Out of the boxes,out of the silos: The need of interdisciplinary collaboration to reduce poor-quality medical products in the supply chain

In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area.     

稳定期慢性阻塞性肺疾病患者报告结局现状及影响因素分析

目的 了解稳定期慢性阻塞性肺疾病 (chronic obstructive pulmonary disease,COPD) 患者报告结局现状,分析其影响因素及与炎症指标的相关性,为开展以患者为中心的早期护理干预提供依据。 方法 采用便利抽样法,选取2020年10月—2021年7月于南宁市某三级甲等医院呼吸内科门诊就诊的稳定期COPD患者作为调查对象,采用一般资料调查表、COPD患者报告结局量表修订版 (the Modified Patient-Reported Outcome Scale for COPD,mCOPD-PRO) 进行调查,并收集患者就诊时炎症指标的结果。采用多元线性回归分析稳定期COPD患者报告结局的影响因素,采用相关性分析探讨患者报告结局与炎症指标的关系。结果 该研究共纳入204例稳定期COPD患者,mCOPD-PRO得分为 (1.75±0.58) 分。多元线性回归分析显示,性别、合并疾病数量、病程、肺功能分级是稳定期COPD患者报告结局的影响因素 (P<0.05),可解释稳定期COPD患者报告结局10.8%的总变异。相关性分析显示,白细胞计数、中性粒细胞计数、嗜酸性粒细胞计数与稳定期COPD患者的mCOPD-PRO得分呈正相关 (P<0.05) ;总白蛋白浓度与其呈负相关 (P<0.05) 。结论 稳定期COPD患者报告结局有待改善,女性、合并疾病数量>3种、病程较长、肺功能分级较高的COPD患者报告的结局较差。COPD患者报告结局与白细胞计数、中性粒细胞计数、嗜酸性粒细胞计数、总白蛋白浓度相关。护理人员应关注稳定期COPD患者报告结局及炎症指标,在早期采取针对性的干预措施,以改善患者的生活质量。     

Hirschsprung-associated inflammatory bowel disease: A multicenter study from the APSA Hirschsprung disease interest group

Background/PurposeA small number of Hirschsprung disease (HD) patients develop inflammatory bowel disease (IBD)-like symptoms after pullthrough surgery. The etiology and pathophysiology of Hirschsprung-associated IBD (HD-IBD) remains unknown. This study aims to further characterize HD-IBD, to identify potential risk factors and to evaluate response to treatment in a large group of patients.MethodsRetrospective study of patients diagnosed with IBD after pullthrough surgery between 2000 and 2021 at 17 institutions. Data regarding clinical presentation and course of HD and IBD were reviewed. Effectiveness of medical therapy for IBD was recorded using a Likert scale.ResultsThere were 55 patients (78% male). 50% (n = 28) had long segment disease. Hirschsprung-associated enterocolitis (HAEC) was reported in 68% (n = 36). Ten patients (18%) had Trisomy 21. IBD was diagnosed after age 5 in 63% (n = 34). IBD presentation consisted of colonic or small bowel inflammation resembling IBD in 69% (n = 38), unexplained or persistent fistula in 18% (n = 10) and unexplained HAEC >5 years old or unresponsive to standard treatment in 13% (n = 7). Biological agents were the most effective (80%) medications. A third of patients required a surgical procedure for IBD.ConclusionMore than half of the patients were diagnosed with HD-IBD after 5 years old. Long segment disease, HAEC after pull through operation and trisomy 21 may represent risk factors for this condition. Investigation for possible IBD should be considered in children with unexplained fistulae, HAEC beyond the age of 5 or unresponsive to standard therapy, and symptoms suggestive of IBD. Biological agents were the most effective medical treatment.Level of EvidenceLevel 4     

冠状动脉慢血流的危险因素及冠状动脉病变特点的研究

目的研究冠状动脉慢血流现象(CSFP)患者的危险因素和分析累及冠状动脉病变的特点。方法回顾性收集本院2019年1月—2021年1月因疑似冠心病行冠状动脉造影术的514例患者,分析患者的临床资料、实验室指标及冠状动脉造影结果等相关资料,按照TIMI血流分级分为慢血流组(n=288)和对照组(n=226),比较两组之间的差异,并通过logistics回归分析探讨CSFP患者的危险因素。结果 (1)两组间在性别、民族、吸烟及饮酒史上存在统计学差异(P<0.05)。(2)CSFP组的血红蛋白、游离三碘甲状原氨酸、血肌酐值、血尿酸水平、空腹血糖水平和左室舒张末期大小均高于对照组(P<0.05);而CSFP组的血小板分布宽度、游离甲状腺素、总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、载脂蛋白A1和白蛋白水平均低于对照组(P<0.05);(3)CSFP以三支血管病变最多见,为124例(43.0%),而单支血管病变和双支血管病变病例数一样,均为82例(28.5%)。单支血管病变中最多见的是前降支67例(81.7%),其次是右冠状动脉12例(14.6%),左回旋支较少见;(4)多因素logistic回归分析发现:性别、民族、游离甲状腺素、载脂蛋白A1和白蛋白水平是CSFP患者的独立危险因素。结论 (1)男性、少数民族、游离甲状腺素、载脂蛋白A1和白蛋白水平是CSFP的独立危险因素;(2)CSFP更常见于三支冠状动脉病变组,单支冠状动脉病变者更常见于左前降支。     

Comparison study of patient demographics and patient-related risk factors for peri-prosthetic joint infections following primary total shoulder arthroplasty

BackgroundWhile studies have demonstrated favorable outcomes in utilization of primary total shoulder arthroplasty (TSA) for the treatment of glenohumeral osteoarthritis (OA), adverse events such as infections can still occur. Periprosthetic joint infections (PJIs) are associated with worse outcomes and patient morbidity. The purpose of this study was to: (1) compare patient demographics amongst TSA patients with and without PJIs following primary TSA; and (2) identify patient-related risk factors for PJIs following primary TSA.MethodsPatients undergoing primary TSA for the treatment of glenohumeral OA were identified using the Mariner administrative claims database by CPT code 23,472. Laterality modifiers were utilized to ensure PJIs were developing in the correct laterality as those patients undergoing primary TSA. Inclusion for the study group consisted of patients who developed PJIs within 2-years after the index procedure, whereas patients who did not develop PJIs served as the comparison cohort. Primary outcomes analyzed included patient demographics and patient-related risk factors for PJIs following primary TSA. A stepwise backwards elimination multivariate binomial logistic regression analyses was performed to determine the odds (OR) of PJIs in patients undergoing primary TSA. A P value less than .05 was considered statistically significant.ResultsThe query yielded 15,396 patients who underwent primary TSA for glenohumeral OA, of which 191 patients developed PJIs and 15,205 did not develop PJIs. The study found statistically significant differences amongst patients who did and did not develop PJIs following primary TSA with respect to age, sex, and presence of comorbid conditions. Risk factors associated with developing PJIs following primary TSA included: pathologic weight loss (OR: 2.06, P < .0001), obesity (OR: 1.56, P = .0001), male sex (OR: 1.52, P = .007), and peripheral vascular disease (OR: 1.46, P = .022).ConclusionAs the number of primary TSAs for the treatment of glenohumeral OA increase worldwide, identifying modifiable risk-factors to reduce the incidence of infection is critical. The study found various modifiable and non-modifiable risk factors associated with developing PJIs following primary TSA. This study is valuable to orthopedists in order to identify and risk-stratify patients with regard to PJI in the setting of primary TSA for OA.Level of EvidenceLevel III; Case-Control Study     

老年人生命晚期获知疾病信息意向及影响因素CSCD

目的了解老年人生命晚期获知疾病相关信息意向及影响因素。方法2016年10月至2017年6月,采用生命晚期疾病信息意向问卷,利用方便抽样法对福州市中心城区7所养老机构及15个社区的414例年龄≥60岁的老年人进行横断面调查,采用单因素分析、多元线性回归与有序多分类logistic回归分析老年人对疾病相关信息的需求水平、获知程度意向及其影响因素。结果414例老年人疾病相关信息需求得分为(17.1±4.9)分;48.8%(202/414)希望详尽知晓,30.7%(127/414)希望选择性了解,20.5%(85/414)不想知道任何信息;多元线性回归分析显示,年龄、文化程度、是否接受/见过其他生命维持治疗(LSTs)是影响老年人疾病相关信息需求水平的主要因素(标准化回归系数分别为-0.141、0.116、0.115,均P<0.05);有序多分类logistic分析显示,年龄(以60~69岁为参照,70~79岁:OR=0.544,95%CI:0.310~0.957;80~89岁:OR=0.526,95%CI:0.289~0.956)、文化程度(以小学及以下为参照,大专及以上:OR=2.166,95%CI:1.093~4.290)、主要生活费来源(以其他补贴为参照,家人支持:OR=7.303,95%CI:1.157~46.108;退休金:OR=9.288,95%CI:1.502~57.415;公积金/储蓄:OR=15.676,95%CI:2.122~115.793)、是否接受/见过其他LSTs(以是为参照,OR=1.985,95%CI:1.150~3.425)是影响老年人疾病相关信息获知程度意向的主要因素。结论老年人生命晚期获知疾病相关信息的意向程度较高,年龄、文化程度、主要生活费来源、是否接受/见过其他生命维持治疗等是其主要影响因素。     

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.