Assessing Patients' Perceptions of Safety Culture in the Hospital Setting: Development and Initial Evaluation of the Patients' Perceptions of Safety Culture Scale.

OBJECTIVES: Both patient satisfaction and hospital safety culture have been recognized as key characteristics of healthcare quality and patient safety. Thus, both characteristics are measured widely to support quality and safety improvement efforts. However, because safety culture surveys focus exclusively on the perspective of hospital staff, the complimentary information to be gained from patients' perceptions of safety culture has received little research attention so far. We aimed to develop a measure explicitly focusing on patients' perceptions of safety culture in the hospital setting and perform an initial evaluation of its measurement properties. METHODS: We employed a multistep development approach including (a) literature review of survey instruments for patient experience and safety culture and (b) item categorization and selection. We evaluated the measurement properties of the final item set focusing on factor structure, internal consistency, item difficulty, and discrimination. Data were collected from June to December 2015 via an online patient survey conducted routinely by a health insurer. RESULTS: Overall, 112,814 insured persons participated in the online survey (response rate = 19.7%). The final 11-item set formed a single scale that was named Patients' Perceptions of Safety Culture scale. Its measurement properties were deemed satisfactory based on this initial evaluation. CONCLUSIONS: The Patients' Perceptions of Safety Culture scale contributes to both a more comprehensive view of patients' experience of healthcare and a more balanced approach to safety culture measurement in healthcare. It contributes to an increased recognition of patients' views on safety-relevant aspects of their care that provide important inputs to patient safety improvement.

["Hope Dies Last  " - Cross-Sectoral Cooperation in Integrated Care]. / "Die Hoffnung stirbt zuletzt  " ­ sektorenübergreifende Kooperation in der Integrierten Versorgung.

Objective Multiple models of Integrated Care (IC) have been implemented in German mental health services in the last decade in order to improve cross-sectoral, interdisciplinary cooperation. This study investigates an IC network model providing home treatment, case management and a 24/7 hotline. The aim of the study was to explore how health professionals working in this service model perceive both cooperation within their facilities and with external stakeholders. Methods 5 focus groups with 39 health professionals working in an IC mental health network were conducted and analyzed with qualitative content analysis. Results Focus groups participants reported on excellent cooperation within their facilities. The cooperation with external stakeholders, i. e. physicians, psychotherapists and psychiatric clinics, leaves room for improvement. Conclusions Until now little consideration has been given to the perspectives of health professionals. Cooperation within IC mental health networks seems to be effective. Cooperation with stakeholders outside the networks needs to be enhanced.

What contributes to good patient outcomes in the home treatment of the severely mentally ill: study protocol of a multi-centre analysis.

BACKGROUND: While evidence is available that home treatment could be effective for treating severe mental illness, there is a lack of evidence on what exactly makes home treatment effective. The study presented here aims to develop recommendations for structures and processes in home treatment that are necessary for its effectiveness. METHODS/DESIGN: 14 provider networks of home treatment for severe mental illness will be analyzed and compared according to their structures, processes and patient-related outcomes. Data will be drawn from health care claims data, routine assessments of psychosocial functioning, and from questionnaires on structures and processes. The primary outcome will be psychosocial functioning; secondary outcomes, quality of life and days spent in hospital. The relation between structures and processes on one hand side and outcomes on the other side will be identified by multilevel analysis. In addition, focus groups with patients, relatives and network staff will be held to add further insight into relevant processes. All networks will receive individual quality reports, providing them with feedback on the results of this research and benchmarking them against the average. Based on this research, recommendations for processes and structures of home treatment will be developed. DISCUSSION: The research will use longitudinal data on outcomes routinely assessed since 2009 and claims data. Routine data is also used for the assessment of structures and processes. By way of additional questionnaires developed in discussion with providers, further relevant factors can be included. The approach of this study becomes more comprehensive by conducting focus groups with patients, relatives and providers and by having the chance to evaluate the results with the networks by providing feedback of results. Several factors such as outcomes related to regional availability of hospital beds or size of networks might limit this study.

Impact of the site of anastomosis after oncologic esophagectomy on quality of life--a prospective, longitudinal outcome study.

BACKGROUND: For patients undergoing oncologic surgery, the quality of life (QoL) is generally accepted as an important outcome parameter in addition to long-term survival, mortality, and complication rates. Our study focused on outcome in terms of QoL in patients with esophageal cancer, comparing the sites of anastomosis (cervical versus thoracic anastomosis). METHODS: In a prospective longitudinal single-center study from 1998 to 2005, 105 patients underwent surgery for esophageal cancer. To assess QoL the EORTC-QLQ-C-30 and a tumor-specific module were administered before surgery, at discharge, and three, six, 12, and 24 months after surgery. Clinical data were collected prospectively and follow-up was performed every six months. RESULTS: The histological type was squamous cell carcinoma in 51.4% of the cases, adenocarcinoma in 41.9%, and some other type in 6.7%. There was no significant difference between cervical and thoracic anastomosis with regard to morbidity, mortality, and survival rates (30% five-year survival rate), whereas tumor stage was a significant (p < 0.001) prognostic factor. Most QoL scores dropped significantly below baseline in the early postoperative period. Even though they recovered slowly during the follow-up period, they never reached preoperative levels again. There was no statistically significant difference in any of the QoL scales between patients with a cervical or a thoracic anastomosis. CONCLUSIONS: Esophageal resections are associated with significant deterioration of QoL, which persists during the follow-up period. The surgical technique and position of the esophagogastrostomy did not affect QoL deterioration.

Impact of psychotherapeutic support for patients with gastrointestinal cancer undergoing surgery: 10-year survival results of a randomized trial.

PURPOSE: The impact of psychotherapeutic support on survival for patients with gastrointestinal cancer undergoing surgery was studied. PATIENTS AND METHODS: A randomized controlled trial was conducted in cooperation with the Departments of General Surgery and Medical Psychology, University Hospital of Hamburg, Germany, from January 1991 to January 1993. Consenting patients (N = 271) with a preliminary diagnosis of cancer of the esophagus, stomach, liver/gallbladder, pancreas, or colon/rectum were stratified by sex and randomly assigned to a control group that received standard care as provided on the surgical wards, or to an experimental group that received formal psychotherapeutic support in addition to routine care during the hospital stay. From June 2003 to December 2003, the 10-year follow-up was conducted. Survival status for all patients was determined from our own records and from three external sources: the Hamburg cancer registry, family doctors, and the general citizen registration offices. RESULTS: Kaplan-Meier survival curves demonstrated better survival for the experimental group than the control group. The unadjusted significance level for group differences was P = .0006 for survival to 10 years. Cox regression models that took TNM staging or the residual tumor classification and tumor site into account also found significant differences at 10 years. Secondary analyses found that differences in favor of the experimental group occurred in patients with stomach, pancreatic, primary liver, or colorectal cancer. CONCLUSION: The results of this study indicate that patients with gastrointestinal cancer, who undergo surgery for stomach, pancreatic, primary liver, or colorectal cancer, benefit from a formal program of psychotherapeutic support during the inpatient hospital stay in terms of long-term survival.

Prescription practice for LH-RH analogs and androgen receptor antagonists in the treatment of advanced prostate cancer in Germany (1993-2003).

INTRODUCTION: Nearly 80% of the patients suffering from advanced stages of prostate cancer in Germany are treated currently with luteinizing hormone-releasing hormone (LH-RH) analogs alone or in combination with androgen receptor antagonists. The aim of this study was to assess whether the prescription practice for LH-RH analogs and direct antiandrogens between 1993 and 2003 parallels the rise in the incidence rates for prostate cancer associated with the proportional rise in daily doses. METHODS: Between 1993 and 2000 a yearly randomly selected number of receipts has been evaluated from official pharmacies in Germany which have been billed to public health insurance companies. Data concerning drug use, number of daily doses, and total cost of the respective drugs have been calculated by the Research Institute of the AOK (Wissenschaftliches Institut der AOK, WIdO). These prescription data have been related to incidence and mortality rates of patients with prostate cancer. RESULTS: Between 1993 and 2003 the age-standardized incidence rate of carcinomas of the prostate has risen by 180%, while the disease-specific mortality practically has remained nearly at the same level. The daily prescribed doses of LH-RH analogs have risen by a factor of 8.5 from 3.9 to 33.5 million daily doses during this time. In contrast, the daily doses of androgen receptor antagonists have remained unchanged between 1997 and 2001, followed by a rise of 50% between 2001 and 2003. CONCLUSIONS: The first analysis of the prescription practice of antiandrogens in the treatment of prostate cancer with respect to the incidence rates in Germany could only be facilitated by the fact that these medications are in exclusive use for this indication in Germany. The rise in prescriptions may be explained by the therapy shift from surgery to LH-RH application until the year 2000; the reasons for a further rise since 2000 remain speculative. In conclusion, only prevalence data would allow the exact calculation of medication needs among prostate cancer patients.

Validation of the German prostate-specific module.

Theoretically, all patients newly diagnosed with prostate cancer are faced with a choice of treatment options: radical prostatectomy or radio therapy. Although these different treatments may have no differences in terms of survival, they may have very different consequences on the subsequent quality of life (QoL). Prerequisite to analyze QoL is a reliable and valid instrument to assess these differences not only in terms of general QoL (EORTC QLQ-C30) but prostate specific symptoms with a prostate specific module as well. Therefore, the aim of this study was a psychometric evaluation (validation) of the prostate-specific module (PSM). Five historical cohort studies were put together for an empirical meta-analysis. The main objective was to analyze the module's psychometric properties. The total sample consisted of 1,185 patients, of whom 950 completed the QoL questionnaires (EORTC QLQ-C30 and a prostate specific module developed by Kuechler et al.). First step of analysis was a principal component analysis that revealed the following scales: urinary problems, incontinence, erectile dysfunction, sexual problems, problems with partner, pain, heat, nutrition, and psychic strain. The module showed good reliability and concurrent validity and very good construct validity, since the module is able to discriminate between different treatment regimes, tumor stages and age. The German PSM is a reliable, valid and applicable tool for QoL in patients with prostate cancer.

Gender differences in quality of life of patients with rectal cancer. A five-year prospective study.

To determine how quality of life changes over time and to assess gender-related differences in quality of life of rectal cancer patients we conducted a 5-year study. Little is known about how quality of life (QoL) changes over time in patients after surgery for rectal cancer, and whether gender of the patients is associated with a different perception of QoL. The aim of this study was to assess prospectively, changes in quality of life after surgery for rectal cancer, with a focus on gender related differences. Over a 5-year period, the EORTC-QLQ-C-30 and a tumor-specific module were prospectively administered to patients before surgery, at discharge, 3, 6, 12, and 24 months postoperatively. Comparisons were made between female and male patients. A total of 519 patients participated in the study, 264 men and 255 women. The two groups were comparable in terms of surgical procedures, adjuvant treatment, tumor stage, and histology. Most QoL scores dropped significantly below baseline in the early postoperative period. From the third month onward, global health, emotional and physical functioning, improved. Female gender was associated with significantly worse global health and physical functioning and with higher scores on treatment strain and fatigue. Men reported difficulties with sexual enjoyment; furthermore, over time, sexual problems created high levels of strain in men, worse than baseline levels in the early postoperative period. These problems tended to continue over the course of time. The findings in this study confirm that QoL changes after surgery and differs between men and women. Women appear to be affected by impaired physical functioning and global health. Female gender is associated with significantly higher fatigue levels and increased strain values after surgery. Through impaired sexual enjoyment, men are put more under strain than woman.

Prospective evaluation of quality of life of patients receiving either abdominoperineal resection or sphincter-preserving procedure for rectal cancer.

BACKGROUND: Study results on quality of life (QoL) between patients receiving an anterior resection (AR) or abdominoperineal resection (APR) for rectal cancer vary greatly. A main reason is grounded in unequal methodology. The aims of this study were to assess differences in perceived QoL over time among patients treated with AR or APR with a recommended study design and methodology. METHODS: In a prospective study, the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 and a tumor-specific module were administered to patients with rectal cancer before surgery, at discharge, and 3, 6, and 12 months after the operation. Comparisons were made between patients receiving an AR and those receiving an APR. RESULTS: Two hundred forty-nine patients were included; 46 patients received an APR and 203 an AR. QoL data were available for 212 patients, of which 112 were female and 100 male. No differences in the distribution of age, sex, or tumor stage were observed between groups. EORTC function scales showed no significant differences, including body image scales, between patients receiving an AR and those receiving an APR. In symptom scores, AR patients had more difficulty with diarrhea and constipation, whereas patients with APR experienced more impaired sexuality and pain in the anoperineal region. At discharge, patients receiving an AR were more confident about their future. CONCLUSIONS: QoL in patients receiving an AR and those receiving an APR is not different. Although patients with APR experience more impaired sexuality, patients receiving an AR experience decreases in QoL because of impaired bowel function.

Ten-year historic cohort of quality of life and sexuality in patients with rectal cancer.

PURPOSE: In various studies, type of surgery, age, and gender had different impact on sexuality and quality of life in patients with rectal cancer. This study was designed to investigate how sexuality and quality of life are affected by age, gender, and type of surgery. METHODS: A total of 516 patients who had undergone surgery for rectal cancer in our department from 1992 to 2002 were included. Within one year after the operation, 117 patients died. Questionnaires were sent to 373 patients 12 to 18 months after surgery. We received quality of life data from 261 patients. Comparisons were made after adjusting age, gender, and type of surgical procedure. RESULTS: For patients receiving abdominoperineal resection sexuality was most impaired. Significant differences were seen in symptom and function scales between males and females. Females reported more distress from the medical treatment insomnia, fatigue, and constipation. Both genders had impaired sexual life; however, males had significantly higher values and felt more distressed by this impairment. Younger females felt more distress through impaired sexuality. In males sexuality was impaired independent of age. Adjuvant therapy had no influence on sexuality but on quality of life one year after surgery. CONCLUSIONS: Assessing quality of life with general and specific instruments is helpful to determine whether patients improved through the treatment. The study showed that gender, age, and type of surgery influence sexuality and that quality of life after surgery for rectal cancer is impacted. Because quality of life is a predictor for complications and survival, availability of such data may help to direct supportive treatment to improve outcome.

Impact of age on quality of life in patients with rectal cancer.

Some studies indicate that age at the time of surgery has a general effect on outcomes. The impact of age on the quality of life (QOL) of patients with rectal cancer, however, has not been investigated. The present study was conducted to address this issue. Over a 5-year period the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C-30 and a tumor-specific module were prospectively administered to patients before surgery, at discharge, and at 3, 6, 12, and 24 months postoperatively. Comparisons were made between age groups. A total of 519 patients participated in the study. QOL data were available for 253 patients. Significant differences were observed only between patients aged 69 years and younger (< or =69 years) (169/253) and those aged 70 years and older (> or =70 years) (85/253). Physical and role functioning was better for patients < or =69 years; patients > or =70 years suffered from increased pain and fatigue. Younger patients had more difficulty with sexual enjoyment, and over time sexual strain was worse for patients aged > or =70 years during the early postoperative period but improved, whereas patients aged < or =69 years had increasing levels of strain over time. The findings in this study confirmed that QOL is dynamic over time and that age has an impact on QOL and sexuality. Patients aged > or =70 years are affected by impaired physical functioning, global health, and fatigue, whereas increased treatment strain during the early postoperative period improves over time. Patients aged < or =69 years experience increased strain because of impaired sexual function.

Quality of life associated with surgery for esophageal cancer: differences between collar and intrathoracic anastomoses.

Postoperative survival and complication rates have traditionally been the standard parameters of outcome after oncologic surgery. In tumors with poor patient survival, such as esophageal cancer, studies about quality of life are rare. The objectives of this study were to assess outcomes in terms of quality of life in patients with esophageal cancer when investigating differences between two surgical reconstructive procedures: intrathoracic anastomosis and collar anastomosis. A total of 108 patients with esophageal cancer had undergone surgery for esophageal cancer in our department from 1992 to 2000. Median survival was 36 months with no significant differences between patients undergoing collar or intrathoracic anastomosis. After determining the survival status, questionnaires on quality of life were sent to all patients 1 to 2 years after surgery. We received data from 46 patients. The responders were divided into groups of intrathoracic anastomosis ( n = 24) and collar anastomosis ( n = 22). Patients with the collar anastomosis showed significantly better physical and social functioning and global health status. From the viewpoint of postoperative quality of life, reflux-related symptoms were the major problem for patients with an intrathoracic anastomosis. These symptoms cause significant insomnia and impair social and physical function. The study showed that assessing quality of life with specific and general instruments is helpful for determining the differences between surgical procedures where standard parameters such as survival have their limitations.

Palliation of metastatic gastric cancer: impact of preoperative symptoms and the type of operation on survival and quality of life.

Patients with advanced, incurable gastric cancer may present with mild symptoms or require immediate therapeutic intervention. The influence of the intensity of preoperative symptoms on postoperative survival and quality of life (QoL) was evaluated in a palliative setting. In a historical cohort analysis of 492 patients with gastric cancer treated between 1992 and 2001, a total of 169 (34.4%) patients had incurable disease (i.e., pTxNxM1). Patients were classified as having major symptoms if they presented with upper gastrointestinal bleeding (i.e., hematemesis or bloody stools), gastric inlet or outlet obstruction (i.e., symptomatic and endoscopically proven stenosis), or perforation caused by the tumor. All other patients were defined as having minor symptoms. QoL was assessed prospectively using the EORTC questionnaire. The questionnaire was given to the patients before operation, before discharge, and 3 months after operation; and it was analyzed by the Mann-Whitney U-test. Survival, demographic data, and histopathologic characteristics were assessed and analyzed by the log-rank test and the chi(2) test, respectively. Of the 169 patients, 75 (44.3%) presented with major symptoms and 94 (55.7%) with minor symptoms. The distribution of patients undergoing resection or exploration was comparable for the two groups [major: 61 (81.5%)/14 (18.5%); minor: 77 (81.9%)/17 (18.1%)]. Despite comparable demographic and histopathologic characteristics with equal hospital mortality and morbidity (14.6% vs. 8.5%/49.3% vs. 40.4%), the median survival rates in two groups were 4 and 6 months, respectively ( p < 0.05). This was not influenced by the type of operation. QoL was not different in patients with major or minor symptoms before operation or 3 months thereafter. However, preoperative symptoms such as nausea/vomiting and melena were rated significantly higher in patients with major symptoms. In patients with incurable gastric cancer the preoperative intensity of symptoms has a significant impact on survival and QoL, which is not influenced by the operation. The necessity of surgery in patients with minor symptoms requires careful consideration.