scholarly journals Voluntary disclosures of payments from pharmaceutical companies to healthcare professionals in Germany: a descriptive study of disclosures in 2015 and 2016

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e037395
Author(s):  
Marlene Stoll ◽  
Lara Hubenschmid ◽  
Cora Koch ◽  
Klaus Lieb

ObjectiveTo analyse voluntary payment reports of pharmaceutical companies to German healthcare professionals (HCPs) in 2015 and 2016 based on an industry-self-regulating transparency codex.Design and participantsCohort study of all German HCPs who voluntarily agreed that at least one payment they received in 2015 and 2016 from pharmaceutical companies is disclosed.Main outcome measuresNumber of HCPs who disclosed at least one payment in the database; separated by year of disclosure and whether they disclosed once or repeatedly. Amount of disclosed payments and distribution parameters of disclosed annual payment sums per person; separated by year of disclosure und whether they disclosed once or repeatedly.Results28 230 HCPs agreed to the disclosure of at least one payment in the database. In 2015, 19 905 HCPs agreed to the disclosure, decreasing to 15 782 HCPs in 2016. Whereas 7457 disclosed payments in both years, 12 448 disclosed only in 2015 and 8325 only in 2016. Payments of €32 426 721 in 2015 and €23 289 343 in 2016 were disclosed, that is, 27% and 23% of the total amounts spent on HCPs, respectively. Distribution of annual payments was skewed: the top 1% of HCPs disclosed annual payment sums between €17 049 and €200 194, while the median disclosed annual payment sum per person was €536 (IQR €1092). Disclosed payments were higher in male physicians and in physicians with higher academic degree.ConclusionsIf voluntary, disclosure rates of payments are low and therefore only provide a fragmented picture of interactions between HCPs and pharmaceutical companies. Efforts must be intensified to ensure obligatory disclosure of all payments worldwide.

Author(s):  
Ángela Flores ◽  
Sylvaine Balmy ◽  
Elena Guardiola ◽  
Nuria Escudero ◽  
María-Ángeles Hernández ◽  
...  

The medical information (MI) function within the pharmaceutical industry plays a significant role in the provision of scientific answers for patients and healthcare professionals. The purpose of this study is to identify the current structure, organization, and functions of MI departments in Spain. Sixty local and international pharmaceutical companies based in Spain were invited to participate in this study between May and July 2019. An online 34–item questionnaire developed by the AMIFE MI Working Group was distributed to the companies. Data were analyzed through descriptive statistics using response frequencies. A total of 44 responses from 60 surveys (73%) were received. More than half of the respondents were employed in international companies based in Europe (57%, n = 25). Seventy-one percent (n = 31) of the companies had 100 to 1,000 employees in Spain. Most respondents declared that they had an MI department in their company (73%, n = 32), with most (53%) having two to five employees working on MI. Most MI (n = 50) specialists had a biomedical academic degree (predominantly pharmacy, biology, and medicine). MI departments were involved in many functions, the most common being answering enquiries (100%), handling drug information requests (97%), preparing written responses (94%), and literature services for external use (77%). The mean annual volume of MI enquiries was 2,301 (median 1,100). The results of this survey contribute to a better understanding of MI departments in Spanish pharmaceutical companies, as well as their functions and responsibilities, and could help identify opportunities and areas for improvement.


2021 ◽  
pp. 135910532098832
Author(s):  
Rachel Dieterich ◽  
Judy Chang ◽  
Cynthia Danford ◽  
Paul W Scott ◽  
Caroline Wend ◽  
...  

Weight stigmatization is related to emotional and psychological distress including low self-esteem, body image dissatisfaction, depression, and anxiety; all linked with suboptimal breastfeeding outcomes. This qualitative descriptive study explored postpartum individuals’ recalled experiences of weight stigma during interactions with perinatal healthcare professionals and its perceived influence on their breastfeeding experiences. Semi-structured phone interviews were conducted with (n= 18) participants. Three themes emerged: (1) “Size Doesn’t Matter: They Looked Beyond the Scale,” (2) “My Self-Confidence and Desire to Breastfeed is More Important than Weight,” and (3) “I Was on My Own”— Limited Social Support not Weight Stigma Influenced Breastfeeding.


Author(s):  
Martin Theiler ◽  
Nicole Knöpfel ◽  
Susanne von der Heydt ◽  
Agnes Schwieger-Briel ◽  
Isabelle Luchsinger ◽  
...  

AbstractSleep problems are frequently reported in infants treated with propranolol for infantile hemangiomas, possibly serving as a marker for a negative impact on central nervous system function. In this cohort study, we objectively investigate the sleep behavior of infants with infantile hemangiomas on propranolol compared to a healthy, untreated control group. Sleep of propranolol-treated infants and controls was investigated using ankle actigraphy and a 24-h diary for 7–10 days at ages 3 and 6 months. The main outcome measures were the Number of Nighttime Awakenings and Sleep Efficiency. The main secondary outcome measures included 24-hour Total Sleep, daytime sleep behavior, and parent-rated infant sleep quality and behavioral development based on the Brief Infant Sleep Questionnaire (BISQ) and the age-appropriate Ages-and-Stages Questionnaire (ASQ), respectively. Fifty-four term-born infants were included in each cohort. No group difference in any investigated parameter was seen at age 3 months. At age 6 months, the propranolol group exhibited a decrease in Sleep Efficiency and a trend towards an increased Number of Nighttime Awakenings compared to the control group. Treated infants at 6 months also had shorter daytime waking periods. 24-hour Total Sleep was unaffected by propranolol. No negative impact of propranolol on subjective sleep quality and behavioral development was noted.Conclusion: Propranolol exerts a measurable yet mild impact on objectively assessed infants’ sleep measures. Behavioral developmental scores were unaffected. Our results support propranolol as first-line therapy for complicated infantile hemangiomas. What is Known:• Sleep disorders are frequently reported in infants with infantile hemangiomas treated with propranolol and often lead to treatment discontinuation.• Investigations of the sleep pattern in this patient group using objective measures are lacking. What is New:• The sleep pattern of propranolol-treated infants is assessed using actigraphy and a 24-h sleep diary and compared to healthy, untreated controls.• Propranolol leads to a decreased sleep efficiency at night and an increased demand of daytime sleep, yet effects are mild overall.


BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e047235
Author(s):  
Iona Pearson ◽  
Sue Blackwell ◽  
Rebecca Fish ◽  
Sarah Daniels ◽  
Malcolm West ◽  
...  

IntroductionPrehabilitation in colorectal surgery is evolving and may minimise postoperative morbidity and mortality. With many different healthcare professionals contributing to the prehabilitation literature, there is significant variation in reported primary endpoints that restricts comparison. In addition, there has been limited work on patient-related outcome measures suggesting that patients with colorectal cancer needs and issues are being overlooked. The Defining Standards in Colorectal Optimisation Study aims to achieve international consensus from all stakeholders on key standards to provide a framework for reporting future prehabilitation research.Methods and analysisA systematic review will identify key standards reported in trials of prehabilitation in colorectal surgery. Standards that are important to patients will be identified by a patient and public involvement (PPI) event. The longlist of standards generated from the systematic review and PPI event will be used to develop a three-round online Delphi process. This will engage all stakeholders (healthcare professionals and patients) both nationally and internationally. The results of the Delphi will be followed by a face-to-face interactive consensus meeting that will define the final standards for prehabilitation for elective colorectal surgery.Ethics and disseminationThe University of Glasgow College of Medical, Veterinary and Life Sciences Ethics Committee has approved this protocol, which is registered as a study (200190120) with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of the standards developed by all stakeholders will increase the potential for comparative research that advances understanding of the clinical application of prehabilitation.PROSPERO registration numberCRD42019120381.


2010 ◽  
Vol 124 (6) ◽  
pp. 623-630 ◽  
Author(s):  
P M Patel ◽  
S Maskell ◽  
R Heywood ◽  
N Eze ◽  
J Hern

AbstractBackground:Many outcome measures exist for rhinosinusitis. However, few are used in the clinical setting due to their long completion times.Objective:To assess the validity, reliability and responsiveness of the rhinogram, compared with two validated rhinosinusitis outcome measures: the Sino-Nasal Outcome Test-20 and the Heath-Related Quality of Life questionnaire.Methods:Fifty-one patients were entered into a prospective, comparative, cohort study using all three outcome measures one week pre-operatively and three months post-operatively. Outcome scores were then correlated using non-parametric Spearman's rank correlation and chi-square testing for the diagnostic criteria of all three outcome measures.Results:Statistically significant correlations were found between all three outcome measures for all symptom scores, individually as well as combined (p < 0.01 for all calculations). Comparison of the diagnostic accuracy of the rhinogram, compared with the Sino-Nasal Outcome Test-20 and the Heath-Related Quality of Life questionnaire, showed statistical significance (p < 0.05; chi-square test).Conclusion:The rhinogram is a reliable, valid and responsive rhinosinusitis outcome measure which can assist patient diagnosis and management in the clinical setting. Due to its quick completion time, this outcome measure could be used in rhinology out-patient clinics.


2020 ◽  
Vol 17 (1) ◽  
pp. 35-40
Author(s):  
Nicole Shao-Yuen Lim ◽  
John Males

Aim: To determine whether there is an association between Fuchs endothelial corneal dystrophy (FECD) and shorter axial length (AL), shallower anterior chamber depth (ACD) and higher spherical equivalent (SE). In addition, to evaluate whether there is a correlation between AL and severity of corneal decompensation in FECD, using corneal thickness as a proxy. Design: Retrospective cohort study. Methods: This was a single-centre study conducted in a cornea clinic in Sydney, Australia. Detailed clinical measurements of 91 eyes of 50 FECD patients were compared with 110 eyes of 55 controls. Main outcome measures included AL, ACD and SE. Other outcome measures included central corneal thickness, visual acuity, intraocular pressure and keratometry. Results: Mean AL of FECD patients was 23.6 mm (standard deviation [SD] ±0.9 mm), compared with 24.7 mm (SD ±1.8 mm) for controls (1.1 mm difference [95% confidence interval [CI] 0.5-1.6], p < 0.001, independent sample t-test); corresponding means for ACD were 3.0 and 3.3 mm (0.32 mm difference [95%CI 0.2-0.5], p < 0.001, independent t-test). Eleven out of the 22 FECD patients with available refraction data had hypermetropic refraction compared with 16 out of 36 controls (p = 0.68, chi-squared test). The mean SE of FECD patients (+0.10D) was higher than controls (−1.33D) (1.4D difference [0.1-2.8], p = 0.04, independent t-test). No statistically significant correlation was found between AL and corneal thickness (p = 0.28, linear regression). Conclusion: In this retrospective cohort study, a strong association was established between FECD and small eyes, with shorter AL and shallower ACD, compared with controls. These results have important implications for surgical planning, as shorter AL and ACD in FECD patients likely contribute to their high risk of corneal decompensation following cataract surgery.


BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e053624
Author(s):  
Daniel Smith ◽  
Kathryn Willan ◽  
Stephanie L Prady ◽  
Josie Dickerson ◽  
Gillian Santorelli ◽  
...  

ObjectivesWe aimed to examine agreement between common mental disorders (CMDs) from primary care records and repeated CMD questionnaire data from ALSPAC (the Avon Longitudinal Study of Parents and Children) over adolescence and young adulthood, explore factors affecting CMD identification in primary care records, and construct models predicting ALSPAC-derived CMDs using only primary care data.Design and settingProspective cohort study (ALSPAC) in Southwest England with linkage to electronic primary care records.ParticipantsPrimary care records were extracted for 11 807 participants (80% of 14 731 eligible). Between 31% (3633; age 15/16) and 11% (1298; age 21/22) of participants had both primary care and ALSPAC CMD data.Outcome measuresALSPAC outcome measures were diagnoses of suspected depression and/or CMDs. Primary care outcome measure were Read codes for diagnosis, symptoms and treatment of depression/CMDs. For each time point, sensitivities and specificities for primary care CMD diagnoses were calculated for predicting ALSPAC-derived measures of CMDs, and the factors associated with identification of primary care-based CMDs in those with suspected ALSPAC-derived CMDs explored. Lasso (least absolute selection and shrinkage operator) models were used at each time point to predict ALSPAC-derived CMDs using only primary care data, with internal validation by randomly splitting data into 60% training and 40% validation samples.ResultsSensitivities for primary care diagnoses were low for CMDs (range: 3.5%–19.1%) and depression (range: 1.6%–34.0%), while specificities were high (nearly all >95%). The strongest predictors of identification in the primary care data for those with ALSPAC-derived CMDs were symptom severity indices. The lasso models had relatively low prediction rates, especially in the validation sample (deviance ratio range: −1.3 to 12.6%), but improved with age.ConclusionsPrimary care data underestimate CMDs compared to population-based studies. Improving general practitioner identification, and using free-text or secondary care data, is needed to improve the accuracy of models using clinical data.


Author(s):  
Roberta G. PEIXE ◽  
Maria C. SODRÉ ◽  
Beatriz B. OLIVEIRA ◽  
Luana P. GONÇALVES ◽  
Ian G. HALM ◽  
...  

Objectives: To classify injectable drugs used in a general hospital inventory according to latex presence or absence in vials with rubber stoppers, antibiotics, and electrolytes bags. Methods: The information about latex content has been collected from medicine industries, after identification of authorized manufacturers in Brazil, through the National Health Surveillance Agency (ANVISA) medicine search database. Medicines have been grouped per pharmaceutical manufacturers, and data were collected through telephone or e-mail. Only written information from pharmaceutical companies were considered. Results: Among 161 medicines used in the hospital packaged in vials with rubber stoppers, antibiotics, and electrolytes bags, 123 (76.4%) medicine-related responses were received, covering 540 (82.2%) different presentations. For this, from 87 contacts, 70 (80.5%) companies responded and 65 (74.7%) provided information related to the presence or absence of the allergen. Among the medicine list, 8 (6.5%) were identified as containing latex (in 12 different presentations – 2.2%) and 101 medications (82.1%) in 507 presentations (93.9%) do not contain latex. The manufacturers responded that the medicine was latex-free, but could not confirm for raw materials (6 medicines – 4.9% - in 6 different presentations – 1.1%) and that they were unable to ensure there was no contact with latex during manipulation (4 medicines – 3.3% - in 8 different presentations – 1.5%). For 4 medicines (3.3%) in 7 different presentations (1.3%), the companies were inconclusive, as they could not confirm whether they were latex-free or not. Conclusion: Although latex is a known allergen, information about the presence of latex components in pharmaceutical packaging and package inserts needs improvement, since the active search identified 161 medicines packaged in vials with rubber stoppers, antibiotics, and electrolytes bags that failed to depict this information. The results of this survey endorse the Importance of displaying this information on medicines label or packaging in order to ensure healthcare professionals easy access and prompt consultation.


Cancer ◽  
2021 ◽  
Author(s):  
Daniel E. Meyers ◽  
Benjamin S. Meyers ◽  
Timothy M. Chisamore ◽  
Kristin Wright ◽  
Bishal Gyawali ◽  
...  

Author(s):  
Giovanni Bronzetti ◽  
Romilda Mazzotta ◽  
Graziella Sicoli ◽  
Maria Assunta Baldini

The purpose of this chapter is to analyze the level and the quality of voluntary disclosures of Intellectual Capital (IC) in the sustainability reports on a sample of Italian listed companies. The authors conducted an analysis of twelve sustainability reports for two years (2009-2010). These are related to six firms selected among the most capitalized 37 Italian listed companies. To investigate the “level of disclosure,” the authors identified the presence of IC information, while to evaluate the “IC quality,” they constructed a voluntary disclosure index based on content analysis. IC information disclosure is more likely present in sustainability reports of firms with a higher levels of application of the Global Reporting Initiative framework. The results confirm that the sustainability report can adequately represent the intellectual capital, especially in order to understand its role in the firm and the interaction with other variables present in the firm.


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