bluuebunny/crossref_metadata_2025_split huggingface dataset:
No Need for More Regulation: Payors and Their Role in Balancing the Cost and Safety Considerations of Off-Label Prescriptions
Authors: Todd Amy E. 
Published: January 2017

In 2009, health care expenditures in the United States totaled $2.5 trillion and accounted for almost eighteen percent of the national Gross Domestic Product (GDP). Rising health care costs are an increasing concern in the national health care industry and in government policy reform. When estimates show that thirty percent of health care is unnecessary, improving quality and efficiency of health care could eliminate a significant amount of excessive spending.Prescription drugs contributed to ten percent of national health expenditures in 2009, comprising about $250 billion. And while the rate of growth for overall health care spending declined as a result of the recent recession, “the number of prescription drugs dispensed rebounded to prerecession rate of growth.” Estimates show that off-label drug use comprises between twenty and sixty percent of U.S. prescriptions. This could be a troubling percentage considering that off-label use carries an increased risk of harm or ineffectiveness.
Tobacco Control and Beyond: The Broader Implications of United States—Clove Cigarettes for Non-Communicable Diseases
Authors: McGrady Benn , Jones Alexandra 
Published: January 2017

As implementation of the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) accelerates and states seek to address risk factors for non-communicable disease more broadly, tension has increased between the law of the World Trade Organization (WTO) and public health. For example, Indonesia recently brought a successful claim against a U.S. law that prohibits cigarettes with a characterizing flavor other than menthol or tobacco. Indonesia succeeded in arguing that the regulation discriminates against clove-flavored cigarettes of Indonesian origin in favor of menthol-flavored cigarettes of U.S. origin.Also in the WTO context, the Dominican Republic, Honduras, and Ukraine have challenged an Australian law prohibiting the presence of branding on tobacco packaging other than product and variant names in a standardized location, font size, and style. This regulation, commonly referred to as “plain packaging,” is the first of its kind and may represent a turning point in the regulation of tobacco packaging.
Safeguards for Tobacco Control: Options for the TPPA
Authors: Stumberg Robert 
Published: January 2017

With tobacco trade, the past is prologue. In the 1980s, the U.S. government used domestic trade remedies (“Super 301”) to pry open markets for U.S. tobacco companies. The targets included Japan, South Korea, Taiwan, and Thailand. A grateful tobacco industry donated a renovation of the Treaty Room in the U.S. Department of State, declaring at the dedication: “Tobacco is intimately and historically associated with American diplomacy.”Thailand responded by banning imported cigarettes on grounds that the imports were more addictive and marketing of imports was driving up consumption. The United States then challenged Thailand for violating the General Agreement on Tariffs and Trade (GATT). The GATT panel ruled against Thailand, finding that the import ban failed to satisfy the health exception of GATT Article XX.
The Role of Private Law in the Control of Risks Associated with Tobacco Smoking: The Canadian Experience
Authors: Khoury Lara , Couture-Ménard Marie-Eve , Redko Olga 
Published: January 2017

Can private law litigation serve as a tool for advancing public health objectives? With this contentious and oft-asked question in mind, we tackle Canada's recent tobacco litigation. This Article first presents critical commentary regarding various lawsuits waged against Canadian cigarette manufacturers by citizens acting as individuals or as parties to class action lawsuits. We then turn to analyze how Canada's provincial governments rely on targeted legislation to facilitate private law recourses for recouping the healthcare costs of treating tobacco-related diseases. We address challenges to the constitutionality of this type of legislation, as well as attempts by manufacturers to transfer responsibility to the federal government.Canadian litigation in this field is nothing like that of the United States with regards to both the volume and variety of its individual and class action litigation claims. This is also true with regard to the stage of advancement of governmental claims in Canada. Nevertheless, particularities of the Canadian context may provide interesting contrast with the situation in the United States.
Medicaid on the Eve of Expansion: A Survey of State Medicaid Officials on the Affordable Care Act
Authors: Sommers Benjamin D. , Gordon Sarah , Somers Stephen , Ingram Carolyn , Epstein Arnold M. 
Published: January 2017

As of January 2014, 26 states had chosen to expand Medicaid under the Affordable Care Act (ACA) to cover individuals with incomes up to 138% of the federal poverty level. In these states, Medicaid agencies are facing one of the largest implementation challenges in the program’s history. We undertook a survey of high-ranking Medicaid officials in these states to assess their priorities, expectations, and programmatic decisions related to the coming expansion.The Medicaid expansion poses major challenges in the domains of enrollment, management of health care costs, and providing adequate access to services for beneficiaries. Previous research has documented that millions of individuals eligible for Medicaid are currently not enrolled and remain uninsured, suggesting that state outreach strategies may underpin the success or failure of the ACA’s coverage expansion.
Tubular Compression in the Treatment of Venous Ulcers of the Leg: A New Graduated Tubular Device
Authors: Gardon-Mollard C. 
Published: January 2017

Background: Compression treatment remains an effective method of healing of venous ulceration. Traditional bandaging techniques require considerable nursing time to apply. Elastic stockings are comfortable but patients find these difficult to put on over dressings. Aim: To develop a tubular compression bandage system that can be easily applied to patients with venous leg ulceration. Methods: A tubular bandage has been designed (Tubulcus) which applies 30-40 mmHg compression at the ankle with graduated compression above this. An applicator system has been designed (Tricolore) which allows the compression bandage to be applied over ulcer dressings. The device has been evaluated on a cylindrical former and an anatomical model of a leg, in order to assess its suitability for clinical trials. It has been compared with three types of compression bandage. Results: The tubular bandaging system provides sustained compression to be applied to leg ulcers whilst facilitating dressing changes. The graduated compression profile achieved with this system is more easily obtained than when using any of the three types of bandage. Conclusion: A system of application of elastic compression has been designed specifically for use in patients with venous ulceration. Clinical trials are now required to demonstrate the efficacy of this system.
Systematic Reviews of Prevention of Venous Ulcer Recurrence
Authors: Nelson E. A. 
Published: January 2017

Aim: To illustrate and discuss the role of systematic reviews in assessing the effect of interventions used in preventing recurrence of venous ulceration. Method: Systematic review of randomised controlled trials (RCTs) reporting the recurrence of venous ulcers. We searched the Cochrane Wounds Group specialised trial register in June 2000. This contains results of searches for RCTs in 18 electronic databases and hand searches. Trials were assessed for inclusion by two people and data extraction was performed using a standard proforma. Synthesis: We found weak evidence that wearing compression hosiery reduces recurrence rates. There was insufficient evidence for the effectiveness of drugs, vein surgery, exercise or leg elevation. Conclusions: Where systematic reviews provide clear implications for practice are found, clinicians can incorporate these into treatment regimens. Where results indicate that there is clinical uncertainty, as in the prevention of recurrence, this can assist commissioners and researchers in prioritising research questions.
A Simple Way to Improve DVT Protocol Compliance
Authors: Birks M. E. , Aiono S. , Magee T. R. , Galland R. B. 
Published: January 2017

Objective: To assess the impact on deep vein thrombosis (DVT) protocol violations of the introduction of a label attached to the patient's drug chart, which specifically allows low-dose subcutaneous heparin or thromboembolic deterrent stockings (TEDS) to be prescribed as appropriate. Design: An audit study. Setting: Department of General Surgery of a District General Hospital in the United Kingdom. Method: All adult general surgical inpatients on a Weekday were studied. Staff were not forewarned of the studies. Patient details and risk factors for DVT were noted. Details of administered DVT prophylaxis were recorded. In total four separate studies were undertaken, namely: with original protocols (I), with refined protocol 1 and 3 years later (II, III) and finally after introduction of the label (IV). Results: Protocol violations were defined as being ‘acceptable’ or ‘unacceptable’. Raising awareness between studies I and II reduced acceptable violations to zero. There was no statistically significant reduction in unacceptable violations (24 in 80 patients, 1; 17 in 75, II; 13 in 60, III). In study IV, following introduction of the label, there were only 6 violations in 51 patients ( p<0.02). Conclusion: Combining increased awareness with the attachment of a label to the drug chart reduced unacceptable violations by 63%.
Randomized Trial of an Occlusive Dressing in the Treatment of Chronic Non-Healing Leg Ulcers
Authors: Moffatt C. J. , Franks P. J. , Oldroyd M. I. , Greenhalgh R. M. 
Published: January 2017

Objective: To determine whether an occlusive dressing improves healing in chronic resistant venous ulceration. Design: Prospective controlled randomized trial. Setting: Hospital outpatients and community ulcer Patients: Sixty patients with chronic non-healing venous ulceration. Patients had either been treated for 12 weeks and their ulcer had failed to reduce by 20% of their original size, or had failed to completely heal within 24 weeks of treatment with the four-layer bandage. Interventions: Patients continued treatment with the four-layer bandage, and randomized to receive either an occlusive dressing or a simple non-adherent (NA) dressing. Main outcome measure: Time to complete healing analysed by life tables up to 12 weeks from randomization. Results: At the end of the trial 43% of the patients randomized to an occlusive dressing and 23% to an NA dressing had completely healed. Life table analysis failed to show a significant difference (relative risk = 2.25; 95% confidence interval 0.88–5.75; p=0.077). Conclusions: Good response of patients to an occlusive dressing has indicated the need for a larger study. A trial of 180 patients could detect a significant difference if crude rates are maintained in a larger study (80% Power, 5% significance).
Selective Saphenous Vein Repair: A 5-Year Follow-up Study
Authors: Belcaro G. , Errichi B. M. 
Published: January 2017

objective: To evaluate the effect of selective saphenous vein repair (SSVR) in a 5-year follow-up study. Design: Prospective, randomized study of 44 subjects randomized to an SSVR group and a control group. Setting: University Clinic, Chieti, and Angiology and vascular Surgery Clinic, Pescara, Italy. Patients: Twenty-two patients in the SSVR group and 22 in the control group. Inclusion criteria were incompetence of the saphenofemoral junction (SFJ) with presence of valve cusps and two to five venous sites in the long saphenous vein. interventions: SFJ plication and selective interruption of the incompetent sites under general anaesthetic. Main outcome measures: Ambulatory venous pressure measurements (refilling time) and colour duplex scanning to detect the number of incompetent sites. Result: After 5 years, 18 patients in the SSVR group and 19 in the control group completed the study. SSVR increased refilling time ( p<0.02) and the number of incompetent sites was decreased ( p<0.02); in the control group, refilling time remained short and the number of incompetent sites increased ( p<0.05). Conclusion: SSVR is an effective treatment with good 5-year results on incompetence and the development of new incompetent venous sites.
Physical Examination, Doppler Ultrasound and Colour Flow Duplex Scanning: Guides to Therapy for Primary Varicose Veins
Authors: DePalma R. G. , Hart M. T. , Zanin L. , Massarin E. H. 
Published: January 2017

Objective: To compare physical examination (PE) and continuous-wave hand-held Doppler (CWD) examination with colour flow duplex scanning as a gold standard for greater saphenous vein (GSV) reflux. Design: Prospective performance of PE and CWD by two clinical examiners and subsequent duplex scanning by two vascular laboratory technicians unaware of the results of the PE and CWD examinations. Tapes were then reviewed; results of the duplex scanning were compared with physical and CWD findings. Patients: Thirty-one women and nine men, aged 27–64 years, with symptomatic class I primary varicosities in distribution of the GSV. Eighty limbs were evaluated Prospectively in 40 consecutive patients, including 22 limbs in 14 patients with a history of prior GSV stripping. Interventions: GSV ligation and stripping in 50 limbs when duplex demonstrated saphenofemoral or truncal reflux; 30 limbs were treated by stab avulsion, cluster excision and sclerotherapy. Main outcome measures: Demonstration of saphenofemoral reflux by duplex was confirmed by operative findings. Sensitivity, specificity and positive and negative predictive values of PE and CWD were calculated in comparison to duplex scans. Results: For PE, sensitivity ad specificity were 48% and 73%; positive predictive and negative predictive values were 75% and 46%. For CWD, sensitivity and specificity were 48% and 83%; positive predictive and negative predictive values were 83% and 44%. CWD was falsely positive for saphenofemoral reflux in 10 instances. The GSV was spared in these 10 limbs and in 20 other limbs based on negative colour flow duplex examinations. At 12–18 months clinical results were similar in 50 limbs treated by ligation and GSV stripping as compared with 30 treated by stab avulsion, cluster and sclerotherapy. Conclusion: Sensitivity and negative predictive values for PE and CWD were low while specificity and postitive predictive values were high. CWD false postitives were due to insonation of veins close to the bulb or upper superficial femoral vein reflux subsequently detected by duplex scans. Colour flow duplex scanning is recommended prior to intervention for primary saphenous varicosities; exceptions occur in slender subjects where PE and CWD are more specific and predictive for reflux.
Sclerotherapy or Surgery as Treatment for Varicose Veins: A Prospective Randomized Study
Authors: Einarsson E. , Eklöf B. , Neglén P. 
Published: January 2017

Objective: To compare the long-term results following radical surgery or compression sclerotherapy (CST) of primary varicose veins. Design: Prospective, randomized study of 164 patients. The patients were assessed with clinical tests and foot volumetry, before the 6 months, 1, 3 and 5 years after treatment. Setting: Department of Surgery, University of Lund, Sweden. Patients: 164 patients referred to the clinic for treatment of symptomatic primary varicose veins. Eighty patients were randomized to surgery and 84 to CST. Interventions: Sclerotherapy was applied using the ‘empty vein’ technique followed by compression bandage for 6 weeks. The extent of surgery was determined by each patient's disease and included flush ligation of the long or short saphenous veins and subsequent stripping, ligation of incompetent perforating veins and resection of local varicosities. Main outcome measures: The recurrence rate of varicose veins and incompetence of perforators and saphenous veins. Results: Good results were achieved in both treatment groups immediately after the procedure, but the failures appeared earlier in the CST group and the number was higher compared with the surgery group. After 5 years only 10% of the operated patients were considered as treatment failures compared with 74% of the patients treated with CST. The clinical results were supported by the foot volumetry measurements. Conclusions: This study clearly indicates that patients with primary varicose veins and incompetent saphenous veins should be treated with surgery, and CST should be confined to local varicosities, isolated insufficient perforators or recurrences after adequate surgery.
Long Saphenous Vein Stripping in the Treatment of Varicose Veins: Self- and Surgeon-Assessed Results after 10 Years
Authors: Laurikka J. , Sisto T. , Salenius J.-P. , Tarkka M. , Auvinen O. 
Published: January 2017

Objective: To establish the 10-year results of long saphenous vein stripping in the treatment of varicose veins. Design: Single patient group study of patients who received surgical treatment for varicose veins 10 years earlier. Setting: Department of Surgery, University Hospital of Tampere, Finland. Patients: All men and a randomly picked sample of women were invited to attend for a follow-up examination; 81% (52 men, 74 women) participated. Intervention: Long saphenous vein stripping in all Patients. Main outcome measures: The presence of visible varicose veins as graded in four categories by clinical examination. Results: Seventy per cent of the operated legs in women free of varicosities or showed only minor varicose veins compared with 51% in men; 28% of the patients required further treatment (mostly sclerotherapy) for varicose veins. Conclusions: Long saphenous vein stripping combined with additional procedures results in a relatively low rate of severe recurrent varicose veins in 10 years.
The Australian Polidocanol (Aethoxysklerol) Study: Results at 1 Year
Authors: Conrad P. , Malouf G. M. , Stacey M. C. 
Published: January 2017

Objective: To evaluate the complications of polidocanol and compare its effectiveness and complications with sodium tetradecyl sulphate (STD) and hypertonic saline. Design: A single-arm prospective study of polidocanol complications and its effectiveness as a sclerosant. This was compared with each investigator's previous experience with other sclerosing agents. Setting: Multiple investigators in both private practices and hospital settings. Patients: Patients had either varicose veins or venule ectasias and/or spider veins (telangiectasia). A total of 8177 limbs were injected by 75 investigators. Interventions: Sclerotherapy was performed with 0.5% or 1% polidocanol for telangiectasias or spider veins, and with 3% polidocanol for varicose veins. The effectiveness of the sclerotherapy and any complications were reported during a 12-month period. Results: There were very few complications reported with polidocanol. There were no reported deaths or anaphylaxis. The investigators with previous experience of other sclerosants considered that the effectiveness of polidocanol was superior to STD (77%) and hypertonic saline (75%). Ninety-one per cent of investigators considered that polidocanol had less frequent complications than STD, and 96% considered that these were less severe. Sixty-nine per cent considered that polidocanol had fewer side-effects than hypertonic saline, and 71% considered that these were less severe. Conclusions: Polidocanol is an effective sclerosant that has few complications.
Venous Disease: The New International Challenge
Authors: Bosanquet N. , Franks P. 
Published: January 2017

This paper reviews data on the socio-economic aspects of venous disease and venous insufficiency. It will cover data on the burden of disease and the effects of venous insufficiency on quality of life. It will also cover varicose veins, chronic venous insufficiency and venous ulcers of the leg. The use of the WHO International Classification of Diseases allows for comparisons across countries, with costs expressed not only in local currency, but also in terms of ECUs and as a percentage of health care costs. The paper presents estimates on the costs of venous disease in the UK, France and Germany. Using standard diagnoses, costs are estimated to amount to 1.5–2.0% of total health care expenditure in these three countries. This is divided between inpatient, outpatient and community nursing programmes. Prescribing costs for venous diseases range from 0.26% of the total in the UK to 5.38% in France, with Germany in the middle of the range at 2.87%. The paper also summarizes costs in terms of reduced quality of life and loss of work-time. In Germany venous diseases contributed significantly to total disability, accounting for 1.2% of invalidity days in the late 1980s. As a result of dissatisfaction with current treatment programmes there have been moves towards new ones. The paper sets out the evidence on innovations in care through investment programmes aimed at reducing costs and improving efficacy. Current developments in Britain, Germany and France are set out, summarizing likely costs and benefits.
Diflunisal, a New-Acting Analgesic and Prostaglandin Inhibitor: Effect of Concomitant Acetylsalicylic Acid Therapy on Ototoxicity and on Disposition of Both Drugs
Authors: Schulz P , Perrier C V , Ferber-Perret F , VandenHeuvel W J A , Steelman S L 
Published: January 2017

Intermittent and concomitant acetylsalicylic acid (ASA) therapy was superimposed onto a 21-day regimen with diflunisal 250 mg b.i.d. Low doses of ASA (600 mg single dose or 300 mg q.i.d.) did not influence significantly diflunisal blood levels whereas a 600 mg q.i.d. dosing caused a small significant drop, especially at trough level. This drop is not expected to be clinically significant. No ototoxicity could be demonstrated with any treatment of diflunisal though four of fourteen subjects reported mild tinnitus during concomitant therapy at the higher doses of ASA. Diflunisal at 375 mg b.i.d. failed to alter the metabolism of a single dose of labelled ASA (600 mg) as judged by plasma levels, urinary excretion and plasma binding. Daily urinary excretion of prostaglandins E1 and E2 major metabolite was decreased by about 70% by diflunisal.
Comparison of a New Hypnotic (Finorgal) with Placebo in a Double-Blind Trial
Authors: Baiotti Gianni 
Published: January 2017

The hypnotic effects of Finorgal (ethchlorvynol with diphenhydramine) were compared with those of placebo in a double-blind study with crossover of treatments in thirty-five hospital in-patients. During the four-week period of Finorgal treatment there was a significant reduction in the mean time elapsing between the administration of the hypnotic and the onset of sleep, and a significant increase in the duration of sleep, compared with the four weeks of placebo treatment. There was also a significant increase in the proportion of nights when the patients felt they had slept well, and in the incidence of morning ‘hangover’ and nocturnal confusion during the Finorgal treatment periods. Patients had to be actively woken in the morning significantly more often following Finorgal administration. In patients experiencing pain in the night there was a significant reduction in the occurrence of pain during the nights when Finorgal had been given.