Appraising qualitative health research--towards a differentiated approach
Introduction Qualitative health research provides important evidence for healthcare practice and is the most suitable approach for exploring healthcare perspectives and experiences. Appraisal of health research is an essential part of practising evidence-based healthcare (EBHC). This applies to all types of research, be it quantitative or qualitative. Within EBHC education there has arguably been more attention paid to developing differentiated critical appraisal tools for different methodologies. Numerous frameworks and tools to aid the appraisal of specific research designs have been developed and published, usually in t...
Source: Evidence-Based Medicine - July 28, 2022 Category: Internal Medicine Authors: Williams, V., Boylan, A.-M., Newhouse, N., Nunan, D. Tags: EBM learning Source Type: research

Data-dredging bias
Background: what is data dredging bias? Data-dredging bias encompasses a number of more specific questionable practices (eg, fishing, p-hacking) all of which involve probing data using unplanned analyses and then reporting salient results without accurately describing the processes by which the results were generated. Almost any process of data analysis involves numerous decisions necessary to complete the analysis (eg, how to handle outliers, whether to combine groups, including/excluding covariates). Where possible, it is the best practice for these decisions to be guided by a principled approach and prespecified in a pu...
Source: Evidence-Based Medicine - July 28, 2022 Category: Internal Medicine Authors: Erasmus, A., Holman, B., Ioannidis, J. P. A. Tags: EBM learning Source Type: research

Colorectal cancer screening at a younger age: pitfalls in the model-based recommendation of the USPSTF
Over the last 15 years, there have been dramatic changes in colorectal cancer (CRC) screening guidelines by the US Preventive Services Task Force (USPSTF). In 2008, grade A USPSTF screening recommendations for CRC suggested adults aged 50–75 receive either a flexible sigmoidoscopy (FS), faecal occult blood test (FOBT) or colonoscopy.1 In 2016, the USPSTF expanded the screening recommendations to include faecal immunochemical tests (FITs) and blood-based cancer screening for methylated SEPT9 DNA,2 the latter of which is theorised to improve screening rates owing to its non-invasive nature and preference over stool tes...
Source: Evidence-Based Medicine - July 28, 2022 Category: Internal Medicine Authors: Powell, K., Prasad, V. Tags: EBM opinion and debate Source Type: research

Transparency of COVID-19 vaccine trials: decisions without data
Summary box Data transparency has become a well-established norm in biomedical research, and is especially important for broadly used public health interventions like COVID-19 vaccines. Tax payers helped fund COVID-19 vaccine trials and should have the right to access the results. There is inadequate availability of COVID-19 vaccine trial documents and data; individual participant data will not be available for months, perhaps years, for most vaccines. Widespread use of interventions without full data transparency raises concerns over the rational use of COVID-19 vaccines. Trial transparency must start early and be continu...
Source: Evidence-Based Medicine - July 28, 2022 Category: Internal Medicine Authors: Tanveer, S., Rowhani-Farid, A., Hong, K., Jefferson, T., Doshi, P. Tags: General Medicine, COVID-19 EBM analysis Source Type: research

Early experience with the FDAs regulatory review of novel gene therapies
Introduction Recent advances in gene therapies offer novel therapeutic options for many diseases that are otherwise resistant to pharmacologic treatment. Through gene therapy, scientists now have the opportunity to replace disease-causing genes with healthy copies, inactivate genes functioning improperly and introduce genes into the body to help fight disease.1 As of 31 December 2020, the US Food and Drug Administration (FDA) has approved five gene therapies, and more than 900 are in clinical development.2 Based on an assessment of the current pipeline, the FDA predicts it will approve 10–20 gene therapy products per...
Source: Evidence-Based Medicine - July 28, 2022 Category: Internal Medicine Authors: Puthumana, J., Egilman, A. C., Ramachandran, R., Naushad, N., Shah, N., Ross, J. Tags: EBM analysis Source Type: research

The 'double whammy of low prevalence in clinical risk prediction
Background Worldwide, around 800 000 people die each year from suicide,1 which is the leading cause of death in the UK in young adults.2 Prediction modelling studies have attempted to incorporate demographic, clinical and other factors to identify high-risk individuals so that appropriate interventions can be offered.3 4 This approach has a large literature but has not always been judged successful. In one review, all 35 suicide risk prediction studies assessed were classified as having high risk of bias or insufficient diagnostic accuracy, based on targets of 80% sensitivity and 50% specificity.5 Others have written of a ...
Source: Evidence-Based Medicine - July 28, 2022 Category: Internal Medicine Authors: Fanshawe, T. R., Fazel, S. Tags: EBM analysis Source Type: research

Quality appraisal of evidence generated during a crisis: in defence of 'timeliness and 'clarity as criteria
In 2020, SARS-CoV-2 spread across the globe with incredible speed. Policymakers had to make impossible decisions and act quickly. With gold-standard systematic reviews taking 6 months–2 years to complete,1 it is no surprise that many authors used rapid review methods instead in order to provide guidance in a matter of days or weeks. In their review, Abbott et al graded the quality of 280 reviews published in the first 5 months of the pandemic and found 46 that were rapid reviews.2 This included our paper3: ‘The psychological impact of quarantine and how to reduce it: rapid review of the evidence’. Rapid r...
Source: Evidence-Based Medicine - May 24, 2022 Category: Internal Medicine Authors: Rubin, G. J., Wessely, S., Greenberg, N., Brooks, S. K. Tags: Letters Source Type: research

Evidence on the efficacy of ivermectin for COVID-19: another story of apples and oranges
The antiparasitic ivermectin has received particular attention as a potential treatment option for COVID-19. Understandably, there is high interest in repurposing an approved inexpensive drug, readily available as an oral formulation. However, Garegnani et al1 recently pointed out the proportion of misleading information on ivermectin for COVID-19 published in journals, on preprint servers and websites. A relevant number of systematic reviews report the use of methodological tools such as assessing bias at study level with the Cochrane Risk of Bias tool or grading the certainty of the evidence following the Grading of Reco...
Source: Evidence-Based Medicine - May 24, 2022 Category: Internal Medicine Authors: Popp, M., Kranke, P., Meybohm, P., Metzendorf, M.-I., Skoetz, N., Stegemann, M. S., Weibel, S. Tags: Open access, COVID-19 Letters Source Type: research

COVID-19 information in news media: room for greater transparency
Access to accurate scientific information is of paramount importance, particularly amid a global pandemic. We access scientific information through various platforms, including social media, news outlets (print and video), Twitter, magazines, peer-reviewed journal articles and more recently, through preprints. However, following some high-profile retractions of influential COVID-19 scientific articles, there is much mistrust and confusion around what news is accurate.1 In situations like this, there is an even higher premium on ensuring that the data underlying scientific findings are publicly accessible. Thus, news outlet...
Source: Evidence-Based Medicine - May 24, 2022 Category: Internal Medicine Authors: Rowhani-Farid, A., Hong, K. Tags: COVID-19 Letters Source Type: research

Combination fixed-dose {beta} agonist and steroid inhaler as required for adults or children with mild asthma: a Cochrane systematic review
Conclusions FABA/ICS as required is clinically effective in adults and adolescents with mild asthma and reduced exacerbations, hospital admissions or unscheduled healthcare visits and exposure to systemic corticosteroids and probably reduces adverse events compared with FABA as required alone. FABA/ICS as required is as effective as regular ICS and reduced asthma-related hospital admissions or unscheduled healthcare visits, and average exposure to ICS, and is unlikely associated with increased adverse events. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - May 24, 2022 Category: Internal Medicine Authors: Crossingham, I., Turner, S., Ramakrishnan, S., Fries, A., Gowell, M., Yasmin, F., Richardson, R., Webb, P., O'Boyle, E., Hinks, T. S. C. Tags: Open access, Primary care Evidence synthesis Source Type: research

Characteristics, quality and volume of the first 5 months of the COVID-19 evidence synthesis infodemic: a meta-research study
Discussion This meta-research of early published COVID-19 evidence syntheses found low-quality reviews being published at pace, often with short publication turnarounds. Despite being of low quality and many lacking robust methods, the reviews received substantial attention across both academic and public platforms, and the attention was not related to the quality of review methods. Interpretation Flaws in systematic review methods limit the validity of a review and the generalisability of its findings. Yet, by being reported as ‘systematic reviews’, many readers may well regard them as high-quality evidence, ...
Source: Evidence-Based Medicine - May 24, 2022 Category: Internal Medicine Authors: Abbott, R., Bethel, A., Rogers, M., Whear, R., Orr, N., Shaw, L., Stein, K., Thompson Coon, J. Tags: Open access, COVID-19 Evidence synthesis Source Type: research

Face-to-face versus online clinically integrated EBM teaching in an undergraduate medical school: a pilot study
Conclusions It was feasible to deliver both models of clinically integrated EBM teaching. While students in the face-to-face model scored higher in EPs; there was no significant difference between the two models of teaching as measured by performances in the ACE tool or the summative assessments. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - May 24, 2022 Category: Internal Medicine Authors: Kumaravel, B., Stewart, C., Ilic, D. Tags: Original research Source Type: research

Can shared decision making address COVID-19 vaccine hesitancy?
Background The COVID-19 pandemic continues to affect millions of people worldwide. While hygiene, behavioural measures and government-driven restrictions are in place, a globally implemented vaccination programme shows promise at mitigating the levels of illness and mortality caused by the virus.1 The exceptional magnitude of the pandemic, combined with the unprecedented speed of vaccine development has caused difficulty ensuring that information is neutral, standardised, coherent and evidence-based.2 As a result, misinformation about the virus and the COVID-19 vaccine, often combined with conspiracy theories, has become a...
Source: Evidence-Based Medicine - May 24, 2022 Category: Internal Medicine Authors: Durand, M.-A., Scalia, P., Elwyn, G. Tags: COVID-19 EBM opinion and debate Source Type: research

Misleading clinical evidence and systematic reviews on ivermectin for COVID-19
Since WHO declared the COVID-19 as a pandemic,1 2 healthcare systems all over the world have focused their efforts on limiting the spread of SARS-CoV-2, and despite the ceaseless development of strategies to struggle with the impact of COVID-19, there is no sign of let-up. And the stress and overburden elicited by the pandemic—especially in vulnerable or marginalised populations—remain unstoppable, while the possibility of massive vaccination gives hope for a respite.3 4 Beyond public health interventions, several drugs have been considered for the treatment of SARS-CoV-2 infection,5 which triggers severe respi...
Source: Evidence-Based Medicine - May 24, 2022 Category: Internal Medicine Authors: Garegnani, L. I., Madrid, E., Meza, N. Tags: COVID-19 EBM opinion and debate Source Type: research

Patient-reported outcome measures (PROMs) as proof of treatment efficacy
Introduction In recent years, patient-reported outcome measures (PROMs) have become increasingly popular in clinical practice and clinical trials. In this paper, we highlight the need for introducing measures to control for the bias associated with these inherently subjective measures and combining PROMs with objective outcomes, which do not depend on judgement, experience or performance. PROMs measure the subjective elements of patients’ conditions, including health-related quality of life, pain intensity, activity limitations, participation restrictions, satisfaction or adherence to treatment and help to evaluate t...
Source: Evidence-Based Medicine - May 24, 2022 Category: Internal Medicine Authors: Kluzek, S., Dean, B., Wartolowska, K. A. Tags: Open access EBM opinion and debate Source Type: research