[Practical considerations for implementing health outcomes measurement projects within a healthcare organization: Delphi Expert Consensus Study]. / Consideraciones prácticas para la implementación de proyectos de medición de resultados en salud en una organización sanitaria: Estudio Delphi de consenso de expertos.

INTRODUCTION: Measuring health outcomes and costs per patient is an essential element of value-based healthcare (VBHC). The aim of the study was to generate expert consensus on the activities required to implement it. METHODS: A two-round modified Delphi study with healthcare professionals, quality and clinical management methodologists and managers with academic and/or practical experience in outcome measurement projects. A median equal to or greater than 4 and a relative interquartile range (RIQR) equal to or greater than 25% were established as consensus criteria. RESULTS: Consensus was obtained on 91% of the items (N=74/81). In terms of feasibility, the items that received the highest score and consensus were the existence of data protection guarantees (median=5; mean=4.8; RIQR=0%), the vision and motivation of healthcare professionals (median=5; mean=4.7; RIQR=20%), the existence and availability of ICT tools (or systems) for data recording (median=5; mean=4.5; RIQR=20%), and having sufficient funding to undertake the project (median=5; mean=4.2; RIQR=20%). The most highly rated factors adding complexity were the number of units or departments involved in the care process for the clinical condition (median=5; mean=4.4; RIQR=20%), having an accepted set of monitoring indicators for the condition (median=5; mean=4.4; RIQR=20%), and the involvement of several levels of care in the project (median=5; mean=4.3; RIQR=20%). CONCLUSIONS: We describe practical aspects for the application of systematic outcomes measurement in routine clinical practice. These results can serve as a tool for prioritising, sizing, resource planning, and estimating implementation costs.

Design of an assistance protocol for the restart of scheduled urologic surgery in a COVID-19 epidemic period. / Diseño de un protocolo asistencial para el reinicio de la cirugía urológica programada en periodo de epidemia COVID-19.

OBJECTIVE: Design a care protocol to restart scheduled surgical activity in a Urology service of a third level hospital in the Community of Madrid, in a safe way for our patients and professionals in the context of the SARS-CoV-2 coronavirus epidemic. MATERIAL AND METHODS: A multidisciplinary group reviewed the different recommendations of the literature, national and international health organizations and scientific societies, as well as their application to our environment. Once scheduled surgery has restarted, the patients undergoing surgery for complications related to COVID-19 are being followed up. RESULTS: Since the resumption of surgical activity, 19 patients have been scheduled, of which 2 have been suspended for presenting COVID-19, one diagnosed by positive PCR for SARS-CoV-2, and another by laboratory and imaging findings compatible with this infection. With a median follow-up of 10 days (4-14 days), no complications related to COVID-19 were detected. CONCLUSIONS: Preliminary results indicate that the protocol designed to ensure the correct application of preventive measures against the transmission of coronavirus infection is being safe and effective.

[Detection of adverse events in thyroid and parathyroid surgery using trigger tool and Minimum Basic Data Set (MBDS)]. / Detección de eventos adversos en la cirugía tiroidea y paratiroidea utilizando la herramienta trigger y el Conjunto Mínimo de Datos Básicos (CMBD).

OBJECTIVES: To compare the ability of the trigger tool) and the Minimum Basic Data Set (MBDS) in detecting adverse events (AE) in hospitalized surgical patients with thyroid and parathyroid disease. METHODS: A descriptive, cross-sectional observational study, retrospective and cross-sectional study was conducted from May 2014 to April 2015 analysing retrospectively data on of patients submitted to thyroidectomy and parathyroidectomy in order to detect AE through the identification of triggers (an event often associated to an AE) and the MBDS. triggers and AE were located by systematic review of clinical documentation. The MBDS was got from the data base. Once an AE was detected, it was characterized. RESULTS: 203 AE were identified in 251 patients, being the 90.04% detected by trigger tool and 10.34% by MBDS. 126 patients had at least one AE (50.2%). Without the cases in which uncontrolled pain was the only AE, the percentage of patients that suffering AE was 38.65%. 187 AE were considered preventable and 16 AE were considered unpreventable. The trigger tool and the MBDS demonstrated a sensitivity of 91.27 and 13.49%, a specificity of 4.8 and 100%, a positive predictive value of 49,15 and 100%, and a negative predictive value of 35.29 and 53.42%, respectively. The triggers with more predictive power in AE detection were «antiemetic administration¼ and «calcium administration¼. CONCLUSIONS: Trigger tool shows higher sensitivity for detecting AE than the MBDS. All the detected AE were considered low severity and most of them were preventable.

[Comparison of the "Trigger" tool with the minimum basic data set for detecting adverse events in general surgery]. / Comparación de la herramienta Trigger con el conjunto mínimo básico de datos (CMBD) para la detección de eventos adversos en cirugía general.

INTRODUCTION: Surgery is a high risk for the occurrence of adverse events (AE). The main objective of this study is to compare the effectiveness of the Trigger tool with the Hospital National Health System registration of Discharges, the minimum basic data set (MBDS), in detecting adverse events in patients admitted to General Surgery and undergoing surgery. MATERIAL AND METHODS: Observational and descriptive retrospective study of patients admitted to general surgery of a tertiary hospital, and undergoing surgery in 2012. The identification of adverse events was made by reviewing the medical records, using an adaptation of "Global Trigger Tool" methodology, as well as the (MBDS) registered on the same patients. Once the AE were identified, they were classified according to damage and to the extent to which these could have been avoided. The area under the curve (ROC) were used to determine the discriminatory power of the tools. The Hanley and Mcneil test was used to compare both tools. RESULTS: AE prevalence was 36.8%. The TT detected 89.9% of all AE, while the MBDS detected 28.48%. The TT provides more information on the nature and characteristics of the AE. The area under the curve was 0.89 for the TT and 0.66 for the MBDS. These differences were statistically significant (P<.001). CONCLUSIONS: The Trigger tool detects three times more adverse events than the MBDS registry. The prevalence of adverse events in General Surgery is higher than that estimated in other studies.

[An analysis of complaints received in a Neurology Service]. / Análisis de reclamaciones en un servicio de neurología.

AIMS: To determine the number of complaints received by the Neurology Service in one year, to carry out a qualitative analysis, and to examine how they are dealt with in order to provide patients with a solution. MATERIALS AND METHODS: The work involved a retrospective study of the complaints from patients in the Neurology Service throughout the year 2004, using the information provided by the Patient Advice and Liaison Service. The following quality indicators were used to evaluate how these claims were managed: the percentage of complaints that were attended in less than 30 days after being received and the percentage of complaints that were resolved. RESULTS: Throughout the period under study a total of 183 complaints were received: 1/478 hospital admissions (0.21%), 71/43,841 medical visits (0.16%), 110/5,522 neurophysiological studies (2%) and 3 due to other reasons. It was found that 90.2% of all complaints had to do with waiting lists, 3.3% were related to dealings with staff and the rest were due to other causes. 86.3% of the complaints were resolved, 10.2% were dismissed and the others were passed on or shelved. 77.5% of the claims were attended within 30 days (quality parameter), the mean delay being 21.3 days (standard deviation: 11.3). CONCLUSIONS: Our rate of complaints is low, although improvements must be introduced both quantitatively and in their management. Practically no data has been published to date concerning these aspects of clinical management in neurology services.

[End-of-life care in the pediatric intensive care unit. A literature review]. / Cuidados al final de la vida en la unidad de cuidados intensivos pediátrica. Revisión de la bibliografía.

INTRODUCTION: In the last few years, there has been growing concern in the literature about issues related to end-of-life care in pediatric intensive care units (PICUs), with special attention on the family/patient unit, communication, and a dignified death. OBJECTIVE: To evaluate the experience and development of end-of-life care in PICUs through a literature review, by determining the type of studies that have been performed, their topics, the issues discussed, and their development in the last few years. MATERIAL AND METHODS: Review of the medical literature in Medline and the database of the National Library of Medicine Gateway, using the key words from MeSH: "end of life", "pediatric intensive care", "critical care", "palliative care", "death", and "compassionate care". The earliest year of the search was 1990. The languages selected were English and Spanish. Inclusion criteria were the relationship with the topic to be studied, excluding articles with no abstract. Additional searches were made of references in selected articles. RESULTS: Eighty-one articles were retrieved from the initial search. Of these, 43 were selected as the most relevant investigations in end-of-life care in ICUs and 18 placed special emphasis on the PICU. More than half of the articles (62 %) were reviews and the remaining articles were descriptive or observational studies. The number of publications increased after 1995. Most of the studies were performed in the USA or Canada and only three studies were performed in Spain. CONCLUSIONS: In the last few years, several studies have been performed that reveal increasing concern about limits to therapeutic intervention and the need to improve end-of-life care in the PICU setting.

[Detection of adverse events in hospitalized adult patients by using the Global Trigger Tool method]. / Detección de eventos adversos en pacientes adultos hospitalizados mediante el método Global TriggerTool.

OBJECTIVES: To identify and characterize adverse events (AE) in an Internal Medicine Department of a district hospital using an extension of the Global Trigger Tool (GTT), analyzing the diagnostic validity of the tool. METHODS: An observational, analytical, descriptive and retrospective study was conducted on 2013 clinical charts from an Internal Medicine Department in order to detect EA through the identification of 'triggers' (an event often related to an AE). The 'triggers' and AE were located by systematic review of clinical documentation. The AE were characterized after they were identified. RESULTS: A total of 149 AE were detected in 291 clinical charts during 2013, of which 75.3% were detected directly by the tool, while the rest were not associated with a trigger. The percentage of charts that had at least one AE was 35.4%. The most frequent AE found was pressure ulcer (12%), followed by delirium, constipation, nosocomial respiratory infection and altered level of consciousness by drugs. Almost half (47.6%) of the AE were related to drug use, and 32.2% of all AE were considered preventable. The tool demonstrated a sensitivity of 91.3% (95%CI: 88.9-93.2) and a specificity of 32.5% (95%CI: 29.9-35.1). It had a positive predictive value of 42.5% (95%CI: 40.1-45.1) and a negative predictive value of 87.1% (95%CI: 83.8-89.9). CONCLUSIONS: The tool used in this study is valid, useful and reproducible for the detection of AE. It also serves to determine rates of injury and to observe their progression over time. A high frequency of both AE and preventable events were observed in this study.

[Treatment in spontaneous intracerebral haemorrhage. Analysis of Spanish clinical series]. / Tratamiento de la hemorragia intracerebral espontánea. Análisis de las series clínicas españolas.

OBJECTIVE: In the spontaneous intracerebral hemorrhage (SICH) there are a small number of unequivocally indicators of surgical or conservative treatment. DEVELOPMENT: An extensive bibliographic revision of studies of patients with spontaneous ICH admitted to Spanish Hospitals has been completed. Later on, studies related to analyses and results of mortality and functional state of surgical and conservative treatments of ICH were gathered. Using the Cochrane Collaboration Manual the methodological quality of the studies has been evaluated. CONCLUSIONS: The chosen studies were 25 clinical series. Only two studies comparing the surgical against the conservative treatment of supratentorial ICH has been found. The intrinsic methodological quality associated to this type of studies does not allow to establish valid conclusions on the efficacy of one treatment over another. Nonetheless it has utility considering that it reveals the chosen treatment and the outcomes in the published studies. We did not found studies evaluating the efficacy of both treatments in Spain with a prospective randomised design, with an adequate size, analysing mortality, dependency and quality of life of the affected patients. Therefore, our final conclusion is that given the importance of the information that could be extracted from these studies in order to design the more efficient treatment of ICH no delay to complete them can be admitted.

[Lasegue's test as prognostic factor for patients undergoing lumbar disc surgery]. / El test de Lásegue postoperatorio como factor pronóstico de los pacientes intervenidos de hernia discal lumbar.

INTRODUCTION: In patients operated for herniated lumbar disc it could be very useful to develop physical examination criteria that would allow early prediction of medium or long term clinical outcomes. The result of the Lasegue test after surgery depends on the occurrence of recurrent herniated disc and/or scar formation around the nerve root. Previous studies have shown the association between the result of Lasegue test, assessed 4 months after surgery, and the short term functional outcome. OBJECTIVE: To determine the prognostic value of postoperative Lasegue test in relation with medium term functional and clinical outcomes which were estimated by analyzing the functional grade, employment status, quality of life, reoperation for recurrent disc herniation, and the number of clinical revisions and imaging studies needed during the follow-up. PATIENTS AND METHODS: 243 patients who underwent hemilaminectomy for lumbar herniated disc between 1996 and 2002 were studied. The Lasegue sign was tested 3 months after surgery. A modification of Spangfort's criteria (to measure the functional grade) and the 12-item Short-form health survey (SF-12) method (to measure the quality of life) were used to quantify outcomes at 12, 24 and 36 months after initial surgery. RESULTS: This investigation has proved the prognostic value of Lasegue test assessed 3 months after initial surgery. A statistically significant correlation was found between a positive straight leg raising test and a poor functional status at 24 and 36 months, and the risk do not return to work because of persistent pain at 12, 24 and 36 months. A statistically significant correlation was also found between the result of the test and the frequency of reoperation for recurrent disc herniation and the number of clinical revisions and imaging control studies needed through the follow-up. Likewise, the prognostic value of Lasegue test on different aspects of quality of life (health perception, functional performances, poor social interaction and severe pain) analyzed at 24 and 36 months after surgery were also confirmed. CONCLUSION: This study provides additional information about the predictive value of the straight leg raising tested 3 months after surgery on the clinical (diagnostic resources consumption, successive outpatient revisions, etc) and functional (quality of life, functional grade and return to work) outcomes assessed 24 and 36 months after initial surgery.

[Quality analysis and evaluation of surgery for herniated lumbar disk. I. Methodology]. / Análisis y evaluación de la calidad en la cirugía de la hernia discal lumbar I. Metodología.

A method for the analysis of the quality of the lumbar disc surgery was developed. The method assesses the important quality parameters such as scientific and technical quality (STQ), functional grades, quality of life, patients satisfaction and economic costs. The STQ related to the measurement of the care according to the available medical and technological knowledge was determined according to the performance of explicit criteria and standards in the clinic documentation (PEP method: Performance Evaluation Procedure). To measure the functional grade, a modification of Spanfort's criteria was used. To assess the quality of life a modification of 12-item Short Form health survey was applied. This form includes aspects like pain, social interaction, family characteristics, employment and psychological status. A questionnaire was used to measure satisfaction. The form was previously designed taking into account the patients and professionals criteria. In every stage care given, information issued, management and hosting, the patients and professionals opinions was considered and weighted. To calculate the cost three different systems were proposed i.e., Analytic economic management system (ABC-ABM), Weight related costs of DRGs (Diagnostic Related Groups) and Costs computed from price listing for consulting and hospitalization established by INSALUD.

[Evaluation of the surgical process for herniated lumbar disk. II. Approximation to scientific-technical quality]. / Evaluación del proceso quirúrgico de la hernia discal lumbar II. Una aproximación a la calidad científico técnica.

INTRODUCTION: The procedure of surgical treatment of lumbar disc herniation belongs to the group of clinical practice procedures that have a great repercussion on health care systems. The high prevalence of this disease, the management variability and the possibility of improvement, explain the great interest in the evaluation of the quality of both treatment procedure and outcomes. OBJECTIVE: To determine and analyze the scientific and technical quality (STQ) of lumbar disc disease surgery and its correlation with some outcome measurements (clinical efficacy-functional grade and quality of life). METHODS: 172 patients who underwent a hemilaminectomy for lumbar herniated disc between 1996 and 1999 were studied. To analyze the STQ, we used the PEP (Performance Evaluation Procedure) method. A modification of Spangfort's criteria: to measure the functional grade- and the 12-item Short-form health survey (SF-12) to measure the quality of life- were the methods used to quantify outcomes, assessed after 12, 24 and 36 months after surgery. RESULTS: The mean overall STQ score was 0.83 (0-1). The anamnesis was the stage with worse information quality. Though neurosurgeons usually consider the anamnesis and physical examination data as the most important factors for decision making, these were no the best collected in the clinical reports. Surprisingly, data considered not relevant by neurosurgeons were registered with higher fidelity. An statistically significant correlation was found between STQ score and employment status among other parameters associated to the quality of life. The highest STQ scores were found in patients who did not return to work because of persistent pain 12 or 24 months after surgery (p < 0.02 and p < 0.04) and in patients showing poor social interaction and severe pain 12 months after surgery. When analyzing the completeness of clinical history data, statistically significant differences were observed in relation to the type of employment and the degree of physical effort needed at work. Patients working in positions without high skill requirements (p < 0.002) and involving a great physical effort (p < 0.05) had better registered data. Patients with better registered information tended to show a lesser clear surgical indication as a common characteristic, i.e., negative straight leg raising test, length of the current episode lasting more than 6 months and absence of symptoms (p < 0.01) for more than one year since the initial visit to the physician from the beginning of symptoms (p < 0.01), etc. CONCLUSIONS: This method established a significant correlation between STQ and clinical and presurgical variables, as well as between STQ and pain and activity after surgery.

[Opinions on the organisation of health care in strokes. A survey among hospital medical directors in Spain]. / Opinión sobre la organización asistencial en el ictus. Encuesta a directores médicos hospitalarios en España.

INTRODUCTION: Therapy to treat strokes has changed dramatically. Around 70 years ago, it could not be treated and today it is a medical emergency. Awareness of this change has still not reached many layers of the medical or health care professions or of society itself. AIM: To use a survey to evaluate the attitudes of medical directors and hospital specialists towards the problems involved in the inpatient care of stroke patients. Materials and methods. A survey was carried out by means of a pilot study in hospitals in Madrid with specific sub-surveys for medical managers in charge of neurology departments, neurosurgery services and stroke units. These surveys were sent out to 108 acute care hospitals with over 250 beds in 2003-2004. RESULTS: Only the results of the survey administered by medical directors are analysed. Finally, 52 surveys were obtained from 108 hospitals. Information was collected about several aspects of stroke patients, including care in hospital emergency department, admission to hospital, rehabilitation treatment and staffing in stroke units. Care of stroke patients was given a significantly more positive score (better stroke care) by medical directors than by hospital neurologists. CONCLUSIONS: The survey revealed a great care burden from stroke in hospital emergency departments and from hospital admissions, deficits in neurological duty services and in the capacity to perform fibrinolysis and, above all, in stroke units. The data obtained show that medical directors should improve their attitudes with regard to the care of stroke patients.

Psychometric validation of the Spanish version of the Patient-Doctor Relationship Questionnaire (PDRQ).

INTRODUCTION: The main aim of this study was to make a Spanish adaption of the international Patient-Doctor Relationship Questionnaire (PDRQ) that assesses the quality of patient-doctor relationship in Spanish patients admitted to an Internal Medicine Service under conditions of regular clinical practice. METHOD: A total of 188 adult patients of 6 Internal Medicine physicians from a University Hospital in downtown Madrid were analyzed. Sociodemographic and clinical variables were collected and the PDRQ Spanish version questionnaire was administered. RESULTS: Results showed excellent psychometric data on reliability, factorial, and construct validity. Furthermore, based on scientific literature, criteria validity was determined, considering continuity of care as external criteria. Results ratify previous data related to positive relation between quality of doctor-patient relation and continuity of care. CONCLUSIONS: The Spanish 13 item version of the PDRQ (CREM-P in Spanish) proved to be a valid instrument for assessing the quality of patient-doctor relation in adult patients, with clinical and research value.

Incidence of adverse events related to health care in Spain: results of the Spanish National Study of Adverse Events.

OBJECTIVE: To determine the incidence and incidence density of adverse events (AEs) in Spanish hospitals (including the pre-hospitalisation period). METHOD: Retrospective cohort study. RESULTS: The incidence of patients with AEs relating directly to hospital care was 8.4% (95% CI 7.7% to 9.1%) and rose 9.3% (95% CI 8.6% to 10.1%), including those from the pre-hospitalisation period. The incidence density was 1.2 AEs per 100 patient-days (95% CI 1.1 to 1.3). The incidence of moderate and serious AEs was 5.6 AEs per 1000 patient-days (95% CI 4.9% to 6.3%). In 66.3% of AEs, additional procedures were required and in 69.9% additional treatments were required. In total 42.8% of AEs were considered as avoidable. Of the subjects with some intrinsic risk factors, 13.2% developed AEs compared with 5.2% of the subjects who had no risk factors (p<0.001), and 9.5% of the subjects who had some extrinsic risk factors developed AEs compared with 3.4% of the subjects who had not (p<0.001). Patients older than 65 years of age showed a higher frequency of AEs than those under this age (12.4% vs 5.4%, p<0.001, RR 2.5). The most frequent AEs were those associated with medication (37.4%), hospital infections of any type (25.3%) and those relating to technical problems during a procedure (25.0%). A total of 31.4% of the AEs involved an increase in the length of stay. The AEs associated with medical assistance caused 6.1 additional hospital stays by patient. CONCLUSIONS: The incidence of patients with AE related to medical assistance in Spanish hospitals was relevant and similar to those found in the studies from Canada and New Zealand that had been conducted with comparable methodology. Patient vulnerability has been identified therein as playing a major role in generating healthcare-related AEs. These and other recent results indicate the need for AEs to be considered a public health priority in Europe.