Involvement of Patients and Medical Professionals in the Assessment of Relative Effectiveness: A Need for Closer Cooperation

ObjectivesInvolvement of patients and medical professionals in assessment of relative effectiveness (relative effectiveness assessment) contributes to an efficient and effective health technology assessment (HTA) process and supports acceptance and implementation of the outcome. This study aimed to analyze stakeholder involvement in assessing relative effectiveness and how the parties involved value this collaboration.MethodsThis is a document analysis of all drug assessments completed in 2019 (20) by the public HTA agency of The Netherlands, enriched with semistructured interviews with employees of the HTA agency (18) and representatives of patient (5) and medical (11) associations involved in these assessments. Data were analyzed, coded, and categorized.ResultsIn almost half of the assessments, there was no coordination with the medical associations at the start of the relative effectiveness assessment and no patient associations involved in this phase. During the assessment procedure, patient and medical associations were always asked to comment on the draft report. Nevertheless, the strict 5-day deadline that the HTA agency uses as a response period often hampered a proper response and involvement. According to interviewees of the HTA agency, this leads to a great diversity in the substantive quality of their input. Patient and medical associations indicated that the HTA agency relies too much on “paper knowledge,” which leads to a (perceived) lack of alignment with clinical practice.ConclusionsThe limited involvement results in a lack of coordination and mutual trust. Optimizing involvement of patients and medical professionals in HTA practice requires effort from all parties involved. Procedural adjustments and better coordination, especially at the start of the assessment, would probably improve cooperation.     

Fourteen years of the Pregnancy Registry on maternal immunisation with a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine

BackgroundGSK initiated a Pregnancy Registry in the United States (US) for the reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap; Boostrix, GSK) vaccine with the aim to detect and describe pregnancy outcomes in women vaccinated with Boostrix 28 days before estimated conception or during pregnancy.MethodsVoluntary reports of pregnancy exposure to Boostrix received from spontaneous and post-marketing surveillance sources in the US were assessed. Reports were classified as prospective or retrospective based on the knowledge of pregnancy outcomes at the time of reporting. For completeness, reports of exposure to Boostrix or to the Tdap-inactivated poliovirus vaccine (Boostrix-IPV, GSK) reported to the global safety database from countries outside the US were also evaluated.ResultsFrom May 2005 to August 2019, 1517 (1455 prospective and 62 retrospective) pregnancy reports were received in the Boostrix US Pregnancy Registry. Of the prospective reports, 250 had known outcomes: 244 live infants with no apparent birth defects (BDs), three live infants with BDs, and three spontaneous abortions with no apparent BDs. Of the retrospective reports, 55 had known outcomes: 33 live infants with no apparent BDs, 16 live infants with BDs, one spontaneous abortion with no apparent BDs, four stillbirths with no apparent BDs, and one stillbirth with BDs. Cumulatively, 1321 pregnancy reports (1006 for Boostrix; 315 for Boostrix-IPV) were received from countries outside the US. Of these, 163 prospective reports and 551 retrospective reports had known outcomes. Results were in line with those from the Boostrix US Pregnancy Registry.ConclusionsData currently available from the Boostrix US Pregnancy Registry and from countries outside the US suggested that exposure to Boostrix or Boostrix-IPV during pregnancy does not raise safety concerns related to adverse pregnancy outcomes or BDs.     

Dose Rate Simulation of the Urine Collection Bag of Patients Undergoing Bone Scintigraphy

ObjectiveThe objective of the study was to estimate the determined dose rate in the urine collection bag of patients undergoing bone scintigraphy.MethodThe ^99m Tc-methylene diphosphonate accumulated activity eliminatedin urine was estimated and calculated by the Committee on Medical Internal Radiation Dose 14 method. This allowed the calculation of the dose rate emitted at distances of 10, 50, and 100 cm and the creation of a simulation collection bag to validate the calculations by means of measurements carried out with a Geiger Müller counter in the same situations. A linear regression test was performed to verify the significant difference between the measurements and validate the dose rate estimate.ResultsThe calculated and measured dose rates showed the highest values at a distance of 10 cm up to 3 hours after administering the radiopharmaceutical to the patient. After this period, as the collection bag was emptied for image acquisition, the dose rate was close to the background radiation.ConclusionThe maximum accumulated activity in the urine collection bag, and consequently, the maximum dose rate, occurs at the time of emptying the bag for image acquisition. Therefore, in addition to exposure to radiation, there is a considerable risk of contamination by ionizing radiation for the professional who performs the procedure. To minimize this risk and the exposure, the recommendation is to use personal protective equipment and to consider radiological protection factors, which are shorter exposure time, longer distance, and greater barrier between the professional and the radioactive source.     

Ethics as ritual: smoothing over moments of dislocation in biomedicine

Applications of biomedical R&D currently imply substantial societal concerns. This paper explores, based on semi‐structured interviews with scientists in Norway, how biomedical researchers experience and tackle such concerns in their daily work. It shows how ritualised routine responses to dislocatory moments help maintain order in the daily work of the interviewed scientists; they do not address directly but instead smooth over concerns by a ritualised way of using ethics. This may foreclose substantive reflection and function as a stabiliser for ‘business as usual’. Overall, the current way of responding to concerns as described by the interviewees may contribute to a depoliticisation of important issues. The paper contributes to sociological work on ethics by linking it to recent discussions on Responsible Research and Innovation (RRI) and by the empirical research presented. The insights can also help improve science policies such as RRI.     

急诊住院医师的教学查房模式

教学查房是床旁教学的一种重要手段,对住院医师进行教学查房能够有效提高住院医师的岗位胜任力和职业能力,培养急诊住院医师的急诊临床思维。近年来由于国家住院医师规范化培训改革在不断深入,对急诊住院医师的教学查房引起了人们的高度关注,然后在实际的急诊住院医师的教学查房中却还存在着诸多问题,教学查房与日常的临床查房概念混淆、教学查房准备不充分、教学查房目的不明确以及教学查房的互动性不强都严重影响了教学查房的质量。因此需要积极探究急诊住院医师的教学查房的有效模式,从而不断提升住院医师的临床实践能力。     

心脏外科专业型硕士研究生培养模式思考

在我国临床医学专业学位硕士研究生同住院医师规范化培训并轨政策全面落实的背景下,心脏外科专业型硕士研究生从招生到培养过程中呈现出一些问题,通过从规范化培训计划的制定、人文素养和科研素养培育3个方面,结合教学体会提出了当前培养模式下对心脏外科专业型硕士研究生综合培养的思考。     

Writing your first paper: An informal guide for medical radiation sciences professionals*

Writing and submitting a paper can be a daunting prospect, especially the first time. One of the more challenging aspects is knowing how to begin. Countless projects in the workplace never make it past local dissemination or conference presentation. This informal guide will help you take that next step and begin the peer-reviewed publication journey.