Translation of a patient-surgeon relationship assessment instrument (Q-PASREL) into six languages.

The Questionnaire for Patient-Surgeon Relationship (Q-PASREL) is a French "Patient-Reported Experience Measure" for hand surgery patients. It is the only one which considers the impact of the patient-surgeon relationship on time to return to work and cooperation by the surgeon for administrative issues. It has been shown that a good Q-PASREL score is associated with shorter sick leave and faster return to work. To make this instrument available to more countries, we translated the Q-PASREL into six languages (English, Spanish, German, Italian, Arabic and Persian), following a validated "translation and cultural adaptation" process guideline. This process includes multiple forward and backward translations, discussions and reconciliations with final harmonization and cognitive debriefing. For each language, a team was set up, comprising a key in-country hand surgery consultant, native target-language speaker and fluent in French, and several forward and back translators. The final translated versions were reviewed and approved by the project manager. The six versions of Q-PASREL are now available in the appendices of this publication.

Patient Perspectives on Value Dimensions of Lung Cancer Care: Cross-sectional Web-Based Survey.

BACKGROUND: While the lung cancer (LC) treatment landscape has rapidly evolved in recent years, easing symptom burden and treatment side effects remain central considerations in disease control. OBJECTIVE: The aim of this study was to assess the relative importance of dimensions of LC care to patients, and to explore the disease burden, including socioeconomic aspects not commonly covered in patient-reported outcomes instruments. METHODS: A questionnaire was sent to patients with LC and their caregivers to rate the value of a diverse set of quality of life dimensions in care, to evaluate communication between health care professionals (HCPs) and patients, and to explore the economic impact on respondents. The survey included questions on the dimensions of care covered by patient-reported outcomes instruments for quality-of-life evaluation (Functional Assessment of Cancer Therapy-Lung scale, EQ-5D, the European Organization for Research and Treatment of Cancer's Core Quality of Life questionnaire, and the European Organization for Research and Treatment of Cancer's Core Quality of Life in lung cancer 13-item questionnaire), as well as the International Consortium for Health Outcomes Measurement (ICHOM) standard set of patient-centered outcomes for LC. The survey respondents were participants on Carenity's patient community platform, living either in France, the United Kingdom, Germany, Italy, or Spain. RESULTS: The survey included 150 respondents (115 patients and 35 caregivers). "Physical well-being" and "end-of-life care" (median scores of 9.6, IQR 7.7-10, and 9.7, IQR 8.0-10, on a 10-point scale) were rated highest among the different value dimensions assessed. "Physical well-being and functioning" was the dimension most frequently discussed with health care professionals (82/150, 55%), while only (17/100, 17%) reported discussing "end-of-life care." After diagnosis, 43% (49/112) of patients younger than 65 years stopped working. Among respondents who indicated their monthly household income before and after diagnosis, 55% (38/69) reported a loss of income. CONCLUSIONS: Our results showed the relevance of a broad range of aspects of care for the quality of life of patients with LC. End-of-life care was the dimension of care rated highest by patients with LC, irrespective of stage at diagnosis; however, this aspect is least frequently discussed with HCPs. The results also highlight the considerable socioeconomic impact of the disease, despite insurance coverage of direct costs.

Comparable reliability and acceptability of telepsychiatry and face-to-face psychiatric assessments in the emergency room setting.

OBJECTIVE: This study aims to compare the reliability and acceptability of psychiatric interviews using telepsychiatry and face-to-face modalities in the emergency room setting. METHODS: In this prospective observational feasibility study, psychiatric patients (n = 38) who presented in emergency rooms between April and June 2020, went through face-to-face and videoconference telepsychiatry interviews in a non-randomised varying order. Interviewers and a senior psychiatry resident who observed both interviews determined diagnosis, recommended disposition and indication for involuntary admission. Patients and psychiatrists completed acceptability post-assessment surveys. RESULTS: Agreement between raters on recommended disposition and indication for involuntary admission as measured by Cohen's kappa was 'strong' to 'almost perfect' (0.84/0.81, 0.95/0.87 and 0.89/0.94 for face-to-face vs. telepsychiatry, observer vs. face-to-face and observer vs. telepsychiatry, respectively). Partial agreement between the raters on diagnosis was 'strong' (Cohen's kappa of 0.81, 0.85 and 0.85 for face-to-face vs. telepsychiatry, observer vs. face-to-face and observer vs. telepsychiatry, respectively).Psychiatrists' and patients' satisfaction rates, and psychiatrists' perceived certainty rates, were comparably high in both face-to-face and telepsychiatry groups. CONCLUSIONS: Telepsychiatry is a reliable and acceptable alternative to face-to-face psychiatric assessments in the emergency room setting. Implementing telepsychiatry may improve the quality and accessibility of mental health services.Key pointsTelepsychiatry and face-to-face psychiatric assessments in the emergency room setting have comparable reliability.Patients and providers report a comparable high level of satisfaction with telepsychiatry and face-to-face modalities in the emergency room setting.Providers report a comparable level of perceived certainty in their clinical decisions based on telepsychiatry and face-to-face psychiatric assessments in the emergency room setting.

Validity of the French version of Catquest-9SF and use of an electronic notepad for entering patient-reported outcome measures.

BACKGROUND: The Catquest-9SF questionnaire is a patient reported outcome measure that quantifies the visual benefits from cataract surgery. The purpose of this study was to translate and adapt the Catquest-9SF questionnaire for France, to assess its psychometric properties via Rasch analysis, and to assess its validity when completed using an electronic notepad. METHODS: The Catquest-9SF questionnaire was translated following the guidelines of the International Society for Pharmacoeconomics and Outcomes Research. Catquest-9SF and clinical data were collected from patients before and after routine cataract surgery. All questionnaire data were collected via an electronic notepad. Rasch analysis was performed to assess psychometric properties, and sensitivity to change was analysed for patients with complete paired pre- and post-operative questionnaires. RESULTS: A complete filled-in preoperative questionnaire was obtained for 848 patients. Rasch analysis showed good precision (person separation: 2.32, person reliability: 0.84), ordered category probability curves, no item misfit, and unidimensionality. The respondents were slightly more able than the level of item difficulty (targeting: -1.12 logits). Sensitivity was analysed on 211 paired questionnaires, and the postoperative questionnaires showed a clear ceiling effect. The effect size was 2.6. The use of an electronic notepad for completing the questionnaire worked out very well after some adjustments. CONCLUSIONS: The French version of Catquest-9SF has good psychometric properties and is suitable for use in French-speaking patients. The use of the Catquest-9SF questionnaire in an electronic format showed good validity.

Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price Negotiation.

Real-world data (RWD) and real-world evidence (RWE) appear now as complementary to traditional randomized controlled trials (RCT), that remain the gold standard of the evidence. This review aims to illustrate how health authorities in France, United States (USA) and United Kingdom (UK) can integrate RWD and RWE in market authorization discussions and in new pathways of price and reimbursement negotiations. We conducted a review from the literature, online investigations and interviews. RWD and RWE can be valuable in the context of market access, reimbursement decisions, price negotiation, pharmacovigilance and positive patient outcomes. While RWD could open new areas of innovative approaches and improve the efficiency of health systems, they have methodological limitations requiring further analysis to reach a sufficient level of proof. Moreover, misleading use of "RWD" and "RWE" terms is very frequent and even the definitions used by stakeholders (when they have one) are heterogenous. Because of the intrinsic characteristics of each product, the value given to these RWD may differ a lot, making them a useful tool more than an indispensable one. In sum, RWD and, more precisely, RWE have the potential to bring value to the health system at every step of the drug development process, from the discovery to the pharmacovigilance phase.

Impact of Patient-Surgeon Relationship on Patient's Return to Work.

BACKGROUND: Upper-limb injuries and musculoskeletal disorders represent a major economic burden for both patients and society, largely due to limitations in returning to work. We hypothesized that a positive patient-surgeon relationship may facilitate patients' recovery and lead to a faster return to work. METHODS: This longitudinal observational study comprised 219 patients, from 8 French hand trauma centers, who were 18 to 55 years of age and were on sick leave from work because of an injury or musculoskeletal disorder of the upper limb. In addition to instruments measuring patients' functional scores and quality of life, the quality of the patient-surgeon relationship was assessed at enrollment using a specific questionnaire (Q-PASREL [Quality of PAtient-Surgeon RELationship]). Six months after enrollment, the return-to-work status was assessed. Logistic and Cox regression models were developed to identify predictors of return to work (yes/no) and the time off from work in days. RESULTS: Overall, 74% of the patients who returned to work within 6 months after enrollment had a high or medium-high Q-PASREL score, whereas 64% of the patients who were still on sick leave had a low or medium-low Q-PASREL score. The odds of patients with a low or medium-low Q-PASREL score returning to work were, respectively, 95% and 71% lower than the odds of patients with a high score doing so, with a percent difference of 56% (95% confidence interval [CI] = 40% to 71%) for low versus high (odds ratio [OR] = 0.05 [95% CI = 0.02 to 0.13]) and 25% (95% CI = 6% to 44%) for medium-low versus high (OR = 0.29 [95% CI = 0.11 to 0.76]). All Q-PASREL items and scores were significantly associated with return to work. CONCLUSIONS: Patients with a lower Q-PASREL score and more severe disability were less likely to return to work within 6 months and had a longer time off from work. Efforts to improve the quality of patient-surgeon relationships may minimize the duration of sick leaves and accelerate patient recovery. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Systemic Lupus Erythematosus and Increased Prevalence of Atherosclerotic Cardiovascular Disease in Hospitalized Patients.

OBJECTIVE: To assess the prevalence of atherosclerotic cardiovascular disease (ASCVD) and its individual phenotypes of coronary artery disease (CAD), peripheral artery disease (PAD), and cerebrovascular disease by age and sex in a large US cohort of hospitalized patients with systemic lupus erythematosus (SLE). METHODS: A nested case-control study of adults with and without SLE was conducted from the January 1, 2008, through December 31, 2014, National Inpatient Sample. Hospitalized patients with SLE were matched (1:3) by age, sex, race, and calendar year to hospitalized patients without SLE. The prevalences of CAD, PAD, and cerebrovascular disease were evaluated, and associations with SLE were determined after adjustment for common cardiovascular risk factors. RESULTS: Among the 252,676 patients with SLE and 758,034 matched patients without SLE, the mean age was 51 years, 89% were women, and 49% were white. Patients with SLE had a higher prevalence of ASCVD vs those without SLE (25.6% vs 19.2%; OR, 1.45; 95% CI, 1.44-1.47; P<.001). After multivariable adjustment, SLE was associated with a greater odds of ASCVD (adjusted odds ratio [aOR], 1.46; 95% CI, 1.41-1.51). The association between SLE and ASCVD was observed in women and men and was attenuated with increasing age. Also, SLE was associated with increased odds of CAD (aOR, 1.42; 95% CI, 1.40-1.44), PAD (aOR, 1.25; 95% CI, 1.22-1.28), and cerebrovascular disease (aOR, 1.68; 95% CI, 1.65-1.71). CONCLUSION: In hospitalized US patients, SLE was associated with increased ASCVD prevalence, which was observed in both sexes and was greatest in younger patients.

21st-Century Oncology Drug Safety via New-Age Regulatory Standards and Practices.

There is no such thing as a drug that is 100% safe or effective. Determining whether or not a new oncology treatment (or an additional indication for an existing medicine) should be approved by a regulatory licensing authority is, ultimately, as much regulatory science as public health art and nuance. There are many dynamic shifts in regulatory science (expedited review pathways, biomarker validation, use of real-world evidence, expanded off-label usage, etc) interpreted and expressed within the context of 21st-century oncology drug development, and these new tools and the learnings gleaned from them are helping to advance patient care. They are also helping us to carefully reconsider the levels of uncertainty we find in benefit-risk data and clinical calculations. New-Age Pharmacovigilance can be a tool in product development, regulatory review, postmarketing surveillance and enhanced clinical outcomes.

[The French health care funding system for research and innovation in oncology]. / Place des missions d'intérêt général (MIG) relatives à la recherche et à l'innovation dans le financement des établissements de santé en cancérologie.

INTRODUCTION: This article provides an overview of the French health system with respect to allocation of public resources to hospitals, to encourage research and innovation, particularly in the field of oncology. It is explained in a historical, economic and scientific perspective. RESULTS: Important structural and conceptual reforms (T2A, HPST law, etc.) have been carried out. These have significantly impacted the way public funding is allocated. Funding of innovation and research has been modified into a more incentive logic, aimed at strengthening competitiveness between all health care actors. The funding allocation system has evolved towards a more ubiquitous redistribution, including non-academic and private institutions. The baseline endowment includes indicators relating to scientific publications (60% of the endowment), teaching (25%) and clinical trials (15%). Research funding is then redistributed by regional health agencies, and used in health care institutions at the discretion of the directorates. Other funding sources such as calls for grants, funding for mobile research centers and teams, tumor banks and temporary user licenses are also part of the funding by the French Ministry of health. CONCLUSION: Changes in the health research funding system have an incentive purpose. They have significantly modified the global healthcare landscape. Feedback on these changes will be necessary to assess the success of the reinforcement of the dynamics of research and innovation.

Systemic lupus erythematosus and the risk of perioperative major adverse cardiovascular events.

Systemic lupus erythematosus (SLE) is a significant risk factor for cardiovascular disease. The relationship between SLE and perioperative cardiovascular risks following non-cardiac surgery is uncertain. We investigated associations between a diagnosis of SLE and outcomes following major non-cardiac surgery in a large national database from the United States. Patients age ≥ 18 years requiring major non-cardiac surgery were identified from Healthcare Cost and Utilization Project's National Inpatient Sample data from 2004 to 2014. Systemic lupus erythematosus and perioperative major adverse cardiovascular events (MACE; myocardial infarction, ischemic stroke or death) were defined by ICD-9 diagnosis codes. Perioperative MACE were reported for SLE patients stratified by age and sex. From 2004 to 2014, a total of 17,853,194 hospitalizations for major non-cardiac surgery met study inclusion criteria. SLE was identified in 70,578 (0.4%) hospitalizations. Overall, the frequency of perioperative MACE was higher in patients with vs. without SLE [2.4 vs. 2.0%, p < 0.001; adjusted OR (aOR) 1.25; 95% CI 1.18-1.31]. Perioperative MACE associated with SLE was largely driven by increased death (aOR 1.58 95% CI 1.40-1.77) and myocardial infarction (aOR 1.32; 95% CI 1.05-1.66) in younger patients with SLE. The increased risk of perioperative MACE associated with SLE in younger patients was attenuated with increasing age. A diagnosis of SLE is associated with increased risk of perioperative MACE, particularly among younger patients. Efforts to improve the perioperative management and outcomes of patients with SLE are needed.

Development of an instrument evaluating the impact of surgeon-patient relationship in patients on sick leave.

Background: To date, no specific instruments exist to measure the quality of the patient-surgeon relationship despite its potential to influence clinical and economic outcomes in patients undergoing surgery for musculoskeletal disorders (MSDs). Objective: The objective was to develop and validate an instrument to assess the quality of the patient-surgeon relationship, taking into account the return to work after functional restoration surgery. Methods: The instrument development was based on literature review, cognitive interviews and expert examinations. The instrument's psychometric properties were explored in a sample of 50 French patients on sick leave with musculoskeletal disorders or hand injuries. Face validity, internal consistency and test-retest reliability were evaluated. The dimensionality of the instrument was studied using an exploratory principal component analysis. Results: The 11-item instrument showed good psychometric properties. The cognitive interviews allowed enhancing the validity of the instrument content by capturing patients' point of view. The exploratory principal component analysis demonstrated the uni-dimensionality of the instrument with the first factor accounting for 83% of the total explained variance. Conclusion:This study has developed the first instrument capable of the specific assessment of the impact of the surgeon-patient relationship on recovery, in patients with hand traumas and MSDs.

Implications of CRISPR-Based Germline Engineering for Cancer Survivors.

Cancer survivors can carry germline mutations that will be transmitted to their progeny. Today, many of these mutations have been identified and can be tracked. With the recent development of genome-editing technologies and CRISPR (clustered regularly interspaced short palindromic repeats), the possibility of genetically modifying the human germline-gametes and embryos-has never been closer. This perspective has sparked a controversy within the scientific community with reactions ranging from calls for a ban on germline modification to cautious approval of further research. This Editorial analyzes the possible adoption of CRISPR-based germline engineering to prevent the spread of cancer predispositions in the human population. We discuss whether the genomic edition of human sperm and eggs would contribute to rectifying or altering the heritable genome. We anticipate the emergence of a new form of liberal eugenics fueled by a logic of offer and demand from stakeholders such as cancer survivors and their relatives and offspring, but also from fertility clinics, biotech firms, insurers, and clinicians. From a regulatory perspective, validating the clinical safety and utility of CRISPR-based germline engineering is an essential step. However, with time, gradually perfecting the technology and assessing the economic benefits for stakeholders could soften society's resistance and align opinions in support of genomic decontamination of human germlines. This progressive shift would be justified in the name of cancer prevention as well as a moral obligation to facilitate the conception of cancer-free children at a cost that is acceptable to individuals and health systems.

A Randomized Trial of Fixed-Dose Combination Brinzolamide 1%/Brimonidine 0.2% as Adjunctive Therapy to Travoprost 0.004.

PURPOSE: To evaluate the safety and efficacy of adding fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) as adjunctive therapy to travoprost 0.004% (TRAV) in patients with open-angle glaucoma or ocular hypertension. DESIGN: Multicenter, randomized, double-masked, parallel-group phase 4 clinical trial. METHODS: setting: Multicenter; 32 sites in the United States. PATIENT POPULATION: Total of 233 patients with open-angle glaucoma or ocular hypertension and with mean intraocular pressure (IOP) ≥21 mm Hg and <32 mm Hg while receiving once-daily TRAV monotherapy. INTERVENTION: Masked BBFC or vehicle (3 times daily) adjunctive to TRAV for 6 weeks. MAIN OUTCOME MEASURE: Mean diurnal IOP averaged over 8 AM, 10 AM, 3 PM, and 5 PM time points at week 6. Superiority of BBFC+TRAV over vehicle+TRAV was based on statistical significance of a treatment difference favoring BBFC+TRAV. RESULTS: Mean diurnal IOP at week 6 (least squares mean ± standard error) was 17.6 ± 0.4 mm Hg and 20.7 ± 0.4 mm Hg in the BBFC+TRAV and vehicle+TRAV groups, respectively (between-group difference, -3.2 ± 0.5 mm Hg; P < .0001). Superiority of BBFC+TRAV over vehicle+TRAV was established. Mean and percent diurnal IOP change from baseline were significantly greater with BBFC+TRAV compared with vehicle+TRAV (P < .0001 for both). Conjunctival hyperemia was the most common treatment-related adverse event in either group (BBFC+TRAV, 12.8%; vehicle+TRAV, 6.0%). CONCLUSIONS: Adjunctive treatment with BBFC added to TRAV resulted in lower mean diurnal IOP after 6 weeks of treatment compared with vehicle added to TRAV; this difference was both statistically and clinically significant.

Cannabis and Alcohol Abuse Among First Psychotic Episode Inpatients.

BACKGROUND: Psychoactive substance abuse, which includes abuse of alcohol and street drugs, is common among first-episode psychosis patients, but the prevalence of cannabis abuse is particularly high. However, there have been very few reported studies concerning the occurrence of psychoactive substance abuse among first-episode psychotic individuals using standard toxicological testing. We study the prevalence of cannabis and alcohol abuse among first-psychoticepisode inpatients as well as compare the demographic, diagnostic, and psychopathological profiles of substance abusers versus nonusers. METHODS: Subjects were recruited from the Jerusalem Mental Health Center between 2012 and 2014. Ninety-one consecutively admitted psychiatric patients diagnosed using the DSM-IV criteria with a first psychotic episode due to schizophrenia, schizophreniform disorder, bipolar disorder, brief psychotic episode, and psychosis NOS disorder entered the study. The diagnoses of schizophrenia (all types), psychosis NOS disorder, brief psychotic episode, and schizophreniform disorder were categorized as "only psychosis" and those of bipolar disorder manic episode with psychotic features (congruent and incongruent) and severe depression with psychotic features were categorized as "predominantly affective symptoms." Urine tests for tetrahydrocannabinol (THC) were performed during the first 48 hours of admission, and likewise self-report questionnaires were administered. Alcohol abuse and dependence were diagnosed by self-report. RESULTS: Of the 91 subjects in the study, 49 (53.8%) did not abuse any illegal psychoactive substance. Twenty patients (22%) abused only cannabis; 14 (15.4%) abused cannabis and another psychoactive substance; 54 (59.3%) of the subjects reported no alcohol abuse; 33 (36.3%) reported occasional drinking (between two and ten times a month); and 4 (4.4%) reported continuous repeated drinking (more than ten times a month). There was no correlation between the demographic characteristics and the abuse of cannabis. Two-thirds of the "predominantly affective symptoms" subjects were positive for THC, whereas only a third of the "only psychosis" subjects screened positive for THC. CONCLUSIONS: The percentage of cannabis and alcohol abuse in the study population is much higher than one would expect to see in the general Israeli population (according to the Knesset Research Department 7.6-10.2% of the adult Israeli population abuse cannabis). Different patterns of cannabis abuse among "predominantly affective" and "psychotic only" patients may lend credence to the preferential use of a specific substance per diagnosis.

Banking or Bankrupting: Strategies for Sustaining the Economic Future of Public Cord Blood Banks.

BACKGROUND: Cord blood is an important source of stem cells. However, nearly 90% of public cord blood banks have declared that they are struggling to maintain their financial sustainability and avoid bankruptcy. The objective of this study is to evaluate how characteristics of cord blood units influence their utilization, then use this information to model the economic viability and therapeutic value of different banking strategies. METHODS: Retrospective analysis of cord blood data registered between January 1st, 2009 and December 31st, 2011 in Bone Marrow Donor Worldwide. Data were collected from four public banks in France, Germany and the USA. Samples were eligible for inclusion in the analysis if data on cord blood and maternal HLA typing and biological characteristics after processing were available (total nucleated and CD34+ cell counts). 9,396 banked cord blood units were analyzed, of which 5,815 were Caucasian in origin. A multivariate logistic regression model assessed the influence of three parameters on the CBU utilization rate: ethnic background, total nucleated and CD34+ cell counts. From this model, we elaborated a Utilization Score reflecting the probability of transplantation for each cord blood unit. We stratified three Utilization Score thresholds representing four different banking strategies, from the least selective (scenario A) to the most selective (scenario D). We measured the cost-effectiveness ratio for each strategy by comparing performance in terms of number of transplanted cord blood units and level of financial deficit. RESULTS: When comparing inputs and outputs over three years, Scenario A represented the most extreme case as it delivered the highest therapeutic value for patients (284 CBUs transplanted) along with the highest financial deficit (USD 5.89 million). We found that scenario C resulted in 219 CBUs transplanted with a limited deficit (USD 0.98 million) that charities and public health could realistically finance over the long term. We also found that using a pre-freezing level of 18 x 10(8) TNC would be the most cost-effective strategy for a public bank. CONCLUSION: Our study shows that a swift transition from strategy A to C can play a vital role in preventing public cord blood banks worldwide from collapsing.

Economic Impact of Gene Expression Profiling in Patients with Early-Stage Breast Cancer in France.

BACKGROUND AND AIMS: The heterogeneous nature of breast cancer can make decisions on adjuvant chemotherapy following surgical resection challenging. Oncotype DX is a validated gene expression profiling test that predicts the likelihood of adjuvant chemotherapy benefit in early-stage breast cancer. The aim of this study is to determine the costs of chemotherapy in private hospitals in France, and evaluate the cost-effectiveness of Oncotype DX from national insurance and societal perspectives. METHODS: A multicenter study was conducted in seven French private hospitals, capturing retrospective data from 106 patient files. Cost estimates were used in conjunction with a published Markov model to assess the cost-effectiveness of using Oncotype DX to inform chemotherapy decision making versus standard care. Sensitivity analyses were performed. RESULTS: The cost of adjuvant chemotherapy in private hospitals was estimated at EUR 8,218 per patient from a national insurance perspective and EUR 10,305 from a societal perspective. Cost-effectiveness analysis indicated that introducing Oncotype DX improved life expectancy (+0.18 years) and quality-adjusted life expectancy (+0.17 QALYs) versus standard care. Oncotype DX was found cost-effective from a national insurance perspective (EUR 2,134 per QALY gained) and cost saving from a societal perspective versus standard care. Inclusion of lost productivity costs in the modeling analysis meant that costs for eligible patients undergoing Oncotype DX testing were on average EUR 602 lower than costs for those receiving standard care. CONCLUSIONS: As Oncotype DX was found both cost and life-saving from a societal perspective, the test was considered to be dominant to standard care. However, the delay in coverage has the potential to erode the quality of the French healthcare system, thus depriving patients of technologies that could improve clinical outcomes and allow healthcare professionals to better allocate hospital resources to improve the standard of care for all patients.

Drug-eluting stents: the past, present, and future.

Since the advent of percutaneous coronary intervention, enormous advances have been made in the treatment of coronary artery disease. Angioplasty and bare metal stents were plagued by high rates of restenosis leading to repeat revascularization procedures. Examination of the underlying pathophysiology of restenosis led to the development of drug-eluting stents to reduce neointimal hyperplasia. However, as restenosis rates declined, length of dual antiplatelet therapy use and risk of long-term stent thrombosis associated with drug-eluting stents increased. Subsequent generations have improved each facet of stent design. Novel alloys maintain durability and reduce strut thickness to increase deliverability, biocompatible polymers decrease the inflammatory response and improve drug elution kinetics, and new generations of drugs predictably inhibit restenosis. Developments on the horizon include stents with bioabsorbable polymers and platforms. The purpose of this review is to assess the evolution of stent design and the evidence behind each generation and to peer into the future of stent technology.

Applying quality principles to orthopaedic surgery.

The unsustainable rising cost of medical care is creating financial pressures that will critically alter the way that health care is paid for and delivered. Limited resources dictate that physicians must become more efficient at providing high quality care. In an effort to provide financial incentive for delivering quality care, the federal government instituted value-based purchasing to transform Medicare from a passive payer of claims to an active purchaser of medical care. Healthcare providers must follow the basic tenants of certain quality principles to maximize reimbursement under the value-based purchasing system.

Cannabis Withdrawal - A New Diagnostic Category in DSM-5.

BACKGROUND: Cannabis withdrawal was not formally recognized by the DSM-IV classification but is listed, albeit without diagnostic criteria by ICD-10. The American Psychiatric Association recently has included cannabis withdrawal into DSM-5 classification as part of the "Substance-Related and Addictive Disorders" Section. However, many psychiatrists as well as other medical professionals have very little information, if at all, about the new diagnostic entity. METHOD: The information was obtained from PubMed (research words: Cannabis, THC, Hashish, Marijuana and Withdrawal). The different clinical symptoms of the phenomena as well as some pathophysiological mechanisms and treatment considerations were summarized and discussed. RESULTS AND CONCLUSIONS: A substantial amount of scientific data has been obtained in recent years concerning reliability, validity and clinical importance of cannabis withdrawal.The possible influence of cannabis withdrawal on the severity of major psychiatric disturbances is far from being understood and deserves further research. LIMITATIONS: The reviewed studies varied in sample size, design and methodology limiting clear conclusions.