Effects of the COVID-19 Pandemic on Prehospital Emergency Care for Adults with Stroke and Transient Ischaemic Attack: A Systematic Review and Meta-Analysis.

INTRODUCTION: COVID-19 has challenged global health care systems and resulted in prehospital delays for time-sensitive emergencies, like stroke and transient ischemic attacks (TIA). However, there are conflicting international reports on the level of effect of the pandemic on ambulance response intervals and emergency call volumes for these conditions. OBJECTIVES: The purpose of this study was to synthesize the international evidence on the effect of COVID-19 on ambulance response intervals and emergency call volume for suspected stroke and TIA. METHODS: Following a published protocol, we conducted a systematic search of six databases through May 31, 2022. We re-ran this search on April 14, 2023, to check for any new papers. We considered for inclusion peer-reviewed quantitative studies comparing prehospital emergency care for adults with suspected stroke/TIA before and during the COVID-19 pandemic. Two authors screened title/abstract and full text articles. One author carried out data extraction, with a random selection of articles being checked by another author. We calculated overall pooled estimates of ambulance intervals (activation, response, patient care, and total prehospital intervals) and stroke/TIA emergency call volume. Subgroup and sensitivity analyses included location and stroke/TIA diagnosis. Two authors assessed study quality using the appropriate Joanna Briggs Institute tool. We worked with patient and public involvement contributors and clinical and policy stakeholders throughout the review. RESULTS: Of 4,083 studies identified, 52 unique articles met the inclusion criteria. Mean response interval (-1.29 min [-2.19 to -0.38]) and mean total prehospital interval (-6.42 min [-10.60 to -2.25]) were shorter in the pre-COVID-19 period, compared to the COVID-19 period. Furthermore, there was a higher incidence rate of emergency call volume for suspected stroke/TIA per day pre-COVID-19 compared with the COVID-19 period (log IRR = 0.17 [0.02 to 0.33]). Ambulance response interval definitions and terminology varied between regions and countries. CONCLUSIONS: Our review indicates that prehospital delays for suspected stroke/TIA increased during the COVID-19 pandemic. Furthermore, emergency call volume for suspected stroke/TIA decreased during this period. In order to minimize delays in future pandemics or other health care emergencies future research may involve understanding the potential reasons for these delays.

Exploring the Use of an Electronic Competency Assessment Document Using iPad Minis to Assess Clinical Practice Competency in a Preregistration Nursing Program: A Cross-sectional Feasibility Study.

The aim of this study was to explore the feasibility of using iPad minis as a method of completing competency assessment in clinical practice. Digital technology helps to revolutionize all aspects of our lives. The use of digital technologies in clinical practice can facilitate a move toward a more flexible learning environment and enable students to adapt in a rapidly changing, interconnected world. The introduction of electronic clinical booklets in practice placements could facilitate the sharing of clinical information through connected healthcare systems, thus improving the student experience. A cross-sectional design was used in this study. A sample of BSc nursing students (n = 53) and clinically based healthcare professionals (n = 27) (preceptors and clinical placement coordinators) participated in this study. Data were collected using a modified version of Garrett and colleagues' instrument, the System Usability Scale, a demographics questionnaire, and three open-ended questions. There was a significant difference between the students and preceptors/clinical placement coordinators across all items with higher proportions of students (ranging from 66% to 75.5%), indicating that they agreed or strongly agreed with the reliability, ease of use, and effectiveness of the device in assessing their clinical competency (ranging from 11.1% to 40.7%). In addition, the iPad minis were found to be smaller, lighter, and easier to carry than paper-based booklets and encouraged students to access timely online learning resources during placement to help augment their learning. The use of iPad mini to complete the electronic competency assessment document as a replacement for a paper-based system to assess clinical practice is feasible. The introduction of electronic assessment documents should incorporate a robust training plan and standard operating procedures.

L-Thyroxine Therapy for Older Adults With Subclinical Hypothyroidism and Hypothyroid Symptoms: Secondary Analysis of a Randomized Trial.

BACKGROUND: L-thyroxine does not improve hypothyroid symptoms among adults with subclinical hypothyroidism (SCH). However, those with greater symptom burden before treatment may still benefit. OBJECTIVE: To determine whether L-thyroxine improves hypothyroid symptoms and tiredness among older adults with SCH and greater symptom burden. DESIGN: Secondary analysis of the randomized, placebo-controlled trial TRUST (Thyroid Hormone Replacement for Untreated Older Adults with Subclinical Hypothyroidism Trial). (ClinicalTrials.gov: NCT01660126). SETTING: Switzerland, Ireland, the Netherlands, and Scotland. PARTICIPANTS: 638 persons aged 65 years or older with persistent SCH (thyroid-stimulating hormone level of 4.60 to 19.9 mIU/L for >3 months and normal free thyroxine level) and complete outcome data. INTERVENTION: L-thyroxine or matching placebo with mock dose titration. MEASUREMENTS: 1-year change in Hypothyroid Symptoms and Tiredness scores (range, 0 to 100; higher scores indicate more symptoms) on the Thyroid-Related Quality-of-Life Patient-Reported Outcome Questionnaire among participants with high symptom burden (baseline Hypothyroid Symptoms score >30 or Tiredness score >40) versus lower symptom burden. RESULTS: 132 participants had Hypothyroid Symptoms scores greater than 30, and 133 had Tiredness scores greater than 40. Among the group with high symptom burden, the Hypothyroid Symptoms score improved similarly between those receiving L-thyroxine (mean within-group change, -12.3 [95% CI, -16.6 to -8.0]) and those receiving placebo (mean within-group change, -10.4 [CI, -15.3 to -5.4]) at 1 year; the adjusted between-group difference was -2.0 (CI, -5.5 to 1.5; P = 0.27). Improvements in Tiredness scores were also similar between those receiving L-thyroxine (mean within-group change, -8.9 [CI, -14.5 to -3.3]) and those receiving placebo (mean within-group change, -10.9 [CI, -16.0 to -5.8]); the adjusted between-group difference was 0.0 (CI, -4.1 to 4.0; P = 0.99). There was no evidence that baseline Hypothyroid Symptoms score or Tiredness score modified the effects of L-thyroxine versus placebo (P for interaction = 0.20 and 0.82, respectively). LIMITATION: Post hoc analysis, small sample size, and examination of only patients with 1-year outcome data. CONCLUSION: In older adults with SCH and high symptom burden at baseline, L-thyroxine did not improve hypothyroid symptoms or tiredness compared with placebo. PRIMARY FUNDING SOURCE: European Union FP7.

The preferences of people with asthma or chronic obstructive pulmonary disease for self-management support: A qualitative descriptive study.

AIMS AND OBJECTIVES: The aim of this study was to explore and describe the self-management support (SMS) preferences of adults with asthma and/or chronic obstructive pulmonary disease (COPD). BACKGROUND: Self-management support interventions have had beneficial outcomes for people with asthma and people with COPD, though challenges remain in their implementation. Increased understanding of the support preferences of people with asthma/COPD can help inform the development of future interventions to address patients' preferences. DESIGN: A qualitative descriptive design was used. METHODS: Semi-structured focus group and individual interviews were conducted with 20 adult participants who had asthma and/or COPD in Ireland. Qualitative content analysis was used to analyse interviews. The SRQR reporting guideline was used. RESULTS: Three themes were identified. Support accessibility included having access to routine and unscheduled support from healthcare professionals with specialist knowledge. Consultation content described the need for comprehensive and person-centred support. The person-provider relationship described the value of healthcare professionals acknowledging patient concerns, noted as a challenge for people with asthma, and continuity in relationships over time. CONCLUSIONS: Routine support for people with asthma/COPD needs to be comprehensive in addressing the individual patient's challenges. Access to timely advice during exacerbations was a priority for people with asthma/COPD, suggesting that flexible access to services as well as routine review may be optimal for supporting self-management of asthma/COPD. Feeling listened to regarding symptoms experienced may be of intrinsic value to people with asthma/COPD. RELEVANCE TO CLINICAL PRACTICE: The study emphasises the importance of continued training in communications skills for healthcare professionals supporting people with asthma/COPD, particularly acknowledging the patient's concerns in the context of symptom changes/flare-up. A respiratory nurse specialist was valued as being a care coordinator who could support routine management as well as managing exacerbations, having specialist knowledge and knowing the patient over time.

Impact of clinical leadership in advanced practice roles on outcomes in health care: A scoping review.

AIM: To undertake a scoping review of the literature exploring the impact of clinical leadership in advanced practice roles in relation to patient, staff and organisational outcomes. BACKGROUND: An increasing number of publications as well as job specifications have identified clinical leadership as a cornerstone of advanced practice roles. However, it is unclear whether embedding clinical leadership in such roles has led to improvements in patient, staff or organisational outcomes. Therefore, identifying the extent to which clinical leadership in advanced practice roles relates to patient, staff and organisational outcomes is needed. METHOD: A scoping review examining the relationship between clinical leadership in advanced practice roles and health care outcomes. Searching in SCOPUS, PubMed, Psychinfo and CINAHL Plus and Web of Science identified 765 potential articles. Independent selection, data extraction tabulation of findings and analysis were completed. RESULTS: Seven studies were identified that met the inclusion criteria. Only studies reporting on nurses in advanced practice roles were included; no studies were identified that reported on the advanced practice roles of allied health professionals. The results indicate that there is no objective evidence of the impact of advanced practitioners' clinical leadership on patient, staff or organisational outcomes. CONCLUSION: There is a paucity of objective evidence to identify the extent to which clinical leadership is enacted in advanced practice roles. The review indicates a need for closer alignment of AP clinical leadership policy aspirations and formal operational leadership opportunities for APs. IMPLICATIONS FOR NURSING MANAGEMENT: Nurse managers have a key role in supporting and equipping APs with leadership competencies and opportunities to enable both capability and capacity building of such roles. Nurse managers should involve APs in health care leadership at an organisational level to maximize their contribution to health, quality practice environments and health care reform. Additionally, a distinct involvement in staff development, change, operational strategic decisions and policy development should be part of the AP role, which is facilitated by management.

Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism.

BACKGROUND: The use of levothyroxine to treat subclinical hypothyroidism is controversial. We aimed to determine whether levothyroxine provided clinical benefits in older persons with this condition. METHODS: We conducted a double-blind, randomized, placebo-controlled, parallel-group trial involving 737 adults who were at least 65 years of age and who had persisting subclinical hypothyroidism (thyrotropin level, 4.60 to 19.99 mIU per liter; free thyroxine level within the reference range). A total of 368 patients were assigned to receive levothyroxine (at a starting dose of 50 µg daily, or 25 µg if the body weight was <50 kg or the patient had coronary heart disease), with dose adjustment according to the thyrotropin level; 369 patients were assigned to receive placebo with mock dose adjustment. The two primary outcomes were the change in the Hypothyroid Symptoms score and Tiredness score on a thyroid-related quality-of-life questionnaire at 1 year (range of each scale is 0 to 100, with higher scores indicating more symptoms or tiredness, respectively; minimum clinically important difference, 9 points). RESULTS: The mean age of the patients was 74.4 years, and 396 patients (53.7%) were women. The mean (±SD) thyrotropin level was 6.40±2.01 mIU per liter at baseline; at 1 year, this level had decreased to 5.48 mIU per liter in the placebo group, as compared with 3.63 mIU per liter in the levothyroxine group (P<0.001), at a median dose of 50 µg. We found no differences in the mean change at 1 year in the Hypothyroid Symptoms score (0.2±15.3 in the placebo group and 0.2±14.4 in the levothyroxine group; between-group difference, 0.0; 95% confidence interval [CI], -2.0 to 2.1) or the Tiredness score (3.2±17.7 and 3.8±18.4, respectively; between-group difference, 0.4; 95% CI, -2.1 to 2.9). No beneficial effects of levothyroxine were seen on secondary-outcome measures. There was no significant excess of serious adverse events prespecified as being of special interest. CONCLUSIONS: Levothyroxine provided no apparent benefits in older persons with subclinical hypothyroidism. (Funded by European Union FP7 and others; TRUST ClinicalTrials.gov number, NCT01660126 .).

Ethical frameworks for quality improvement activities: an analysis of international practice.

PURPOSE: To examine international approaches to the ethical oversight and regulation of quality improvement and clinical audit in healthcare systems. DATA SOURCES: We searched grey literature including websites of national research and ethics regulatory bodies and health departments of selected countries. STUDY SELECTION: National guidance documents were included from six countries: Ireland, England, Australia, New Zealand, the United States of America and Canada. DATA EXTRACTION: Data were extracted from 19 documents using an a priori framework developed from the published literature. RESULTS: We organized data under five themes: ethical frameworks; guidance on ethical review; consent, vulnerable groups and personal health data. Quality improvement activity tended to be outside the scope of the ethics frameworks in most countries. Only New Zealand had integrated national ethics standards for both research and quality improvement. Across countries, there is consensus that this activity should not be automatically exempted from ethical review but requires proportionate review or organizational oversight for minimal risk projects. In the majority of countries, there is a lack of guidance on participant consent, use of personal health information and inclusion of vulnerable groups in routine quality improvement. CONCLUSION: Where countries fail to provide specific ethics frameworks for quality improvement, guidance is dispersed across several organizations which may lack legal certainty. Our review demonstrates a need for appropriate oversight and responsive infrastructure for quality improvement underpinned by ethical frameworks that build equivalence with research oversight. It outlines aspects of good practice, especially The New Zealand framework that integrates research and quality improvement ethics.

Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism - a randomised placebo controlled Trial (TRUST).

BACKGROUND: Subclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large randomised controlled trial (RCT) of Levothyroxine treatment for SCH. METHODS: Participants are community-dwelling subjects aged ≥65 years with SCH, diagnosed by elevated TSH levels (≥4.6 and ≤19.9 mU/L) on a minimum of two measures ≥ three months apart, with fT4 levels within laboratory reference range. The study is a randomised double-blind placebo-controlled parallel group trial, starting with levothyroxine 50 micrograms daily (25 micrograms in subjects <50Kg body weight or known coronary heart disease) with titration of dose in the active treatment group according to TSH level, and a mock titration in the placebo group. The primary outcomes are changes in two domains (hypothyroid symptoms and fatigue / vitality) on the thyroid-related quality of life questionnaire (ThyPRO) at one year. The study has 80% power (at p = 0.025, 2-tailed) to detect a change with levothyroxine treatment of 3.0% on the hypothyroid scale and 4.1% on the fatigue / vitality scale with a total target sample size of 750 patients. Secondary outcomes include general health-related quality of life (EuroQol), fatal and non-fatal cardiovascular events, handgrip strength, executive cognitive function (Letter Digit Coding Test), basic and instrumental activities of daily living, haemoglobin, blood pressure, weight, body mass index and waist circumference. Patients are monitored for specific adverse events of interest including incident atrial fibrillation, heart failure and bone fracture. DISCUSSION: This large multicentre RCT of levothyroxine treatment of subclinical hypothyroidism is powered to detect clinically relevant change in symptoms / quality of life and is likely to be highly influential in guiding treatment of this common condition. TRIAL REGISTRATION: Clinicaltrials.gov NCT01660126 ; registered 8th June 2012.

Physician's Prescribing Preference as an Instrumental Variable: Exploring Assumptions Using Survey Data.

BACKGROUND: Physician's prescribing preference is increasingly used as an instrumental variable in studies of therapeutic effects. However, differences in prescribing patterns among physicians may reflect differences in preferences or in case-mix. Furthermore, there is debate regarding the possible assumptions for point estimation using physician's preference as an instrument. METHODS: A survey was sent to general practitioners (GPs) in The Netherlands, the United Kingdom, New Zealand, Ireland, Switzerland, and Germany, asking whether they would prescribe levothyroxine to eight fictitious patients with subclinical hypothyroidism. We investigated (1) whether variation in physician's preference was observable and to what extent it was explained by characteristics of GPs and their patient populations and (2) whether the data were compatible with deterministic and stochastic monotonicity assumptions. RESULTS: Levothyroxine prescriptions varied substantially among the 526 responding GPs. Between-GP variance in levothyroxine prescriptions (logit scale) was 9.9 (95% confidence interval: 8.0, 12) in the initial mixed effects logistic model, 8.3 (6.7, 10) after adding a fixed effect for country and 8.2 (6.6, 10) after adding GP characteristics. The occurring prescription patterns falsified the deterministic monotonicity assumption. All cases in all countries were more likely to receive levothyroxine if a different case of the same GP received levothyroxine, which is compatible with the stochastic monotonicity assumption. The data were incompatible with this assumption for a different definition of the instrument. CONCLUSIONS: Our study supports the existence of physician's preference as a determinant in treatment decisions. Deterministic monotonicity will generally not be plausible for physician's preference as an instrument. Depending on the definition of the instrument, stochastic monotonicity may be plausible.

Reducing challenging behaviours among children and adolescents with intellectual disabilities in community settings: a systematic review of interventions.

Background: Challenging behaviours are common among children and adolescents with intellectual disabilities. Such behaviours often result in poor quality of life outcomes such as physical injury, difficulties with relationships and community integration. Aim: This systematic review aimed to synthesise evidence from studies that assessed the effect of interventions used to reduce/manage challenging behaviour among children with intellectual disabilities in community settings. Methods: Studies published between January 2015 and January 2021 were sought from five electronic databases. The quality of studies was assessed, and a narrative synthesis was conducted. Results: A total of 11 studies were included which utilised various non-pharmacological interventions including multi-model interventions, microswitch technology, cognitive behavioural therapy, art, music and illustrated stories. Microswitch cluster technology was the most used intervention. Studies using pharmacological interventions were not retrieved. Results indicated that a person-centred planning approach was key to offering individualised treatment. Conclusions: The superiority of one intervention or a combination of interventions could not be determined from this review given the heterogeneity of studies. Future research is required to explore the use and effects of pharmacological interventions to compare outcomes and improve quality of care of children with intellectual disabilities.

Patient-Reported Satisfaction with Thyroid Hormone Replacement Therapy for Subclinical Hypothyroidism in Older Adults: A Pooled Analysis of Individual Participant Data from Two Randomized Controlled Trials.

Background: The benefit of levothyroxine treatment of subclinical hypothyroidism (SCH) is subject to debate. This study compared treatment satisfaction between older adults with SCH using levothyroxine or placebo. Methods: We analyzed pooled individual participant data from two randomized, double-blind, placebo-controlled trials investigating the effects of levothyroxine treatment in older adults with SCH. Community-dwelling participants aged ≥65 years, with SCH (persistent thyrotropin levels 4.60-19.99 mIU/L for >3 months and normal free T4 level), were included. Intervention dose titration until thyrotropin levels normalized, with a mock dose adjustment of placebo. Treatment satisfaction was determined during the final study visit using the Treatment Satisfaction Questionnaire for Medication (TSQM), encompassing perceived effectiveness, side effects, convenience, and global satisfaction, along with the participants' desire to continue study medication after the trial. Results: We included 536 participants. At baseline, the median (interquartile range [IQR]) age was 74.9 (69.7-81.4) years, and 292 (55%) were women. The median (IQR) thyrotropin levels were 5.80 (5.10-7.00) mIU/L at baseline in both groups; at final visit, 4.97 (3.90-6.35) mIU/L in the placebo and 3.24 (2.49-4.41) mIU/L in the levothyroxine group. After treatment, the groups did not differ significantly in global satisfaction (mean difference [CI] -1.1 [-4.5 to 2.1], p = 0.48), nor in any other domain of treatment satisfaction. These results held true regardless of baseline thyrotropin levels or symptom burden. No major differences were found in the numbers of participants who wished to continue medication after the trial (levothyroxine 35% vs. placebo 27%), did not wish to continue (levothyroxine 27% vs. placebo 30%), or did not know (levothyroxine 37% vs. placebo 42%) (p = 0.14). In a subpopulation with high symptom burden from hypothyroid symptoms at baseline, those using levothyroxine more often desired to continue the medication after the trial than those using placebo (mean difference [CI]: -21.1% [-35.6% to -6.5%]). Conclusion: These pooled data from two RCTs showed no major differences in treatment satisfaction between older adults receiving levothyroxine or placebo. This finding has important implications for decision-making regarding initiating levothyroxine treatment for SCH. Our findings generally support refraining from routinely prescribing levothyroxine in older adults with SCH.

The association between nurse staffing and quality of care in emergency departments: A systematic review.

BACKGROUND: The relationship between nurse staffing, skill-mix and quality of care has been well-established in medical and surgical settings, however, there is relatively limited evidence of this relationship in emergency departments. Those that have been published identified that lower nurse staffing levels in emergency departments are generally associated with worse outcomes with the conclusion that the evidence in emergency settings was, at best, weak. METHODS: We searched thirteen electronic databases for potentially eligible papers published in English up to December 2023. Studies were included if they reported on patient outcomes associated with nurse staffing within emergency departments. Observational, cross-sectional, prospective, retrospective, interrupted time-series designs, difference-in-difference, randomised control trials or quasi-experimental studies and controlled before and after studies study designs were considered for inclusion. Team members independently screened titles and abstracts. Data was synthesised using a narrative approach. RESULTS: We identified 16 papers for inclusion; the majority of the studies (n = 10/16) were observational. The evidence reviewed identified that poorer staffing levels within emergency departments are associated with increased patient wait times, a higher proportion of patients who leave without being seen and an increased length of stay. Lower levels of nurse staffing are also associated with an increase in time to medications and therapeutic interventions, and increased risk of cardiac arrest within the emergency department. CONCLUSION: Overall, there remains limited high-quality empirical evidence addressing the association between emergency department nurse staffing and patient outcomes. However, it is evident that lower levels of nurse staffing are associated with adverse events that can result in delays to the provision of care and serious outcomes for patients. There is a need for longitudinal studies coupled with research that considers the relationship with skill-mix, other staffing grades and patient outcomes as well as a wider range of geographical settings. TWEETABLE ABSTRACT: Lower levels of nurse staffing in emergency departments are associated with delays in patients receiving treatments and poor quality care including an increase in leaving without being seen, delay in accessing treatments and medications and cardiac arrest.

Effects of the COVID-19 pandemic on prehospital emergency care for adults with stroke and transient ischaemic attack: A protocol for a systematic review and meta-analysis.

Background: The COVID-19 pandemic impacted on health service provision worldwide, including care for acute time sensitive conditions. Stroke and transient ischaemic attacks (TIA) are particularly vulnerable to pressures on healthcare delivery as they require immediate diagnosis and treatment. The global impact of the COVID-19 pandemic on prehospital emergency care for stroke/TIA is still largely unknown. Thus, the aim of this study is to conduct a systematic review and meta-analysis to investigate the impact of the COVID-19 pandemic on prehospital emergency care for stroke and TIA. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines, the review is registered on PROSPERO (registration number CRD42022315260). Peer-reviewed quantitative studies comparing prehospital emergency care for adults with stroke/TIA before and during the COVID-19 pandemic will be considered for inclusion. The outcomes of interest are ambulance times and emergency call volumes for stroke/TIA. A systematic search of databases including PubMed, Embase and Scopus will be conducted. Two authors will independently screen studies for inclusion based on predetermined inclusion and exclusion criteria. Data extraction and quality assessment will be conducted by two authors. Meta-analysis will be performed to calculate overall pooled estimates of ambulance times (primary outcome) and stroke/TIA call volumes (secondary outcome), where appropriate.  Where heterogeneity is low a fixed-effects model will be used and where heterogeneity is high a random-effects model will be used. Subgroup and sensitivity analyses will include location, stroke/TIA diagnosis and COVID-19 case numbers. Results: Data on primary and secondary outcomes will be provided. Results of subgroup/sensitivity analyses and quality assessment will also be presented. Conclusions: This review will identify existing evidence reporting the impact of the COVID-19 pandemic on prehospital emergency care for adult patients with stroke/TIA and provide summary estimates of effects on ambulance response times.

No Effect of Levothyroxine on Hemoglobin in Older Adults With Subclinical Hypothyroidism: Pooled Results From 2 Randomized Controlled Trials.

CONTEXT: Subclinical thyroid dysfunction and anemia are common disorders, and both have increasing prevalence with advancing age. OBJECTIVE: The aim of this study was to assess whether levothyroxine treatment leads to a rise in hemoglobin levels in older persons with subclinical hypothyroidism. METHODS: This preplanned combined analysis of 2 randomized controlled trials included community-dwelling persons aged 65 years and older with subclinical hypothyroidism who were randomly assigned to levothyroxine or placebo treatment. The levothyroxine dose was periodically titrated aiming at thyroid stimulating hormone (TSH) level within the reference range, with mock titrations in the placebo group. The main outcome measure was the change in hemoglobin level after 12 months. RESULTS: Analyses included 669 participants (placebo n = 337, levothyroxine n = 332) with a median age of 75 years (range, 65-97) and mean baseline hemoglobin of 13.8 ±â€…1.3 g/dL. Although levothyroxine treatment resulted in a reduction in TSH from baseline after 12 months of follow-up compared with placebo, the change in hemoglobin level was not different between the levothyroxine and the placebo groups (-0.03 g/dL [95% CI, -0.16 to 0.11]). Similar results were found in stratified analyses including sex, age, or TSH levels. No difference in change of hemoglobin levels after 12 months was identified in 69 participants with anemia at baseline (-0.33 g/dL [95% CI, -0.87 to 0.21]). CONCLUSION: In persons aged 65 years and older with subclinical hypothyroidism, treatment with levothyroxine does not lead to a rise in hemoglobin levels, regardless of the presence of anemia.

Self-management support preferences of people with asthma or chronic obstructive pulmonary disease: A systematic review and meta-synthesis of qualitative studies.

OBJECTIVES: To synthesise findings from qualitative studies on the preferences of people with asthma or chronic obstructive pulmonary disease (COPD) for self-management support. METHODS: A thematic synthesis of literature was carried out. Six databases (ASSIA, CINAHL, MEDLINE, PsycINFO, Psychology and the Behavioural Sciences and SSCI) were used to search for qualitative studies eliciting perspectives of adults with asthma and/or COPD on self-management support, published between May 2008 and April 2018. RESULTS: A total of 968 articles were retrieved across databases, with 15 articles included in the synthesis. Three themes were identified: Types of Support described the range of supports valued by participants in the studies, particularly education provided by competent healthcare professionals; The Support Relationship highlighted the importance of a collaborative relationship with one's healthcare professional which was characterised by communication, trust and continuity over time and Accessibility identified the considerations of participants relating to physically accessible, prompt support which is provided in a format preferred by the individual. DISCUSSION: Increased understanding of patients' preferences may provide insight which can be used to enhance engagement with self-management support. Further research needs to examine self-management support preferences outside the context of evaluating interventions for people with asthma/COPD and needs to address the optimal means of enhancing accessibility.

An International Perspective on Definitions and Terminology Used to Describe Serious Reportable Patient Safety Incidents: A Systematic Review.

OBJECTIVES: Patients are unintentionally, yet frequently, harmed in situations that are deemed preventable. Incident reporting systems help prevent harm, yet there is considerable variability in how patient safety incidents are reported. This may lead to inconsistent or unnecessary patterns of incident reporting and failures to identify serious patient safety incidents. This systematic review aims to describe international approaches in relation to defining serious reportable patient safety incidents. METHODS: Multiple electronic and gray literature databases were searched for articles published between 2009 and 2019. Empirical studies, reviews, national reports, and policies were included. A narrative synthesis was conducted because of study heterogeneity. RESULTS: A total of 50 articles were included. There was wide variation in the terminology used to represent serious reportable patient safety incidents. Several countries defined a specific subset of incidents, which are considered sufficiently serious, yet preventable if appropriate safety measures are taken. Terms such as "never events," "serious reportable events," or "always review and report" were used. The following dimensions were identified to define a serious reportable patient safety incident: (1) incidents being largely preventable; (2) having the potential for significant learning; (3) causing serious harm or have the potential to cause serious harm; (4) being identifiable, measurable, and feasible for inclusion in an incident reporting system; and (5) running the risk of recurrence. CONCLUSIONS: Variations in terminology and reporting systems between countries might contribute to missed opportunities for learning. International standardized definitions and blame-free reporting systems would enable comparison and international learning to enhance patient safety.

Effect of Thyroid Hormone Therapy on Fatigability in Older Adults With Subclinical Hypothyroidism: A Nested Study Within a Randomized Placebo-Controlled Trial.

BACKGROUND: Fatigue often triggers screening for and treatment of subclinical hypothyroidism. However, data on the impact of levothyroxine on fatigue is limited and previous studies might not have captured all aspects of fatigue. METHOD: This study is nested within the randomized, placebo-controlled, multicenter TRUST trial, including community-dwelling participants aged ≥65 and older, with persistent subclinical hypothyroidism (TSH 4.60-19.99 mIU/L, normal free thyroxine levels) from Switzerland and Ireland. Interventions consisted of daily levothyroxine starting with 50 µg (25 µg if weight <50 kg or known coronary heart diseases) together with dose adjustments to achieve a normal TSH and mock titration in the placebo group. Main outcome was the change in physical and mental fatigability using the Pittsburgh Fatigability Scale over 1 year, assessed through multivariable linear regression with adjustment for country, sex, and levothyroxine starting dose. RESULTS: Among 230 participants, the mean ± standard deviation (SD) TSH was 6.2 ± 1.9 mIU/L at baseline and decreased to 3.1 ± 1.3 with LT4 (n = 119) versus 5.3 ± 2.3 with placebo (n = 111, p < .001) after 1 year. After adjustment we found no between-group difference at 1 year on perceived physical (0.2; 95% CI -1.8 to 2.1; p = .88), or mental fatigability (-1.0; 95% CI -2.8 to 0.8; p = .26). In participants with higher fatigability at baseline (≥15 points for the physical score [n = 88] or ≥13 points for the mental score [n = 41]), the adjusted between-group differences at 1 year were 0.4 (95% CI -3.6 to 2.8, p = .79) and -2.2 (95% CI -8.8 to 4.5, p = .51). CONCLUSIONS: Levothyroxine in older adults with mild subclinical hypothyroidism provides no change in physical or mental fatigability.

Exploring patient information needs in type 2 diabetes: A cross sectional study of questions.

This study set out to analyze questions about type 2 diabetes mellitus (T2DM) from patients and the public. The aim was to better understand people's information needs by starting with what they do not know, discovered through their own questions, rather than starting with what we know about T2DM and subsequently finding ways to communicate that information to people affected by or at risk of the disease. One hundred and sixty-four questions were collected from 120 patients attending outpatient diabetes clinics and 300 questions from 100 members of the public through the Amazon Mechanical Turk crowdsourcing platform. Twenty-three general and diabetes-specific topics and five phases of disease progression were identified; these were used to manually categorize the questions. Analyses were performed to determine which topics, if any, were significant predictors of a question's being asked by a patient or the public, and similarly for questions from a woman or a man. Further analysis identified the individual topics that were assigned significantly more often to the crowdsourced or clinic questions. These were Causes (CI: [-0.07, -0.03], p < .001), Risk Factors ([-0.08, -0.03], p < .001), Prevention ([-0.06, -0.02], p < .001), Diagnosis ([-0.05, -0.02], p < .001), and Distribution of a Disease in a Population ([-0.05,-0.01], p = .0016) for the crowdsourced questions and Treatment ([0.03, 0.01], p = .0019), Disease Complications ([0.02, 0.07], p < .001), and Psychosocial ([0.05, 0.1], p < .001) for the clinic questions. No highly significant gender-specific topics emerged in our study, but questions about Weight were more likely to come from women and Psychosocial questions from men. There were significantly more crowdsourced questions about the time Prior to any Diagnosis ([(-0.11, -0.04], p = .0013) and significantly more clinic questions about Health Maintenance and Prevention after diagnosis ([0.07. 0.17], p < .001). A descriptive analysis pointed to the value provided by the specificity of questions, their potential to disclose emotions behind questions, and the as-yet unrecognized information needs they can reveal. Large-scale collection of questions from patients across the spectrum of T2DM progression and from the public-a significant percentage of whom are likely to be as yet undiagnosed-is expected to yield further valuable insights.

Prevalence of potentially inappropriate prescribing in a subpopulation of older European clinical trial participants: a cross-sectional study.

OBJECTIVES: To estimate and compare the prevalence and type of potentially inappropriate prescribing (PIP) and potential prescribing omissions (PPOs) among community-dwelling older adults (≥65 years) enrolled to a clinical trial in three European countries. DESIGN: A secondary analysis of the Thyroid Hormone Replacement for Subclinical Hypothyroidism Trial dataset. PARTICIPANTS: A subset of 48/80 PIP and 22/34 PPOs indicators from the Screening Tool of Older Persons Prescriptions/Screening Tool to Alert doctors to Right Treatment (STOPP/START) V2 criteria were applied to prescribed medication data for 532/737 trial participants in Ireland, Switzerland and the Netherlands. RESULTS: The overall prevalence of PIP was lower in the Irish participants (8.7%) compared with the Swiss (16.7%) and Dutch (12.5%) participants (P=0.15) and was not statistically significant. The overall prevalence of PPOs was approximately one-quarter in the Swiss (25.3%) and Dutch (24%) participants and lower in the Irish (14%) participants (P=0.04) and the difference was statistically significant. The hypnotic Z-drugs were the most frequent PIP in Irish participants, (3.5%, n=4), while it was non-steroidal anti-inflammatory drug and oral anticoagulant combination, sulfonylureas with a long duration of action, and benzodiazepines (all 4.3%, n=7) in Swiss, and benzodiazepines (7.1%, n=18) in Dutch participants. The most frequent PPOs in Irish participants were vitamin D and calcium in osteoporosis (3.5%, n=4). In the Swiss and Dutch participants, they were bone antiresorptive/anabolic therapy in osteoporosis (9.9%, n=16, 8.6%, n=22) respectively. The odds of any PIP after adjusting for age, sex, multimorbidity and polypharmacy were (adjusted OR (aOR)) 3.04 (95% CI 1.33 to 6.95, P<0.01) for Swiss participants and aOR 1.74 (95% CI 0.79 to 3.85, P=0.17) for Dutch participants compared with Irish participants. The odds of any PPOs were aOR 2.48 (95% CI 1.27 to 4.85, P<0.01) for Swiss participants and aOR 2.10 (95% CI 1.11 to 3.96, P=0.02) for Dutch participants compared with Irish participants. CONCLUSIONS: This study has estimated and compared the prevalence and type of PIP and PPOs among this cohort of community-dwelling older people. It demonstrated a significant difference in the prevalence of PPOs between the three populations. Further research is urgently needed into the impact of system level factors as this has important implications for patient safety, healthcare provision and economic costs.

Soliciting and Responding to Patients' Questions about Diabetes Through Online Sources.

When patients cannot get answers from health professionals or retain the information given, increasingly they search online for answers, with limited success. Researchers from the United States, Ireland, and the United Kingdom explored this problem for patients with type 2 diabetes mellitus (T2DM). In 2014, patients attending an outpatient clinic (UK) were asked to submit questions about diabetes. Ten questions judged representative of different types of patient concerns were selected by the researchers and submitted to search engines within trusted and vetted websites in the United States, Ireland, and the United Kingdom. Two researchers independently assessed if answers could be found in the three top-ranked documents returned at each website. The 2014 search was repeated in June, 2016, examining the two top-ranked documents returned. One hundred and sixty-four questions were collected from 120 patients during 12 outpatient clinics. Most patients had T2DM (95%). Most questions were about diabetes (N = 155) with the remainder related to clinic operation (N = 9). Of the questions on diabetes, 152 were about T2DM. The 2014 assessment found no adequate answers to the questions in 90 documents (10 questions, 3 websites, 3 top documents). In the 2016 assessment, 1 document out of 60 (10 questions, 3 websites, 2 top documents) provided an adequate answer relating to 1 of the 10 questions. Available online sources of information do not provide answers to questions from patients with diabetes. Our results highlight the urgent need to develop novel ways of providing answers to patient questions about T2DM.