各国生物类似药参照药管理比对研究及完善我国生物类似药参照药管理的建议

参照药是生物类似药研发的标杆,对参照药进行规范管理,有利于保证生物类似药的研发质量。通过对美欧日韩等国家以及WHO对于生物类似药参照药的相关要求进行对比研究,提炼管理要素;结合我国参照药的现状、设计问卷、开展调研和专家研讨;综合对比研究、调研和研讨,提出完善我国生物类似药参照药管理的建议及建议的考量。     

Outcomes of a bypass-first strategy in chronic limb-threatening ischemia based on the Global Vascular Guidelines

ObjectiveThe Global Vascular Guidelines (GVGs) recommend initial revascularization (bypass or endovascular therapy) for chronic limb-threatening ischemia (CLTI) based on anatomical complexity and limb severity. This decision is made based on a prediction of the outcomes after endovascular intervention. This study was performed to evaluate outcomes after distal bypass in cases recommended for GVG bypass.MethodsA total of 239 distal bypasses for CLTI were evaluated in 195 patients with a GVG bypass recommendation treated between 2009 and 2020 at a single center in Japan. Comparisons were made between crural and pedal bypass cases.ResultsThe 195 patients (median age, 77 years; 67% male) underwent 133 crural bypasses (106 patients; 54%) and 106 pedal bypasses (89 patients; 46%). Hemodialysis was more common in pedal cases than in crural cases (P = .03). Hospital deaths occurred in two cases (1%) within 30 days. The whole cohort has a follow-up rate of 96% over a mean of 28 ± 26 months, with 3-year limb salvage rates of 87% and 3-year primary, assisted primary, and secondary patency rates of 40%, 65%, and 67%, all without significant differences between crural and pedal cases. The 1-year wound healing rate was 88% and tended to be higher in crural cases than in pedal cases (P = .068). The 3-year survival rate was 52% in the cohort and did not differ significantly between crural and pedal cases.ConclusionsPatients with CLTI with a GVG bypass recommendation had acceptable limb salvage, graft patency, wound healing, and survival after distal bypass, regardless of the bypass method. These findings indicate that a GVG bypass recommendation as an initial revascularization method is valid in the real world.     

Mode of physical activity participation by body mass index: 2015 behavioural risk factor surveillance system

Body mass index (BMI) continues to be used as a marker of health due its strong correlation with adiposity and health. Physical activity (PA) has been shown to be favourably associated with a desirable BMI. Few studies have examined mode of PA participation across BMI indices with a mutually exclusive underweight BMI range. The purpose of this study was to examine the relationship between modes of PA and BMI. Data from the 2015 Behavioral Risk Factor Surveillance System was analysed.

Underweight, overweight, and obese BMI categories possessed 35, 20, and 46% lower odds of meeting current PA guidelines. The obese BMI group was found to have lower odds of meeting the aerobic only and strength only guidelines. Underweight, overweight, and obese groups possessed 63, 18, and 76% greater odds of meeting neither PA guideline, respectively.     

Closed incision negative pressure therapy: international multidisciplinary consensus recommendations

Surgical site occurrences (SSOs) affect up to or over 25% of patients undergoing operative procedures, with the subset of surgical site infections (SSIs) being the most common. Commercially available closed incision negative pressure therapy (ciNPT) may offer surgeons an additional option to manage clean, closed surgical incisions. We conducted an extensive literature search for studies describing ciNPT use and assembled a diverse panel of experts to create consensus recommendations for when using ciNPT may be appropriate. A literature search of MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials using key words ‘prevention’, ‘negative pressure wound therapy (NPWT)’, ‘active incisional management’, ‘incisional vacuum therapy’, ‘incisional NPWT’, ‘incisional wound VAC’, ‘closed incisional NPWT’, ‘wound infection’, and ‘SSIs’ identified peer‐reviewed studies published from 2000 to 2015. During a multidisciplinary consensus meeting, the 12 experts reviewed the literature, presented their own ciNPT experiences, identified risk factors for SSOs and developed comprehensive consensus recommendations. A total of 100 publications satisfied the search requirements for ciNPT use. A majority presented data supporting ciNPT use. Numerous publications reported SSI risk factors, with the most common including obesity (body mass index ≥30 kg/m²); diabetes mellitus; tobacco use; or prolonged surgical time. We recommend that the surgeon assess the individual patient's risk factors and surgical risks. Surgeons should consider using ciNPT for patients at high risk for developing SSOs or who are undergoing a high‐risk procedure or a procedure that would have highly morbid consequences if an SSI occurred.     

Health Care Provider in Triage to Improve Outcomes

ProblemEmergency departments throughout the nation are experiencing crowding related to increased patient volumes and decreased hospital inpatient bed capacity. As a result of lengthy wait times, patients are leaving without having medical treatment, and satisfaction is poor. The purpose of this quality improvement initiative was placing a provider in triage to complement the existing split-flow process aimed to decrease wait times to see a provider, length of stay (LOS), left without being seen (LWBS) rates, and improve patient satisfaction.MethodsA multiprofessional team was established. Nurses, advanced practice providers, and physicians collaborated on a project to place a provider in triage to assist in seeing patients as soon as possible and begin care or treatment.ResultsThe outcomes of the initiative were positive for ED LOS metrics and patient satisfaction. Door-to-provider time decreased from a high of 56 minutes to a low of 13 minutes. The percentage of patients LWBS decreased from a high of 12% to a low of 1.62%.DiscussionThe project showed that the evidence-based practice of a combined split-flow and provider-in-triage model resulted in improvements in throughput for patients who were treated and released from the emergency department.     

Development of a new Adolescent Patient-Provider Interaction Scale (APPIS) for youth at risk for STDs/HIV

PurposeAlthough an adult model of patient-provider mutual exchange of information has been proposed, there is no guiding model for adolescents or measurement methodology. Our purpose was to develop a new scale of patient-provider interaction for adolescents accessing reproductive health care and at risk for sexually transmitted diseases (STDs) and human immunodeficiency virus (HIV), and assess the reliability and validity of the scale.MethodsThe Adolescent Patient-Provider Interaction Scale (APPIS) was developed from the Roter and Hall theory of doctor-patient relationships, previously validated adolescent satisfaction and communication scales, and focus group and individual elicitation interviews. To assess construct validity, the new nine-item APPIS was compared with the satisfaction scale used by the Young Adult Health Care Survey (YAHCS), and Kahn’s Provider Communication Scale. Pearson correlation coefficients were used to examine convergence across scales, and factor analysis of the APPIS was performed.ResultsThe study recruited 192 African American girls aged 17.9 ± 1.7 years (range 15–21 years) from three sites: a county STD clinic (n = 51), urban adolescent clinic (n = 99), and a family planning clinic (n = 42). Most participants (85%) rated their overall health care highly (≥ 7 on a 10-point scale); 49% felt that both the provider and patient were “in charge” of the visit, and 88% “strongly agreed” or “agreed” that there was an equal “exchange of information” during the visit. The APPIS showed good internal consistency (Cronbach alpha = .75), and moderate convergence with the six-item YAHCS scale (r = .57, p < .001) and seven-item Kahn scale (r = .48, p < .001). Three factors emerged from exploratory factor analyses, supporting our conceptualization of patient-provider interaction as being multi-dimensional.ConclusionsA new theory-based scale of adolescent patient-provider interaction compares favorably with previous scales of health care satisfaction and communication. The new APPIS may be useful for evaluating approaches to improve health care outcomes for adolescents at-risk for STDs and HIV.     

Provider choice of quality and surplus

We study the quality choices of institutional health-care providers, such as hospitals, assuming that the utility function of the key organizational decision maker includes both quality of care and financial surplus. We are primarily concerned with how changes in outside claims—particularly proportional outside claims—on the provider’s financial surplus affect his choice of quality. We use the term “rate of surplus retention” to refer to the fraction of surplus remaining after deducting all such claims. Using the Arrow-Pratt coefficient of relative risk aversion as a measure of curvature of the provider’s utility-from-money function, we show that increasing the surplus retention rate increases (decreases) quality if the provider’s coefficient of relative risk aversion is greater than (less than) 1. JEL Classification I1