What makes hospitalized patients more vulnerable and increases their risk of experiencing an adverse event?

OBJECTIVE: To analyze the relationship between the appearance of adverse events (AEs) and both patient comorbidities and the use of medical devices. DESIGN: Retrospective medical records review study. SETTING: Twenty-four Spanish public hospitals. PARTICIPANTS: Clinical records of 5624 discharged patients. MAIN OUTCOME MEASURE: Incidence of AEs. RESULTS: Patients aged >65 have 2.4 times the risk of experiencing an AE compared with those aged <65. The presence of certain comorbidities and devices (neoplasia, chronic hepatic alteration, cardiac insufficiency, coronary disease, high blood pressure, urethral catheterization, catheterization of a vessel, tracheostomy or stay of >7 days) were associated with developing an AE during hospitalization. There is a trend effect if we consider the number of comorbidities and the number of devices used. Thus, the risk of an AE in subjects who present no comorbidities was 3.2%, which rose to 9.9% in those with one intrinsic risk factor, 16.7% in those with two and 29.3% in those with three or more. Similarly, subjects without extrinsic risk factor experienced an AE in 4.4% of cases, which rose to 9.6% when there was one risk factor, to 13.4% when there were two and to 33.0% when there were three or more risk factors. The effect of some of these pathologies and that associated with age disappeared on adjusting in line with other variables. CONCLUSIONS: The true risk resides in the number of exposures to potentially iatrogenic actions, rather than being intrinsic to age or the presence of certain comorbidities.

[Strategic measures for patient safety in the National Health System: on-line training resources and access to scientific knowledge]. / Acciones estratégicas en seguridad del paciente para el Sistema Nacional de Salud. Recursos on-line en formación y acceso al conocimiento científico.

INTRODUCTION: Patient safety (PS) is a priority strategy included in the Quality Plan for the Spanish National Health System and its first objective is to promote PS culture among professionals and patients. The Internet is playing a key role in the access to clinical evidence and in the training of health professionals. MATERIAL AND METHOD: A multidisciplinary working group was created, who defined the criteria to help improve clinical practice in the field of patient safety, by making available and using web-based patient safety training resources and information. RESULTS: Taking advantage of the possibilities offered by the Internet in terms of training, two online self-training tutorials were developed on risk management, patient safety and adverse event prevention. A Newsletter was also launched, together with two specific patient safety Supplements. Moreover, to extend the reach of the PS Strategy, a patient safety web page and weblog were created, in addition to a collaborative (internal) working group tool. Excelenciaclinica.net was also developed; a meta-search engine specialized in evidence-based information for health professionals, to make it easier to access reliable and valuable information. Health professionals were also allowed to consult, free of charge, reliable health information resources, such as the GuiaSalud platform, the Cochrane Library Plus and the resources of the Joanna Briggs Institute. CONCLUSIONS: The involvement of health professionals in these measures and the role that these measures may be expected to play in the development of a premium-quality health service.

[The Spanish National Health System patient safety strategy, results for the period 2005-2007]. / Resultados de la estrategia en seguridad del paciente del Sistema Nacional de Salud español, período 2005-2007.

BACKGROUND AND OBJECTIVES: In 2005 the Spanish National Health System (SNHS) implemented a strategy aimed at improving patient safety in Spanish healthcare centres. SPECIFIC AIMS: Promote and develop knowledge of patient safety and a patient safety culture among health professionals and patients; design and implement adverse event information and reporting systems for learning purposes; introduce recommended safe practices in SNHS centres; promote patient safety research and public and patient involvement in patient safety policies. MATERIAL AND METHOD: An Institutional Technical Committee was created with representatives from all the Spanish regions. All national organizations involved in healthcare quality and patient safety took part in the project. The strategy follows the WHO World Alliance for Patient Safety and Council of Europe recommendations. Budget allocated in the period 2005-2007: approximately EUR35 million. RESULTS: Around 5,000 health professionals were educated in PS concepts. Several studies were conducted on: adverse events in Hospitals and Primary Care, as well as studies to obtain information on health professionals' perceptions on safety, the use of medications and the situation regarding hospital-acquired infections. All the regions have introduced safe clinical practices related with the strategy. CONCLUSIONS: The strategy has been implemented in all the Spanish regions. Awareness was raised among health professionals and the public. A network of alliances has been set up with the regions, universities, schools, agencies and other organizations supporting the strategy.

[In case of an adverse event don´t forget to say sorry]. / Si ocurrió un evento adverso piense en decir "lo siento".

BACKGROUND: Disclosing information to a patient who is a victim of an adverse event (AE) presents some particularities depending on the legal framework in the country where the AE occurred. The aim of this study is to identify the limits and conditions when apologizing to a patient who has suffered an AE. METHODS: A consensus conference involving 26 professionals from different autonomous communities, institutions, and profiles (health, insurance, inspection, academic) with accredited experience in patient safety management systems and criminal law. RESULTS: Open disclosure should include an apology expressed in neutral terms (showing empathy and regret for what has happened) without the informant being identified as responsible for the damage, blaming third parties, or offering compensation on behalf of the insurance company. The professional who feels most directly involved in the incident is usually the least likely to report it and apologise. The informant profile must conform to the type and severity of the AE. The rules and conditions of liability insurance advise against providing specific information on the amount of compensation. CONCLUSIONS: The apology should be offered in terms of the regulatory framework in force in each country. In Spain, an appropriate response of empathy for the patient is warranted, expressing regret for what happened (apologising), which can facilitate the relationship with the patient, mitigate their mistrust, and reduce the number of disputes.

Efficacy of senna versus lactulose in terminal cancer patients treated with opioids.

The best laxative for terminal cancer patients treated with opioids still remains to be determined. This comparative study was conducted with the objective of determining treatment and cost efficiency for senna and lactulose in terminal cancer patients treated with opioids. The methodology used a randomized, open, parallel group design. The study was conducted in the Palliative Care Unit in one Madrid Health Care District. Ninety-one terminal cancer patients were randomized into two groups: A = treated with senna (starting with 0.4 mL daily), and B = treated with lactulose (starting with 15 mL daily) for a 27-day period. The main outcome measures were defecation-free intervals of 72 hr, days with defecation, general health status, and treatment cost. Laxative efficacy was analyzed through t test and analysis of variance. No difference was found between the laxatives in defecation-free intervals or in days with defecation. The final scores for general health status were similar in both groups. Given that the two treatments have similar efficacy and adverse effects, a recommendation is made for the use of senna because its cost is lower than lactulose.

Chemotherapy versus best supportive care for extensive small cell lung cancer.

BACKGROUND: Combination chemotherapy has been the mainstay of treatment for extensive stage small cell lung cancer (SCLC) over the last 25 years even though it only gives a short prolongation in median survival time. The main goal for these patients, if their survival prognosis is limited, should be adequate palliation with the aim of improving their quality of life. OBJECTIVES: To evaluate the effectiveness of chemotherapy in extensive SCLC compared with best supportive care (BSC) or placebo treatment. SEARCH STRATEGY: Medline (1966-Jan 2003), Embase (1974-Jan 2003), Cancerlit (1993-Jan 2003) and the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 4, 2002) were searched. In addition experts in the field were contacted to identify further studies not found by electronic searches. SELECTION CRITERIA: Randomised controlled trials in which any chemotherapy treatment was compared with a placebo group or best supportive care in patients with extensive stage SCLC. DATA COLLECTION AND ANALYSIS: Data extraction and quality assessment were undertaken independently by two reviewers and disagreements were resolved by a third author. Additional information on the included studies was obtained from the author of the original studies. MAIN RESULTS: Only two studies (the first published in 1977 and the second in 1982) met the inclusion criteria of the review. A total of 65 patients with extensive disease (33 in the first study and 32 in the second) were randomised to received either placebo treatment or ifosfamide. In the second study a third arm of comparison included ifosfamide plus CCNU. Ifosfamide gave an extra 78.5 days survival (mean survival time) compared with the placebo group. Partial tumour response was greater with the active treatment. Toxicity was only seen in the chemotherapy group. Pooled analysis was not possible because only mean survival time was reported in both studies for patients with extensive disease. REVIEWER'S CONCLUSIONS: Chemotherapeutic treatment prolongs survival in comparison with placebo in patients with advanced SCLC. Nevertheless the impact of chemotherapy on quality of life and in patients with poor prognosis is unknown. Well-designed, controlled trials are needed to further evaluate the risks and benefits of different chemotherapeutic schedules in patients with advanced small cell lung cancer.

[Evaluation of psychometric properties of the Spanish version of the Rotterdam Symptom Checklist to assess quality of life of cancer patients]. / Evaluación de las propiedades psicométricas de la versión española del Rotterdam Symptom Checklist para medir calidad de vida en personas con cáncer.

BACKGROUND: In this work the validation of the Spanish version of the Rotterdam Symptom Checklist (RSCL) to assess quality of life in cancer patients has been approached. The main goal of this study is to evaluate the psychometric properties of the questionnaire and its equivalence with the original English questionnaire. METHODS: The questionnaire was administered to a sample of 162 terminal cancer patients and 59 cancer patients treated with chemotherapy. The internal structure, was evaluated through a confirmatory factor analysis in TCP, the discriminatory power according to clinical situation of cancer patients, the internal consistency in both samples and the responsiveness to the changes over time after chemotherapy treatment was evaluated in PQT. RESULTS: The internal structure of scales was similar in TCP to the original version. The cancer patients showed worse scores than the PQT. The reliability was > or = 0.70 for the scales and > or = 0.50 for the subscales except chemotherapy subscale. The scores of the scales were different (p < 0.05) before and after treatment, except for the psychological scale. CONCLUSIONS: These results confirm the usefulness of the spanish version of the RSCL as a subjective measure of well-being in cancer patients.

Spanish version of the Rotterdam Symptom Check List: cross-cultural adaptation and preliminary validity in a sample of terminal cancer patients.

We report on the process of adaptation into Spanish of the Rotterdam Symptom Check List (RSCL). The original version was translated and back-translated by professional bilingual translators. A quantitative rating method was used to select the items to include in the final Spanish version. Validity (discriminant and construction) and reliability were test in 118 terminal cancer patients. In addition to the RSCL the Nottingham Health Profile (NHP) and the Karnofsky Performance Status (KPS) were used. The RSCL showed different ratings on all scales according to the functional level of the patients. The scales were moderately to highly correlated with the NHP (from 0.48 to 0.71). Internal consistency, measured by Cronbach's alpha coefficient ranged from 0.74 (physical) to 0.90 (activity). Twenty-four hours test-retest intraclass correlation coefficient ranged from 0.71 to 0.88. The results of this study suggest that the Spanish version of the RSCL is conceptually equivalent to the original. More research is needed to assess the responsiveness of the version before using it in clinical trials.