Hospital discharge data is not accurate enough to monitor the incidence of postpartum hemorrhage.

Postpartum hemorrhage remains a leading cause of maternal morbidity and mortality worldwide. Therefore, cumulative incidence of postpartum hemorrhage and severe postpartum hemorrhage are commonly monitored within and compared across maternity hospitals or countries for obstetrical safety improvement. These indicators are usually based on hospital discharge data though their accuracy is seldom assessed. We aimed to measure postpartum hemorrhage and severe postpartum hemorrhage using electronic health records and hospital discharge data separately and compare the detection accuracy of these methods to manual chart review, and to examine the temporal trends in cumulative incidence of these potentially avoidable adverse outcomes. We analyzed routinely collected data of 7904 singleton deliveries from a large Swiss university hospital for a three year period (2014-2016). We identified postpartum hemorrhage and severe postpartum hemorrhage in electronic health records by text mining discharge letters and operative reports and calculating drop in hemoglobin from laboratory tests. Diagnostic and procedure codes were used to identify cases in hospital discharge data. A sample of 334 charts was reviewed manually to provide a reference-standard and evaluate the accuracy of the other detection methods. Sensitivities of detection algorithms based on electronic health records and hospital discharge data were 95.2% (95% CI: 92.6% 97.8%) and 38.2% (33.3% to 43.0%), respectively for postpartum hemorrhage, and 87.5% (85.2% to 89.8%) and 36.2% (26.3% to 46.1%) for severe postpartum hemorrhage. Postpartum hemorrhage cumulative incidence based on electronic health records decreased from 15.6% (13.1% to 18.2%) to 8.5% (6.7% to 10.5%) from the beginning of 2014 to the end of 2016, with an average of 12.5% (11.8% to 13.3%). The cumulative incidence of severe postpartum hemorrhage remained at approximately 4% (3.5% to 4.4%). Hospital discharge data-based algorithms provided significantly underestimated incidences. Hospital discharge data is not accurate enough to assess the incidence of postpartum hemorrhage at hospital or national level. Instead, automated algorithms based on structured and textual data from electronic health records should be considered, as they provide accurate and timely estimates for monitoring and improvement in obstetrical safety. Furthermore, they have the potential to better code for postpartum hemorrhage thus improving hospital reimbursement

Management and prognosis of status epilepticus according to hospital setting: a prospective study.

BACKGROUND: The treatment of status epilepticus (SE) is based on relatively little evidence although several guidelines have been published. A recent study reported a worse SE prognosis in a large urban setting as compared to a peripheral hospital, postulating better management in the latter. The aim of this study was to analyse SE episodes occurring in different settings and address possible explanatory variables regarding outcome, including treatment quality. METHODS: Over six months we prospectively recorded consecutive adults with SE (fit lasting five or more minutes) at the Centre Hospitalier Universitaire Vaudois (CHUV) and in six peripheral hospitals (PH) in the same region. Demographical, historical and clinical variables were collected, including SE severity estimation (STESS score) and adherence to Swiss SE treatment guidelines. Outcome at discharge was categorised as "good" (return to baseline), or "poor" (persistent neurological sequelae or death). RESULTS: Of 54 patients (CHUV: 36; PH 18), 33% had a poor outcome. Whilst age, SE severity, percentage of SE episodes lasting less than 30 minutes and total SE duration were similar, fewer patients had a good outcome at the CHUV (61% vs 83%; OR 3.57; 95% CI 0.8-22.1). Mortality was 14% at the CHUV and 5% at the PH. Most treatments were in agreement with national guidelines, although less often in PH (78% vs 97%, P = 0.04). CONCLUSION: Although not statistically significant, we observed a slightly worse SE prognosis in a large academic centre as compared to smaller hospitals. Since SE severity was similar in the two settings but adherence to national treatment guidelines was higher in the academic centre, further investigation on the prognostic role of SE treatment and outcome determinants is required

Effect of measuring patient satisfaction during or after staying in a psychiatric hospital

BACKGROUND: Patient satisfaction surveys are commonly conducted to evaluate health care quality. However, little is known about the impact of the time point of survey administration on the level of satisfaction, questionnaire acceptability, and costs, especially for inpatient psychiatric care. AIMS: To assess whether inpatient satisfaction, questionnaire acceptability, and total costs of study differ according to the time point of questionnaire administration for inpatient psychiatric care. METHOD AND SAMPLE: Inpatients completed the ©Saphora-Psy, a French validated tool measuring satisfaction with care with 35 items assessing 7 dimensions of care, 2-3 days before leaving the ward (first phase). Four to eight weeks after discharge, patients received the same instrument at home (second phase). Time needed to fill the questionnaire and items assessing its acceptability were requested. RESULTS: Only fifty of 104 inpatients in the acute psychiatric hospital, aged &gt;18, who completed the first questionnaire, participated to the second phase, although they all agreed to complete it twice. The participation rate during the hospital stay was 47%. Acceptability did not differ significantly. The mean proportion of missing values was slightly higher after hospital stay (3.84%) than during hospital stay (3.52%), while the number of manuscript comments was identical (n=13). Global evaluation of the questionnaire was similar when administered after or before discharge (excellent/very good : 41% and 42% respectively). General satisfaction with care was rated higher when measured during (vs after) hospital stay. Satisfaction was significantly lower when measured after discharge on four items: nursing staff's empathy (p=0.02) and communication about care (p=0.03), smoking directives (p=0.01), and information regarding treatment after discharge (p=0.01). Costs were about eight times higher during the first phase. CONCLUSIONS: Satisfaction appeared to vary slightly according to the time point of questionnaire administration, with higher ratings measured during hospital stay. In terms of acceptability, the surveys offered identical rates. The costs were much higher during the first phase, due to the hot pursuit of patients about to leave the hospital. [Authors]]]> Patient Satisfaction; Quality of Health Care; Questionnaires; Hospitals, Psychiatric; Hospitalization eng oai:serval.unil.ch:BIB_8CB02C4CD096 2022-05-07T01:22:28Z openaire documents urnserval <oai_dc:dc xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:xs="http://www.w3.org/2001/XMLSchema" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:oai_dc="http://www.openarchives.org/OAI/2.0/oai_dc/" xsi:schemaLocation="http://www.openarchives.org/OAI/2.0/oai_dc/ http://www.openarchives.org/OAI/2.0/oai_dc.xsd"> https://serval.unil.ch/notice/serval:BIB_8CB02C4CD096 Change in defense mechanisms and coping patterns during the course of 2-year-long psychotherapy and psychoanalysis for recurrent depression: a pilot study of a randomized controlled trial. info:doi:10.1097/NMD.0b013e3182982982 info:eu-repo/semantics/altIdentifier/doi/10.1097/NMD.0b013e3182982982 info:eu-repo/semantics/altIdentifier/pmid/23817160 Kramer, U. de Roten, Y. Perry, J.C. Despland, J.N. info:eu-repo/semantics/article article 2013 Journal of Nervous and Mental Disease, vol. 201, no. 7, pp. 614-620 info:eu-repo/semantics/altIdentifier/eissn/1539-736X urn:issn:0022-3018 <![CDATA[Very little research has been conducted so far to study the potential mechanisms of change in long-term active psychological treatments of recurrent depression. The present pilot randomized controlled trial aimed to determine the feasibility of studying the change process occurring in patients during the course of 2-year-long dynamic psychotherapy, psychoanalysis, and cognitive therapy, as compared with clinical management. In total, eight outpatients presenting with recurrent depression, two patients per treatment arm, were included. All patients were randomly assigned to one of the four treatment conditions. Defense mechanisms and coping patterns were assessed using validated observer-rated methodology based on transcribed, semistructured follow-along independent dynamic interviews. The results indicated that, whereas some patients in the active treatments changed on the symptomatic levels, some others remained unchanged during the course of their 2-year-long treatment. However, with regard to potential mechanisms of change in these patients, changes in defense mechanisms and coping patterns were revealed to be important processes over time in successful therapies and, to a lesser extent, in less successful treatments. No change was found either on outcome or on the process measure for the control condition, that is, clinical management. These results are discussed along with previous data comparing change in defense mechanisms and coping during the course of treatments

The BEST study - a prospective study to compare business class versus economy class air travel as a cause of thrombosis

Background. As many as 10% of airline passengers travelling without prophylaxis for long distances may develop a venous thrombosis. There is, however, no evidence that economy class travellers are at increased risk of thrombosis.Objectives. A suitably powered prospective study, based on the incidence of deep-vein thrombosis (DVT) reported in previous studies on long-haul flights, was designed to determine the incidence of positive venous duplex scans and D-dimer elevations in low and intermediate-risk passengers, comparing passengers travelling in business and economy class.Patients/methods. Eight hundred and ninety-nine passengers were recruited (180 travelling business class and 719 travelling economy). D-dimers were measured before and after the flight. A value greater than 500 ng/ml was accepted as abnormal. A thrombophilia screen was conducted which included the factor V Leiden mutation, the prothombin 20210A mutation, protein C and S levels, antithrombin levels, and anticardiolipin antibodies immunoglobulin G (IgG) and immunoglobulin M (IgM). On arrival, lower limb compression ultrasonography of the deep veins was performed. Logistical regression analysis was used to determine the risk factors related to abnormally high D-dimer levels.Results. Only 434 subjects had a full venous duplex scan performed. None had ultrasonic evidence of venous thrombosis. Nine passengers tested at departure had elevated D-dimer levels and these volunteers were excluded from further study. Seventy-four of the 899 passengers had raised D-dimers on arrival. Twenty-two of 180 business class passengers (12%) developed elevated D-dimers compared with 52 of 719 economy class passengers (7%). There was no significant association between elevation of D-dimers and the class flown (odds ratio (OR) 0.61, p = 0.109). The factor V Leiden mutation, factor VIII levels and the use of aspirin were, however, associated with raised D-dimers (OR 3.36, p = 0.024; OR 1.01, p = 0.014; and OR 2.04, p = 0.038, respectively). Five hundred and five passengers were contacted within 6 months and none reported any symptoms of a clinical thrombosis or pulmonary embolus.Conclusion. The incidence of ultrasonically proven DVT is much lower than previously reported. However, more than 10% of all passengers developed raised D-dimers, which were unrelated to the class flown. A rise in D-dimers is associated with an inherent risk of thrombosis and/ or thrombophilia, demonstrates activation of both the coagulation and fibrinolytic systems during long-haul flights, and may indicate the development of small thrombi

What differences are detected by superiority trials or ruled out by noninferiority trials? A cross-sectional study on a random sample of two-hundred two-arms parallel group randomized clinical trials

<p>Abstract</p> <p>Background</p> <p>The smallest difference to be detected in superiority trials or the largest difference to be ruled out in noninferiority trials is a key determinant of sample size, but little guidance exists to help researchers in their choice. The objectives were to examine the distribution of differences that researchers aim to detect in clinical trials and to verify that those differences are smaller in noninferiority compared to superiority trials.</p> <p>Methods</p> <p>Cross-sectional study based on a random sample of two hundred two-arm, parallel group superiority (100) and noninferiority (100) randomized clinical trials published between 2004 and 2009 in 27 leading medical journals. The main outcome measure was the smallest difference in favor of the new treatment to be detected (superiority trials) or largest unfavorable difference to be ruled out (noninferiority trials) used for sample size computation, expressed as standardized difference in proportions, or standardized difference in means. Student t test and analysis of variance were used.</p> <p>Results</p> <p>The differences to be detected or ruled out varied considerably from one study to the next; e.g., for superiority trials, the standardized difference in means ranged from 0.007 to 0.87, and the standardized difference in proportions from 0.04 to 1.56. On average, superiority trials were designed to detect larger differences than noninferiority trials (standardized difference in proportions: mean 0.37 versus 0.27, <it>P </it>= 0.001; standardized difference in means: 0.56 versus 0.40, <it>P </it>= 0.006). Standardized differences were lower for mortality than for other outcomes, and lower in cardiovascular trials than in other research areas.</p> <p>Conclusions</p> <p>Superiority trials are designed to detect larger differences than noninferiority trials are designed to rule out. The variability between studies is considerable and is partly explained by the type of outcome and the medical context. A more explicit and rational approach to choosing the difference to be detected or to be ruled out in clinical trials may be desirable.</p

What differences are detected by superiority trials or ruled out by noninferiority trials? A cross-sectional study on a random sample of two-hundred two-arms parallel group randomized clinical trials

BACKGROUND: The smallest difference to be detected in superiority trials or the largest difference to be ruled out in noninferiority trials is a key determinant of sample size, but little guidance exists to help researchers in their choice. The objectives were to examine the distribution of differences that researchers aim to detect in clinical trials and to verify that those differences are smaller in noninferiority compared to superiority trials. METHODS: Cross-sectional study based on a random sample of two hundred two-arm, parallel group superiority (100) and noninferiority (100) randomized clinical trials published between 2004 and 2009 in 27 leading medical journals. The main outcome measure was the smallest difference in favor of the new treatment to be detected (superiority trials) or largest unfavorable difference to be ruled out (noninferiority trials) used for sample size computation, expressed as standardized difference in proportions, or standardized difference in means. Student t test and analysis of variance were used. RESULTS: The differences to be detected or ruled out varied considerably from one study to the next; e.g., for superiority trials, the standardized difference in means ranged from 0.007 to 0.87, and the standardized difference in proportions from 0.04 to 1.56. On average, superiority trials were designed to detect larger differences than noninferiority trials (standardized difference in proportions: mean 0.37 versus 0.27, P = 0.001; standardized difference in means: 0.56 versus 0.40, P = 0.006). Standardized differences were lower for mortality than for other outcomes, and lower in cardiovascular trials than in other research areas. CONCLUSIONS: Superiority trials are designed to detect larger differences than noninferiority trials are designed to rule out. The variability between studies is considerable and is partly explained by the type of outcome and the medical context. A more explicit and rational approach to choosing the difference to be detected or to be ruled out in clinical trials may be desirable

Primary care physicians' attitude and reported prescribing behavior for chronic low back pain: An exploratory cross-sectional study.

Recent guidelines for chronic or recurrent low back pain recommend non-pharmacologic treatments as first-line options. The objective of this study was thus to explore the perceived usefulness of several conventional and complementary medicine treatments for chronic or recurrent low back pain by primary care physicians and their reported prescribing behavior. An exploratory cross-sectional study. Primary care physicians of the French-speaking part of Switzerland. Primary care physicians' perceived usefulness of each conventional and complementary medicine treatment and their reported recommendation behavior were considered dependent variables in multivariate logistic regression models. All correlations were computed between binary variables, and phi coefficients were calculated to estimate correlation strengths. 533 primary care physicians answered the questionnaire (response rate: 25.6%). The top 3 conventional treatments most often considered useful by primary care physicians for chronic or recurrent low back pain were physiotherapy (94.8%), nonsteroidal anti-inflammatory drugs (87.9%), and manual therapy (82.5%), whereas the most prescribed conventional treatments were physiotherapy (99.2%), nonsteroidal anti-inflammatory drugs (97.4%), and acetaminophen (94.4%). Osteopathic treatment (78.4%), yoga (69.3%), and therapeutic massage (63.9%) were the complementary medicine treatments most often considered useful by primary care physicians in managing chronic or recurrent low back pain. Being a female physician, younger than 56 years, trained in complementary medicine, or using complementary medicine were all associated with higher perceived usefulness of complementary medicine treatments in general. The most recommended complementary medicine treatments by primary care physicians were osteopathic treatment (87.3%), acupuncture (69.3%), and therapeutic massage (58.7%). Being a female physician, younger than 56, and using complementary medicine were all associated with more complementary medicine recommendation in general. Our results highlight the importance of better understanding the prescribing patterns of primary care physicians for chronic or recurrent low back pain. Considering the frequency and burden of chronic or recurrent low back pain, programs focusing on the most (cost-) effective treatments should be implemented

Feasibility, acceptability and effectiveness of integrated care for COPD patients: a mixed methods evaluation of a pilot community-based programme.

The aim of this study was to assess the feasibility, acceptability and effectiveness of a pilot COPD integrated care programme implemented in Valais, Switzerland. The programme was adapted from the self-management programme Living Well with COPD, and included the following elements: self-management patient-education group sessions, telephone and medical follow-ups, multidisciplinary teams, training of healthcare professionals, and evidence-based COPD care. A process and outcome evaluation of the pilot phase of the programme was conducted by means of qualitative and quantitative methods. Reach (coverage, participation rates), dosage (interventions carried out), fidelity (delivered as intended) and stakeholders' acceptance of the programme were evaluated through data monitoring and conduct of focus groups with patients and healthcare professionals. Effectiveness was assessed with pre-post analyses (before and after the intervention). The primary outcome measures were; (1) generic and disease-specific quality of life (36-Item Short Form Health Survey, Chronic Respiratory Questionnaire); and (2) hospitalisations (all-cause and for acute exacerbations) in the past 12 months. Secondary outcomes included self-efficacy, number of exacerbations and exercise capacity. Finally, controlled pre-post comparisons were also made with patients from the Swiss COPD Cohort for three common outcome measures (dyspnoea [mMRC score], number of exacerbations and smoking status). During the first 2 years of the programme, eight series of group-based education sessions were delivered to 57 patients with COPD in three different locations of the canton of Valais. Coverage objectives were achieved and attendance rate at the education sessions was high (83.6%). Patients' and healthcare professionals' reported a high degree of satisfaction, except for multidisciplinarity and transfer of information. Exploration of the effectiveness of this pilot programme suggested positive pre-post results at 12 months, with improvements in terms of health-related quality of life, self-efficacy, exercise capacity, immunisation coverage and Patient Assessment of Chronic Illness Care score. No other outcome, including the number of hospital admissions, differed significantly after 12 months. We observed no differences from the control group. The evaluation demonstrated the feasibility and acceptability of the programme and confirmed the relevance of mixed method process evaluation to adjust and improve programme implementation. The introduction of multidisciplinary teams in a context characterised by fragmentation of care was identified as the main challenge in the programme implementation and could not be achieved as expected. Despite this area for improvement, patients' feedback and early effectiveness results confirmed the benefits of COPD integrated care programmes emphasising self-management education

Prevalence, characteristics, and publication of discontinued randomized trials.

IMPORTANCE: The discontinuation of randomized clinical trials (RCTs) raises ethical concerns and often wastes scarce research resources. The epidemiology of discontinued RCTs, however, remains unclear. OBJECTIVES: To determine the prevalence, characteristics, and publication history of discontinued RCTs and to investigate factors associated with RCT discontinuation due to poor recruitment and with nonpublication. DESIGN AND SETTING: Retrospective cohort of RCTs based on archived protocols approved by 6 research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We recorded trial characteristics and planned recruitment from included protocols. Last follow-up of RCTs was April 27, 2013. MAIN OUTCOMES AND MEASURES: Completion status, reported reasons for discontinuation, and publication status of RCTs as determined by correspondence with the research ethics committees, literature searches, and investigator surveys. RESULTS: After a median follow-up of 11.6 years (range, 8.8-12.6 years), 253 of 1017 included RCTs were discontinued (24.9% [95% CI, 22.3%-27.6%]). Only 96 of 253 discontinuations (37.9% [95% CI, 32.0%-44.3%]) were reported to ethics committees. The most frequent reason for discontinuation was poor recruitment (101/1017; 9.9% [95% CI, 8.2%-12.0%]). In multivariable analysis, industry sponsorship vs investigator sponsorship (8.4% vs 26.5%; odds ratio [OR], 0.25 [95% CI, 0.15-0.43]; P &lt; .001) and a larger planned sample size in increments of 100 (-0.7%; OR, 0.96 [95% CI, 0.92-1.00]; P = .04) were associated with lower rates of discontinuation due to poor recruitment. Discontinued trials were more likely to remain unpublished than completed trials (55.1% vs 33.6%; OR, 3.19 [95% CI, 2.29-4.43]; P &lt; .001). CONCLUSIONS AND RELEVANCE: In this sample of trials based on RCT protocols from 6 research ethics committees, discontinuation was common, with poor recruitment being the most frequently reported reason. Greater efforts are needed to ensure the reporting of trial discontinuation to research ethics committees and the publication of results of discontinued trials

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

BACKGROUND: Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. METHODS AND FINDINGS: We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. CONCLUSIONS: Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol