Influence of the work environment of nurses on the 30-day mortality of patients hospitalized in Polish hospitals. cross-sectional studies.

BACKGROUND: An optimal work environment for nurses is characterized primarily by appropriate staffing, good team relations, and support from the management staff. These factors are consistently associated with a positive assessment of patient safety by a hospital's employees and a reduction in hospital mortality rates. AIM: To understand the relationships between the work environment as perceived by nurses on the 30-day mortality of patients treated in Polish hospitals. BACKGROUND: An optimal work environment for nurses is characterized primarily by appropriate staffing, good team relations, and support from the management staff. These factors are consistently associated with a positive assessment of patient safety by a hospital's employees and a reduction in hospital mortality rates. MATERIAL AND METHODS: The analysis used discharge data from 108,284 patients hospitalized in internal medicine and surgery departments in 21 hospitals (with 24/7 operations) in Poland. Administrative data included coded data to estimate 30-day mortality. A Nurses' satisfaction questionnaire, including the PES-NWI scale and the SAQ questionnaire, was used to assess the work environment of nurses (n = 1,929). Correlations between variables were assessed using the Pearson coefficient. The analysis used a Poisson regression model, which belongs to the class of generalized linear models. RESULTS: A lower 30-day mortality rate amongst patients was found among those treated in hospitals where the personnel feel that they may question the decisions or actions of their superiors regarding the care provided (r = - 0.50); nurses are informed about changes introduced on the basis of reports about negligence and mistakes (r = - 0.50); the ward nurse is a good manager (r = - 0.41); nurses receive timely information from the head of the department that may have an impact on their work (r = - 0.41). CONCLUSIONS: Factors related to care during hospital stay such as the organization of care at the ward level, analysis of care errors, the number of staff providing direct patient care, informing nurses about mistakes without punishment, and the possibility of nurses challenging the decisions or actions of superiors, which concerns care providing, affect the 30-day mortality of patients after the end of hospitalization in Polish hospitals.

Nurses' attitudes towards factors determining the safety of patients treated in intensive care units: Cross-sectional study.

BACKGROUND: The goal of health care systems is to ensure high quality of medical services provided, including patient safety. The intensive care unit (ICU) is an environment conducive to the occurrence of adverse events and medical errors because of the complexity of the care provided, the severity of the conditions of patients treated in these units and work often performed under stressful conditions. AIMS: Assessment of attitudes of nurses working in ICUs towards patient safety. STUDY DESIGN: A cross-sectional, descriptive study was conducted in a group of 214 nurses employed in ICUs in hospitals located in the southern part of Poland. METHOD: The study used the Polish version of the Attitudes towards safety: (SAQ-SF PL) questionnaire and an original questionnaire consisting of questions on socio-demographic and professional data. RESULTS: The overall SAQ score for the whole group was 61.89, 57.29 for adult ICU nurses and 68.20 for children's ICU. The surveyed nurses in general obtained the highest average results in terms of teamwork climate (TC)-66.92, while the lowest scores were given to the management-hospital management (PM)-45.08 and working conditions (WC)-57.56. job satisfaction (JS) positively correlated with the assessment of the TC, the assessment of the safety climate (SC), the assessment of the management staff (Head of Department) (PM), the assessment of the management staff (hospital management) (PM) and the assessment of work conditions (WC). A statistically significant, negative correlation was found between the assessment of JS and the assessment of stress recognition (SR) (r = -.20; p < .01). CONCLUSIONS: In the surveyed ICU branches, there is a low SC, and it is related, among others, to the perception of WC and the role of the management staff. The level of JS among nursing staff mainly depends on the SC, the TC, WC and the support of the management staff. RELEVANCE TO CLINICAL PRACTICE: The results of the research presented here provide valuable assistance in identifying areas related to patient safety in ICUs. Managers' awareness of the importance of coping with occupational stress, WC or effective teamwork can help to improve staff attitudes and attitudes towards patient safety. When shaping a safe culture in a health care organization, it is important to remember that ensuring safe patient care is not only about programmes, standards or procedures, but safety is primarily about human resources-the staff involved in the treatment process-doctors, nurses, paramedics and physiotherapists. High awareness of safety at work, cooperation in an interdisciplinary team, assessment of safety culture at work and analysis and drawing conclusions may result in a real increase in quality and safety, and the patient will feel safer in 'XX' hospitals.

Nurses' intention to leave their jobs in relation to work environment factors in Polish hospitals: Cross-sectional study.

BACKGROUND: The lack of nursing staff is a current problem not only in Poland, but also in the world. The decision of nurses to leave the workplace, apart from the financial aspect, often results from unfavourable working conditions related to the work environment. MATERIAL AND METHODS: The study was multicentre, cross-sectional. The study was conducted among a group of 1509 nurses employed in surgical and internal medicine wards in 21 hospitals in Poland. The key variables of the study were: the intention of the nurses to leave their jobs, the nurses' working environment, the level of satisfaction, the level of occupational burnout and the number of patients cared for on the last shift, the number of nurses on the last shift. The Practice Environment Scale of the Nursing Work Index (PES-NWI) and the Maslach Burnout Inventory (MBI) questionnaire were used in the research. RESULTS: Almost half of the surveyed nurses (48.84%) declared their willingness to leave their current workplace. The statistical analysis showed that nurses declaring their willingness to quit their job in the hospital where they were employed were significantly younger (42.88 vs. 45.04, p = 0.000), had shorter total length of service overall (19.96 vs. 23.20), and also in the hospital where they were employed (15.86 vs. 18.50, p = 0.000). The increase in the number of patients by one was significantly associated with a 1% increase in the risk of leaving work (OR = 1.01, 95% CI 1.00-1.02). An increase in emotional exhaustion significantly increased the risk of leaving work by 2% (OR = 1.02, 95% CI 0.99-1.03). CONCLUSIONS: Younger age of nurses, greater workload resulting from more patients and occupational burnout - emotional exhaustion is correlated with the risk of leaving work in the hospital. A lower risk of leaving the job is associated with a higher level of job satisfaction in the hospital, salary and promotion opportunities. Med Pr Work Health Saf. 2023;74(5):377-87.

Opinion of nurses of internal medicine wards regarding factors determining their work - observational and cross-sectional studies.

OBJECTIVES: The aim of the study was to assess the factors determining the work of nurses in internal medicine departments. METHODS: The study was multicentre, cross-sectional, and observational. The selection of the research group was intentional. The subject of the study were 209 nurses working in 11 internal medicine departments in 10 hospitals in the region of southern Poland. RESULTS: The number of patients cared for by one nurse, nurses' participation in the decision-making process, and nurses' age were shown to be direct predictors of emotional exhaustion. The number of patients cared for by a single nurse, nurses' participation in the decision-making process, and age were direct predictors of depersonalization. It was shown that significant (p < 0.05) independent (multivariate analysis) variables of the job satisfaction subscale were information on support for nurses at work by managerial staff and nurses' participation in the decision-making process. After analysing the impact of socio-demographic factors on the nurses' working environment, it was found that the participation of nurses in the decision-making process was significantly lower in the youngest group than in the other age groups (p = 0.006). CONCLUSIONS: Participation of nurses in the decision-making process is a direct determinant of occupational burnout. A higher number of patients under the care of a nurse, lack of participation in the decision-making process and a higher age of nurses are predictors of emotional exhaustion and depersonalization.

Factors Influencing the Rationing of Nursing Care in Selected Polish Hospitals.

Introduction: The rationalization of nursing care can be a direct consequence of the low employment rate or unfavorable working environment of nurses. Aim: The aim of the study was to learn about the factors influencing the rationing of nursing care. Methods: The study group consisted of 209 nurses working in internal medicine departments. The study used the method of a diagnostic survey, a survey technique with the use of research tools: the BERNCA-R questionnaire and the PES-NWI questionnaire (which includes the occupational burnout questionnaire). Results: The mean total BERNCA score for rationing nursing care was 1.94 ± 0.75 on a scale from 0 to 4. A statistically significant relationship was demonstrated between the work environment and the rationing of nursing care. The results of the BERNCA-R scale correlated statistically significantly and positively (r > 0) with two (out of three) subscales of the occupational burnout questionnaire (MBI­Maslach Burnout Inventory): emotional exhaustion and depersonalization (p < 0.001), and with all types of adverse events analyzed (p < 0.05). Conclusions: The higher the frequency of care rationing, the worse the assessment of working conditions by nurses, and, therefore, more frequent care rationing determined the more frequent occurrence of adverse events. The more frequent the care rationing, the more frequent adverse events occur.

Adapting the Geriatric Institutional Assessment Profile for different countries and languages: A multi-language translation and content validation study.

BACKGROUND: Hospitalization can be hazardous for older people, but most hospitals in Europe are not prepared to meet the unique needs of older adult inpatients. Adaptations of the physical environment, care processes, and staff knowledge and skills in geriatric care are essential to improve the quality of care for older people. An assessment of baseline organizational approaches to older adult care is an important first step toward recognizing the challenges organizations face when delivering acute care services to older adults and attempting to improve them. The Geriatric Institutional Assessment Profile could be a promising tool for this endeavor. OBJECTIVES: To describe a systematic process implemented across seven countries and languages that sought to develop valid and culturally-appropriate translations of the Geriatric Institutional Assessment Profile. DESIGN: Cross-cultural instrument translation and content validation study. SETTING AND PARTICIPANTS: Expert review panels comprised of 68 practicing nurses from seven European or EU associated countries (Austria (German), Belgium (Dutch), Denmark (Danish), Israel (Hebrew), Poland (Polish), Switzerland (German, French), and Turkey (Turkish)) evaluated cross-cultural relevance, including translation, of the Geriatric Institutional Assessment Profile. METHOD: A systematic approach to translating and validating a cross-cultural survey instrument, including back-to-back translation, adaptation, and evaluation of content validity using content validity indexing (CVI) techniques for each country and language, assessing translation and relevance content validity separately. The item, subscale and domain content validity index scores were calculated and adjusted for chance agreement among raters for all parts of the Geriatric Institutional Assessment Profile: the four subscales of geriatric care environment, the general knowledge about older adults subscale, and the clinical geriatric knowledge subscale. Consensus discussions among the raters then finalized translations. RESULTS: CVI scores for relevance and translation were all in the "good" to "excellent" range. The geriatric care environment scale's CVI scores were 0.84 to 0.94 for relevance and 0.82 to 0.98 for translation. The clinical geriatric knowledge subscale's CVI scores were 0.83 to 0.97 for relevance and 0.94 to 0.98 for translation. The general knowledge about older adults subscale received high translation agreement (0.93 to 0.99) but slightly lower scores for relevance, ranging from 0.46 to 0.94. CONCLUSION: Study results provided preliminary evidence of the applicability and validity of a multi-factor measure of age-friendly care in diverse health care systems, in German, Dutch, Danish, Hebrew, Polish, French, and Turkish languages.

Evaluating Polish nurses' working conditions and patient safety during the COVID-19 pandemic.

AIM: To study the relationship between Polish nurses' working conditions and their attitudes towards patient safety during the COVID-19 pandemic. BACKGROUND: Facing the COVID-19 pandemic, caused by the SARS-CoV-2 virus, healthcare worldwide has been reorganised. How these changes affected patient safety for hospitalised persons is not well understood. INTRODUCTION: Difficult working conditions related to the outbreak of the COVID-19 pandemic may affect the provision of safe and effective care by healthcare staff. METHODS: This observational research was performed on the group of 577 nurses working during the COVID-19 pandemic in isolation infection wards (n = 201) and non-infectious diseases wards (n = 376) in Polish hospitals. The evaluation of working conditions was performed with an author's questionnaire, while the evaluation of factors influencing attitudes towards safety of the hospitalised patients was performed using Safety Attitudes Questionnaire. The STROBE checklist was used to report this study. RESULTS: The procedures developed by management in advance for COVID-19 patient treatment had a statistically significant influence on nurses' 'evaluation of teamwork climate, safety climate, job satisfaction, perception of management and work conditions'. Providing management with the ability to perform a swab polymerase chain reaction SARS-CoV-2 test for hospital staff in the workplace, and psychological support from professionals and employers were statistically significant for higher ratings of 'teamwork climate, safety climate, job satisfaction, stress recognition, perception of management and work conditions' by the Polish nurses. Hospital workload during the COVID-19 pandemic was significantly correlated with lower evaluation of work conditions. DISCUSSION: Our study reinforces the existing literature on many fronts and demonstrates how even when operating under the COVID-19 pandemic conditions, some factors remain critical for fostering a culture of patient safety. Reinforcing patient safety practices is a imperative under these conditions. CONCLUSIONS AND IMPLICATIONS FOR NURSING: Working conditions influence nurses' attitudes towards safety of the hospitalised patients. These are largely modifiable factors related to the workplace and include prior preparation of procedures, restrictions to extending daily work hours and psychological counselling for the staff.

The Correlation between Nurses' COVID-19 Infections and Their Emotional State and Work Conditions during the SARS-CoV-2 Pandemic.

The COVID-19 pandemic caused by the SARS-CoV-2 virus has significantly influenced the functioning of Polish hospitals, and thus, the working conditions of nurses. Research on the presence of specific negative emotions in nurses may help identify deficits in the future, as well as directing preventive actions. The present research was performed among nurses (n = 158) working in Polish healthcare facilities during the third wave of the COVID-19 pandemic caused by the SARS-CoV-2 virus, where Group A (n = 79) consisted of nurses diagnosed with COVID-19, and Group B (n = 79) nurses who have never been infected with COVID-19. To perform the research, the Courtauld Emotional Control Scale (CECS), Trait Anxiety Scale (Polish: SL-C) and the authors' survey questionnaire were used. A positive test result was generally determined more often among nurses who indicated a noninfectious ward as their main workplace, compared to nurses employed in infectious wards (64.55% positive vs 33.45% negative). Over a half of the subjects identified moderate levels of emotion suppression as the method to regulate strong emotions, while one-quarter cited high levels of suppression. Anxiety was suppressed at high and moderate levels by 97% of the subjects, depression by 86.71%, and anger by 79.48%. Infection with COVID-19 results in a higher level of anxiety and depression, as well as a feeling of increased work load.

Nurses and physicians attitudes towards factors related to hospitalized patient safety.

INTRODUCTION: The attitudes of healthcare staff towards patients' safety, including awareness of the risk for adverse events, are significant elements of an organization's safety culture. AIM OF RESEARCH: To evaluate nurses and physicians' attitudes towards factors influencing hospitalized patient safety. MATERIALS AND METHODS: The research included 606 nurses and 527 physicians employed in surgical and medical wards in 21 Polish hospitals around the country. The Polish adaptation of the Safety Attitudes Questionnaire (SAQ) was used to evaluate the factors influencing attitudes towards patient safety. RESULTS: Both nurses and physicians scored highest in stress recognition (SR) (71.6 and 80.86), while they evaluated working conditions (WC) the lowest (45.82 and 52,09). Nurses achieved statistically significantly lower scores compared to physicians in every aspect of the safety attitudes evaluation (p<0.05). The staff working in surgical wards obtained higher scores within stress recognition (SR) compared to the staff working in medical wards (78.12 vs. 73.72; p = 0.001). Overall, positive working conditions and effective teamwork can contribute to improving employees' attitudes towards patient safety. CONCLUSIONS: The results help identify unit level vulnerabilities associated with staff attitudes toward patient safety. They underscore the importance of management strategies that account for staff coping with occupational stressors to improve patient safety.

Impact of the Work Environment on Patients' Safety as Perceived by Nurses in Poland-A Cross-Sectional Study.

Numerous studies have found that organizational features connected with the work environment of nurses have a significant influence on patients' safety. The aim of this research was to capture nurses' opinions about patients' safety and discern relationships with work environment characteristics. This cross-sectional study surveyed 1825 nurses. The research used questionnaire consisting of four parts: (1) covered The Practice Environment Scale of the Nursing Work Index (PES-NWI); (2) assessed the quality of nursing care and care safety; (3) contained information on the most recent duty served by the nurses and (4) captured social and demographic data of participants. The research identified strong association between patient safety assessment and work environment of nurses in the aspect of employment adequacy, cooperation between nurses and doctors, support for nurses from the managing staff, the possibility to participate in the management as well as professional promotion of nurses employed in the hospital (p < 0.001). Nurses rated patient safety higher when responsible for a smaller number of patients. Work environment factors such as proper staffing, good cooperation with doctors, support from the management, as well as professional independence are significantly related to nurses' assessment of patients' safety.

Emotional Control among Nurses against Work Conditions and the Support Received during the SARS-CoV-2 Pandemic.

INTRODUCTION: Working in the state of a pandemic is a huge mental load for the medical environment. AIM: Evaluation of emotional control among nurses against work conditions and the support received during the SARS-CoV-2 pandemic. MATERIAL AND METHODS: The research was performed among nurses (n = 577) working during the pandemic caused by the SARS-CoV-2 virus in infectious (n = 201) and non-infectious (n = 376) wards in 11 Polish hospitals. To evaluate work conditions, the questionnaire prepared by the authors and the Emotional Control Scale (Courtauld Emotional Control Scale-CECS), which rates the control of anger, depression, and fear were used. RESULTS: In the entire research group, fear had the highest rate of suppression among the negative emotions-18.25 points, 17.91 points in infectious wards and 18.44 points among nurses working in non-infectious wards; p > 0.05. The nurses fear was significantly repressed when there was no possibility of the nurses having to perform a COVID-19 test in the workplace; p < 0.05. A larger emotional supressed occurred in nurses who simultaneously declared the perception of increased stress level; p < 0.05. CONCLUSIONS: A high level of emotion suppression, especially regarding fear, combined with higher stress levels, occurring irrespective of the ward, points at the need for mental support for the researched nurses.

Cultural adaptation of the Safety Attitudes Questionnaire - Short Form (SAQ-SF) in Poland.

BACKGROUND: It is essential to provide safe healthcare in complex, difficult, and quickly changing conditions. The quality of healthcare services directly influences the safety of both the patients and staff. Understanding healthcare staff attitudes toward safety in the healthcare delivery context is foundational for building a culture of safety. AIM OF THE WORK: To adapt, via a structured translation methodology, the Safety Attitudes Questionnaire-Short Form (SAQ-SF), which assesses how employees of the health care sector perceive the safety climate in their workplace, to the Polish context. METHODS: Using a content validation approach to structure the translation process, we tested and psychometrically analysed the translated SAQ-SF. The sample comprised 322 employees of a district hospital (second referral level, which ensures 24/7 emergency care services) in Poland. RESULTS: The reliability of the sub-scales of the Polish version of the SAQ-SF ranged from 0.66 to 0.95. The discriminatory power of particular SAQ items ranged between 0.02 and 0.90. For 6 out of the 8 scale dimensions, the questions with the highest factor loadings were those measuring the same dimensions of the safety climate, according to the original scale. CONCLUSIONS: The Polish version of the SAQ-SF (SAQ-SF-PL) meets the criteria of psychometric and functional validation as well as demonstrates good reliability as a measure of patient safety culture in the Polish context. The SAQ-SF-PL is an instrument that enable a valid and reliable assessment of patient safety climate in the Polish healthcare facilities and identify opportunities for improvement. International comparisons will also become easier.

[Dual practice of nurses in Poland against the current staff resources]. / Podwójna praktyka pielegniarek w Polsce na tle aktualnych zasobów kadrowych.

BACKGROUND: Employment of health care workers simultaneously in 2 workplaces (the so called dual practice) is a common phenomenon in almost every country. In Poland, a possibility of employment in 2 or more workplaces arose with the socio-political changes and the reform of the health care system. In Poland, the scale of the phenomenon, as well as its motifs and potential effects influencing both employees and the whole health care system, are still not known despite numerous studies being conducted to that end. MATERIAL AND METHODS: The study group consisted of 1023 nurses (males and females) employed in public and non-public health care facilities in the territory of the Lesser Poland Voivodeship. The research tool was the authors' poll questionnaire. In the statistical elaboration, the non-parametric Mann-Whitney U test and the χ2 independence test were used. For all the analyses, the maximum permissible error of type I, α = 0.05, was accepted, and p ≤ 0.05 was recognized as statistically significant. RESULTS: Work experience of the nurses studied ranged 1-43 years, on average it was 23.1 years (SD = 11.1). Persons aged >40 years accounted for 77.5% (N = 793), out of whom 38.2% (N = 391) were aged 41-years and 39.3% (N = 402) >50 years. In the study group, 450 (44%) people were employed in 2 workplaces, out of whom 93.5% in the nurse position, working >160 h/month (39%). A decisive reason to take up an additional job (93.3% of the study group) were financial matters. CONCLUSIONS: Financial matters are the main reason for which almost half of the studied nurses undertake additional employment, in the scope twice as high as the work load. Research suggests the need to verify the Central Registry of Nurses and Midwives in order to precisely estimate the number of dual practice positions and the number of persons employed as nurses not only in the south of Poland but also in whole country. The results point to the necessity of further research concerning both the reasons for and consequences of dual practice for nurses, and the impact of this phenomenon on the quality of care and patient safety. Med Pr. 2021;72(2):113-21.

New alternative in the treatment of rheumatoid arthritis: clinical utility of baricitinib.

Baricitinib is an innovative small-molecule drug that reversibly inhibits continuous activation of JAK/STAT pathway, thus reducing joint inflammation. The drug was approved for use as monotherapy or in combination with methotrexate (MTX) in the treatment of adults with moderately to severely active rheumatoid arthritis (RA). The aim of this paper was to review the studies on pharmacology, mode of action, pharmacokinetics, efficacy, and safety of baricitinib in patients with RA. Baricitinib provides an innovative approach to modulating the immune and inflammatory response in patients with RA, which is especially important in individuals who do not respond to disease-modifying antirheumatic drugs or standard biologic drugs (tumor necrosis factor inhibitors) or who lose response over time. Baricitinib therapy reduces symptoms of RA and improves the quality of life. Moreover, it has shown high efficacy and an acceptable safety profile in Phase III randomized controlled trials (RCTs) and become another JAK inhibitor approved for RA treatment, providing a useful alternative option. RCTs have revealed a significant benefit of baricitinib over placebo, MTX, and adalimumab in terms of standard efficacy outcomes, especially the American College of Rheumatology ACR20, ACR50, and ACR70 response rates. Additionally, a clinically meaningful improvement in patient-reported outcomes, including the quality of life, compared with placebo has been reported. The safety profile seems acceptable, although some rare but potentially severe adverse events have been observed, such as serious infections, opportunistic infections (eg, herpes zoster), malignancies, and cardiac or hepatic disorders. Baricitinib administered at an approved dose of 2 or 4 mg once daily offers a novel and promising alternative to parenterally administered biologic drugs used in RA treatment.

European perspective on the management of rheumatoid arthritis: clinical utility of tofacitinib.

Xeljanz® (tofacitinib) is an oral small-molecule inhibitor that reversibly inhibits Janus-activated kinase (JAK)-dependent cytokine signaling, thus reducing inflammation. As a result of these mechanisms, effects on the immune system such as a moderate decrease in the total lymphocyte count, a dose-dependent decrease in natural killer (NK) cell count, and an increase in B-cell count have been observed. Therefore, tofacitinib provides an innovative approach to modulating the immune and inflammatory responses in patients with rheumatoid arthritis (RA), which is especially important in individuals who do not respond to tumor necrosis factor inhibitors or show a loss of response over time. The aim of this article was to review studies on the pharmacology, mode of action, pharmacokinetics, efficacy, and safety of tofacitinib in patients with RA. Tofacitinib has been shown to reduce symptoms of RA and improve the quality of life in the analyzed groups of patients. Moreover, it showed high efficacy and an acceptable safety profile in Phase III randomized clinical trials on RA and was the first JAK inhibitor approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in the RA therapy, thus providing a useful alternative treatment strategy. Randomized controlled studies revealed a significant benefit over placebo in efficacy outcomes (American College of Rheumatology [ACR] 20 and ACR50 response rates); accordingly, clinically meaningful improvements in patient-related outcomes compared with placebo have been reported. The safety profile seems acceptable, although some severe adverse effects have been observed, including serious infections, opportunistic infections (including tuberculosis and herpes zoster), malignancies, and cardiovascular events, which require strict monitoring irrespective of the duration of tofacitinib administration. As an oral drug, tofacitinib offers an alternative to subcutaneous or intravenous biologic drugs and should be recognized as a more convenient way of drug administration.

Efficacy and safety of ustekinumab in the induction therapy of TNF-α-refractory Crohn's disease patients: a systematic review and meta-analysis.

AIM: The aim of the systematic review and meta-analysis was to assess the efficacy and safety of ustekinumab in the induction therapy of anti-TNF-α failure patients with Crohn's disease. METHODS: A systematic literature search was conducted in Medline (PubMed), EMBASE, Cochrane Library until 30 December 2016. We included randomized controlled trials that compared efficacy (clinical response and remission) and safety profile of ustekinumab in TNF-α failure Crohn's disease patients; primary and secondary TNF-α nonresponders or intolerant patients were also assessed. Included studies were critically appraised according to the PRISMA statement protocol; data aggregation with a RevMan® software was performed. RESULTS: Three randomized controlled trials were revealed in the systematic review but only two of them (CERTIFI and UNITI-1) were homogenous to be included in the meta-analysis; aggregation of data only for induction phase of therapy was possible. Clinical response was significantly higher for patients who received ustekinumab compared with placebo patients in a group of TNF-α antagonist failure patients (relative benefit [RB] = 1.62; 95% CI: 1.28-2.04) and in the following subgroups: secondary nonresponders (RB = 1.98; 95% CI: 1.49-2.63), intolerant patients (RB = 1.47; 95% CI: 1.01-2.13) and patients who failed at least two TNF-α antagonists (RB = 2.19; 95% CI: 1.53-3.14) but in case of primary nonresponders it occurred insignificant (RB = 1.22; 95% CI: 0.76-1.98). The clinical remission in TNF-α antagonist failure population was significantly higher for patients who received ustekinumab compared with placebo (RB = 1.72; 95% CI: 1.17-2.53). Pooled analysis revealed that risk of adverse events in induction phase of therapy was not significantly different (risk ratio = 0.96; 95% CI: 0.86-1.06) between ustekinumab and placebo groups. CONCLUSION: The clinical response was significantly higher for TNF-α antagonist failure patients who received ustekinumab as well as in subgroups of secondary nonresponders or intolerant patients but not in case of primary nonresponders. Ustekinumab occurred as safe as placebo in the induction as well as in a maintenance phase of therapy.

Lenvatinib for the treatment of radioiodine-refractory differentiated thyroid carcinoma: a systematic review and indirect comparison with sorafenib.

INTRODUCTION: Thyroid carcinoma is the most prevalent endocrine malignancy, with an increasing incidence over the past decades. Treatment of differentiated thyroid cancer consists of surgery followed by radioactive iodine (RAI) ablation of the thyroid remnant, and TSH suppression. Among new therapeutic solutions for patients with advanced RR-DTC stage, the most promising seem to be sorafenib and lenvatinib, up to now considered to be orphan drugs. Areas covered: We performed a systematic review of medical databases to collect all eligible clinical trials referring to the topic of our analysis. Due to the lack of direct clinical trials comparing the drugs we used an adjusted indirect comparison of efficacy and safety of tyrosine kinase inhibitors (TKIs) by Bucher method. Expert commentary: Lenvatinib and sorafenib are drugs with strong evidence on efficacy in treatment of RR-DTC. Based on the currently available clinical data lenvatinib occurred more efficacious then sorafenib in RR-DTC therapy. Safety profile of the drugs was acceptable and comparative. Kinase inhibitors constitute a substantial progress in treatment of advanced thyroid cancer, have achieved long-lasting response and have improved survival without progress of the disease. In the near future we will deal with a range of therapeutic options for patients.

Vedolizumab Compared with Certolizumab in the Therapy of Crohn Disease: A Systematic Review and Indirect Comparison.

OBJECTIVES: The increasing prevalence of Crohn disease (CD) underscores the need to identify new effective drugs, which is particularly important for patients who do not respond or do not tolerate standard biologic therapies. The purpose of this analysis was to compare the efficacy and safety of vedolizumab and certolizumab pegol in patients with active moderate to severe CD. METHODS: This analysis was prepared according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic literature search of Medline (PubMed), Embase, and the Cochrane Library was conducted through March 5, 2016. Studies included were randomized controlled trials (RCTs) that enrolled patients treated for CD with vedolizumab or certolizumab pegol. All studies were critically appraised; indirect comparison was performed with the Bucher method. RESULTS: Eight RCTs were identified, and four were homogeneous enough to be included in the indirect comparison of the induction phase of treatment. No statistically significant differences were found in clinical response (relative risk [RR] 1.23, 95% confidence interval [CI] 0.81-1.88) or remission (RR 1.35, 95% CI 0.89-2.07) between vedolizumab and certolizumab pegol in the overall population. Similar nonstatistically significant differences in response and remission were noted in a subgroup analysis of anti-tumor necrosis factor-naive patients (RR 1.10, 95% CI 0.72-1.66 and RR 1.98, 95% CI 0.95-4.11, respectively). In addition, there were no statistically significant differences in safety profiles. CONCLUSIONS: This indirect comparison analysis demonstrated no statistically significant differences in efficacy and safety between vedolizumab and certolizumab pegol.

"There's No Place Like Home": A Scoping Review on the Impact of Homelike Residential Care Models on Resident-, Family-, and Staff-Related Outcomes.

BACKGROUND: There is increasing emphasis on promoting "homelike" residential care models enabling care-dependent people to continue living in a self-determined manner. Yet, little is known about the outcomes of homelike residential care models. PURPOSE: We aimed to (1) identify homelike residential care models for older care-dependent people with and without dementia, and (2) explore the impact of these models on resident-, family-, and staff-related outcomes. DESIGN AND METHODS: We applied a scoping review method and conducted a comprehensive literature search in PubMed, Embase, and CINAHL in May 2015. RESULTS: We included 14 studies, reported in 21 articles. Studies were conducted between 1994 and 2014, most using a quasi-experimental design and comparing the Eden Alternative (n = 5), nondementia-specific small houses (eg Green House homes) (n = 2), and dementia-specific small houses (n = 7) with usual care in traditional nursing homes. The studies revealed evidence of benefit related to physical functioning of residents living in dementia-specific small houses and satisfaction with care of residents living in nondementia-specific small houses compared with those living in traditional nursing homes. We did not find other significant benefits related to physical and psychosocial outcomes of residents, or in family- and staff-related outcomes. IMPLICATIONS: The current evidence on homelike residential care models is limited. Comparative-effectiveness research building on a clear theoretical framework and/or logic model and including a standardized set of resident-, family-, and staff-related outcomes, as well as cost evaluation, is needed to provide a stronger evidence base to justify the uptake of more homelike residential care models.