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The Centre for Evidence-Based Medicine (CEBM) at Oxford University develops, promotes and disseminates better evidence for health care.
Management of asthma in primary care in the changing context of the COVID-19 pandemic: a qualitative longitudinal study with patients
Background: The COVID-19 pandemic dramatically affected asthma monitoring in primary care. Yet, patients’ views and experiences of managing their asthma and seeking help from primary care during the pandemic have not been explored. Aim: To investigate patients’ experiences of asthma management in the community during the COVID-19 pandemic. Design and setting: A qualitative longitudinal study using semi-structured interviews with asthma patients usually managed in primary care. Method: Interviews were audio recorded, transcribed and analysed using inductive temporal thematic analysis and trajectory approach. Results: Forty-six interviews were conducted with 18 asthma patients over eight months that covered contrasting stages of the pandemic. Patients felt less vulnerable as the pandemic subsided but the process of making sense of risk was dynamic and influenced by multiple factors. Patients relied on self-management strategies but felt that routine asthma reviews should still have been conducted during the COVID-19 pandemic and highlighted limited opportunities to discuss their asthma with health care professionals. Patients with well controlled symptoms felt that remote reviews were largely satisfactory but still felt that face to face reviews were necessary for certain aspects such as physical examination and patient-led discussion of sensitive or broader issues associated with asthma including mental health. Conclusions: The dynamic nature of patients’ perception of risk throughout the pandemic highlighted the need for a greater clarity regarding patients’ personal risk. Having opportunity to discuss their asthma is important to patients even during periods when access to face to face consultations in primary care is more restricted than usual.
Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis.
Background: Oral hormone pregnancy tests (HPTs), such as Primodos, containing ethinylestradiol and high doses of norethisterone, were given to over a million women from 1958 to 1978, when Primodos was withdrawn from the market because of concerns about possible teratogenicity. We aimed to study the association between maternal exposure to oral HPTs and congenital malformations. Methods: We have performed a systematic review and meta-analysis of case-control and cohort studies that included data from pregnant women and were exposed to oral HPTs within the estimated first three months of pregnancy, if compared with a relevant control group. We used random-effects meta-analysis and assessed the quality of each study using the Newcastle-Ottawa Scale for non-randomized studies. Results: We found 16 case control studies and 10 prospective cohort studies, together including 71 330 women, of whom 4,209 were exposed to HPTs. Exposure to oral HPTs was associated with a 40% increased risk of all congenital malformations: pooled odds ratio (OR) = 1.40 (95% CI 1.18 to 1.66; P<0.0001; I 2 = 0%). Exposure to HPTs was associated with an increased risk of congenital heart malformations: pooled OR = 1.89 (95% CI 1.32 to 2.72; P = 0.0006; I 2=0%); nervous system malformations OR = 2.98 (95% CI 1.32 to 6.76; P = 0.0109 I 2 = 78%); gastrointestinal malformations, OR = 4.50 (95% CI 0.63 to 32.20; P = 0.13; I 2 = 54%); musculoskeletal malformations, OR = 2.24 (95% CI 1.23 to 4.08; P= 0.009; I 2 = 0%); the VACTERL syndrome (Vertebral defects, Anal atresia, Cardiovascular anomalies, Tracheoesophageal fistula, Esophageal atresia, Renal anomalies, and Limb defects), OR = 7.47 (95% CI 2.92 to 19.07; P < 0.0001; I 2 = 0%). Conclusions: This systematic review and meta-analysis shows that use of oral HPTs in pregnancy is associated with increased risks of congenital malformations.
Association of Weight Loss in Ambulatory Care Settings with First Diagnosis of Lung Cancer in the US
IMPORTANCE Lung cancer, the US's leading cause of cancer death, is often diagnosed following presentation to health care settings with symptoms, and many patients present with late stage disease. OBJECTIVE To investigate the association between weight loss and subsequent diagnosis of incident lung cancer in an ambulatory care population and to assess whether recorded weight change had higher odds of lung cancer diagnosis than objective measurements. DESIGN, SETTING, AND PARTICIPANTS This case-control study included patients visiting a US academic medical center between January 1, 2012, and December 31, 2019. Data were derived from US ambulatory care electronic health records from the University of Washington Medical Center linked to the local Surveillance, Epidemiology, and End Results cancer registry. Cases were identified from patients who had a primary lung cancer diagnosis between 2012 and 2019; controls were matched on age, sex, smoking status, and presenting to the same type of ambulatory clinic as cases. Data were analyzed from March 2022 through January 2023. EXPOSURE Continuous and categorical weight change were assessed. MAIN OUTCOMES AND MEASURES Odds ratios estimating the likelihood of a diagnosis of lung cancer were calculated using univariable and multivariable conditional logistic regression. RESULTS A total of 625 patients aged 40 years or older with a first primary lung cancer diagnosis and 4606 matched controls were included (1915 [36.6%] ages 60 to 69 years; 418 [8.0%] Asian, 389 [7.4%] Black, 4092 [78.2%] White). In unadjusted analyses, participants with weight loss of 1% to 3% (odds ratio [OR], 1.12; 95% CI, 0.88-1.41), 3% to 5% (OR, 1.36; 95% CI, 0.99-1.88), or 5% to 10% (OR, 1.23; 95% CI, 0.82-1.85) over a 2-year period did not have statistically significantly increased risk of lung cancer diagnosis compared with those who maintained a steady weight. However, participants with weight loss of 10% to 50% had more than twice the odds of a lung cancer diagnosis (OR, 2.27; 95% CI, 1.27-4.05). Most categories of weight loss showed significant associations with an increased risk of lung cancer diagnosis for at least 6 months prior to diagnosis. Patients who had weight loss both recorded in clinicians’ notes and measured had higher odds of lung cancer compared with patients who had only recorded (OR, 1.26; odds; 95% CI, 1.04-1.52) or measured (OR, 8.53; 95% CI, 6.99-10.40) weight loss. CONCLUSIONS AND RELEVANCE In this case-control study, weight loss in the prior 6 months was associated with incident lung cancer diagnosis and was present whether weight loss was recorded as a symptom by the clinician or based on changes in routinely measured weight, demonstrating a potential opportunity for early diagnosis. The association between measured and recorded weight loss by clinicians presents novel results for the US.
Home-built environment interventions and inflammation biomarkers: a systematic review and meta-analysis protocol
Background: Inflammation control is a fundamental part of chronic care in patients with a history of cancer and comorbidity. As the risk–benefit profile of anti-inflammatory drugs is unclear in survivors of cancer, GPs and patients could benefit from alternative non-pharmacological treatment options for dysregulated inflammation. There is a potential for home-built environment (H-BE) interventions to modulate inflammation; however, discrepancies exist between studies. Aim: To evaluate the effectiveness of H-BE interventions on cancer-associated inflammation biomarkers. Design & setting: A systematic review and meta-analysis of randomised and non-randomised trials in community-dwelling adults. Method: PubMed and MEDLINE, Embase, Web of Science, and Google Scholar will be searched for clinical trials published in January 2000 onwards. The study will include H-BE interventions modifying air quality, thermal comfort, non-ionising radiation, noise, nature, and water. No restrictions to study population will be applied to allow deriving expectations for effects of the interventions in cancer survivors from available source populations. Outcome measures will be inflammatory biomarkers clinically and physiologically relevant to cancer. The first reviewer will independently screen articles together with GPs and extract data that will be verified by a second reviewer. The quality of studies will be assessed using the Cochrane risk-of-bias tools. Depending on the clinical and methodological homogeneity of populations, interventions, and outcomes, a meta-analysis will be conducted using random-effects models. Conclusion: Findings will determine the effectiveness of H-BE interventions on inflammatory parameters, guide future directions for its provision in community-dwelling survivors of cancer and support GPs with safer anti-inflammatory treatment options in high-risk patients for clinical complications.
Changes in medication safety indicators in England throughout the covid-19 pandemic using OpenSAFELY: population based, retrospective cohort study of 57 million patients using federated analytics
ObjectiveTo implement complex, PINCER (pharmacist led information technology intervention) prescribing indicators, on a national scale with general practice data to describe the impact of the covid-19 pandemic on safe prescribing.DesignPopulation based, retrospective cohort study using federated analytics.SettingElectronic general practice health record data from 56.8 million NHS patients by use of the OpenSAFELY platform, with the approval of the National Health Service (NHS) England.ParticipantsNHS patients (aged 18-120 years) who were alive and registered at a general practice that used TPP or EMIS computer systems and were recorded as at risk of at least one potentially hazardous PINCER indicator.Main outcome measureBetween 1 September 2019 and 1 September 2021, monthly trends and between practice variation for compliance with 13 PINCER indicators, as calculated on the first of every month, were reported. Prescriptions that do not adhere to these indicators are potentially hazardous and can cause gastrointestinal bleeds; are cautioned against in specific conditions (specifically heart failure, asthma, and chronic renal failure); or require blood test monitoring. The percentage for each indicator is formed of a numerator of patients deemed to be at risk of a potentially hazardous prescribing event and the denominator is of patients for which assessment of the indicator is clinically meaningful. Higher indicator percentages represent potentially poorer performance on medication safety.ResultsThe PINCER indicators were successfully implemented across general practice data for 56.8 million patient records from 6367 practices in OpenSAFELY. Hazardous prescribing remained largely unchanged during the covid-19 pandemic, with no evidence of increases in indicators of harm as captured by the PINCER indicators. The percentage of patients at risk of potentially hazardous prescribing, as defined by each PINCER indicator, at mean quarter 1 (Q1) 2020 (representing before the pandemic) ranged from 1.11% (age ≥65 years and non-steroidal anti-inflammatory drugs) to 36.20% (amiodarone and no thyroid function test), while Q1 2021 (representing after the pandemic) percentages ranged from 0.75% (age ≥65 years and non-steroidal anti-inflammatory drugs) to 39.23% (amiodarone and no thyroid function test). Transient delays occurred in blood test monitoring for some medications, particularly angiotensin-converting enzyme inhibitors (where blood monitoring worsened from a mean of 5.16% in Q1 2020 to 12.14% in Q1 2021, and began to recover in June 2021). All indicators substantially recovered by September 2021. We identified 1 813 058 patients (3.1%) at risk of at least one potentially hazardous prescribing event.ConclusionNHS data from general practices can be analysed at national scale to generate insights into service delivery. Potentially hazardous prescribing was largely unaffected by the covid-19 pandemic in primary care health records in England.
SARS-CoV-2 and the role of airborne transmission: a systematic review
Background: Airborne transmission is the spread of an infectious agent caused by the dissemination of droplet nuclei (aerosols) that remain infectious when suspended in the air. We carried out a systematic review to identify, appraise and summarise the evidence from studies of the role of airborne transmission of SARS-CoV-2. Methods: We searched LitCovid, MedRxiv, Google Scholar and the WHO Covid-19 database from 1 February 2020 to 30 May 2022 and included studies on airborne transmission. Data were dual extracted, and we assessed quality using a modified QUADAS 2 risk of bias tool. Results: We included 128 primary studies and 29 reviews on airborne SARS-CoV-2. Of the 128 primary studies, 105 (82%) reported data on RT-PCR from air samples, 28 (22%) report cycle threshold values and 36 (28%) copies per sample volume. All primary studies were observational. The research often lacked standard methods, standard sampling sizes and reporting items. We found 69 descriptions of different air samplers deployed. Of the 80 in-hospital studies that reported binary RT-PCR tests, 362/3079 air samples from 75 studies conducted in hospital ward environments were positive (median 8%, IQR=0 to 23%); 23 studies reported 74/703 RT-PCR positive air samples in the ICU setting (median 17%, IQR=0% to 38%) Thirty-eight studies reported potential air transmission in the outdoors or in the community. Twenty-six studies attempted viral culture, none of which definitively demonstrated that replication-competent SARS-CoV-2 could be recovered in the air. Conclusion: SARS-CoV-2 RNA is detectable intermittently in the air in various settings. Standardized guidelines for conducting and reporting research on airborne transmission are needed. The lack of recoverable viral culture of SARS-CoV-2 from air samples prevents firm conclusions about the definitive role of airborne transmission in SARS-CoV-2.
CARE Guidelines for Case Reports: Explanation and Elaboration Document. Translation into Russian
Background. Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 2011–2012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages.Objectives. This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports.Article design and setting. Each item from the CARE Checklist is explained and accompanied by published examples. The explanations and examples in this document are designed to support the writing of high-quality case reports by authors and their critical appraisal by editors, peer reviewers, and readers.Results and conclusion. This article and the 2013 CARE Statement and Checklist, available from the CARE website [www.care-statement.org] and the EQUATOR Network [www.equator-network.org], are resources for improving the completeness and transparency of case reports.Source. This article is a translation of the original paper «CARE guidelines for case reports: explanation and elaboration document» in the Journal of Clinical Epidemiology (doi: 10.1016/j.jclinepi.2017.04.026), prepared under the permission of the copyright holder (Elsevier Inc.), with supervision from the Scientific Editor by Professor E.G. Starostina, MD, PhD (translator) (Moscow, Russia). Present translation was first published in Digital Diagnostics. doi: 10.17816/DD105291. It is published with minor changes related to the literary editing of the translation itself. Keywords: case report; case study; EQUATOR network; health research reporting guidelines; CARE guideline; timelines; N-of-1 For citation: Riley David S., Barber Melissa S., Kienle Gunver S., Aronson Jeffrey K., von Schoen-Angerer Tido, Tugwell Peter, Kiene Helmut, Helfand Mark, Altman Douglas G., Sox Harold, Werthmann Paul G., Moher David, Rison Richard A., Shamseer Larissa, Koch Christian A., Sun Gordon H., Hanaway Patrick, Sudak Nancy L., Kaszkin-Bettag Marietta, Carpenter James E., Gagnier Joel J. CARE Guidelines for Case Reports: Explanation and Elaboration Document. Translation into Russian. Voprosy sovremennoi pediatrii — Current Pediatrics. 2023;22(2):88–108. (In Russ). doi: https://doi.org/10.15690/vsp.v22i2.2540
The quality of paediatric asthma guidelines: evidence underpinning diagnostic test recommendations from a meta-epidemiological study
Abstract Background Asthma is one of the most frequent reasons children visit a general practitioner (GP). The diagnosis of childhood asthma is challenging, and a variety of diagnostic tests for asthma exist. GPs may refer to clinical practice guidelines when deciding which tests, if any, are appropriate, but the quality of these guidelines is unknown. Objectives To determine (i) the methodological quality and reporting of paediatric guidelines for the diagnosis of childhood asthma in primary care, and (ii) the strength of evidence supporting diagnostic test recommendations. Design Meta-epidemiological study of English-language guidelines from the United Kingdom and other high-income countries with comparable primary care systems including diagnostic testing recommendations for childhood asthma in primary care. The AGREE-II tool was used to assess the quality and reporting of the guidelines. The quality of the evidence was assessed using GRADE. Results Eleven guidelines met the eligibility criteria. The methodology and reporting quality varied across the AGREE II domains (median score 4.5 out of 7, range 2–6). The quality of evidence supporting diagnostic recommendations was generally of very low quality. All guidelines recommended the use of spirometry and reversibility testing for children aged ≥5 years, however, the recommended spirometry thresholds for diagnosis differed across guidelines. There were disagreements in testing recommendations for 3 of the 7 included tests. Conclusions The variable quality of guidelines, lack of good quality evidence, and inconsistent recommendations for diagnostic tests may contribute to poor clinician adherence to guidelines and variation in testing for diagnosing childhood asthma.