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      Choosing wisely in oncology: necessity and obstacles

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          Abstract

          In the last decades, the survival of many patients with cancer improved thanks to modern diagnostic methods and progresses in therapy. Still for several tumours, especially when diagnosed at an advanced stage, the benefits of treatment in terms of increased survival or quality of life are at best modest when not marginal, and should be weighed against the potential discomfort caused by medical procedures. As in other specialties, in oncology as well the dialogue between doctor and patient should be encouraged about the potential overuse of diagnostic procedures or treatments. Several oncological societies produced recommendations similar to those proposed by other medical disciplines adhering to the Choosing Wisely (CW) campaign. In this review, we describe what was reported in the medical literature concerning adequacy of screening, diagnostic, treatment and follow-up procedures and the potential impact on them of the CW. We only marginally touch on the more complex topic of treatment appropriateness, for which several evaluation methods have been developed (including the European Society for Medical Oncology—magnitude of clinical benefit scale). Finally, we review the possible obstacles for the development of CW in the oncological setting and focus on the strategies which could allow CW to evolve in the cancer field, so as to enhance the therapeutic relationship between medical professionals and patients and promote more appropriate management.

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          Most cited references71

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          Scope and impact of financial conflicts of interest in biomedical research: a systematic review.

          Despite increasing awareness about the potential impact of financial conflicts of interest on biomedical research, no comprehensive synthesis of the body of evidence relating to financial conflicts of interest has been performed. To review original, quantitative studies on the extent, impact, and management of financial conflicts of interest in biomedical research. Studies were identified by searching MEDLINE (January 1980-October 2002), the Web of Science citation database, references of articles, letters, commentaries, editorials, and books and by contacting experts. All English-language studies containing original, quantitative data on financial relationships among industry, scientific investigators, and academic institutions were included. A total of 1664 citations were screened, 144 potentially eligible full articles were retrieved, and 37 studies met our inclusion criteria. One investigator (J.E.B.) extracted data from each of the 37 studies. The main outcomes were the prevalence of specific types of industry relationships, the relation between industry sponsorship and study outcome or investigator behavior, and the process for disclosure, review, and management of financial conflicts of interest. Approximately one fourth of investigators have industry affiliations, and roughly two thirds of academic institutions hold equity in start-ups that sponsor research performed at the same institutions. Eight articles, which together evaluated 1140 original studies, assessed the relation between industry sponsorship and outcome in original research. Aggregating the results of these articles showed a statistically significant association between industry sponsorship and pro-industry conclusions (pooled Mantel-Haenszel odds ratio, 3.60; 95% confidence interval, 2.63-4.91). Industry sponsorship was also associated with restrictions on publication and data sharing. The approach to managing financial conflicts varied substantially across academic institutions and peer-reviewed journals. Financial relationships among industry, scientific investigators, and academic institutions are widespread. Conflicts of interest arising from these ties can influence biomedical research in important ways.
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            Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13

            Objective To determine the availability of data on overall survival and quality of life benefits of cancer drugs approved in Europe. Design Retrospective cohort study. Setting Publicly accessible regulatory and scientific reports on cancer approvals by the European Medicines Agency (EMA) from 2009 to 2013. Main outcome measures Pivotal and postmarketing trials of cancer drugs according to their design features (randomisation, crossover, blinding), comparators, and endpoints. Availability and magnitude of benefit on overall survival or quality of life determined at time of approval and after market entry. Validated European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) used to assess the clinical value of the reported gains in published studies of cancer drugs. Results From 2009 to 2013, the EMA approved the use of 48 cancer drugs for 68 indications. Of these, eight indications (12%) were approved on the basis of a single arm study. At the time of market approval, there was significant prolongation of survival in 24 of the 68 (35%). The magnitude of the benefit on overall survival ranged from 1.0 to 5.8 months (median 2.7 months). At the time of market approval, there was an improvement in quality of life in seven of 68 indications (10%). Out of 44 indications for which there was no evidence of a survival gain at the time of market authorisation, in the subsequent postmarketing period there was evidence for extension of life in three (7%) and reported benefit on quality of life in five (11%). Of the 68 cancer indications with EMA approval, and with a median of 5.4 years’ follow-up (minimum 3.3 years, maximum 8.1 years), only 35 (51%) had shown a significant improvement in survival or quality of life, while 33 (49%) remained uncertain. Of 23 indications associated with a survival benefit that could be scored with the ESMO-MCBS tool, the benefit was judged to be clinically meaningful in less than half (11/23, 48%). Conclusions This systematic evaluation of oncology approvals by the EMA in 2009-13 shows that most drugs entered the market without evidence of benefit on survival or quality of life. At a minimum of 3.3 years after market entry, there was still no conclusive evidence that these drugs either extended or improved life for most cancer indications. When there were survival gains over existing treatment options or placebo, they were often marginal.
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              Malpractice risk according to physician specialty.

              Data are lacking on the proportion of physicians who face malpractice claims in a year, the size of those claims, and the cumulative career malpractice risk according to specialty. We analyzed malpractice data from 1991 through 2005 for all physicians who were covered by a large professional liability insurer with a nationwide client base (40,916 physicians and 233,738 physician-years of coverage). For 25 specialties, we reported the proportion of physicians who had malpractice claims in a year, the proportion of claims leading to an indemnity payment (compensation paid to a plaintiff), and the size of indemnity payments. We estimated the cumulative risk of ever being sued among physicians in high- and low-risk specialties. Each year during the study period, 7.4% of all physicians had a malpractice claim, with 1.6% having a claim leading to a payment (i.e., 78% of all claims did not result in payments to claimants). The proportion of physicians facing a claim each year ranged from 19.1% in neurosurgery, 18.9% in thoracic-cardiovascular surgery, and 15.3% in general surgery to 5.2% in family medicine, 3.1% in pediatrics, and 2.6% in psychiatry. The mean indemnity payment was $274,887, and the median was $111,749. Mean payments ranged from $117,832 for dermatology to $520,923 for pediatrics. It was estimated that by the age of 65 years, 75% of physicians in low-risk specialties had faced a malpractice claim, as compared with 99% of physicians in high-risk specialties. There is substantial variation in the likelihood of malpractice suits and the size of indemnity payments across specialties. The cumulative risk of facing a malpractice claim is high in all specialties, although most claims do not lead to payments to plaintiffs. (Funded by the RAND Institute for Civil Justice and the National Institute on Aging.).
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                Author and article information

                Journal
                ESMO Open
                ESMO Open
                esmoopen
                esmoopen
                ESMO Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2059-7029
                2018
                11 July 2018
                : 3
                : 5
                : e000382
                Affiliations
                [1 ] departmentMedical Oncology Clinic , Oncology Institute of Southern Switzerland , Bellinzona, Switzerland
                [2 ] departmentPalliative and Supportive Care Clinic , Oncology Institute of Southern Switzerland , Bellinzona, Switzerland
                [3 ] departmentInternal Medicine Department , Ente Ospedaliero Cantonale (EOC), Choosing Wisely EOC , Bellinzona, Switzerland
                Author notes
                [Correspondence to ] Dr Piercarlo Saletti; piercarlo.saletti@ 123456eoc.ch
                Article
                esmoopen-2018-000382
                10.1136/esmoopen-2018-000382
                6045771
                ba2cc059-0dd3-44cf-a24f-752841cacaa6
                © European Society for Medical Oncology 2018. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 19 April 2018
                : 25 May 2018
                : 26 May 2018
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                1506
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                choosing wisely,cancer,cost effectiveness,patient care
                choosing wisely, cancer, cost effectiveness, patient care

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