Explore the vast range of titles available.

ObjectiveTo assess the extent to which cancer centres in Arab countries adhere to the 2016 American Society of Clinical Oncology/Oncology Nursing Society (ASCO/ONS) chemotherapy administration safety standards.DesignMulticentre cross-sectional survey.SettingSample of the largest cancer treatment facilities across 10 Arab countries, including governmental, private, university-affiliated and daycare centres where chemotherapy is administered.ParticipantsA multidisciplinary team of healthcare professionals (including head nurses, oncologists, oncology pharmacists and quality staff) at each centre completed a structured survey on adherence to the ASCO/ONS chemotherapy administration safety standards.Outcome measuresThe primary outcome was the proportion of cancer centres fully implementing each of the 46 ASCO/ONS safety standards, grouped into four domains: (1) creating a safe environment—staffing and general policy; (2) treatment planning, patient consent and education; (3) ordering, preparing, dispensing and administering chemotherapy; and (4) monitoring after chemotherapy administration.ResultsOf the 25 centres invited, 19 (76%) participated. The domain most frequently fully implemented was treatment planning, patient consent and education (12/19 centres, 63.2%). The remaining domains were fully implemented by four centres or fewer. The lowest implementation was observed for standards requiring policies for documentation and follow-up of patients who miss or cancel scheduled visits or chemotherapy treatments. Centres accredited by the Joint Commission International and those that specifically reported adherence to internationally recognised oncology guidelines were more likely to fully implement specific domains of the ASCO/ONS chemotherapy administration safety standards.ConclusionsSignificant gaps exist in the implementation of ASCO/ONS chemotherapy administration safety standards at cancer centres across Arab countries. These findings highlight opportunities for targeted interventions and policy development to improve chemotherapy safety in the region.

Using field observation in mental health settings is challenging and necessitates careful planning and transparent data collection and analysis. Lack of requirements for reporting observation methods increases the potential for researchers to omit important details, leading to ambiguity in interpretation, challenges in replicating the study, and misinformed conclusions. Despite the availability of reporting guidelines for qualitative methods such as interviews and focus groups, guidelines or frameworks for reporting field observation methods are lacking. There is a need to address this gap by starting with an examination of current research that employs and reports on observation methods. As a result, we conducted an integrative review to analyze and synthesize research studies that implemented qualitative observation in mental health inpatient settings. We navigated the detailed reporting of contextual information, bias, rigor, participants, observer information, observation procedures, ethical considerations, data analysis, and limitations. Informed by the strengths and limitations of the observation methods used and described in the literature, we developed a guideline for reporting field observation research methods in mental health inpatient settings. The guideline outlines the key characteristics and information to include when reporting observation procedures. The guideline has five categories covering: i) context, ii) access and ethics, iii) observer-related factors, iv) observation procedures, and v) data collection and analysis. It is designed for reporting field observation methods, but may also help researchers plan and conduct field observation. Plain Language Summary Research using direct observation of patients, health care providers (HCPs) and their daily activities on mental health inpatient units can provide important information. Observation can help understand the situations and challenges that patients and staff experience while receiving or providing mental health care. However, observing and collecting data in mental health settings can be difficult and requires careful planning. Researchers may not have clear guidelines on how to report their observation methods and important details can be missed. This makes it hard to understand the research, repeat the study, and reach accurate conclusions. While there are good reporting guidelines for interviews and focus groups, reporting guidelines are lacking for field observation. To fill this gap, we reviewed existing research studies that used observation methods in mental health inpatient settings. We focused on relevant aspects of each study, such as, the purpose and context, the people involved, ethical issues, the procedures used, potential biases and how the data were analyzed. Based on our review findings, we created a guideline to help researchers report their observation methods more clearly. The guideline includes five categories: study context, ethical considerations, factors related to the observer, the observation procedures used, and how data are collected and analyzed. The guideline not only helps with reporting but can also guide researchers in planning their observation studies.

ObjectivesClinical trials (CTs) are considered an important method for developing new treatments and providing access to potentially effective drugs that are still under investigation. Measuring the public’s knowledge of and attitudes toward CTs is important for assessing their readiness for and acceptance of human drug testing, which has previously not been assessed in the Kingdom of Saudi Arabia (KSA). The objective of this study is to explore the Saudi public’s knowledge of and attitudes toward CTs as well as participation in trials to test new or approved drugs.DesignCross-sectional.SettingThe 2016 Al Jenadriyah cultural/heritage festival in Riyadh, KSA.ParticipantsParticipating booths and exhibition halls, as well as festival visitors, were approached to participate in the study.Primary and secondary outcome measuresKnowledge of and attitudes toward CTs.ResultsThe final number of participants was 938. The responses were converted to a percentage mean score (out of 100) for each knowledge-related response and attitude. The total mean knowledge score was 56.8±24.8 and the attitude-related score was 61.5±28.0. Although most of the participants supported testing approved or off-label and new drugs on adult and paediatric patients, only a third (30.5%) agreed that new drugs could be tested on healthy volunteers. The results indicated that gender, educational level, income, medical background, age and health insurance were independently associated with the level of knowledge of CTs. In terms of attitudes toward CTs, the factors that were independently associated were gender, educational level and medical background.ConclusionsThe Saudi public has a low level of knowledge and a moderately positive attitude toward CTs. There is a moderate positive correlation between the two factors such that as knowledge of CTs increases, the Saudi public will hold more positive attitudes toward CTs.

Background It is recommended that critically ill patients undergo routine delirium monitoring with a valid and reliable tool such as the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). However, the validity and reliability of the Arabic version of the CAM-ICU has not been investigated. Here, we test the validity and reliability of the Arabic CAM-ICU. Methods We conducted a psychometric study at ICUs in a tertiary-care hospital in Saudi Arabia. We recruited consecutive adult Arabic-speaking patients, who had stayed in the ICU for at least 24 hours, and had a Richmond Agitation-Sedation Scale (RASS) score ≥ − 2 at examination. Two well-trained examiners (ICU nurse and intensivist) independently assessed delirium in eligible patients with the Arabic CAM-ICU. Evaluations by the two examiners were compared with psychiatrist blind clinical assessment of delirium according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Subgroup analyses were conducted for age, invasive mechanical ventilation, and gender. Results We included 108 patients (mean age: 62.6 ± 17.6; male: 51.9%), of whom 37% were on invasive mechanical ventilation. Delirium was diagnosed in 63% of enrolled patients as per the psychiatrist clinical assessment. The Arabic CAM-ICU sensitivity was 74% (95% confidence interval [CI] = 0.63–0.84) and 56% (95%CI = 0.44–0.68) for the ICU nurse and intensivist, respectively. Specificity was 98% (95%CI = 0.93–1.0) and 92% (95%CI = 0.84–1.0), respectively. Sensitivity was greater for mechanically-ventilated patients, women, and those aged ≥65 years. Specificity was greater for those aged < 65 years, non-mechanically-ventilated patients and men. The median duration to complete the Arabic CAM-ICU was 2 min (interquartile range, 2–3) and 4.5 min (IQR, 3–5) for the ICU nurse and intensivist, respectively. Inter-rater reliability (kappa) was 0.66. Conclusions The Arabic CAM-ICU demonstrated acceptable reliability and validity to assess delirium in Arabic-speaking ICU patients.

Corticosteroid therapy is commonly used among critically ill patients with Middle East Respiratory Syndrome (MERS), but its impact on outcomes is uncertain. Analyses of observational studies often do not account for patients' clinical condition at the time of corticosteroid therapy initiation. To investigate the association of corticosteroid therapy on mortality and on MERS coronavirus RNA clearance in critically ill patients with MERS. ICU patients with MERs were included from 14 Saudi Arabian centers between September 2012 and October 2015. We performed marginal structural modeling to account for baseline and time-varying confounders. Of 309 patients, 151 received corticosteroids. Corticosteroids were initiated at a median of 3.0 days (quartile 1 [Q1]-Q3, 1.0-7.0) from ICU admission. Patients who received corticosteroids were more likely to receive invasive ventilation (141 of 151 [93.4%] vs. 121 of 158 [76.6%]; P < 0.0001) and had higher 90-day crude mortality (112 of 151 [74.2%] vs. 91 of 158 [57.6%]; P = 0.002). Using marginal structural modeling, corticosteroid therapy was not significantly associated with 90-day mortality (adjusted odds ratio, 0.75; 95% confidence interval, 0.52-1.07; P = 0.12) but was associated with delay in MERS coronavirus RNA clearance (adjusted hazard ratio, 0.35; 95% CI, 0.17-0.72; P = 0.005). Corticosteroid therapy in patients with MERS was not associated with a difference in mortality after adjustment for time-varying confounders but was associated with delayed MERS coronavirus RNA clearance. These findings highlight the challenges and importance of adjusting for baseline and time-varying confounders when estimating clinical effects of treatments using observational studies.

Diagnosis, epidemiology, virology/pathogenesis, treatment, prevention, review/commentary/editorial/experiences, animal models, transmission, and social (including health care providers and public).

The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-β1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The aim of this article is to describe the statistical analysis plan for the MIRACLE trial. The primary outcome is 90-day mortality. The primary analysis will follow the intention-to-treat principle. The MIRACLE trial is the first randomized controlled trial for MERS treatment. Trial registration ClinicalTrials.gov, NCT02845843 . Registered on 27 July 2016.

Animal and human data indicate variable effects of interferons in treating coronavirus infections according to inflammatory status and timing of therapy. In this sub-study of the MIRACLE trial (MERS-CoV Infection Treated with a Combination of Lopinavir–Ritonavir and Interferon β-1b), we evaluated the heterogeneity of treatment effect of interferon-β1b and lopinavir–ritonavir versus placebo among hospitalized patients with MERS on 90-day mortality, according to cytokine levels and timing of therapy. We measured plasma levels of 17 cytokines at enrollment and tested the treatment effect on 90-day mortality according to cytokine levels (higher versus lower levels using the upper tertile (67%) as a cutoff point) and time to treatment (≤ 7 days versus > 7 days of symptom onset) using interaction tests. Among 70 included patients, 32 received interferon-β1b and lopinavir–ritonavir and 38 received placebo. Interferon-β1b and lopinavir–ritonavir reduced mortality in patients with lower IL-2, IL-8 and IL-13 plasma concentrations but not in patients with higher levels (p-value for interaction = 0.09, 0.07, and 0.05, respectively) and with early but not late therapy (p = 0.002). There was no statistically significant heterogeneity of treatment effect according to other cytokine levels. Further work is needed to evaluate whether the assessment of inflammatory status can help in identifying patients with MERS who may benefit from interferon-β1b and lopinavir–ritonavir. Trial registration: This is a sub-study of the MIRACLE trial (ClinicalTrials.gov number, NCT02845843).

It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-[beta]1b (IFN-[beta]1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-[beta]1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018.

Background Computerized Physician Order Entry (CPOE) analgesia-sedation protocols may improve sedation practice and patients’ outcomes. We aimed to evaluate the impact of the introduction of CPOE protocol. Methods This was a prospective, observational cohort study of adult patients receiving mechanical ventilation, requiring intravenous infusion of analgesics and/or sedatives, and expected to stay in the intensive care unit (ICU) ≥24 h. As a quality improvement project, the study had three phases: phase 1, no protocol, July 1st to September 30th, 2010; phase 2, post implementation of CPOE protocol, October 1st to December 31st, 2010; and phase 3, revised (age, kidney and liver function adjusted) CPOE protocol, August 1st to October 31st, 2011. Multivariate analyses were performed to determine the independent predictors of mortality. Results Two hundred seventy nine patients were included (no protocol = 91, CPOE protocol = 97, revised CPOE protocol = 91). Implementation of CPOE protocol was associated with increase of the average daily dose of fentanyl (3720 ± 3286 vs. 2647 ± 2212 mcg/day; p  = 0.009) and decrease of hospital length of stay (40 ± 37 vs. 63 ± 85 days, p  = 0.02). The revised CPOE protocol was associated with, compared to the CPOE protocol, a decrease of the average daily dose of fentanyl (2208 ± 2115 vs. 3720 ± 3286 mcg/day, p  = 0.0002) and lorazepam (0 ± 0 vs. 0.06 ± 0.26 mg/day, p  = 0.04), sedation-related complications during ICU stay (3.3 % vs. 29.9 %, p <0.0001), and ICU mortality (18 % vs. 39 %, p  = 0.001). The impact of the revised CPOE protocol was more evident on patients aged >70 years or with severe kidney or liver impairment. Both the original CPOE protocol and the revised CPOE protocol were not independent predictors of ICU (adjusted odds ratio [aOR] = 1.85, confidence interval [CI] = 0.90–3.78; p  = 0.09; aOR = 0.70, CI = 0.32–1.53, p  = 0.37; respectively) or hospital mortality (aOR = 1.12, CI = 0.57–2.21, p  = 0.74; aOR = 0.80, CI = 0.40–1.59, p  = 0.52; respectively). Conclusions The implementation of a CPOE analgesia-sedation protocol was not associated with improved sedation practices or patients’ outcome but with unpredicted increases of an analgesic dose. However, the revised CPOE protocol (age, kidney and liver function adjusted) was associated with improved sedation practices. This study highlights the importance of carefully evaluating the impact of changes in practice to detect unanticipated outcomes.