Pharmaceutical procurement among public sector procurers in CARICOM.

OBJECTIVE: To examine multiple aspects of the medicines in CARICOM procurement markets, including manufacturer headquarters location, regulatory history, and type (innovator versus generic); the proportion of World Health Organization (WHO) essential medicines; and the most expensive medicines procured. METHODS: An analysis of procurement information from selected CARICOM procurers. Four public sector procurement lists were obtained based on public availability or sharing of data from public sector procurers. Analyses were based on parameters available or deduced from these data. RESULTS: The majority of products come from manufacturers headquartered in North America and Europe (63%-67%). The percentage of medicines procured from generic companies is 60%-87%; and 25%-50% of medicines procured are on the WHO Essential Medicines List. Wide price variations exist in the most expensive medicines purchased. CONCLUSIONS: The analysis identifies vulnerabilities and opportunities in the procurement situation of CARICOM states, particularly related to quality and rational use of medicines. This analysis represents a baseline that governments and other stakeholders can use in the future.

Buprenorphine shared medical appointments for the treatment of opioid dependence in a homeless clinic.

BACKGROUND: Opioid misuse and dependence are prevalent and rising problems in the United States. Treatment with buprenorphine is a successful treatment option for individuals with opioid dependence. This study describes and preliminarily evaluates a unique delivery system that provides buprenorphine treatment via a shared medical appointment. METHODS: A retrospective medical record review on all 77 opioid-dependent patients referred for a buprenorphine shared medical appointment in a homeless clinic from 2010 to 2012. RESULTS: Most patients were currently homeless (61%), unemployed (92%), had an Axis I psychiatric diagnosis (81%), and had recent polysubstance use (53%). Of the 77 patients, 95% attended at least 1 shared medical appointment. Treatment retention at 12 and 24 weeks was 86% and 70%, respectively. CONCLUSIONS: In a patient population with complex social and mental health histories, buprenorphine treatment via a shared medical appointment had high retention rates. Findings can help guide the development of unique delivery systems to serve real-world complex patients with opioid dependence.

Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states.

Improving basic capacities for regulation of medicines and health technologies through regulatory systems strengthening is particularly challenging in resource-constrained settings. "Regionalization"-an approach in which countries with common histories, cultural values, languages, and economic conditions work together to establish more efficient systems-may be one answer. This report describes the Caribbean Regulatory System (CRS), a regionalization initiative being implemented in the mostly small countries of the Caribbean Community and Common Market (CARICOM). This initiative is an innovative effort to strengthen regulatory systems in the Caribbean, where capacity is limited compared to other subregions of the Americas. The initiative's concept and design includes a number of features and steps intended to enhance sustainability in resource-constrained contexts. The latter include 1) leveraging existing platforms for centralized cooperation, governance, and infrastructure; 2) strengthening regulatory capacities with the largest potential public health impact; 3) incorporating policies that promote reliance on reference authorities; 4) changing the system to encourage industry to market their products in CARICOM (e.g., using a centralized portal of entry to reduce regulatory burdens); and 5) building human resource capacity. If implemented properly, the CRS will be self-sustaining through user fees. The experience and lessons learned thus far in implementing this initiative, described in this report, can serve as a case study for the development of similar regulatory strengthening initiatives in resource-constrained environments.

A comparison of orthodontic treatment outcomes using the Objective Grading System (OGS) and the Peer Assessment Rating (PAR) index.

INTRODUCTION: The use of objective criteria is essential to uniformly quantify and measure the severity of malocclusions and the efficacy of different treatment modalities. The Peer Assessment Rating (PAR) index and, more recently, the American Board of Orthodontics Objective Grading System (OGS) were developed to fulfill this need. AIM: The aim of this retrospective study was to assess and compare treatment outcomes using the UK and US weighted PAR and the OGS. MATERIALS AND METHODS: The sample consisted of randomly selected records of 50 patients treated by residents in one postgraduate orthodontic clinic. UK and US weightings for the PAR index were applied and compared with OGS. RESULTS: There was no statistically significant association between the OGS and the PAR index grading systems. Neither the UK nor the US PAR weightings showed statistically significant correlation with the OGS. All cases were 'greatly improved' or 'improved' according to the PAR index, while most cases (62%) failed according to OGS. There was a statistically significant correlation between the unweighted PAR index and the OGS (r = -0.32, p = 0.024). The US and the UK weightings for the PAR were highly correlated (r = 0.90, p < 0.001). Both weighting systems were also highly correlated with the unweighted PAR (p < 0.001). There were no gender differences found in any of the scoring systems. CONCLUSIONS: The current PAR index cannot replace the OGS for evaluating treatment outcomes. The current OGS cannot detect the improvement achieved in a treated case.

Relative fixation strength of rabbit subscapularis repair is comparable to human supraspinatus repair at time 0.

BACKGROUND: Recent evidence suggests that the rabbit subscapularis tendon may be anatomically, biomechanically, and histologically suitable to study rotator cuff pathology and repair. However, biomechanical comparisons of rotator cuff repairs in this model have not been evaluated and compared to those in human cadaveric specimens. QUESTIONS/PURPOSES: We quantified the biomechanical properties of the repaired rabbit subscapularis tendon after (1) single-row, (2) double-row, and (3) transosseous-equivalent rotator cuff repair techniques and compared the ratios of repairs to previously published data for human repairs. METHODS: Tensile testing was performed on 21 New Zealand White rabbit subscapularis tendon-humerus complexes for single-row repair, double-row repair, and transosseous-equivalent repair (n = 7 for each group). Video digitizing software was used to quantify deformation. Load elongation data were then used to quantify structural properties. We compared the ratios of rotator cuff repairs for the rabbit data to data from human supraspinatus repair studies previously performed in our laboratory. For our primary end points (linear stiffness, yield load, ultimate load, and energy absorbed to failure), with the numbers available, our statistical power to detect a clinically important difference (defined as 15%) was 85%. RESULTS: The ratios of single-row/double-row repair were 0.72, 0.73, 0.71, and 0.66 for human supraspinatus and 0.77, 0.74, 0.79, and 0.89 for rabbit subscapularis repair for linear stiffness, yield load, ultimate load, and energy absorbed to failure, respectively. The ratios of double-row/transosseous-equivalent repair were 1.0, 0.86, 0.70, and 0.41 for human supraspinatus and 1.22, 0.85, 0.76, and 0.60 for rabbit subscapularis for linear stiffness, yield load, ultimate load, and energy absorbed to failure, respectively. There were no differences comparing rabbit to human repair ratios for any parameter (p > 0.09 for all comparisons). CONCLUSIONS: Subscapularis repairs in the rabbit at Time 0 result in comparable ratios to human supraspinatus repairs. CLINICAL RELEVANCE: The biomechanical similarities between the different types of rotator cuff repair in the rabbit subscapularis and human supraspinatus at Time 0 provide more evidence that the rabbit subscapularis may be an appropriate model to study rotator cuff repairs.

Long-term occlusal changes assessed by the American Board of Orthodontics' model grading system.

INTRODUCTION: The purpose of this study was to assess the long-term posttreatment changes in all criteria of the American Board of Orthodontics' (ABO) model grading system. METHODS: We used plaster models from patients' final and posttreatment records. Thirty patients treated by 1 orthodontist using 1 bracket prescription were selected. An initial discrepancy index for each subject was performed to determine the complexity of each case. The final models were then graded using the ABO's model grading system immediately at posttreatment and postretention. Statistical analysis was performed on the 8 criteria of the model grading system, including paired t tests and Pearson correlations. An alpha of 0.05 was considered statistically significant. RESULTS: The average length of time between the posttreatment and postretention records was 12.7 ± 4.4 years. It was shown that alignment and rotations worsened by postretention (P = 0.014), and a weak statistically significant correlation at posttreatment and postretention was found (0.44; P = 0.016). Both marginal ridges and occlusal contacts scored less well at posttreatment. These criteria showed a significant decrease in scores between posttreatment and postretention (P <0.001), but the correlations were not statistically significant. The average total score showed a significant decrease between posttreatment and postretention (P <0.001), partly because of the large decrease in the previous 2 criteria. CONCLUSIONS: Higher scores for occlusal contacts and marginal ridges were found at the end of treatment; however, those scores and the overall scores for the 30 subjects improved in the postretention phase.

The prevalence of dental anomalies in orthodontic patients at the State University of New York at Buffalo.

OBJECTIVE: To determine the prevalence of permanent tooth anomalies in patients attending the graduate orthodontic clinic at the State University of New York at Buffalo. MATERIALS AND METHODS: Charts of 496 subjects (310 females and 186 males) met the inclusion criteria for this study. The mean ages were 16 years and 3 months for the combined gender sample that received orthodontic treatment in the graduate orthodontic clinic between 2007 and 2010. Full pretreatment records (intraoral photographs, digital study models, lateral cephalograms and panoramic radiographs) were used for the assessment. Charts were examined for these anomalies: agenesis, supernumerary, impaction and delayed tooth eruption. Subjects were categorized by gender and ethnicity. The percentages of the anomalies were assessed according to type of malocclusion, gender, race, location, tooth class and region in the dental arches. RESULTS: Sixty-four subjects (12.9%) had at least one occurrence of delayed eruption and impaction (DEI), followed by 47 subjects (9.5%) who had at least one occurrence of agenesis, and seven (1.4%) had a supernumerary condition. Approximately 80% of the subjects had no dental anomalies. The presence of more than one anomaly was observed in 61 subjects. Twelve subjects (2.4%) had both agenesis and DEI. Agenesis tended to be more common in class II malocclusions (p=0.012). CONCLUSION: The prevalence of permanent tooth anomalies was (20.4%). The percentage occurrence of DEI was the highest (12.9%) followed by dental agenesis (9.5%) and supernumerary teeth (1.4%) in the orthodontic patients at the State University of New York at Buffalo.

Strengthening medical product regulation in low- and middle-income countries.

In summary, the case studies exploring global product supply chains and diethylene glycol poisoning in Panama, clinical trials regulation through AVAREF, premarket assurance through PEPFAR tentative approval, post-market surveillance in sub-Saharan Africa through research on drug and vaccine safety systems, and regulatory science through the creation of a low-cost meningitis vaccine for low- and middle-income countries, demonstrate the essential value of regulatory systems to low- and middle-income countries. When they work, people live; when they fail, people die. As the challenges of globalization mount, and efforts to provide medical products to low- and middle-income countries scale up, there is no better time to put regulatory system strengthening squarely on the global health and development agenda.

Correlation between craniofacial structures, anthropometric measurements, and nasopharyngeal dimensions in black adolescents.

OBJECTIVES: To evaluate the correlation between craniofacial structures, anthropometric measurements, and bony and soft tissue nasopharyngeal dimensions in African Black adolescents. METHODS: This retrospective cross-sectional study was conducted on 483 healthy adolescents (250 females and 233 males), randomly selected from one dental clinic. The inclusion criteria were skeletal and dental Class I, Black ethnicity, pubertal growth period as determined by the Greulich and Pyle atlas criteria, and no history of orthodontic treatment. Anthropometric measurements (stature, upper body height, lower body height, and BMI) and radiographic records (hand-wrist radiographs, and lateral cephalograms) were obtained. One investigator traced and analysed all cephalograms to determine three skeletal craniofacial parameters (maxillary length [Ar- ANS], mandibular length [Ar-Gn], and lower anterior facial height [ANS-Me]), and 14 (8 skeletal and 6 soft tissue) nasopharyngeal parameters. Pearson correlation coefficients and stepwise multiple linear regression analyses were conducted. RESULTS: The mean skeletal ages of females and males were 11.31±2.31y and 12.66±1.85y, respectively. Multiple linear regression analyses showed that stature, posterior height of nasal cavity (S-PNS), length of nasal floor (AA-PNS), and mean area of bony nasopharynx (Area 1) were significantly correlated with maxillary length, P<.001. Stature, BMI, S-PNS, vertical angle of nasopharynx (Ba-S-PNS), Area 1, adenoid height (AD), and linear hyoid bone measurements (H-AA, H-RGN, H-Ax) were all correlated with mandibular length, P<.05. Lower facial height showed sexual dimorphism and was significantly associated with vertical nasopharyngeal measurements, BMI and upper body height. CONCLUSIONS: Craniofacial structures were significantly associated with stature and upper body height. Maxillary growth was associated with bony nasopharyngeal variables. Mandibular growth and lower facial height were associated with bony and soft tissue nasopharyngeal variables. The sexual dimorphism in lower facial height warrants future studies to fully understand and manage the craniofacial complex and nasopharyngeal airway in African Black adolescents.

Addressing the challenges of regulatory systems strengthening in small states.

Countries should ensure equitable access to quality medicines. Regulatory systems for medicines and other health technologies are an essential part of well-functioning health systems and are a requisite for achieving Universal Health and the Sustainable Development Goals. The Pan American Health Organization, the World health Organization (WHO) regional office for the Americas, has assessed national regulatory capacities using a precursor of WHO Global Benchmarking Tool, and conducted an analysis of the data which suggests an association of regulatory capacity with population and the size of the economy. Regulatory capacity tends to decrease as population and gross domestic product decreases. This predominantly impacts the Caribbean sub-region in the Americas, which includes many states with small populations and economies. This paper will use the World Bank's term 'small states' to refer to countries with 1.5 million people or less and other larger countries that face similar challenges. The regulatory challenges of small states include small markets and limited human and financial resources. However, small states can build regulatory systems with a narrower scope that are less resource intensive and still ensure appropriate regulation and oversight. The approach should be tailored to accomplish a subset of WHO recommended essential functions, including marketing authorisation, licensing of establishments and postmarket surveillance/pharmacovigilance, depending on the need to oversee local manufacturing, which requires a comprehensive system. The approach should also include adoption of efficiencies, such as regionalisation and reliance. This model is currently being put in practice in the small states of the Caribbean Community and Pacific Islands and can inform other small states around the world.

Correlation between craniofacial growth and upper and lower body heights in subjects with Class I occlusion.

OBJECTIVE: To correlate skeletal age, standing height, upper and lower body lengths, and selected craniofacial growth features in a sample of growing individuals, and to model craniofacial growth using multivariate regression. METHODS: This was a retrospective cross-sectional study with 447 African black boys and girls, between the ages 8 and 16 years, who attended the dental clinic at one hospital. The skeletal maturational age was determined from hand-wrist radiographs using the Greulich and Pyle atlas. Craniofacial measurements representing maxillary length (Ar-ANS), mandibular length (Ar-Gn), and lower facial height (ANS-Me) were calculated from lateral cephalograms in habitual occlusion. Body lengths were clinically measured in centimeters. RESULTS: Moderate correlations (r=0.42 to 0.68) were observed between skeletal age and the three selected craniofacial measurements. Statistically significant correlations were also found between the craniofacial measurements and both upper and lower body lengths. The mandibular length had a stronger correlation with the upper body length than with the lower body length. Multiple regression analyses to determine maxillary and mandibular lengths suggested that sex, upper and lower body lengths might be used to determine maxillary length; while skeletal age, upper and lower body lengths might help determine mandibular length. CONCLUSIONS: Based on the relatively strong correlation between upper body length and mandibular length, further research in this area may warrant its use as a predictor for mandibular growth modification timing.

PREVALENCE AND RISK FACTORS OF TRICHOMONAS GALLINAE AND TRICHOMONOSIS IN GOLDEN EAGLE ( AQUILA CHRYSAETOS) NESTLINGS IN WESTERN NORTH AMERICA.

Avian trichomonosis, caused by the protozoan Trichomonas gallinae, affects bird-eating raptors worldwide. Raptors can develop trichomonosis by feeding on infected prey, particularly Rock Pigeons (C olumba livia), which are a reservoir for T. gallinae. Raptors may be particularly vulnerable to T. gallinae infection in degraded habitats, where changes in resources may cause raptors to switch from foraging on native prey to synanthropic avian species such as Rock Pigeons. Golden Eagles ( Aquila chrysaetos) typically forage on mammals; however, habitat across much of their range is experiencing degradation through changes in land use, climate, and human encroachment. In 2015, we examined the prevalence of T. gallinae infection in Golden Eagle nestlings across western North America and conducted an intensive study on factors associated with T. gallinae infection and trichomonosis in southwestern Idaho. We found T. gallinae infection in 13% (12/96) of eagle nestlings across 10 western states and in 41% (13/32) of nestlings in southwestern Idaho. At the Idaho site, the probability of T. gallinae infection increased as the proportion of Rock Pigeons in nestling diet increased. Nestlings with diets that consisted of ≥10% Rock Pigeons had a very high probability of T. gallinae infection. We compared historical (1971-81) and recent (2014-15) diet data and incidence of trichomonosis lesions of nestling eagles in Idaho and found that the proportion of Rock Pigeons in eagle diets was higher in recent versus historical periods, as was the proportion of eagle nestlings with trichomonosis lesions. Our results suggested that localized shifts in eagle diet that result from habitat degradation and loss of historical prey resources have the potential to affect Golden Eagle nestling survival and supported the hypothesis that land use change can alter biologic communities in a way that might have consequences for disease infection and host susceptibility.

Factors associated with prolonged wound drainage after primary total hip and knee arthroplasty.

BACKGROUND: Prolonged wound drainage following total hip or total knee arthroplasty has been associated with an increased risk of postoperative morbidity. The purpose of this study was to determine the pharmacologic, surgical, and patient-specific factors that are associated with prolonged wound drainage and the relationship of this complication to the length of hospital stay and the rate of wound infections. METHODS: We conducted a retrospective observational study of 1211 primary total hip arthroplasties and 1226 primary total knee arthroplasties. Prospectively collected data included body mass index, intraoperative blood loss, surgical time, type of prophylaxis against deep venous thrombosis, and length of hospital stay. The association of these factors with the duration of postoperative wound drainage was analyzed. An acute infection developed after fifteen primary total hip arthroplasties and ten primary total knee arthroplasties. The patients with an acute postoperative infection were compared with their uninfected counterparts, and an odds ratio was determined to estimate the risk of prolonged wound drainage resulting in a wound infection. RESULTS: Morbid obesity was strongly associated with prolonged wound drainage in the total hip arthroplasty group (p = 0.001) but not in the total knee arthroplasty group (p = 0.590). An increased volume of drain output was an independent risk factor for prolonged wound drainage in both groups. Patients who received low-molecular-weight heparin for prophylaxis against deep venous thrombosis had a longer time until the postoperative wound was dry than did those treated with aspirin and mechanical foot compression or those who received Coumadin (warfarin); this difference was significant on the fifth postoperative day (p = 0.003) but not by the eighth postoperative day. Prolonged wound drainage resulted in a significantly longer hospital stay in both groups (p < 0.001). Each day of prolonged wound drainage increased the risk of wound infection by 42% following a total hip arthroplasty and by 29% following a total knee arthroplasty. CONCLUSIONS: Morbid obesity, the use of low-molecular-weight heparin, and a higher drain output were associated with a prolonged time until the postoperative wound was dry following a primary total hip arthroplasty, whereas a higher drain output was the only risk factor associated with prolonged drainage following a primary total knee arthroplasty. Prolonged drainage was associated with a higher rate of infection following a primary total hip arthroplasty, whereas obesity was the only identified independent risk factor for postoperative infection following a primary total knee arthroplasty.

Leveling the curve of Spee with a continuous archwire technique: a long term cephalometric study.

INTRODUCTION: The orthodontic technique favored by a clinician frequently determines how a deep curve of Spee (COS) is leveled. The primary purpose of this investigation was to confirm radiographically the long-term effectiveness of a continuous archwire technique--the Alexander discipline--in leveling the COS in patients with Class II Division 1 deep-bite malocclusions treated without extractions. METHODS: The sample for this retrospective cephalometric study consisted of the randomly selected orthodontic records of 31 subjects (22 female, 9 male) treated with the continuous archwire technique in the private practice of Dr R.G. "Wick" Alexander in Arlington, Texas. RESULTS: The mean pretreatment COS for this sample was 2.47 mm, and the corresponding mean posttreatment COS was 0.19 mm. The COS was completely level in 21 patients after treatment, and the rest had slight residual COS at the end of this phase. Ten of the 31 subjects remained level from 5 to 25 years after orthodontic treatment. CONCLUSIONS: The results indicate that most leveling was accomplished by the extrusion of the premolars. The continuous archwire technique is effective in leveling the COS in patients with Class II Division 1 deep-bite malocclusions treated without extractions when the initial COS is 2 to 4 mm. The leveling of the COS with the continuous archwire technique takes place by a combination of premolar extrusion and, to a lesser extent, incisor intrusion.

Antibiotic susceptibility of bacteria infecting total joint arthroplasty sites.

BACKGROUND: Currently, there is no consensus regarding the principles of empiric antibiotic treatment of suspected periprosthetic infection following total knee and hip arthroplasties. This study was undertaken to attempt to establish such principles. METHODS: We performed a retrospective analysis of 146 patients who had had a total of 194 positive cultures of specimens obtained at the time of a reoperation following a total knee or total hip arthroplasty at one of two institutions. Patient demographic data, comorbid conditions, bacterial species, the antibiotic sensitivity profile, and the postoperative day on which the culture tested positive were recorded. RESULTS: Specimens from 110 hips and eighty-four knees were positive on culture. Seventy percent of the infections were classified as chronic; 17%, as acute postoperative; and 13%, as acute hematogenous. The mean time between the operation and the positive culture results was three days. Gram-positive organisms caused the majority of the infections. In the series as a whole, 88% of the bacteria were sensitive to gentamicin; 96%, to vancomycin; and 61%, to cefazolin. The most antibiotic-resistant bacterial strains were from patients for whom prior antibiotic treatment had failed. Acute postoperative infections had a greater resistance profile than did chronic or hematogenous infections. Bacteria isolated from patients with a hematogenous infection had a high sensitivity to both cefazolin and gentamicin. CONCLUSIONS: Empiric antibiotic treatment for suspected periprosthetic infection should be guided by the class of the infection and the findings of Gram staining. We believe that, until the final culture results are available, acute hematogenous infections should initially be treated by a combination of cefazolin and gentamicin therapy. All chronic and acute postoperative infections with Gram-positive bacteria and all cases in which a Gram stain fails to identify bacteria should be managed with vancomycin. Infections with Gram-negative bacteria should be managed with a third or fourth-generation cephalosporin. Infections with mixed Gram-positive and Gram-negative bacteria should be managed with a combination of vancomycin and a third or fourth-generation cephalosporin. Furthermore, we believe that if culture results and other confirmatory tests are not positive by the fourth postoperative day, termination of empiric antibiotic therapy should be considered.

Fixation of periprosthetic femoral shaft fractures associated with cemented femoral stems: a biomechanical comparison of locked plating and conventional cable plates.

UNLABELLED: To determine which of 2 techniques for the treatment of periprosthetic femoral shaft fractures is of greater stiffness. DESIGN: A laboratory study using 8 pairs of matched, embalmed femurs. METHODS: Femurs implanted with a cemented total hip prosthesis had a simulated periprosthetic femur fracture created distal to the implant. Fractures were fixed with a plate with locked screws or a plate with cables (Ogden construct). Fixation stability was compared in various loading modalities before and after cycling. Failure in torsional loading was then determined. The cement mantle was tested for crack propagation that may have occurred secondary to locked screw insertion and loading. OUTCOME MEASUREMENTS: Fixation stiffness (the ratio of applied load to displacement at the fracture site), torsional strength, mode of failure for each system, and cement mantle evaluation for cracks after screw insertion. RESULTS: Locked plating was stiffer than the Ogden construct in pre- and post-cyclic axial loading and torsion. There was no difference in lateral bending stability or torsional failure loads. CONCLUSIONS: Locked plating constructs were stiffer than the Ogden construct in axial loading and torsion. Although no differences in loads to failure during torsion were noted, locked plating constructs exhibited catastrophic failure not observed with the Ogden construct.

The consistency between scientific papers presented at the Orthopaedic Trauma Association and their subsequent full-text publication.

OBJECTIVES: To determine the consistency of conclusions/statements made in podium presentations at the annual meeting of the Orthopaedic Trauma Association (OTA) with those in subsequent full-text publications. Also, to evaluate the nature and consistency of study design, methods, sample sizes, results and assign a corresponding level of evidence. DATA SOURCES: Abstracts of the scientific programs of the OTA from 1994 to 1997 (N = 254) were queried by using the PubMed database to identify those studies resulting in a peer-reviewed, full-text publication. STUDY SELECTION: Of the 169 articles retrieved, 137 studies were the basis of our study after the exclusion criteria were applied: non-English language, basic science studies, anatomic dissection studies, and articles published in non-peer-reviewed journals. DATA EXTRACTION/SYNTHESIS: Information was abstracted onto a data form: first from the abstract published in the final meeting program, and then from the published journal article. Information was recorded regarding study issues, including the study design, primary objective, sample size, and statistical methods. We provided descriptive statistics about the frequency of consistent results between abstracts and full-text publications. The results were recorded as percentages and a 95% confidence interval was applied to each value. Study results were recorded for the abstract and full-text publication comparing results and the overall conclusion. A level of scientific-based evidence was assigned to each full-text publication. RESULTS: The final conclusion of the study remained the same 93.4% of the time. The method of study was an observational case series 52% of the time and a statement regarding the rate of patient follow-up was reported 42% of the time. Of the studies published, 18.2% consisted of a sample size smaller than the previously presented abstract. When the published papers had their level of evidence graded, 11% were level I, 16% level II, 17% level III, and 56% level IV. CONCLUSIONS: Authors conclusions were consistent with those in full-text publications. Most studies were observational, less than half reported on the rate of patient follow-up. Many abstracts followed by publication had a smaller sample size in the published paper. Half of all studies were graded level IV evidence.

Pharmaceutical procurement among public sector procurers in CARICOM / Compras farmacéuticas por parte de organismos del sector público de CARICOM / Aquisição de produtos farmacêuticos por compradores do setor público da CARICOM

ABSTRACT Objective. To examine multiple aspects of the medicines in CARICOM procurement markets, including manufacturer headquarters location, regulatory history, and type (innovator versus generic); the proportion of World Health Organization (WHO) essential medicines; and the most expensive medicines procured. Methods. An analysis of procurement information from selected CARICOM procurers. Four public sector procurement lists were obtained based on public availability or sharing of data from public sector procurers. Analyses were based on parameters available or deduced from these data. Results. The majority of products come from manufacturers headquartered in North America and Europe (63%-67%). The percentage of medicines procured from generic companies is 60%-87%; and 25%-50% of medicines procured are on the WHO Essential Medicines List. Wide price variations exist in the most expensive medicines purchased. Conclusions. The analysis identifies vulnerabilities and opportunities in the procurement situation of CARICOM states, particularly related to quality and rational use of medicines. This analysis represents a baseline that governments and other stakeholders can use in the future.

RESUMEN Objetivo. Revisar los múltiples aspectos de los medicamentos en los mercados de compras y los proveedores de CARICOM, como la ubicación de la sede del fabricante, el historial de regulación, el tipo (patentado versus genérico); la proporción de medicamentos esenciales de la Organización Mundial de la Salud (OMS); y los medicamentos comprados más caros. Métodos. Se analizó información sobre la compra por parte de determinados organismos de CARICOM. La información procedía de cuatro listas de organismos del sector público que realizan las compras, que se consiguieron en función de su disponibilidad pública o de los datos distribuidos por los organismos del sector público que realizan las compras. Los análisis estaban basados en los parámetros disponibles o derivados de estos datos. Resultados. La mayoría de los productos proviene de fabricantes radicados en América del Norte y Europa (entre 63% y 67%). El porcentaje de medicamentos que se compra de empresas genéricas oscila entre 60% y 87%; y de 25% a 50% de los medicamentos que se compran están en la Lista de Medicamentos Esenciales de la OMS. Hay una gran divergencia de precios entre los medicamentos comprados más caros. Conclusiones. En el análisis se han encontrado vulnerabilidades y oportunidades con respecto a la situación de las compras de medicamentos de los Estados de CARICOM, especialmente en cuanto a la calidad y al uso racional de los medicamentos. Este análisis representa una línea de base que los gobiernos u otros interesados directos pueden utilizar en el futuro.

RESUMO Objetivo. Examinar vários aspectos relacionados aos mercados e fornecedores de produtos farmacêuticos da CARICOM, incluindo a localização da sede do laboratório fabricante, histórico regulatório e tipo de produtos (inovadores versus genéricos); proporção de medicamentos adquiridos que constam da relação de medicamentos essenciais da Organização Mundial da Saúde (OMS); e medicamentos mais caros comprados. Métodos. Foi realizada uma análise de informação sobre compras feitas por compradores selecionados da CARICOM. Quatro listas de compras do setor público foram obtidas com informação de acesso público ou compartilhada pelos compradores. As análises foram feitas com base em parâmetros disponíveis ou inferidos a partir dos dados. Resultados. A maioria dos produtos farmacêuticos é proveniente de laboratórios com sedes na América do Norte e Europa (63%-67%). Do total, 60%-87% dos medicamentos adquiridos são de laboratórios de produtos genéricos e 25%-50% constam da relação de medicamentos essenciais da OMS. Existe uma ampla variação nos preços dos medicamentos mais caros comprados. Conclusões. Foram identificadas fragilidades e oportunidades na situação de compras dos países da CARICOM, em particular relacionadas à qualidade dos produtos e ao uso racional dos medicamentos. Esta análise serve de referência a ser usada futuramente pelos governos e outras partes interessadas.

Serum interleukin-6 as a marker of periprosthetic infection following total hip and knee arthroplasty.

BACKGROUND: The erythrocyte sedimentation rate, the C-reactive protein serum level, and the white blood-cell count are routinely used to diagnose periprosthetic infection. In the present study, the diagnostic accuracy of the interleukin-6 serum level was compared with the accuracy of these standard tests for the evaluation of a group of patients who had had a total hip or total knee arthroplasty and were undergoing a reoperation for the treatment of an infection or another implant-related problem. METHODS: A prospective, case-control study of fifty-eight patients who had had a total hip or knee replacement and were undergoing a reoperation because of an infection (seventeen patients) or another implant-related problem (forty-one patients) was conducted. The serum levels of interleukin-6 and C-reactive protein, the erythrocyte sedimentation rate, and the white blood-cell count were measured. The definitive diagnosis of an infection was determined on the basis of positive histopathological evidence of infection and growth of bacteria on culture of intraoperative specimens. Two-sample Wilcoxon rank-sum (Mann-Whitney) tests were used to determine the presence of a significant difference between patients with and without infection with regard to each laboratory value studied. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of each text were also calculated. RESULTS: The serum interleukin-6 level, erythrocyte sedimentation rate, and C-reactive protein level were significantly higher in patients who had an infection than in those who did not, both when all patients were considered together and when the total hip arthroplasty and total knee arthroplasty groups were considered separately. With the numbers available, there was no significant difference with regard to the white blood-cell count between patients with and without infection. With a normal serum interleukin-6 level defined as <10 pg/mL, the serum interleukin-6 test had a sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 1.0, 0.95, 0.89, 1.0, and 97%, respectively. CONCLUSIONS: An elevated serum interleukin-6 level correlated positively with the presence of periprosthetic infection in patients undergoing a reoperation at the site of a total hip or knee arthroplasty. The serum interleukin-6 level is valuable for the diagnosis of periprosthetic infection in patients who have had a total hip or total knee arthroplasty.

Osteotomy about the knee: applications, techniques, and results.

Varus or valgus malalignment of the knee may be either a cause or a consequence of unicompartmental knee arthritis in young, active adults. Proximal tibial osteotomy for the varus knee and distal femoral osteotomy for the valgus knee have been used for decades to manage this condition; however, their use has decreased significantly in recent years as the popularity of unicompartmental and total knee arthroplasty has grown. With the advent of biologic resurfacing techniques for focal full-thickness articular cartilage injury, combined or staged high tibial osteotomy is becoming increasingly popular. In addition, in the face of cruciate ligamentous instability with or without posterolateral corner instability coupled with varus malalignment, high tibial osteotomy with and without ligament reconstruction provides a solution to complex orthopedic problems. Recent long-term follow-up studies have concluded osteotomy allows for improved function and pain relief in properly selected young patients.