Human papillomavirus vaccination 2020 guideline update: American Cancer Society guideline adaptation.

The American Cancer Society (ACS) presents an adaptation of the current Advisory Committee on Immunization Practices recommendations for human papillomavirus (HPV) vaccination. The ACS recommends routine HPV vaccination between ages 9 and 12 years to achieve higher on-time vaccination rates, which will lead to increased numbers of cancers prevented. Health care providers are encouraged to start offering the HPV vaccine series at age 9 or 10 years. Catch-up HPV vaccination is recommended for all persons through age 26 years who are not adequately vaccinated. Providers should inform individuals aged 22 to 26 years who have not been previously vaccinated or who have not completed the series that vaccination at older ages is less effective in lowering cancer risk. Catch-up HPV vaccination is not recommended for adults aged older than 26 years. The ACS does not endorse the 2019 Advisory Committee on Immunization Practices recommendation for shared clinical decision making for some adults aged 27 through 45 years who are not adequately vaccinated because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision making on patients and clinicians, and the lack of sufficient guidance on the selection of individuals who might benefit.

Mailed fecal immunochemical test outreach for colorectal cancer screening: Summary of a Centers for Disease Control and Prevention-sponsored Summit.

Uptake of colorectal cancer screening remains suboptimal. Mailed fecal immunochemical testing (FIT) offers promise for increasing screening rates, but optimal strategies for implementation have not been well synthesized. In June 2019, the Centers for Disease Control and Prevention convened a meeting of subject matter experts and stakeholders to answer key questions regarding mailed FIT implementation in the United States. Points of agreement included: 1) primers, such as texts, telephone calls, and printed mailings before mailed FIT, appear to contribute to effectiveness; 2) invitation letters should be brief and easy to read, and the signatory should be tailored based on setting; 3) instructions for FIT completion should be simple and address challenges that may lead to failed laboratory processing, such as notation of collection date; 4) reminders delivered to initial noncompleters should be used to increase the FIT return rate; 5) data infrastructure should identify eligible patients and track each step in the outreach process, from primer delivery through abnormal FIT follow-up; 6) protocols and procedures such as navigation should be in place to promote colonoscopy after abnormal FIT; 7) a high-quality, 1-sample FIT should be used; 8) sustainability requires a program champion and organizational support for the work, including sufficient funding and external policies (such as quality reporting requirements) to drive commitment to program investment; and 9) the cost effectiveness of mailed FIT has been established. Participants concluded that mailed FIT is an effective and efficient strategy with great potential for increasing colorectal cancer screening in diverse health care settings if more widely implemented.

Retrospective genetic testing (Traceback) in women with early-onset breast cancer after revised national guidelines: a clinical implementation study.

PURPOSE: This study focused on identifying a hereditary predisposition in women previously diagnosed with early-onset breast cancer through a retrospective outreach activity (Traceback). The objectives were to evaluate the possible clinical implementation of a simplified Traceback strategy and to identify carriers of pathogenic variants among previously untested women. METHODS: Three hundred and fifteen Traceback-eligible women diagnosed with breast cancer at 36-40 years in Southern Sweden between 2000 and 2019 were identified and offered an analysis of the genes ATM, BARD1, BRCA1, BRCA2, CHEK2, PALB2, RAD51C, and RAD51D through a standardized letter. Women who chose to participate were asked about their experiences through a questionnaire. The workload for the study personnel was measured and recorded. RESULTS: One hundred and seventy-six women underwent genetic testing and pathogenic variants were identified in 9.7%: ATM (n = 6), BARD1 (n = 1), BRCA1 (n = 3), CHEK2 (n = 5), and PALB2 (n = 2). Women with normal test results were informed through a standardized letter. Carriers of pathogenic variants were contacted by telephone and offered in-person genetic counseling. One hundred and thirty-four women returned the subsequent questionnaire. Most study participants were satisfied with both written pre- and post-test information and many expressed their gratitude. The extra workload as compared to routine clinical genetic counseling was modest (8 min per patient). CONCLUSION: The insights from the participants' perspectives and sentiments throughout the process support the notion that the Traceback procedure is a safe and an appreciated complement to routine genetic counseling. The genetic yield of almost 10% also suggests that the associated extra workload for genetic counselors could be viewed as acceptable in clinical implementation scenarios.

The Collaborative Service Design Playbook to plan, design, and implement sustainable health services for impact.

This paper sets out the Collaborative Service Design Playbook, to guide planning, design, and implementation of co-created health services. Successful health service development and implementation is best guided by theoretically informed approaches; however, organisations often lack design and implementation know-how and have difficulty applying it. This study seeks to improve health service design and potential for scale-up by proposing a tool to guide an end-to-end process, drawing together service design, co-design, and implementation science; and exploring the tool's feasibility to establish a sustainable service solution developed with participants and experts that is scalable and sustainable. The Collaborative Service Design Playbook phases include, (1) Define the opportunity and initiatives, (2) Design the concept and prototype, (3) Deliver to scale and evaluate; and (4) Optimise to transform and sustain. This paper has implications for health marketing through providing an end-to-end approach with phased guidance for health service development, implementation, and scale up.

On-the-Go Adaptation of Implementation Approaches and Strategies in Health: Emerging Perspectives and Research Opportunities.

In many cases, implementation approaches (composed of one or more strategies) may need to change over time to work optimally. We use a literature review to inform a mechanistic analysis of such on-the-go adaptations. We suggest that such adaptations of implementation strategies consist of three necessary steps. The first component is the initial effect of the implementation approach on intended implementation, service delivery, or clinical outcomes. Second, these initial effects must in turn be used to modify, alter, intensify, or otherwise change the implementation approach. Third, the modified approach itself has effects. Conceiving of adaptation as all three steps implies that a full understanding of adaptation involves (a) a sense of initial effects, (b) conceptualizing and documenting content and rationale for changes in approach (e.g., alteration, intensification), and (c) the effects of the changed approach (including how the latter effects depend on initial effects). Conceptualizing these steps can help researchers ask questions about adaptation (e.g., thresholds for change, dosing, potentiation, sequencing) to advance our understanding of implementation strategies.

Healthy eating and active living policy, systems, and environmental changes in rural Louisiana: a contextual inquiry to inform implementation strategies.

BACKGROUND: Healthy eating and active living policy, systems, and environmental (PSE) changes are implemented across the United States through Cooperative Extension. However, translating multisector PSE changes to practice in community settings is challenging and there is a lack of knowledge about barriers and facilitators to PSE changes among state Extension systems using standardized frameworks. Therefore, a research-to-practice partnership effort aimed to identify Louisiana Cooperative Extension Service Family and Consumer Science (LFCS) practitioners' barriers and facilitators to implementing PSE changes in rural Louisiana communities. METHODS: A qualitative approach using the 2022 Consolidated Framework for Implementation Research (2022 CFIR) was used. Focus group discussions were conducted at five LFCS regional trainings between February and May 2022. All LFCS practitioners with any level of experience implementing healthy eating and active living PSE changes were eligible to participate, with emphasis on understanding efforts within more rural communities. Focus group discussions were audio-recorded and transcribed verbatim. Researchers analyzed qualitative data using the constant comparison method and 2022 CFIR domains and constructs including Inner Setting (LFCS organization), Outer Setting (rural Louisiana communities), Innovation (PSE changes), and Individuals (PSE change implementation actors/partners). RESULTS: Across the five regions, LFCS practitioners (n = 40) described more barriers (n = 210) than facilitators (n = 100); findings were often coded with multiple 2022 CFIR domains. Reported Inner Setting barriers were lack of formal or informal information sharing and lack of access to knowledge and information. Outer Setting barriers included sustaining and initiating community partnerships and local environmental or political conditions. Individual barriers included a lack of time and expertise, and Innovation barriers included the complex nature of rural PSE changes. Facilitators were mentioned at multiple levels and included community partner buy-in and practitioners' motivation to implement PSE changes. CONCLUSIONS: Implementation strategies are needed to build on organizational strengths and to overcome multi-level barriers to PSE change implementation among LFCS practitioners. The results from the in-depth contextual inquiry used could serve as a guide for future pragmatic assessment efforts among other state Extension systems or as a model for identifying barriers and facilitators and associated implementation strategies among other public health systems in the U.S. and abroad.

Local public health projectification in practice: a qualitative study of facilitators and barriers to a public health plan implementation.

AIMS: To identify factors perceived by local government employees to affect the implementation of a municipal public health plan. METHODS: Qualitative individual interviews (n=13) were carried out. Participants were sampled from three districts in Oslo municipality, Norway, and asked about their experiences with an ongoing implementation of the Oslo Public Health Plan (2017-2020). The conceptual framework of public sector projectification - a growing reliance on project organisation of policies - informed the study. The consolidated framework for implementation research was used to aid data coding and subsequent thematic analysis. RESULTS: Implementation facilitators included factors perceived to support flexibility, including plan adaptability to the local setting, and factors perceived to enable structure and control during the implementation process, such as the articulation of specific goals and a shared understanding of public health work. Barriers were mainly related to complex aspects of the plan, such as the need to involve multiple stakeholders and levels of governance, and to tensions between the time-limited implementation process and the permanent organisational structures. CONCLUSIONS: This study has demonstrated how research-based methods can be used for the evaluation of a local community implementation process. It has identified implementation determinants using a predetermined taxonomy of operationally defined factors that are likely to influence implementation. However, while implementing a time-limited public health plan can be seen as 'taking action' in relation to multidimensional and complex problems, further research is needed to investigate whether plan implementation has a long-term impact on the surrounding organisation and, eventually, on public health outcomes.

iCHECK-DH: Guidelines and Checklist for the Reporting on Digital Health Implementations.

BACKGROUND: Implementation of digital health technologies has grown rapidly, but many remain limited to pilot studies due to challenges, such as a lack of evidence or barriers to implementation. Overcoming these challenges requires learning from previous implementations and systematically documenting implementation processes to better understand the real-world impact of a technology and identify effective strategies for future implementation. OBJECTIVE: A group of global experts, facilitated by the Geneva Digital Health Hub, developed the Guidelines and Checklist for the Reporting on Digital Health Implementations (iCHECK-DH, pronounced "I checked") to improve the completeness of reporting on digital health implementations. METHODS: A guideline development group was convened to define key considerations and criteria for reporting on digital health implementations. To ensure the practicality and effectiveness of the checklist, it was pilot-tested by applying it to several real-world digital health implementations, and adjustments were made based on the feedback received. The guiding principle for the development of iCHECK-DH was to identify the minimum set of information needed to comprehensively define a digital health implementation, to support the identification of key factors for success and failure, and to enable others to replicate it in different settings. RESULTS: The result was a 20-item checklist with detailed explanations and examples in this paper. The authors anticipate that widespread adoption will standardize the quality of reporting and, indirectly, improve implementation standards and best practices. CONCLUSIONS: Guidelines for reporting on digital health implementations are important to ensure the accuracy, completeness, and consistency of reported information. This allows for meaningful comparison and evaluation of results, transparency, and accountability and informs stakeholder decision-making. i-CHECK-DH facilitates standardization of the way information is collected and reported, improving systematic documentation and knowledge transfer that can lead to the development of more effective digital health interventions and better health outcomes.

Mechanism mapping to advance research on implementation strategies.

Elvin Hsing Geng and colleagues discuss mechanism mapping and its utility in conceptualizing and understanding how implementation strategies produce desired effects.

TRIDENT-2: National Implementation of Genome-wide Non-invasive Prenatal Testing as a First-Tier Screening Test in the Netherlands.

The Netherlands launched a nationwide implementation study on non-invasive prenatal testing (NIPT) as a first-tier test offered to all pregnant women. This started on April 1, 2017 as the TRIDENT-2 study, licensed by the Dutch Ministry of Health. In the first year, NIPT was performed in 73,239 pregnancies (42% of all pregnancies), 7,239 (4%) chose first-trimester combined testing, and 54% did not participate. The number of trisomies 21 (239, 0.33%), 18 (49, 0.07%), and 13 (55, 0.08%) found in this study is comparable to earlier studies, but the Positive Predictive Values (PPV)-96% for trisomy 21, 98% for trisomy 18, and 53% for trisomy 13-were higher than expected. Findings other than trisomy 21, 18, or 13 were reported on request of the pregnant women; 78% of women chose to have these reported. The number of additional findings was 207 (0.36%); these included other trisomies (101, 0.18%, PPV 6%, many of the remaining 94% of cases are likely confined placental mosaics and possibly clinically significant), structural chromosomal aberrations (95, 0.16%, PPV 32%,) and complex abnormal profiles indicative of maternal malignancies (11, 0.02%, PPV 64%). The implementation of genome-wide NIPT is under debate because the benefits of detecting other fetal chromosomal aberrations must be balanced against the risks of discordant positives, parental anxiety, and a potential increase in (invasive) diagnostic procedures. Our first-year data, including clinical data and laboratory follow-up data, will fuel this debate. Furthermore, we describe how NIPT can successfully be embedded into a national screening program with a single chain for prenatal care including counseling, testing, and follow-up.

Call to action: how can the US Ending the HIV Epidemic initiative succeed?

With more than 1·2 million people living with HIV in the USA, a complex epidemic across the large and diverse country, and a fragmented health-care system marked by widening health disparities, the US HIV epidemic requires sustained scientific and public health attention. The epidemic has been stubbornly persistent; high incidence densities have been sustained over decades and the epidemic is increasingly concentrated among racial, ethnic, and sexual and gender minority communities. This fact remains true despite extraordinary scientific advances in prevention, treatment, and care-advances that have been led, to a substantial degree, by US-supported science and researchers. In this watershed year of 2021 and in the face of the COVID-19 pandemic, it is clear that the USA will not meet the stated goals of the National HIV/AIDS Strategy, particularly those goals relating to reductions in new infections, decreases in morbidity, and reductions in HIV stigma. The six papers in the Lancet Series on HIV in the USA have each examined the underlying causes of these challenges and laid out paths forward for an invigorated, sustained, and more equitable response to the US HIV epidemic than has been seen to date. The sciences of HIV surveillance, prevention, treatment, and implementation all suggest that the visionary goals of the Ending the HIV Epidemic initiative in the USA might be achievable. However, fundamental barriers and challenges need to be addressed and the research effort sustained if we are to succeed.

Implementation of a national HIV pre-exposure prophylaxis service is associated with changes in characteristics of people with newly diagnosed HIV: a retrospective cohort study.

OBJECTIVES: To review characteristics of individuals newly diagnosed with HIV following implementation of a national pre-exposure prophylaxis (PrEP) programme (comprehensive PrEP services, delivered in sexual health clinics) to inform future delivery and broader HIV prevention strategies. METHODS: We extracted data from national HIV databases (July 2015-June 2018). We compared sociodemographic characteristics of individuals diagnosed in the period before and after PrEP implementation, and determined the proportion of 'potentially preventable' infections with the sexual health clinic-based PrEP delivery model used. RESULTS: Those diagnosed with HIV before PrEP implementation were more likely to be male (342/418, 81.8% vs 142/197, 72.1%, p=0.005), be white indigenous (327/418, 78.2% vs 126/197, 64.0%, p<0.001), report transmission route as sex between men (219/418, 52.4% vs 81/197, 41.1%, p=0.014), and have acquired HIV in the country of the programme (302/418, 72.2% vs 114/197, 57.9% p<0.001) and less likely to report transmission through heterosexual sex (114/418, 27.3% vs 77/197, 39.1%, p=0.002) than after implementation.Pre-implementation, 8.6% (36/418) diagnoses were 'potentially preventable' with the PrEP model used. Post-implementation, this was 6.6% (13/197), but higher among those with recently acquired HIV (49/170, 28.8%). Overall, individuals with 'potentially preventable' infections were more likely to be male (49/49, 100% vs 435/566, 76.9%, p<0.001), aged <40 years (37/49, 75.5% vs 307/566, 54.2%, p=0.004), report transmission route as sex between men (49/49, 100% vs 251/566, 44.3%, p<0.001), have previously received post-exposure prophylaxis (12/49, 24.5% vs 7/566, 1.2%, p<0.001) and less likely to be black African (0/49, 0% vs 67/566, 11.8%, p=0.010) than those not meeting this definition. CONCLUSIONS: The sexual health clinic-based national PrEP delivery model appeared to best suit men who have sex with men and white indigenous individuals but had limited reach into other key vulnerable groups. Enhanced models of delivery and HIV combination prevention are required to widen access to individuals not benefiting from PrEP at present.

Breast cancer screening in sub-Saharan Africa: a systematic review and ethical appraisal.

BACKGROUND: The aim of this systematic review was to evaluate the evidence and clinical outcomes of screening interventions and implementation trials in sub-Saharan Africa (SSA) and also appraise some ethical issues related to screening in the region through quantitative and qualitative narrative synthesis of the literature. METHODS: We searched Pubmed, OvidMEDLINE, Embase, and Web of Science to identify studies published on breast cancer screening interventions and outcomes in SSA. Descriptive statistics were used to summarize the frequency and proportions of extracted variables, and narrative syntheses was used to evaluate the clinical outcomes of the different screening modalities. The mixed methods appraisal tool was used to assess the quality of studies included in the review. RESULTS: Fifteen studies were included, which consisted of 72,572 women in ten countries in SSA. 63% (8/15) of the included publications evaluated Clinical Breast Examination (CBE), 47% (7/15) evaluated mammography and 7% (1/15) evaluated ultrasound screening. The cancer detection rate was < 1/1000 to 3.3/1000 and 3.3/100 to 56/1000 for CBE and mammography screening respectively. There was a lot of heterogeneity in CBE methods, target age for screening and no clear documentation of screening interval. Cost-effective analyses showed that CBE screening linked to comprehensive cancer care is most cost effective. There was limited discussion of the ethics of screening, including the possible harms of screening in the absence of linkage to care. The gap between conducting good screening program and the appropriate follow-up with diagnosis and treatment remains one of the major challenges of screening in SSA. DISCUSSION: There is insufficient real-world data to support the systematic implementation of national breast cancer screening in SSA. Further research is needed to answer important questions about screening, and national and international partnerships are needed to ensure that appropriate diagnostic and treatment modalities are available to patients who screen positive.

Integration of breast cancer care in a middle-income country: learning from Suandok Breast Cancer Network (SBCN).

BACKGROUND: Breast cancer incidence in Northern Thailand has shown a continuous increase since records began in 1983. In 2002 the urgency of the situation prompted Maharaj Nakorn Chiang Mai Hospital to initiate the Suandok Breast Cancer Network (SBCN). METHODS: The SBCN is a not-for-profit organization in the university hospital which serves as a training and education center and provides highly specialized medical care for patients in Chiang Mai and in 5 provinces of northern Thailand, with the key mission of improving breast cancer care. The short-term goal was to overcome the barriers to engagement with breast cancer and its treatment and the long-term goal was to increase the overall survival rate of breast cancer patients in our region. RESULTS: We enrolled breast cancer patients treated at Maharaj Nakorn Chiang Mai Hospital between January 2006 and December 2015 and divided into 2 cohorts: 1485 patients who were diagnosed from 2006 to 2009 (cohort 1: early implementation of SBCN) and 2383 patients who were diagnosed from 2010 to 2015 (cohort 2: full implementation of SBCN). Criteria to measure improved cancer waiting time (CWT) would include: time to diagnosis, time to surgery, and time to radiotherapy. The 5-year overall survival (OS) of the cohort 2 was higher than that in cohort 1, at 73.8 (72.0-75.5) compared to 71.5 (69.2-73.7) (p-value = 0.03). CONCLUSIONS: Reasons behind the success of project include the uniformity of care encouragement, service network development and timely access to each step of breast cancer management. The model used in SBCN could be adopted as a learning guide to improve healthcare access and outcome for breast cancer patients in low- to middle-income countries.

Impact of the DREAMS Program on New HIV Diagnoses in Adolescent Girls and Young Women Attending Antenatal Care - Lesotho, 2015-2020.

Lesotho is a small, landlocked country in southern Africa with a population of approximately 2 million persons, approximately two thirds of whom live in rural areas (1). Lesotho has the second highest prevalence of HIV infection in the world (2). In 2017, 25.6% of persons aged 15-59 years living in Lesotho were HIV-positive (3). Strategies implemented in recent years to control HIV include efforts to reduce mother-to-child transmission and improve coverage with antiretroviral therapy, as well as increasing testing for HIV. Among persons aged 15-24 years, the HIV prevalence among females in 2017 (11.1%) was approximately three times that among males (3.4%) (3). The Determined, Resilient, Empowered, AIDS-Free, Mentored, and Safe (DREAMS)* program in Lesotho was started during October 2016 in two districts. DREAMS comprises a package of biomedical, behavioral, and structural interventions to address factors that make adolescent girls and young women vulnerable to HIV acquisition (4). The goal of the DREAMS program was to decrease HIV incidence among adolescent girls and young women by 25% after 1 year and by 40% after 2 years (4). After 3.5 years of program implementation in Lesotho, new HIV diagnoses among adolescent girls and young women attending antenatal care (ANC) decreased 71.4% in the two districts that implemented DREAMS compared with a reduction of 48.4% in three comparison districts without the program (p = 0.002). During 2016-2020, reductions in new HIV diagnoses among adolescent girls and young women attending ANC in Lesotho have been substantial, both in districts that have and have not implemented the DREAMS program (DREAMS and non-DREAMS districts). Apart from the DREAMS program, the decrease in new HIV diagnoses might be a result of the reduction in viral load in the population because more persons living with HIV infection became virally suppressed while on antiviral therapy, as well as other interventions such as preexposure prophylaxis, voluntary medical male circumcision, behavior change, and increased HIV diagnostic coverage.

Implementing multidisciplinary tumor boards in oncology: a narrative review.

The healthcare industry compares unfavorably with other ultra-safe industries such as aviation and nuclear power plants, which address complexity by reducing the vulnerability of a single person and promoting teams and strong systems. A multidisciplinary tumor board (MTB) is an evidence-based organizational approach to implementing a more effective concept in oncology practice. Studies addressing the correlation between MTBs and cancer outcomes show promising results, and other potential benefits are also addressed. The objectives of this article are to define and characterize MTBs in modern oncology practice, review the current literature on MTBs effectiveness and address challenges to the implementation and maintenance of MTBs. In this commentary-type narrative review, the authors present their opinions and, whenever possible, substantiate recommendations by citing supportive literature.

Lay abstract Compared with other ultra-safe industries such as aviation and nuclear power plants, the healthcare industry operates with lower safety standards. Multidisciplinary tumor boards (MTBs) are regular meetings of various specialist doctors and other health professionals involved in cancer care to discuss cases of patients with cancer. MTBs are considered valuable tools to promote the quality of care in oncology by reducing the vulnerability of a single person and promoting teams and strong systems. Studies have shown that MTBs correlate with better treatment results, and other potential benefits are also addressed. The objectives of this paper are to define and characterize MTBs in modern oncology practice, review the current literature on MTBs and address challenges to the implementation and maintenance of MTBs. The authors substantiate their views with literature citations where possible.

Meaningful patient and public involvement in digital health innovation, implementation and evaluation: A systematic review.

INTRODUCTION: The importance of meaningfully involving patients and the public in digital health innovation is widely acknowledged, but often poorly understood. This review, therefore, sought to explore how patients and the public are involved in digital health innovation and to identify factors that support and inhibit meaningful patient and public involvement (PPI) in digital health innovation, implementation and evaluation. METHODS: Searches were undertaken from 2010 to July 2020 in the electronic databases MEDLINE, EMBASE, PsycINFO, CINAHL, Scopus and ACM Digital Library. Grey literature searches were also undertaken using the Patient Experience Library database and Google Scholar. RESULTS: Of the 10,540 articles identified, 433 were included. The majority of included articles were published in the United States, United Kingdom, Canada and Australia, with representation from 42 countries highlighting the international relevance of PPI in digital health. 112 topic areas where PPI had reportedly taken place were identified. Areas most often described included cancer (n = 50), mental health (n = 43), diabetes (n = 26) and long-term conditions (n = 19). Interestingly, over 133 terms were used to describe PPI; few were explicitly defined. Patients were often most involved in the final, passive stages of an innovation journey, for example, usability testing, where the ability to proactively influence change was severely limited. Common barriers to achieving meaningful PPI included data privacy and security concerns, not involving patients early enough and lack of trust. Suggested enablers were often designed to counteract such challenges. CONCLUSIONS: PPI is largely viewed as valuable and essential in digital health innovation, but rarely practised. Several barriers exist for both innovators and patients, which currently limits the quality, frequency and duration of PPI in digital health innovation, although improvements have been made in the past decade. Some reported barriers and enablers such as the importance of data privacy and security appear to be unique to PPI in digital innovation. Greater efforts should be made to support innovators and patients to become meaningfully involved in digital health innovations from the outset, given its reported benefits and impacts. Stakeholder consensus on the principles that underpin meaningful PPI in digital health innovation would be helpful in providing evidence-based guidance on how to achieve this. PATIENT OR PUBLIC CONTRIBUTION: This review has received extensive patient and public contributions with a representative from the Patient Experience Library involved throughout the review's conception, from design (including suggested revisions to the search strategy) through to article production and dissemination. Other areas of patient and public contributor involvement include contributing to the inductive thematic analysis process, refining the thematic framework and finalizing theme wording, helping to ensure relevance, value and meaning from a patient perspective. Findings from this review have also been presented to a variety of stakeholders including patients, patient advocates and clinicians through a series of focus groups and webinars. Given their extensive involvement, the representative from the Patient Experience Library is rightly included as an author of this review.

Can systematic implementation support improve programme fidelity by improving care providers' perceptions of implementation factors? A cluster randomized trial.

BACKGROUND: Investigations of implementation factors (e.g., collegial support and sense of coherence) are recommended to better understand and address inadequate implementation outcomes. Little is known about the relationship between implementation factors and outcomes, especially in later phases of an implementation effort. The aims of this study were to assess the association between implementation success (measured by programme fidelity) and care providers' perceptions of implementation factors during an implementation process and to investigate whether these perceptions are affected by systematic implementation support. METHODS: Using a cluster-randomized design, mental health clinics were drawn to receive implementation support for one (intervention) and not for another (control) of four evidence-based practices. Programme fidelity and care providers' perceptions (Implementation Process Assessment Tool questionnaire) were scored for both intervention and control groups at baseline, 6-, 12- and 18-months. Associations and group differences were tested by means of descriptive statistics (mean, standard deviation and confidence interval) and linear mixed effect analysis. RESULTS: Including 33 mental health centres or wards, we found care providers' perceptions of a set of implementation factors to be associated with fidelity but not at baseline. After 18 months of implementation effort, fidelity and care providers' perceptions were strongly correlated (B (95% CI) = .7 (.2, 1.1), p = .004). Care providers perceived implementation factors more positively when implementation support was provided than when it was not (t (140) = 2.22, p = .028). CONCLUSIONS: Implementation support can facilitate positive perceptions among care providers, which is associated with higher programme fidelity. To improve implementation success, we should pay more attention to how care providers constantly perceive implementation factors during all phases of the implementation effort. Further research is needed to investigate the validity of our findings in other settings and to improve our understanding of ongoing decision-making among care providers, i.e., the mechanisms of sustaining the high fidelity of recommended practices. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03271242 (registration date: 05.09.2017).