61 research outputs found

    Methods to Estimate the Comparative Effectiveness of Clinical Strategies that Administer the Same Intervention at Different Times

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    Clinical guidelines that rely on observational data due to the absence of data from randomized trials benefit when the observational data or its analysis emulates trial data or its analysis. In this paper, we review a methodology for emulating trials that compare the effects of different timing strategies, that is, strategies that vary the frequency of delivery of a medical intervention or procedure. We review trial emulation for comparing (i) single applications of the procedure at different times, (ii) fixed schedules of application, and (iii) schedules adapted to the evolving clinical characteristics of the patients. For illustration, we describe an application in which we estimate the effect of surveillance colonoscopies in patients who had an adenoma detected during the Norwegian Colorectal Cancer Prevention (NORCCAP) trial

    Følger Helsedirektoratets retningslinjer internasjonale standarder for troverdighet?

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    BAKGRUNN - Helsedirektoratet produserer nasjonale faglige retningslinjer for helsetjenesten, og utviklingen av retningslinjene skal følge internasjonale standarder for troverdighet. Vi undersøkte om standardene blir fulgt. MATERIALE OG METODE - Vi benyttet skåringsverktøyet National Guideline Clearinghouse Extent of Adherence to Trustworthy Standards Instrument (NEATS), og vurderte ett tilfeldig valgt kapittel fra nasjonale faglige retningslinjer publisert eller oppdatert fra 2013 til januar 2022. NEATS har 15 domener: tre vurderes med svaralternativene ja/nei/ukjent, og tolv vurderes på en Likert-skala fra 1 til 5, der 1 tilsvarer svært lav troverdighet og 5 utmerket troverdighet. Vurderingene ble gjort individuelt av to forfattere. Interobservatørsamsvar ble vurdert med eksakt og nært samsvar samt Cohens kappa. RESULTATER - Vi inkluderte 60 gjeldende retningslinjer. For ni av tolv NEATS-domener vurdert med Likert-skala var det svært lav eller lav overholdelse av standarder for troverdige retningslinjer (median skår 1 eller 2). Domenene med lavest skår (median skår 1) var «studieseleksjon», «beskrivelse av studiene og resultatene», «gradering av styrken på anbefalingene» og «ekstern høring». Domenet med høyest skår var «spesifikk og utvetydig formulering av anbefalingene» (median skår 4). FORTOLKNING - Flertallet av de nasjonale faglige retningslinjene overholdt i liten grad standarder for troverdige retningslinjer vurdert med skåringsverktøyet NEATS.<p

    Mortality in Norway and Sweden during the COVID-19 pandemic

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    Background: Norway and Sweden are similar countries in terms of socioeconomics and health care. Norway implemented extensive COVID-19 measures, such as school closures and lockdowns, whereas Sweden did not. Aims: To compare mortality in Norway and Sweden, two similar countries with very different mitigation measures against COVID-19. Methods: Using real-world data from national registries, we compared all-cause and COVID-19-related mortality rates with 95% confidence intervals (CI) per 100,000 person-weeks and mortality rate ratios (MRR) comparing the five preceding years (2015–2019) with the pandemic year (2020) in Norway and Sweden. Results: In Norway, all-cause mortality was stable from 2015 to 2019 (mortality rate 14.6–15.1 per 100,000 person-weeks; mean mortality rate 14.9) and was lower in 2020 than from 2015 to 2019 (mortality rate 14.4; MRR 0.97; 95% CI 0.96–0.98). In Sweden, all-cause mortality was stable from 2015 to 2018 (mortality rate 17.0–17.8; mean mortality rate 17.1) and similar to that in 2020 (mortality rate 17.6), but lower in 2019 (mortality rate 16.2). Compared with the years 2015–2019, all-cause mortality in the pandemic year was 3% higher due to the lower rate in 2019 (MRR 1.03; 95% CI 1.02–1.04). Excess mortality was confined to people aged ⩾70 years in Sweden compared with previous years. The COVID-19-associated mortality rates per 100,000 person-weeks during the first wave of the pandemic were 0.3 in Norway and 2.9 in Sweden. Conclusions: All-cause mortality in 2020 decreased in Norway and increased in Sweden compared with previous years. The observed excess deaths in Sweden during the pandemic may, in part, be explained by mortality displacement due to the low all-cause mortality in the previous year

    A pilot study of implementation of endoscopic sleeve gastroplasty (ESG) in Norway

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    Background and aim - Bariatric surgery is the most effective treatment for obesity but is invasive and associated with serious complications. Endoscopic sleeve gastroplasty (ESG) is a less invasive weight loss procedure to reduce the stomach volume by full-thickness sutures. ESG has been adopted in many countries, but implementation at Scandinavian centres has not yet been documented. We performed a clinical pilot trial at a Norwegian centre with the primary objective to assess the feasibility of the ESG procedure. Patients and methods - We included the first 10 patients treated with ESG at a Norwegian centre in a single-arm pilot study. The eligibility criteria were either a body mass index (BMI) of 40–49.9 kg/m2, BMI 35–39.9 kg/m2 and at least one obesity-related comorbidity, or BMI 30–34.9 kg/m2 and type 2 diabetes. Patient follow-up resembled the scheme used for bariatric surgery at the center, including dietary plans and outpatient visits. Results - All procedures were technically successful except for one patient who had adhesions between the stomach and anterior abdominal wall, related to a prior hernia repair, resulting in less-than-intended stomach volume reduction. Mean total body weight loss (TBWL) after 26 and 52 weeks was 12.2% (95% CI 8.1–16.2) and 9.1% (95% CI 3.3 − 15.0). One patient experienced a minor suture-induced diaphragmatic injury, which was successfully managed conservatively. Conclusions - This first Scandinavian clinical trial of ESG, documenting the implementation of the procedure at a Norwegian center, demonstrated acceptable feasibility and safety, with large variations in individual weight loss during the 52-week follow-up period

    Improved breast cancer survival following introduction of an organized mammography screening program among both screened and unscreened women: a population-based cohort study

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    Introduction: Mammography screening reduces breast cancer mortality through earlier diagnosis but may convey further benefit if screening is associated with optimized treatment through multidisciplinary medical care. In Norway, a national mammography screening program was introduced among women aged 50 to 69 years during 1995/6 to 2004. Also during this time, multidisciplinary breast cancer care units were implemented. Methods: We constructed three cohorts of breast cancer patients: 1) the pre-program group comprising women diagnosed and treated before mammography screening began in their county of residence, 2) the post-program group comprising women diagnosed and treated through multidisciplinary breast cancer care units in their county but before they had been invited to mammography screening; and 3) the screening group comprising women diagnosed and treated after invitation to screening. We calculated Kaplan-Meier plots and multivariable Cox proportional hazard models. Results: We studied 41,833 women with breast cancer. The nine-year breast cancer-specific survival rate was 0.66 (95%CI: 0.65 to 0.67) in the pre-program group; 0.72 (95%CI: 0.70 to 0.74) in the post-program group; and 0.84 (95%CI: 0.80 to 0.88) in the screening group. In multivariable analyses, the risk of death from breast cancer was 14% lower in the post-program group than in the pre-program group (hazard ratio 0.86; (95%CI: 0.78 to 0.95, P = 0.003)). Conclusions: After nine years follow-up, at least 33% of the improved survival is attributable to improved breast cancer management through multidisciplinary medical care

    Colorectal cancer screening with faecal immunochemical testing, sigmoidoscopy or colonoscopy: a clinical practice guideline

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    Clinical question Recent 15-year updates of sigmoidoscopy screening trials triggered the clinical questions: Does colorectal cancer screening make an important difference to health outcomes in individuals initiating screening at age 50 to 79? Is there a preferable approach among the screening options faecal immunochemical test (FIT) every year or every two years, or a single sigmoidoscopy or colonoscopy

    Towards a cancer mission in Horizon Europe: recommendations.

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    A comprehensive translational cancer research approach focused on personalized and precision medicine, and covering the entire cancer research-care-prevention continuum has the potential to achieve in 2030 a 10-year cancer-specific survival for 75% of patients diagnosed in European Union (EU) member states with a well-developed healthcare system. Concerted actions across this continuum that spans from basic and preclinical research through clinical and prevention research to outcomes research, along with the establishment of interconnected high-quality infrastructures for translational research, clinical and prevention trials and outcomes research, will ensure that science-driven and social innovations benefit patients and individuals at risk across the EU. European infrastructures involving comprehensive cancer centres (CCCs) and CCC-like entities will provide researchers with access to the required critical mass of patients, biological materials and technological resources and can bridge research with healthcare systems. Here, we prioritize research areas to ensure a balanced research portfolio and provide recommendations for achieving key targets. Meeting these targets will require harmonization of EU and national priorities and policies, improved research coordination at the national, regional and EU level and increasingly efficient and flexible funding mechanisms. Long-term support by the EU and commitment of Member States to specialized schemes are also needed for the establishment and sustainability of trans-border infrastructures and networks. In addition to effectively engaging policymakers, all relevant stakeholders within the entire continuum should consensually inform policy through evidence-based advice
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