Applying global standards to short-term global health clinical experiences: the case of Project Salud y Paz.

This case study was extracted from an administrative report generated for Project Salud y Paz (SYP), a non-governmental organization (NGO) that supports short term global health clinical experiences (STGHCE) in Guatemala. As a basis to generate criticisms and offer recommendations, the analysis used the shared themes of two sets of standards recently published by Globalization and Health (GH) and the American College of Physicians (ACP). These standards respectively address the ethical responsibilities of organizations and of physicians in the conduct of STGHCE. Information used in the original quality analysis and quality improvement consultation for SYP was gathered from interviews, medical committee minutes, output statistics, and observations in the course of a real-time trip. This case study describes how the standards served as a useful lens to assess SYP and as a platform from which to make recommendations for improved compliance with global conventions. Additionally, the standards provide SYP a body of consensus wisdom for holding itself accountable to patients, host communities, volunteers, and the donor community on a continuing basis. While the shared themes of these standards are intentionally broad and require context in their application, NGOs that support STGHCE may find it instructive to benchmark them to assure their own compliance with global standards for both the organization and their volunteer physicians.

Why do they care? Narratives of physician volunteers on motivations for participation in short-term medical missions abroad.

BACKGROUND: Short-term medical missions (STMMs) refer to the provision of direct pro bono medical services in lower and middle income countries for periods ranging from days to a few weeks by physicians from rich countries. Survey data have provided limited information on demographic and professional profiles of physicians as well as monetary and manpower inputs. Understanding why physicians participate, however, remains incomplete. The study's objective was to elicit physicians' motivations directly. METHODS: Semi-structured interviews of physicians identified through snowball recruiting were conducted to explore motivational themes and then analyzed using narrative software employing directed content analysis methodology. RESULTS: Twenty physicians from varying backgrounds and specialties were interviewed. Responses identified aspects of the decision to participate and the relative influence of economic, diplomatic, value-related, and emotive constructs. CONCLUSION: Personality traits may be more influential to participation than demographic, professional, or socioeconomic determinants. Word-of-mouth recruitment appears to underlie the increase in STMM activity, facilitated by information technology. Reported key motivators for physician participation in STMMs tend to parallel schools of thought regarding philanthropy and volunteering and include satisfaction from helping in challenging conditions of limited resources, learning experiences, appreciation from patients, sense of renewal, and the legacy effect of teaching.

Economic assessment of US physician participation in short-term medical missions.

BACKGROUND: Short term medical missions (STMMs) are a form of unregulated and unsanctioned, grass roots, direct medical service aid from wealthier countries to low and middle income countries. The US leads the world in STMM activity. The magnitude of monetary and man power inputs towards STMMs is not clear. The objective of this study is to estimate the prevalence of physician participation in STMMs from the US and the related expenditures of cash and resources. METHODS: An online survey solicited information on physician participation in STMMs. Responses regarding costs were aggregated to estimate individual and global expenditures. RESULTS: Sample statistics from 601 respondent physicians indicate an increasing participation by US physicians in STMMs. Including opportunity cost, average total economic inputs for an individual physician pursuing an STMM exceed $11,000. Composite expenditures for STMM deployment from the US are estimated at near $3.7 billion annually and the resource investment equates with nearly 5800 physician fulltime equivalents. CONCLUSIONS: STMM participation and mission numbers have been increasing in the millennium. The aggregate costs are material when benchmarked against formal US aid transfers. Understanding the drivers of physician volunteerism in this activity is thereby worthy of study and relevant to future policy deliberation.

Demographic profile of physician participants in short-term medical missions.

BACKGROUND: The US is the leading sending country for short term medical missions (STMMs), an unregulated and unsanctioned, grass roots form of direct medical service aid from richer countries to low and middle income countries. The objective of this study is to profile US physicians who go on such missions by means of a survey sample of the US physician population. METHODS: An online survey solicited information on physician participation in STMMS as well as demographic and professional features. Responses were descriptively tabulated and multivariate regressions were performed to model for physician profiles related to STMM participation. RESULTS: Physician participants in STMMs are more likely to be a surgeon, anesthesiologist or pediatrician, married with few or no children at home, later in their career and have an income of $200-250 K. CONCLUSIONS: Specialty is the strongest predictor of participation. STMM participation does not differ by race, ethnicity nor religion. Descriptive statistics further provide a limited profile of participants. Direct expenses may have less influence on participation than opportunity costs. Potential clues about motivation that may be inferred from the features of the profile are discussed.

A systematic review of social, economic and diplomatic aspects of short-term medical missions.

BACKGROUND: Short-term medical missions (STMMs) represent a grass-roots form of aid, transferring medical services rather than funds or equipment. The objective of this paper is to review empirical studies on social, economic and diplomatic aspects of STMMs. METHODS: A systematic literature review was conducted by searching PubMed and EBSCOhost for articles published from 1947-2014 about medical missions to lower and middle income countries (LMICs). Publications focused on military, disaster and dental service trips were excluded. A data extraction process was used to identify publications relevant to our objective stated above. RESULTS: PubMed and EBSCOhost searches provided 4138 and 3262 articles respectively for review. Most articles that provide useful information have appeared in the current millennium and are found in focused surgical journals. Little attention is paid to aspects of volunteerism, altruism and philanthropy related to STMM activity in the literature reviewed (1 article). Evidence of professionalization remains scarce, although elements including guidelines and tactical instructions have been emerging (27 articles). Information on costs (10 articles) and commentary on the relevance of market forces (1 article) are limited. Analyses of spill-over effects, i.e., changing attitudes of physicians or their communities towards aid, and characterizations of STMMs as meaningful foreign aid or strategic diplomacy are few (4 articles). CONCLUSIONS: The literature on key social, economic and diplomatic aspects of STMMs and their consequences is sparse. Guidelines, tactical instructions and attempts at outcome measures are emerging that may better professionalize the otherwise unregulated activity. A broader discussion of these key aspects may lead to improved accountability and intercultural professionalism to accompany medical professionalism in STMM activity.

Improved differential diagnosis of anemia of chronic disease and iron deficiency anemia: a prospective multicenter evaluation of soluble transferrin receptor and the sTfR/log ferritin index.

Anemia of chronic disease (ACD) and iron deficiency anemia (IDA) are the most prevalent forms of anemia and often occur concurrently. Standard tests of iron status used in differential diagnosis are affected by inflammation, hindering clinical interpretation. In contrast, soluble transferrin receptor (sTfR) indicates iron deficiency and is unaffected by inflammation. Objectives of this prospective multicenter clinical trial were to evaluate and compare the diagnostic accuracy of sTfR and the sTfR/log ferritin index (sTfR Index) for differential diagnosis using the automated Access(®) sTfR assay (Beckman Coulter) and sTfR Index. We consecutively enrolled 145 anemic patients with common disorders associated with IDA and ACD. Subjects with IDA or ACD + IDA had significantly higher sTfR and sTfR Index values than subjects with ACD (P < 0.0001). ROC curves produced the following cutoffs for sTfR: 21 nmol/L (or 1.55 mg/L), and the sTfR Index: 14 (using nmol/L) (or 1.03 using mg/L). The sTfR Index was superior to sTfR (AUC 0.87 vs. 0.74, P < 0.0001). Use of all three parameters in combination more than doubled the detection of IDA, from 41% (ferritin alone) to 92% (ferritin, sTfR, sTfR Index). Use of sTfR and the sTfR Index improves detection of IDA, particularly in situations where routine markers provide equivocal results. Findings demonstrate a significant advantage in the simultaneous determination of ferritin, sTfR and sTfR Index. Obtaining a ferritin level alone may delay diagnosis of combined IDA and ACD.

Safety and Efficacy of Intravenous Golimumab in Adults with Ankylosing Spondylitis: Results through 1 Year of the GO-ALIVE Study.

OBJECTIVE: Evaluate safety and efficacy of intravenous (IV) golimumab (GOL) in patients with active ankylosing spondylitis (AS) through 1 year. METHODS: A total of 208 patients were randomized to IV infusions of GOL 2 mg/kg (n = 105) at weeks 0, 4, and every 8 weeks thereafter or placebo (n = 103) at weeks 0, 4, and 12, then crossover to GOL at weeks 16, 20, and every 8 weeks thereafter through Week 52. Efficacy was assessed using the Assessment of Spondyloarthritis international Society (ASAS) criteria, the Ankylosing Spondylitis Disease Activity Score (ASDAS), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Index (BASFI). Health-related quality of life was assessed using the AS Quality of Life (ASQoL) index. Efficacy and safety were monitored through Week 52 and Week 60, respectively. RESULTS: The primary endpoint (ASAS20) and all controlled endpoints at Week 16 were achieved. At Week 52, 69.5% and 65.0% of patients in the GOL group and placebo crossover group, respectively, achieved an ASAS20; 56.2% and 51.5% achieved an ASAS40; 56.2% and 55.3% achieved a BASDAI50; 24.8% and 24.3% achieved ASAS partial remission; and 25.7% and 26.2% met ASDAS inactive disease criteria (all last observation carried forward). Mean changes from baseline to Week 52 in BASFI and ASQoL scores were similar between the GOL group and the placebo crossover group (BASFI: -2.7 and -2.6; ASQoL: -5.5 and -5.4). Through Week 60, 55.4% of all GOL-treated patients had ≥ 1 adverse events (AE); 3.4% had ≥ 1 serious AE. CONCLUSION: Efficacy was maintained through 1 year with IV GOL 2 mg/kg among patients with active AS. AE were consistent with the known safety profile of GOL.

Why (not) go east? Comparison of findings from FDA Investigational New Drug study site inspections performed in Central and Eastern Europe with results from the USA, Western Europe, and other parts of the world.

Since the mid-1990s, investigational sites in the countries of Central and Eastern Europe (CEE) have been increasingly utilized by pharmaceutical companies because of their high productivity in terms of patient enrolment into clinical trials. Based on the FDA's publicly accessible Clinical Investigator Inspection List, we present an analysis of findings and outcome classifications from FDA inspections during Investigational New Drug (IND) studies and compare the results for the CEE region to those from Western European countries and the USA. Data from all 5531 FDA clinical trials inspections that occurred between 1994 (when the FDA first performed inspections in CEE) and the end of 2010 were entered into the database for comparative analysis. Of these, 4865 routine data audit (DA) inspections were analyzed: 401 from clinical trials performed in Western Europe, 230 in CEE, 3858 in the USA, and 376 in other countries. The average number of deficiencies per inspection ranged between 0.99 for CEE and 1.97 in Western Europe. No deficiencies were noted during 16.6%, 39.0%, and 21.5% of the inspections in Western Europe, CEE and USA, respectively. The percentages of inspections after which no follow-up action was indicated were 36.9% for Western Europe, 55.7% for CEE, and 44.3% for US sites. CEE was also the region with the lowest percentage of inspections that required official or voluntary action. On the basis of FDA inspection data, the high productivity of CEE sites appears to be accompanied by regulatory compliance as well as by data quality standards that are not inferior to those in Western regions.