An ethics analysis of the rationale for publicly funded plastic surgery
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ABSTRACT:
SUBMITTER: Sandman L
PROVIDER: S-EPMC7531084 | biostudies-literature | 2020 Jan
REPOSITORIES: biostudies-literature
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Project description:Publicly funded trials regularly fail to recruit their target sample size or find a significant positive result. Adaptive clinical trials which may partly mediate against the problems are not often applied. In this paper we investigate the potential of a form of adaption in a clinical trial - a futility analysis - to see if it has potential to improve publicly funded trials.Outcome data from trials funded by two UK bodies, the Health Technology Assessment (HTA) programme and the UK Medical Research Council (MRC), were collected. These data were then used to simulate each trial with a single futility analysis using conditional power, undertaken after 50% to 90% of the patients had been recruited. Thirty-three trials recruiting between 2002 and 2008 met the inclusion criteria. Stopping boundaries of conditional powers of 20%, 30% and 40% were considered and outcomes included the number of trials successfully stopped and number of patients saved.Inclusion of a futility analysis after 75% of the patients had been recruited would have potentially resulted in 10 trials, which went on to have negative results, correctly stopping for futility using a stopping boundary of 30%. A total of 807 patients across all the trials would potentially have been saved using these futility parameters. The proportion of studies successfully recruiting would also have increased from 45% to 64%.A futility assessment has the potential to increase efficiency, save patients and decrease costs in publicly funded trials. While there are logistical issues in undertaking futility assessments we recommend that investigators should aim to include a futility analysis in their trial design wherever possible.
| S-EPMC3945066 | biostudies-other
Project description:BackgroundDementia is the leading cause of loss of independence in older adults worldwide. In the U.S., approximately 15 million family members provide care to relatives with dementia. This paper presents the rationale and design for a translational study in which an evidence-based, non-pharmacologic intervention for older adults with dementia and family caregivers (CGs) is incorporated into a publicly-funded home care program for older adults at risk for nursing home admission.MethodsThe 4-month Care of Persons with Dementia in their Environments (COPE) intervention is designed to optimize older adults' functional independence, and to improve CG dementia management skills and health-related outcomes. COPE features 10 in-home occupational therapy visits, and 1 in-home visit and 1 telephone contact by an advanced practice nurse. COPE was deemed efficacious in a published randomized clinical trial. In the present study, older adults with dementia enrolled in the Connecticut Home Care Program for Elders (CHCPE) and their CGs are randomly assigned to receive COPE plus their ongoing CHCPE services, or to continue receiving CHCPE services only.OutcomesThe primary outcome for older adults with dementia is functional independence; secondary outcomes are activity engagement, quality of life, and prevention or alleviation of neuropsychiatric symptoms. CG outcomes include perceived well-being and confidence in using activities to manage dementia symptoms. Translational outcomes include net financial benefit of COPE, and feasibility and acceptability of COPE implementation into the CHCPE. COPE has the potential to improve health-related outcomes while saving Medicaid waiver and state revenue-funded home care program costs nationwide.
| S-EPMC4979745 | biostudies-literature
Project description:BACKGROUND:The implementation of population-wide breast cancer screening programs has important budget implications. We evaluated the cost-effectiveness of various breast cancer screening scenarios in Canada from a publicly funded health care system perspective using an established breast cancer simulation model. METHODS:Breast cancer incidence, outcomes and total health care system costs (screening, investigation, diagnosis and treatment) for the Canadian health care environment were modelled. The model predicted costs (in 2012 dollars), life-years gained and quality-adjusted life-years (QALYs) gained for 11 active screening scenarios that varied by age range for starting and stopping screening (40-74 yr) and frequency of screening (annual, biennial or triennial) relative to no screening. All outcomes were discounted. Marginal and incremental cost-effectiveness analyses were conducted. One-way sensitivity analyses of key parameters assessed robustness. RESULTS:The lifetime overall costs (undiscounted) to the health care system for annual screening per 1000 women ranged from $7.4 million (for women aged 50-69 yr) to $10.7 million (40-74 yr). For biennial and triennial screening per 1000 women (aged 50-74 yr), costs were less, at about $6.1 million and $5.3 million, respectively. The incremental cost-utility ratio varied from $36 981/QALY for triennial screening in women aged 50-69 versus no screening to $38 142/QALY for biennial screening in those aged 50-69 and $83 845/QALY for annual screening in those aged 40-74. INTERPRETATION:Our economic analysis showed that both benefits of mortality reduction and costs rose together linearly with the number of lifetime screens per women. The decision on how to screen is related mainly to willingness to pay and additional considerations such as the number of women recalled after a positive screening result.
| S-EPMC5878949 | biostudies-literature
Project description:IntroductionFederal recommendations for providing quality family planning services were published in 2014 and included preconception care (PCC). This paper aims to describe the prevalence of PCC delivery among publicly funded clinics, prior to the recommendations.MethodsPrevalence of providing occasional or frequent PCC in the last 3 months and having written protocols for recommended PCC screenings were estimated in 2015 using survey data collected from a nationally representative sample of publicly funded clinic administrators (2013-2014, N=1,615). Analyses included examination of differential distributions of outcomes by clinic characteristics (p<0.05) and multivariable regression.ResultsPrevalence of occasional or frequent PCC delivery was 81% for women and 38% for men. The percentage of clinics with written protocols for specific PCC screenings ranged from 74% to 88% (women) and 66% to 83% (men). Prevalence of having written protocols for all PCC screenings was 29% for women and 22% for men. Characteristics negatively associated with having written protocols for all PCC screenings for women and men (respectively) were as follows: not receiving Title X funding (adjusted prevalence ratio [APR]=0.6, 95% CI=0.50, 0.76; APR=0.6, 95% CI=0.47, 0.77) and being a community health center (APR=0.5, 95% CI=0.37, 0.72; APR=0.5, 95% CI=0.30, 0.67); health department (APR=0.7, 95% CI=0.61, 0.87; APR=0.6, 95% CI=0.49, 0.76); or hospital/other (APR=0.6, 95% CI=0.50, 0.79; APR=0.6, 95% CI=0.43, 0.75) (versus Planned Parenthood).ConclusionsProvision of PCC appears to differ by clinic characteristics and by interpretation of the phrase "preconception care," suggesting opportunities for education and improvement.
| S-EPMC5379123 | biostudies-literature
Project description:BACKGROUND/AIMS:Randomized clinical trials are widely recognized as essential to address worldwide clinical and public health research questions. However, their size and duration can overwhelm available public and private resources. To remain competitive in international research settings, advocates and practitioners of clinical trials must implement practices that reduce their cost. We identify approaches and practices for large, publicly funded, international trials that reduce cost without compromising data integrity and recommend an approach to cost reporting that permits comparison of clinical trials. METHODS:We describe the organizational and financial characteristics of The International Network for Strategic Initiatives in Global HIV Trials, an infectious disease research network that conducts multiple, large, long-term, international trials, and examine challenges associated with simple and streamlined governance and an infrastructure and financial management model that is based on performance, transparency, and accountability. RESULTS:It is possible to reduce costs of participants' follow-up and not compromise clinical trial quality or integrity. The International Network for Strategic Initiatives in Global HIV Trials network has successfully completed three large HIV trials using cost-efficient practices that have not adversely affected investigator enthusiasm, accrual rates, loss-to-follow-up, adherence to the protocol, and completion of data collection. This experience is relevant to the conduct of large, publicly funded trials in other disease areas, particularly trials dependent on international collaborations. CONCLUSION:New approaches, or creative adaption of traditional clinical trial infrastructure and financial management tools, can render large, international clinical trials more cost-efficient by emphasizing structural simplicity, minimal up-front costs, payments for performance, and uniform algorithms and fees-for-service, irrespective of location. However, challenges remain. They include institutional resistance to financial change, growing trial complexity, and the difficulty of sustaining network infrastructure absent stable research work. There is also a need for more central monitoring, improved and harmonized regulations, and a widely applied metric for measuring and comparing cost efficiency in clinical trials. ClinicalTrials.gov is recommended as a location where standardized trial cost information could be made publicly accessible.
| S-EPMC4785062 | biostudies-literature
Project description:BackgroundThe contributions of Academic Medical Centers (AMCs) to biomedical innovation have been difficult to measure because of the challenges involved in tracing knowledge flows from their origin to their uses.MethodsThe authors examined patent citation linkages between AMC research funded by the National Institutes of Health (NIH) and patents. In prospective analyses, they examine the extent to which articles resulting from NIH grants to AMCs awarded between 1990 and 1995 were cited in drug and medical patents. The authors then examine the extent to which these patents are associated with marketed drugs. In retrospective analyses, they examine the share of drugs approved between 2000 and 2009 that have citation links to NIH-funded AMC research.ResultsThe prospective analyses show over a third of AMC grants resulted in publications that were cited in patents. Most the patents are drug and biotechnology patents, and are assigned to private firms. Patents citing NIH-funded AMC publications were associated with 106 new FDA approved drugs, half of which are new molecular entities and a quarter of which are priority NMEs. The retrospective analyses showed that about half of the new molecular entities approved over the 2000-2009 period had citations links to NIH-funded AMC research.ConclusionsThere are strong links between articles from NIH-funded AMC research and private sector medical patenting, including drugs. More research is needed to better understand the types of links the citations represent and their implications for public policy.
| S-EPMC4787535 | biostudies-literature
Project description:BackgroundMedical students receive limited exposure to the field of plastic surgery because most students will not rotate in plastic surgery, especially those at schools without dedicated plastic surgery residency programs. This study aimed to create and validate a plastic surgery learning module for medical students to dispel media-propagated myths and misrepresentation of the breadth of plastic surgery and equip students with referral-making capabilities.MethodsThe plastic surgery learning module was created using Articulate Storyline 360 (New York, N.Y.). Student participants were recruited from a single medical school across all four classes. Pre- and postmodule surveys were administered via Qualtrics (Provo, Utah). Scores were computed for the general surgical knowledge section and for each specialty referral question.ResultsTwelve students completed usability testing and edits were subsequently made to optimize the module. The module took on average 66 minutes to complete. Sixty-five students (19 MS1, 16 MS2, 15 MS3, 15 MS4) completed efficacy testing. In the premodule survey, students were nearly 100% accurate in identifying breast-related referrals, unlike pediatric/craniofacial (avg: 68%), reconstruction/microsurgery (avg: 64%), and hand/upper extremity (avg: 30%) referrals. Students of all classes exhibited significant improvement in all testing categories except for the breast category, with the most improvement in the hand referrals category. Prior exposure to plastic surgery (57%) correlated with higher premodule hand (P = 0.003) and breast/cosmetic (P = 0.01) referral scores.ConclusionThe plastic surgery learning module shows promise to be a comprehensive yet affordable and time-efficient tool for medical students to learn about basic surgical principles and the scope of plastic surgery.
| S-EPMC8769105 | biostudies-literature
Project description:To describe differences in weight loss (WL) trajectory patterns at a publicly funded clinical weight management centre.Groups with differences in the attainment of a 5% total body WL and percentage WL patterns over time were identified in 7,121 patients who attended a physician lead multi-disciplinary clinical lifestyle weight management that predominantly focused on education and diet counselling. Resultant health differences were examined.Patients had 3.2?±?6.3%WL with 35% of patients achieving and maintaining a 5%WL. Half of these patients achieved the 5%WL within 6?months, while the other half had a more gradual approach. Another 10% achieved 5%WL, but regained weight after 6?months. There were seven distinct WL patterns identified: LargeWL (Mean WL: 21.2?±?8.1%; Probability of group membership (PGM): 2.4%), ModerateWL (15.1?±?5.1%WL; 5.4%PGM), SlowWL (6.7?±?3.2%WL; 20.1%PGM) and MinimalWL (2.4?±?2.2%WL; 34.6%PGM), WL Regain (9.4?±?3.5%WL; 8.2%PGM), Weight Stable (1.2?±?3.2%WL; 28.5%PGM) and Weight Gain (18.4?±?11.2%WG; 0.8%PGM) groups. Improvements in blood pressure, lipids and glucose were generally related to the magnitude of WL achieved more than the pattern or speed of WL.There are large differences in the absolute WL attained and the pattern of WL during a publicly funded weight management program. Changes in clinical health markers appear to be more strongly related with the absolute WL attained as opposed to patterns of weight change. © 2016 The Authors. Obesity Science & Practice published by John Wiley & Sons Ltd, World Obesity and The Obesity Society.
| S-EPMC5523699 | biostudies-other
Project description:BackgroundThere is little systematic assessment of how total health expenditure is distributed across diseases and comorbidities. The objective of this study was to use statistical methods to disaggregate all publicly funded health expenditure by disease and comorbidities in order to answer three research questions: (1) What is health expenditure by disease phase for noncommunicable diseases (NCDs) in New Zealand? (2) Is the cost of having two NCDs more or less than that expected given the independent costs of each NCD? (3) How is total health spending disaggregated by NCDs across age and by sex?Methods and findingsWe used linked data for all adult New Zealanders for publicly funded events, including hospitalisation, outpatient, pharmaceutical, laboratory testing, and primary care from 1 July 2007 to 30 June 2014. These data include 18.9 million person-years and $26.4 billion in spending (US$ 2016). We used case definition algorithms to identify if a person had any of six NCDs (cancer, cardiovascular disease [CVD], diabetes, musculoskeletal, neurological, and a chronic lung/liver/kidney [LLK] disease). Indicator variables were used to identify the presence of any of the 15 possible comorbidity pairings of these six NCDs. Regression was used to estimate excess annual health expenditure per person. Cause deletion methods were used to estimate total population expenditure by disease. A majority (59%) of health expenditure was attributable to NCDs. Expenditure due to diseases was generally highest in the year of diagnosis and year of death. A person having two diseases simultaneously generally had greater health expenditure than the expected sum of having the diseases separately, for all 15 comorbidity pairs except the CVD-cancer pair. For example, a 60-64-year-old female with none of the six NCDs had $633 per annum expenditure. If she had both CVD and chronic LLK, additional expenditure for CVD separately was $6,443/$839/$9,225 for the first year of diagnosis/prevalent years/last year of life if dying of CVD; additional expenditure for chronic LLK separately was $6,443/$1,291/$9,051; and the additional comorbidity expenditure of having both CVD and LLK was $2,456 (95% confidence interval [CI] $2,238-$2,674). The pattern was similar for males (e.g., additional comorbidity expenditure for a 60-64-year-old male with CVD and chronic LLK was $2,498 [95% CI $2,264-$2,632]). In addition to this, the excess comorbidity costs for a person with two diseases was greater at younger ages, e.g., excess expenditure for 45-49-year-old males with CVD and chronic LLK was 10 times higher than for 75-79-year-old males and six times higher for females. At the population level, 23.8% of total health expenditure was attributable to higher costs of having one of the 15 comorbidity pairs over and above the six NCDs separately; of the remaining expenditure, CVD accounted for 18.7%, followed by musculoskeletal (16.2%), neurological (14.4%), cancer (14.1%), chronic LLK disease (7.4%), and diabetes (5.5%). Major limitations included incomplete linkage to all costed events (although these were largely non-NCD events) and missing private expenditure.ConclusionsThe costs of having two NCDs simultaneously is typically superadditive, and more so for younger adults. Neurological and musculoskeletal diseases contributed the largest health system costs, in accord with burden of disease studies finding that they contribute large morbidity. Just as burden of disease methodology has advanced the understanding of disease burden, there is a need to create disease-based costing studies that facilitate the disaggregation of health budgets at a national level.
| S-EPMC6324792 | biostudies-literature
Project description:BackgroundProjecting the demand for plastic surgeons has become increasingly important in a climate of scarce public resource within a single payer health-care system. The goal of this study is to provide a comprehensive workforce update and describe the perceptions of the workforce among Canadian Plastic Surgery residents and surgeons.MethodsTwo questionnaires were developed by a national task force under the Canadian Plastic Surgery Research Collaborative. The surveys were distributed to residents and practicing surgeons, respectively.ResultsTwo-hundred fifteen (49%) surgeons responded, with a mean age of 51.4 years (standard deviation [SD] = 11.5); 78% were male. Thirty-three percent had been in practice for 25 years or longer. More than half of respondents were practicing in a large urban center. Fifty-nine percent believed their group was going to hire in the next 2 to 3 years; however, only 36% believed their health authority/provincial government had the necessary resources. The mean desired age of retirement was 67 years (SD = 6.4). We predict the surgeons-to-population ratio to be 1.55:100?000 and the graduate-to-retiree ratio to be 2.16:1 within the next 5 to 10 years. Seventy-seven (49%) residents responded. Most were "very satisfied" with their training (61%) and operative experience (90%). Eighty-nine percent of respondents planned to pursue addqitional training after residency, with 70% stating that the current job market was contributing to their decision. Most residents responded that they were concerned with the current job market.ConclusionsThe results of this study predict an adequate number of plastic surgeons will be trained within the next 10 years to suit the population's requirements; however, there is concern that newly trained surgeons will not have access to the necessary resources to meet growing demands. Furthermore, there is an evident shortage of those practicing in rural areas. Many trainees worry about the availability of jobs, despite evidence of active recruitment. The workforce may benefit from structured career mentorship in residency and improved transparency in hiring practices, particularly to attract young surgeons to smaller communities. It may also benefit from a coordinated national approach to recruitment and succession planning.
| S-EPMC6236507 | biostudies-literature