scholarly journals Does The Reformed Cancer Drug Fund Generate Evidence On Effectiveness? A Cross-sectional Analysis On Publicly Accessible Documentation

Author(s):  
Helen Macdonald ◽  
Ben Goldacre

AbstractIntroductionThe Cancer Drugs Fund (CDF) was reformed in 2016 with an ambition to generate new evidence on effectiveness, and to review existing drugs in the fund. We set out to evaluate: whether drugs transitioning from the old CDF were re-reviewed as planned; whether new drugs have a “data collection arrangement” (DCA) as planned; and whether evidence generated under the DCA using routine data from the “Systemic Anti-Cancer Treatment” (SACT) database was of high quality.MethodsWe accessed documents from NHS England, Public Health England and NICE at August 2018. We calculated the proportion of old CDF drugs re-reviewed, and of new drugs and indications with a DCA. We described key features of the DCAs. For all SACT studies we set out to obtain a protocol in order to analyse the quality of the planned methods.Results47 old drugs and indications transitioned to the new CDF. For 14 there was no evidence of a re-review; 9 of these remain under CDF at August 2019 (all off-label uses). 33 had marketing authorisations: 22 of these had a review completed by September 2017 as planned (67%). 20 new drugs and indications entered the CDF by August 2018: 19 had a DCA; one (off-label) had no DCA or equivalent. All DCAs identify uncertainty about overall survival; all express an intent to conduct observational analysis using SACT data; SACT data was central to decision-making for 6 (32%). We were able to find 0 protocols of the 19 planned SACT studies (0). Following Freedom of Information requests we were told these protocols are prepared after the data are collected, and posted with the reappraisal: however we could not locate any protocol for either of the two published re-appraisals. We were therefore unable to assess the quality of the methods in any of the proposed SACT studies.ConclusionsThe revised CDF has not been implemented as planned. Reporting of observational analyses in SACT data fall substantially short of best practice, and the full methods used cannot be established. There is very little information in the public domain around evaluation of off-label uses. Lastly, SACT data itself does not appear to be able to support clinical decision-making in the manner suggested by the CDF policy documents. NHS England should review the conduct of the fund, but also the planning, as unrealistic commitments may have been made.

2013 ◽  
Vol 137 (11) ◽  
pp. 1599-1602 ◽  
Author(s):  
Sara Lankshear ◽  
John Srigley ◽  
Thomas McGowan ◽  
Marta Yurcan ◽  
Carol Sawka

Context.—Cancer Care Ontario implemented synoptic pathology reporting across Ontario, impacting the practice of pathologists, surgeons, and medical and radiation oncologists. The benefits of standardized synoptic pathology reporting include enhanced completeness and improved consistency in comparison with narrative reports, with reported challenges including increased workload and report turnaround time. Objective.—To determine the impact of synoptic pathology reporting on physician satisfaction specific to practice and process. Design.—A descriptive, cross-sectional design was utilized involving 970 clinicians across 27 hospitals. An 11-item survey was developed to obtain information regarding timeliness, completeness, clarity, and usability. Open-ended questions were also employed to obtain qualitative comments. Results.—A 51% response rate was obtained, with descriptive statistics reporting that physicians perceive synoptic reports as significantly better than narrative reports. Correlation analysis revealed a moderately strong, positive relationship between respondents' perceptions of overall satisfaction with the level of information provided and perceptions of completeness for clinical decision making (r = 0.750, P < .001) and ease of finding information for clinical decision making (r = 0.663, P < .001). Dependent t tests showed a statistically significant difference in the satisfaction scores of pathologists and oncologists (t169 = 3.044, P = .003). Qualitative comments revealed technology-related issues as the most frequently cited factor impacting timeliness of report completion. Conclusion.—This study provides evidence of strong physician satisfaction with synoptic cancer pathology reporting as a clinical decision support tool in the diagnosis, prognosis, and treatment of cancer patients.


2020 ◽  
Vol 3 (4) ◽  
pp. 125-133
Author(s):  
M. Aminul Islam ◽  
M. Abdul Awal

ABSTRACT Introduction Selecting the most appropriate treatment for each patient is the key activity in patient-physician encounters and providing healthcare services. Achieving desirable clinical goals mostly depends on making the right decision at the right time in any healthcare setting. But little is known about physicians' clinical decision-making in the primary care setting in Bangladesh. Therefore, this study explored the factors that influence decisions about prescribing medications, ordering pathologic tests, counseling patients, average length of patient visits in a consultation session, and referral of patients to other physicians or hospitals by physicians at Upazila Health Complexes (UHCs) in the country. It also explored the structure of physicians' social networks and their association with the decision-making process. Methods This was a cross-sectional descriptive study that used primary data collected from 85 physicians. The respondents, who work at UHCs in the Rajshahi Division, were selected purposively. The collected data were analyzed with descriptive statistics including frequency, percentage, one-way analysis of variance, and linear regression to understand relationships among the variables. Results The results of the study reveal that multiple factors influence physicians' decisions about prescribing medications, ordering pathologic tests, length of visits, counseling patients, and referring patients to other physicians or hospitals at the UHCs. Most physicians prescribe drugs to their patients, keeping in mind their purchasing capacity. Risk of violence by patients' relatives and better management are the two key factors that influence physicians' referral decisions. The physicians' professional and personal social networks also play an influential role in the decision-making process. It was found that physicians dedicate on average 16.17 minutes to a patient in a consultation session. The length of visits is influenced by various factors including the distance between the physicians' residence and their workplace, their level of education, and the number of colleagues with whom they have regular contact and from whom they can seek help. Conclusion The results of the study have yielded some novel insights about the complexity of physicians' everyday tasks at the UHCs in Bangladesh. The results would be of interest to public health researchers and policy makers.


2003 ◽  
Vol 21 (18) ◽  
pp. 3502-3511 ◽  
Author(s):  
Fabio Efficace ◽  
Andrew Bottomley ◽  
David Osoba ◽  
Carolyn Gotay ◽  
Henning Flechtner ◽  
...  

Purpose: The aim of this study was to evaluate whether the inclusion of health-related quality of life (HRQOL), as a part of the trial design in a randomized controlled trial (RCT) setting, has supported clinical decision making for the planning of future medical treatments in prostate cancer. Materials and Methods: A minimum standard checklist for evaluating HRQOL outcomes in cancer clinical trials was devised to assess the quality of the HRQOL reporting and to classify the studies on the grounds of their robustness. It comprises 11 key HRQOL issues grouped into four broader sections: conceptual, measurement, methodology, and interpretation. Relevant studies were identified in a number of databases, including MEDLINE and the Cochrane Controlled Trials Register. Both their HRQOL and traditional clinical reported outcomes were systematically analyzed to evaluate their consistency and their relevance for supporting clinical decision making. Results: Although 54% of the identified studies did not show any differences in traditional clinical end points between treatment arms and 17% showed a difference in overall survival, 74% of the studies showed some difference in terms of HRQOL outcomes. One third of the RCTs provided a comprehensive picture of the whole treatment including HRQOL outcomes to support their conclusions. Conclusion: A minimum set of criteria for assessing the reported outcomes in cancer clinical trials is necessary to make informed decisions in clinical practice. Using a checklist developed for this study, it was found that HRQOL is a valuable source of information in RCTs of treatment in metastatic prostate cancer.


2009 ◽  
Vol 91 (1) ◽  
pp. 10-12
Author(s):  
Jon Hackett

While the NHS has expressed a commitment to innovation with a succession of dedicated 'arms length bodies,' there are numerous high-profile cases in which advances on the ground have not received as much support as they might. In his recent Next Stage Review report, Lord Darzi has emphasised a commitment to clinical decision-making at all levels of the NHS but whether this will involve embracing best practice from the bottom up remains to be seen. For this article I spoke to two surgeons, whose sometimes controversial innovations were admired by many, about the obstacles they faced.


2019 ◽  
Vol 104 (9) ◽  
pp. 3812-3820 ◽  
Author(s):  
Dipti Rao ◽  
Anouk van Berkel ◽  
Ianthe Piscaer ◽  
William F Young ◽  
Lucinda Gruber ◽  
...  

Abstract Context Cross-sectional imaging with CT or MRI is regarded as a first-choice modality for tumor localization in patients with pheochromocytoma and paraganglioma (PPGL). 123I-labeled metaiodobenzylguanidine (123I-MIBG) is widely used for functional imaging but the added diagnostic value is controversial. Objective To establish the virtual impact of adding 123I-MIBG scintigraphy to CT or MRI on diagnosis and treatment of PPGL. Design International multicenter retrospective study. Intervention None. Patients Two hundred thirty-six unilateral adrenal, 18 bilateral adrenal, 48 unifocal extra-adrenal, 12 multifocal, and 26 metastatic PPGL. Main Outcome Measures Patients underwent both anatomical imaging (CT and/or MRI) and 123I-MIBG scintigraphy. Local imaging reports were analyzed centrally by two independent observers who were blinded to the diagnosis. Imaging-based diagnoses determined by CT/MRI only, 123I-MIBG only, and CT/MRI combined with 123I-MIBG scintigraphy were compared with the correct diagnoses. Results The rates of correct imaging-based diagnoses determined by CT/MRI only versus CT/MRI plus 123I-MIBG scintigraphy were similar: 89.4 versus 88.8%, respectively (P = 0.50). Adding 123I-MIBG scintigraphy to CT/MRI resulted in a correct change in the imaging-based diagnosis and ensuing virtual treatment in four cases (1.2%: two metastatic instead of nonmetastatic, one multifocal instead of single, one unilateral instead of bilateral adrenal) at the cost of an incorrect change in seven cases (2.1%: four metastatic instead of nonmetastatic, two multifocal instead of unifocal and one bilateral instead of unilateral adrenal). Conclusions For the initial localization of PPGL, the addition of 123I-MIBG scintigraphy to CT/MRI rarely improves the diagnostic accuracy at the cost of incorrect interpretation in others, even when 123I-MIBG scintigraphy is restricted to patients who are at risk for metastatic disease. In this setting, the impact of 123I-MIBG scintigraphy on clinical decision-making appears very limited.


1993 ◽  
Vol 11 (2) ◽  
pp. 378-381 ◽  
Author(s):  
F Porzsolt ◽  
I Tannock

The major conclusions of the Workshop on Goals of Palliative Cancer Therapy are as follows: 1. The goals of any cancer therapy should be stated explicitly. 2. If the goal of treatment is palliation, this should be documented according to one of the established and validated methods for assessment of quality of life. Several validated methods are available, and although imperfect, have been shown to give reliable information. 3. The use of simple measures of quality of life (eg, symptom checklists, pain assessment cards) should become routine in oncology practice. The act of introducing such measures improves palliation. 4. Measures of cost-effectiveness should be used more widely in clinical decision making to ensure the appropriate deployment of resources. 5. There must be improved education of all health professionals with regard to the multiple methods for provision of palliative treatment to cancer patients and the assessment of palliation.


2020 ◽  
pp. 088307382096693
Author(s):  
Patrick J. McDonald ◽  
Viorica Hrincu ◽  
Mary B. Connolly ◽  
Mark J. Harrison ◽  
George M. Ibrahim ◽  
...  

This qualitative study investigated factors that guide physicians’ choices for minimally invasive and neuromodulatory interventions as alternatives to conventional surgery or medical management for pediatric drug-resistant epilepsy. North American physicians were recruited to one of 4 focus groups at national conferences. Discussions were analyzed using qualitative content analysis. A pragmatic neuroethics framework was applied to interpret results. Discussions revealed 2 major thematic branches: (1) clinical decision making and (2) ethical considerations. Under clinical decision making, physicians emphasized scientific evidence and patient candidacy when assessing neurotechnologies for patients. Ongoing seizures without intervention was important for safety and neurodevelopment. Under ethical considerations, resource allocation, among other financial considerations for technology adoption, were considerable sources of pressure on decision making. Access to neurotechnology was a salient theme differentiating Canadian and American contexts. When assessing novel neurotechnological interventions for pediatric drug-resistant epilepsy, physicians balance clinical and ethical factors to guide decision making and best practice.


2001 ◽  
Vol 19 (2) ◽  
pp. 594-595 ◽  
Author(s):  
Mark Somerfield ◽  
Aminah Jatoi ◽  
Phuong L. Nguyen ◽  
Shaji Kumar ◽  
Jeff Sloan ◽  
...  

Diagnosis ◽  
2014 ◽  
Vol 1 (2) ◽  
pp. 189-193 ◽  
Author(s):  
David Allan Watters ◽  
Spencer Wynyard Beasley ◽  
Wendy Crebbin

AbstractProceduralists who fail to review their decision making are unlikely to learn from their experiences, irrespective of whether the operative outcome is successful or not. Teaching junior surgeons to develop ‘insight’ into their own decision making has long been a challenge. Surgeons and staff of the Royal Australasian College of Surgeons worked together to develop a model to help explain the processes around clinical decision making and incorporated this model into a Clinical Decision Making (CDM) training course. In this course, faculty apply the model to specific surgical cases, within the model’s framework of how clinical decisions are made; thus providing an opportunity to identify specific decision making processes as they occur and to highlight some of the learning opportunities they provide. The conversation in this paper illustrates the kinds of case-based interactions which typically occur in the development and teaching of the CDM course.The focus in this, the second of two papers, is on reviewing post-operative clinical decisions made in relation to one case, to improve the quality of subsequent decision making.


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