Attributes for a discrete-choice experiment on preferences of patients for oncology pharmacy consultations.

PURPOSE: To ensure the safe use of oral anticancer drugs, oncology pharmacy consultations (OPCs) have been established in France. They are conditioned by the needs, expectations, and involvement of the patients in their care. Thus, it is essential to elicit their preferences. The discrete-choice experiment (DCE) is a method recommended by the ISPOR for such a task. The "selection and validation of attributes and their values" step is fundamental in this process. In this context, the aim of this study was to present our research approach to identify and validate the attributes that characterize an OPC and their values. METHODS: Due to the lack of relevant published data in the literature, the focus-group method was used in accordance with good research practices for the application of conjoint-analysis of the ISPOR. The two-round Delphi method was used to validate the attributes and their values identified by the focus-group method. RESULTS: The focus-group method enabled identification of nine attributes. Thirty-seven healthcare professionals at a national level, including 30 pharmacists and seven physicians, were selected to take part in the Delphi procedure. Seven attributes (frequency, planification, operation mode, duration, content, written support, and report) and their values were thus validated. CONCLUSION: Based on these results, the next step will be to elicit patient preferences for OPCs and to then shed light on the issues of pharmaceutical support for patients by comparing their preferences with those of informal caregivers and, in particular, those of the healthcare professionals involved in their care.

Laparoscopic Repair of Larrey Hernia: A Case Report and Literature Review.

Morgagni-Larrey hernia is a rare pathology resulting from an anterior diaphragmatic defect. Diagnosis is often made in adulthood due to the lack of symptoms associated with this condition. Various surgical techniques have been reported for its treatment, but no standard approach has been established due to its rarity. Here, we present the case of a 42-year-old patient with a symptomatic Larrey hernia successfully treated with a laparoscopic approach. The rationale for documenting this case lies in contributing to the understanding and management of this rare condition.

Evaluating the impact and costs of conversional or revisional metabolic bariatric surgery on obstructive sleep apnea: Insights from a French nationwide cohort.

BACKGROUND: This study assesses the effectiveness of 5 main conversional or revisional metabolic bariatric surgery sequences after sleeve gastrectomy, adjustable gastric banding and gastric bypass on reimbursement and cost of continuous positive airway pressure therapy, the first line treatment for obstructive sleep apnea, in France. METHODS: This nationwide observational population-based cohort study analyzed data from the French National Health Insurance database. It included all patients who had undergone primary metabolic bariatric surgery in France between January 1, 2012, and December 31, 2014, and followed until December 31, 2020. The study assessed continuous positive airway pressure therapy reimbursement discontinuation and costs of reimbursed continuous positive airway pressure therapy across 5 different conversional or revisional metabolic bariatric surgery sequences. RESULTS: During follow-up, 6,396 patients underwent the following sequences: sleeve gastrectomy-gastric bypass (n = 2,400), adjustable gastric banding-sleeve gastrectomy (n = 2,277), adjustable gastric banding-gastric bypass (n = 1,173), sleeve gastrectomy-sleeve gastrectomy (n = 546), and gastric bypass-others (n =332), with a rate of obstructive sleep apnea of 15.2%, 12.4%, 15.5% 12.8%, and 9.9% in the year before conversional or revisional metabolic bariatric surgery. The rates of patients who had a discontinuation of continuous positive airway pressure were at 2 and 4 years: 41.1%, 41.9%, 46.4%, 29.3%, and 33.3%; 62.3%, 57.0%, 78.2%; 57.5%, and 44.4%, respectively. At 4 years, the mean annual costs (euros) of obstructive sleep apnea treatment per patient were significantly lower (P < .01) than the costs in the year before conversional or revisional metabolic bariatric surgery for each sequence: 526.9 ± 414.4 vs 257.4 ± 349.7; 368.0 ± 247.5 vs 230.9 ± 288.4; 433.7 ± 326.0 vs 116.8 ± 238.3; 540.7 ± 275.3 vs 248.0 ± 308.4 and 501.2 ± 254.0 vs 281.1 ± 287.0, respectively. CONCLUSIONS: Our study underscore the effectiveness of conversional or revisional metabolic bariatric surgery in significantly reducing the need and associated costs of continuous positive airway pressure therapy for patients with obstructive sleep apnea postprimary metabolic bariatric surgery over a 4-year period.

Effectiveness of conversional metabolic and bariatric surgery on dyslipidemia and the cost of lipid-lowering medications over 4 years: a French nationwide study.

BACKGROUND: The need for conversional metabolic and bariatric surgery (CMBS) is still growing. No large-scale prospective cohort studies have assessed changes in lipid-lowering treatment (LLT) after CMBS. OBJECTIVES: This study assesses and compares the effectiveness of the 4 main CMBS sequences after sleeve gastrectomy (SG) and adjustable gastric banding (AGB) on reimbursement and cost of LLT. SETTING: France. METHODS: This nationwide observational population-based cohort study analyzed data from the French National Health Insurance database. It included all patients who had undergone primary SG and AGB in France between January 1, 2012, and December 31, 2014, and followed until December 31, 2020. The study assessed LLT reimbursement evolution and costs across 4 different CMBS sequences. RESULTS: During follow-up, 6396 patients underwent the 4 CMBS sequences: SG-RYGB (Roux-en-Y gastric bypass) (n = 2400), AGB-SG (n = 2277), AGB-RYGB (n = 1173), and SG-SG (n = 546), with a rate of LLT reimbursement of 9.8%, 3.6%, 6.6%, and 7.9%, respectively, in the year before CMBS. The rates of discontinuation of treatment at 2 and 4 years were 41.9%, 35.4%, 45.6%, 20.5% and 45.6%, 31.3%, 64.3%, 31.6%, respectively. At 4 years, the median [interquartile range] annual costs (euros) per patient were significantly lower (P < .01) than the costs in the year before CMBS for each sequence: 86.8 [57.3; 136.1] versus 38.0 [.0; 64.6], 79.1 [50.5; 120.1] versus 50.4 [15.6; 64.1], 89.0 [66.5; 139.6] versus .0 [.0; 58.8], and 89.8 [66.1; 121.4] versus 63.1 [.0; 93.4]. CONCLUSIONS: Our study underlines the effectiveness of CMBS in significantly reducing the need and associated costs of LLT for patients with dyslipidemia over a 4-year period.

Cost-Effectiveness of Sleeve Gastrectomy and Gastric Bypass as Revisional Surgery on Antidiabetic Reimbursement: A Nationwide Cohort Study.

Objective: This study compared the effectiveness of 4 main revisional bariatric surgery (RBS) sequences after sleeve gastrectomy (SG) and adjustable gastric banding (AGB), on the reimbursement of antidiabetic treatments in France. Background: Few large-scale prospective cohort studies have assessed the changes in antidiabetic treatments after RBS. Method: This nationwide observational population-based cohort study analyzed data from the French National Health Insurance Database. All patients who underwent primary SG and AGB in France between January 2012 and December 2014 were included and followed up until December 31, 2020. The changes in categories and costs of reimbursed antidiabetic treatments across different RBS sequences were assessed (presented as follows: bariatric surgery (BS)-RBS). Results: Among the 107,088 patients who underwent BS, 6396 underwent RBS, 2400 SG-GBP (SG converted to gastric bypass [GBP] during follow-up), 2277 AGB-SG, 1173 AGB-GBP, and 546 SG-SG. Pre-RBS insulin was used in 10 (2.9%), 4 (0.9%), 8 (2.4%), and 10 (2.6%) patients, respectively. Two years after RBS, the treatment discontinuation or decrease (the change of treatment to a lighter one category rates [eg, insulin to bi/tritherapy]) was 47%, 47%, 49%, and 34%, respectively. Four years after RBS, the median annual cost per patient compared with baseline was lower (P < 0.01) for all sequences, except SG-SG (P = 0.24). The most notable effect concerned AGB-GBP (median of more than 220 euros to 0). Conclusions: This study demonstrated the positive impact of RBS over a 4-year follow-up period on antidiabetic treatments reimbursement, through the reduction or discontinuation of treatments and a significant decrease in costs per patient.

Benefits of Homeopathic Complementary Treatment in Patients With Breast Cancer: A Retrospective Cohort Study Based on the French Nationwide Healthcare Database.

BACKGROUND: Complementary therapy in oncology aims to help patients better cope with the illness and side effects (SEs) of cancer treatments that affect their quality of life (QOL). This study aimed to assess the benefits of homeopathic treatment on the health-related QOL (HRQOL) of patients with non-metastatic breast cancer (BC) prescribed in postsurgical complementary therapy. PATIENTS AND METHODS: An extraction from the French nationwide healthcare database targeted all patients who underwent mastectomy for newly diagnosed BC between 2012 and 2013. HRQOL was proxied by the quantity of medication used to palliate the SEs of cancer treatments. RESULTS: A total of 98,009 patients were included (mean age: 61 ± 13 years). Homeopathy was used in 11%, 26%, and 22% of patients respectively during the 7 to 12 months before surgery, the 6 months before, and 6 months after. Thereafter, the use remained stable at 15% for 4 years. Six months after surgery, there was a significant overall decrease (RR = 0.88, confidence interval (CI)95 = 0.87-0.89) in the dispensing of medication associated with SEs in patients treated with ≥ 3 dispensing of homeopathy compared to none. The decrease appeared to be greater for immunostimulants (RR = 0.79, (CI)95 = 0.74-0.84), corticosteroids (RR = 0.82, (CI)95 = 0.79-0.85), and antidiarrheals (RR = 0.83, (CI)95 = 0.77-0.88). CONCLUSION: The study showed an increasing use of homeopathy in patients with BC following diagnosis. This use was maintained after surgery and seemed to play a role in helping patients to better tolerate the SEs of cancer treatments.

Study of the Catalytic Activity of the Compounds Hydrotalcite Type Treated by Microwave in the Self-Condensation of Acetone.

The self-condensation reaction of acetone, producing diacetone alcohol (DAA), is of great industrial importance. It was used to study the catalytic activity of Mg-Al catalysts synthesized by the coprecipitation method. For this purpose, we synthesized Mg-Al based hydrotalcite with a molar ratio of 3, obtained either after conventional heating or after microwave irradiation with of 100 W for three minutes. Structural and chemical properties of the obtained catalysts were characterized, using different techniques: X-ray diffraction (XRD), Fourier transform infrared spectra (FTIR), scanning electron microscope (SEM), equipped with energy dispersive X-ray (EDX), and specific surface area of the catalysts were determined by the methylene blue (MB) adsorption method. Also, these catalysts were tested in the self-condensation reaction of acetone at 273 K in the liquid phase without solvent, a reaction which requires very high catalytic activity. The microwave treatment improves the catalyst activity, and the conversion of acetone to diacetone alcohol increases from 13.2 to 18.3% after 8 h of reaction. Moreover, the microwave-treated hydrotalcite catalyst, calcined at 723 K and rehydrated under a flow of N2, is the most active and gives conversion of acetone of 52% under the same reaction conditions.

Valorization of crude olive stone in the removing of polyphenols from crude olive mill wastewater: kinetic, isotherm and mechanism study.

Removal of polyphenols from crude olive mill wastewaters (COMWW) is vital to the development of olive industries. In addition, the exploitation of the residue of the olive oil industry such as crude olive stone (COS) constitutes a valorization of this substance and makes a contribution to the fight against environmental pollution. For this purpose, this study concerns the utilization of COS as an adsorbent of polyphenols from COMWW. The characterization of COS was realized by FTIR, XRD, SEM, PZN, BET and TGA-DTA. The adsorption kinetics and isotherms of polyphenols was analyzed by pseudo-first-order (PFO), pseudo-second-order (PSO), intraparticle diffusion models (MW) and nonlinear models of isotherms Langmuir (LM) and Freundlich (FM) respectively. This study goal at understanding the adsorption mechanism of polyphenols on COS by FTIR and XRD study. The results of adsorption kinetics demonstred that the adsorption capacity of polyphenols 'PP' onto COS is decreased from 381 mg g-1 to 235 mg g-1, with the increasing of the temperature, from 25 °C to 45 °C, indicating an exothermic process, which is confirmed by the negative values of enthalpy ΔH°. Moreover, the negative values of free energy ΔG° and entropy ΔS° indicate the spontaneous and ordered adsorption phenomenon. Kinetic and isotherms studies showed that polyphenols adsorption onto crude olive stone followed PSO kinetic, the FM and LM models were the best fitted. Consequently, this study indicates that crude olive stone could be used as a cheap adsorbent for removing of polyphenols from crude COMWW.

A Method for Designing a Patient Burden Questionnaire in Dermatology.

INTRODUCTION: In recent years, the concept of "disease burden" has been given a central role in evaluating patient care, particularly in skin diseases. Measuring patient-reported outcomes (PRO) such as symptoms and disease burden may be useful. AIM: To present a methodology that facilitates the development and validation of burden questionnaires for patients suffering from skin diseases. METHODOLOGY: Based on past published burden questionnaires, a methodology for designing skin disease burden questionnaires was to be developed. RESULTS: Based on 16 burden questionnaires developed and published over the last 10 years, the authors propose a standardized methodology for the easy design and validation of disease burden questionnaires for patients with chronic skin diseases. The authors provide detailed guidance for the conception, development and validation of the questionnaires, including reliability, internal consistency, external validity, cognitive debriefing, testing-retesting, translation and cross-cultural adaptation, as well as for statistical analysis. CONCLUSION: The proposed methodology enhances the design and validation of disease burden questionnaires in dermatology. Burden questionnaires may be used in clinical research as well as in daily clinical practice.

Incontinentia pigmenti burden scale: designing a family burden questionnaire.

BACKGROUND: Incontentia pigmenti (IP) is a rare multisystem disorder of ectodermal origin comprising skin, dental, ocular and central nervous system features. Symptomatic treatments are adapted to each family according to the patient's disability. Due to its rarity, the family IP burden in its broadest sense (psychological, social, economic and physical) has not yet been evaluated. AIM: To design a questionnaire allowing assessing the family burden of IP (F'BoIP). METHOD: A questionnaire was developed using a standardized methodology for designing quality of life questionnaires according to the following steps: conception, development, and validation. A multidisciplinary working group was designed, including experts in questionnaire development, dermatologists specialised in IP patient care and representatives of the French IP association. A cultural and linguistic validation into US English was conducted, based on the original French version. RESULTS: A 20-item conceptual questionnaire was generated. Subsequent confirmatory analyses produced a 20-item questionnaire grouped into four domains, demonstrating internal consistency (Cronbach's alpha: 0.93), reproducibility and high reliability. The F'BoIP questionnaire significantly correlated with other validated questionnaires: Family Dermatology Life Quality Index (F-DLQI), Perceived Stress Scale (PSS) and SF-12 mental and SF12 physical scores, indicating good external validity. CONCLUSION: The F'BoIP questionnaire is the first specific tool to assess the family burden of IP and can be used by both family members of IP patients and by health care professionals. It is a valuable tool which evaluates medical and nonmedical strategies to improve the daily life of families affected by this orphan disease.

Burden of adult neurofibromatosis 1: development and validation of a burden assessment tool.

BACKGROUND: Neurofibromatosis Type 1 (NF1) is a common genetic neurocutaneous disease, with an autosomal dominant inheritance mode. Quality of life has been shown impaired in NF1, due to severe complications, cosmetic features, and uncertainty about the disorder. METHODS: This study sought to develop a self-administered questionnaire in French to assess the burden of NF1 (BoN), then translate and linguistically and cross-culturally validate it into American English, standardized methodology applied, as outlined in the report. RESULTS: Based on several discussions with NF1 patients, a 17-item conceptual questionnaire was first produced. Of the 91 NF1 adult patients who responded to the conceptual questionnaire, 65 (64.6% females) were accessible. Subsequent confirmatory analyses generated a 15-item questionnaire grouped into four domains, demonstrating internal consistency (Cronbach's alpha: 091), discriminant validity, and high reliability. The BoN was likewise shown to significantly correlate with other validated questionnaires, such as Dermatology Life Quality Index, Perceived Stress Scale, and SF12 mental score, indicating good external validity. CONCLUSIONS: BoN is a specific tool for assessing the burden that NF1 generates on many practical aspects of the patient daily activities, beyond the notion of quality of life". Given the increasing relevance that regulatory authorities attribute to patient-reported outcomes, the BoN questionnaire provides such supplementary information while accounting for the burden of NF1 patients in the broadest sense.

P-wave and QRS complex measurements in patients undergoing hemodialysis.

Hemodialysis (HD) has been associated with an increase in the amplitude of QRS complexes. Experience in a single patient with multiple measurements has shown that HD leads also to augmentation of P-wave amplitude. The objective of this investigation was to evaluate electrocardiogram (ECG) changes with HD in a cohort of patients undergoing this procedure with particular emphasis on the P-wave and QRS complex changes. The sum of amplitudes of P waves (OP) and QRS complexes (OQRS) in millimeters in the 12 leads of the ECG, along with a host of other ECG parameters, body weight, blood pressure, heart rate, electrolytes, and hemoglobin/hematocrit were measured before and immediately after HD in 47 patients. Hemodialysis resulted in a loss of a mean of 3 kg of weight and an increase in the SigmaP, SigmaQRS, mean QRS duration, maximum P-wave duration, and P-wave duration measured in lead II, whereas the changes in mean P-wave and corrected QT interval durations were not statistically significant. Percentage change (Delta%) in SigmaP and SigmaQRS correlated poorly with Delta% in electrolytes, hematocrit, blood pressure, heart rate, and weight. Values for SigmaP and SigmaQRS vs weight were r = 0.105, P = .48 and r = 0.09, P = .51, respectively. The Delta% in SigmaP correlated well with Delta% in SigmaQRS (r = 0.42, P = .003). Alterations in P-wave amplitudes and duration commensurate with the ones affecting the corresponding QRS complexes occur in patients undergoing HD and indicate that evaluation of measurements in serial ECGs should take this into account. The mechanisms of these phenomena continue to be elusive, and whether they represent cardiac and/or extracardiac influences has not as yet been unraveled.

Burden of albinism: development and validation of a burden assessment tool.

BACKGROUND: Albinism comprises a group of autosomal recessive diseases that are characterized by poor vision and a variable hypopigmentation phenotype. A comprehensive literature review showed that no tool can assess the burden experienced by individuals who present with albinism, although such a tool is needed and would be beneficial for clinicians and patients alike. METHOD: The questionnaire was devised using standardized methodology for developing and validating questionnaires on the quality of life of subjects according to the following chronological structure: conceptual phase, development phase, and then validation phase. A multidisciplinary working group was assembled, including experts on questionnaire design and development, dermatologists specializing in care for patients with albinism, and representatives of the Genespoir association. RESULTS: Based on an initial verbatim report, the workgroup compiled a list of items that were transcribed and reformulated into questions. During the validation phase, principal component analysis (PCA) was conducted on the 24 items, which allowed the questionnaire to be reduced to 20 questions [Q]. The standardized regression coefficients were all greater than 0.5 for their corresponding factors. Based on their normalized regression coefficients, each group of questions was linked to one of the following four dimensions, with each dimension consisting of at least three questions: "Live with" (8 Q), "Daily life" (3 Q), "Resignation" (3 Q), and "Fear of the future" (6 Q). All dimensions correlated well with the overall BoA score. Cronbach's α was 0.92 for the entire BoA scale, confirming excellent internal coherence. Intradimensional coherences all demonstrated excellent reliability (α > 0.65). The BoA questionnaire was highly correlated with the SF12, RSES and DLQI validated questionnaires. This outcome confirmed the external validity. CONCLUSION: This questionnaire represents the first specific assessment tool for evaluating the burden of albinism. It is easy to use and relatively quick to complete, which will allow the burden to be evaluated over time with a reproducible questionnaire. To ensure that this questionnaire can be used by as many people as possible, cultural and linguistic validation in US English was conducted with the original French version.

Impact of falling reimbursement rates on physician preferences regarding drug therapy for osteoarthritis using a discrete choice experiment.

OBJECTIVES: In the European context of falling reimbursement rates for some osteoarthritis (OA) treatments, we performed a study to determine whether the cost covered by patients influenced the decisions of their physicians' prescriptions for medication. METHODS: The study involved 106 general practitioners (GPs) and 82 rheumatologists. Preferences were elicited using a discrete choice experiment. Scenarios were generated including seven treatment attributes with associated different levels: pain relief, improvement in function, retardation of joint degradation, risk of moderate side effects, risk of serious side effects, cost borne by the patient and degree of patient acceptance of the treatment. KEY FINDINGS: OA treatment choices were significantly influenced by pain relief (ß = 1.1533, P < 0.0001 for GPs and ß = 0.5043, P = 0.0024 for rheumatologists), improvement in function (ß = 1.2140 for GPs and ß = 0.7192 for rheumatologists, P < 0.0001), annual cost to the patient (ß = -0.0054 for GPs and ß = -0.0038 for rheumatologists, P < 0.0001) and serious side effects (ß = -0.5524 for GPs and ß = -0.4268 for rheumatologists, P < 0.0001). The risk of moderate side effects only had an impact on GP decision making (ß = 0.0282, P = 0.0028). All physicians were willing to make patients bear an extra annual cost of: (1) €225 among GPs and €189 among rheumatologists so that they could benefit from one unit improvement in function; and (2) €214 among GPs and €133 among rheumatologists so that they could benefit from a one unit improvement in pain relief. CONCLUSION: When making decisions about which treatment to prescribe, physicians take into account the cost to patients. Changes in reimbursement rates for some OA treatments may lead to changes in prescribing practices.