Provision of gender affirming care among medical and allied health practitioners: The influence of transnormative beliefs in working with gender diverse patients.

Gender diverse patients (including gender diverse, transgender, and non-binary people) deserve quality health care, which has been referred to as gender affirming care. Given that practitioners' attitudes and competence can influence their provision of gender affirming care, this study used a lens of transnormativity (Bradford & Syed, 2019; Johnson, 2016) to develop a measure of practitioners' transnormative beliefs. The aim of the study was to determine if these beliefs were related to practitioners' gender affirming attitudes and perceptions of competence in gender affirming practice. Survey data were collected from Australian medical and allied health practitioners (N = 95). Exploratory factor analysis was applied to items measuring transnormative beliefs, with the results supporting three higher order factors; conditional approval, narrative, and gender role beliefs. Conditional approval reflected belief in gender diverse identity as authentic and worthy of intervention. Narrative beliefs reflected understanding of common developmental experiences among gender diverse populations, specifically experiences of victimisation and nascence. Gender role beliefs reflected belief in the existence of gender roles. In models that regressed gender affirming attitudes and self-perceived competency on all transnormative beliefs, controlling for demographics and work history, practitioners higher in conditional approval were lower in gender affirming attitudes and practitioners higher in narrative beliefs were higher in gender affirming attitudes and competency. Conditional approval was not significantly associated with competency, and gender role beliefs were not significantly associated with attitudes or competency. Results indicate that practitioners' transnormative beliefs are related to their gender affirming attitudes and suggest that targeting these beliefs through training opportunities could bridge the gap between gender diverse people's healthcare needs and the ability of healthcare practitioners to provide high quality care.

Eye Donation: Awareness, Knowledge, Willingness, and Barriers among Paramedical and Allied Health Science Students at a Tertiary Care Teaching Hospital in South India.

BACKGROUND: Visual impairments have physical, emotional, social, and economical consequences and are a crucial element influencing one's quality of life. A total of 1.285 million people are estimated to be visually impaired worldwide of which 39 million are categorised as blind. These figures are startling, given that 80 percent of known vision impairments are either treatable or preventable. Corneal transplants appear to be our best hope for resolving this problem; however, a global shortage of available donors continues to dampen efforts addressing this issue. METHODS: This two-year cross-sectional study employed a convenience sampling technique and a standardised questionnaire to survey 150 paramedical and allied health science students at a tertiary care teaching hospital and assessed the awareness, knowledge, willingness and barriers regarding eye donation. RESULTS: The study revealed a 93.3% awareness rate of the donation procedure, of which 46% attributed their awareness to media sources. However, other aspects assessed had much lower awareness rates; when the eyes are donated (53.3%), optimal time period for retrieval of tissue/organ (54%), ideal part transplanted (54%), age limit not restricting donation (67%), donation by donors using spectacles (48%), confidentiality of the donor and recipient (54%), hospital having the facility of an eye bank (63%). 49 percent of the respondents were willing to pledge themselves as eye donors, and a majority of the unwilling respondents reported that familial opposition was the reason for their hesitation. CONCLUSION: Knowledge levels appear to be below expectations, and more effort is required to ensure that knowledge is imparted to our healthcare practitioners, who will then transfer this knowledge to the population, resulting in an increase in donation rates.

Emergency department interventions that could be conducted in subacute care settings for patients with nonemergent conditions transported by paramedics: a modified Delphi study.

BACKGROUND: As the number of patients with nonemergent conditions who are transported by paramedics continues to increase in Ontario, redirecting specific patients to subacute settings may be more beneficial and suitable for both patients and emergency departments. We aimed to evaluate whether emergency department interventions conducted on patients with nonemergent conditions who are transported by paramedics could be conducted in subacute health centres. METHODS: We conducted a RAND/UCLA modified Delphi study in Ontario between Oct. 13 and Dec. 19, 2020. We used purposive sampling to recruit practising emergency and primary care physicians for an expert panel. We abstracted interventions given to adult patients with nonemergent conditions (18 yr of age or older) who were transported by paramedics to an emergency department from the National Ambulatory Care Reporting System (NACRS) database (Jan. 1, 2014, to Mar. 31, 2018). Participants in the expert panel rated the suitability of the 150 most frequently recorded emergency department interventions from the NACRS database, for completion in subacute health care centres. We set consensus at 70% agreement. RESULTS: We invited 25 physician experts, 21 of whom consented to participate; 20 physicians completed round 1, and 18 physicians completed both rounds. After 2 rounds, consensus was reached on 146 (97.3%) interventions; 103 interventions (68.7%) were suitable for subacute centres, 43 (28.7%) for only the emergency department and 4 (2.6%) did not receive consensus. For subacute centres, all 103 interventions were rated for urgent care centres; walk-in medical centres were applicable for 46 (30.6%) interventions and clinics led by nurse practitioners for 47 (31.3%) interventions. INTERPRETATION: Most interventions provided to patients with nonemergent conditions transported by paramedics to emergency departments were identified as suitable for urgent care clinics, with one-third being suitable for either walk-in medical centres or clinics led by nurse practitioners. This study has potential to inform a patient classification model for paramedic-initiated redirection of patients from emergency departments, although further contextualization is required for this to be implemented in clinical practice. STUDY REGISTRATION: ID ISRCTN22901977.

Comparison of Vie Scope® and Macintosh laryngoscopes for intubation during resuscitation by paramedics wearing personal protective equipment.

BACKGROUND: Endotracheal intubation (ETI) is still the gold standard of airway management, but in cases of sudden cardiac arrest in patients with suspected SARS-CoV-2 infection, ETI is associated with risks for both the patient and the medical personnel. We hypothesized that the Vie Scope® is more useful for endotracheal intubation of suspected or confirmed COVID-19 cardiac arrest patients than the conventional laryngoscope with Macintosh blade when operators are wearing personal protective equipment (PPE). METHODS: Study was designed as a prospective, multicenter, randomized clinical trial performed by Emergency Medical Services in Poland. Patients with suspected or confirmed COVID-19 diagnosis who needed cardiopulmonary resuscitation in prehospital setting were included. Patients under 18 years old or with criteria predictive of impossible intubation under direct laryngoscopy, were excluded. Patients were randomly allocated 1:1 to Vie Scope® versus direct laryngoscopy with a Macintosh blade. Study groups were compared on success of intubation attempts, time to intubation, glottis visualization and number of optimization maneuvers. RESULTS: We enrolled 90 out-of-hospital cardiac arrest (OHCA) patients, aged 43-92 years. Compared to the VieScope® laryngoscope, use of the Macintosh laryngoscope required longer times for tracheal intubation with an estimated mean difference of -48 s (95%CI confidence interval [CI], -60.23, -35.77; p < 0.001). Moreover VieScope® improved first attempt success rate, 93.3% vs. 51.1% respectively (odds ratio [OR] = 13.39; 95%CI: 3.62, 49.58; p < 0.001). CONCLUSIONS: The use of the Vie Scope® laryngoscope in OHCA patients improved the first attempt success rate, and reduced intubation time compared to Macintosh laryngoscope in paramedics wearing PPE for against aerosol generating procedures. TRIAL REGISTRATION: ClinicalTrials registration number NCT04365608.

Deriving Effective Decision-Making Strategies of Prosthetists: Using Hidden Markov Modeling and Qualitative Analysis to Compare Experts and Novices.

OBJECTIVE: This research focuses on studying the clinical decision-making strategies of expert and novice prosthetists for different case complexities. BACKGROUND: With an increasing global amputee population, there is an urgent need for improved amputee care. However, current prosthetic prescription standards are based on subjective expertise, making the process challenging for novices, specifically during complex patient cases. Hence, there is a need for studying the decision-making strategies of prosthetists. METHOD: An interactive web-based survey was developed with two case studies of varying complexities. Navigation between survey pages and time spent were recorded for 28 participants including experts (n = 20) and novices (n = 8). Using these data, decision-making strategies, or patterns of decisions, during prosthetic prescription were derived using hidden Markov modeling. A qualitative analysis of participants' rationale regarding decisions was used to add a deep contextualized understanding of decision-making strategies derived from the quantitative analysis. RESULTS: Unique decision-making strategies were observed across expert and novice participants. Experts tended to focus on the personal details, activity level, and state of the residual limb prior to prescription, and this strategy was independent of case complexity. Novices tended to change strategies dependent upon case complexity, fixating on certain factors when case complexity was high. CONCLUSION: The decision-making strategies of experts stayed the same across the two cases, whereas the novices exhibited mixed strategies. APPLICATION: By modeling the decision-making strategies of experts and novices, this study builds a foundation for development of an automated decision-support tool for prosthetic prescription, advancing novice training, and amputee care.

Musculoskeletal symptoms among radiation technologists in Saudi Arabia: prevalence and causative factors.

BACKGROUND: Radiation technologists usually perform several physical tasks as part of their work routine that are related to imaging equipment and handling patients. These kinds of physical activities increase their risk of developing musculoskeletal symptoms (MSS). PURPOSE: To determine the prevalence and causative factors of MSS among radiation technologists in Saudi Arabia. MATERIAL AND METHODS: A previously validated and published questionnaire was sent electronically to 800 radiation technologists in Saudi Arabia. It focused on the presence and prior diagnosis of MSS. Questions to determine risk factors were included. RESULTS: A total of 381 responses were obtained. MSS were indicated by 326 responders (85.6%). Furthermore, it was reported that 309 responders (81.1%) spent more than 2 h per day in awkward postures. Of the responders, 164 (43%) stated that they worked 4 h per day on a personal computer or PACS. The most frequently selected reasons for MSS included patient transfer (50.6%), chairs (38.5%), lead aprons (25.6%), moving heavy equipment (23.1%), and fixed table height (19.4%). An association between work-related MSS and gender was observed (χ2(1) = 5.338; P = 0.021). Similarly, an association between work-related MSS and age was also observed (χ2(3) = 48.58; P = 0.000). CONCLUSION: Radiation technologists in Saudi Arabia reported a fairly high incidence of MSS, more commonly among female and senior workers. To have a better and safer workplace for radiation technologists, this study suggests preventive measures on organizational and individual levels.

Prevalence and Predictors of Home Health Care Workers' General, Physical, and Mental Health: Findings From the 2014‒2018 Behavioral Risk Factor Surveillance System.

Objectives. To determine the prevalence and predictors of US home health care workers' (HHWs') self-reported general, physical, and mental health. Methods. Using the 2014-2018 Behavioral Risk Factor Surveillance System, we analyzed the characteristics and health of 2987 HHWs (weighted n = 659 000) compared with 2 similar low-wage worker groups (health care aides and health care support workers, not working in the home). We conducted multivariable logistic regression to determine which characteristics predicted HHWs' health. Results. Overall, 26.6% of HHWs had fair or poor general health, 14.1% had poor physical health, and 20.9% had poor mental health; the prevalence of each outcome was significantly higher than that of the comparison groups. Among HHWs, certain factors, such as low household income, an inability to see a doctor because of cost, and a history of depression, were associated with all 3 aspects of suboptimal health. Conclusions. HHWs had worse general, physical, and mental health compared with low-wage workers not in home health. Public Health Implications. Increased attention to the health of HHWs by public health experts and policymakers is warranted. In addition, targeted interventions appropriate to their specific health needs may be required. (Am J Public Health. 2021;111(12):2239-2250. https://doi.org/10.2105/AJPH.2021.306512).

The impact of COVID-19 on patient safety attendant use.

ABSTRACT: Patient safety attendants (PSAs) provide constant direct observation to patients who have cognitive impairments or thoughts. Some estimates report that an acute care hospital in the United States may spend more than $1 million annually on PSAs, an expenditure often not reimbursed. With no national defined standards to regulate or monitor PSA use, this study sought to determine the impact of COVID-19 on a PSA reduction program in a large Midwestern healthcare system.

'It's not hands-on therapy, so it's very limited': Telehealth use and views among allied health clinicians during the coronavirus pandemic.

BACKGROUND: Telehealth services have helped enable continuity of care during the coronavirus pandemic. We aimed to investigate use and views towards telehealth among allied health clinicians treating people with musculoskeletal conditions during the pandemic. METHODS: Cross-sectional international survey of allied health clinicians who used telehealth to manage musculoskeletal conditions during the coronavirus pandemic. Questions covered demographics, clinician-related factors (e.g. profession, clinical experience and setting), telehealth use (e.g. proportion of caseload, treatments used), attitudes towards telehealth (Likert scale), and perceived barriers and enablers (open questions). Data were presented descriptively, and an inductive thematic content analysis approach was used for qualitative data, based on the Capability-Opportunity-Motivation Behavioural Model. RESULTS: 827 clinicians participated, mostly physiotherapists (82%) working in Australia (70%). Most (71%, 587/827) reported reduced revenue (mean (SD) 62% (24.7%)) since the pandemic commenced. Median proportion of people seen via telehealth increased from 0% pre (IQR 0 to 1) to 60% during the pandemic (IQR 10 to 100). Most clinicians reported managing common musculoskeletal conditions via telehealth. Less than half (42%) of clinicians surveyed believed telehealth was as effective as face-to-face care. A quarter or less believed patients value telehealth to the same extent (25%), or that they have sufficient telehealth training (21%). Lack of physical contact when working through telehealth was perceived to hamper accurate and effective diagnosis and management. CONCLUSION: Although telehealth was adopted by allied health clinicians during the coronavirus pandemic, we identified barriers that may limit continued telehealth use among allied health clinicians beyond the current pandemic.

Comparison of the effects of shortening rest intervals on the quality of cardiopulmonary resuscitation, physiological parameters, and hemodynamic parameters in well-trained rescuers: Randomized simulation study.

BACKGROUND: Cardiopulmonary resuscitation (CPR) performance depends on individual ability and training. Well-trained or professional rescuers can maintain high-quality CPR for longer than laypeople. This study aimed to examine the effects of reducing resting intervals on CPR performance, physiological parameters, and hemodynamic parameters during prolonged CPR in well-trained providers. METHODS: The study enrolled 90 volunteers from the paramedic students of our institution. They were randomly divided into 3 groups: 2 minutes, 1 minute 45 seconds, and 1 minute 30 seconds rest groups. Each participant performed 5 cycles of chest compression only CPR (2 min/cycle) with different resting intervals according to grouping. CPR quality, physiological variations, and hemodynamic variations were measured for each cycle and compared across the groups. RESULTS: Of the 90 volunteers, 79 well-trained providers were finally included. The variation of the average chest compression depth across the 5 cycles showed significant differences between the 3 groups: from cycle 1 to 2: 1.2 (3.1) mm, -0.8 (2.0) mm, and -2.0 (3.0) mm in the 2 minutes, 1 minute 45 seconds, and 1 minute 30 seconds groups, respectively (P < .001); from cycle 1 to 3: 0.0 (3.0) mm, -0.7 (3.2) mm, and -2.6 (3.9) mm, respectively (P = .030). However, all 3 groups maintained the recommended rate and chest compression depth for all 5 cycles. Physiological and hemodynamic parameters showed no significant differences between the groups. CONCLUSIONS: Well-trained providers were able to maintain high-quality CPR despite reducing rest intervals. Adjusting the rest interval may help maintain overall CPR quality in special situations or where layperson rescuers are involved.

Factors influencing hospital conveyance following ambulance attendance for people with diabetes: A retrospective observational study.

AIM: To assess variables contributing to hospital conveyance for people with diabetes and the interactions between them. A secondary aim was to generate hypotheses for further research into interventions that might reduce avoidable hospital admissions. METHODS: A national retrospective data set including 30 999 diabetes-related callouts from the Scottish Ambulance Service was utilized covering a 5-year period between 2013 and 2017. The relationship between diabetes-related hospital conveyance and seven potential risk factors was analysed. Independent variables included: age, gender, deprivation, paramedic attendance, treatment at the scene, first blood glucose measurement and day of the week. RESULTS: In Scotland, hyperglycaemia was associated with a higher number of people being conveyed to hospital than hypoglycaemia (49.8% with high blood glucose vs. 39.3% with low glucose, P ≤ 0.0001). Treatment provided in pre-hospital care was associated with reduced conveyance rates (47.3% vs. 58.2% where treatment was not administered, P ≤ 0.0001). Paramedic attendance was also associated with reduced conveyance to hospital (51.4% vs. 59.5% where paramedic was not present, P ≤ 0.0001). Paramedic attendance in hyperglycaemic cases was associated with significantly reduced odds of conveyance (odds ratio 0.52, P ≤ 0.001). CONCLUSIONS: A higher rate of conveyance associated with hyperglycaemic cases indicates a need for more resources, education and training in this area. Higher conveyance rates were also associated with no paramedic being present and no treatment being administered. This suggests that paramedic attendance may be crucial in reducing avoidable admissions. Developing and validating protocols for pre-hospital services and treatment may help to reduce hospital conveyance rates.

Burnout and distress among allied health care professionals in a cardiovascular centre of a quaternary hospital network: a cross-sectional survey.

BACKGROUND: Burnout and distress negatively affect the well-being of health care professionals and the treatment they provide. Our aim was to measure the prevalence of burnout and distress among allied health care staff at a cardiovascular centre of a quaternary hospital network in Canada, and compare outcomes to those for nonphysician employees in the United States. METHODS: We conducted a survey of allied health care staff, including physical, respiratory and occupational therapists, pharmacists, social workers, dietitians and speech-language pathologists, in a cardiovascular centre at 2 quaternary referral hospitals in Toronto, Ontario, between Nov. 27, 2018, and Jan. 31, 2019. The survey tool included the Well-Being Index (WBI), which measures fatigue, depression, burnout, anxiety or stress, quality of life, work-life integration, meaning in work and overall distress; a score of 2 or higher indicated high distress. We carried out standard univariate statistical comparisons using the χ2, Fisher exact or Kruskal-Wallis test as appropriate to perform univariate comparisons in the sample of respondents. We assessed the relation between a WBI score of 2 or higher and demographic characteristics. We compared univariate associations among WBI data for nonphysician employees in the US who completed the WBI to responses from our participants. RESULTS: The response rate to the survey was 86% (45/52). Thirty-three respondents (73%) reported experiencing burnout in the previous month, and 31 (69%) reported emotional problems. Compared to respondents who perceived fair treatment in the workplace, those who perceived unfair treatment (20 [44%]) were more likely to report emotional problems (17 [85%] v. 13 [54%], p = 0.05), to worry that work was hardening them emotionally (15 [75%] v. 8 [33%], p = 0.008), and to feel down, depressed or hopeless (12 [60%] v. 4 [17%], p = 0.005). Twenty-five respondents (56%) and 13 respondents (29%) reported WBI scores consistent with high (≥ 2) or severe (≥ 5) distress, respectively. Respondents were more likely to have a high WBI score if they perceived unfair treatment or inadequate staffing levels. Our respondents had a higher prevalence of burnout (73.3% v. 53.6%, p = 0.008) and a higher average WBI score (2.6 [SD 2.8] v. 1.7 [SD 2.6], p = 0.05) than 9096 nonphysician employees in the US. INTERPRETATION: The prevalence of burnout, emotional problems and distress was high among allied health care staff. Fair treatment in the workplace and adequate staffing may lower distress levels and improve the work experience of these health care professionals.

Contemporary occupational therapy philosophy and practice in hospital settings.

BACKGROUND: Occupational therapists have sought to reconnect with the foundations of the profession for many years, and a key focus has been the place of occupation in practice. Existing literature suggests that therapists working in acute settings experience difficulties practicing in ways that centralise occupation. AIM/OBJECTIVE: This scoping review aimed to explore the existing literature on contemporary occupational therapy philosophy and practice in acute hospital settings. METHODS: A five step scoping review process was implemented. Four electronic databases were searched using a combination of search terms. Searching reference lists of papers was also completed. Results were summarised using numeric and thematic analysis. RESULTS: Twenty four publications were included. Four themes were identified; attitudes towards occupation-based practice, benefits of occupation-based approaches, challenges implementing occupation-based practice, and strategies to overcome challenges. CONCLUSION AND SIGNIFICANCE: Findings highlighted therapists value occupation as an important aspect of practice, however they experience many environmental and personal challenges in acute settings. Strategies to overcome these challenges related to individual's changing their practice to be more occupation-focussed and changes within the practice context including adapting environments, documentation and intervention protocols to focus on occupation. These strategies may support therapists to align practice with their professional values.

Danish translation, cultural adaptation and initial validation of the Self-Assessment of modes questionnaire (D-SAMQ).

BACKGROUND: The Self-Assessment of Modes Questionnaire (SAMQ) was developed for occupational therapists (OTs) to identify their therapeutic style when interacting with clients. To provide Danish Occupational Therapists (OTs) with access to the SAMQ, a rigorous translation, cultural adaptation and validation are required. AIM: To describe the process of translating and culturally adapting the SAMQ into Danish (D-SAMQ) and examining initial validation of the SAMQ in terms of relevance and comprehensiveness in a Danish context. MATERIAL AND METHODS: A 10-step process for translation and cultural adaptation was followed: (1) Preparation, (2) Forward translation, (3) Reconciliation, (4) Back translation, (5) Back-translation review, (6) Harmonization, (7) Cognitive debriefing, (8) Review of cognitive debriefing results and finalization, (9) Proofreading and (10) Final report. The cognitive debriefing also involved validation. RESULTS: Seven OTs and one OT student were included in the cognitive debriefing. Adaptations were made in eight of twenty cases, and modifications regarding the choice of words, sentence structure, and rephrasing were performed. The participants suggested more contextual details in the case descriptions. CONCLUSION: The SAMQ was translated into Danish (D-SAMQ) and adapted and validated by Danish OTs. The D-SAMQ may enable OTs to identify their therapeutic style, and thereby improve the client-therapist relationship.

Routine Use of a Bougie Improves First-Attempt Intubation Success in the Out-of-Hospital Setting.

STUDY OBJECTIVE: The bougie is typically treated as a rescue device for difficult airways. We evaluate whether first-attempt success rate during paramedic intubation in the out-of-hospital setting changed with routine use of a bougie. METHODS: A prospective, observational, pre-post study design was used to compare first-attempt success rate during out-of-hospital intubation with direct laryngoscopy for patients intubated 18 months before and 18 months after a protocol change that directed the use of the bougie on the first intubation attempt. We included all patients with a paramedic-performed intubation attempt. Logistic regression was used to examine the association between routine bougie use and first-attempt success rate. RESULTS: Paramedics attempted intubation in 823 patients during the control period and 771 during the bougie period. The first-attempt success rate increased from 70% to 77% (difference 7.0% [95% confidence interval 3% to 11%]). Higher first-attempt success rate was observed during the bougie period across Cormack-Lehane grades, with rates of 91%, 60%, 27%, and 6% for Cormack-Lehane grade 1, 2, 3, and 4 views, respectively, during the control period and 96%, 85%, 50%, and 14%, respectively, during the bougie period. Intubation during the bougie period was independently associated with higher first-attempt success rate (adjusted odds ratio 2.82 [95% confidence interval 1.96 to 4.01]). CONCLUSION: Routine out-of-hospital use of the bougie during direct laryngoscopy was associated with increased first-attempt intubation success rate.

Archetypal meanings of being a paramedic: A hermeneutic review.

BACKGROUND: Interpretations of being a paramedic are normally unspoken in the literature and easily overlooked in the busyness of everyday work. The premise of this study was to explicate historical and cultural archetypes of the paramedic from within relevant literature. METHODS: A hermeneutic review was conducted to explore meanings associated with being a paramedic. This was a novel approach to exploring meanings of being and provided a rich depiction of the cultural and historical nuances inherent in paramedic work. RESULTS: Six paramedic archetypes were identified and related broadly to the principles of service, care and stoicism. These archetypes provided glimpses of how the paramedic is theorised both within and external to the profession, as well as gaps related to how the phenomenon of being a paramedic is experienced amid everyday practice situations. CONCLUSION: Historical archetypes of the paramedic need to be recognised by paramedics as important in shaping the inherited cultural meanings of the work they do. However, due to the limited ability of fixed archetypes to capture the dynamic meanings of being a paramedic further research is required to understand how paramedics experience their caring work as meaningful across diverse contexts.

Frequency of Occupational Bloodborne Infections and Sharps Injuries among Polish Paramedics from Selected Ambulance Stations.

To evaluate the prevalence of bloodborne infections (BBIs) and assess the incidence and selected risk factors for sharps injuries (SIs), a cross-sectional serosurvey was performed between December 2018 and October 2019 among 286 paramedics (76.5% males; mean age, 37 years) from 17 randomly selected ambulance stations in the West Pomeranian region of Poland. An ELISA system was used to detect anti-HBc, anti-HCV, and anti-HIV. HBV vaccination uptake was 95.6%; 7.3% (95% CI: 4.6-11.0%) paramedics were anti-HBc positive, and anti-HCV/anti-HIV seropositivity was not reported. Almost one-fourth of paramedics reported having had ≥1 SI during the preceding year (Me = 6.0, range 1-100). Most recent exposures primarily took place during an emergency procedure (76.7%), in an ambulance (45.2%), caused by hollow-bore needles (73.8%), and were not reported (50.0%). Additionally, 52.2% of paramedics reported needle recapping, and 52.6% did not use safety engineered devices (SEDs) at work. Mean knowledge score was low (2.6 ± 1.7); 3.4% had never participated in infection-control (IC) training, and those not trained were more likely to suffer a SI (odds ratio (OR) 4.64; p = 0.03). Due to frequent SIs, of which half are unreported, paramedics remain at risk of acquiring occupational BBIs. SI risk could be reduced by providing training on IC procedures, ensuring better compliance with safe work practices, and supplying more SEDs.

Risk Minimisation Evaluation with Process Indicators and Behavioural or Health Outcomes in Europe: Systematic Review.

BACKGROUND: European Pharmacovigilance regulatory guidance recommends the evaluation of additional risk minimisation measures (aRMMs) with process indicators and outcomes. Evaluation of both measures within the same evaluation helps to establish the relationship between the implementation of aRMMs (across process indicators) and the impact on drug safety-related outcomes. The term risk minimisation evaluation (RMEv) was used to describe a study or group of studies that assesses the effectiveness of aRMMs for one specific product. OBJECTIVES: The objective of this systematic review was to describe the characteristics and results of RMEv that include both process indicators and outcomes as well as those of studies that conform the RMEv in Europe. METHODS: We conducted a systematic search in the European Union Register of Post-Authorization Studies, PubMed and grey literature (Google and abstracts of the International Conference on Pharmacoepidemiology and Therapeutic Risk Management) to identify studies that assessed the effectiveness of aRMMs including at least one European country, from 1 January, 2011 to 12 October, 2019. Identified studies linked to one product were considered part of the product RMEv. Only RMEv that included both process indicators and outcomes (behavioural and/or health/safety outcomes) were eligible. Data were abstracted from reports, manuscripts and abstracts. RESULTS: Eighteen of 102 (18%) RMEv had both process indicators and outcomes, and were included in this review. Of the 18 RMEv, ten consisted of one study only, five of two studies, and three of three or more studies. A total of 30 studies were included within the 18 RMEv. The designs of the studies were: 19 (63%) cross-sectional surveys (47% targeted patients and 89% healthcare professionals), 17 (57%) retrospective studies (47% using pre/post approach) and 3 (10%) prospective studies. Nineteen studies included process indicators that were receipt (n = 14), use (n = 12), knowledge (n = 17) and self-reported behaviour (n = 15). Regarding outcomes, 67% of the 18 RMEv evaluated behavioural outcomes and 50% health/safety outcomes. Three of the 18 RMEv evaluated both behavioural and health/safety outcomes. For five RMEv, correlations between process indicators and outcomes were performed, two at the patient level. Results were available for 14 of the 18 RMEv. In healthcare professional surveys, the median percentage was 57% for receipt, 92% for reading, 80% for use, 77% for knowledge and 74% for behaviour. In patient surveys, the median percentage was 56% for receipt, 87% for reading, 65% for use, 47% for knowledge and 69% for behaviour. Knowledge was better in healthcare professionals than patients (p < 0.05). Of the three RMEv with a correlation analysis, only one found a positive trend for a lower occurrence of outcomes as process indicators improved, though this was not statistically significant. CONCLUSIONS: A minority of RMEv assessed both process indicators and outcomes. More RMEv require approaches that correlate process indicators and outcomes at the patient level to evaluate more comprehensively the implementation of aRMMs.