Implementing the WHO Safe Childbirth Checklist: lessons from a global collaboration.

The WHO Safe Childbirth Checklist (SCC) was developed to ensure the delivery of essential maternal and perinatal care practices around the time of childbirth. A research collaboration was subsequently established to explore factors that influence use of the Checklist in a range of settings around the world. This analysis article presents an overview of the WHO SCC Collaboration and the lessons garnered from implementing the Checklist across a diverse range of settings. Project leads from each collaboration site were asked to distribute two surveys. The first was given to end users, and the second to implementation teams to describe their respective experiences using the Checklist. A total of 134 end users and 38 implementation teams responded to the surveys, from 19 countries across all levels of income. End users were willing to adopt the SCC and found it easy to use. Training and the provision of supervision while using the Checklist, alongside leadership engagement and local ownership, were important factors which helped facilitate initial implementation and successful uptake of the Checklist. Teams identified several challenges, but more importantly successfully implemented the WHO SCC. A critical step in all settings was the adaptation of the Checklist to reflect local context and national protocols and standards. These findings were invaluable in developing the final version of the WHO SCC and its associated implementation guide. Our experience will provide useful insights for any institution wishing to implement the Checklist.

Assessing and improving data quality from community health workers: a successful intervention in Neno, Malawi.

SETTING: A community health worker (CHW) program was established in Neno District, Malawi, in 2007 by Partners In Health in support of Ministry of Health activities. Routinely generated CHW data provide critical information for program monitoring and evaluation. Informal assessments of the CHW reports indicated poor quality, limiting the usefulness of the data. OBJECTIVES: 1) To establish the quality of aggregated measures contained in CHW reports; 2) to develop interventions to address poor data quality; and 3) to evaluate changes in data quality following the intervention. DESIGN: We developed a lot quality assurance sampling-based data quality assessment tool to identify sites with high or low reporting quality. Following the first assessment, we identified challenges and best practices and followed the interventions with two subsequent assessments. RESULTS: At baseline, four of five areas were classified as low data quality. After 8 months, all five areas had achieved high data quality, and the reports generated from our electronic database became consistent and plausible. CONCLUSION: Program changes included improving the usability of the reporting forms, shifting aggregation responsibility to designated assistants and providing aggregation support tools. Local quality assessments and targeted interventions resulted in immediate improvements in data quality.

The quality of care received by HIV patients without a primary provider.

The goal of this study was to compare the quality of care received by HIV patients who report that their primary HIV care provider is a physician, a nurse practitioner (NP) or a physician assistant (PA) to that of patients who cannot identify a primary HIV provider. We used data from patients who participated in the HIV Cost and Services Utilization Study (HCSUS), a study of a probability sample of non-institutionalized HIV-infected individuals in care in the US. We compared patients who did and did not name a primary HIV care provider in terms of patient and care site characteristics, and level of clinician HIV expertise. Care quality measures included receipt of highly active antiretroviral therapy (HAART), reported problems with care, satisfaction with care, unmet needs and perceived access to care. Patients in care who did not report having a primary HIV care provider received HAART at significantly lower rates (p<0.05) and were less satisfied with their care (p<0.05) than patients with a primary HIV care provider, after adjusting for illness severity and other patient characteristics. There were similar but non-significant trends for reported problems, unmet needs and perceived access to care. Patients who had lower income or were drug users were more likely not to have a primary provider. We conclude that having a primary HIV care provider who is knowledgeable about a patient's care is related to the quality of medical care received by persons with HIV infection.

The CASE adherence index: A novel method for measuring adherence to antiretroviral therapy.

The Center for Adherence Support Evaluation (CASE) Adherence Index, a simple composite measure of self-reported antiretroviral therapy (ART) adherence, was compared to a standard three-day self-reported adherence measure among participants in a longitudinal, prospective cross-site evaluation of 12 adherence programs throughout the United States. The CASE Adherence Index, consisting of three unique adherence questions developed for the cross-site study, along with a three-day adherence self-report were administered by interviews every three months over a one-year period. Data from the three cross-site adherence questions (individually and in combination) were compared to three -day self-report data and HIV RNA and CD4 outcomes in cross-sectional analyses. The CASE Adherence Index correlated strongly with the three-day self-reported adherence data (p < 0.001) and was more strongly associated with HIV outcomes, including a 1-log decline in HIV RNA level (maximum OR = 2.34; p < 0.05), HIV RNA < 400 copies/ml (maximum OR = 2.33; p < 0.05) and performed as well as the three-day self-report when predicting CD4 count status. Participants with a CASE Index score >10 achieved a 98 cell mean increase in CD4 count over 12 months, compared to a 41 cell increase for those with scores < or =10 (p < 0.05). The CASE Adherence Index is an easy to administer instrument that provides an alternative method for assessing ART adherence in clinical settings.

Sources of disseminated Mycobacterium avium infection in AIDS.

OBJECTIVES: To identify the sources of disseminated Mycobacterium avium complex (MAC) infection in AIDS. METHODS: HIV positive subjects with CD4 counts <100/mm(3) in Atlanta, Boston, New Hampshire and Finland were entered in a prospective cohort study. Subjects were interviewed about potential MAC exposures, had phlebotomy performed for determination of antibody to mycobacterial lipoarabinomannin and for culture. Patient-directed water samples were collected from places of residence, work and recreation. Patients were followed for the development of disseminated MAC. Univariate and multivariate risk factors for MAC were analyzed. RESULTS: Disseminated MAC was identified in 31 (9%) subjects. Significant risks in univariate analysis included prior Pneumocystis carinii pneumonia (PCP) (hazard ratio 1.821), consumption of spring water (4.909), consumption of raw seafood (34.3), gastrointestinal endoscopy (2.894), and showering outside the home (0.388). PCP, showering and endoscopy remained significant in a Cox proportional hazards model. There was no association between M. avium colonization of home water and risk of MAC. In patients with CD4<25, median OD antibody levels to lipoarabinomannin at baseline were 0.054 among patients who did not develop MAC and 0.021 among patients who did develop MAC (P=0.077). CONCLUSIONS: MAC infection results from diverse and likely undetectable environmental and nosocomial exposures. Mycobacterial infection before HIV infection may confer protection against disseminated MAC in advanced AIDS.

HIV/AIDS patients' perspectives on adhering to regimens containing protease inhibitors.

OBJECTIVE: To gather qualitative data regarding HIV/AIDS patients' perspectives about HIV-1 protease inhibitors (PIs), and about their experiences taking and adhering to regimens containing PIs. DESIGN: Six focus groups of persons under care for HIV were conducted between September and November 1996 regarding participants' knowledge, awareness, experiences when taking, and adherence to antiretroviral regimens containing PIs. An identical discussion guide was used to facilitate all six groups. Focus group proceedings were audiotaped, transcribed, coded for themes, and analyzed qualitatively. SETTING: HIV/AIDS practices of three teaching hospitals and two community health centers. PATIENTS/PARTICIPANTS: Fifty-six patients with HIV disease: 28 men and 28 women. MEASUREMENTS AND MAIN RESULTS: Knowledge and positive impressions of PIs were prevalent among this diverse group of persons with HIV, and did not differ by race/ethnicity or gender. Most knew that these were new, potent medications for treating HIV/AIDS. Networks of persons with HIV and medical providers were the most important information sources. Those taking PIs were aware that adherence to the regimen is important, and most were using special strategies to maximize their own adherence, but expressed considerable frustration about the central role these medication regimens had assumed in their life. A subset who did not believe they would adhere to these regimens had declined treatment with them. Motivating factors for taking and adhering to these complex regimens were improving CD4 counts and viral loads and the patient-provider relationship. CONCLUSIONS: Among those with HIV/AIDS, awareness of PIs and their effectiveness is substantial, owing to the impact of informal networks and medical providers. This early positive "reputation" of PIs may enhance motivation for adherence. Those who are taking PIs invest substantial effort adhering to these complex regimens, but resent the need to make medications the focus of their lives.

Response of lymphoepithelial parotid cysts to antiretroviral treatment in HIV-infected adults.

BACKGROUND: Surgical resection has been the usual therapy for HIV-infected patients with lymphoepithelial parotid cysts. OBJECTIVE: To study antiretroviral therapy for lymphoepithelial parotid cysts. DESIGN: Case series. SETTING: HIV outpatient clinics. PATIENTS: HIV-infected patients with lymphoepithelial parotid cysts. INTERVENTION: Antiretroviral therapy. MEASUREMENTS: Change in size of the parotid cyst, CD4 lymphocyte count, and HIV viral load. RESULTS: Nine HIV-infected adults presented with chronic, large parotid cysts, eight of which were bilateral. In at least seven patients, the cysts were the initial sign of HIV infection. In six patients, the cysts resolved completely with combination antiretroviral therapy. Four of these patients also received prednisone. Three patients who did not comply with antiretroviral therapy had partial responses followed by relapses. CONCLUSIONS: Parotid cysts are an unrecognized sign of early HIV infection. These cysts respond to combination antiretroviral therapy, with or without corticosteroids. Surgical resection should be reserved for patients in whom medical therapy has failed or those who refuse or are poorly compliant with medical therapy.

Kaposi's sarcoma in women with AIDS.

OBJECTIVE: To describe the presentation and incidence of Kaposi's sarcoma (KS) in a cohort of women infected with HIV and to compare their clinical characteristics with men at the same institution. DESIGN: Retrospective chart and database review. SETTING: Adult clinical AIDS program outpatient clinics at a municipal teaching hospital. RESULTS: One hundred and seven people with KS were found of whom twelve (11.2%) were women. The prevalence of KS in women was 3.6% compared with 9.9% among men (P < 0.001). Women born outside the United States were at increased risk of developing KS (P < 0.05). At initial KS presentation, no difference in HIV stage or CD4 count was found between men and women. Women presented with more advanced KS than men, with increased incidence of non-cutaneous disease (P < 0.001), lymphedema (P < 0.0001), lymph-node disease (P < 0.0001) and visceral disease (P = 0.03). Women had decreased survival after KS diagnosis compared to men, although the difference was not significant (P = 0.41). CONCLUSIONS: KS is not a rare diagnosis in HIV-infected women followed at our institution. Although the increased risk of KS in men is most likely to be related to differences in exposure, the sex-related differences in presentation and course may be due in part to delay in diagnosis. KS should be considered in the spectrum of HIV-related complications in women as well as in men.

Nosocomial colonization and infection in persons infected with human immunodeficiency virus.

Nosocomial infections appear to be increased in patients with acquired immunodeficiency syndrome (AIDS), compared to individuals with asymptomatic infection due to human immunodeficiency virus (HIV). Risk factors for bacterial colonization and infection include immunosuppression, prior treatment with some antibiotics, increased hospitalizations with longer lengths of stay, greater exposure to invasive devices such as indwelling intravenous or urinary catheters, and the degree of immunosuppression. Data suggest that other infectious agents such as Pneumocystis carinii, Mycobacterium tuberculosis, Mycobacterium avium complex, and Cryptosporidium may be acquired in healthcare facilities. Diagnosis and management of nosocomial infections in HIV-infected persons may be complicated by an atypical presentation, increased rates of relapse following treatment, presence of multiple infections, and early discharge from the inpatient setting. Accurate assessment of nosocomial infections and outbreaks in the hospital is complicated by limited data on the risk of transmission of both traditional and unusual pathogens in this population. Furthermore, some patients may acquire nosocomial pathogens during their initial hospitalization and present later with infections that normally would be classified as community acquired. Therefore, there probably is an underestimation of current nosocomial infection rates, and perhaps "hospital-associated" or "healthcare-facility-associated" might be more accurate terms for these infections.

Epidemiology of community-acquired Clostridium difficile-associated diarrhea.

The epidemiology of clinically recognized community-acquired Clostridium difficile-associated diarrhea was assessed in a retrospective cohort study of members of a health maintenance organization (HMO). Potential cases were identified through positive toxin assay results and confirmed by review of automated full-text medical records. Of 51 cases identified (7.7 per 100,000 person-years), 42 (82%) were diagnosed and treated exclusively in the ambulatory care setting; 33 cases occurred within 42 days after 494,491 exposures to antibiotics dispensed by an HMO pharmacy. Antibiotic-specific attack rates varied from 0 to 2040 cases per 100,000 exposures. Increased age was associated with C. difficile-associated diarrhea (P < .001). Age-adjusted antibiotic-specific attack rates were at least 10-fold higher (P < .05) for nitrofurantoin, cefuroxime, cephalexin plus dicloxacillin, ampicillin/clavulanate plus cefaclor, and ampicillin/clavulanate plus cefuroxime than for ampicillin or amoxicillin; several other antibiotics were associated with similar but not significantly increased risks.

Electronic surveillance of antibiotic exposure and coded discharge diagnoses as indicators of postoperative infection and other quality assurance measures.

OBJECTIVES: To assess postoperative exposure to parenteral antibiotics and coded discharge diagnoses of infection as markers of nosocomial infection, postoperative morbidity, and potentially inappropriate antibiotic use after cesarean section. DESIGN: Retrospective cohort study to compare automated markers with the criterion of record review. SETTING: Tertiary care hospital. PATIENTS: Women admitted to a large teaching hospital after April 15, 1987, and discharged before October 1, 1989, who underwent a nonrepeat, nonelective cesarean section and had received prophylaxis with a cephalosporin. METHODS: Antibiotic exposure and discharge diagnosis codes were obtained from a large electronic hospital data base. A sample of charts was reviewed to determine the presence of infection, other postoperative complications, and postoperative antibiotic exposure. RESULTS: A total of 2,197 women who had undergone a nonrepeat nonelective cesarean section were included in the study cohort. These women were assigned to 6 subgroups based on postoperative antibiotic exposure status and discharge codes suggesting endometritis, other postoperative infection, or no infection. Review of 457 records indicated that the overall infection rate was 9%. Eight percent of all the patients had a coded diagnosis for infection, and 16% received some parenteral antibiotics after the first postoperative day. Exposure to at least 2 days of parenteral postoperative antibiotics was the best marker by which to discriminate between infected and uninfected patients, with a sensitivity of 81%, a specificity of 95%, and a positive predictive value of 61% for detecting infection. The corresponding figures for coded diagnoses for infection had rates of 65%, 97%, and 74%, respectively. The combination of discharge codes and exposure to parenteral postoperative antibiotics resulted in a more accurate but less sensitive marker for nosocomial infections, with a positive predictive value of 94% and a sensitivity of 59%. The groups with discordant parenteral postoperative antibiotics exposure and discharge codes for infection were enriched for errors in coding, noninfectious morbidity, and unexplained antibiotic use. Less than 1% of the entire cohort had > or = to 2 days of parenteral postoperative antibiotics without any reason apparent in the medical record. CONCLUSIONS: Parenteral postoperative antibiotic exposure determined from automated pharmacy records correlated with the results of the more labor-intensive manual review of medical records for the identification of nosocomial infection. In addition, information on antibiotic exposure combined with coded discharge diagnoses provided a rapid screen to identify subgroups of patients with higher rates of infectious and noninfectious morbidity, unexplained antibiotic use, and errors in discharge coding. Information derived from electronic data bases created for administrative purposes may be useful as a marker for infectious complications, inappropriate antibiotic prescribing, and other issues related to total quality hospital monitoring.

Confirmation of the regional localization of the genes for human acid alpha-glucosidase (GAA) and adenosine deaminase (ADA) by somatic cell hybridization.

We have confirmed the localization of human acid alpha-glucosidase (GAA) to 17q21----q25 and of adenosine deaminase (ADA) to 20q13----20qter by examination of hybrid clones derived from a fusion between a human cell line carrying a 17/20 balanced translocation (17pter----17q25::20q13----20qter;20pter-- --20q13::17q25----17qter) and a mouse line deficient in thymidine kinase. These hybrids were constantly maintained in HAT selective media in order to select for the presence of the human thymidine kinase gene on the intact chromosome 17 (17q21----22) or the 17/20 (17pter----17q25::20q13----20qter) translocation chromosome. We detected human GAA by rocket immunoelectrophoresis, using a heterologous antibody raised against human acid alpha-glucosidase. A clone which contained the 17/20 translocation and no intact chromosome 17 was still positive for GAA. This finding confirms the exclusion of GAA from 17q25----17qter reported by Nickel et al. (1982). Combined with earlier results (Weil et al. 1979), GAA can be assigned to 17q21----17q25. A clone which contained only the 17/20 translocation chromosome and no intact chromosome 20 contained ADA. This confirms the previous localization of ADA to 20q13.2----qter by gene dosage studies (Philip et al. 1980).