Does Adopting Western Low-density Lipoprotein Cholesterol Targets Expose Indians to a Higher Risk of Cardiovascular Events? Expert Opinion From the Lipid Association of India.

Adverse cardiovascular (CV) events have declined in Western countries due at least in part to aggressive risk factor control, including dyslipidemia management. The American and European (Western) dyslipidemia treatment guidelines have contributed significantly to the reduction in atherosclerotic cardiovascular disease (ASCVD) incidence in the respective populations. However, their direct extrapolation to Indian patients does not seem appropriate for the reasons described below. In the US, mean low-density lipoprotein cholesterol (LDL-C) levels have markedly declined over the last 2 decades, correlating with a proportional reduction in CV events. Conversely, poor risk factor control and dyslipidemia management have led to increased CV and coronary artery disease (CAD) mortality rates in India. The population-attributable risk of dyslipidemia is about 50% for myocardial infarction, signifying its major role in CV events. In addition, the pattern of dyslipidemia in Indians differs considerably from that in Western populations, requiring unique strategies for lipid management in Indians and modified treatment targets. The Lipid Association of India (LAI) recognized the need for tailored LDL-C targets for Indians and recommended lower targets compared to Western guidelines. For individuals with established ASCVD or diabetes with additional risk factors, an LDL-C target of <50 mg/dL was recommended, with an optional target of ≤30 mg/dL for individuals at extremely high risk. There are several reasons that necessitate these lower targets. In Indian subjects, CAD develops 10 years earlier than in Western populations and is more malignant. Additionally, Indians experience higher CAD mortality despite having lower basal LDL-C levels, requiring greater LDL-C reduction to achieve a comparable CV event reduction. The Indian Council for Medical Research-India Diabetes study described a high prevalence of dyslipidemia among Indians, characterized by relatively lower LDL-C levels, higher triglyceride levels, and lower high-density lipoprotein cholesterol (HDL-C) levels compared to Western populations. About 30% of Indians have hypertriglyceridemia, aggravating ASCVD risk and complicating dyslipidemia management. The levels of atherogenic triglyceride-rich lipoproteins, including remnant lipoproteins, are increased in hypertriglyceridemia and are predictive of CV events. Hypertriglyceridemia is also associated with higher levels of small, dense LDL particles, which are more atherogenic, and higher levels of apolipoprotein B (Apo B), reflecting a higher burden of circulating atherogenic lipoprotein particles. A high prevalence of low HDL-C, which is often dysfunctional, and elevated lipoprotein(a) [Lp(a)] levels further contribute to the heightened atherogenicity and premature CAD in Indians. Considering the unique characteristics of atherogenic dyslipidemia in Indians, lower LDL-C, non-HDL-C, and Apo B goals compared to Western guidelines are required for effective control of ASCVD risk in Indians. South Asian ancestry is identified as a risk enhancer in the American lipid management guidelines, highlighting the elevated ASCVD risk of Indian and other South Asian individuals, suggesting a need for more aggressive LDL-C lowering in such individuals. Hence, the LDL-C goals recommended by the Western guidelines may be excessively high for Indians and could result in significant residual ASCVD risk attributable to inadequate LDL-C lowering. Further, the results of Mendelian randomization studies have shown that lowering LDL-C by 5-10 mg/dL reduces CV risk by 8-18%. The lower LDL-C targets proposed by LAI can yield these incremental benefits. In conclusion, Western LDL-C targets may not be suitable for Indian subjects, given the earlier presentation of ASCVD at lower LDL-C levels. They may result in greater CV events that could otherwise be prevented with lower LDL-C targets. The atherogenic dyslipidemia in Indian individuals necessitates more aggressive LDL-C and non-HDL-C lowering, as recommended by the LAI, in order to stem the epidemic of ASCVD in India.

Protocol: Assessing the impact of interest-holder engagement on guideline development: A systematic review.

This is the protocol for a Campbell systematic review. The objectives are as follows. The objective of this review is to identify and synthesize empirical research on the impacts of interest-holder engagement on the guideline development process and content. Our research questions are as follows: (1) What are the empirical examples of impact on the process in health guideline development across any of the 18 steps of the GIN-McMaster checklist? (2) What are the empirical examples of impact on the content in health guideline development across any of the 18 steps of the GIN-McMaster checklist?

Research Coproduction: An Underused Pathway to Impact.

Knowledge translation and implementation science have made many advances in the last two decades. However, research is still not making expedient differences to practice, policy, and service delivery. It is time to evolve our approach to knowledge production and implementation. In this editorial we advance research coproduction as a neglected pathway to impact. Our starting point is that research impact is a function of how research is done and who is involved, arguing that researchers and non-researchers have an equal voice and role to play. We outline principles of coproduction including sharing power, valuing different sources of knowledge and viewpoints, equality, open communication, inclusivity, and mutuality. We consider implications at micro, meso, and macro system levels. In calling for this shift in the way knowledge is produced and applied, we anticipate it leading to inclusive research that more rapidly translates to better, more equitable health and care for all.

Planning for implementation success: insights from conducting an implementation needs assessment.

AIM: The aim of this paper is to provide insights into conducting an implementation needs assessment using a case example in a less-research-intensive setting. DESIGN AND METHODS: In the case example, an implementation needs assessment was conducted, including1 an environmental scan of the organization's website and preliminary discussions with key informants to learn about the implementation context, and2 a formal analysis of the evidence-practice gap (use of sedation interruptions) deploying a chart audit methodology using legal electronic reports. RESULTS: Our needs assessment was conducted over 5 months and demonstrated how environmental scans reveal valuable information that can inform the evidence-practice gap analysis. A well-designed gap analysis, using suitable indicators of best practice, can reveal compliance rates with local protocol recommendations, even with a small sample size. In our case, compliance with the prescribed practices for sedation interruptions ranged from 65% (n=53) to as high as 84% (n=69). CONCLUSIONS: Implementation needs assessments provide valuable information that can inform implementation planning. Such assessments should include an environmental scan to understand the local context and identify both current recommended best practices and local best practices for the intervention of interest. When addressing an evidence-practice gap, analyses should quantify the difference between local practice and desired best practice. IMPACT: The insights gained from the case example presented in this paper are likely transferrable to implementation research or studies conducted in similar, less-research-intensive settings. SPANISH ABSTRACT: http://links.lww.com/IJEBH/A257.

Revisiting sustainable resources in the combustion products of alumina-rich coal: Critical metal (Li, Ga, Nb, and REY) potential of ash from the Togtoh Power Plant, Inner Mongolia, China.

Coal fly ash has gained much attention as a potential alternative source for extracting critical metals such as Li, Ga, Nb, and lanthanides and yttrium (REY). This study investigates their distribution characteristics and modes of occurrence in alumina-rich fly ashes from the Togtoh Power Plant in Inner Mongolia, using various analytical methods. The objective was to provide a reference for the pre-enrichment of critical metals in fly ash. Lithium is primarily present in the glass phase, and its concentration is extremely low in the crystalline phases. Lithium is mainly concentrated in "pure" aluminosilicate glass, and is present but at a low level in Ca-rich aluminosilicate glass. Gallium is primarily present in the glass phase and in corundum, while Nb mainly exists in submicron zircon particles surrounded by Si-Al-Ca glass. Lanthanides and yttrium primarily occur in the glass phase and in crystalline phases, including an intermediate phase composed of the three end-member minerals of the gorceixite-crandallite-florencite series, as well as in monazite, crystalline forms of iron oxides and REY oxides. The Li concentrations in the alumina-rich fly ashes range from 562 to 894 µg/g for Li2O, from 43.9 to 81.9 µg/g for Ga, from 58.7 to 70.6 µg/g for Nb2O5, and from 258 to 450 µg/g for REY oxides, respectively, indicating their substantial potential for resource recovery. Especially, the 2nd row fly ash has the highest contents of these metals, allowing for direct extraction without the necessity for complex pre-processing. Physical separation can further enrich Li, Ga, Nb, and REY in the fly ash. In particular, particle size separation enriches these elements in the < 20 µm size range and magnetic separation enriches Li, Ga, Nb, and REY (except Ce) in the non-magnetic fraction. However, Ce is significantly enriched in the magnetic fraction compared to the original fly ash.

A Global Perspective on Cardiovascular Risk Factors by Educational Level in CHD Patients: SURF CHD II.

Background: Clinical guidelines recommend lifestyle modifications and medication use to control cardiovascular risk factors in coronary heart disease (CHD) patients. However, risk factor control remains challenging especially in patients with lower educational level. Objective: To assess inequalities by educational level in the secondary prevention of CHD in the Survey of Risk Factors in Coronary Heart Disease (SURF CHD II). Methods: SURF CHD II is a cross-sectional clinical audit on secondary prevention of CHD, conducted during routine clinical visits in 29 countries. The easy-to-perform design of the survey facilitates its implementation in settings with limited resources. We reported risk factor recording, attainment of guideline-defined risk factor targets, and treatment in CHD patients. Differences by educational level in target attainment and treatment were assessed with logistic regression stratified for high- (HIC), upper middle- (UMIC), and lower middle-income (LMIC) countries. Results: SURF CHD II included 13,884 patients from 2019 to 2022, of which 25.0% were female and 18.6% had achieved only primary school level. Risk factor recording ranged from 22.2% for waist circumference to 95.6% for smoking status, and target attainment from 15.9% for waist circumference to 78.7% for smoking. Most patients used cardioprotective medications and 50.5% attended cardiac rehabilitation.Patients with secondary or tertiary education were more likely to meet targets for smoking, LDL cholesterol and physical activity in HICs and LMICs; for physical activity and triglycerides in UMICs; but less likely to meet targets for blood pressure in HICs and LDL <1.4mmol/L in UMICs. Higher education was positively associated with medication use and cardiac rehabilitation participation. Conclusion: CHD patients generally have poor attainment of risk factor targets, but patients with a higher educational level are generally more likely to participate in cardiac rehabilitation, use medication, and meet targets. Main messages: Target attainment and participation in cardiac rehabilitation are poor in CHD patients globally.Patients with higher education are more likely to meet risk factor targets, showing health inequities in secondary prevention of CHD.The association between education and risk factor target attainment and treatment varies with country income level.

What to Measure in Aneurysmal Subarachnoid Haemorrhage Research-An International Delphi Survey.

Aneurysmal subarachnoid haemorrhage (aSAH) is a devastating condition with high mortality and morbidity. The outcome measures used in aSAH clinical research vary making it challenging to compare and combine different studies. Additionally, there may be a mismatch between the outcomes prioritized by patients, caregivers, and health care providers and those selected by researchers. We conducted an international, online, multiple round Delphi study to develop consensus on domains (where a domain is a health concept or aspect) prioritized by key stakeholders including those with lived experience of aSAH, health care providers, and researchers, funders, or industry professionals. One hundred seventy-five people participated in the survey, 59% of whom had lived experience of aSAH. Over three rounds, 32 domains reached the consensus threshold pre-defined as 70% of participants rating the domain as being critically important. During the fourth round, participants ranked the importance of each of these 32 domains. The top ten domains ranked highest to lowest were (1) Cognition and executive function, (2) Aneurysm obliteration, (3) Cerebral infarction, (4) Functional outcomes including ability to walk, (5) Delayed cerebral ischemia, (6) The overall quality of life as reported by the SAH survivor, (7) Changes to emotions or mood (including depression), (8) The basic activities of daily living, (9) Vasospasm, and (10) ICU complications. Our findings confirm that there is a mismatch between domains prioritized by stakeholders and outcomes used in clinical research. Our future work aims to address this mismatch through the development of a core outcome set in aSAH research.

Morphology, repulsion, and ordering of red blood cells in viscoelastic flows under confinement.

Red blood cells (RBC), the primary carriers of oxygen in the body, play a crucial role across several biomedical applications, while also being an essential model system of a deformable object in the microfluidics and soft matter fields. However, RBC behavior in viscoelastic liquids, which holds promise in enhancing microfluidic diagnostic applications, remains poorly studied. We here show that using viscoelastic polymer solutions as a suspending carrier causes changes in the clustering and shape of flowing RBC in microfluidic flows when compared to a standard Newtonian suspending liquid. Additionally, when the local RBC concentration increases to a point where hydrodynamic interactions take place, we observe the formation of equally-spaced RBC structures, resembling the viscoelasticity-driven ordered particles observed previously in the literature, thus providing the first experimental evidence of viscoelasticity-driven cell ordering. The observed RBC ordering, unaffected by polymer molecular architecture, persists as long as the surrounding medium exhibits shear-thinning, viscoelastic properties. Complementary numerical simulations reveal that viscoelasticity-induced repulsion between RBCs leads to equidistant structures, with shear-thinning modulating this effect. Our results open the way for the development of new biomedical technologies based on the use of viscoelastic liquids while also clarifying fundamental aspects related to multibody hydrodynamic interactions in viscoelastic microfluidic flows.

Interventions that have potential to help older adults living with social frailty: a systematic scoping review.

BACKGROUND: The impact of social frailty on older adults is profound including mortality risk, functional decline, falls, and disability. However, effective strategies that respond to the needs of socially frail older adults are lacking and few studies have unpacked how social determinants operate or how interventions can be adapted during periods requiring social distancing and isolation such as the COVID-19 pandemic. To address these gaps, we conducted a scoping review using JBI methodology to identify interventions that have the best potential to help socially frail older adults (age ≥65 years). METHODS: We searched MEDLINE, CINAHL (EPSCO), EMBASE and COVID-19 databases and the grey literature. Eligibility criteria were developed using the PICOS framework. Our results were summarized descriptively according to study, patient, intervention and outcome characteristics. Data synthesis involved charting and categorizing identified interventions using a social frailty framework.  RESULTS: Of 263 included studies, we identified 495 interventions involving ~124,498 older adults who were mostly female. The largest proportion of older adults (40.5%) had a mean age range of 70-79 years. The 495 interventions were spread across four social frailty domains: social resource (40%), self-management (32%), social behavioural activity (28%), and general resource (0.4%). Of these, 189 interventions were effective for improving loneliness, social and health and wellbeing outcomes across psychological self-management, self-management education, leisure activity, physical activity, Information Communication Technology and socially assistive robot interventions. Sixty-three interventions were identified as feasible to be adapted during infectious disease outbreaks (e.g., COVID-19, flu) to help socially frail older adults. CONCLUSIONS: Our scoping review identified promising interventions with the best potential to help older adults living with social frailty.

Co-production of a systematic review on decision coaching: a mixed methods case study within a review.

BACKGROUND: Co-production is a collaborative approach to prepare, plan, conduct, and apply research with those who will use or be impacted by research (knowledge users). Our team of knowledge users and researchers sought to conduct and evaluate co-production of a systematic review on decision coaching. METHODS: We conducted a mixed-methods case study within a review to describe team co-production of a systematic review. We used the Collaborative Research Framework to support an integrated knowledge translation approach to guide a team through the steps in co-production of a systematic review. The team agreed to conduct self-study as a study within a review to learn from belonging to a co-production research team. A core group that includes a patient partner developed and conducted the study within a review. Data sources were surveys and documents. The study coordinator administered surveys to determine participant preferred and actual levels of engagement, experiences, and perceptions. We included frequency counts, content, and document analysis. RESULTS: We describe co-production of a systematic review. Of 17 team members, 14 (82%) agreed to study participation and of those 12 (86%) provided data pre- and post-systematic review. Most participants identified as women (n = 9, 75.0%), researchers (n = 7, 58%), trainees (n = 4, 33%), and/or clinicians (n = 2, 17%) with two patient/caregiver partners (17%). The team self-organized study governance with an executive and Steering Committee and agreed on research co-production actions and strategies. Satisfaction for engagement in the 11 systematic review steps ranged from 75 to 92%, with one participant who did not respond to any of the questions (8%) for all. Participants reported positive experiences with team communication processes (n = 12, 100%), collaboration (n = 12, 100%), and negotiation (n = 10-12, 83-100%). Participants perceived the systematic review as co-produced (n = 12, 100%) with collaborative (n = 8, 67%) and engagement activities to characterize co-production (n = 8, 67%). Participants indicated that they would not change the co-production approach (n = 8, 66%). Five participants (42%) reported team logistics challenges and four (33%) were unaware of challenges. CONCLUSIONS: Our results indicate that it is feasible to use an integrated knowledge translation approach to conduct a systematic review. We demonstrate the importance of a relational approach to research co-production, and that it is essential to plan and actively support team engagement in the research lifecycle.

Development of a training program prototype to enhance implementation leadership competencies and behaviours of Chinese unit nurse managers: a qualitative descriptive study.

BACKGROUND: Unit nurse managers hold essential positions that can facilitate implementation of evidence-based practice. Studies showed that nurse managers in China lacked competencies and behaviours necessary to lead evidence-based practice implementation. The aim of the current study was to develop a context-fit training program prototype to enhance leadership competencies and behaviours regarding evidence-based practice implementation of Chinese unit nurse managers. METHOD: We used a descriptive qualitative study design and followed the integrated knowledge translation approach to co-develop the prototype in a tertiary hospital in Changsha, China. Seven nurse managers from the participated hospital and a researcher co-developed the prototype based on the Ottawa Model of Implementation Leadership (O-MILe). The development process encompassed four phases from November 2021 to March 2022 that involved group discussions (n = 4) and individual interviews (n = 21). All data were analysed by two independent researchers using the thematic analysis method. RESULTS: Managers agreed that all O-MILe behaviours were important to evidence-based practice implementation, and only minor modifications were needed for clarification and adaptation. The actions managers identified that could operationalize the leadership behaviours were related to current clinical practices, evidence-based practice, nurses, patients, interprofessional staff members, incentives and resources, organization and external entities. Three types of general competencies related to evidence-based practice, professional nursing, and implementation leadership were identified. Multimodal activities such as lectures, experience sharing, group discussions, plan development and coaching were suggested to deliver the training program. CONCLUSIONS: All O-MILe leadership behaviours were perceived as essential for unit nurse managers to lead EBP implementation in the hospital context in China. We identified the leadership actions and the competencies required for nursing managers to implement EBP in China. Further studies are required to evaluate the acceptability and impact of this prototype. Further studies with large sample sizes across various clinical settings are needed to facilitate the generalization of the findings and gain an in-depth understanding of the program.

International Variations in Surgical Quality of Care in Men With Prostate Cancer: Results From the TrueNTH Global Registry.

PURPOSE: Functional problems such as incontinence and sexual dysfunction after radical prostatectomy (RP) are important outcomes to evaluate surgical quality in prostate cancer (PC) care. Differences in survival after RP between countries are known, but differences in functional outcomes after RP between providers from different countries are not well described. METHODS: Data from a multinational database of patients with PC (nonmetastatic, treated by RP) who answered the EPIC-26 questionnaire at baseline (before RP, T0) and 1 year after RP (T1) were used, linking survey data to clinical information. Casemix-adjusted incontinence and sexual function scores (T1) were calculated for each country and provider on the basis of regression models and then compared using minimally important differences (MIDs). RESULTS: A total of 21,922 patients treated by 151 providers from 10 countries were included. For the EPIC-26 incontinence domain, the median adjusted T1 score of countries was 76, with one country performing more than one MID (for incontinence: 6) worse than the median. Eighteen percent of the variance (R2) of incontinence scores was explained by the country of the providers. The median adjusted T1 score of sexual function was 33 with no country performing perceivably worse than the median (more than one MID worse), and 34% (R2) of the variance of the providers' scores could be explained by country. CONCLUSION: To our knowledge, this is the first comparison of functional outcomes 1 year after surgical treatment of patients with PC between different countries. Country is a relevant predictor for providers' incontinence and sexual function scores. Although the results are limited because of small samples from some countries, they should be used to enhance cross-country initiatives on quality improvement in PC care.

Economic Evaluations of Chimeric Antigen Receptor T-Cell Therapies for Hematologic and Solid Malignancies: A Systematic Review.

OBJECTIVES: This study aimed to systematically review evidence on the cost-effectiveness of chimeric antigen receptor T-cell (CAR-T) therapies for patients with cancer. METHODS: Electronic databases were searched in October 2022 and updated in September 2023. Systematic reviews, health technology assessments, and economic evaluations that compared costs and effects of CAR-T therapy in patients with cancer were included. Two reviewers independently screened studies, extracted data, synthesized results, and critically appraised studies using the Philips checklist. Cost data were presented in 2022 US dollars. RESULTS: Our search yielded 1809 records, 47 of which were included. Most of included studies were cost-utility analysis, published between 2018 and 2023, and conducted in the United States. Tisagenlecleucel, axicabtagene ciloleucel, idecabtagene vicleucel, ciltacabtagene autoleucel, lisocabtagene maraleucel, brexucabtagene autoleucel, and relmacabtagene autoleucel were compared with various standard of care chemotherapies. The incremental cost-effectiveness ratio (ICER) for CAR-T therapies ranged from $9424 to $4 124 105 per quality-adjusted life-year (QALY) in adults and from $20 784 to $243 177 per QALY in pediatric patients. Incremental cost-effectiveness ratios were found to improve over longer time horizons or when an earlier cure point was assumed. Most studies failed to meet the Philips checklist due to a lack of head-to-head comparisons and uncertainty surrounding CAR-T costs and curative effects. CONCLUSIONS: CAR-T therapies were more expensive and generated more QALYs than comparators, but their cost-effectiveness was uncertain and dependent on patient population, cancer type, and model assumptions. This highlights the need for more nuanced economic evaluations and continued research to better understand the value of CAR-T therapies in diverse patient populations.

Interventions on gender equity in the workplace: a scoping review.

BACKGROUND: Various studies have demonstrated gender disparities in workplace settings and the need for further intervention. This study identifies and examines evidence from randomized controlled trials (RCTs) on interventions examining gender equity in workplace or volunteer settings. An additional aim was to determine whether interventions considered intersection of gender and other variables, including PROGRESS-Plus equity variables (e.g., race/ethnicity). METHODS: Scoping review conducted using the JBI guide. Literature was searched in MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, ERIC, Index to Legal Periodicals and Books, PAIS Index, Policy Index File, and the Canadian Business & Current Affairs Database from inception to May 9, 2022, with an updated search on October 17, 2022. Results were reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension to scoping reviews (PRISMA-ScR), Sex and Gender Equity in Research (SAGER) guidance, Strengthening the Integration of Intersectionality Theory in Health Inequality Analysis (SIITHIA) checklist, and Guidance for Reporting Involvement of Patients and the Public (GRIPP) version 2 checklist. All employment or volunteer sectors settings were included. Included interventions were designed to promote workplace gender equity that targeted: (a) individuals, (b) organizations, or (c) systems. Any comparator was eligible. Outcomes measures included any gender equity related outcome, whether it was measuring intervention effectiveness (as defined by included studies) or implementation. Data analyses were descriptive in nature. As recommended in the JBI guide to scoping reviews, only high-level content analysis was conducted to categorize the interventions, which were reported using a previously published framework. RESULTS: We screened 8855 citations, 803 grey literature sources, and 663 full-text articles, resulting in 24 unique RCTs and one companion report that met inclusion criteria. Most studies (91.7%) failed to report how they established sex or gender. Twenty-three of 24 (95.8%) studies reported at least one PROGRESS-Plus variable: typically sex or gender or occupation. Two RCTs (8.3%) identified a non-binary gender identity. None of the RCTs reported on relationships between gender and other characteristics (e.g., disability, age, etc.). We identified 24 gender equity promoting interventions in the workplace that were evaluated and categorized into one or more of the following themes: (i) quantifying gender impacts; (ii) behavioural or systemic changes; (iii) career flexibility; (iv) increased visibility, recognition, and representation; (v) creating opportunities for development, mentorship, and sponsorship; and (vi) financial support. Of these interventions, 20/24 (83.3%) had positive conclusion statements for their primary outcomes (e.g., improved academic productivity, increased self-esteem) across heterogeneous outcomes. CONCLUSIONS: There is a paucity of literature on interventions to promote workplace gender equity. While some interventions elicited positive conclusions across a variety of outcomes, standardized outcome measures considering specific contexts and cultures are required. Few PROGRESS-Plus items were reported. Non-binary gender identities and issues related to intersectionality were not adequately considered. Future research should provide consistent and contemporary definitions of gender and sex. TRIAL REGISTRATION: Open Science Framework https://osf.io/x8yae .

Describing the content of trial recruitment interventions using the TIDieR reporting checklist: a systematic methodology review.

BACKGROUND: Recruiting participants to clinical trials is an ongoing challenge, and relatively little is known about what recruitment strategies lead to better recruitment. Recruitment interventions can be considered complex interventions, often involving multiple components, targeting a variety of groups, and tailoring to different groups. We used the Template for Intervention Description and Replication (TIDieR) reporting checklist (which comprises 12 items recommended for reporting complex interventions) to guide the assessment of how recruitment interventions are described. We aimed to (1) examine to what extent we could identify information about each TIDieR item within recruitment intervention studies, and (2) observe additional detail for each item to describe useful variation among these studies. METHODS: We identified randomized, nested recruitment intervention studies providing recruitment or willingness to participate rates from two sources: a Cochrane review of trials evaluating strategies to improve recruitment to randomized trials, and the Online Resource for Research in Clinical triAls database. First, we assessed to what extent authors reported information about each TIDieR item. Second, we developed descriptive categorical variables for 7 TIDieR items and extracting relevant quotes for the other 5 items. RESULTS: We assessed 122 recruitment intervention studies. We were able to extract information relevant to most TIDieR items (e.g., brief rationale, materials, procedure) with the exception of a few items that were only rarely reported (e.g., tailoring, modifications, planned/actual fidelity). The descriptive variables provided a useful overview of study characteristics, with most studies using various forms of informational interventions (55%) delivered at a single time point (90%), often by a member of the research team (59%) in a clinical care setting (41%). CONCLUSIONS: Our TIDieR-based variables provide a useful description of the core elements of complex trial recruitment interventions. Recruitment intervention studies report core elements of complex interventions variably; some process elements (e.g., mode of delivery, location) are almost always described, while others (e.g., duration, fidelity) are reported infrequently, with little indication of a reason for their absence. Future research should explore whether these TIDieR-based variables can form the basis of an approach to better reporting of elements of successful recruitment interventions.

Evidence for clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications among adults with peripheral artery disease: protocol for a systematic review and meta-analysis.

INTRODUCTION: International guidelines recommend that adults with peripheral artery disease (PAD) be prescribed antiplatelet, statin and antihypertensive medications. However, it is unclear how often people with PAD are underprescribed these drugs, which characteristics predict clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications, and whether underprescription and non-adherence are associated with adverse health and health system outcomes. METHODS AND ANALYSIS: We will search MEDLINE, EMBASE and Evidence-Based Medicine Reviews from 2006 onwards. Two investigators will independently review abstracts and full-text studies. We will include studies that enrolled adults and reported the incidence and/or prevalence of clinician underprescription of or patient non-adherence to guideline-recommended cardiovascular medications among people with PAD; adjusted risk factors for underprescription of/non-adherence to these medications; and adjusted associations between underprescription/non-adherence to these medications and outcomes. Outcomes will include mortality, major adverse cardiac and limb events (including revascularisation procedures and amputations), other reported morbidities, healthcare resource use and costs. Two investigators will independently extract data and evaluate study risk of bias. We will calculate summary estimates of the incidence and prevalence of clinician underprescription/patient non-adherence across studies. We will also conduct subgroup meta-analyses and meta-regression to determine if estimates vary by country, characteristics of the patients and treating clinicians, population-based versus non-population-based design, and study risks of bias. Finally, we will calculate pooled adjusted risk factors for underprescription/non-adherence and adjusted associations between underprescription/non-adherence and outcomes. We will use Grading of Recommendations, Assessment, Development and Evaluation to determine estimate certainty. ETHICS AND DISSEMINATION: Ethics approval is not required as we are studying published data. This systematic review will synthesise existing evidence regarding clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications in adults with PAD. Results will be used to identify evidence-care gaps and inform where interventions may be required to improve clinician prescribing and patient adherence to prescribed medications. PROSPERO REGISTRATION NUMBER: CRD42022362801.