Perceived Health Status and Capability after Hip Fracture: Secondary Outcomes from an Randomized Controlled Trial.

INTRODUCTION: Hip fractures can have a significant impact on the lives of older people and their families. We conducted a pragmatic randomized controlled trial of post-discharge comprehensive geriatric care (CGC) for community-dwelling older adults after a surgically repaired hip fracture. The objective of this study was to conduct a secondary analysis to compare changes in health status and perceived capability from baseline to 12 months after randomization with: the EuroQol 5-Dimension (EQ-5D-5L) (1) utility score and (2) visual analog scale (VAS); and (3) well-being as measured by participants' perceptions of their ability (or capability) toward completing life activities using the ICEpop Capability Measure for Older People (ICECAP-O). METHODS: We tested the effect of usual care (control) versus usual care and an outpatient CGC clinic (intervention) on mobility after hip fracture in community-dwelling older adults (65 years+). In this secondary analysis, we report the following outcomes: EQ-5D-5L utility score and VAS collected monthly via telephone and ICECAP-O collected in person three times at baseline, 6 months, and 12 months. Data were analyzed using area under the curve and regression adjusted for baseline values for utility scores and capability, and constrained longitudinal data analysis for VAS. RESULTS: We enrolled 53 older adults, including 34 women and 19 men, with mean (SD) age of 80 (8) years. There were no statistical or clinically meaningful differences between groups (control group - intervention group values) for all variables: utility score = -0.028 (95% CI: -0.071, 0.014; p = 0.18); VAS: -0.03 (95% CI: -0.39 to 0.33; p = 0.86); and capability = -0.021 (95% CI: -0.090, 0.046; p = 0.54). CONCLUSIONS: There were no differences in outcomes between groups over 12 months, but values remained constant, contrary to a potential decline for this age group, especially after a major life event like a hip fracture.

Co-Designing a Mobile-Based Game to Improve Misinformation Resistance and Vaccine Knowledge in Uganda, Kenya, and Rwanda.

Misinformation can decrease public confidence in vaccines, and reduce vaccination intent and uptake. One strategy for countering these negative impacts comes from inoculation theory. Similar to biological vaccination, inoculation theory posits that exposure to a weakened form of misinformation can develop cognitive immunity, reducing the likelihood of being misled. Online games offer an interactive, technology-driven, and scalable solution using an active form of inoculation that engages and incentivizes players to build resilience against misinformation. We document the development of the critical thinking game Cranky Uncle Vaccine. The game applies research findings from inoculation theory, critical thinking, humor in science communication, and serious games. The game content was iterated through a series of co-design workshops in Kampala (Uganda), Kitale (Kenya), and Kigali (Rwanda). Workshop participants offered feedback on cartoon character design, gameplay experience, and the game's content, helping to make the game more culturally relevant and avoid unintended consequences in East African countries. Our co-design methodology offers an approach for further adaptation of the Cranky Uncle Vaccine game to other regions, as well as a template for developing locally relevant interventions to counter future infodemics.

IPNA clinical practice recommendations for the diagnosis and management of children with steroid-sensitive nephrotic syndrome.

Idiopathic nephrotic syndrome is the most frequent pediatric glomerular disease, affecting from 1.15 to 16.9 per 100,000 children per year globally. It is characterized by massive proteinuria, hypoalbuminemia, and/or concomitant edema. Approximately 85-90% of patients attain complete remission of proteinuria within 4-6 weeks of treatment with glucocorticoids, and therefore, have steroid-sensitive nephrotic syndrome (SSNS). Among those patients who are steroid sensitive, 70-80% will have at least one relapse during follow-up, and up to 50% of these patients will experience frequent relapses or become dependent on glucocorticoids to maintain remission. The dose and duration of steroid treatment to prolong time between relapses remains a subject of much debate, and patients continue to experience a high prevalence of steroid-related morbidity. Various steroid-sparing immunosuppressive drugs have been used in clinical practice; however, there is marked practice variation in the selection of these drugs and timing of their introduction during the course of the disease. Therefore, international evidence-based clinical practice recommendations (CPRs) are needed to guide clinical practice and reduce practice variation. The International Pediatric Nephrology Association (IPNA) convened a team of experts including pediatric nephrologists, an adult nephrologist, and a patient representative to develop comprehensive CPRs on the diagnosis and management of SSNS in children. After performing a systematic literature review on 12 clinically relevant PICO (Patient or Population covered, Intervention, Comparator, Outcome) questions, recommendations were formulated and formally graded at several virtual consensus meetings. New definitions for treatment outcomes to help guide change of therapy and recommendations for important research questions are given.

Adaptation and Testing of a Military Version of the Measure of Moral Distress for Healthcare Professionals.

BACKGROUND: Moral distress is well-documented among civilian critical care nurses and adversely affects patient outcomes, care delivery, and retention of health care providers. Despite its recognized significance, few studies have addressed moral distress in military critical care nurses. OBJECTIVES: To refine and validate an instrument to assess moral distress in military critical care nurses. METHODS: This study examined moral distress in military critical care nurses (N = 245) using a new instrument, the Measure of Moral Distress for Healthcare Professionals-Military (MMD-HP-M). The psychometric properties of the refined scale were assessed by use of descriptive statistics, tests of reliability and validity, exploratory factor analysis, correlations, and qualitative analysis of open-ended responses. RESULTS: Initial testing showed promising evidence of instrument performance. The Cronbach α (0.94) suggested good internal consistency of the instrument for the overall sample. Scores for the MMD-HP items and the MMD-HP-M items showed a strong, significant correlation (α= 0.78, P < .001). Unique attributes of military nursing that contribute to moral distress included resource access, futile care, and austere conditions. Exploratory factor analysis established a new military-centric factor for question items associated with inadequate training for patient care, providing care in resource-limited settings, and personal exhaustion. CONCLUSIONS: These results will help guide specific, targeted interventions to reduce the negative effects of moral distress on our military health care providers, especially in terms of readiness for the next global pandemic and retention of these invaluable personnel.

Economic Evaluation of Using Daily Prednisolone versus Placebo at the Time of an Upper Respiratory Tract Infection for the Management of Children with Steroid-Sensitive Nephrotic Syndrome: A Model-Based Analysis.

BACKGROUND: Childhood steroid-sensitive nephrotic syndrome is a frequently relapsing disease with significant short- and long-term complications, leading to high healthcare costs and reduced quality of life for patients. The majority of relapses are triggered by upper respiratory tract infections (URTIs) and evidence shows that daily low-dose prednisolone at the time of infection may reduce the risk of relapse. OBJECTIVE: The aim of this study was to assess the cost effectiveness of a 6-day course of low-dose prednisolone at the start of a URTI when compared with placebo. METHODS: A state-transition Markov model was developed to conduct a cost-utility analysis with the outcome measured in quality-adjusted life-years (QALYs). Resource use and outcome data were derived from the PREDNOS2 trial. The analysis was performed from a UK National Health Service perspective and the results were extrapolated to adulthood. Model parameter and structural uncertainty were assessed using sensitivity analyses. RESULTS: The base-case results showed that administering low-dose prednisolone at the time of a URTI generated more QALYs and a lower mean cost at 1 year compared with placebo. In the long-term, low-dose prednisolone was associated with a cost saving (£176) and increased effectiveness (0.01 QALYs) compared with placebo and thus remained the dominant treatment option. These findings were robust to all sensitivity analyses. CONCLUSION: A 6-day course of low-dose prednisolone at the time of a URTI in children with steroid-sensitive nephrotic syndrome has the potential to reduce healthcare costs and improve quality of life compared with placebo.

Daily low-dose prednisolone to prevent relapse of steroid-sensitive nephrotic syndrome in children with an upper respiratory tract infection: PREDNOS2 RCT.

BACKGROUND: Most children with steroid-sensitive nephrotic syndrome have relapses that are triggered by upper respiratory tract infections. Four small trials, mostly in children already taking maintenance corticosteroid in countries of different upper respiratory tract infection epidemiology, showed that giving daily low-dose prednisone/prednisolone for 5-7 days during an upper respiratory tract infection reduces the risk of relapse. OBJECTIVES: To determine if these findings were replicated in a large UK population of children with relapsing steroid-sensitive nephrotic syndrome on different background medication or none. DESIGN: A randomised double-blind placebo-controlled trial, including a cost-effectiveness analysis. SETTING: A total of 122 UK paediatric departments, of which 91 recruited patients. PARTICIPANTS: A total of 365 children with relapsing steroid-sensitive nephrotic syndrome (mean age 7.6 ± 3.5 years) were randomised (1 : 1) according to a minimisation algorithm based on background treatment. Eighty children completed 12 months of follow-up without an upper respiratory tract infection. Thirty-two children were withdrawn from the trial (14 prior to an upper respiratory tract infection), leaving a modified intention-to-treat analysis population of 271 children (134 and 137 children in the prednisolone and placebo arms, respectively). INTERVENTIONS: At the start of an upper respiratory tract infection, children received 6 days of prednisolone (15 mg/m2) or an equivalent dose of placebo. MAIN OUTCOME MEASURES: The primary outcome was the incidence of first upper respiratory tract infection-related relapse following any upper respiratory tract infection over 12 months. The secondary outcomes were the overall rate of relapse, changes in background treatment, cumulative dose of prednisolone, rates of serious adverse events, incidence of corticosteroid adverse effects, change in Achenbach Child Behaviour Checklist score and quality of life. Analysis was by intention-to-treat principle. The cost-effectiveness analysis used trial data and a decision-analytic model to estimate quality-adjusted life-years and costs at 1 year, which were then extrapolated over 16 years. RESULTS: There were 384 upper respiratory tract infections and 82 upper respiratory tract infection-related relapses in the prednisolone arm, and 407 upper respiratory tract infections and 82 upper respiratory tract infection-related relapses in the placebo arm. The number of patients experiencing an upper respiratory tract infection-related relapse was 56 (42.7%) and 58 (44.3%) in the prednisolone and placebo arms, respectively (adjusted risk difference -0.024, 95% confidence interval -0.14 to 0.09; p = 0.70). There was no evidence that the treatment effect differed when data were analysed according to background treatment. There were no significant differences in secondary outcomes between treatment arms. Giving daily prednisolone at the time of an upper respiratory tract infection was associated with increased quality-adjusted life-years (0.9427 vs. 0.9424) and decreased average costs (£252 vs. £254), when compared with standard care. The cost saving was driven by background therapy and hospitalisations after relapse. The finding was robust to sensitivity analysis. LIMITATIONS: A larger number of children than expected did not have an upper respiratory tract infection and the sample size attrition rate was adjusted accordingly during the trial. CONCLUSIONS: The clinical analysis indicated that giving 6 days of daily low-dose prednisolone at the time of an upper respiratory tract infection does not reduce the risk of relapse of steroid-sensitive nephrotic syndrome in UK children. However, there was an economic benefit from costs associated with background therapy and relapse, and the health-related quality-of-life impact of having a relapse. FUTURE WORK: Further work is needed to investigate the clinical and health economic impact of relapses, interethnic differences in treatment response, the effect of different corticosteroid regimens in treating relapses, and the pathogenesis of individual viral infections and their effect on steroid-sensitive nephrotic syndrome. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10900733 and EudraCT 2012-003476-39. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 3. See the NIHR Journals Library website for further project information.

Steroid-sensitive nephrotic syndrome is a kidney condition in which protein leaks into the urine, causing generalised swelling. In most children, the condition recurs or relapses. Relapses often occur following an upper respiratory tract infection (i.e. a cough, cold or sore throat). Research in tropical countries suggests that if children have a small dose of daily steroids for a week at the time of an upper respiratory tract infection then they are less likely to relapse. The selection of children for these studies and the different patterns of infection mean that we are not certain if this treatment would work in the UK. A total of 365 children with relapsing nephrotic syndrome took part. Half of the children took a steroid and the other half took dummy tablets (placebo) for 6 days at the start of an upper respiratory tract infection. We followed up the children for 12 months and collected information on relapses and other treatments and information from questionnaires about behaviour and quality of life. We also investigated whether or not there were cost savings with this treatment. There were 271 children who had an upper respiratory tract infection in the 12 months of the study and so only these children were included in the analyses. Giving 6 days of a low-dose steroid at the time of an upper respiratory tract infection did not reduce the risk of a relapse. There was also no effect on the overall number of relapses, the number of children needing to start extra preventative treatments or side effects of steroids. Although there was no clinical effect, the economic evaluation found that giving prednisolone led to lower treatment costs overall and higher quality of life and might, therefore, offer better value for money, but this has to be interpreted against the clinical evidence of no significant effect. Our conclusion is that there is no clinical benefit to giving children low-dose prednisolone at the time of an upper respiratory tract infection.

Evaluation of Daily Low-Dose Prednisolone During Upper Respiratory Tract Infection to Prevent Relapse in Children With Relapsing Steroid-Sensitive Nephrotic Syndrome: The PREDNOS 2 Randomized Clinical Trial.

IMPORTANCE: In children with corticosteroid-sensitive nephrotic syndrome, many relapses are triggered by upper respiratory tract infections. Four small studies found that administration of daily low-dose prednisolone for 5 to 7 days at the time of an upper respiratory tract infection reduced the risk of relapse, but the generalizability of their findings is limited by location of the studies and selection of study population. OBJECTIVE: To investigate the use of daily low-dose prednisolone for the treatment of upper respiratory tract infection-related relapses. DESIGN, SETTING, AND PARTICIPANTS: This double-blind, placebo-controlled randomized clinical trial (Prednisolone in Nephrotic Syndrome [PREDNOS] 2) evaluated 365 children with relapsing steroid-sensitive nephrotic syndrome with and without background immunosuppressive treatment at 122 pediatric departments in the UK from February 1, 2013, to January 31, 2020. Data from the modified intention-to-treat population were analyzed from July 1, 2020, to December 31, 2020. INTERVENTIONS: At the start of an upper respiratory tract infection, children received 6 days of prednisolone, 15 mg/m2 daily, or matching placebo preparation. Those already taking alternate-day prednisolone rounded their daily dose using trial medication to the equivalent of 15 mg/m2 daily or their alternate-day dose, whichever was greater. MAIN OUTCOMES AND MEASURES: The primary outcome was the incidence of first upper respiratory tract infection-related relapse. Secondary outcomes included overall rate of relapse, changes in background immunosuppressive treatment, cumulative dose of prednisolone, rates of serious adverse events, incidence of corticosteroid adverse effects, and quality of life. RESULTS: The modified intention-to-treat analysis population comprised 271 children (mean [SD] age, 7.6 [3.5] years; 174 [64.2%] male), with 134 in the prednisolone arm and 137 in the placebo arm. The number of patients experiencing an upper respiratory tract infection-related relapse was 56 of 131 (42.7%) in the prednisolone arm and 58 of 131 (44.3%) in the placebo arm (adjusted risk difference, -0.02; 95% CI, -0.14 to 0.10; P = .70). No evidence was found that the treatment effect differed according to background immunosuppressive treatment. No significant differences were found in secondary outcomes between the treatment arms. A post hoc subgroup analysis assessing the primary outcome in 54 children of South Asian ethnicity (risk ratio, 0.66; 95% CI, 0.40-1.10) vs 208 children of other ethnicity (risk ratio, 1.11; 95% CI, 0.81-1.54) found no difference in efficacy of intervention in those of South Asian ethnicity (test for interaction P = .09). CONCLUSIONS AND RELEVANCE: The results of PREDNOS 2 suggest that administering 6 days of daily low-dose prednisolone at the time of an upper respiratory tract infection does not reduce the risk of relapse of nephrotic syndrome in children in the UK. Further work is needed to investigate interethnic differences in treatment response. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN10900733; EudraCT 2012-003476-39.

Exploring the Shared Experiences of Yazidis Who Survived Genocide.

In August 2014, the Islamic State of Iraq (ISIS) and the Levant (ISIL) brutally attacked the Yazidi people and occupied Sinjar and other villages in Northern Iraq. The massacre of Yazidis that began in August 2014 was declared by the United Nations as genocide. To gain a better understanding and raise awareness of these atrocities, we conducted a qualitative, phenomenological study with 35 Yazidis, who survived the genocide. The aim of the study was to elucidate the Yazidis' processing of the genocide and how it affects their psychological functioning. Coding and theming were the methods used to categorize, bring meaning and identity to Yazidis'genocidal experiences. The interviews took place between April and June 2019. Data analysis of the interview transcripts revealed that Yazidis, who survived the genocide of 2014, commonly experienced 11 themes related to hopelessness, fear, loss, grief, distrust, change, advocacy, optimism, shock, intrusive memories, and guilt. Results from this study reveal the vulnerabilities of ethnic minorities at risk of being abducted, killed, raped, and displaced. Moreover, the inherent risk of future genocides is illustrated through the experiences shared by the Yazidis.

Exercise, Processing Speed, and Subsequent Falls: A Secondary Analysis of a 12-Month Randomized Controlled Trial.

BACKGROUND: Strength and balance retraining exercises reduce the rate of subsequent falls in community-dwelling older adults who have previously fallen. Exercise can also improve cognitive function, including processing speed. Given processing speed predicts subsequent falls, we aimed to determine whether improved processing speed mediated the effects of the Otago Exercise Program on the rate of subsequent: (i) total falls, (ii) non-injurious falls, (iii) moderate injurious falls, and (iv) serious injurious falls. METHOD: A secondary complete case analysis of a 12-month, single-blind, randomized clinical trial among 256 of 344 adults aged at least 70 years who fell in the previous 12 months. Participants were randomized 1:1 to receive usual care plus the Otago Exercise Program (n = 123) or usual care (n = 133), consisting of fall prevention care provided by a geriatrician. The primary outcome was self-reported number of falls over 12 months (ie, rate of falls). Processing speed was assessed at baseline and at 12 months by the Digit Symbol Substitution Test (DSST). Causal mediation analyses were conducted using quasi-Bayesian estimates and 95% confidence intervals. RESULTS: Exercise significantly reduced the rate of subsequent moderate injurious falls (IRR = 0.49; 95% CI: 0.31, 0.77; p = .002) and improved processing speed (estimated mean difference: 1.16 points; 95% CI: 0.11, 2.21). Improved DSST mediated the effect of exercise on the rate of subsequent moderate injurious falls (estimate: -0.06; 95% CI: -0.15, -0.001; p = .036). CONCLUSION: Improved processing speed may be a mechanism by which exercise reduces subsequent moderate injurious falls in older adults who fell previously. CLINICAL TRIALS REGISTRATION NUMBER: ClinicalTrials.gov Protocol Registration System:NCT01029171: https://clinicaltrials.gov/ct2/show/NCT01029171NCT00323596: https://clinicaltrials.gov/ct2/show/NCT00323596.

Comprehensive Geriatric Care to Improve Mobility after Hip Fracture: An RCT.

BACKGROUND: Comprehensive geriatric care (CGC) for older adults during hospitalization for hip fracture can improve mobility, but it is unclear whether CGC delivered after a return to community living improves mobility compared with usual post-discharge care. OBJECTIVE: To determine if an outpatient clinic-based CGC regime in the first year after hip fracture improved mobility performance at 12 months. METHODS: A two-arm, 1:1 parallel group, pragmatic, single-blind, single-center, randomized controlled trial at 3 hospitals in Vancouver, BC, Canada. Participants were community-dwelling adults, aged ≥65 years, with a hip fracture in the previous 3-12 months, who had no dementia and walked ≥10 m before the fracture occurred. Target enrollment was 130 participants. Clinic-based CGC was delivered by a geriatrician, physiotherapist, and occupational therapist. Primary outcome was the Short Physical Performance Battery (SPPB; 0-12) at 12 months. RESULTS: We randomized 53/313 eligible participants with a mean (SD) age of 79.7 (7.9) years to intervention (n = 26) and usual care (UC, n = 27), and 49/53 (92%) completed the study. Mean 12-month (SD) SPPB scores in the intervention and UC groups were 9.08 (3.03) and 8.24 (2.44). The between-group difference was 0.9 (95% CI -0.3 to 2.0, p = 0.13). Adverse events were similar in the 2 groups. CONCLUSION: The small sample size of less than half our recruitment target precludes definitive conclusions about the effect of our intervention. However, our results are consistent with similar studies on this population and intervention.

Action Seniors! Cost-Effectiveness Analysis of a Secondary Falls Prevention Strategy Among Community-Dwelling Older Fallers.

BACKGROUND: The Otago Exercise Program (OEP) has demonstrated cost-effectiveness for the primary prevention of falls in a general community setting. The cost-effectiveness of exercise as a secondary falls prevention (ie, preventing falls among those who have already fallen) strategy remains unknown. The primary objective was to estimate the cost-effectiveness (incremental cost-effectiveness/utility ratio) of the OEP from a healthcare system perspective. DESIGN: A concurrent 12-month prospective economic evaluation conducted alongside the Action Seniors! randomized critical trial (OEP compared with usual care). SETTING: Vancouver Falls Prevention Clinic (Vancouver, BC, Canada; http://www.fallsclinic.ca). PARTICIPANTS: A total of 344 community-dwelling older adults, aged 70 years and older, who attended a geriatrician-led Falls Prevention Clinic in Vancouver, after sustaining a fall in the previous 12 months. MEASUREMENTS: Main outcome measures included: incidence rate ratio for falls, healthcare costs, incremental cost per fall prevented, and incremental cost per quality-adjusted life year (QALY) gained. RESULTS: The OEP costs $393 CAD per participant to implement. The incremental cost per fall prevented resulted in a savings of $2 CAD. The incremental cost per QALY gained (where QALYs were estimated using the Euro-Qol 5D three-level version [EQ-5D-3L]) indicated the OEP was less effective than usual care. The incremental cost per QALY gained (where QALYs were estimated using the Short Form 6D [SF-6D]) indicated the OEP was more effective and less costly than usual care. The incremental QALYs estimated using the EQ-5D-3L and the SF-6D were not clinically significant and close to zero, indicating no change in quality of life. CONCLUSION: Compared with usual care, healthcare system costs are saved and falls are prevented when older fallers who attend a geriatrician-led falls clinic are allocated to, and provided, the physiotherapist-guided exercise-based falls prevention program (the OEP).

Effect of a Home-Based Exercise Program on Subsequent Falls Among Community-Dwelling High-Risk Older Adults After a Fall: A Randomized Clinical Trial.

Importance: Whether exercise reduces subsequent falls in high-risk older adults who have already experienced a fall is unknown. Objective: To assess the effect of a home-based exercise program as a fall prevention strategy in older adults who were referred to a fall prevention clinic after an index fall. Design, Setting, and Participants: A 12-month, single-blind, randomized clinical trial conducted from April 22, 2009, to June 5, 2018, among adults aged at least 70 years who had a fall within the past 12 months and were recruited from a fall prevention clinic. Interventions: Participants were randomized to receive usual care plus a home-based strength and balance retraining exercise program delivered by a physical therapist (intervention group; n = 173) or usual care, consisting of fall prevention care provided by a geriatrician (usual care group; n = 172). Both were provided for 12 months. Main Outcomes and Measures: The primary outcome was self-reported number of falls over 12 months. Adverse event data were collected in the exercise group only and consisted of falls, injuries, or muscle soreness related to the exercise intervention. Results: Among 345 randomized patients (mean age, 81.6 [SD, 6.1] years; 67% women), 296 (86%) completed the trial. During a mean follow-up of 338 (SD, 81) days, a total of 236 falls occurred among 172 participants in the exercise group vs 366 falls among 172 participants in the usual care group. Estimated incidence rates of falls per person-year were 1.4 (95% CI, 0.1-2.0) vs 2.1 (95% CI, 0.1-3.2), respectively. The absolute difference in fall incidence was 0.74 (95% CI, 0.04-1.78; P = .006) falls per person-year and the incident rate ratio was 0.64 (95% CI, 0.46-0.90; P = .009). No adverse events related to the intervention were reported. Conclusions and Relevance: Among older adults receiving care at a fall prevention clinic after a fall, a home-based strength and balance retraining exercise program significantly reduced the rate of subsequent falls compared with usual care provided by a geriatrician. These findings support the use of this home-based exercise program for secondary fall prevention but require replication in other clinical settings. Trial Registration: ClinicalTrials.gov Identifiers: NCT01029171; NCT00323596.

Older Adults' Sedentary Behavior and Physical Activity After Hip Fracture: Results From an Outpatient Rehabilitation Randomized Controlled Trial.

BACKGROUND AND PURPOSE: Prolonged sedentary time and limited physical activity can result in deleterious effects on health and mobility, especially for older adults with fall-related hip fracture. Therefore, the purpose of this study was to examine the effect of a multidisciplinary clinic on sedentary behavior and physical activity (prespecified secondary outcomes) and provide descriptions of activity patterns over 1 year for men and women. METHODS: We conducted a parallel-group, single-blinded randomized controlled trial comparing a multidisciplinary clinic and usual care (intervention) with usual care (control). We recruited 53 community-dwelling older adults aged 65+ years who were 3 to 12 months postfracture and collected data at baseline, 6, and 12 months; study staff were blinded to group allocation. The clinic included a geriatric assessment by the geriatrician, physiotherapist, and occupational therapist. Referrals were made to other professionals, when indicated. We collected the accelerometer-measured sedentary behavior and physical activity at 3 time points. We used linear mixed-effects models to compare groups at 6 and 12 months and mixed models to compare outcomes between men and women. RESULTS: Participants were sedentary for more than 10 hours of a 13-hour day, and there were no significant differences between the study groups at 6 months (2.4 [95% confidence interval: -22.4 to 27.2] minutes) or 12 months (-3.7 [95% confidence interval: -33.6 to 26.1] minutes). Compared with women, men spent 47.2 min/d more in sedentary time (P = .052) and 43.8 min/d less in light physical activity (P = .047). DISCUSSION: Older adults after hip fracture spend prolonged periods of waking hours sedentary with very little activity.

Collaborating With Parents of Children With Chronic Conditions and Professionals to Design, Develop and Pre-pilot PLAnT (the Parent Learning Needs and Preferences Assessment Tool).

PURPOSE: This study aimed to design, develop and pre-pilot an assessment tool (PLAnT) to identify parents' learning needs and preferences when carrying out home-based clinical care for their child with a chronic condition. DESIGN AND METHODS: A mixed methods, two-phased design was used. Phase 1: a total of 10 parents/carers and 13 professionals from six UK's children's kidney units participated in qualitative interviews. Interview data were used to develop the PLAnT. Eight of these participants subsequently took part in an online survey to refine the PLAnT. Phase 2: thirteen parents were paired with one of nine professionals to undertake a pre-pilot evaluation of PLAnT. Data were analyzed using the Framework approach. RESULTS: A key emergent theme identifying parents' learning needs and preferences was identified. The importance of professionals being aware of parents' learning needs and preferences was recognised. Participants discussed how parents' learning needs and preferences should be identified, including: the purpose for doing this, the process for doing this, and what would the outcome be of identifying parents' needs. CONCLUSIONS: The evidence suggests that asking parents directly about their learning needs and preferences may be the most reliable way for professionals to ascertain how to support individual parents' learning when sharing management of their child's chronic condition. PRACTICE IMPLICATIONS: With the increasing emphasis on parent-professional shared management of childhood chronic conditions, professionals can be guided by PLAnT in their assessment of parents' learning needs and preferences, based on identified barriers and facilitators to parental learning.

Incontinence and Nocturia in Older Adults After Hip Fracture: Analysis of a Secondary Outcome for a Parallel Group, Randomized Controlled Trial.

Objective: To test the effect of a follow-up clinic on urinary incontinence (UI) and nocturia among older adults with hip fracture. Method: Fifty-three older adults (≥65 years) 3 to 12 months following hip fracture were enrolled and randomized to receive usual care plus the intervention (B4), or usual care (UC) only. The B4 group received management by health professionals, with need-based referrals. UI, nocturia, and quality of life were measured with questionnaires at baseline, 6 months, and 12 months. Results: There were 48 participants included in this analysis, and at baseline, 44% of study participants self-reported UI. At final assessment, six out of 24 B4 participants and 12 out of 24 UC participants reported UI. Four out of five study participants reported nocturia at baseline; this did not decrease during the study. Discussion: Following hip fracture, many older adults report UI and most report nocturia. Health professionals should be aware of the high occurrence of urinary symptoms among older adults post hip fracture.

Reflections on Hip Fracture Recovery From Older Adults Enrolled in a Clinical Trial.

This study describes patients' perspectives on recovery during participation in a randomized controlled trial that tested a postoperative hip fracture management program (B4 Clinic), compared with usual care, on mobility. Semistructured qualitative interviews were conducted with 50 older adults with hip fracture (from both groups) twice over 12 months. A total of 32 women (64%) and 18 men (36%) participated in the study with a mean age at baseline of 82 (range = 65-98) years. A total of 40 participants reported recovery goals at some point during their recovery from hip fracture but only 18 participants realized their goals within 12 months. Recovering mobility, returning to prefracture activities, and obtaining stable health were the most commonly reported goals. Participants described good social support, access to physiotherapy, and positive perspective as most important to recovery. These factors were influenced by participants' knowledge, resources, and monthly contact with study staff (perceived as a form of social support). The most frequently reported barriers to participants' recovery were the onset of complications, pain, and limited access to physiotherapy. Potential implications of these findings include design and modification of new or preexisting fracture programs, prioritizing patient engagement and enhanced knowledge for future clinical research in hip fracture recovery.

Indications of Recruitment Challenges in Research with U.S. Military Service Members: A ClinicalTrials.gov Review.

INTRODUCTION: The success of military-relevant health research often depends on recruiting adequate numbers of U.S. military service members as research participants. Researchers have reported difficulties in recruiting service member research participants. Reviews of ClinicalTrials.gov, an online clinical trial registry of publicly and privately sponsored studies, have identified challenges in participant recruitment and barriers to study completion in various research populations. The purpose of this study was to identify indications of difficulty recruiting U.S. military service members as research participants based on data from study records in ClinicalTrials.gov. MATERIALS AND METHODS: Records of studies starting between 2005 and 2014 were collected from ClinicalTrials.gov and updated through January 2016. Three hundred and two studies that included ≥25% U.S. military service member research participants were (1) compared to a comparison group of 302 studies, each with <5% service member participants and (2) compared by the proportion of service member participants within studies in the military group ("many" ≥25% but <100% service members and "all" 100% service members). Groups were evaluated and compared for recruitment status; reasons for study withdrawal, termination, or suspension; achievement of ≥85% of the anticipated enrollment; and differences in achieving recruitment goals according to study sponsor. RESULTS: Twelve percent of studies in the military group had been withdrawn, terminated, or suspended; enrollment and funding problems were the most common reasons. The comparison group had 11% of studies withdrawn, terminated, or suspended; the most common reasons were enrollment problems and sponsor decision. All study groups had indications of difficulty adequately achieving participant enrollment goals. Among studies with known anticipated and actual enrollment, approximately half in both the military group (47.9%) and comparison group (50.3%) achieved ≥85% of the anticipated enrollment (p = 0.722). Half of studies with many service members and 44% of studies with all service members achieved ≥85% of the anticipated enrollment (p = 0.600). In comparing the many and all service member subgroups, significant differences were found in the median values for anticipated enrollment and actual enrollment, even when accounting for Bonferroni correction. Evaluations of mean values did not show a statistical difference between the military subgroups. There were no significant differences according to study sponsor (military, academic, Veterans Affairs, National Institutes of Health, nonprofit organization, or industry) for a study achieving or not achieving ≥85% of the anticipated enrollment. CONCLUSION: This review supports anecdotal reports of difficulty recruiting service members as research participants. However, the findings also indicate that in many regards, there is not much difference in the difficulties recruiting service members versus other research participants. Findings suggest that it is often difficult to recruit research participants regardless of the specific population or type of study sponsor, and that studies with either many or all service member participants have similar achievement of recruitment goals. Findings in this study may be useful for those who design research that includes service members or for those who are apprehensive about including service members in their research.

US Military Service Members' Reasons for Deciding to Participate in Health Research.

Researchers have reported challenges in recruiting US military service members as research participants. We explored their reasons for participating. Eighteen US military service members who had participated in at least one health-related research study within the previous 3 years completed semi-structured individual interviews in person or by telephone, focused on the service members' past decisions regarding research participation. Service members described participation decisions for 34 individual research experiences in 27 separate studies. Service members' reasons for participation in research clustered in three themes: others-, self-, and fit-focused. Each decision included reasons characterized by at least two themes. Reasons from all three themes were apparent in two-thirds of individual participation decisions. Reasons described by at least half of the service members included a desire to make things better for others, to improve an organization, to help researchers, and to improve one's health; understanding how they fit in studies; and convenience of participation. Findings may help researchers, study sponsors, ethicists, military leaders, and military decision-makers better understand service members' reasons for participating in research and improve future recruitment of service members in health research. © 2017 Wiley Periodicals, Inc.

Quantity and Quality of Economic Evaluations in U.S. Nursing Research, 1997-2015: A Systematic Review.

BACKGROUND: The United States has a complex healthcare system that is undergoing substantial reformations. There is a need for high-quality, economic evaluations of nursing practice. An updated review of completed economic evaluations relevant to the field of nursing within the U.S. healthcare system is timely and needed. OBJECTIVES: The purpose of this study was to evaluate and describe the quantity and quality of economic evaluations in nursing-relevant research performed in the United States between 1997 and 2015. METHODS: Four databases were searched. Titles, abstracts, and full-text content were reviewed to identify studies that analyzed both costs and outcomes, relevant to nursing, performed in the United States, and used the quality-adjusted life year to measure effectiveness. For included studies, data were extracted from full-text articles using criteria from U.S. Public Health Service's Panel on Cost-Effectiveness in Health and Medicine. RESULTS: Twenty-eight studies met the inclusion criteria. Most (n = 25, 89%) were published in the last decade of the analysis, from 2006 to 2015. Assessment of quality, based on selected items from the panel guidelines, found that the evaluations did not consistently use the recommended societal perspective, use multiple resource utilization categories, use constant dollars, discount future costs and outcomes, use a lifetime horizon, or include an indication of uncertainty in results. The only resource utilization category consistently included across studies was healthcare resources. DISCUSSION: Only 28 nursing-related studies meeting the inclusion criteria were identified as meeting robust health economic evaluation methodological criteria, and most did not include all important guideline items. Despite increases in absolute numbers of published studies over the past decade, economic evaluation has been underutilized in U.S. nursing-relevant research in the past two decades.

Trends in Research with U.S. Military Service Member Participants: A Population-Specific ClinicalTrials.gov Review.

BACKGROUND: ClinicalTrials.gov reviews have evaluated research trends for specific conditions and age groups but not for specific populations of research participants. No ClinicalTrials.gov reviews have evaluated research with military service member participants. PURPOSE: Study objectives were (a) to use ClinicalTrials.gov to identify trends in biomedical research from 2005 to 2014 in which U.S. military service members actively participated as research participants and (b) to describe a search strategy for adaptation in future ClinicalTrials.gov reviews of specific participant populations. METHODS: A systematic review of ClinicalTrials.gov was performed to identify studies that included U.S. service members as participants, either exclusively or with other groups of participants. RESULTS: U.S. service members were identified as participants in 512 studies. Service members participated together with other groups in 392 studies, while 120 studies included only service members. The top five conditions of interest were post-traumatic stress disorder, traumatic brain injury, amputations, burns, and ocular injuries/disorders. The number of studies started each year peaked in 2011 and declined from 2012 to 2014. Twenty-five percent of studies exclusive to service members aimed to enroll 500 or more participants. Research exclusive to Guard and Reserve service members during this period was limited. CONCLUSIONS: U.S. military service members participate in biomedical research. To address the health needs of U.S. service members, it is important to ensure there is not a prolonged decline in research among this population. The search strategy may be adapted to ClinicalTrials.gov reviews of specific participant populations for which straightforward searches are not possible.