RESUMEN
INTRODUCTION: Despite growing calls for the explicit application of theory when designing behaviour change interventions, limited empirical evidence exists regarding the effectiveness of these methods compared to non-theoretical approaches. A cluster randomized controlled trial (Hide and Seek Project - HaSP) tested two implementation approaches for improving hereditary cancer referral practices with one key distinction: implementation strategies were designed based explicitly on psychological theory, or based on stakeholder intuition. This study presents the detailed methods and resources used to facilitate this comparison, whilst examining the strategies generated through both approaches. METHODS: Across seven Australian hospitals, clinical stakeholders attended focus-groups to co-design site-specific strategies for improving Lynch syndrome referral. Co-design methods differed according to trial arm. Implementation strategy content was examined, with intuitively-derived strategies retrospectively coded to determine theoretical alignment. RESULTS: Fifty-one strategies were proposed across all sites (theory-based arm = 32, intuition-based arm = 19). Overall, nine Behaviour Change Technique (BCT) categories were used on 77 occasions. In the theory-based trial arm, eight BCT categories were identified on 53 occasions; versus five BCT categories on 24 occasions in the intuition-based arm. BCT categories were largely similar across both arms. After retrospectively coding intuitively-derived strategies, 42% contained mechanistic links, thereby demonstrating theoretical alignment. CONCLUSION: Methods facilitated robust comparison of theoretical and intuitive approaches to implementation strategy design. Recognising the known benefits of theory for enhancing scientific learning, applying these methods on a larger scale may provide definitive evidence about the comparative effectiveness of theoretical approaches.
RESUMEN
INTRODUCTION: Accessing compassionate access schemes to obtain novel therapeutic agents for children with hard-to-treat cancers can be fraught with challenges such as regulatory barriers and limited resources. This study aimed to explore clinician perspectives on the barriers, impacts and ethical considerations of accessing novel therapeutic agents within the context of a paediatric oncology precision medicine trial. METHODS: We gathered data from 37 semi-structured interviews with paediatric oncologists participating in the PRecISion Medicine for Children with Cancer (PRISM) study, a precision medicine clinical trial in Australia. The interviews, conducted over 2 years, focused on paediatric oncologist's experiences with the PRISM trial. Interviews were re-analysed to identify themes related to access pathways and any challenges in obtaining novel agents through thematic analysis. The resulting thematic framework was discussed and refined by a multidisciplinary team. RESULTS: Three main themes were identified: (i) barriers to access, including poor drug availability, lack of evidence and the time burden of the application process; (ii) impacts of inaccessibility, encompassing medical consequences and financial burden on families; and (iii) ethical considerations, centred around balancing realistic expectations and providing compassionate care to patients and families. Paediatric oncologists expressed frustration with the complex regulatory landscape and the lack of systematic reporting on applications and outcomes of obtaining novel agents. Lengthy wait times for decision notifications were also highlighted, raising concerns about missed therapeutic opportunities for patients. CONCLUSION: This study provides insight to the challenges faced when seeking access to novel therapies for paediatric oncology patients. There is a clear need for improved communication, streamlining processes and increased resources to facilitate access to novel agents. Further resource development is necessary to address these complexities in accessing novel therapy agents to ultimately ensure equitable and timely access.
RESUMEN
OBJECTIVES: To report the long-term outcomes from a longitudinal psychosocial study that forms part of the 'Identification of Men with a genetic predisposition to ProstAte Cancer: Targeted Screening in men at higher genetic risk and controls' (IMPACT) study. The IMPACT study is a multi-national study of targeted prostate cancer (PrCa) screening in individuals with a known germline pathogenic variant (GPV) in either the BReast CAncer gene 1 (BRCA1) or the BReast CAncer gene 2 (BRCA2). SUBJECTS AND METHODS: Participants enrolled in the IMPACT study were invited to complete a psychosocial questionnaire prior to each annual screening visit for a minimum of 5 years. The questionnaire included questions on sociodemographics and the following measures: Hospital Anxiety and Depression Scale, Impact of Event Scale, 36-item Short-Form Health Survey, Memorial Anxiety Scale for PrCa, Cancer Worry Scale, risk perception and knowledge. RESULTS: A total of 760 participants completed questionnaires: 207 participants with GPV in BRCA1, 265 with GPV in BRCA2 and 288 controls (non-carriers from families with a known GPV). We found no evidence of clinically concerning levels of general or cancer-specific distress or poor health-related quality of life in the cohort as a whole. Individuals in the control group had significantly less worry about PrCa compared with the carriers; however, all mean scores were low and within reported general population norms, where available. BRCA2 carriers with previously high prostate-specific antigen (PSA) levels experience a small but significant increase in PrCa anxiety (P = 0.01) and PSA-specific anxiety (P < 0.001). Cancer risk perceptions reflected information provided during genetic counselling and participants had good levels of knowledge, although this declined over time. CONCLUSION: This is the first study to report the longitudinal psychosocial impact of a targeted PrCa screening programme for BRCA1 and BRCA2 carriers. The results reassure that an annual PSA-based screening programme does not have an adverse impact on psychosocial health or health-related quality of life in these higher-risk individuals. These results are important as more PrCa screening is targeted to higher-risk groups.
Asunto(s)
Detección Precoz del Cáncer , Predisposición Genética a la Enfermedad , Neoplasias de la Próstata , Humanos , Masculino , Neoplasias de la Próstata/psicología , Neoplasias de la Próstata/genética , Neoplasias de la Próstata/diagnóstico , Persona de Mediana Edad , Anciano , Predisposición Genética a la Enfermedad/psicología , Detección Precoz del Cáncer/psicología , Calidad de Vida , Genes BRCA1 , Encuestas y Cuestionarios , Genes BRCA2 , Heterocigoto , Ansiedad/etiología , Estudios LongitudinalesRESUMEN
Objectives: Paediatric oncologists often encounter challenges when seeking compassionate access to off-label therapies for their patients. This study employed implementation science and co-design techniques to develop the ProCure medicines database, with the goal of streamlining the application process and addressing identified barriers in paediatric oncology. Methods: This study utilised an exploratory qualitative research design. Seventeen healthcare providers, including oncologists, nurse consultants, and allied health professionals, participated in semi-structured interviews guided by the Consolidated Framework for Implementation Research (CFIR) and a visual process map aid. Deductive qualitative data analysis, according to the CFIR constructs, identified key barriers and facilitators. Collaborative design sessions engaged multidisciplinary teams to develop the ProCure beta version. Results: Barriers to off-label therapy access included resource-intensive applications, time sensitive decision-making, and complex pharmaceutical information. Facilitators included Drug Access Navigators, Molecular Tumour Boards, and a multi-disciplinary approach. ProCure addressed end-user needs by centralising medicines information. Additional features suggested by healthcare providers included blood-brain-barrier penetrability data and successful application examples. Conclusion: ProCure represents a promising solution to the challenges paediatric oncologists face in accessing off-label therapies. By centralising information, it simplifies the application process, aids decision-making, and promotes a collaborative approach to patient care. The potential of the database to stream and enhance off-label therapy access underscores its relevance in improving paediatric oncology practise. Further research and implementation efforts are warranted to assess ProCure's real-world impact and refine its features based on user feedback.
RESUMEN
BACKGROUND: Adolescents and young adults (AYAs) diagnosed with cancer experience physical, cognitive, and psychosocial effects from cancer treatment that can negatively affect their ability to remain engaged in education or work through cancer treatment and in the long term. Disengagement from education or work can have lasting implications for AYAs' financial independence, psychosocial well-being, and quality of life. Australian AYAs with cancer lack access to adequate specialist support for their education and work needs and report a preference for web-based support that they can access from anywhere, in their own time. However, it remains unclear what web-based resources exist that are tailored to support AYAs with cancer in reaching their educational or work goals. OBJECTIVE: This study aimed to determine what web-based resources exist for Australian AYAs with cancer to (1) support return to education or work and (2) identify the degree to which existing resources are age-specific, cancer-specific, culturally inclusive, and evidence-based; are co-designed with AYAs; use age-appropriate language; and are easy to find. METHODS: We conducted an environmental scan by searching Google with English search terms in August 2022 to identify information resources about employment and education for AYAs ever diagnosed with cancer. Data extraction was conducted in Microsoft Excel, and the following were assessed: understandability and actionability (using the Patient Education and Materials Tool), readability (using the Sydney Health Literacy Laboratory Health Literacy Editor), and whether the resource was easy to locate, evidence-based, co-designed with AYAs, and culturally inclusive of Aboriginal and Torres Strait Islander peoples. The latter was assessed using 7 criteria previously developed by members of the research team. RESULTS: We identified 24 web-based resources, comprising 22 written text resources and 12 video resources. Most resources (21/24, 88%) were published by nongovernmental organizations in Australia, Canada, the United States, and the United Kingdom. A total of 7 resources focused on education, 8 focused on work, and 9 focused on both education and work. The evaluation of resources demonstrated poor understandability and actionability. Resources were rarely evidence-based or co-designed by AYAs, difficult to locate on the internet, and largely not inclusive of Aboriginal and Torres Strait Islander populations. CONCLUSIONS: Although web-based resources for AYAs with cancer are often available through the websites of hospitals or nongovernmental organizations, this environmental scan suggests they would benefit from more evidence-based and actionable resources that are available in multiple formats (eg, text and audio-visual) and tailored to be age-appropriate and culturally inclusive.
RESUMEN
OBJECTIVE: Limited real-world evidence exists to better understand the patient experience of living with symptoms and impacts of non-alcoholic steatohepatitis (NASH). This study aimed to (1) describe patient-reported perspectives of NASH symptoms and impacts on patients' daily lives and (2) develop a patient-centered conceptual NASH model. METHODS: A cross-sectional study using semi-structured qualitative interviews was conducted among adults (≥18 years) in the United States living with NASH. Eligible participants were diagnosed with NASH, had mild to advanced fibrosis (F1-F3), and no other causes of liver disease. The interview guide was informed by a targeted literature review (TLR) to identify clinical signs, symptoms, impacts, and unmet treatment needs of NASH. Participants described their experiences and perspectives around NASH and the symptoms, symptom severity/bother, and impact of NASH on their daily activities. Interviews were audio-recorded and transcribed verbatim for coding and thematic analysis. RESULTS: Twenty participants (age: 42.4 years; female: 50.0%) were interviewed. Participants discussed their experience with NASH symptoms (most frequent: fatigue [75.0%]; weakness/lethargy [70.0%]) and impacts (most frequent: physical and psychological/emotional [70.0% each]; dietary [68.4%]). Participants considered most symptoms to be moderately severe or severe and moderately or highly bothersome. Findings from the TLR and qualitative interviews were incorporated into a conceptual model that describes patient-reported symptoms and impacts of NASH, clinical signs, risk factors, and unmet treatment needs. CONCLUSION: Our study provides insights into patients' perspectives of NASH symptoms and their impact on their daily lives. These findings may guide patient-physician conversations, supporting patient-centered treatment decisions and disease management.
Study findings help to address the gap in current literature about patients' perspectives on NASH and its symptoms as well as its impact on daily life.The study proposes a holistic conceptual model that describes patients' perspectives of living with NASH, including symptoms and their impact, the clinical signs and risk factors of NASH, and the unmet treatment needs of the disease.Healthcare providers can use study findings to inform patient-focused decisions around treatment strategies for NASH.
Asunto(s)
Enfermedad del Hígado Graso no Alcohólico , Adulto , Humanos , Femenino , Enfermedad del Hígado Graso no Alcohólico/complicaciones , Enfermedad del Hígado Graso no Alcohólico/epidemiología , Estudios Transversales , Comorbilidad , Factores de RiesgoRESUMEN
OBJECTIVES: Hard-to-treat childhood cancers are those where standard treatment options do not exist and the prognosis is poor. Healthcare professionals (HCPs) are responsible for communicating with families about prognosis and complex experimental treatments. We aimed to identify HCPs' key challenges and skills required when communicating with families about hard-to-treat cancers and their perceptions of communication-related training. METHODS: We interviewed Australian HCPs who had direct responsibilities in managing children/adolescents with hard-to-treat cancer within the past 24 months. Interviews were analyzed using qualitative content analysis. RESULTS: We interviewed 10 oncologists, 7 nurses, and 3 social workers. HCPs identified several challenges for communication with families including: balancing information provision while maintaining realistic hope; managing their own uncertainty; and nurses and social workers being underutilized during conversations with families, despite widespread preferences for multidisciplinary teamwork. HCPs perceived that making themselves available to families, empowering them to ask questions, and repeating information helped to establish and maintain trusting relationships with families. Half the HCPs reported receiving no formal training for communicating prognosis and treatment options with families of children with hard-to-treat cancers. Nurses, social workers, and less experienced oncologists supported the development of communication training resources, more so than more experienced oncologists. SIGNIFICANCE OF RESULTS: Resources are needed which support HCPs to communicate with families of children with hard-to-treat cancers. Such resources may be particularly beneficial for junior oncologists and other HCPs during their training, and they should aim to prepare them for common challenges and foster greater multidisciplinary collaboration.
Asunto(s)
Comunicación , Personal de Salud , Neoplasias , Investigación Cualitativa , Humanos , Neoplasias/psicología , Neoplasias/terapia , Personal de Salud/psicología , Personal de Salud/estadística & datos numéricos , Femenino , Masculino , Adulto , Australia , Relaciones Profesional-Familia , Persona de Mediana Edad , Adolescente , NiñoRESUMEN
PURPOSE: To examine the effectiveness of professionally led support groups for people with advanced or metastatic cancer, and identify factors critical to implementation success within real-world settings. METHODS: Databases (MEDLINE; PsychINFO; CINAHL) and grey literature were searched for empirical publications and evaluations. Articles were screened for eligibility and data systematically extracted, charted and summarised using a modified scoping review methodology. Implementation factors were mapped using Proctor's implementation framework and the Consolidated Framework for Implementation Research 2.0. RESULTS: A total of 1691 publications were identified; 19 were eligible for inclusion (8 randomised controlled trials, 7 qualitative studies, 2 cohort studies, 2 mixed methods studies). Most (n=18) studies focused on tumour-specific support groups. Evidence supported professionally led support groups in reducing mood disturbances (n=5), distress (i.e. traumatic stress, depression) (n=4) and pain (n=2). Other benefits included social connectedness (n=6), addressing existential distress (n=5), information and knowledge (n=6), empowerment and sense of control (n=2), relationships with families (n=2) and communication with health professionals (n=2). Thirteen studies identified factors predicting successful adoption, implementation or sustainment, including acceptability (n=12; 63%), feasibility (n=6; 32%) and appropriateness (n=1; 5%). Key determinants of successful implementation included group leaders' skills/experience, mode of operation, travelling distance, group composition and membership and resourcing. CONCLUSIONS: Professionally led tumour-specific support groups demonstrate effectiveness in reducing mood disturbances, distress and pain among patients. Successful implementation hinges on factors such as leadership expertise, operational methods and resource allocation. IMPLICATIONS FOR CANCER SURVIVORS: Professionally led support groups may fill an important gap in supportive care for people with advanced or metastatic cancer.
RESUMEN
Late-transition-metal catalysts for polymerization of olefins have drawn a significant amount of attention owing to their ability to tolerate and incorporate polar comonomers. However, a systematic way to experimentally quantify the electronic properties of the ligands used in these systems has not been developed. Quantified ligand parameters will allow for the rational design of tailored polymerization catalysts, which would target specific polymer properties. We report a series of platinum complexes bearing bisphosphinemonoxide ligands, which resemble those used in the polymerization catalysts of Nozaki and Chen. Their electronic properties are investigated experimentally, and trends are rationalized by using computed spectral properties. Benchmarking computational data with known experimental parameters further enhances the utility of both methods for determining optimal ligands for catalytic application.
RESUMEN
INTRODUCTION: Wearable sensor technologies enable Defence to optimise human performance, remotely identify physiological abnormalities and enhance medical support. Maximising the acceptability of devices will ensure they are worn alongside other equipment. This study assessed the acceptability and comfort of four devices at different anatomical locations during military training. METHOD: A cross-sectional pilot study during a live firing infantry exercise or adventurous training assessed four anatomical locations concurrently over 5 days: finger, wrist, upper arm and chest. Participants rated comfort, acceptability and preference using a standardised questionnaire after 12 hours and 5 days of wear. RESULTS: Twenty-one regular British Army personnel soldiers participated, aged 24.4 (4.3) years. The upper arm location received the highest rating by participants for comfort, followed in order by wrist, finger and chest (p=0.002, Χ2=40.0). The finger was most commonly identified as uncomfortable during specific activities (76%), followed by chest (48%), wrist (23%) and upper arm devices (14%). There was no significant difference in participant confidence in the devices to collect data or allow movement, but there was a trend towards greater confidence in upper arm and wrist locations to stay in position than the others (p=0.059, Χ2=28.0). After 5 days of wear, 43% of participants said they preferred the upper arm for comfort, followed by wrist (36%), finger (24%) and chest (10%). 73% and 71% would wear the wrist and upper arm devices on deployed operations, compared with 29% and 24% for chest and finger devices, respectively. CONCLUSION: The upper arm location offered greater acceptability and comfort than finger, wrist or chest locations. It is essential to consider such findings from occupationally relevant settings when selecting wearable technology. A larger service evaluation in diverse settings is recommended to guide the choice of the most acceptable wearable devices across different equipment, roles and environments.
RESUMEN
OBJECTIVE: This scoping review will examine the literature describing models of care, barriers and facilitators of care, and gaps in care delivery for children and adolescents with a cancer predisposition syndrome (CPS). It will also explore how advanced practice nurses contribute to the delivery of care for children and adolescents with a CPS. INTRODUCTION: Cancer remains a leading cause of death in children and adolescents. Pediatric CPS clinics proactively aim for early diagnosis or prevention of cancer in children and adolescents with a CPS. Additionally, the holistic well-being of individuals requires a multidisciplinary team, including advanced practice nurses, to manage their complex health care needs. INCLUSION CRITERIA: This review will consider both published and unpublished literature exploring aspects of models of care and the role of the nurse in pediatric CPS clinics. Literature published in English from 1991 will be considered. METHODS: This scoping review will follow the JBI methodology for scoping reviews. The review will include searches in MEDLINE, Embase, and CINAHL Complete. Gray literature searches will be conducted in OAIster and Social Science Research Network (SSRN), as well as websites of hospitals in the USA and the UK with large pediatric cancer centers. Two reviewers will screen titles, abstracts, and full-text articles. An extraction table will be used to extract relevant data from all included articles and facilitate data analysis. Results will be presented in narrative and tabular format. REVIEW REGISTRATION: Open Science Framework osf.io/axkp7/.
RESUMEN
BACKGROUND: Health care professionals play a central role in offering reproductive genetic carrier screening but face challenges when integrating the offer into practice. The aim of this study was to design, execute, and evaluate theory-informed implementation strategies to support health care professionals in offering carrier screening. METHODS: An exploratory multi-method approach was systematically employed based on the Theoretical Domain Framework (TDF). Implementation strategies were designed by aligning TDF barriers reported by health care professionals involved in a large carrier screening study, to behaviour change techniques combined with study genetic counsellors' experiential knowledge. The strategies were trialled with a subset of health care professionals and evaluated against controls, using findings from questionnaires and interviews with healthcare professionals. The primary outcome measure was the number of couples who initiated enrolment. RESULTS: Health care professionals (n = 151) reported barriers in the TDF Domains of skills, e.g., lack of practice in offering screening, and challenges of environmental context and resources, e.g., lack of time, which informed the design of a skills video and a waiting room poster using the TDF-behaviour change technique linking tool. Following implementation, (Skills video n = 29 vs control n = 31 and Poster n = 46 vs control n = 34) TDF barrier scores decreased across all groups and little change was observed in the primary outcome measure. The skills video, though welcomed by health care professionals, was reportedly too long at seven minutes. The waiting room poster was seen as easily implementable. CONCLUSIONS: As carrier screening moves towards mainstream healthcare, health care professionals report barriers to offering screening. To meet their needs, developing and testing experiential and theory-informed strategies that acknowledge contextual factors are essential.
Asunto(s)
Atención a la Salud , Personal de Salud , Humanos , Tamización de Portadores Genéticos , AustraliaRESUMEN
Purpose: To validate the Identification of Medication Adherence Barriers Questionnaire (IMAB-Q) as a tool to guide practitioners to identify patients who require support to take their medicines as prescribed, their key barriers to adherence and select relevant behaviour change techniques. Patients and Methods: Adults prescribed medication for cardiovascular disease prevention were recruited from nine community pharmacies in England. Participants completed the IMAB-Q comprising 30 items representing potential barriers to adherence developed from our previous mixed methods study (scoping review and focus groups) underpinned by the Theoretical Domains Framework. Participants also self-reported their adherence on a visual analogue scale (VAS) ranging from perfect adherence (100) to non-adherence (1). A subgroup of 30 participants completed the IMAB-Q twice to investigate test-retest reliability using weighted Kappa. Mokken scaling was used to investigate IMAB-Q structure. Spearman correlation was used to investigate IMAB-Q criterion validity compared to the VAS score. Results: From 1407 invitations, 608 valid responses were received. Respondents had a mean (SD) age of 70.12 (9.9) years and were prescribed a median (IQ) 4 (3, 6) medicines. Worry about unwanted effects (n = 212, 34.5%) and negative emotions evoked by medicine taking (n = 99, 16.1%) were most frequently reported. Mokken scaling did not organise related IMAB-Q items according to the TDF domains (scalability coefficient H = 0.3 to 0.6). Lower VAS self-reported adherence correlated with greater IMAB-Q reported barriers (rho = -0.14, p = 0.001). Test-retest reliability of IMAB-Q items ranged from kappa co-efficient 0.9 to 0.3 (p < 0.05). Conclusion: The IMAB-Q is valid and reliable for identifying people not adhering and their barriers to adherence. Each IMAB-Q item is linked to a TDF domain which in turn is linked to relevant behaviour change techniques. The IMAB-Q can therefore guide patients and practitioners to select strategies tailored to a patient's identified barriers.
RESUMEN
BACKGROUND: Pregnant patients are at high risk of maternal and fetal complications from Coronavirus Disease 2019 (COVID-19) infections. The COVID-19 pandemic prompted a surge in the development and repurposing of therapies for the SARS-CoV-2 virus. Evidence is sparse on the efficacy and safety of these therapies in pregnant patients. Our objective was to describe adverse events (AEs) to COVID-19 therapeutics in pregnant patients. METHODS: This was a case series of AEs reported to the FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance Project between November 23, 2020, and June 28, 2022. FACT is an ongoing toxicosurveillance project at 17 sites to proactively identify and report AEs associated with COVID-19 therapeutics. Abstracted information includes demographics, case narratives, exposure details, clinical information, pregnancy details, treatments, and outcomes. RESULTS: Forty-six COVID-19-positive pregnant patients who developed AEs following COVID-19 therapeutics were reported to the FACT Pharmacovigilance Project over 19 months. The most reported medications were remdesivir in 22 patients (47.8%) and casirivimab/imdevimab in 8 patients (17.4%). Four patients (8.7%) had life-threatening clinical manifestation, and 16 patients (34.8%) required intervention to prevent permanent damage. The most common maternal and fetal events were elevated serum alanine aminotransferase (26.1%) and non-reassuring fetal heart patterns (20.0%), respectively. CONCLUSIONS: This case series reports AEs of elevated serum alanine aminotransferase, maternal bradycardia, maternal hypothermia, non-reassuring fetal heart patterns, and emergent or unplanned cesarean sections following administration of several COVID-19 therapeutics. This study was not designed to definitely identify causation, and further study is needed to evaluate the causal role of these therapeutics in AEs affecting pregnant COVID-19 patients.
Asunto(s)
COVID-19 , Complicaciones Infecciosas del Embarazo , Embarazo , Femenino , Humanos , SARS-CoV-2 , Pandemias , Alanina Transaminasa , Complicaciones Infecciosas del Embarazo/tratamiento farmacológicoRESUMEN
BACKGROUND: Disentangling the interplay between experience-based intuition and theory-informed implementation is crucial for identifying the direct contribution theory can make for generating behaviour changes needed for successful evidence translation. In the context of 'clinicogenomics', a complex and rapidly evolving field demanding swift practice change, we aimed to (a) describe a combined clinician intuition- and theory-driven method for identifying determinants of and strategies for implementing clinicogenomics, and (b) articulate a structured approach to standardise hypothesised behavioural pathways and make potential underlying theory explicit. METHODS: Interview data from 16 non-genetic medical specialists using genomics in practice identified three target behaviour areas across the testing process: (1) identifying patients, (2) test ordering and reporting, (3) communicating results. The Theoretical Domains Framework (TDF) was used to group barriers and facilitators to performing these actions. Barriers were grouped by distinct TDF domains, with 'overarching' TDF themes identified for overlapping barriers. Clinician intuitively-derived implementation strategies were matched with corresponding barriers, and retrospectively coded against behaviour change techniques (BCTs). Where no intuitive strategies were provided, theory-driven strategies were generated. An algorithm was developed and applied to articulate how implementation strategies address barriers to influence behaviour change. RESULTS: Across all target behaviour areas, 32 identified barriers were coded across seven distinct TDF domains and eight overarching TDF themes. Within the 29 intuitive strategies, 21 BCTs were represented and used on 49 occasions to address 23 barriers. On 10 (20%) of these occasions, existing empirical links were found between BCTs and corresponding distinct TDF-coded barriers. Twenty additional theory-driven implementation strategies (using 19 BCTs on 31 occasions) were developed to address nine remaining barriers. CONCLUSION: Clinicians naturally generate their own solutions when implementing clinical interventions, and in this clinicogenomics example these intuitive strategies aligned with theoretical recommendations 20% of the time. We have matched intuitive strategies with theory-driven BCTs to make potential underlying theory explicit through proposed structured hypothesised causal pathways. Transparency and efficiency are enhanced, providing a novel method to identify determinants of implementation. Operationalising this approach to support the design of implementation strategies may optimise practice change in response to rapidly evolving scientific advances requiring swift translation into healthcare.
Asunto(s)
Terapia Conductista , Intuición , Humanos , Estudios RetrospectivosRESUMEN
BACKGROUND: Newborn screening (NBS) is an effective public health intervention that reduces death and disability from treatable genetic diseases, but many conditions are not screened due to a lack of a suitable assay. Whole genome and whole exome sequencing can potentially expand NBS but there remain many technical challenges preventing their use in population NBS. We investigated if targeted gene sequencing (TGS) is a feasible methodology for expanding NBS. METHODS: We constructed a TGS panel of 164 genes which screens for a broad range of inherited conditions. We designed a high-volume, low-turnaround laboratory and bioinformatics workflow that avoids the technical and data interpretation challenges associated with whole genome and whole exome sequencing. A methods-based analytical validation of the assay was completed and test performance in 2552 newborns examined. We calculated annual birth estimates for each condition to assess cost-effectiveness. RESULTS: Assay analytical sensitivity was >99% and specificity was 100%. Of the newborns screened, 1.3% tested positive for a condition. On average, each individual had 225 variants to interpret and 1.8% were variants of uncertain significance (VUS). The turnaround time was 7 to 10 days. Maximum batch size was 1536 samples. CONCLUSIONS: We demonstrate that a TGS assay could be incorporated into an NBS program soon to increase the number of conditions screened. Additionally, we conclude that NBS using TGS may be cost-effective.
Asunto(s)
Biología Computacional , Tamizaje Neonatal , Recién Nacido , Humanos , Tamizaje Neonatal/métodos , Estudios de Factibilidad , ADN , Análisis de Secuencia de ADNRESUMEN
BACKGROUND: Unprofessional behaviour among hospital staff is common. Such behaviour negatively impacts on staff wellbeing and patient outcomes. Professional accountability programs collect information about unprofessional staff behaviour from colleagues or patients, providing this as informal feedback to raise awareness, promote reflection, and change behaviour. Despite increased adoption, studies have not assessed the implementation of these programs utilising implementation theory. This study aims to (1) identify factors influencing the implementation of a whole-of-hospital professional accountability and culture change program, Ethos, implemented in eight hospitals within a large healthcare provider group, and (2) examine whether expert recommended implementation strategies were intuitively used during implementation, and the degree to which they were operationalised to address identified barriers. METHOD: Data relating to implementation of Ethos from organisational documents, interviews with senior and middle management, and surveys of hospital staff and peer messengers were obtained and coded in NVivo using the Consolidated Framework for Implementation Research (CFIR). Implementation strategies to address identified barriers were generated using Expert Recommendations for Implementing Change (ERIC) strategies and used in a second round of targeted coding, then assessed for degree of alignment to contextual barriers. RESULTS: Four enablers, seven barriers, and three mixed factors were found, including perceived limitations in the confidential nature of the online messaging tool ('Design quality and packaging'), which had downstream challenges for the capacity to provide feedback about utilisation of Ethos ('Goals and Feedback', 'Access to Knowledge and Information'). Fourteen recommended implementation strategies were used, however, only four of these were operationalised to completely address contextual barriers. CONCLUSION: Aspects of the inner setting (e.g., 'Leadership Engagement', 'Tension for Change') had the greatest influence on implementation and should be considered prior to the implementation of future professional accountability programs. Theory can improve understanding of factors affecting implementation, and support strategies to address them.
Asunto(s)
Hospitales , Humanos , Australia , Estudios RetrospectivosRESUMEN
Introduction: "Mainstreaming" is a proposed strategy to integrate genomic testing into oncology. The aim of this paper is to develop a mainstreaming oncogenomics model by identifying health system interventions and implementation strategies for mainstreaming Lynch syndrome genomic testing. Methods: A rigorous theoretical approach inclusive of conducting a systematic review and qualitative and quantitative studies was undertaken using the Consolidated Framework for Implementation Research. Theory-informed implementation data were mapped to the Genomic Medicine Integrative Research framework to generate potential strategies. Results: The systematic review identified a lack of theory-guided health system interventions and evaluation for Lynch syndrome and other mainstreaming programs. The qualitative study phase included 22 participants from 12 health organizations. The quantitative Lynch syndrome survey included 198 responses: 26% and 66% from genetic and oncology health professionals, respectively. Studies identified the relative advantage and clinical utility of mainstreaming to improve genetic test access and to streamline care, and adaptation of current processes was recognized for results delivery and follow-up. Barriers identified included funding, infrastructure and resources, and the need for process and role delineation. The interventions to overcome barriers were as follows: embedded mainstream genetic counselors, electronic medical record genetic test ordering, results tracking, and mainstreaming education resources. Implementation evidence was connected through the Genomic Medicine Integrative Research framework resulting in a mainstreaming oncogenomics model. Discussion: The proposed mainstreaming oncogenomics model acts as a complex intervention. It features an adaptable suite of implementation strategies to inform Lynch syndrome and other hereditary cancer service delivery. Implementation and evaluation of the model are required in future research.