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1.  BARRIERS TO ADHERENCE TO ANTIRETROVIRAL MEDICATIONS AMONG PATIENTS LIVING WITH HIV IN SOUTHERN CHINA: A QUALITATIVE STUDY 
AIDS care  2008;20(10):1242-1250.
Although China’s government is rapidly expanding access to antiretroviral therapy, little is known about barriers to adherence among Chinese HIV-infected patients, particularly among injection drug users (IDUs). To better understand barriers to antiretroviral treatment adherence, we conducted a qualitative research study, using both focus group and key informant methods, among 36 HIV-positive men and women in Dali, in southwestern China. All interviews utilized semi-structured question guides and were conducted in Mandarin, audio-recorded, and translated into English for analysis. The most commonly cited adherence challenges were stigma, including secondary stigma experienced by family members; mental health issues; and economic concerns, particularly related to finding and maintaining employment. Distinctive gender differences emerged, partly due to previous heroin use among male respondents. Optimizing adherence may require that antiretroviral therapy programs be linked to other services, including drug addiction treatment, mental health services, and vocational treatment and support. HIV care and service providers, and policy makers in China responsible for HIV treatment, should be aware of these important barriers to adherence.
doi:10.1080/09540120801918651
PMCID: PMC3888993  PMID: 19012083
HIV; AIDS; antiretroviral therapy; adherence; injection drug users; qualitative research; China; mental health; stigma; vocational support
2.  Impact of enhanced infection control at two neonatal intensive care units in the Philippines 
Background
The growing burden of neonatal mortality due to hospital acquired neonatal sepsis in the developing world creates an urgent need for low cost effective infection control measures in low resource settings.
Methods
Using a pre/post comparison design, we measured how rates of staff hand hygiene compliance, colonization with resistant pathogens (defined as ceftazidime- and/or gentamicin-resistant gram-negative rods (GNRs) and resistant gram-positive cocci), bacteremia, and overall mortality changed following the introduction of a simplified package of infection control measures at two neonatal intensive care units (NICUs) in Manila, the Philippines.
Results
Of 1828 NICU neonates admitted, 45.6% became newly colonized with resistant bacteria, 19.6% became bacteremic (78.2% from GNRs), and 33.6% died. 2903 resistant colonizing bacteria were identified of which 85% were resistant GNRs (predominantly Klebsiella spp., Pseudomonas spp., and Acinetobacter spp.) and 14% were Methicillin-resistant Staphylococcus aureus. Contrasting control vs. intervention periods at each NICU, staff hand hygiene compliance improved (At NICU 1 RR=1.3, 95% CI 1.1–1.5; At NICU 2 RR=1.6, 95% CI 1.4–2.0) and overall mortality declined (NICU 1 RR=0.5, 95%CI 0.4–0.6; NICU 2 RR=0.8, 95% CI 0.7–0.9). However, colonization with resistant pathogens and sepsis rates did not change significantly at either NICU.
Discussion
Nosocomial transmission of resistant pathogens was intense at these two Philippines NICUs and dominated by resistant GNRs. Infection control interventions are feasible and possibly effective in resource limited hospital settings.
doi:10.1086/594120
PMCID: PMC3866590  PMID: 19025496
Infection Control; Philippines; NICU; Drug Resistance; Hand Hygiene
3.  Importance of dose timing to achieving undetectable viral loads 
AIDS and behavior  2009;14(4):10.1007/s10461-009-9555-9.
Little is known about the importance of dose timing to successful antiretroviral therapy (ART). In a cohort comprised of Chinese HIV/AIDS patients, we measured adherence among subjects for six months using three methods in parallel: self-report using a visual analog scale (SR-VAS), pill count, and electronic drug monitors (EDM). We calculated two adherence metrics using the EDM data. The first metric used the proportion of doses taken; the second metric credited doses as adherent only if taken within a 1-hour window of a pre-specified dose time (EDM ‘proportion taken within dose time’). Of the adherence measures, EDM had the strongest associations with viral suppression. Of the two EDM metrics, incorporating dose timing had a stronger association with viral suppression. We conclude that dose timing is also an important determinant of successful ART, and should be considered as an additional dimension to overall adherence.
doi:10.1007/s10461-009-9555-9
PMCID: PMC3857692  PMID: 19353263
HIV/AIDS; antiretroviral therapy; adherence; dose timing; China; non nucleoside reverse transcriptase inhibitor
4.  How often do US-based human subjects research studies register on time, and how often do they post their results? A statistical analysis of the Clinicaltrials.gov database 
BMJ Open  2012;2(4):e001186.
Context
The Food and Drug Administration Modernization Act of 1997 (FDAMA) and the FDA Amendment Act of 2007 (FDAAA), respectively, established mandates for registration of interventional human research studies on the website clinicaltrials.gov (CTG) and for posting of results of completed studies.
Objective
To characterise, contrast and explain rates of compliance with ontime registration of new studies and posting of results for completed studies on CTG.
Design
Statistical analysis of publically available data downloaded from the CTG website.
Participants
US studies registered on CTG since 1 November 1999, the date when the CTG website became operational, through 24 June 2011, the date the data set was downloaded for analysis.
Main outcome measures
Ontime registration (within 21 days of study start); average delay from study start to registration; proportion of studies posting their results from within the group of studies listed as completed on CTG.
Results
As of 24 June 2011, CTG contained 54 890 studies registered in the USA. Prior to 2005, an estimated 80% of US studies were not being registered. Among registered studies, only 55.7% registered within the 21-day reporting window. The average delay on CTG was 322 days. Between 28 September 2007 and June 23 2010, 28% of intervention studies at Phase II or beyond posted their study results on CTG, compared with 8.4% for studies without industry funding (RR 4.2, 95% CI 3.7 to 4.8). Factors associated with posting of results included exclusively paediatric studies (adjusted OR (AOR) 2.9, 95% CI 2.1 to 4.0), and later phase clinical trials (relative to Phase II studies, AOR for Phase III was 3.4, 95% CI 2.8 to 4.1; AOR for Phase IV was 6.0, 95% CI 4.8 to 7.6).
Conclusions
Non-compliance with FDAMA and FDAAA appears to be very common, although compliance is higher for studies sponsored by industry. Further oversight may be required to improve compliance.
doi:10.1136/bmjopen-2012-001186
PMCID: PMC3432835  PMID: 22936820
5.  Feasibility and Acceptability of a Real-Time Adherence Device among HIV-Positive IDU Patients in China 
AIDS Research and Treatment  2013;2013:957862.
We collected data on feasibility and acceptability of a real-time web-linked adherence monitoring container among HIV-positive injection drug users (IDU) in China. “Wisepill” uses wireless technology to track on-time medication dosing. Ten patients on antiretroviral therapy (ART) at the Guangxi CDC HIV clinic in Nanning, China, used Wisepill for one ART medication for one month. We monitored device use and adherence and explored acceptability of the device among patients. Mean adherence was 89.2% (SD 10.6%). Half of the subjects reported a positive overall experience with Wisepill. Seven said that it was inconvenient, supported by comments that it was large and conspicuous. Five worried about disclosure of HIV status due to the device; no disclosures were reported. Twelve signal lapses occurred (5.4% of prescribed doses), of which one was due to technical reasons, nine to behavioral reasons (both intentional and unintentional), and two to unclear reasons. Although the technical components must be monitored carefully, and acceptability to patients presents challenges which warrant further exploration, the Wisepill device has potential for adherence interventions that deliver rapid adherence-support behavioral feedback directly to patients, including IDU. The use of wireless technology appears uniquely promising for providing time-sensitive communication on patient behavior that can be harnessed to maximize the benefits of HIV treatment.
doi:10.1155/2013/957862
PMCID: PMC3730150  PMID: 23956851
6.  Training Zambian traditional birth attendants to reduce neonatal mortality in the Lufwanyama Neonatal Survival Project (LUNESP) 
Objective
To provide relevant details on how interventions in the Lufwanyama Neonatal Survival Project (LUNESP) were developed and how Zambian traditional birth attendants (TBAs) were trained to perform them.
Methods
The study tested 2 interventions: a simplified version of the American Academy of Pediatrics’ neonatal resuscitation protocol (NRP); and antibiotics with facilitated referral (AFR).
Results
Key elements that enabled the positive study result were: focusing on common and correctible causes of mortality; selecting a study population with high unmet public health need; early community mobilization to build awareness and support; emphasizing simplicity in the intervention technology and algorithms; using a traditional training approach appropriate to students with low literacy rates; requiring TBAs to demonstrate their competence before completing each workshop; and minimizing attrition of skills by retraining and reassessing the TBAs regularly throughout the study.
Conclusion
An effective NRP training model was created that is suitable for community-based neonatal interventions, in research or programmatic settings, and by practitioners with limited obstetric skills and low rates of literacy.
doi:10.1016/j.ijgo.2012.02.012
PMCID: PMC3366059  PMID: 22542215
Birth asphyxia; LUNESP; Neonatal hypothermia; Neonatal resuscitation protocol; Neonatal sepsis; Traditional birth attendant
7.  Effect of training traditional birth attendants on neonatal mortality (Lufwanyama Neonatal Survival Project): randomised controlled study 
Objective To determine whether training traditional birth attendants to manage several common perinatal conditions could reduce neonatal mortality in the setting of a resource poor country with limited access to healthcare.
Design Prospective, cluster randomised and controlled effectiveness study.
Setting Lufwanyama, an agrarian, poorly developed district located in the Copperbelt province, Zambia. All births carried out by study birth attendants occurred at mothers’ homes, in rural village settings.
Participants 127 traditional birth attendants and mothers and their newborns (3559 infants delivered regardless of vital status) from Lufwanyama district.
Interventions Using an unblinded design, birth attendants were cluster randomised to intervention or control groups. The intervention had two components: training in a modified version of the neonatal resuscitation protocol, and single dose amoxicillin coupled with facilitated referral of infants to a health centre. Control birth attendants continued their existing standard of care (basic obstetric skills and use of clean delivery kits).
Main outcome measures The primary outcome was the proportion of liveborn infants who died by day 28 after birth, with rate ratios statistically adjusted for clustering. Secondary outcomes were mortality at different time points; and comparison of causes of death based on verbal autopsy data.
Results Among 3497 deliveries with reliable information, mortality at day 28 after birth was 45% lower among liveborn infants delivered by intervention birth attendants than control birth attendants (rate ratio 0.55, 95% confidence interval 0.33 to 0.90). The greatest reductions in mortality were in the first 24 hours after birth: 7.8 deaths per 1000 live births for infants delivered by intervention birth attendants compared with 19.9 per 1000 for infants delivered by control birth attendants (0.40, 0.19 to 0.83). Deaths due to birth asphyxia were reduced by 63% among infants delivered by intervention birth attendants (0.37, 0.17 to 0.81) and by 81% within the first two days after birth (0.19, 0.07 to 0.52). Stillbirths and deaths from serious infection occurred at similar rates in both groups.
Conclusions Training traditional birth attendants to manage common perinatal conditions significantly reduced neonatal mortality in a rural African setting. This approach has high potential to be applied to similar settings with dispersed rural populations.
Trial registration Clinicaltrials.gov NCT00518856.
doi:10.1136/bmj.d346
PMCID: PMC3032994  PMID: 21292711
8.  Persistence of immune responses after a single dose of Novartis meningococcal serogroup A, C, W-135 and Y CRM-197 conjugate vaccine (Menveo®) or Menactra® among healthy adolescents 
Human Vaccines  2010;6(11):881-887.
The persistence of human bactericidal activity (hSBA) responses in adolescents was assessed 22 months after vaccination with one dose of Menveo® (MenACWY-CRM; Novartis) or Menactra® (MCV4) (sanofi pasteur). The proportion of subjects with hSBA titers ≥8 was significantly higher among recipients of MenACWY-CRM than MCV4 for serogroups A, W-135 and Y.
doi:10.4161/hv.6.11.12849
PMCID: PMC3060384  PMID: 21339701
meningococcal disease; CRM-197; Menveo; Menactra; conjugate vaccine; neisseria meningitidis
9.  Using Electronic Drug Monitor Feedback to Improve Adherence to Antiretroviral Therapy Among HIV-Positive Patients in China 
AIDS and Behavior  2009;14(3):580-589.
Effective antiretroviral therapy (ART) requires excellent adherence. Little is known about how to improve ART adherence in many HIV/AIDS-affected countries, including China. We therefore assessed an adherence intervention among HIV-positive patients in southwestern China. Eighty subjects were enrolled and monitored for 6 months. Sixty-eight remaining subjects were randomized to intervention/control arms. In months 7–12, intervention subjects were counseled using EDM feedback; controls continued with standard of care. Among randomized subjects, mean adherence and CD4 count were 86.8 vs. 83.8% and 297 vs. 357 cells/μl in intervention vs. control subjects, respectively. At month 12, among 64 subjects who completed the trial, mean adherence had risen significantly among intervention subjects to 96.5% but remained unchanged in controls. Mean CD4 count rose by 90 cells/μl and declined by 9 cells/μl among intervention and control subjects, respectively. EDM feedback as a counseling tool appears promising for management of HIV and other chronic diseases.
doi:10.1007/s10461-009-9615-1
PMCID: PMC2865631  PMID: 19771504
AIDS; Medication adherence; Antiretroviral medication; China; Electronic drug monitoring
10.  Patient Retention in Antiretroviral Therapy Programs in Sub-Saharan Africa: A Systematic Review 
PLoS Medicine  2007;4(10):e298.
Background
Long-term retention of patients in Africa's rapidly expanding antiretroviral therapy (ART) programs for HIV/AIDS is essential for these programs' success but has received relatively little attention. In this paper we present a systematic review of patient retention in ART programs in sub-Saharan Africa.
Methods and Findings
We searched Medline, other literature databases, conference abstracts, publications archives, and the “gray literature” (project reports available online) between 2000 and 2007 for reports on the proportion of adult patients retained (i.e., remaining in care and on ART) after 6 mo or longer in sub-Saharan African, non-research ART programs, with and without donor support. Estimated retention rates at 6, 12, and 24 mo were calculated and plotted for each program. Retention was also estimated using Kaplan-Meier curves. In sensitivity analyses we considered best-case, worst-case, and midpoint scenarios for retention at 2 y; the best-case scenario assumed no further attrition beyond that reported, while the worst-case scenario assumed that attrition would continue in a linear fashion. We reviewed 32 publications reporting on 33 patient cohorts (74,192 patients, 13 countries). For all studies, the weighted average follow-up period reported was 9.9 mo, after which 77.5% of patients were retained. Loss to follow-up and death accounted for 56% and 40% of attrition, respectively. Weighted mean retention rates as reported were 79.1%, 75.0% and 61.6 % at 6, 12, and 24 mo, respectively. Of those reporting 24 mo of follow-up, the best program retained 85% of patients and the worst retained 46%. Attrition was higher in studies with shorter reporting periods, leading to monthly weighted mean attrition rates of 3.3%/mo, 1.9%/mo, and 1.6%/month for studies reporting to 6, 12, and 24 months, respectively, and suggesting that overall patient retention may be overestimated in the published reports. In sensitivity analyses, estimated retention rates ranged from 24% in the worse case to 77% in the best case at the end of 2 y, with a plausible midpoint scenario of 50%.
Conclusions
Since the inception of large-scale ART access early in this decade, ART programs in Africa have retained about 60% of their patients at the end of 2 y. Loss to follow-up is the major cause of attrition, followed by death. Better patient tracing procedures, better understanding of loss to follow-up, and earlier initiation of ART to reduce mortality are needed if retention is to be improved. Retention varies widely across programs, and programs that have achieved higher retention rates can serve as models for future improvements.
Almost half of people entering African HIV treatment programs were lost to follow-up or died within two years, according to this systematic review by Sydney Rosen and colleagues.
Editors' Summary
Background.
About 25 million people in sub-Saharan Africa are infected with the human immunodeficiency virus (HIV), the cause of acquired immunodeficiency syndrome (AIDS). Every year, about three million more people become infected with HIV and 2 million die from AIDS in this region, where the pandemic has reduced life expectancy, orphaned many children, and reversed economic growth. Since 1996, HIV-positive people living in wealthier parts of the world have had access to cocktails of antiretroviral drugs that hold HIV in check and allow them to live relatively normal, healthy lives. But these drugs are expensive and it is only in the past five years that antiretroviral therapy (ART) programs have been initiated in sub-Saharan Africa, often with international support.
Why Was This Study Done?
For ART to work, HIV-infected individuals whose immune systems have been damaged by the virus have to take antiretroviral drugs regularly for the rest of their lives. If people take ART irregularly or stop taking their medications they may become sicker or die, or the viruses they carry may become resistant to antiretroviral drugs. Several studies have looked at how well patients on ART stick to their day-to-day medication schedules, but how long patients stay in treatment programs, which they must do to prevent illness and death from AIDS, has received little attention. In this study the researchers reviewed reports of whether patients stay in treatment in ART programs in sub-Saharan Africa, and also looked at the reasons why they drop out.
What Did the Researchers Do and Find?
The researchers identified 32 scientific reports published or presented at meetings between 2000 and 2007 that gave details of the proportion of adult patients retained (alive and receiving ART) in ART treatment programs (not including research studies) in 13 countries in sub-Saharan Africa. The average follow-up time of the programs (adjusted for number of patients in each) was 9.9 months. At this time, 77.5% of the patients were retained on average. Of the patients not retained, just under half had died and half had been lost to follow up. That is, they had missed clinic visits or had not picked up their medication. Estimated average retention rates at 6, 12, and 24 months were 79.08%, 75% and 61.6%, respectively; retention rates reported at 24 months ranged between 46% and 85% of patients. Finally, using sensitivity analysis (a technique that can estimate best- and worst-case possibilities), the researchers estimated that actual retention in ART programs after 2 years probably lies between one-quarter and three-quarters of patients.
What Do These Findings Mean?
These results show that roughly half of people starting HIV treatment programs in Africa are no longer receiving treatment after two years. The overall success rates of African treatment programs may actually be even lower, if one takes into account that programs with very low retention may be unlikely to publish their results. This study therefore indicates that a worrying number of patients in sub-Saharan Africa who need ART are lost from treatment programs. Because many of these patients are lost because they die from AIDS, one way to improve retention might be to start treating people with ART earlier, before they become seriously ill from HIV. Better efforts to find out exactly why patients drop out of programs (for example, the cost of drugs and/or of transport to clinics) might reduce the number of patients lost to follow up. The researchers also suggest that ART programs with very high retention rates might serve as models to improve retention rates in other programs.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040298.
Information is available from the US National Institute of Allergy and Infectious Diseases on HIV infection and AIDS
HIV InSite is a regional page on sub-Saharan Africa from the University of California, San Francisco
Information is provided by the US Centers for Disease Control and Prevention on the US President's Emergency Plan for AIDS Relief in various countries and regions
Avert is an international AIDS charity that provides information on HIV and AIDS in Africa
Aidsmap is an international AIDS organization that summarizes research about HIV/AIDS and reports news (in English, Spanish, Portuguese, French, and Russian)
doi:10.1371/journal.pmed.0040298
PMCID: PMC2020494  PMID: 17941716
11.  Adherence to HAART: A Systematic Review of Developed and Developing Nation Patient-Reported Barriers and Facilitators 
PLoS Medicine  2006;3(11):e438.
Background
Adherence to highly active antiretroviral therapy (HAART) medication is the greatest patient-enabled predictor of treatment success and mortality for those who have access to drugs. We systematically reviewed the literature to determine patient-reported barriers and facilitators to adhering to antiretroviral therapy.
Methods and Findings
We examined both developed and developing nations. We searched the following databases: AMED (inception to June 2005), Campbell Collaboration (inception to June 2005), CinAhl (inception to June 2005), Cochrane Library (inception to June 2005), Embase (inception to June 2005), ERIC (inception to June 2005), MedLine (inception to June 2005), and NHS EED (inception to June 2005). We retrieved studies conducted in both developed and developing nation settings that examined barriers and facilitators addressing adherence. Both qualitative and quantitative studies were included. We independently, in duplicate, extracted data reported in qualitative studies addressing adherence. We then examined all quantitative studies addressing barriers and facilitators noted from the qualitative studies. In order to place the findings of the qualitative studies in a generalizable context, we meta-analyzed the surveys to determine a best estimate of the overall prevalence of issues. We included 37 qualitative studies and 47 studies using a quantitative methodology (surveys). Seventy-two studies (35 qualitative) were conducted in developed nations, while the remaining 12 (two qualitative) were conducted in developing nations. Important barriers reported in both economic settings included fear of disclosure, concomitant substance abuse, forgetfulness, suspicions of treatment, regimens that are too complicated, number of pills required, decreased quality of life, work and family responsibilities, falling asleep, and access to medication. Important facilitators reported by patients in developed nation settings included having a sense of self-worth, seeing positive effects of antiretrovirals, accepting their seropositivity, understanding the need for strict adherence, making use of reminder tools, and having a simple regimen. Among 37 separate meta-analyses examining the generalizability of these findings, we found large heterogeneity.
Conclusions
We found that important barriers to adherence are consistent across multiple settings and countries. Research is urgently needed to determine patient-important factors for adherence in developing world settings. Clinicians should use this information to engage in open discussion with patients to promote adherence and identify barriers and facilitators within their own populations.
An analysis of qualitative and quantitative studies found consistent barriers to adherence to HIV therapy across multiple settings and countries, ranging from access to medication to problems with complicated regimens.
Editors' Summary
Background.
The World Health Organization has estimated that in 2005, about 38 million people worldwide were living with HIV/AIDS; the mortality caused by HIV/AIDS is very high. Antiretroviral drugs are effective at controlling the disease and extending life span. However, it is important for people to stick to the drug regimens exactly in order to keep levels of HIV low, prevent it from becoming resistant to drugs, and stop the illness from progressing. However, many people find it very difficult to take antiretroviral drugs precisely as they should. There is already some evidence from research studies on the reasons why this is the case. There are two different research approaches taken by these studies: “qualitative” methods, which try to find out about attitudes and behaviors using focus groups, interviews, or other techniques; and “quantitative” methods, which try to find out about peoples' opinions and experience using surveys with set questions for the participants to answer, and then count the different responses.
Why Was This Study Done?
The investigators wanted to put together all of the available evidence from published research studies (called doing a “systematic review”) on which factors affected people's adherence to antiretroviral drugs. They wanted to do a systematic review because it is thought to be a very rigorous way of appraising all the available evidence (although there is considerable debate about the value of using such a method to analyze the results of qualitative research).
What Did the Researchers Do and Find?
The study team searched biomedical literature databases as well as conference abstracts and research registries using a defined set of search queries. They screened all the scientific papers they found; those reporting results of original research into factors affecting antiretroviral adherence were then analyzed in more detail. 84 relevant studies were identified, of which 37 used “qualitative” methods (focus groups, interviews, open-ended questioning) and 47 used “quantitative” methods (surveys). Most of these studies had been carried out in the developed world. Then, the researchers extracted the factors affecting adherence from the original studies, which could be either “positive” factors (helping adherence) or “negative” ones (making adherence more difficult). They classified the factors into four key themes: “patient related” (e.g., seeing positive results, fear of disclosure, being depressed); “beliefs about medication” (e.g., faith in how well the drugs worked, side effects); “daily schedules” (e.g., using reminder tools, disruptions to routine); and “interpersonal relationships” (e.g., trusting relations with health-care provider; social isolation).
  Many barriers to adherence were common to both developed and developing settings. Some factors were unique to the studies conducted in the developing world, such as financial constraints and problems with traveling to get access to treatment. Fear of disclosure was an important barrier identified in many of the studies.
What Do These Findings Mean?
The researchers combined the results of many different studies and identified factors that help or obstruct adherence to antiretroviral treatment. By identifying influences common to the different settings, greater weight can be placed on the factors that were identified. Only 12 of the studies included in this research were from the developing world, where the majority of HIV/AIDS patients live; hence more work is needed to examine and address the factors influencing antiretroviral adherence in these parts of the world. This study provides researchers and health policy makers with a starting point for changes that might help to ensure greater adherence to antiretroviral treatment.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030438.
Medline Plus information on AIDS medicines (Medline Plus is a service of the US National Library of Medicine and the National Institutes of Health)
Joint United Nations Programme on HIV/AIDS has information about the state of the HIV/AIDS epidemic worldwide
The World Health Organization has an HIV/AIDS program site providing comprehensive information on the HIV/AIDS epidemic worldwide
The World Health Organization pages on antiretroviral therapy
doi:10.1371/journal.pmed.0030438
PMCID: PMC1637123  PMID: 17121449
13.  Why clinicians are natural bayesians 
BMJ : British Medical Journal  2005;330(7499):1080-1083.
Thought you didn't understand bayesian statistics? Read on and find out why doctors are expert in applying the theory, whether they realise it or not
PMCID: PMC557240  PMID: 15879401
14.  Alfalfa Seed Decontamination in Salmonella Outbreak 
Emerging Infectious Diseases  2003;9(4):474-479.
Based on in vitro data, the U.S. Food and Drug Administration recommends chemical disinfection of raw sprout seeds to reduce enteric pathogens contaminating the seed coats. However, little is known about the effectiveness of decontamination at preventing human disease. In 1999, an outbreak of Salmonella enterica serotype Mbandaka occurred in Oregon, Washington, Idaho, and California. Based on epidemiologic and pulsed-field gel electrophoresis evidence from 87 confirmed cases, the outbreak was linked to contaminated alfalfa seeds grown in California’s Imperial Valley. Trace-back and trace-forward investigations identified a single lot of seeds used by five sprout growers during the outbreak period. Cases of salmonellosis were linked with two sprout growers who had not employed chemical disinfection; no cases were linked to three sprout growers who used disinfection. This natural experiment provides empiric evidence that chemical disinfection can reduce the human risk for disease posed by contaminated seed sprouts.
doi:10.3201/eid0904.020519
PMCID: PMC2957971  PMID: 12702229
Alfalfa; seed sprouts; salmonellosis; foodborne illness; salmonella outbreak; Oregon; seed disinfection; food safety
15.  Costs and Cost-Effectiveness of Training Traditional Birth Attendants to Reduce Neonatal Mortality in the Lufwanyama Neonatal Survival Study (LUNESP) 
PLoS ONE  2012;7(4):e35560.
Background
The Lufwanyama Neonatal Survival Project (“LUNESP”) was a cluster randomized, controlled trial that showed that training traditional birth attendants (TBAs) to perform interventions targeting birth asphyxia, hypothermia, and neonatal sepsis reduced all-cause neonatal mortality by 45%. This companion analysis was undertaken to analyze intervention costs and cost-effectiveness, and factors that might improve cost-effectiveness.
Methods and Findings
We calculated LUNESP's financial and economic costs and the economic cost of implementation for a forecasted ten-year program (2011–2020). In each case, we calculated the incremental cost per death avoided and disability-adjusted life years (DALYs) averted in real 2011 US dollars. The forecasted 10-year program analysis included a base case as well as ‘conservative’ and ‘optimistic’ scenarios. Uncertainty was characterized using one-way sensitivity analyses and a multivariate probabilistic sensitivity analysis. The estimated financial and economic costs of LUNESP were $118,574 and $127,756, respectively, or $49,469 and $53,550 per year. Fixed costs accounted for nearly 90% of total costs. For the 10-year program, discounted total and annual program costs were $256,455 and $26,834 respectively; for the base case, optimistic, and conservative scenarios, the estimated cost per death avoided was $1,866, $591, and $3,024, and cost per DALY averted was $74, $24, and $120, respectively. Outcomes were robust to variations in local costs, but sensitive to variations in intervention effect size, number of births attended by TBAs, and the extent of foreign consultants' participation.
Conclusions
Based on established guidelines, the strategy of using trained TBAs to reduce neonatal mortality was ‘highly cost effective’. We strongly recommend consideration of this approach for other remote rural populations with limited access to health care.
doi:10.1371/journal.pone.0035560
PMCID: PMC3335866  PMID: 22545117

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