Clinical guidelines: potential benefits, limitations, and harms of clinical guidelines.
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ABSTRACT:
SUBMITTER: Woolf SH
PROVIDER: S-EPMC1114973 | biostudies-literature | 1999 Feb
REPOSITORIES: biostudies-literature
Publications
Clinical guidelines: potential benefits, limitations, and harms of clinical guidelines.
Woolf S H SH Grol R R Hutchinson A A Eccles M M Grimshaw J J
BMJ (Clinical research ed.) 19990201 7182
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Project description:Guidelines for prostate specific antigen (PSA) testing in Australia recommend that men at average risk of prostate cancer who have been informed of the benefits and harms, and who decide to undergo regular testing, should be offered testing every 2 years from 50 to 69 years. This study aimed to estimate the benefits and harms of regular testing in this context. We constructed Policy1-Prostate, a discrete event microsimulation platform of the natural history of prostate cancer and prostate cancer survival, and PSA testing patterns and subsequent management in Australia. The model was calibrated to pre-PSA (before 1985) prostate cancer incidence and mortality and validated against incidence and mortality trends from 1985 to 2011 and international trials. The model predictions were concordant with trials and Australian observed incidence and mortality data from 1985 to 2011. Out of 1000 men who choose to test according to the guidelines, 36 [21-41] men will die from prostate cancer and 126 [119-133] men will be diagnosed with prostate cancer, compared with 50 [47-54] and 94 [90-98] men who do not test, respectively. During the 20 years of active PSA testing, 32.3% [25.6%-38.8%] of all PSA-test detected cancers are overdiagnosed cases that is, 30 [21-42] out of 94 [83-107] PSA-test detected cancers. Australian men choosing to test with PSA every two years from 50 to 69 will reduce their risk of ever dying from prostate cancer and incur a risk of overdiagnosis: for every man who avoids dying from prostate cancer, two will be overdiagnosed with prostate cancer between 50 and 69 years of age. Australian men, with health professionals, can use these results to inform decision-making about PSA testing.
| S-EPMC11296206 | biostudies-literature
Project description:Selenium Chemoprevention: Benefits and Harms
| PRJNA673534 | ENA
Project description:Selenium Chemoprevention: Benefits and Harms
| PRJNA673535 | 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:IntroductionCancer screening guidelines should be based on the best available evidence, presenting both the benefits and harms of screening in a manner applicable to stakeholders. How the potential benefits and harms of screening are presented determine the intent of guideline developers and the delivery of recommendations. Therefore, we will systematically review the cancer screening guidelines for Koreans to evaluate the presentation and detailed ways of the benefits and harms of the recommended cancer screening practices.Methods and analysisTo identify cancer screening guidelines for Koreans, we will search international electronic databases, including MEDLINE, Embase and domestic literature databases (Korean Studies Information Service System, Research Information Sharing Service, KoreaMED, Korean Medical Database, National Assembly Library and Korea Institute of Science and Technology Information) as well as guideline databases (Guideline International Network, National Institute for Health and Care Excellence, Turning Research Into Practice medical database, WHO guidelines and Korean Medical Guideline Information Center), from inception to November 2022. We will include cancer screening guidelines for healthcare practitioners and patients. Furthermore, we will focus on the most updated guidelines when multiple versions of guidelines are available for a specific intervention and cancer pairs from the same development group. Two reviewers will independently and in duplicate conduct reference screening and data extraction. Data will be extracted based on recommendations from each guideline and how their benefits and harms are presented. The general characteristics of cancer screening guidelines, including cancer type, recommended screening methods, certainty of evidence, direction and strength of recommendation, will be collected. In addition, we will obtain key information on the presentation of the benefits and harms of screening interventions, including quantification of their relative and absolute effects of screening interventions. Finally, our findings will be presented descriptively, and a summary of the results will be provided.Ethics and disseminationEthics approval is not required as we will only use published materials. We will disseminate our findings through publication in peer-reviewed journals.
| S-EPMC9772665 | biostudies-literature
Project description:ObjectiveTo 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.DesignProbabilistic clinical decision analysis.SettingHypothetical population of white UK women aged 50 years with different baseline risks for breast cancer.Main outcome measureGain or loss in quality adjusted life years (QALYs).ResultsWomen 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.ConclusionsHRT 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