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Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Siobhan Wong ◽  
Leanne Hassett ◽  
Harriet Koorts ◽  
Anne Grunseit ◽  
Allison Tong ◽  

Abstract Background There is currently little evidence of planning for real-world implementation of physical activity interventions. We are undertaking the ComeBACK (Coaching and Exercise for Better Walking) study, a 3-arm hybrid Type 1 randomised controlled trial evaluating a health coaching intervention and a text messaging intervention. We used an implementation planning framework, the PRACTical planning for Implementation and Scale-up (PRACTIS), to guide the process evaluation for the trial. The aim of this paper is to describe the protocol for the process evaluation of the ComeBACK trial using the framework of the PRACTIS guide. Methods A mixed methods process evaluation protocol was developed informed by the Medical Research Council (MRC) guidance on process evaluations for complex interventions and the PRACTIS guide. Quantitative data, including participant questionnaires, health coach and administrative logbooks, and website and text message usage data, is being collected over the trial period. Semi-structured interviews and focus groups with trial participants, health coaches and health service stakeholders will explore expectations, factors influencing the delivery of the ComeBACK interventions and potential scalability within existing health services. These data will be mapped against the steps of the PRACTIS guide, with reporting at the level of the individual, provider, organisational and community/systems. Quantitative and qualitative data will elicit potential contextual barriers and facilitators to implementation and scale-up. Quantitative data will be reported descriptively, and qualitative data analysed thematically. Discussion This process evaluation integrates an evaluation of prospective implementation and scale-up. It is envisaged this will inform barriers and enablers to future delivery, implementation and scale-up of physical activity interventions. To our knowledge, this is the first paper to describe the application of PRACTIS to guide the process evaluation of physical activity interventions. Trial registration Australian and New Zealand Clinical Trials Registry (ANZCTR) Registration date: 10/12/2018.

2022 ◽  
Vol 22 (1) ◽  
Rebekah Pratt ◽  
Daniel M. Saman ◽  
Clayton Allen ◽  
Benjamin Crabtree ◽  
Kris Ohnsorg ◽  

Abstract Background In this paper we describe the use of the Consolidated Framework for Implementation Research (CFIR) to study implementation of a web-based, point-of-care, EHR-linked clinical decision support (CDS) tool designed to identify and provide care recommendations for adults with prediabetes (Pre-D CDS). Methods As part of a large NIH-funded clinic-randomized trial, we identified a convenience sample of interview participants from 22 primary care clinics in Minnesota, North Dakota, and Wisconsin that were randomly allocated to receive or not receive a web-based EHR-integrated prediabetes CDS intervention. Participants included 11 clinicians, 6 rooming staff, and 7 nurse or clinic managers recruited by study staff to participate in telephone interviews conducted by an expert in qualitative methods. Interviews were recorded and transcribed, and data analysis was conducted using a constructivist version of grounded theory. Results Implementing a prediabetes CDS tool into primary care clinics was useful and well received. The intervention was integrated with clinic workflows, supported primary care clinicians in clearly communicating prediabetes risk and management options with patients, and in identifying actionable care opportunities. The main barriers to CDS use were time and competing priorities. Finally, while the implementation process worked well, opportunities remain in engaging the care team more broadly in CDS use. Conclusions The use of CDS tools for engaging patients and providers in care improvement opportunities for prediabetes is a promising and potentially effective strategy in primary care settings. A workflow that incorporates the whole care team in the use of such tools may optimize the implementation of CDS tools like these in primary care settings. Trial registration Name of the registry: Trial registration number: NCT02759055. Date of registration: 05/03/2016. URL of trial registry record: Prospectively registered.

2022 ◽  
Vol 23 (1) ◽  
Maciej J. K. Simon ◽  
Jennifer A. Coghlan ◽  
Jeff Hughes ◽  
Warwick Wright ◽  
Richard J. Dallalana ◽  

Abstract Background In an anatomic shoulder replacement (aTSR) good results have been reported with the use of a stemless humeral prosthesis. In vitro a ceramic articulation with polyethylene has been shown to produce less polyethylene wear particles than with metal. This study aims to evaluate clinical and radiographic results of a stemless aTSR with a ceramic head articulating with a polyethylene glenoid component, with mid-term follow-up. Methods All patients (n = 92) in this prospective study had an aTSR utilizing a stemless humeral component with a ceramic head and a cemented double pegged cemented polyethylene glenoid component for glenohumeral osteoarthritis. Pre- and postoperative clinical evaluations at 2 years were performed using the ASES score, Constant score, SPADI score, DASH score, VAS pain score, patient satisfaction and range of motion. There was a 5-year evaluation of SPADI, ASES, pain, and satisfaction, plus radiographic assessment of glenoid component radiolucent lines and humeral osteolysis. Results Seventy-four cases (68.1 ± 7.1 years) had a five-year follow-up and demonstrated active elevation improvement from 91.3° preoperatively to 151.1° (p < 0.001). Further improvement was identified with the ASES from 41.6 to 94.3, the SPADI from 62.9 to 4.3, VAS pain from 5.6 to 0.4 (0–10), and satisfaction levels were at 96%. Sixty-two cases had no glenoid radiolucent lines with a maximum Lazarus score of 2 in one patient. Constant scores, available up to 2 years, improved significantly from 30.3 to 77.9 (p < 0.001). There was one case that required revision for glenoid loosening. Conclusions Overall, the 5-year results of this ceramic head prosthesis demonstrated good radiographic and clinical outcomes. Trial registration ACTRN12613001183774. Registered: 29 October 2013 - Retrospectively registered. Australian New Zealand Clinical Trials Registry (ANZCTR).

PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0261751
Ariadna Forray ◽  
Amanda Mele ◽  
Nancy Byatt ◽  
Amalia Londono Tobon ◽  
Kathryn Gilstad-Hayden ◽  

Introduction The prevalence of opioid use disorder (OUD) in pregnancy increased nearly five-fold over the past decade. Despite this, obstetric providers are less likely to treat pregnant women with medication for OUD than non-obstetric providers (75% vs 91%). A major reason is many obstetricians feel unprepared to prescribe medication for opioid use disorder (MOUD). Education and support may increase prescribing and overall comfort in delivering care for pregnant women with OUD, but optimal models of education and support are yet to be determined. Methods and analysis We describe the rationale and conduct of a matched-pair cluster randomized clinical trial to compare the effectiveness of two models of support for reproductive health clinicians to provide care for pregnant and postpartum women with OUD. The primary outcomes of this trial are patient treatment engagement and retention in OUD treatment. This study compares two support models: 1) a collaborative care approach, based upon the Massachusetts Office-Based-Opioid Treatment Model, that provides practice-level training and support to providers and patients through the use of care managers, versus 2) a telesupport approach based on the Project Extension for Community Healthcare Outcomes, a remote education model that provides mentorship, guided practice, and participation in a learning community, via video conferencing. Discussion This clustered randomized clinical trial aims to test the effectiveness of two approaches to support practitioners who care for pregnant women with an OUD. The results of this trial will help determine the best model to improve the capacity of obstetrical providers to deliver treatment for OUD in prenatal clinics. Trial registration trial registration number: NCT0424039.

H. M. Thomas ◽  
K. C. Runions ◽  
L. Lester ◽  
K. Lombardi ◽  
M. Epstein ◽  

Abstract Background The impacts of the COVID-19 pandemic have been vast and are not limited to physical health. Many adolescents have experienced disruptions to daily life, including changes in their school routine and family’s financial or emotional security, potentially impacting their emotional wellbeing. In low COVID-19 prevalence settings, the impact of isolation has been mitigated for most young people through continued face-to-face schooling, yet there may still be significant impacts on their wellbeing that could be attributed to the pandemic. Methods We report on data from 32,849 surveys from Year 7–12 students in 40 schools over two 2020 survey cycles (June/July: 19,240; October: 13,609), drawn from a study of 79 primary and secondary schools across Western Australia, Australia. The Child Health Utility Index (CHU9D) was used to measure difficulties and distress in responding secondary school students only. Using comparable Australian data collected six years prior to the pandemic, the CHU9D was calibrated against the Kessler-10 to establish a reliable threshold for CHU9D-rated distress. Results Compared to 14% of responding 12–18-year-olds in 2013/2014, in both 2020 survey cycles almost 40% of secondary students returned a CHU9D score above a threshold indicative of elevated difficulties and distress. Student distress increased significantly between June and October 2020. Female students, those in older Grades, those with few friendships or perceived poor quality friendships, and those with poor connectedness to school were more likely to score above the threshold. Conclusions In a large dataset collected during the first year of the COVID-19 pandemic, the proportion of secondary school students with scores indicative of difficulties and distress was substantially higher than a 2013/2014 benchmark, and distress increased as the pandemic progressed, despite the low local prevalence of COVID-19. This may indicate a general decline in social and emotional wellbeing exacerbated by the events of the pandemic. Trial registration: ANZCTRN (ACTRN12620000922976). Retrospectively registered 17/08/2020.

2022 ◽  
Vol 9 (2) ◽  
pp. e1120
Omar Al-Louzi ◽  
Vijay Letchuman ◽  
Sargis Manukyan ◽  
Erin S. Beck ◽  
Snehashis Roy ◽  

Background and ObjectivesThe central vein sign (CVS), a central linear hypointensity within lesions on T2*-weighted imaging, has been established as a sensitive and specific biomarker for the diagnosis of multiple sclerosis (MS). However, the CVS has not yet been comprehensively studied in newly developing MS lesions. We aimed to identify the CVS profiles of new white matter lesions in patients with MS followed over time and investigate demographic and clinical risk factors associated with new CVS+ or CVS− lesion development.MethodsIn this retrospective longitudinal cohort study, adults from the NIH MS Natural History Study were considered for inclusion. Participants with new T2 or enhancing lesions were identified through review of the radiology report and/or longitudinal subtraction imaging. Each new lesion was evaluated for the CVS. Clinical characteristics were identified through chart review.ResultsA total of 153 adults (95 relapsing-remitting MS, 27 secondary progressive MS, 16 primary progressive MS, 5 clinically isolated syndrome, and 10 healthy; 67% female) were included. Of this cohort, 96 had at least 1 new T2 or contrast-enhancing lesion during median 3.1 years (Q1–Q3: 0.7–6.3) of follow-up; lesions eligible for CVS evaluation were found in 62 (65%). Of 233 new CVS-eligible lesions, 159 (68%) were CVS+, with 30 (48%) individuals having only CVS+, 12 (19%) only CVS−, and 20 (32%) both CVS+ and CVS− lesions. In gadolinium-enhancing (Gd+) lesions, the CVS+ percentage increased from 102/152 (67%) at the first time point where the lesion was observed, to 92/114 (82%) after a median follow-up of 2.8 years. Younger age (OR = 0.5 per 10-year increase, 95% CI = 0.3–0.8) and higher CVS+ percentage at baseline (OR = 1.4 per 10% increase, 95% CI = 1.1–1.9) were associated with increased likelihood of new CVS+ lesion development.DiscussionIn a cohort of adults with MS followed over a median duration of 3 years, most newly developing T2 or enhancing lesions were CVS+ (68%), and nearly half (48%) developed new CVS+ lesions only. Importantly, the effects of edema and T2 signal changes can obscure small veins in Gd+ lesions; therefore, caution and follow-up is necessary when determining their CVS status.Trial Registration InformationClinical trial registration number NCT00001248.Classification of EvidenceThis study provides Class III evidence that younger age and higher CVS+ percentage at baseline are associated with new CVS+ lesion development.

2022 ◽  
Vol 23 (1) ◽  
Anke Schwarz ◽  
Roland Schmitt ◽  
Gunilla Einecke ◽  
Frieder Keller ◽  
Ulrike Bode ◽  

Abstract Background After kidney transplantation, pregnancy and graft function may have a reciprocal interaction. We evaluated the influence of graft function on the course of pregnancy and vice versa. Methods We performed a retrospective observational study of 92 pregnancies beyond the first trimester in 67 women after renal transplantation from 1972 to 2019. Pre-pregnancy eGFR was correlated with outcome parameters; graft function was evaluated by Kaplan Meier analysis. The course of graft function in 28 women who became pregnant after kidney transplantation with an eGFR of < 50 mL/min/1.73m2 was compared to a control group of 79 non-pregnant women after kidney transplantation during a comparable time period and with a matched basal graft function. Results Live births were 90.5% (fetal death n = 9). Maternal complications of pregnancy were preeclampsia 24% (graft loss 1, fetal death 3), graft rejection 5.4% (graft loss 1), hemolytic uremic syndrome 2% (graft loss 1, fetal death 1), maternal hemorrhage 2% (fetal death 1), urinary obstruction 10%, and cesarian section. (76%). Fetal complications were low gestational age (34.44 ± 5.02 weeks) and low birth weight (2322.26 ± 781.98 g). Mean pre-pregnancy eGFR was 59.39 ± 17.62 mL/min/1.73m2 (15% of cases < 40 mL/min/1.73m2). Pre-pregnancy eGFR correlated with gestation week at delivery (R = 0.393, p = 0.01) and with percent eGFR decline during pregnancy (R = 0.243, p = 0.04). Pregnancy-related eGFR decline was inversely correlated with the time from end of pregnancy to chronic graft failure or maternal death (R = -0.47, p = 0.001). Kaplan Meier curves comparing women with pre-pregnancy eGFR of ≥ 50 to < 50 mL/min showed a significantly longer post-pregnancy graft survival in the higher eGFR group (p = 0.04). Women after kidney transplantation who became pregnant with a low eGFR of > 25 to < 50 mL/min/1.73m2 had a marked decline of renal function compared to a matched non-pregnant control group (eGFR decline in percent of basal eGFR 19.34 ± 22.10%, n = 28, versus 2.61 ± 10.95%, n = 79, p < 0.0001). Conclusions After renal transplantation, pre-pregnancy graft function has a key role for pregnancy outcomes and graft function. In women with a low pre-pregnancy eGFR, pregnancy per se has a deleterious influence on graft function. Trial registration Since this was a retrospective observational case series and written consent of the patients was obtained for publication, according to our ethics’ board the analysis was exempt from IRB approval. Clinical Trial Registration was not done. The study protocol was approved by the Ethics Committee of Hannover Medical School, Chairman Prof. Dr. H. D. Troeger, Hannover, December 12, 2015 (IRB No. 2995–2015).

2022 ◽  
Abhisit Prawang ◽  
Naphatsawan Chanjamlong ◽  
Woranattha Rungwara ◽  
Wichai Santimaleeworagun ◽  
Taniya Paiboonvong ◽  

Abstract Background: Stenotrophomonas maltophilia is a multidrug-resistant bacteria that is difficult to treat in hospitals around the world. It has become a public health issue, as well as being linked to a high mortality rate. Several studies have shown a variety of treatment and clinical outcomes; however, the efficacy of combination therapy remains limited. Therefore, the purpose of this study is to investigate the effect of monotherapy and combination therapy for S. maltophilia infections on mortality outcome.Methods: We performed a systematic review and meta-analysis of combination therapy versus monotherapy in the treatment of S. maltophilia infections on mortality as a clinical outcome. Electronic databases, including Cochrane Library, PubMed, EMBASE,, Scopus, and OpenGrey, were systematically searched from the inception of the database until September 3, 2021. Results: Of which 6,524 articles identified, a total of 13 studies and 2 cohort studies were included for systematic review of combination therapy and meta-analysis, respectively. The systematic review of combination antimicrobial therapy had been showed clinically desirable outcome on mortality in S. maltopholia infection, especially in complex or severe infection. In the fixed-effects meta-analysis of the cohort study, monotherapy was surprisingly shown to have statistically significant effects on the decreased risk of mortality (hazard ratio 1.42; 95% confidence interval, 1.04-1.94). Conclusions: Our results found that the combination antimicrobial therapy had been showed clinically desirable outcome on mortality in S. maltopholia infection and monotherapy has a trend toward improved better outcome than combination therapy on mortality for the treatment of S. maltophilia infections. A longitudinal study that further explores this association is warranted. Trial registration: This study was registered with the trial registration number ID: 210843 under the international prospective register of systematic reviews (PROSPERO:

10.2196/27631 ◽  
2022 ◽  
Vol 9 (1) ◽  
pp. e27631
Kate M Gunn ◽  
Gemma Skaczkowski ◽  
James Dollman ◽  
Andrew D Vincent ◽  
Camille E Short ◽  

Background Farming is physically and psychologically hazardous. Farmers face many barriers to help seeking from traditional physical and mental health services; however, improved internet access now provides promising avenues for offering support. Objective This study aims to co-design with farmers the content and functionality of a website that helps them adopt transferable coping strategies and test its acceptability in the broader farming population. Methods Research evidence and expert opinions were synthesized to inform key design principles. A total of 18 farmers detailed what they would like from this type of website. Intervention logic and relevant evidence-based strategies were mapped. Website content was drafted and reviewed by 2 independent mental health professionals. A total of 9 farmers provided detailed qualitative feedback on the face validity of the draft content. Subsequently, 9 farmers provided feedback on the website prototype. Following amendments and internal prototype testing and optimization, prototype usability (ie, completion rate) was examined with 157 registered website users who were (105/157, 66.9%) female, aged 21-73 years; 95.5% (149/156) residing in inner regional to very remote Australia, and 68.2% (107/157) “sheep, cattle and/or grain farmers.” Acceptability was examined with a subset of 114 users who rated at least module 1. Interviews with 108 farmers who did not complete all 5 modules helped determine why, and detailed interviews were conducted with 18 purposively sampled users. Updates were then made according to adaptive trial design methodology. Results This systematic co-design process resulted in a web-based resource based on acceptance and commitment therapy and designed to overcome barriers to engagement with traditional mental health and well-being strategies—ifarmwell. It was considered an accessible and confidential source of practical and relevant farmer-focused self-help strategies. These strategies were delivered via 5 interactive modules that include written, drawn, and audio- and video-based psychoeducation and exercises, as well as farming-related jokes, metaphors, examples, and imagery. Module 1 included distress screening and information on how to speak to general practitioners about mental health–related concerns (including a personalized conversation script). Modules were completed fortnightly. SMS text messages offered personalized support and reminders. Qualitative interviews and star ratings demonstrated high module acceptability (average 4.06/5 rating) and suggested that additional reminders, higher quality audio recordings, and shorter modules would be useful. Approximately 37.1% (52/140) of users who started module 1 completed all modules, with too busy or not got to it yet being the main reason for non-completion, and previous module acceptability not predicting subsequent module completion. Conclusions Sequential integration of research evidence, expert knowledge, and farmers’ preferences in the co-design process allowed for the development of a self-help intervention that focused on important intervention targets and was acceptable to this difficult-to-engage group. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12617000506392;

2022 ◽  
Thomas Laumon ◽  
Elie Courvalin ◽  
Geoffrey Dagod ◽  
Pauline Deras ◽  
Mehdi Girard ◽  

Abstract Background: Optimal decarboxylation dose under extracorporeal respiratory support to ensure sufficient reduction of mechanical ventilation stress remains unclear and understudied. The aim of this study was to assess the interdependence of blood flow (BF) and gas flow (GF) in predicting CO2 removal and mechanical ventilation reduction (MVR) under extracorporeal respiratory support. Methods: All patients who benefited from veno-venous ECMO (HLS-maquet 7.0, 1.8 m²) and high-flow ECCO2R (HLS-maquet 5.0, 1.3 m²) in our intensive care unit over a period of 18 months were included. CO2 removal was calculated from inlet/outlet blood gases performed in clinical practice during the first 7 days of oxygenator use. The relationship between the BF × GF product and CO2 removal or MVR was studied using linear regression models. Results: Eighteen patients were analysed, corresponding to 24 oxygenators and 261 datasets. CO2 removal was 393 mL/min (IQR, 310–526 mL/min) for 1.8 m2 oxygenators and 179 mL/min (IQR, 165–235 mL/min) for 1.3 m2 oxygenators. The decarboxylation index was associated linearly with CO2 removal (R2 = 0.62 and R2 = 0.77 for the two oxygenators, respectively) and MVR (R2 = 0.72 and R2 = 0.62, respectively). Values in the range 20−30L2/min2 were associated with an MVR ratio between 38% and 58% for 1.8 m2 oxygenators, and between 37% and 55% for 1.3 m2 oxygenators. Conclusion: The decarboxylation index is a simple parameter to predict CO2 removal and MVR under extracorporeal respiratory support. A BF of 2 L2/min2 or more may be necessary to obtain a significant reduction of mechanical convection.Trial Registration: Being a retrospective study, no trial registration was made.

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