were more satisfied with their pain management than were healthcare providers. Professionals were more satisfied with the social services than the patients. CONCLUSION: There are both similarities and differences between patients' and healthcare professionals' views of care. Accurate assessments of quality performed during the accreditation procedure require that both patients' and professionals' views be taken into account.

[Clinical case of the month. Chronic eosinophilic pneumonia]. / Le cas clinique du mois. Suivi d'un poumon à éosinophiles en médecine générale. Pneumopathie chronique idiopathique à éosinophiles ou maladie de Carrington.

We report the case of a 32-year old man who had a feverish pneumopathy with coughing. An idiopathic eosinophilic pneumonia was soon disclosed; the evolution was rapidly favourable under systemic corticotherapy, but marked by a cortico-dependence in the long term. The follow-up of the relapses, when corticotherapy was stopped, showed a perfect correlation between reappearance of somatic plaints and eosinophilic blood levels.

[Prevalence and management of pain in a hospital: a cross-sectional study]. / Prévalence et prise en charge de la douleur à l'hôpital. Une étude transversale.

OBJECTIVES: Improved management of pain, particularly in inpatients, is a public health priority. We conducted this study to ascertain current practices and identify indications useful for measuring their impact. PATIENTS AND METHODS: A "given day" cross-sectional study was conducted in 18 units (11 medicine units and 7 surgery and obstetrics units) at the Cochin Hospital, Paris. All patients hospitalized over 24 hours were included in the study. A short one-page questionnaire was administered by an investigator (nurse or physician) after the patient agreed to participate in the study. All pertinent information concerning pain at admission and/or during the 24 hours of hospitalization (quantified on a simple verbal scale), percent pain relief compared with the initial level, and any circumstances leading to an increase in the pain level during hospitalization were recorded. Data were also collected on antalgesia prescription administered the day of the survey. Social and demographic data as well as discharge diagnosis(es) were also recorded. RESULTS: Nearly 60% of the patients stated they had experienced pain at the time of admission or during the 24-h preceding the survey. In medicine units, 29% of the inpatients with pain were not given any anti-pain treatment (this percentage was 12% in surgery) and 35% stated their pain had been relieved by less than 50% (13% of the patients in surgery). Hospitalization in a medicine unit was associated with fewer and less effective prescriptions in patients experiencing pain. CONCLUSION: Regular and simple indications, specifically the number of patients complaining of pain who have not been given an antalgesic, would provide the health care team with a measurement of pain management useful for assessing its impact and improving patient care.