Clinical guidelines: potential benefits, limitations, and harms of clinical guidelines.
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ABSTRACT:
SUBMITTER: Woolf SH
PROVIDER: S-EPMC1114973 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Selenium Chemoprevention: Benefits and Harms
| PRJNA673535 | ENA
Project description:Selenium Chemoprevention: Benefits and Harms
| PRJNA673534 | ENA
Project description:BackgroundCancer prevention and screening guidelines are ideally suited to the task of providing high-quality benefit-harm information that informs clinical practice. We systematically examined how US guidelines present benefits and harms for recommended cancer prevention and screening interventions.MethodsWe included cancer screening and prevention recommendations from: 1) the United States Preventive Services Task Force, 2) the American Cancer Society, 3) the American College of Physicians, 4) the National Comprehensive Cancer Network, and 5) other US guidelines within the National Guidelines Clearinghouse. Searches took place November 20, 2013, and January 1, 2014, and updates were reviewed through July 1, 2015. Two coders used an abstraction form to code information about benefits and harms presented anywhere within a guideline document, including appendices. The primary outcome was each recommendation's benefit-harm "comparability" rating, based on how benefits and harms were presented. Recommendations presenting absolute effects for both benefits and harms received a "comparable" rating. Other recommendations received an incomplete rating or an asymmetric rating based on prespecified criteria.ResultsFifty-five recommendations for using interventions to prevent or detect breast, prostate, colon, cervical, and lung cancer were identified among 32 guidelines. Thirty point nine percent (n = 17) received a comparable rating, 14.5% (n = 8) received an incomplete rating, and 54.5% (n = 30) received an asymmetric rating.ConclusionsSixty-nine percent of cancer prevention and screening recommendation statements either did not quantify benefits and harms or presented them in an asymmetric manner. Improved presentation of benefits and harms in guidelines would better ensure that clinicians and patients have access to the information required for making informed decisions.
| S-EPMC5009951 | biostudies-literature
Project description:BackgroundThe Checklist for the Reporting of Updated Guidelines (CheckUp) was recently developed. However, so far, no systematic assessment of the reporting of updated clinical guidelines (CGs) exists. We aimed to examine (1) the completeness of reporting the updating process in CGs and (2) the inter-observer reliability of CheckUp.MethodsWe conducted a systematic assessment of the reporting of the updating process in a sample of updated CGs using CheckUp. We performed a systematic search to identify updated CGs published in 2015, developed by a professional society, reporting a systematic review of the evidence, and containing at least one recommendation. Three reviewers independently assessed the CGs with CheckUp (16 items). We calculated the median score per item, per domain, and overall, converting scores to a 10-point scale. Multiple linear regression analyses were used to identify differences according to country, type of organisation, scope, and health topic of updated CGs. We calculated the intraclass coefficient (ICC) and 95% confidence interval (95% CI) for domains and overall score.ResultsWe included in total 60 updated CGs. The median domain score on a 10-point scale for presentation was 5.8 (range 1.7 to 10), for editorial independence 8.3 (range 3.3 to 10), and for methodology 5.7 (range 0 to 10). The median overall score on a 10-point scale was 6.3 (range 3.1 to 10). Presentation and justification items at recommendation level (respectively reported by 27 and 38% of the CGs) and the methods used for the external review and implementing changes in practice were particularly poorly reported (both reported by 38% of the CGs). CGs developed by a European or international institution obtained a statistically significant higher overall score compared to North American or Asian institutions (p = 0.014). Finally, the agreement among the reviewers on the overall score was excellent (ICC 0.88, 95% CI 0.75 to 0.95).ConclusionsThe reporting of updated CGs varies considerably with significant room for improvement. We recommend using CheckUp to assess the updating process in updated CGs and as a blueprint to inform methods and reporting strategies in updating.
| S-EPMC5639761 | biostudies-literature
Project description:OBJECTIVE: To evaluate harms and benefits associated with use of combined hormone replacement therapy (HRT) for five years in women with different baseline risks for breast cancer. DESIGN: Probabilistic clinical decision analysis. SETTING: Hypothetical population of white UK women aged 50 years with different baseline risks for breast cancer. MAIN OUTCOME MEASURE: Gain or loss in quality adjusted life years (QALYs). RESULTS: Women free of menopausal symptoms showed a net harm from HRT use, which increased for increasing baseline risk of breast cancer. Those with a baseline risk of 1.2% would expect a loss in QALYs of 0.4 months (- 0.03 QALYs, 95% credibility interval - 0.05 to - 0.01). The main analysis showed HRT to be on average beneficial in women with symptoms, with benefit decreasing with increasing baseline risk of breast cancer. The results were sensitive to the assumed value of quality of life with menopausal symptoms, therefore a contour plot was developed to show the probability of net harm for a range of different values and baseline risks. CONCLUSIONS: HRT for primary prevention of chronic diseases in women without menopausal symptoms is unjustified. Perceived quality of life in women with symptoms should be taken into account when deciding on HRT. Thus, a decision analysis tailored to an individual woman is more appropriate in clinical practice than a population based approach.
| S-EPMC341383 | biostudies-literature
Project description:Patients with diabetes have been reported to have enhanced susceptibility to severe or fatal COVID-19 infections, including a high risk of being admitted to intensive care units with respiratory failure and septic complications. Given the global prevalence of diabetes, affecting over 450 million people worldwide and still on the rise, the emerging COVID-19 crisis poses a serious threat to an extremely large vulnerable population. However, the broad heterogeneity and complexity of this dysmetabolic condition, with reference to etiologic mechanisms, degree of glycemic derangement and comorbid associations, along with the extensive sexual dimorphism in immune responses, can hamper any patient generalization. Even more relevant, and irrespective of glucose-lowering activities, DPP4 inhibitors and GLP1 receptor agonists may have a favorable impact on the modulation of viral entry and overproduction of inflammatory cytokines during COVID-19 infection, although current evidence is limited and not univocal. Conversely, SGLT2 inhibitors may increase the likelihood of COVID-19-related ketoacidosis decompensation among patients with severe insulin deficiency. Mindful of their widespread popularity in the management of diabetes, addressing potential benefits and harms of novel antidiabetic drugs to clinical prognosis at the time of a COVID-19 pandemic deserves careful consideration.
| S-EPMC7277613 | biostudies-literature
Project description:ObjectivesCancer screening guidelines differ in their recommendations for or against screening. To be able to provide explicit recommendations, guidelines need to specify thresholds for the magnitude of benefits of screening, given its harms and burdens. We evaluated how current cancer screening guidelines address the relative importance of benefits versus harms and burdens of screening.Data sourceWe searched the Guidelines International Network, International Guideline Library, ECRI Institute and Medline. Two pairs of reviewers independently performed guideline selection and data abstraction.Eligibility criteriaWe included all cancer screening guidelines published in English between January 2014 and April 2019.ResultsOf 68 eligible guidelines, 25 included a statement regarding the trade-off between screening benefits versus harms and burdens (14 guidelines), or a statement of direction of the net effect (defined as benefits minus harms or burdens) (13 guidelines). None of these 25 guidelines defined how large a screening benefit should be to recommend screening, given its harms and burdens. 11 guidelines performed an economic evaluation of screening. Of these, six identified a key benefit outcome; two specified a cost-effectiveness threshold for recommending a screening option. Eight guidelines commented on people's values and preferences regarding the trade-off between benefits versus harms and burdens.ConclusionsCurrent cancer screening guidelines fail to specify the values and preferences underlying their recommendations. No guidelines provide a threshold at which they believe the benefits of screening outweigh its harms and burdens.Prospero registration numberCRD42019138590.
| S-EPMC7713181 | biostudies-literature
Project description:BackgroundPatient involvement in health economics modeling has been advocated on numerous grounds, including as a way to better manage social and ethical value judgments in the modeling process. However, some have pointed to potential risks and variables that could influence the overall benefit of involvement. To inform future research, there is a need to generate knowledge on potential benefits, harms, and variables relevant to patient involvement in health economics modeling.MethodsThis analysis used data from a qualitative study in which 22 health economists were asked their views on the possibility of involving patients in the modeling process. Using qualitative methods, the authors organized participants' responses into theory-driven categories ("potential benefits", "potential harms", "variables of interest") and identified data-driven themes and subthemes within those categories.ResultsFindings point to potential benefits and harms to the model, modeler, patient, and modeling process. Variables of interest relevant to future research included patients' specific roles, modeler and patient characteristics, the goals of modeling, dynamics among participators, and features of high-level procedures. The findings raise a number of specific questions that may be fruitful to explore in future research on patient involvement in health economics modeling.
| S-EPMC8200342 | biostudies-literature
Project description:BackgroundStandardized reporting methods facilitate comparisons between studies. Reporting of data on benefits and harms of treatments in surgical RCTs should support clinical decision-making. Correct and complete reporting of the outcomes of clinical trials is mandatory to appreciate available evidence and to inform patients properly before asking informed consent.MethodsRCTs published between January 2005 and January 2017 in 15 leading journals comparing a surgical treatment with any other treatment were reviewed systematically. The CONSORT checklist, including the extension for harms, was used to appraise the publications. Beneficial and harmful treatment outcomes, their definitions and their precision measures were extracted.ResultsOf 1200 RCTs screened, 88 trials were included. For the differences in effect size of beneficial outcomes, 68 per cent of the trials reported a P value only but not a 95 per cent confidence interval. For harmful effects, this was 67 per cent. Only five of the 88 trials (6 per cent) reported a number needed to treat, and no study a number needed to harm. Only 61 per cent of the trials reported on both the beneficial and harmful outcomes of the intervention studied in the same paper.ConclusionDespite CONSORT guidelines, current reporting of benefits and harms in surgical trials does not facilitate clear communication of treatment outcomes with patients. Researchers, reviewers and journal editors should ensure proper reporting of treatment benefits and harms in trials.
| S-EPMC7093777 | biostudies-literature
Project description:Tamoxifen reduces breast cancer incidence in women at increased risk, but may cause side effects. We examined women's knowledge of tamoxifen's potential harms and benefits, and the extent to which knowledge reflects subjective judgments of awareness and decision quality. After a hospital appointment, 408 (55.7%) women at increased risk of breast cancer completed a survey assessing objective knowledge about the potential benefit (risk reduction) and harms (endometrial cancer, thromboembolic events, and menopausal side effects) of tamoxifen, and subjective tamoxifen knowledge and decisional quality. Two hundred fifty-eight (63.2%) completed a 3-month follow-up survey. Sixteen percent (15.7%) of participants recognized the potential benefit and three major harms of using tamoxifen. These women were more likely to have degree-level education [vs. below degree level; OR, 2.24; 95% confidence interval (CI), 1.11-4.55] and good numeracy (vs. poor numeracy; OR, 5.91; 95% CI, 1.33-26.19). Tamoxifen uptake was higher in women who recognized all harms and benefits (vs. not recognizing; OR, 2.47; 95% CI, 0.94-6.54). Sixty-six percent (65.8%) of tamoxifen users were unaware of its potential benefit and harms. Most (87.1%) women reported feeling informed about tamoxifen, and subjective decisional quality was high [Mean (SD), 17.03 (1.87), out of 18]. Knowledge regarding the potential harms and benefit of tamoxifen is low in women considering prevention therapy, and they may need additional support to make informed decisions about tamoxifen preventive therapy.
| S-EPMC7611305 | biostudies-literature