BACKGROUND Bridging the gap between clinical research and everyday health-care practice requires effective communication strategies. To address current shortcomings in conveying practice ...recommendations and supporting evidence, we are creating and testing presentation formats for clinical practice guidelines (CPGs). METHODS We carried out multiple cycles of brainstorming and sketching, developing a prototype. Physicians participating in the user testing viewed CPG formats linked to clinical scenarios and engaged in semistructured interviews applying a think-aloud method for exploring important aspects of user experience. RESULTS We developed a multilayered presentation format that allows clinicians to successively view more in-depth information. Starting with the recommendations, clinicians can, on demand, access a rationale and a key information section containing statements on quality of the evidence, balance between desirable and undesirable consequences, values and preferences, and resource considerations. We collected feedback from 27 stakeholders and performed user testing with 47 practicing physicians from six countries. Advisory group feedback and user testing of the first version revealed problems with conceptual understanding of underlying CPG methodology, as well as difficulties with the complexity of the layout and content. Extensive revisions made before the second round of user testing resulted in most participants expressing overall satisfaction with the final presentation format. CONCLUSIONS We have developed an electronic, multilayered, CPG format that enhances the usability of CPGs for frontline clinicians. We have implemented the format in electronic guideline tools that guideline organizations can now use when authoring and publishing their guidelines.
AbstractObjectiveTo investigate the efficacy and safety of prostate-specific antigen (PSA) testing to screen for prostate cancer.DesignSystematic review and meta-analysis.Data sourcesElectronic ...search of Cochrane Central Register of Controlled Trials, Web of Science, Embase, Scopus, OpenGrey, LILACS, and Medline, and search of scientific meeting abstracts and trial registers to April 2018.Eligibility criteria for selecting studiesRandomised controlled trials comparing PSA screening with usual care in men without a diagnosis of prostate cancer.Data extractionAt least two reviewers screened studies, extracted data, and assessed the quality of eligible studies. A parallel guideline committee (BMJ Rapid Recommendation) provided input on the design and interpretation of the systematic review, including selection of outcomes important to patients. We used a random effects model to obtain pooled incidence rate ratios (IRR) and, when feasible, conducted subgroup analyses (defined a priori) based on age, frequency of screening, family history, ethnicity, and socioeconomic level, as well as a sensitivity analysis based on the risk of bias. The quality of the evidence was assessed with the GRADE approach.ResultsFive randomised controlled trials, enrolling 721 718 men, were included. Studies varied with respect to screening frequency and intervals, PSA thresholds for biopsy, and risk of bias. When considering the whole body of evidence, screening probably has no effect on all-cause mortality (IRR 0.99, 95% CI 0.98 to 1.01; moderate certainty) and may have no effect on prostate-specific mortality (IRR 0.96, 0.85 to 1.08; low certainty). Sensitivity analysis of studies at lower risk of bias (n=1) also demonstrates that screening seems to have no effect on all-cause mortality (IRR 1.0, 0.98 to 1.02; moderate certainty) but may have a small effect on prostate-specific mortality (IRR 0.79, 0.69 to 0.91; moderate certainty). This corresponds to one less death from prostate cancer per 1000 men screened over 10 years. Direct comparative data on biopsy and treatment related complications from the included trials were limited. Using modelling, we estimated that for every 1000 men screened, approximately 1, 3, and 25 more men would be hospitalised for sepsis, require pads for urinary incontinence, and report erectile dysfunction, respectively.ConclusionsAt best, screening for prostate cancer leads to a small reduction in disease-specific mortality over 10 years but has does not affect overall mortality. Clinicians and patients considering PSA based screening need to weigh these benefits against the potential short and long term harms of screening, including complications from biopsies and subsequent treatment, as well as the risk of overdiagnosis and overtreatment.Systematic review registrationPROSPERO registration number CRD42016042347.
Mineralocorticoid receptor antagonists (MRA) can reduce cardiovascular morbidity and mortality in patients with heart failure and ischemic heart disease. In addition, these agents have been used in ...patients with diabetic nephropathy to control proteinuria and slow down chronic kidney disease (CKD) progression. Current guidelines recommend against the use of MRAs in patients with advanced CKD. However, there is growing interest on their use in this population that has unmet needs (high cardiovascular morbidity and mortality) and unique challenges (risk of acute kidney injury or hyperkalemia). This narrative review discusses the emerging role of MRAs for the management of cardiovascular disease and/or the prevention of CKD progression, highlighting results from randomized controlled trials and presenting real-world data from available registries. Results from recent trials in patients on maintenance dialysis are also discussed.
How doctors perceive managed care tools and incentives is not well known. We assessed doctors' opinions about the expected impact of eight managed care tools on quality of care, control of health ...care costs, professional autonomy and relations with patients.
Mail survey of doctors (N = 1546) in Geneva, Switzerland. Respondents were asked to rate the impact of 8 managed care tools on 4 aspects of care on a 5-level scale (1 very negative, 2 rather negative, 3 neutral, 4 rather positive, 5 very positive). For each tool, we obtained a mean score from the 4 separate impacts.
Doctors had predominantly negative opinions of the impact of managed care tools: use of guidelines (mean score 3.18), gate-keeping (2.76), managed care networks (2.77), second opinion requirement (2.65), pay for performance (1.90), pay by salary (2.24), selective contracting (1.56), and pre-approval of expensive treatments (1.77). Estimated impacts on cost control were positive or neutral for most tools, but impacts on professional autonomy were predominantly negative. Primary care doctors held more positive opinions than doctors in other specialties, and psychiatrists were in general the most critical. Older doctors had more negative opinions, as well as those in private practice.
Doctors perceived most managed care tools to have a positive impact on the control of health care costs but a negative impact on medical practice. Tools that are controlled by the profession were better accepted than those that are imposed by payers.
To assess the diagnostic performances of five automated anti-SARS-CoV-2 immunoassays, Epitope (N), Diasorin (S1/S2), Euroimmun (S1), Roche N (N), and Roche S (S-RBD), and to provide a testing ...strategy based on pre-test probability.
We assessed the receiver operating characteristic (ROC) areas under the curve (AUC) values, along with the sensitivity, specificity, positive predictive values (PPVs), and negative predictive values (NPVs), of each assay using a validation sample set of 172 COVID-19 sera and 185 negative controls against a validated S1-immunofluorescence as a reference method. The three assays displaying the highest AUCs were selected for further serodetection of 2033 sera of a large population-based cohort.
In the validation analysis (pre-test probability: 48.1%), Roche N, Roche S and Euroimmun showed the highest discriminant accuracy (AUCs: 0.99, 0.98, and 0.98) with PPVs and NPVs above 96% and 94%, respectively. In the population-based cohort (pre-test probability: 6.2%) these three assays displayed AUCs above 0.97 and PPVs and NPVs above 90.5% and 99.4%, respectively. A sequential strategy using an anti-S assay as screening test and an anti-N as confirmatory assays resulted in a 96.7% PPV and 99.5% NPV, respectively.
Euroimmun and both Roche assays performed equally well in high pre-test probability settings. At a lower prevalence, sequentially combining anti-S and anti-N assays resulted in the optimal trade-off between diagnostic performances and operational considerations.
Objective
eCTAS is a real‐time electronic decision‐support tool designed to standardize the application of the Canadian Triage and Acuity Scale (CTAS). This study addresses the variability of CTAS ...score distributions across institutions pre‐ and post‐eCTAS implementation.
Methods
We used population‐based administrative data from 2016–2018 from all emergency departments (EDs) that had implemented eCTAS for 9 months. Following a 3‐month stabilization period, we compared 6 months post‐eCTAS data to the same 6 months the previous year (pre‐eCTAS). We included triage encounters of adult (≥17 years) patients who presented with 1 of 16 pre‐specified, high‐volume complaints. For each ED, consistency was calculated as the absolute difference in CTAS distribution compared to the average of all included EDs for each presenting complaint. Pre‐eCTAS and post‐eCTAS change scores were compared using a paired‐samples t‐test. We also assessed if eCTAS modifiers were associated with triage consistency.
Results
There were 363,214 (183,231 pre‐eCTAS, 179,983 post‐eCTAS) triage encounters included from 35 EDs. Triage scores were more consistent (P < 0.05) post‐eCTAS for 6 (37.5%) presenting complaints: chest pain (cardiac features), extremity weakness/symptoms of cerebrovascular accident, fever, shortness of breath, syncope, and hyperglycemia. Triage consistency was similar pre‐ and post‐eCTAS for altered level of consciousness, anxiety/situational crisis, confusion, depression/suicidal/deliberate self‐harm, general weakness, head injury, palpitations, seizure, substance misuse/intoxication, and vertigo. Use of eCTAS modifiers was associated with increased triage consistency.
Conclusions
eCTAS increased triage consistency across many, but not all, high‐volume presenting complaints. Modifier use was associated with increased triage consistency, particularly for non‐specific complaints such as fever and general weakness.
Prophylaxis for COVID-19: a systematic review Smit, Mikaela; Marinosci, Annalisa; Agoritsas, Thomas ...
Clinical microbiology and infection,
04/2021, Letnik:
27, Številka:
4
Journal Article
Recenzirano
Odprti dostop
While the landscape of vaccine and treatment candidates against the novel coronavirus disease 2019 (COVID-19) has been reviewed systematically, prophylactic candidates remain unexplored.
To map pre- ...and postexposure prophylactic (PrEP and PEP) candidate for COVID-19.
PubMed/Medline, Embase, International Committee of Medical Journal Editors and International Clinical Trials Registry Platform clinical trial registries and medRxiv.
All studies in humans or animals and randomized controlled trials (RCTs) in humans reporting primary data on prophylactic candidates against COVID-19, excluding studies focused on key populations.
PrEP and PEP candidate for COVID-19.
Systematic review and qualitative synthesis of COVID-19 PrEP and PEP studies and RCTs complemented by search of medRxiv and PubMed and Embase for studies reporting RCT outcomes since systematic review search completion.
We identified 13 studies (from 2119 database records) and 117 RCTs (from 5565 RCTs listed in the registries) that met the inclusion criteria. Non-RCT studies reported on cross-sectional studies using hydroxychloroquine (HCQ) in humans (n = 2) or reported on animal studies (n = 7), most of which used antibodies. All five completed RCTs focused on the use of HCQ as either PrEP or PEP, and these and the cross-sectional studies reported no prophylactic effect. The majority of ongoing RCTs evaluated HCQ or other existing candidates including non–severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, anti(retro)virals or use of vitamins and supplements.
The key message from completed studies and RCTs seems to be that HCQ does not work. There is little evidence regarding other compounds, with all RCTs using candidates other than HCQ still ongoing. It remains to be seen if the portfolio of existing molecules being evaluated in RCTs will identify successful prophylaxis against COVID-19 or if there is a need for the development of new candidates.
Tracing mail survey responses is useful for the management of reminders but may cause concerns about anonymity among prospective participants. We examined the impact of numbering return envelopes on ...the participation and the results of a survey on a sensitive topic among hospital staff.
In a survey about regrets associated with providing healthcare conducted among hospital-based doctors and nurses, two randomly drawn subsamples were provided numbered (N = 1100) and non-numbered (N = 500) envelopes for the return of completed questionnaires. Participation, explicit refusals, and item responses were compared. We also conducted a meta-analysis of the effect of questionnaire/envelope numbering on participation in health surveys.
The participation rate was lower in the "numbered" group than in the "non-numbered" group (30.3% vs. 35.0%, p = 0.073), the proportion of explicit refusals was higher in the "numbered" group (23.1% vs 17.5%, p = 0.016), and the proportion of those who never returned the questionnaire was similar (46.6% vs 47.5%, p = 0.78). The means of responses differed significantly for 12 of 105 items (11.4%), which did not differ significantly from the expected frequency of type 1 errors, i.e., 5% (permutation test, p = 0.078). The meta-analysis of 7 experimental surveys (including this one) indicated that numbering is associated with a 2.4% decrease in the survey response rate (95% confidence interval 0.3% to 4.4%).
Numbered return envelopes may reduce the response rate and increase explicit refusals to participate in a sensitive survey. Reduced participation was confirmed by a meta-analysis of randomized health surveys. There was no strong evidence of bias.
Objective. Collaborative quality improvement programs have been successfully used to manage chronic diseases in adults and acute lung complications in premature infants. Their effectiveness to ...improve pain management in acute care hospitals is currently unknown. The purpose of this study was to determine whether a collaborative quality improvement program implemented at hospital level could improve pain management and overall pain relief.
Design. To assess the effectiveness of the program, we performed a before‐after trial comparing patient's self‐reported pain management and experience before and after program implementation. We included all adult patients hospitalized for more than 24 hours and discharged either to their home or to a nursing facility, between March 1, 2001 and March 31, 2001 (before program implementation) and between September 15, 2005 and October 15, 2005 (after program implementation).
Setting. A teaching hospital of 2,096 beds in Geneva, Switzerland.
Patients. All adult patients hospitalized for more than 24 hours and discharged between 1 to 31 March 2001 (before program) and 15 September to 15 October 2005 (after program implementation).
Interventions. Implementation of a collaborative quality improvement program using multifaceted interventions (staff education, opinion leaders, patient education, audit, and feedback) to improve pain management at hospital level.
Outcome Measures. Patient‐reported pain experience, pain management, and overall hospital experience based on the Picker Patient Experience questionnaire, perceived health (SF‐36 Health survey).
Results. After implementation of the program only 2.3% of the patients reported having no pain relief during their hospital stay (vs 4.5% in 2001, P = 0.05). Among nonsurgical patients, improvements were observed for pain assessment (42.3% vs 27.9% of the patients had pain intensity measured with a visual analog scale, P = 0.012), pain management (staff did everything they could to help in 78.9% vs 67.9% of cases P = 0.003), and pain relief (70.4% vs 57.3% of patients reported full pain relief P = 0.008). In surgical patients, pain assessment also improved (53.7.3% vs 37.6%) as well as pain treatment. More patients received treatments to relieve pain regularly or intermittently after program implementation (95.1% vs 91.9% P = 0.046).
Conclusion. Implementation of a collaborative quality improvement program at hospital level improved both pain management and pain relief in patients. Further studies are needed to determine the overall cost‐effectiveness of such programs.