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1.
J Clin Epidemiol ; 2021 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-34752937

RESUMO

OBJECTIVE: To systematically survey the literature addressing the reporting of studies estimating anchor-based minimal important differences (MIDs) and choice of optimal MIDs. STUDY DESIGN AND SETTING: We searched Medline, Embase and PsycINFO from 1987 to March 2020. Teams of two reviewers independently identified eligible publications and extracted quotations addressing relevant issues for reporting and/or selecting anchor-based MIDs. Using a coding list, we assigned the same code to quotations capturing similar or related issues. For each code, we generated an 'item', i.e. a specific phrase or sentence capturing the underlying concept. When multiple concepts existed under a single code, the team created multiple items for that code. We clustered codes addressing a broader methodological issue into a 'category' and classified items as relevant for reporting, relevant for selecting an anchor-based MID, or both. RESULTS: We identified 136 eligible publications that provided 6 categories (MID definition, anchors, patient-reported outcome measures, generalizability and statistics) and 24 codes. These codes contained 34 items related to reporting MID studies, of which 29 were also related to selecting MIDs. CONCLUSION: The systematic survey identified items related to reporting of anchor-based MID studies and selecting optimal MIDs. These provide a conceptual framework to inform the design of studies related to MIDs, and a basis for developing a reporting standard and a selection approach for MIDs.

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3.
BMJ ; 375: e066045, 2021 Nov 25.
Artigo em Inglês | MEDLINE | ID: mdl-34824101

RESUMO

OBJECTIVE: To investigate whether alignment of strength of recommendations with quality of evidence differs in consensus based versus evidence based guidelines. DESIGN: Empirical analysis. DATA SOURCE: Guidelines developed by the American College of Cardiology and the American Heart Association (ACC/AHA) and the American Society of Clinical Oncology (ASCO) up to 27 March 2021. STUDY SELECTION: Recommendations were clearly categorised as consensus or evidence based, were separated from the remainder of the text, and included both the quality of evidence and the strength of the recommendations. DATA EXTRACTION: Paired authors independently extracted the recommendation characteristics, including type of recommendation (consensus or evidence based), grading system used for developing recommendations, strength of the recommendation, and quality of evidence. The study team also calculated the number of discordant recommendations (strong recommendations with low quality evidence) and inappropriate discordant recommendations (those that did not meet grading of recommendations assessment, development, and evaluation criteria of appropriateness). RESULTS: The study included 12 ACC/AHA guidelines that generated 1434 recommendations and 69 ASCO guidelines that generated 1094 recommendations. Of the 504 ACC/AHA recommendations based on low quality evidence, 200 (40%) proved to be consensus based versus 304 (60%) evidence based; of the 404 ASCO recommendations based on low quality evidence, 292 (72%) were consensus based versus 112 (28%) that were evidence based. In both ACC/AHA and ASCO guidelines, the consensus approach yielded more discordant recommendations (ACC/AHA: odds ratio 2.1, 95% confidence interval 1.5 to 3.1; ASCO: 2.9, 1.1 to 7.8) and inappropriate discordant recommendations (ACC/AHA: 2.6, 1.7 to 3.7; ASCO: 5.1, 1.6 to 16.0) than the evidence based approach. CONCLUSION: Consensus based guidelines produce more recommendations violating the evidence based medicine principles than evidence based guidelines. Ensuring appropriate alignment of quality of evidence with the strength of recommendations is key to the development of "trustworthy" guidelines.

4.
Artigo em Inglês | MEDLINE | ID: mdl-34770099

RESUMO

BACKGROUND: In addition to social and environmental determinants, people's values and preferences determine daily food choices. This study evaluated adults' values and preferences regarding unprocessed red meat (URM) and processed meat (PM) and their willingness to change their consumption in the face of possible undesirable health consequences. METHODS: A cross-sectional mixed-methods study including a quantitative assessment through an online survey, a qualitative inquiry through semi-structured interviews, and a follow-up assessment through a telephone survey. We performed descriptive statistics, logistic regressions, and thematic analysis. RESULTS: Of 304 participants, over 75% were unwilling to stop their consumption of either URM or PM, and of those unwilling to stop, over 80% were also unwilling to reduce. Men were less likely to stop meat intake than women (odds ratios < 0.4). From the semi-structured interviews, we identified three main themes: the social and/or family context of meat consumption, health- and non-health-related concerns about meat, and uncertainty of the evidence. At three months, 63% of participants reported no changes in meat intake. CONCLUSIONS: When informed about the cancer incidence and mortality risks of meat consumption, most respondents would not reduce their intake. Public health and clinical nutrition guidelines should ensure that their recommendations are consistent with population values and preferences.


Assuntos
Dieta , Carne Vermelha , Adulto , Estudos Transversais , Feminino , Preferências Alimentares , Humanos , Masculino , Carne
5.
BMJ ; 374: n2209, 2021 09 30.
Artigo em Inglês | MEDLINE | ID: mdl-34593374

RESUMO

OBJECTIVE: To determine if virtual care with remote automated monitoring (RAM) technology versus standard care increases days alive at home among adults discharged after non-elective surgery during the covid-19 pandemic. DESIGN: Multicentre randomised controlled trial. SETTING: 8 acute care hospitals in Canada. PARTICIPANTS: 905 adults (≥40 years) who resided in areas with mobile phone coverage and were to be discharged from hospital after non-elective surgery were randomised either to virtual care and RAM (n=451) or to standard care (n=454). 903 participants (99.8%) completed the 31 day follow-up. INTERVENTION: Participants in the experimental group received a tablet computer and RAM technology that measured blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, and body weight. For 30 days the participants took daily biophysical measurements and photographs of their wound and interacted with nurses virtually. Participants in the standard care group received post-hospital discharge management according to the centre's usual care. Patients, healthcare providers, and data collectors were aware of patients' group allocations. Outcome adjudicators were blinded to group allocation. MAIN OUTCOME MEASURES: The primary outcome was days alive at home during 31 days of follow-up. The 12 secondary outcomes included acute hospital care, detection and correction of drug errors, and pain at 7, 15, and 30 days after randomisation. RESULTS: All 905 participants (mean age 63.1 years) were analysed in the groups to which they were randomised. Days alive at home during 31 days of follow-up were 29.7 in the virtual care group and 29.5 in the standard care group: relative risk 1.01 (95% confidence interval 0.99 to 1.02); absolute difference 0.2% (95% confidence interval -0.5% to 0.9%). 99 participants (22.0%) in the virtual care group and 124 (27.3%) in the standard care group required acute hospital care: relative risk 0.80 (0.64 to 1.01); absolute difference 5.3% (-0.3% to 10.9%). More participants in the virtual care group than standard care group had a drug error detected (134 (29.7%) v 25 (5.5%); absolute difference 24.2%, 19.5% to 28.9%) and a drug error corrected (absolute difference 24.4%, 19.9% to 28.9%). Fewer participants in the virtual care group than standard care group reported pain at 7, 15, and 30 days after randomisation: absolute differences 13.9% (7.4% to 20.4%), 11.9% (5.1% to 18.7%), and 9.6% (2.9% to 16.3%), respectively. Beneficial effects proved substantially larger in centres with a higher rate of care escalation. CONCLUSION: Virtual care with RAM shows promise in improving outcomes important to patients and to optimal health system function. TRIAL REGISTRATION: ClinicalTrials.gov NCT04344665.


Assuntos
Assistência ao Convalescente/métodos , Monitorização Ambulatorial/métodos , Procedimentos Cirúrgicos Operatórios/enfermagem , Telemedicina/métodos , Idoso , COVID-19/epidemiologia , Canadá/epidemiologia , Feminino , Humanos , Masculino , Erros de Medicação/estatística & dados numéricos , Pessoa de Meia-Idade , Dor Pós-Operatória/epidemiologia , Pandemias , Alta do Paciente , Período Pós-Operatório , Procedimentos Cirúrgicos Operatórios/mortalidade
6.
Artigo em Inglês | MEDLINE | ID: mdl-34624540

RESUMO

Optimal evidence-based clinical practice requires systematic summaries of the best available evidence, including ratings of the quality of that evidence, and is facilitated by the availability of trustworthy guidelines. In this review, we describe the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to rating quality of evidence and moving from evidence to recommendations using examples from allergy-immunology. GRADE focuses on systematic summaries of the best evidence, systematic reviews and trustworthy guidelines, and emphasizes a structured approach to determining quality (certainty) of bodies of evidence, absolute magnitude of effects of desirable and undesirable consequences (benefits and harms), and use of evidence to develop clinical recommendations. Adopted by over 110 organizations worldwide, including the American Academy of Allergy, Asthma, and Immunology/American College of Allergy, Asthma, and Immunology Joint Task Force on Practice Parameters, GRADE is foundational to the optimal interpretation of research evidence and its application in clinical practice. This review supports the clinician's ability to find and use the information in GRADE guidelines to help care for patients in the clinic.

7.
Lancet Glob Health ; 2021 Oct 27.
Artigo em Inglês | MEDLINE | ID: mdl-34717820

RESUMO

BACKGROUND: Recent evidence indicates a potential therapeutic role of fluvoxamine for COVID-19. In the TOGETHER trial for acutely symptomatic patients with COVID-19, we aimed to assess the efficacy of fluvoxamine versus placebo in preventing hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to a tertiary hospital due to COVID-19. METHODS: This placebo-controlled, randomised, adaptive platform trial done among high-risk symptomatic Brazilian adults confirmed positive for SARS-CoV-2 included eligible patients from 11 clinical sites in Brazil with a known risk factor for progression to severe disease. Patients were randomly assigned (1:1) to either fluvoxamine (100 mg twice daily for 10 days) or placebo (or other treatment groups not reported here). The trial team, site staff, and patients were masked to treatment allocation. Our primary outcome was a composite endpoint of hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to tertiary hospital due to COVID-19 up to 28 days post-random assignment on the basis of intention to treat. Modified intention to treat explored patients receiving at least 24 h of treatment before a primary outcome event and per-protocol analysis explored patients with a high level adherence (>80%). We used a Bayesian analytic framework to establish the effects along with probability of success of intervention compared with placebo. The trial is registered at ClinicalTrials.gov (NCT04727424) and is ongoing. FINDINGS: The study team screened 9803 potential participants for this trial. The trial was initiated on June 2, 2020, with the current protocol reporting randomisation to fluvoxamine from Jan 20 to Aug 5, 2021, when the trial arms were stopped for superiority. 741 patients were allocated to fluvoxamine and 756 to placebo. The average age of participants was 50 years (range 18-102 years); 58% were female. The proportion of patients observed in a COVID-19 emergency setting for more than 6 h or transferred to a teritary hospital due to COVID-19 was lower for the fluvoxamine group compared with placebo (79 [11%] of 741 vs 119 [16%] of 756); relative risk [RR] 0·68; 95% Bayesian credible interval [95% BCI]: 0·52-0·88), with a probability of superiority of 99·8% surpassing the prespecified superiority threshold of 97·6% (risk difference 5·0%). Of the composite primary outcome events, 87% were hospitalisations. Findings for the primary outcome were similar for the modified intention-to-treat analysis (RR 0·69, 95% BCI 0·53-0·90) and larger in the per-protocol analysis (RR 0·34, 95% BCI, 0·21-0·54). There were 17 deaths in the fluvoxamine group and 25 deaths in the placebo group in the primary intention-to-treat analysis (odds ratio [OR] 0·68, 95% CI: 0·36-1·27). There was one death in the fluvoxamine group and 12 in the placebo group for the per-protocol population (OR 0·09; 95% CI 0·01-0·47). We found no significant differences in number of treatment emergent adverse events among patients in the fluvoxamine and placebo groups. INTERPRETATION: Treatment with fluvoxamine (100 mg twice daily for 10 days) among high-risk outpatients with early diagnosed COVID-19 reduced the need for hospitalisation defined as retention in a COVID-19 emergency setting or transfer to a tertiary hospital. FUNDING: FastGrants and The Rainwater Charitable Foundation. TRANSLATION: For the Portuguese translation of the abstract see Supplementary Materials section.

8.
Syst Rev ; 10(1): 264, 2021 10 08.
Artigo em Inglês | MEDLINE | ID: mdl-34625092

RESUMO

BACKGROUND: Venous thromboembolism (VTE) and bleeding are serious and potentially fatal complications of surgical procedures. Pharmacological thromboprophylaxis decreases the risk of VTE but increases the risk of major post-operative bleeding. The decision to use pharmacologic prophylaxis therefore represents a trade-off that critically depends on the incidence of VTE and bleeding in the absence of prophylaxis. These baseline risks vary widely between procedures, but their magnitude is uncertain. Systematic reviews addressing baseline risks are scarce, needed, and require innovations in methodology. Indeed, systematic summaries of these baseline risk estimates exist neither in general nor gynecologic surgery. We will fill this knowledge gap by performing a series of systematic reviews and meta-analyses of the procedure-specific and patient risk factor stratified risk estimates in general and gynecologic surgeries. METHODS: We will perform comprehensive literature searches for observational studies in general and gynecologic surgery reporting symptomatic VTE or bleeding estimates. Pairs of methodologically trained reviewers will independently assess the studies for eligibility, evaluate the risk of bias by using an instrument developed for this review, and extract data. We will perform meta-analyses and modeling studies to adjust the reported risk estimates for the use of thromboprophylaxis and length of follow up. We will derive the estimates of risk from the median estimates of studies rated at the lowest risk of bias. The primary outcomes are the risk estimates of symptomatic VTE and major bleeding at 4 weeks post-operatively for each procedure stratified by patient risk factors. We will apply the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rate evidence certainty. DISCUSSION: This series of systematic reviews, modeling studies, and meta-analyses will inform clinicians and patients regarding the trade-off between VTE prevention and bleeding in general and gynecologic surgeries. Our work advances the standards in systematic reviews of surgical complications, including assessment of risk of bias, criteria for arriving at the best estimates of risk (including modeling of the timing of events and dealing with suboptimal data reporting), dealing with subgroups at higher and lower risk of bias, and use of the GRADE approach. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021234119.


Assuntos
Trombose , Tromboembolia Venosa , Anticoagulantes , Feminino , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Hemorragia/etiologia , Humanos , Revisões Sistemáticas como Assunto , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle
9.
Eur Urol Focus ; 2021 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-34688589

RESUMO

In randomized controlled trials, investigators often explore the possibility that the treatment effects differ between subgroups (eg, women vs men, old vs young, more versus less severe disease). Investigators often inappropriately claim subgroup effects (also called "effect modification" or "interaction") when the likelihood of a true effect modification is low. Criteria for assessing the credibility of subgroup analyses, nicely summarized in a formal Instrument for Assessing the Credibility of Effect Modification Analyses (ICEMAN), include investigator postulation of a priori hypotheses with a specified direction; support from prior evidence; a low likelihood that chance explains the apparent subgroup effect; and only testing a small number of subgroup hypotheses. PATIENT SUMMARY: Randomized clinical trials often use subgroup analyses to explore whether a treatment is more or less effective in a particular patient subgroup (eg, women vs men, old vs young). In this mini-review, we explore the common pitfalls of subgroup analyses.

10.
JAMA ; 326(15): 1516-1523, 2021 Oct 19.
Artigo em Inglês | MEDLINE | ID: mdl-34665198

RESUMO

Importance: Clinicians may rely on recommendations from clinical practice guidelines for management of patients. Observations: A clinical practice guideline is a published statement that includes recommendations that are intended to optimize patient care. In the guideline development process, a panel of experts formulates recommendation questions that guide the retrieval of evidence that is used to inform the recommendations. Typically, methods of guideline development, a summary of the supporting evidence, and a justification of the panel's decisions accompany the recommendations. To use such guidelines optimally, clinicians must understand the implications of the recommendations, assess the trustworthiness of the development process, and evaluate the extent to which the recommendations are applicable to patients in their practice settings. Helpful recommendations are clear and actionable, and explicitly specify whether they are strong or weak, are appropriate for all patients, or depend on individual patients' circumstances and values. Rigorous guidelines and recommendations are informed by appropriately conducted, up-to-date systematic reviews that consider outcomes important to patients. Because judgments are involved in the interpretation of the evidence and the process of moving from evidence to recommendations, useful guidelines consider all relevant factors that have a bearing in a clinical decision and are not influenced by conflicts of interest. Conclusions and Relevance: In considering a guideline's recommendations, clinicians must decide whether there are important differences between the factors the guideline panel has considered in making recommendations and their own practice setting.


Assuntos
Fidelidade a Diretrizes , Guias de Prática Clínica como Assunto , Medicina Baseada em Evidências , Humanos , Padrões de Prática Médica , Revisões Sistemáticas como Assunto/normas , Resultado do Tratamento
11.
Eur Urol Focus ; 2021 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-34711529

RESUMO

Variability in the results of randomized trials presents challenges to the interpretation and application of the evidence to patient care. Understanding how systematic reviews deal with this problem of "heterogeneity" will help clinicians in applying results in their patient management. This manuscript offers a review of heterogeneity from the clinical urological perspective. PATIENT SUMMARY: Systematic reviews of the literature are necessary to accurately summarize the available evidence to inform clinical decisions. In this mini-review, we explain how to understand and deal with the differences between studies-which we call heterogeneity-included in these types of reviews.

12.
Foods ; 10(9)2021 Sep 14.
Artigo em Inglês | MEDLINE | ID: mdl-34574291

RESUMO

Introduction: Over the last decade, the possible impact of meat intake on overall cancer incidence and mortality has received considerable attention, and authorities have recommended decreasing consumption; however, the benefits of reducing meat consumption are small and uncertain. As such, individual decisions to reduce consumption are value- and preference-sensitive. Consequently, we undertook a pilot cross-sectional study to explore people's values and preferences towards meat consumption in the face of cancer risk. Methods and analysis: The mixed-method pilot study included a quantitative questionnaire followed by qualitative evaluation to explore the dietary habits of 32 meat eaters, their reasons for eating meat, and willingness to change their meat consumption when faced with a potential risk reduction of cancer over a lifetime based on a systematic review and dose-response meta-analysis. We recruited a convenience sample of participants from two Canadian provinces: Nova Scotia and Prince Edward Island. This project was approved by the Research Ethics Board for Health Sciences research at Dalhousie University, Canada. Results: The average weekly consumption of red meat was 3.4 servings and the average weekly consumption of processed meat was 3 servings. The determinants that influenced meat intake were similar for both red and processed meat. Taste, cost, and family preferences were the three most commonly cited factors impacting red meat intake. Taste, cost, and (lack of) cooking time were the three most commonly cited factors impacting processed meat intake. None of the participants were willing to eliminate red or processed meat from their diet. About half of participants were willing to potentially reduce their meat consumption, with one third definitely willing to reduce their consumption. Strengths and limitations: This study is the first that we are aware of to share data with participants on the association of red meat and processed meat consumption and the risk of cancer mortality and cancer incidence, including the certainty of evidence for the risk reduction. The limitations of this study include its small sample size and its limited geographic sampling. Conclusions: When presented explicit information about the small uncertain cancer risk associated with red and processed meat consumption, study participants were unwilling to eliminate meat, while about one-third were willing to reduce their meat intake.

13.
Eur Urol Focus ; 2021 Sep 22.
Artigo em Inglês | MEDLINE | ID: mdl-34563480

RESUMO

CONTEXT: No meta-analysis has comprehensively addressed both benefits and harms, or the certainty of evidence of the implantable continence devices used in men to treat postprostatectomy urinary incontinence (PPI). OBJECTIVE: To evaluate the benefits and harms of surgical treatments for patients suffering from PPI and assess the certainty of evidence. The primary benefit was cure (one or fewer pad per day), and the primary harm was reoperations defined by surgical procedures following implantation. EVIDENCE ACQUISITION: We perform a search of Medline, PubMed, Embase, Cochrane Library, and gray literature. We included observational studies addressing PPI surgical interventions if they involved cohorts of ≥50 participants. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach provided the framework for certainty of evidence assessment informed by value and preference judgments provided by patients, and an advocacy group member (Canadian Cancer Society). EVIDENCE SYNTHESIS: Of 85 observational studies involving 13 100 patients, three addressed bulking agents, 35 male synthetic slings, ten adjustable continence therapies (ACTs), and 37 artificial urinary sphincters (AUSs). Cure was 26.1% (95% confidence interval [CI]: 10.6-51.4, I2 = 92.8%, very-low-quality evidence) for bulking agents, 58.6% (95% CI: 51.3-65.5, I2 = 89.1%, low-quality evidence) for slings, 63.2% (95% CI: 57.6-68.5, I2 = 22.5%, very-low-quality evidence) for ACT, and 74.0% (95% CI:61.2-83.7, I2 = 92.1%, very-low-quality evidence) for AUS. Estimated rates of reoperation were 5.8% (95% CI: 1.9-11.6, I2 = 94.1%, moderate-quality evidence) for slings, 23.8% (95% CI: 5.9-61.0, I2 = 95.5%, low-quality evidence) for ACT, and 22.2% (95% CI: 15.2-31.3, I2 = 92.3%, high-quality evidence) for AUS. CONCLUSIONS: Available evidence regarding the benefits of surgical interventions for PPI remains mainly uncertain while suggesting important harms. These results should guide consent procedures for PPI surgery in the context of shared decision-making, with disclosure of the uncertainty of evidence. PATIENT SUMMARY: Despite being used worldwide, available evidence regarding the benefits of surgeries to treat postprostatectomy urinary incontinence remains mainly uncertain while suggesting important harms. This highlights the need for a more rigorous evaluation process for commercially available surgical devices.

14.
BMJ ; 374: n2231, 2021 09 23.
Artigo em Inglês | MEDLINE | ID: mdl-34556486

RESUMO

OBJECTIVE: To evaluate the efficacy and safety of antiviral antibody therapies and blood products for the treatment of novel coronavirus disease 2019 (covid-19). DESIGN: Living systematic review and network meta-analysis, with pairwise meta-analysis for outcomes with insufficient data. DATA SOURCES: WHO covid-19 database, a comprehensive multilingual source of global covid-19 literature, and six Chinese databases (up to 21 July 2021). STUDY SELECTION: Trials randomising people with suspected, probable, or confirmed covid-19 to antiviral antibody therapies, blood products, or standard care or placebo. Paired reviewers determined eligibility of trials independently and in duplicate. METHODS: After duplicate data abstraction, we performed random effects bayesian meta-analysis, including network meta-analysis for outcomes with sufficient data. We assessed risk of bias using a modification of the Cochrane risk of bias 2.0 tool. The certainty of the evidence was assessed using the grading of recommendations assessment, development, and evaluation (GRADE) approach. We meta-analysed interventions with ≥100 patients randomised or ≥20 events per treatment arm. RESULTS: As of 21 July 2021, we identified 47 trials evaluating convalescent plasma (21 trials), intravenous immunoglobulin (IVIg) (5 trials), umbilical cord mesenchymal stem cells (5 trials), bamlanivimab (4 trials), casirivimab-imdevimab (4 trials), bamlanivimab-etesevimab (2 trials), control plasma (2 trials), peripheral blood non-haematopoietic enriched stem cells (2 trials), sotrovimab (1 trial), anti-SARS-CoV-2 IVIg (1 trial), therapeutic plasma exchange (1 trial), XAV-19 polyclonal antibody (1 trial), CT-P59 monoclonal antibody (1 trial) and INM005 polyclonal antibody (1 trial) for the treatment of covid-19. Patients with non-severe disease randomised to antiviral monoclonal antibodies had lower risk of hospitalisation than those who received placebo: casirivimab-imdevimab (odds ratio (OR) 0.29 (95% CI 0.17 to 0.47); risk difference (RD) -4.2%; moderate certainty), bamlanivimab (OR 0.24 (0.06 to 0.86); RD -4.1%; low certainty), bamlanivimab-etesevimab (OR 0.31 (0.11 to 0.81); RD -3.8%; low certainty), and sotrovimab (OR 0.17 (0.04 to 0.57); RD -4.8%; low certainty). They did not have an important impact on any other outcome. There was no notable difference between monoclonal antibodies. No other intervention had any meaningful effect on any outcome in patients with non-severe covid-19. No intervention, including antiviral antibodies, had an important impact on any outcome in patients with severe or critical covid-19, except casirivimab-imdevimab, which may reduce mortality in patients who are seronegative. CONCLUSION: In patients with non-severe covid-19, casirivimab-imdevimab probably reduces hospitalisation; bamlanivimab-etesevimab, bamlanivimab, and sotrovimab may reduce hospitalisation. Convalescent plasma, IVIg, and other antibody and cellular interventions may not confer any meaningful benefit. SYSTEMATIC REVIEW REGISTRATION: This review was not registered. The protocol established a priori is included as a data supplement. FUNDING: This study was supported by the Canadian Institutes of Health Research (grant CIHR- IRSC:0579001321). READERS' NOTE: This article is a living systematic review that will be updated to reflect emerging evidence. Interim updates and additional study data will be posted on our website (www.covid19lnma.com).


Assuntos
Anticorpos Antivirais/uso terapêutico , COVID-19/terapia , Terapia Baseada em Transplante de Células e Tecidos/métodos , SARS-CoV-2/imunologia , Anticorpos Monoclonais/uso terapêutico , Antivirais/uso terapêutico , Teorema de Bayes , COVID-19/imunologia , Ensaios Clínicos como Assunto , Humanos , Imunização Passiva , Metanálise em Rede , Resultado do Tratamento
15.
BMJ Open ; 11(9): e050831, 2021 09 07.
Artigo em Inglês | MEDLINE | ID: mdl-34493521

RESUMO

OBJECTIVE: To explore values and preferences towards medical cannabis among people living with chronic pain. DESIGN: Mixed-methods systematic review. DATA SOURCES: We searched MEDLINE, EMBASE and PsycINFO from inception to 17 March 2020. STUDY SELECTION: Pairs of reviewers independently screened search results and included quantitative, qualitative and mixed-methods studies reporting values and preferences towards medical cannabis among people living with chronic pain. REVIEW METHODS: We analysed data using meta-narrative synthesis (quantitative findings were qualitised) and tabulated review findings according to identified themes. We used the Grading of Recommendations Assessment, Development and Evaluation approach to assess certainty of evidence. RESULTS: Of 1838 initial records, 15 studies proved eligible for review. High to moderate certainty evidence showed that patient's use of medical cannabis for chronic pain was influenced by both positive (eg, support from friends and family) and negative social factors (eg, stigma surrounding cannabis use). Most patients using medical cannabis favoured products with balanced ratios of tetrahydrocannabinol (THC) and cannabidiol (CBD), or high levels of CBD, but not high THC preparations. Many valued the effectiveness of medical cannabis for symptom management even when experiencing adverse events related to concentration, memory or fatigue. Reducing use of prescription medication was a motivating factor for use of medical cannabis, and concerns regarding addiction, losing control or acting strangely were disincentives. Out-of-pocket costs were a barrier, whereas legalisation of medical cannabis improved access and incentivised use.Low to very low certainty evidence suggested highly variable values towards medical cannabis among people living with chronic pain. Individuals with pain related to life-limiting disease were more willing to use medical cannabis, and preferred oral over inhaled administration. CONCLUSIONS: Our findings highlight factors that clinicians should consider when discussing medical cannabis. The variability of patients' values and preferences emphasise the need for shared decision making when considering medical cannabis for chronic pain.


Assuntos
Canabidiol , Cannabis , Dor Crônica , Maconha Medicinal , Dor Crônica/tratamento farmacológico , Dronabinol , Humanos , Maconha Medicinal/uso terapêutico
17.
Eur Urol Focus ; 2021 Sep 21.
Artigo em Inglês | MEDLINE | ID: mdl-34556452

RESUMO

ARTS will be the first trial to compare anticoagulation with a direct oral anticoagulant (apixaban) versus no anticoagulation among patients undergoing intra-abdominal, gynecologic, or urologic surgery at sufficiently similar risk of deep vein thrombosis or pulmonary embolism and major bleeding.

18.
BMJ ; 374: n2040, 2021 09 08.
Artigo em Inglês | MEDLINE | ID: mdl-34497062

RESUMO

CLINICAL QUESTION: What is the role of medical cannabis or cannabinoids for people living with chronic pain due to cancer or non-cancer causes? CURRENT PRACTICE: Chronic pain is common and distressing and associated with considerable socioeconomic burden globally. Medical cannabis is increasingly used to manage chronic pain, particularly in jurisdictions that have enacted policies to reduce use of opioids; however, existing guideline recommendations are inconsistent, and cannabis remains illegal for therapeutic use in many countries. RECOMMENDATION: The guideline expert panel issued a weak recommendation to offer a trial of non-inhaled medical cannabis or cannabinoids, in addition to standard care and management (if not sufficient), for people living with chronic cancer or non-cancer pain. HOW THIS GUIDELINE WAS CREATED: An international guideline development panel including patients, clinicians with content expertise, and methodologists produced this recommendation in adherence with standards for trustworthy guidelines using the GRADE approach. The MAGIC Evidence Ecosystem Foundation (MAGIC) provided methodological support. The panel applied an individual patient perspective. THE EVIDENCE: This recommendation is informed by a linked series of four systematic reviews summarising the current body of evidence for benefits and harms, as well as patient values and preferences, regarding medical cannabis or cannabinoids for chronic pain. UNDERSTANDING THE RECOMMENDATION: The recommendation is weak because of the close balance between benefits and harms of medical cannabis for chronic pain. It reflects a high value placed on small to very small improvements in self reported pain intensity, physical functioning, and sleep quality, and willingness to accept a small to modest risk of mostly self limited and transient harms. Shared decision making is required to ensure patients make choices that reflect their values and personal context. Further research is warranted and may alter this recommendation.


Assuntos
Canabinoides/administração & dosagem , Dor Crônica/tratamento farmacológico , Maconha Medicinal/administração & dosagem , Adolescente , Adulto , Canabinoides/efeitos adversos , Criança , Humanos , Maconha Medicinal/efeitos adversos , Adulto Jovem
19.
BMJ Open ; 11(7): e046025, 2021 07 09.
Artigo em Inglês | MEDLINE | ID: mdl-34244262

RESUMO

INTRODUCTION: Chronic, non-cancer, axial or radicular spinal pain is a common condition associated with considerable socioeconomic burden. Clinicians frequently offer patients various interventional procedures for the treatment of chronic spine pain; however, the comparative effectiveness and safety of available procedures remains uncertain. METHODS: We will conduct a systematic review of randomised controlled trials that explores the effectiveness and harms of interventional procedures for the management of axial or radicular, chronic, non-cancer, spine pain. We will identify eligible studies through a systematic search of Medline, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials and Web of Science from inception without language restrictions. Eligible trials will: (1) enrol primarily adult patients (≥18 years old) with axial or radicular, chronic, non-cancer, spine pain, (2) randomise patients to different, currently available, interventional procedures or to an interventional procedure and a placebo/sham procedure or usual care, and (3) measure outcomes at least 1 month after randomisation.Pairs of reviewers will independently screen articles identified through searches and extract information and assess risk of bias of eligible trials. We will use a modified Cochrane instrument to evaluate risk of bias. We will use frequentist random-effects network meta-analyses to assess the relative effects of interventional procedures, and five a priori hypotheses to explore between studies subgroup effects. We will use the Grading of Recommendations Assessment, Development and Evaluation approach to assess the certainty in evidence for each outcome, including direct, indirect and network estimates. ETHICS AND DISSEMINATION: No research ethics approval is required for this systematic review, as no confidential patient data will be used. We will disseminate our findings through publication in a peer-reviewed journal and conference presentations, and our review will support development of a BMJ Rapid Recommendations providing contextualised clinical guidance based on this body of evidence. PROSPERO REGISTRATION NUMBER: CRD42020170667.


Assuntos
Dor Crônica , Dor Musculoesquelética , Adolescente , Adulto , Dor Crônica/terapia , Humanos , Metanálise em Rede , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisões Sistemáticas como Assunto
20.
BMJ Open ; 11(7): e047717, 2021 07 28.
Artigo em Inglês | MEDLINE | ID: mdl-34321302

RESUMO

OBJECTIVE: To assess the efficacy and harms of adding medical cannabis to prescription opioids among people living with chronic pain. DESIGN: Systematic review. DATA SOURCES: CENTRAL, EMBASE and MEDLINE. MAIN OUTCOMES AND MEASURES: Opioid dose reduction, pain relief, sleep disturbance, physical and emotional functioning and adverse events. STUDY SELECTION CRITERIA AND METHODS: We included studies that enrolled patients with chronic pain receiving prescription opioids and explored the impact of adding medical cannabis. We used Grading of Recommendations Assessment, Development and Evaluation to assess the certainty of evidence for each outcome. RESULTS: Eligible studies included five randomised trials (all enrolling chronic cancer-pain patients) and 12 observational studies. All randomised trials instructed participants to maintain their opioid dose, which resulted in a very low certainty evidence that adding cannabis has little or no impact on opioid use (weighted mean difference (WMD) -3.4 milligram morphine equivalent (MME); 95% CI (CI) -12.7 to 5.8). Randomised trials provided high certainty evidence that cannabis addition had little or no effect on pain relief (WMD -0.18 cm; 95% CI -0.38 to 0.02; on a 10 cm Visual Analogue Scale (VAS) for pain) or sleep disturbance (WMD -0.22 cm; 95% CI -0.4 to -0.06; on a 10 cm VAS for sleep disturbance; minimally important difference is 1 cm) among chronic cancer pain patients. Addition of cannabis likely increases nausea (relative risk (RR) 1.43; 95% CI 1.04 to 1.96; risk difference (RD) 4%, 95% CI 0% to 7%) and vomiting (RR 1.5; 95% CI 1.01 to 2.24; RD 3%; 95% CI 0% to 6%) (both moderate certainty) and may have no effect on constipation (RR 0.85; 95% CI 0.54 to 1.35; RD -1%; 95% CI -4% to 2%) (low certainty). Eight observational studies provided very low certainty evidence that adding cannabis reduced opioid use (WMD -22.5 MME; 95% CI -43.06 to -1.97). CONCLUSION: Opioid-sparing effects of medical cannabis for chronic pain remain uncertain due to very low certainty evidence.PROSPERO registration numberCRD42018091098.


Assuntos
Canabinoides , Dor Crônica , Maconha Medicinal , Analgésicos Opioides/uso terapêutico , Canabinoides/uso terapêutico , Dor Crônica/tratamento farmacológico , Humanos , Maconha Medicinal/uso terapêutico , Estudos Observacionais como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Vômito
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