INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE最新文献

Background: Advance care treatment escalation plans (TEPs) are often lost between healthcare settings, leading to duplication of work and loss of patient autonomy.

Objective: This quality improvement project reviewed the usage of TEP forms and aimed to improve completeness of documentation and visibility between admissions.

Methods: Over four months we monitored TEP form documentation using a standardised data extraction form. This examined section completion, seniority of documenting clinician and transfer of forms to our hospital electronic patient record (EPRO). We added reminders to computer monitors on wards to improve EPRO upload.

Results: Initial data demonstrated that 95% of patients (n = 230) had a TEP, with 99% of TEPs recording resuscitation status. However, other sections were not well documented (patient capacity 57% completion and personal priorities 45% completion, respectively). Only 11.9% of TEPs documented consultant involvement. Furthermore, only 44% of TEPs with a do not attempt resuscitation (DNACPR) decision were uploaded. Following this, we added reminders to computer monitors explaining how to upload TEP decisions to EPRO, which increased EPRO uploads to 74%.

Conclusion: Communication of TEPs needs improving across healthcare settings. This project showed that the use of a physical reminder can greatly improve communication of treatment escalation decisions. Furthermore, this intervention has inspired future projects aiming at making communication more sustainable through the use of discharge summaries.

Background: Governmental regulations of drug registration and licensing are not always followed by healthcare providers.

Objective: To explore the global research growth and patterns on systemic use of off-label and unlicensed drugs to gain knowledge about the magnitude of the problem and the main research themes encountered in this field.

Methods: SciVerse Scopus was searched for papers on off-label and unlicensed drug use from 1990 until December 31, 2020, without any language limitations. A bibliometric methodology was adopted to present the following indicators: top-cited documents, the most productive countries, top active journals, international research collaboration, the most frequent author keywords, and research themes.

Results: The search query returned 1320 papers with an h-index of 66, published in 721 different journals. The Hospital Pharmacy journal ranked first (n = 43, 3.3%). In total, 5777 authors (median = 3) from 85 different countries contributed to the retrieved papers. The USA (n = 381, 28.9%) ranked first, followed distantly by Germany and Italy. The percentage of documents with international authors for active countries was from 8.8% for China to 42.3% for the Netherlands. The most frequent author keyword next to off-label was children/pediatrics. The keyword unlicensed was less frequently encountered than that for off-label. Major research themes in the retrieved papers focused on off-label drug use in hospitalized children/pediatrics, biological drugs such as rituximab and rFVIIa, psychiatric disorders, regulations, and questionnaire-based knowledge/attitude studies among community pharmacists and physicians.

Conclusions: Research activity on off-label drug use has witnessed a general increase in the past two decades. The major research theme was off-label drug use in hospitalized children/pediatrics/neonates. The USA and certain European countries made a major contribution to this field.

Background: Adverse events in hospitals may jeopardize the safety of patients. Failure in professional autonomy, organizational learning or in the contact between these two factors may explain the occurrence of injurious incidents in hospitals.

Objective: To study reasons for failure in contact between professional autonomy and organizational learning in resilient management of specialized health care through document analysis.

Methods: A total of 20 reports from the Norwegian Board of Health Supervision were evaluated by a retrospective in-depth document analysis. In the analysis of adverse events, we applied the Braut model to identify function or failure of 1. Professional autonomy, 2. Organizational learning and 3. Contact between professional autonomy and organizational learning.

Results: Multivariable regression analysis showed that failure in organizational learning was the only explanatory variable for failure in contact between doctors and nurses autonomy and organizational learning. Failure in organizational learning had the strongest effect on failure in contact between doctors and nurse's autonomy and organizational learning (B = 1.69; 95% CI = 0.45 to 2.92). Failure in professional autonomy showed no significant effect on this contact.

Conclusions: Failure in organizational learning is associated with failure in contact between professional autonomy and organizational learning. Failure in professional autonomy did not influence this contact.

Background: Human error has been studied for large decades with special application to critical infrastructures and processes where the impact of such errors can induce severe or catastrophic consequences. In this sense it is of utmost importance to extend this type of analysis to other fields as medicine.

Objective: This study proposes a semi-quantitative human error risk assessment methodology, including the analysis of the so-called Performance Shaping Factors (PSFs), in order to contribute to health services improvement.

Methods: A questionnaire including the considered PSFs is answered in order to determine the impact of each PSF and its influence on human error. It allows performing a Human Error Risk Assessment (HERA) for both the patient (HERAp) and the quality of the service (HERAq).

Results: The results show the PSFs with the highest impact factor. After applying corrective measures, it is possible to observe the impact on the reduction of the risk for patient and for the quality of the service.

Conclusions: The application of the methodology with the inclusion of the impact of PSFs allows minimizing or mitigating failure modes with greater risk as well as increasing patient safety and promoting a better quality of medical procedures.

Background: Malnutrition adversely affects clinical outcomes, necessitating a prompt and accurate assessment of nutritional status on admission. A variety of tools exist to aid nutritional assessment, of which the malnutrition universal screening tool (MUST) is recommended, but remains difficult to implement in practice.

Objective: The aim of this audit was to improve the utilisation of the malnutrition universal screening tool (MUST) in the Acute Medical Unit (AMU) at Queen Elizabeth Hospital, King's Lynn. Specifically, patients should have a completed and accurate MUST score within 6 hours of arrival to AMU and high-risk patients (MUST score ≥2) should be referred to dieticians within 48 hours of admission. The first cycle was conducted by March 2019 and the second cycle was completed 1 year later to allow assessment of interventions actioned after the first cycle.

Methods: We conducted a two-cycle audit evaluating the MUST completion and dietician referral rate of high-risk patients (defined as MUST ≥2) on the Acute Medical Unit in a district general hospital, with the standards of 80% and 100% respectively. A questionnaire was distributed after the first cycle exploring nurses' current experience and competence in using MUST.

Results: In the first cycle, MUST scores were calculated correctly in 111/150 patients (74%) and 1/9 (11%) high-risk patients were referred to dieticians. After interventions, MUST scores were calculated correctly in 77/101 patients (76%) and 2/4 high-risk patients (50%) were referred to dieticians. The nurses (n = 19) who took part in the questionnaire felt confident in MUST completion, but the average score in an objective assessment was 67%.

Conclusions: As per the literature, the first cycle demonstrated the under-utilisation of MUST in clinical practice. In response, we proposed additional face-to-face training for existing staff, the inclusion of an e-learning module within the staff's induction, and provision of ward MUST 'troubleshooting' booklets. MUST utilisation rates improved upon re-auditing, but not to target standards. We will need to consider potential barriers to sustainable change and implement interventions such as identification of nursing champions to overcome them.

Background: Previous reports have shown that there are long waiting times to commence therapy in the community-based mental health programme, IAPT (Improving Access to Psychological Therapies).

Objective: This study aimed to explore both causes and potential solutions to alleviate the burden of these waits.

Methods: A Systematic Literature Review (SLR) and Semi-Structured Interviews (SSIs) were conducted to identify causes and effects of these waits. Consequently, meaningful recommendations were made and tested with the aim of improving IAPT's waiting times.

Results: SLR and SSIs revealed high 'Did Not Attend' (DNA) rates and a lack of support between initial appointments as being both a cause and effect of long waits. The identified issues were tackled with the development of an app design. Expert interviews and a mass survey fuelled the iterative process leading to a final prototype. Notable features included: therapist profile page, smart appointment reminders and patient timeline. Positive feedback was received from university students and ICS Digital, with scope to trial the app within Manchester CCG.

Conclusions: In the long run, the app aims to indirectly shorten waiting times by addressing treatment expectations and serving as an IAPT companion along the patient journey, thus reducing anxiety and consequently DNAs.

Background: The General Medical Council (GMC) states that all intimate examinations should have a chaperone offered. Documentation of chaperone identity, or patient's refusal, is essential.

Objective: This project aimed to improve documentation of chaperones during intimate examination of patients based in a Surgical Admissions Unit (SAU) within a large tertiary hospital in the Southwest of the UK.

Methods: A Plan-Do-Study-Act (PDSA) cycle structure was used. Initial data collection and planning occurred in December 2019. Intervention implementation and analysis occurred from January 2020 to March 2021. Intervention 1 involved presenting results at a clinical governance meeting. Intervention 2 was information posters in the SAU and intervention 3 involved training sessions for nursing staff. Intervention 4 was editing the surgical clerking proforma.

Results: Prior to interventions, chaperone identity or patient's refusal was correctly documented only 9.7% (N = 7 out of 72) of the time. Intervention 1 increased this to 34.6%. Following interventions 3 and 4, correct documentation was 25.0% and 28.6% respectively. After intervention 4 correct documentation was at 59.1%.

Conclusions: Initial documentation of chaperones was poor. Interventions 1 to 3 were successful in educating clinicians how to document accurately, but engaging individuals in person was more successful than passive education through posters. Changing the proforma structure was the most successful intervention. This suggests a visual reminder for clinicians at the point of contact with the patient is the most effective way to encourage correct documentation of chaperones, improving patient care and clinical practice.

Background: A set of enduring conditions have been reported in the literature involving persistent sexual dysfunction after discontinuation of serotonin reuptake inhibiting antidepressants, 5 alpha-reductase inhibitors and isotretinoin.

Objective: To develop diagnostic criteria for post-SSRI sexual dysfunction (PSSD), persistent genital arousal disorder (PGAD) following serotonin reuptake inhibitors, post-finasteride syndrome (PFS) and post-retinoid sexual dysfunction (PRSD).

Methods: The original draft was designed using data from two published case series (Hogan et al., 2014 and Healy et al., 2018), which represent the largest public collections of data on these enduring conditions. It was further developed with the involvement of a multidisciplinary panel of experts.

Results: A set of criteria were agreed upon for each of the above conditions. Features of PSSD, PFS and PRSD commonly include decreased genital and orgasmic sensation, decreased sexual desire and erectile dysfunction. Ancillary non-sexual symptoms vary depending on the specific condition but can include emotional blunting and cognitive impairment. PGAD presents with an almost mirror image of unwanted sensations of genital arousal or irritability in the absence of sexual desire. A new term, post-SSRI asexuality, is introduced to describe a dampening of sexual interest and pleasure resulting from a pre-natal or pre-teen exposure to a serotonin reuptake inhibitor.

Conclusions: These criteria will help in both clinical and research settings. As with all criteria, they will likely need modification in the light of developments.

Background: Fluoxetine was approved for depression in children and adolescents based on two placebo-controlled trials, X065 and HCJE, with 96 and 219 participants, respectively.

Objective: To review these trials, which appear to have been misreported.

Methods: Systematic review of the clinical study reports and publications. The primary outcomes were the efficacy variables in the trial protocols, suicidal events, and precursors to suicidality or violence.

Results: Essential information was missing and there were unexplained numerical inconsistencies. (1) The efficacy outcomes were biased in favour of fluoxetine by differential dropouts and missing data. The efficacy on the Children's Depression Rating Scale-Revised was 4% of the baseline score, which is not clinically relevant. Patient ratings did not find fluoxetine effective. (2) Suicidal events were missing in the publications and the study reports. Precursors to suicidality or violence occurred more often on fluoxetine than on placebo. For trial HCJE, the number needed to harm was 6 for nervous system events, 7 for moderate or severe harm, and 10 for severe harm. Fluoxetine reduced height and weight over 19 weeks by 1.0 cm and 1.1 kg, respectively, and prolonged the QT interval.

Conclusions: Our reanalysis of the two pivotal trials showed that fluoxetine is unsafe and ineffective.

Background: The new type of virus (SARS-CoV-2 or COVID-19) from Coronaviridae family, discovered in 2019, caused a global pandemic with several massive lock-downs around the globe. Science and politicians became the center of world attention, receiving many questions without having clear answers. The hopes of many rested on vaccine development, which was done fast, facing novel challenges such as the massive production and distribution for several billions of people.

Objective: In this paper, the global reaction to the pandemic is reviewed along with some critical comments.

Method: Different groups, including nations, took part in global lockdowns, while vaccine development was running in parallel without having enough capacity for some of the biggest medical demands in history. This review will bring together views from all interested groups in this pandemic crisis.

Results: The Western world waited too long (4 months), after the first case was confirmed in China, to introduce lock-down and safety measures. On the other side, vaccine development was done too fast to give clear long-term safety profiles of the medications developed. Due to the focus on development, it was overlooked that production and distribution of sterile products such as vaccines might have limitations globally. Usually when such limitations occur, power comes to the surface. Therefore, buyers who had power will get the vaccines they need first. However, we should recognize the economic impact that directly influenced healthcare funding. All of this will lead to post-crisis challenges, including depression, violence, suicide, migration, and many other social problems.

Conclusions: The COVID-19 pandemic is a test for all of us, which many governments, industries and non-state actors are failing. It is a perfect "general probe" to detect some of the weaknesses of the current structure of global health. If politics and science do not work together to make a global production plan for vaccines and learn from this pandemic, then all of the lives lost were for nothing.