scholarly journals Impact of a health literacy intervention combining general practitioner training and a consumer facing intervention to improve colorectal cancer screening in underserved areas: protocol for a multicentric cluster randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marie-Anne Durand ◽  
Aurore Lamouroux ◽  
Niamh M. Redmond ◽  
Michel Rotily ◽  
Aurélie Bourmaud ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Health Literacy ◽  
Normalization Process Theory ◽  
Trial Registration ◽  
Process Theory ◽  
Crc Screening ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
The Impact ◽  
Normalization Process

Abstract Background Colorectal cancer (CRC) is a leading cause of cancer burden worldwide. In France, it is the second most common cause of cancer death after lung cancer. Systematic uptake of CRC screening can improve survival rates. However, people with limited health literacy (HL) and lower socioeconomic position rarely participate. Our aim is to assess the impact of an intervention combining HL and CRC screening training for general practitioners (GPs) with a pictorial brochure and video targeting eligible patients, to increase CRC screening and other secondary outcomes, after 1 year, in several underserved geographic areas in France. Methods We will use a two-arm multicentric randomized controlled cluster trial with 32 GPs primarily serving underserved populations across four regions in France with 1024 patients recruited. GPs practicing in underserved areas (identified using the European Deprivation Index) will be block-randomized to: 1) a combined intervention (HL and CRC training + brochure and video for eligible patients), or 2) usual care. Patients will be included if they are between 50 and 74 years old, eligible for CRC screening, and present to recruited GPs. The primary outcome is CRC screening uptake after 1 year. Secondary outcomes include increasing knowledge and patient activation. After trial recruitment, we will conduct semi-structured interviews with up to 24 GPs (up to 8 in each region) and up to 48 patients (6 to 12 per region) based on data saturation. We will explore strategies that promote the intervention’s sustained use and rapid implementation using Normalization Process Theory. We will follow a community-based participatory research approach throughout the trial. For the analyses, we will adopt a regression framework for all quantitative data. We will also use exploratory mediation analyses. We will analyze all qualitative data using a framework analysis guided by Normalization Process Theory. Discussion Limited HL and its impact on the general population is a growing public health and policy challenge worldwide. It has received limited attention in France. A combined HL intervention could reduce disparities in CRC screening, increase screening rates among the most vulnerable populations, and increase knowledge and activation (beneficial in the context of repeated screening). Trial registration Registry: ClinicalTrials.gov. Trial registration number: 2020-A01687-32. Date of registration: 17th November 2020.

scholarly journals ‘It Opened My Eyes’—examining the impact of a multifaceted chlamydia testing intervention on general practitioners using Normalization Process Theory

2018 ◽  
Vol 35 (5) ◽  
pp. 626-632 ◽  
Author(s):  
Anna Yeung ◽  
Jane Hocking ◽  
Rebecca Guy ◽  
Christopher K Fairley ◽  
Kirsty Smith ◽  
...  
Keyword(s):  
General Practitioners ◽  
Normalization Process Theory ◽  
Process Theory ◽  
Chlamydia Testing ◽  
The Impact ◽  
Normalization Process

scholarly journals Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rui Luo ◽  
Fangfang Zheng ◽  
Haobo Zhang ◽  
Weiquan Zhu ◽  
Penghui He ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Natural Orifice ◽  
Specimen Extraction ◽  
Natural Orifice Specimen Extraction ◽  
Robotic Assisted ◽  
Randomized Controlled ◽  
Robotic Assisted Surgery ◽  
Secondary Outcomes

Abstract Background Natural orifice specimen extraction surgery for colorectal cancer has been introduced in order to reduce the abdominal incision, demonstrating major development potential in minimally invasive surgery. We are conducting this randomized controlled trial to assess whether robotic NOSES is non-inferior to traditional robotic-assisted surgery for patients with colorectal cancer in terms of primary and secondary outcomes. Method/design Accordingly, a prospective, open-label, randomized controlled, parallel-group, multicenter, and non-inferiority trial will be conducted to discuss the safety and efficacy of robotic natural orifice extraction surgery compared to traditional robotic-assisted surgery. Here, 550 estimated participants will be enrolled to have 80% power to detect differences with a one-sided significance level of 0.025 in consideration of the non-inferiority margin of 10%. The primary outcome is the incidence of surgical complications, which will be classified using the Clavien-Dindo system. Discussion This trial is expected to reveal whether robotic NOSES is non-inferior to traditional robotic-assisted surgery, which is of great significance in regard to the development of robotic NOSES for patients with colorectal cancer in the minimally invasive era. Furthermore, robotic NOSES is expected to exhibit superiority to traditional robotic-assisted surgery in terms of both primary and secondary outcomes. Trial registration ClinicalTrials.govNCT04230772. Registered on January 15, 2020.

scholarly journals National Colorectal Cancer Screening Program in Lithuania: Description of the 5-Year Performance on Population Level

Cancers ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 1129
Author(s):  
Audrius Dulskas ◽  
Tomas Poskus ◽  
Inga Kildusiene ◽  
Ausvydas Patasius ◽  
Rokas Stulpinas ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Quality Assurance ◽  
Cancer Screening ◽  
Colorectal Cancer Screening ◽  
Screening Program ◽  
Histopathological Examination ◽  
Insurance Fund ◽  
Crc Screening ◽  
Cancer Screening Program ◽  
The Impact

We aimed to report the results of the implementation of the National Colorectal Cancer (CRC) Screening Program covering all the country. The National Health Insurance Fund (NHIF) reimburses the institutions for performing each service; each procedure within the program has its own administrative code. Information about services provided within the program was retrieved from the database of NHIF starting from the 1 January 2014 to the 31 December 2018. Exact date and type of all provided services, test results, date and results of biopsy and histopathological examination were extracted together with the vital status at the end of follow-up, date of death and date of emigration when applicable for all men and women born between 1935 and 1968. Results were compared with the guidelines of the European Union for quality assurance in CRC screening and diagnosis. The screening uptake was 49.5% (754,061 patients) during study period. Participation rate varied from 16% to 18.1% per year and was higher among women than among men. Proportion of test-positive and test-negative results was similar during all the study period—8.7% and 91.3% annually. Between 9.2% and 13.5% of test-positive patients received a biopsy of which 52.3–61.8% were positive for colorectal adenoma and 4.6–7.3% for colorectal carcinoma. CRC detection rate among test-positive individuals varied between 0.93% and 1.28%. The colorectal cancer screening program in Lithuania coverage must be improved. A screening database is needed to systematically evaluate the impact and performance of the national CRC screening program and quality assurance within the program.

scholarly journals Combining Realist approaches and Normalization Process Theory to understand implementation: a systematic review

2021 ◽  
Vol 2 (1) ◽  
Author(s):  
Sonia Michelle Dalkin ◽  
Rebecca J. L. Hardwick ◽  
Catherine A. Haighton ◽  
Tracy L. Finch
Keyword(s):  
Systematic Review ◽  
Health Management ◽  
Explanatory Power ◽  
Family Health ◽  
Realist Evaluation ◽  
Normalization Process Theory ◽  
Process Theory ◽  
Scientific Realist ◽  
Health Database ◽  
Normalization Process

Abstract Background Realist approaches and Normalization Process Theory (NPT) have both gained significant traction in implementation research over the past 10 years. The aim of this study was therefore to explore how the approaches are combined to understand problems of implementation, to determine the degree of complementarity of the two approaches and to provide practical approaches for using them together. Methods Systematic review of research studies combining Realist and NPT approaches. Realist methodology is concerned with understanding and explaining causation, that is, how and why policies, programmes and interventions achieve their effects. NPT is a theory of implementation that explains how practices become normalised. Databases searched (January 2020) were ASSIA, CINAHL, Health Research Premium Collection via Proquest (Family Health Database, Health & Medical Collection, Health Management Database, MEDLINE, Nursing & Allied Health Database, Psychology Database, Public Health Database) and PsycARTICLES. Studies were included if the author(s) stated they used both approaches: a scientific Realist perspective applying the principles of Pawson and Tilley’s Realist Evaluation or Pawson’s Realist Synthesis and Normalization Process Theory either solely or in addition to other theories. Two authors screened records; discrepancies were reviewed by a third screener. Data was extracted by three members of the team and a narrative synthesis was undertaken. Results Of 245 total records identified, 223 unique records were screened and 39 full-text papers were reviewed, identifying twelve papers for inclusion in the review. These papers represented eight different studies. Extent and methods of integration of the approaches varied. In most studies (6/8), Realist approaches were the main driver. NPT was mostly used to enhance the explanatory power of Realist analyses, informing development of elements of Contexts, Mechanisms and Outcomes (a common heuristic in realist work). Authors’ reflections on the integration of NPT and Realist approaches were limited. Conclusions Using Realist and NPT approaches in combination can add explanatory power for understanding the implementation of interventions and programmes. Attention to detailed reporting on methods and analytical process when combining approaches, and appraisal of theoretical and practical utility is advised for advancing knowledge of applying these approaches in research. Systematic review registration Not registered.

scholarly journals The Swedish version of the Normalization Process Theory Measure S-NoMAD: translation, adaptation, and pilot testing

2018 ◽  
Vol 13 (1) ◽  
Author(s):  
Marie Elf ◽  
Sofi Nordmark ◽  
Johan Lyhagen ◽  
Inger Lindberg ◽  
Tracy Finch ◽  
...  
Keyword(s):  
Normalization Process Theory ◽  
Process Theory ◽  
Swedish Version ◽  
Pilot Testing ◽  
Normalization Process
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