Early warnings and repayment plans: novel trial management methods for monitoring and managing data return rates in a multi-centre phase III randomised controlled trial with paper Case Report Forms.

BACKGROUND: Monitoring and managing data returns in multi-centre randomised controlled trials is an important aspect of trial management. Maintaining consistently high data return rates has various benefits for trials, including enhancing oversight, improving reliability of central monitoring techniques and helping prepare for database lock and trial analyses. Despite this, there is little evidence to support best practice, and current standard methods may not be optimal. METHODS: We report novel methods from the Trial of Imaging and Schedule in Seminoma Testis (TRISST), a UK-based, multi-centre, phase III trial using paper Case Report Forms to collect data over a 6-year follow-up period for 669 patients. Using an automated database report which summarises the data return rate overall and per centre, we developed a Microsoft Excel-based tool to allow observation of per-centre trends in data return rate over time. The tool allowed us to distinguish between forms that can and cannot be completed retrospectively, to inform understanding of issues at individual centres. We reviewed these statistics at regular trials unit team meetings. We notified centres whose data return rate appeared to be falling, even if they had not yet crossed the pre-defined acceptability threshold of an 80% data return rate. We developed a set method for agreeing targets for gradual improvement with centres having persistent data return problems. We formalised a detailed escalation policy to manage centres who failed to meet agreed targets. We conducted a post-hoc, descriptive analysis of the effectiveness of the new processes. RESULTS: The new processes were used from April 2015 to September 2016. By May 2016, data return rates were higher than they had been at any time previously, and there were no centres with return rates below 80%, which had never been the case before. In total, 10 centres out of 35 were contacted regarding falling data return rates. Six out of these 10 showed improved rates within 6-8 weeks, and the remainder within 4 months. CONCLUSIONS: Our results constitute preliminary effectiveness evidence for novel methods in monitoring and managing data return rates in randomised controlled trials. We encourage other researchers to work on generating better evidence-based methods in this area, whether through more robust evaluation of our methods or of others.

Effect of Endovascular Interventions on General Surgery Trainee Operative Experience; a Comparison of Case Log Reports.

BACKGROUND: Vascular surgery fellowship training has evolved with the widespread adoption of endovascular interventions. The purpose of this study is to examine how general surgery trainee exposure to vascular surgery has changed over time. METHODS: Review of the Accreditation Council for Graduate Medical Education national case log reports for graduating Vascular Surgery Fellows (VF), and general surgery residents (GSR) from 2001 to 2012 was performed. RESULTS: The number of GSR increased from 1021 to 1098, and the number of VF increased from 96 to 121 from 2001 to 2012. The total number of vascular cases done by VF increased by 1161 since 2001 (298-762), whereas the total number of vascular cases done by GSR has decreased by 40% during this time period (186-116). Vascular fellows increase was due primarily to an increase in endovascular experience; a finding not noted in general surgery residents. CONCLUSIONS: Vascular fellow case log changes are due primarily to an increase in endovascular experience that has not been mirrored by general surgery trainees. Open surgery experience has decreased overall for general surgery residents in all major categories, a change not seen in vascular surgery fellows.

ICD-10: are you ready for a brave new world?

The ICD-10 transition will be an evolutionary process. Relying on the EHR or certified coding staff alone will not be sufficient. The EHR can facilitate easy search tools that assist the provider in selecting a diagnosis. Billing staff are an invaluable resource to help validate that coding and documentation are in sync but the burden will clearly rest on the provider. The provider will be juggling a new code structure, drilling down to new levels of complexity and ensuring their documentation supports the specificity of the new codes selected, all while managing a full patient schedule. Education for the provider will be of paramount importance as they navigate this brave new world.

Assessment of the impact on time to complete medical record using an electronic medical record versus a paper record on emergency department patients: a study.

BACKGROUND: Electronic medical records are becoming an integral part of healthcare delivery. OBJECTIVE: The goal of this study was to compare paper documentation versus electronic medical record for non-traumatic chest pain to determine differences in time for physicians to complete medical records using paper versus electronic mediums. We also assessed physician satisfaction with the electronic format. METHODS: We conducted this before-after study in a single large tertiary care academic emergency department. In the 'Before Period', stopwatches determined the time for paper medical recording. In the 'After Period', a template-based electronic medical record was introduced and the time for electronic recording was measured. The time to record in the before and after periods were compared using a two-sided t test. We surveyed physicians to assess satisfaction. RESULTS: We enrolled 100 non-traumatic patients with chest pain in the before period and 73 in the after period. The documentation time was longer using electronic charting, (9.6±5.9 min vs 6.1±2.5 min; p<0.001). 18 of 20 physicians participating in the after period completed surveys. Physicians were not satisfied with the electronic patient recording for non-traumatic chest pain. CONCLUSIONS: This is the first study that we are aware of which compared paper versus electronic medical records in the emergency department. Electronic recording took longer than paper records. Physicians were not satisfied using this electronic record. Given the time pressures on emergency physicians, a solution to minimise the charting time using electronic medical records must be found before widespread uptake of electronic charting will be possible.

[Structured radiology reports].

The paper reviews the problem of using structured radiology reports. Their salient features are as follows: to work out a protocol in accordance with some pattern, to divide it into subheadings arranged consecutively and logically and broken down by main anatomical structures, types of disease, and study, and to use standardized terminology. The RSNA proposed RadLex system is the most known example of structured reports. The experience in using these protocols has shown that the latter may improve the clearness and informative value of roentgenologists' opinions and alleviate their understanding by physicians of other specialties. However, the systems of writing the structured radiology reports have a number of constraints for the time being, which interfere with their wide clinical introduction. Nonetheless, their use is substantially increasing in the years ahead.

[Radiology report: past, present and future].

The analysis of literature data showed that the creation and implementation of a new form of radiology reports into clinical practice is an actual problem of modern medicine. Although imaging modalities have undergone dramatic evolution over the past century, radiology reporting has remained largely static, in both content and structure. In recent years the necessity to create a structured reporting is widely discussed in the literature. A universal format of radiology report hasn't been found yet. The standard of reporting system is absent, a wide variety of styles in radiology reporting currently exists. The challenging goal is improvement of existing protocols and creation of a new form of radiology reports--the protocols of the future.

Improving prescribing safety in patients with renal insufficiency in the ambulatory setting: the Drug Renal Alert Pharmacy (DRAP) program.

STUDY OBJECTIVE: To determine whether a computerized Drug Renal Alert Pharmacy (DRAP) program could decrease the rate of medication errors in drug selection or dosing for 15 target drugs in patients with renal insufficiency. DESIGN: Randomized, controlled, population-based effectiveness trial. SETTING: A large integrated health care delivery system. PATIENTS: A total of 32,917 health plan members who were at least 18 years old, had an estimated creatinine clearance of 50 ml/minute or lower, and were not receiving dialysis between December 1, 2003, and February 28, 2005, were randomly assigned to either the intervention group (16,577 patients) or usual care (control) group (16,340 patients). Of the 32,917 patients, 6125 patients (3025 in the intervention group and 3100 in the usual care group) were prescribed at least one target drug and were included in the analysis. INTERVENTION: A computerized tool--the DRAP program--was used to alert pharmacists at the time of dispensing to possible errors in target drug selection and dosing for patients with renal insufficiency. The 15 target drugs were previously identified based on frequency of use in our health care system and risk of serious adverse events. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the proportion of medication errors, defined as target drugs that should be avoided or were dosed inappropriately, in the intervention and usual care groups. The Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework was used to evaluate the intervention's potential for translation and generalizability. Among the 6125 patients who received a target drug, no significant differences were noted in age, sex, creatinine clearance, comorbid conditions, and number of target drugs between groups at baseline. Over the 15-month intervention period, the proportion of medication errors was significantly lower in the intervention group than the usual care group (33% vs 49%, p<0.001). After the study period, when the intervention was expanded to both groups, a 20% reduction in errors was sustained in the combined groups over the subsequent 7 months. CONCLUSION: The DRAP program was successful in reducing medication errors for patients with renal insufficiency in an ambulatory setting and was demonstrated to have sustainability after study completion.

Prontuário eletrônico como ferramenta de gestão no consultório odontológico / Eletronic assessment as a tool of management in dentist office

Este trabalho, de revisão de literatura, objetiva descrever a utilização da informática para o crescimento do profissional cirurgião-dentista nos dias atuais, enfatizando o uso do prontuário eletrônico. Descreve-se sua facilidade, validade e confiabilidade, mostrando que o mesmo pode atender, também, à saúde pública e até às autoridades judiciais em caso de processos criminais e cíveis. O momento é de transição entre os prontuários de papel e o eletrônico. A segurança e confiabilidade dos prontuários eletrônicos apoiam-se em princípios de integridade, confiabilidade, disponibilidade, autenticação, autorização, legalidade e auditoria geradas pela certificação digital instituída pela Medida Provisória 2200-2 de 2001.

Electronic synoptic operative reporting: assessing the reliability and completeness of synoptic reports for pancreatic resection.

BACKGROUND: Electronic synoptic operative reports (E-SORs) have replaced dictated reports at many institutions, but whether E-SORs adequately document the components and findings of an operation has received limited study. This study assessed the reliability and completeness of E-SORs for pancreatic surgery developed at our institution. STUDY DESIGN: An attending surgeon and surgical fellow prospectively and independently completed an E-SOR after each of 112 major pancreatic resections (78 proximal, 29 distal, and 5 central) over a 10-month period (September 2008 to June 2009). Reliability was assessed by calculating the interobserver agreement between attending physician and fellow reports. Completeness was assessed by comparing E-SORs to a case-matched (surgeon and procedure) historical control of dictated reports, using a 39-item checklist developed through an internal and external query of 13 high-volume pancreatic surgeons. RESULTS: Interobserver agreement between attending and fellow was moderate to very good for individual categorical E-SOR items (kappa = 0.65 to 1.00, p < 0.001 for all items). Compared with dictated reports, E-SORs had significantly higher completeness checklist scores (mean 88.8 +/- 5.4 vs 59.6 +/- 9.2 [maximum possible score, 100], p < 0.01) and were available in patients' electronic records in a significantly shorter interval of time (median 0.5 vs 5.8 days from case end, p < 0.01). The mean time taken to complete E-SORs was 4.0 +/- 1.6 minutes per case. CONCLUSIONS: E-SORs for pancreatic surgery are reliable, complete in data collected, and rapidly available, all of which support their clinical implementation. The inherent strengths of E-SORs offer real promise of a new standard for operative reporting and health communication.

Time trends and predictors of mortality from ill-defined causes in old age: 9 year follow-up of the Bambuí cohort study (Brazil).

The study objective was to examine differentials in time trends and predictors of deaths assigned to symptoms, signs and ill-defined conditions in comparison with other ill-defined conditions (ill-defined cardiovascular diseases, cancer and injury) in a population-based cohort study. Of 1,606 baseline participants aged 60 years and over, 524 died during 9-year follow-up and were included in this study. Deaths coded to "symptoms" declined by 77% in the period from 1997-1999 to 2003-2005. Deaths coded to other ill-defined conditions remained unchanged. The calendar period 2003-2005 (RR = 0.25; 95%CI: 0.09-0.70) and in-hospital deaths (RR = 0.16; 95%CI: 0.08-0.34) were independently associated with "symptoms", but not with other ill-defined conditions. Baseline socio-demographic characteristics and chronic diseases were not predictors of these outcomes. International and national agencies have focused on the reduction of deaths assigned to "symptoms" to improve the registration of vital statistics, while other ill-defined conditions have received little attention. Our data provide evidence supporting the need to redress this situation.

Achieving standardised reporting of suicide in Australia: rationale and program for change.

Suicide and intentional self-harm are issues of major importance in public health and public policy, with rates widely used as progress indicators in these areas. Accurate statistics are vital for appropriately targeted prevention strategies and research, costing of suicide and to combat associated stigma. Underreporting of Australian suicide rates probably grew from 2002 to 2006; Australian Bureau of Statistics (ABS) suicide data were at least 11% or 16% undercounted (depending on case definitions) in 2004. In coronial cases with undetermined intent for 2005 to 2007, intentional self-harm was found in 39%. Systemic reasons for undercounting include: (i) absence of a central authority for producing mortality data; (ii) inconsistent coronial processes for determining intent, as a result of inadequate information inputs, suicide stigma, and high standards of proof; (iii) collection and coding methods that are problematic for data stakeholders; and (iv) lack of systemic resourcing, training and shared expertise. Revision of data after coronial case closure, beginning with ABS deaths registered in 2007, is planned and will reduce undercounting. Other reasons for undercounting, such as missing or ambiguous information (eg, single-vehicle road crashes, drowning), differential ascertainment (eg, between jurisdictions), or lack of recorded information on groups such as Indigenous people and gay, lesbian, bisexual and transgender people require separate responses. A systemic coordinated program should address current inaccuracies, and social stigma about suicide and self-harm must be tackled if widespread underreporting is to stop.

Time trends and predictors of mortality from ill-defined causes in old age: 9 year folllow-up of the Bambuí cohort study (Brazil) / Tendências e fatores associados aos óbitos por causas mal definidas em idosos: nove anos de seguimento da coorte de Bambuí (Brasil)

The study objective was to examine differentials in time trends and predictors of deaths assigned to symptoms, signs and ill-defined conditions in comparison with other ill-defined conditions (ill-defined cardiovascular diseases, cancer and injury) in a population-based cohort study. Of 1,606 baseline participants aged 60 years and over, 524 died during 9-year follow-up and were included in this study. Deaths coded to "symptoms" declined by 77 percent in the period from 1997-1999 to 2003-2005. Deaths coded to other ill-defined conditions remained unchanged. The calendar period 2003-2005 (RR = 0.25; 95 percentCI: 0.09-0.70) and in-hospital deaths (RR = 0.16; 95 percentCI: 0.08-0.34) were independently associated with "symptoms", but not with other ill-defined conditions. Baseline socio-demographic characteristics and chronic diseases were not predictors of these outcomes. International and national agencies have focused on the reduction of deaths assigned to "symptoms" to improve the registration of vital statistics, while other ill-defined conditions have received little attention. Our data provide evidence supporting the need to redress this situation.

As tendências e os determinantes dos óbitos codificados como sinais, sintomas e afecções mal definidas ("sintomas") foram comparados a outras causas mal definidas (algumas doenças cardiovasculares, neoplasias e causas externas). De 1.606 participantes da coorte de base populacional de idosos de Bambuí, Minas Gerais, Brasil, 524 faleceram em nove anos de seguimento e foram incluídos no estudo. As mortes por "sintomas" diminuíram 77 por cento entre 1997-1999 e 2003-2005. Os óbitos por outras causas mal definidas permaneceram inalterados. O período de 2003-2005 (RR = 0,25; IC95 por cento: 0,09-0,70) e os óbitos hospitalares (RR = 0,16; IC95 por cento: 0,08-0,34) associaram-se independentemente com "sintomas", e não com as outras causas mal definidas. Características sócio-demográficas e doenças crônicas na linha de base não apresentaram associações com esses eventos. Estratégias para a redução dos óbitos por "sintomas" têm sido priorizadas por agências internacionais e nacionais, enquanto os óbitos por outras causas mal definidas têm recebido pouca atenção. Os resultados reforçam a necessidade de estratégias para mudar essa situação.

Navigational bronchoscopy: overview of technology and practical considerations--new Current Procedural Terminology codes effective 2010.

Navigational bronchoscopy provides a three-dimensional virtual "roadmap" that enables a physician to maneuver through multiple branches of the bronchial tree to reach targeted lesions in distal regions of the lung. It is designed to be used with a standard bronchoscope to facilitate obtaining tissue samples and for placing radiosurgical or dye markers. This article overviews this technology and the Current Procedural Terminology codes that have been created for its use.