Evaluating the transparency of pharmaceutical company disclosure of payments to patient organisations in the UK

Patient organisations contribute to many areas of pharmaceutical policy. In developing their organisational capacity, many turn to financial support from pharmaceutical companies, which may create conflicts of interests. However, the transparency of the industry’s self-regulatory approach to the disclosure of payments to patient organisations has evaded scrutiny. Using company reports disclosing payments to UK patient organisations in 2012–2016, we evaluate the transparency of reporting using indicators derived from industry’s European patient organisation Code. We found a large proportion of companies did not have any disclosure reports available despite many having made payments, confirmed by comparing with annual financial accounts of patient organisations registered as charities. Where disclosure reports were available, many payments were not adequately described, resulting in large portions of money being disclosed without clarity as to the payment type and purpose. We found companies were clearer regarding whether payments were financial or benefits-in-kind, but transparency was particularly inadequate as to whether it could be determined if payments were indirect or direct and restricted or unrestricted, and almost no companies mentioned the VAT status of payments. Our findings suggest that the industry’s self-regulatory approach to transparency has not been working efficiently. We suggest ways for standardising and increasing the precision of information by pharmaceutical companies and advocate for the introduction of a centralised, and easily accessible national-level payment database.     

一线全科医生视角下对新技术如何融入社区信息系统并服务家庭医生签约的思考

我国的家庭医生签约服务正在如火如荼地进行着，目前关于家庭医生签约的评价、见解、效果反馈的研究多来自管理专业、经济学专业、公共卫生专业的学者，尚缺乏来自签约主体之一的医务人员的视角。本文将从一线全科医生即家庭医生签约服务执行者的视角，阐述现阶段基层医疗信息系统服务家庭医生签约的现状，并对其中存在的问题和可能的解决办法进行探讨。     

Patient-reported Symptom Outcomes and Microsatellite Instability in Patients With Metastatic Colorectal Cancer

BackgroundThe survival of patients with metastatic colorectal cancer (mCRC) is influenced by the genetic and epigenetic changes that might influence the patient experience of symptom burden. Understanding the association of molecular changes with the symptom burden could help clinicians gain insight into the molecular basis of symptom burden and improve treatment tolerance. To date, no studies have compared the patient-reported symptom burden with these molecular subsets among patients with mCRC.Patients and MethodsWe recruited patients with mCRC that was refractory to ≥ 1 line of therapy who had been enrolled in the Assessment of Targeted Therapies Against Colorectal Cancer trial at The University of Texas MD Anderson Cancer Center. All patients completed a baseline gastrointestinal symptom inventory (MD Anderson Symptom Inventory, gastrointestinal). The symptom burden across key demographic variables and molecular changes, including CRC-associated mutations, microsatellite instability (MSI) status, and the CpG island methylator phenotype (CIMP) were compared using χ² tests. Association of the symptom burden with overall survival was examined using Cox regression models.ResultsPatients with an MSI-high (MSI-H) phenotype reported greater pain (odds ratio [OR], 3.06; 95% confidence interval [CI], 1.61-5.84), fatigue (OR, 2.78; 95% CI, 1.41-5.49), sleep (OR, 2.52; 95% CI, 1.32-4.08); and drowsiness (OR, 2.51; 95% CI, 1.32-4.78) compared with microsatellite stable patients. Patients with an MSI-H phenotype also had greater odds of overall symptom burden (OR, 2.48; 95% CI, 1.29-4.74) compared with microsatellite stable patients. The CIMP-high patients experienced greater odds of pain compared with the CIMP-negative patients (OR, 1.72; 95% CI, 1.06-2.80). A greater overall symptom burden was associated with poor overall survival (hazard ratio, 1.42; 95% CI, 0.98-2.06]), although the difference was not significant (P = .06).ConclusionCorrelation of MSI-H–associated tumor features with the symptom burden could help provide a better understanding of underlying mechanisms associated with our findings.     

患者安全目标:加强医学装备安全与警报管理

阐述医疗器械使用安全与警报管理的意义和内涵，分析医疗器械使用安全与警报的风险点，探讨建立医疗器械使用安全与警报风险防范体系的方案，列举了医疗器械使用安全与警报管理的实践案例。     

Factors affecting orthosis adherence after acute traumatic hand tendon repairs: A prospective cohort study

IntroductionCustom-made orthoses are used to prevent contractures and reinjury of tissues such as tendon rupture after traumatic tendon repairs. Despite their wide usage in hand rehabilitation, orthosis adherence is usually an overlooked problem.Purpose of the StudyThis study aims to evaluate the possible factors affecting the orthosis adherence in patients with acute traumatic tendon repairs.Study DesignThis is a prospective cohort study.MethodsTwo hundred twelve patients with acute traumatic hand tendon repair were included in this prospective cohort study. Patients were evaluated on the third day postoperatively and at three weeks. All patients were told to wear their orthosis 24 h a day for three weeks and allowed to take it off to wash the hand carefully once a day. Adherence was measured as fully adherent, partially adherent, and nonadherent. Factors that may affect orthosis adherence were evaluated according to the five dimensions of the multidimensional adherence model including socioeconomic, condition-related, treatment-related, patient-related, and health-care system–related factors. The Modified Hand Injury Severity Scale was used to assess the severity of the injury. Depression and anxiety symptoms were evaluated with the Beck Depression Inventory and Beck Anxiety Inventory. A multivariate logistic regression model was constructed for orthosis adherence.ResultsOne hundred thirty-three patients were analyzed. Forty-four (33.1%) patients were fully adherent with the prescribed orthosis, whereas 67 (50.4%) were partially adherent and 22 (16.5%) were nonadherent. Higher depression symptoms caused orthosis nonadherence [odds ratio = 1.2 (95% confidence interval = 1.1-1.3), P = .001] and partial adherence [odds ratio = 1.1 (95% confidence interval = 1.0-1.2), P = .01].ConclusionsAmong our patients with acute traumatic tendon repair, only one-third of the patients were fully adherent with the orthosis wear program. Depression in the very acute period of injury impaired orthosis adherence.     

Improving patient and staff safety by minimising radiation exposure during trauma surgery: A simple and validated predictive model

IntroductionMinimising radiation exposure, from fluoroscopic equipment during trauma surgery is crucial to safe-guarding patients and staff. This aim of this study was to identify variables associated with increased radiation exposure for 3 of the most common trauma procedures. Secondly, we aimed to derive an internally and externally validated mathematical model for predicting radiation exposure for these procedures.Materials and methodsWe prospectively recorded radiation exposure from 270 sliding hip screw (SHS), ankle and wrist fixation procedures. Patient demographics, fracture severity, surgeon and radiographer grade were assessed using univariate and multivariate analyses. A mathematical model was then created and externally assessed for validity from another unit.ResultsWith regards to the analysis of radiation exposure when fixing wrist fractures, a significant regression equation was found (F (3, 86) = 62.2, p < 0.001), with an adjusted R² of 0.69. Patients' predicted radiation exposure (cGY/cm2) was therefore equal to the positive result of: 81.916(Fracture severity) + 43.426(Surgical grade) + 23.490 (radiographer grade)-203.89.With regards to the analysis of radiation exposure when fixing ankle fractures, a significant regression equation was found, (F (3, 83) = 15.49, p < 0.001), with an adjusted R² of 0.34. Patients' predicted radiation exposure (cGY/cm2) was therefore equal to the positive result of: 39.541(Fracture severity) + 51.937(Surgical grade) + 37.702 (radiographer grade)-124.558 SHS (F (3, 89) = 25.29, p < 0.001), R² of 0.44.61.338(Fracture severity) + 60.945(Surgical grade) + 35.491 (radiographer grade)-105.501. These predictive models were successfully externally validated.ConclusionThis study has demonstrated a workable and externally validated model for accurately predicting the likely radiation exposure using common and easily collectable variables. These models could be used to modify practuce and minimise the radiation exposure to patients and staff.