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1.  Accuracy of Self-Screening for Contraindications to Combined Oral Contraceptive Use 
Obstetrics and gynecology  2008;112(3):572-578.
Objective
To estimate how well a convenience sample of women from the general population could self-screen for contraindications to combined oral contraceptives using a medical checklist.
Methods
Women 18-49 years old (N=1,271) were recruited at two shopping malls and a flea market in El Paso, Texas, and asked first whether they thought pills were medically safe for them. They then used a checklist to determine the presence of level 3 or 4 contraindications to combined oral contraceptives according to the World Health Organization Medical Eligibility Criteria. Women were then interviewed by a blinded nurse practitioner who also measured blood pressure.
Results
The sensitivity of the unaided self-screen to detect true contraindications was 56.2% (95% CI: 51.7%-60.6%) and specificity 57.6% (54.0%-61.1%). The sensitivity of the checklist to detect true contraindications was 83.2% (79.5%-86.3%) and specificity 88.8% (86.3%- 90.9%). Using the checklist, 6.6% (5.2%-8.0%) of women incorrectly thought they were eligible for use when, in fact, they were contraindicated, largely due to unrecognized hypertension. Seven percent (5.4%-8.2%) of women incorrectly thought they were contraindicated when they truly were not, primarily due to misclassification of migraine headaches. In regression analysis, younger women, more educated women and Spanish-speakers were significantly more likely to correctly self-screen (p<0.05).
Conclusion
Self-screening for contraindications to oral contraceptives using a medical checklist is relatively accurate. Unaided screening is inaccurate and reflects common misperceptions about the safety of oral contraceptives. Over-the-counter provision of this method would likely be safe, especially for younger women and if independent blood pressure screening were encouraged.
doi:10.1097/AOG.0b013e31818345f0
PMCID: PMC2615461  PMID: 18757654
2.  Task Shifting for Scale-up of HIV Care: Evaluation of Nurse-Centered Antiretroviral Treatment at Rural Health Centers in Rwanda 
PLoS Medicine  2009;6(10):e1000163.
Fabienne Shumbusho and colleagues evaluate a task-shifting model of nurse-centered antiretroviral treatment prescribing in rural primary health centers in Rwanda and find that nurses can effectively and safely prescribe ART when given adequate training, mentoring, and support.
Background
The shortage of human resources for health, and in particular physicians, is one of the major barriers to achieve universal access to HIV care and treatment. In September 2005, a pilot program of nurse-centered antiretroviral treatment (ART) prescription was launched in three rural primary health centers in Rwanda. We retrospectively evaluated the feasibility and effectiveness of this task-shifting model using descriptive data.
Methods and Findings
Medical records of 1,076 patients enrolled in HIV care and treatment services from September 2005 to March 2008 were reviewed to assess: (i) compliance with national guidelines for ART eligibility and prescription, and patient monitoring and (ii) key outcomes, such as retention, body weight, and CD4 cell count change at 6, 12, 18, and 24 mo after ART initiation. Of these, no ineligible patients were started on ART and only one patient received an inappropriate ART prescription. Of the 435 patients who initiated ART, the vast majority had adherence and side effects assessed at each clinic visit (89% and 84%, respectively). By March 2008, 390 (90%) patients were alive on ART, 29 (7%) had died, one (<1%) was lost to follow-up, and none had stopped treatment. Patient retention was about 92% by 12 mo and 91% by 24 mo. Depending on initial stage of disease, mean CD4 cell count increased between 97 and 128 cells/µl in the first 6 mo after treatment initiation and between 79 and 129 cells/µl from 6 to 24 mo of treatment. Mean weight increased significantly in the first 6 mo, between 1.8 and 4.3 kg, with no significant increases from 6 to 24 mo.
Conclusions
Patient outcomes in our pilot program compared favorably with other ART cohorts in sub-Saharan Africa and with those from a recent evaluation of the national ART program in Rwanda. These findings suggest that nurses can effectively and safely prescribe ART when given adequate training, mentoring, and support.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Infection with the human immunodeficiency virus (HIV) is a serious health problem in sub-Saharan Africa. The virus attacks white blood cells that protect against infection, most commonly a type of white blood cell called CD4. When a person has been infected with HIV for a long time, the number of CD4 cells they have goes down, resulting in acquired immune deficiency syndrome (AIDS), in which the person's immune system no longer functions effectively.
The World Health Organization (WHO) has divided the disease into four stages as it progresses, according to symptoms including weight loss and so-called opportunistic infections. These are known as clinical stage I, II, III, or IV but were revised and renamed 1, 2, 3, and 4 in September 2005. HIV infection and AIDS cannot be cured but they can be managed with antiretroviral treatment (ART). The WHO currently recommends that ART is begun when the CD4 count falls below 350.
Rwanda is a country situated in the central Africa with a population of around 9 million inhabitants; over 3% of the rural population and 7% of the urban population are infected with HIV. In 2007, the WHO estimated that 220,000 Rwandan children had lost one or both parents to AIDS.
Why Was This Study Done?
The WHO estimates that 9.7 million people with HIV in low- to middle-income countries need ART but at the end of 2007, only 30% of these, including in Rwanda, had access to treatment. In many low-income countries a major factor in this is a lack of doctors. Rwanda, for example, has one doctor per 50,000 inhabitants and one nurse per 3,900 inhabitants.
This situation has led the WHO to recommend “task shifting,” i.e., that the task of prescribing ART should be shifted from doctors to nurses so that more patients can be treated. This type of reorganization is well studied in high-income countries, but the researchers wanted to help develop a system for treating AIDS that would be effective and timely in a predominantly rural, low-income setting such as Rwanda.
What Did the Researchers Do and Find?
In conjunction with the Rwandan Ministry of Health, the researchers developed and piloted a task-shifting program, in which one nurse in each of three rural Rwandan primary health centers (PHCs) was trained to examine HIV patients and prescribe ART in simple cases. Nurses had to complete more than 50 consultations observed by the doctor before being permitted to consult patients independently. More complex cases were referred to a doctor. The authors developed standard checklists, instructions, and evaluation forms to guide nurses and the doctors who supervised them once a week.
The authors evaluated the pilot program by reviewing the records of 1,076 patients who enrolled on it between September 2005 and March 2008. They looked to see whether the nurses had followed guidelines and monitored the patients correctly. They also considered health outcomes for the patients, such as their death rate, their body weight, their CD4 cell count, and whether they maintained contact with caregivers.
They found that by March 2008, 451 patients had been eligible for ART. 435 received treatment and none of the patients were prescribed ART when they should not have been. Only one prescription did not follow national guidelines.
At every visit, nurses were supposed to assess whether patients were taking their drugs and to monitor side effects. They did this and maintained records correctly for the vast majority of the 435 patients who were prescribed ART. 390 patients (over 90%) of the 435 prescribed receiving ART continued to take it and maintain contact with the pilot PHC's program. 29 patients died. Only one was lost to follow up and the others transferred to another ART site. The majority gained weight in the first six months and their CD4 cell counts rose. Outcomes, including death rate, were similar to those treated on the (doctor-led) Rwandan national ART program and other sub-Saharan African national (doctor-led) programs.
What Do These Findings Mean?
The study suggests that nurses are able to prescribe ART safely and effectively in a rural sub-Saharan setting, given sufficient training, mentoring, and support. Nurse-led prescribing of ART could mean that timely, appropriate treatment reaches many more HIV patients. It would reduce the burden of HIV care for doctors, freeing their time for other duties, and the study is already being used by the Rwandan Ministry of Health as a basis for plans to adopt a task-shifting strategy for the national ART program.
The study does have some limitations. The pilot program was funded and designed as a health project to deliver ART in rural areas, rather than a research project to compare nurse-led and doctor-led ART programs. There was no group of equivalent patients treated by doctors rather than nurses for direct comparison, although the authors did compare outcomes with those achieved nationally for doctor-led ART. The most promising sites, nurses, and patients were selected for the pilot and careful monitoring may have been an additional motivation for the nurses and doctors taking part. Health professionals in a scaled-up program may not be as committed as those in the pilot, who were carefully monitored. In addition, the nature of the pilot, which lasted for under three years and recruited new patients throughout, meant that patients were followed up for relatively short periods.
The authors also warn that they did not consider in this study the changes task shifting will make to doctors' roles and the skills required of both doctors and nurses. They recommend that task shifting should be implemented as part of a wider investment in health systems, human resources, training, adapted medical records, tools, and protocols.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000163.
PLoS Medicine includes a page collecting together its recent articles on HIV infection and AIDS that includes research articles, perspectives, editorials, and policy forums
SciDev.net provides news, views, and information about science, technology, and the developing world, including a section specific to HIV/AIDs
The World Health Organization (WHO) has published a downloadable booklet Task Shifting to Tackle Health Worker Shortages
The WHO offers information on HIV and AIDS (in Arabic, Chinese, English, French, Russian, and Spanish) as well as health information and fact sheets on individual countries, including on Rwanda
The UNAIDS/WHO working group on HIV/AIDS and Sexually Transmitted Infections (STI) Surveillance gathers and publishes data on the prevalence of HIV and AIDS in individual countries, including on Rwanda
AIDS.ORG provides information to help prevent HIV infections and to improve the lives of those affected by HIV and AIDS. Factsheets on many aspects of HIV and AIDS are available. It is the official online publisher of AIDS Treatment News
doi:10.1371/journal.pmed.1000163
PMCID: PMC2752160  PMID: 19823569
3.  Improving Child Protection in the Emergency Department: A Systematic Review of Professional Interventions for Health Care Providers 
Objective
This systematic review evaluated the effectiveness of professional and organizational interventions aimed at improving medical processes, such as documentation or clinical assessments by health care providers, in the care of pediatric emergency department (ED) patients where abuse was suspected.
Methods
A search of electronic databases, references, key journals/conference proceedings was conducted and primary authors contacted. Studies whose purpose was to evaluate a strategy aimed at improving ED clinical care of suspected abuse were included. Study methodological quality was assessed by two independent reviewers. One reviewer extracted the data and a second checked for completeness and accuracy.
Results
Six studies met the inclusion criteria: one randomized (RCT) and one quasi-randomized trial (qRCT), and four observational studies. Study quality ranged from modest (observational studies) to good (trials). Variation in study interventions and outcomes limited between study comparisons. One qRCT supported self-instructional education kits as a means to improve physician knowledge for both physical abuse (mean pre-test score: 13.12, SD 2.36; mean post-test score: 18.16, SD 1.64) and sexual abuse (mean pre-test score: 10.81, SD 3.20; mean post-test score: 18.45, SD 1.79). Modest quality observational studies evaluated reminder systems for physician documentation with similar results across studies. Compared to standard practice, chart checklists paired with an educational program increased physician consideration of non-accidental burns in burn cases (59% increase), documentation of time of injury (36% increase), as well as documentation of consistency (53% increase) and compatibility (55% increase) of reported histories. Decisional flowcharts for suspected physical abuse also increased documentation of non-accidental physical injury (69.5% increase; p<0.0001) and had a similar significant impact as checklists on increasing documentation of history consistency and compatibility (69.5% and 70.0% increases, respectively; p<0.0001) when compared to standard practice. No improvements were noted in these studies for documentation of consultations or current status with child protective services. The introduction of a specialized team and crisis center to standardize practice had little effect on physician documentation, but did increase documentation of child protective services involvement (22.7% increase; p<0.005) and discharge status (23.7% increase; p<0.02). Referral to social services increased in one study following the introduction of a chart checklist (8.6% increase; p=0.018). A recently conducted multi-site RCT did not support observational findings, reporting no significant effect of educational sessions and/or a chart checklist on ED practices.
Conclusions
The small number of studies identified in this review highlights the need for future studies that address care of a vulnerable clinical population. While moderate quality observational studies suggested education and reminder systems increased clinical knowledge and documentation, these findings were not supported by a single randomized trial. The limited theoretical base for conceptualizing change in health care providers and the influence of the ED environment on clinical practice are limitations to this current evidence base.
doi:10.1111/j.1553-2712.2009.00640.x
PMCID: PMC3023813  PMID: 20370740 CAMSID: cams1630
4.  Child protection procedures in emergency departments 
Emergency Medicine Journal : EMJ  2007;24(12):831-835.
Background
Emergency departments (EDs) may be the first point at which children who have been subject to abuse or neglect come into contact with professionals who are able to act for their protection. In order to ascertain current procedures for identifying and managing child abuse, we conducted a survey of EDs in England and Northern Ireland.
Methods
Questionnaires were sent to the lead professionals in a random sample of 81 EDs in England and 20 in Northern Ireland. Departments were asked to provide copies of their procedures for child protection. These were analysed qualitatively using a structured template.
Results
A total of 74 questionnaires were returned. 91.3% of departments had written protocols for child protection. Of these, 27 provided copies of their protocols for analysis. Factors judged to improve the practical usefulness of protocols included: those that were brief; were specific to the department; incorporated both medical and nursing management; included relevant contact details; included a single page flow chart which could be accessed separately. 25/71 (35.2%) departments reported that they used a checklist to highlight concerns. The most common factors on the checklists included an inconsistent history or one which did not match the examination; frequent attendances; delay in presentation; or concerns about the child's appearance or behaviour, or the parent–child interaction.
Conclusions
There is a lack of consistency in the approach to identifying and responding to child abuse in EDs. Drawing on the results of this survey, we are able to suggest good practice guidelines for the management of suspected child abuse in EDs. Minimum standards could improve management and facilitate clinical audit and relevant training.
doi:10.1136/emj.2007.051011
PMCID: PMC2658353  PMID: 18029514
5.  Barriers to Provider-Initiated Testing and Counselling for Children in a High HIV Prevalence Setting: A Mixed Methods Study 
PLoS Medicine  2014;11(5):e1001649.
Rashida Ferrand and colleagues combine quantitative and qualitative methods to investigate HIV prevalence among older children receiving primary care in Harare, Zimbabwe, and reasons why providers did not pursue testing.
Please see later in the article for the Editors' Summary
Background
There is a substantial burden of HIV infection among older children in sub-Saharan Africa, the majority of whom are diagnosed after presentation with advanced disease. We investigated the provision and uptake of provider-initiated HIV testing and counselling (PITC) among children in primary health care facilities, and explored health care worker (HCW) perspectives on providing HIV testing to children.
Methods and Findings
Children aged 6 to 15 y attending six primary care clinics in Harare, Zimbabwe, were offered PITC, with guardian consent and child assent. The reasons why testing did not occur in eligible children were recorded, and factors associated with HCWs offering and children/guardians refusing HIV testing were investigated using multivariable logistic regression. Semi-structured interviews were conducted with clinic nurses and counsellors to explore these factors. Among 2,831 eligible children, 2,151 (76%) were offered PITC, of whom 1,534 (54.2%) consented to HIV testing. The main reasons HCWs gave for not offering PITC were the perceived unsuitability of the accompanying guardian to provide consent for HIV testing on behalf of the child and lack of availability of staff or HIV testing kits. Children who were asymptomatic, older, or attending with a male or a younger guardian had significantly lower odds of being offered HIV testing. Male guardians were less likely to consent to their child being tested. 82 (5.3%) children tested HIV-positive, with 95% linking to care. Of the 940 guardians who tested with the child, 186 (19.8%) were HIV-positive.
Conclusions
The HIV prevalence among children tested was high, highlighting the need for PITC. For PITC to be successfully implemented, clear legislation about consent and guardianship needs to be developed, and structural issues addressed. HCWs require training on counselling children and guardians, particularly male guardians, who are less likely to engage with health care services. Increased awareness of the risk of HIV infection in asymptomatic older children is needed.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Over 3 million children globally are estimated to be living with HIV (the virus that causes AIDS). While HIV infection is most commonly spread through unprotected sex with an infected person, most HIV infections among children are the result of mother-to-child HIV transmission during pregnancy, delivery, or breastfeeding. Mother-to-child transmission can be prevented by administering antiretroviral therapy to mothers with HIV during pregnancy, delivery, and breast feeding, and to their newborn babies. According to a report by the Joint United Nations Programme on HIV/AIDS published in 2012, 92% of pregnant women with HIV were living in sub-Saharan Africa and just under 60% were receiving antiretroviral therapy. Consequently, sub-Saharan Africa is the region where most children infected with HIV live.
Why Was This Study Done?
If an opportunity to prevent mother-to-child transmission around the time of birth is missed, diagnosis of HIV infection in a child or adolescent is likely to depend on HIV testing in health care facilities. Health care provider–initiated HIV testing and counselling (PITC) for children is important in areas where HIV infection is common because earlier diagnosis allows children to benefit from care that can prevent the development of advanced HIV disease. Even if a child or adolescent appears to be in good health, access to care and antiretroviral therapy provides a health benefit to the individual over the long term. The administration of HIV testing (and counselling) to children relies not only on health care workers (HCWs) offering HIV testing but also on parents or guardians consenting for a child to be tested. However, more than 30% of children in countries with severe HIV epidemics are AIDS orphans, and economic conditions in these countries cause many adults to migrate for work, leaving children under the care of extended families. This study aimed to investigate the reasons for acceptance and rejection of PITC in primary health care settings in Harare, Zimbabwe. By exploring HCW perspectives on providing HIV testing to children and adolescents, the study also sought to gain insight into factors that could be hindering implementation of testing procedures.
What Did the Researchers Do and Find?
The researchers identified all children aged 6 to 15 years old at six primary care clinics in Harare, who were offered HIV testing as part of routine care between 22 January and 31 May 2013. Study fieldworkers collected data on numbers of child attendances, numbers offered testing, numbers who underwent HIV testing, and reasons why HIV testing did not occur. During the study 2,831 children attending the health clinics were eligible for PITC, and just over half (1,534, 54.2%) underwent HIV testing. Eighty-two children tested HIV-positive, and nearly all of them received counselling, medication, and follow-up care. HCWs offered the test to around 75% of those eligible. The most frequent explanation given by HCWs for a diagnostic test not being offered was that the child was accompanied by a guardian not appropriate for providing consent (401 occasions, 59%); Other reasons given were a lack of available counsellors or test kits and counsellors refusing to conduct the test. The likelihood of being offered the test was lower for children not exhibiting symptoms (such as persistent skin problems), older children, or those attending with a male or a younger guardian. In addition, over 100 guardians or parents provided consent but left before the child could be tested.
The researchers also conducted semi-structured interviews with 12 clinic nurses and counsellors (two from each clinic) to explore challenges to implementation of PITC. The researchers recorded the factors associated with testing not taking place, either when offered to eligible children or when HCWs declined to offer the test. The interviewees identified the frequent absence or unavailability of parents or legal guardians as an obstacle, and showed uncertainty or misconceptions around whether testing of the guardian was mandatory (versus recommended) and whether specifically a parent (if one was living) must provide consent. The interviews also revealed HCW concerns about the availability of adequate counselling and child services, and fears that a child might experience maltreatment if he or she tested positive. HCWs also noted long waiting times and test kits being out of stock as practical hindrances to testing.
What Do These Findings Mean?
Prevalence of HIV was high among the children tested, validating the need for PITC in sub-Saharan health care settings. Although 76% of eligible attendees were offered testing, the authors note that this is likely higher than in routine settings because the researchers were actively recording reasons for not offering testing and counselling, which may have encouraged heath care staff to offer PITC more often than usual. The researchers outline strategies that may improve PITC rates and testing acceptance for Zimbabwe and other sub-Saharan settings. These strategies include developing clear laws and guidance concerning guardianship and proxy consent when testing older children for HIV, training HCWs around these policies, strengthening legislation to address discrimination, and increasing public awareness about HIV infection in older children.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001649.
This study is further discussed in a PLOS Medicine Perspective by Davies and Kalk
The Joint United Nations Programme on HIV/AIDS publishes an annual report on the global AIDS epidemic, which provides information on progress towards eliminating new HIV infections
The World Health Organization has more information on mother-to-child transmission of HIV
The World Health Organization's website also has information about treatment for children living with HIV
Personal stories about living with HIV/AIDS, including stories from young people infected with HIV, are available through Avert, through NAM/aidsmap, and through the charity website Healthtalkonline
doi:10.1371/journal.pmed.1001649
PMCID: PMC4035250  PMID: 24866209
6.  Improving preventive service delivery at adult complete health check-ups: the Preventive health Evidence-based Recommendation Form (PERFORM) cluster randomized controlled trial 
BMC Family Practice  2006;7:44.
Background
To determine the effectiveness of a single checklist reminder form to improve the delivery of preventive health services at adult health check-ups in a family practice setting.
Methods
A prospective cluster randomized controlled trial was conducted at four urban family practice clinics among 38 primary care physicians affiliated with the University of Toronto. Preventive Care Checklist Forms© were created to be used by family physicians at adult health check-ups over a five-month period. The sex-specific forms incorporate evidence-based recommendations on preventive health services and documentation space for routine procedures such as physical examination. The forms were used in two intervention clinics and two control clinics. Rates and relative risks (RR) of the performance of 13 preventive health maneuvers at baseline and post-intervention and the percentage of up-to-date preventive health services delivered per patient were compared between the two groups.
Results
Randomly-selected charts were reviewed at baseline (n = 509) and post-intervention (n = 608). Baseline rates for provision of preventive health services ranged from 3% (fecal occult blood testing) to 93% (blood pressure measurement), similar to other settings. The percentage of up-to-date preventive health services delivered per patient at the end of the intervention was 48.9% in the control group and 71.7% in the intervention group. This is an overall 22.8% absolute increase (p = 0.0001), and 46.6% relative increase in the delivery of preventive health services per patient in the intervention group compared to controls. Eight of thirteen preventive health services showed a statistically significant change (p < 0.05) in favor of the intervention (adjusted RR (95% C.I.)): counseling on brushing/flossing teeth (9.2 (4.3–19.6)), folic acid counseling (7.5 (2.7–20.8)), fecal occult blood testing (6.7 (1.9–24.1)), smoking cessation counseling (3.9 (2.2–7.2)), tetanus immunization (3.0 (1.7–5.2)), history of alcohol intake (1.33 (1.2–1.5)), history of smoking habits (1.28 (1.2–1.4)) and blood pressure measurement (1.05 (1.00–1.10)).
Conclusion
This simple, low cost, clinically relevant intervention improves the delivery of preventive health services by prompting physicians of evidence-based recommendations in a checklist format that incorporates existing practice patterns. Periodic updates of the Preventive Care Checklist Forms© will allow a feasible and easy-to-use tool for primary care physicians to provide evidence-based preventive health services to adults at routine health check-ups. The forms can also be incorporated into an electronic health record. The Preventive Care Checklist Forms© are accessible in English and French at the College of Family Physicians of Canada web site.
doi:10.1186/1471-2296-7-44
PMCID: PMC1543627  PMID: 16836761
7.  Surgical checklists: the human factor 
Background
Surgical checklists has been shown to improve patient safety and teamwork in the operating theatre. However, despite the known benefits of the use of checklists in surgery, in some cases the practical implementation has been found to be less than universal. A questionnaire methodology was used to quantitatively evaluate the attitudes of theatre staff towards a modified version of the World Health Organisation (WHO) surgical checklist with relation to: beliefs about levels of compliance and support, impact on patient safety and teamwork, and barriers to the use of the checklist.
Methods
Using the theory of planned behaviour as a framework, 14 semi-structured interviews were conducted with theatre personnel regarding their attitudes towards, and levels of compliance with, a checklist. Based upon the interviews, a 27-item questionnaire was developed and distribute to all theatre personnel in an Irish hospital.
Results
Responses were obtained from 107 theatre staff (42.6% response rate). Particularly for nurses, the overall attitudes towards the effect of the checklist on safety and teamworking were positive. However, there was a lack of rigour with which the checklist was being applied. Nurses were significantly more sensitive to the barriers to the use of the checklist than anaesthetists or surgeons. Moreover, anaesthetists were not as positively disposed to the surgical checklist as surgeons and nurse. This finding was attributed to the tendency for the checklist to be completed during a period of high workload for the anaesthetists, resulting in a lack of engagement with the process.
Conclusion
In order to improve the rigour with which the surgical checklist is applied, there is a need for: the involvement of all members of the theatre team in the checklist process, demonstrated support for the checklist from senior personnel, on-going education and training, and barriers to the implementation of the checklist to be addressed.
doi:10.1186/1754-9493-7-14
PMCID: PMC3669630  PMID: 23672665
Surgical checklist; Surgery; Patient safety
8.  Adjusting team involvement: a grounded theory study of challenges in utilizing a surgical safety checklist as experienced by nurses in the operating room 
BMC Nursing  2012;11:16.
Background
Even though the use of perioperative checklists have resulted in significant reduction in postoperative mortality and morbidity, as well as improvements of important information communication, the utilization of checklists seems to vary, and perceived barriers are likely to influence compliance. In this grounded theory study we aimed to explore the challenges and strategies of performing the WHO’s Safe Surgical Checklist as experienced by the nurses appointed as checklist coordinators.
Methods
Grounded theory was used in gathering and analyzing data from observations of the checklist used in the operating room, in conjunction with single and focus group interviews. A purposeful sample of 14 nurse-anesthetists and operating room nurses as surgical team members in a tertiary teaching hospital participated in the study.
Results
The nurses’ main concern regarding checklist utilization was identified as “how to obtain professional and social acceptance within the team”. The emergent grounded theory of “adjusting team involvement” consisted of three strategies; distancing, moderating and engaging team involvement. The use of these strategies explains how they resolved their challenges. Each strategy had corresponding conditions and consequences, determining checklist compliance, and how the checklist was used.
Conclusion
Even though nurses seem to have a loyal attitude towards the WHO’s checklist regarding their task work, they adjusted their surgical team involvement according to practical, social and professional conditions in their work environment. This might have resulted in the incomplete use of the checklist and therefore a low compliance rate. Findings also emphasized the importance of: a) management support when implementing WHO’s Safe Surgical Checklist, and b) interprofessional education approach to local adaptation of the checklists use.
doi:10.1186/1472-6955-11-16
PMCID: PMC3499446  PMID: 22958326
9.  How do caregivers know when to take their child for immunizations? 
BMC Pediatrics  2005;5:44.
Background
Childhood vaccinations help reduce and eliminate many causes of morbidity and mortality among children. The objective of this study was to compare 4:3:1:3:3 (4+ doses of diphtheria and tetanus toxoids and pertussis vaccine, 3+ doses of poliovirus vaccine, 1+ doses of measles-containing vaccine, 3+ doses of Haemophilus influenzae type b vaccine, and 3+ doses of hepatitis B vaccine) coverage among children whose caregivers learned by different methods when their child's most recent immunization was needed.
Methods
Between July 2001 and December 2002, a portion of households receiving the National Immunization Survey were asked how they knew when to take the child in for his/her most recent immunization. Responses were post-coded into several categories: 'Doctor/nurse reminder at previous immunization visit', 'Shot card/record', 'Reminder/recall', and 'Other'. Respondents could give more than one answer. Children who did not receive any vaccines, had ≤ 1 visits for vaccinations, or whose caregiver did not provide an answer to the question were excluded from analyses. Chi-square analyses were used to compare 4:3:1:3:3 coverage among 19–35 month old children.
Results
Children whose caregivers indicated that a doctor/nurse told them at a previous immunization visit when to return for the next immunization had significantly greater 4:3:1:3:3 coverage than those who did not choose the response (77.2% vs. 70.1%, p < 0.01). However, no significant difference in coverage was found between households that did/did not indicate that reminder/recalls (71.0% vs. 75.5%, p = 0.24) helped them remember when to take their child for their most recent immunization visit; only borderline significance was found between those that did/did not choose shot cards (70.6% vs. 76.2%, p = 0.07).
Conclusion
A doctor or nurse's reminder during an immunization visit of the next scheduled immunization visit effectively encourages caregivers to bring children in for immunizations, providing an inexpensive and easy way to effectively increase immunization coverage.
doi:10.1186/1471-2431-5-44
PMCID: PMC1314897  PMID: 16316458
10.  Implementation of the WHO safe childbirth checklist program at a tertiary care setting in Sri Lanka: a developing country experience 
Background
To study institutionalization of the World Health Organization’s Safe Childbirth Checklist (SCC) in a tertiary care center in Sri Lanka.
Method
A hospital-based, prospective observational study was conducted in the De Soysa Hospital for Women, Colombo, Sri Lanka. Healthcare workers were educated regarding the SCC, which was to be used for each woman admitted to the labor room during the study period. A qualitatively pretested, self-administered questionnaire was given to all nursing and midwifery staff to assess knowledge and attitudes towards the checklist. Each item of the SCC was reviewed for adherence.
Results
A total of 824 births in which the checklist used were studied. There were a total of births 1800 during the period, giving an adoption rate of 45.8%. Out of the 170 health workers in the hospital (nurses, midwives and nurse midwives) 98 answered the questionnaire (response rate = 57.6%). The average number of childbirth practices checked in the checklist was 21 out of 29 (95% CI 20.2, 21.3). Educating the mother to seek help during labor, after delivery and after discharge from hospital, seeking an assistant during labor, early breast-feeding, maternal HIV infection and discussing contraceptive options were checked least often. The mean level of knowledge on the checklist among health workers was 60.1% (95% CI 57.2, 63.1). Attitudes for acceptance of using the checklist were satisfactory. Average adherence to checklist practices was 71.3%. Sixty eight (69.4%) agreed that the Checklist stimulates inter-personal communication and teamwork. Increased workload, poor enthusiasm of health workers towards new additions to their routine schedule and level of user-friendliness of Checklist were limitations to its greater use.
Conclusions
Amongst users, the attitude towards the checklist was satisfactory. Adoption rate amongst all workers was 45.8% and knowledge regarding the checklist was 60.1%. These two factors are probably linked. Therefore prior to introducing it to a facility awareness about the value and correct use of the SCC needs to be increased, while giving attention to satisfactory staffing levels.
doi:10.1186/s12884-015-0436-0
PMCID: PMC4324022  PMID: 25648543
Safe childbirth; Checklist; World health organization; Sri Lanka
11.  Nurse-patient communication in primary care diabetes management: an exploratory study 
BMC Nursing  2013;12:20.
Background
Diabetes is a major health issue for individuals and for health services. There is a considerable literature on the management of diabetes and also on communication in primary care consultations. However, few studies combine these two topics and specifically in relation to nurse communication. This paper describes the nature of nurse-patient communication in diabetes management.
Methods
Thirty-five primary health care consultations involving 18 patients and 10 nurses were video-recorded as part of a larger multi-site study tracking health care interactions between health professionals and patients who were newly diagnosed with Type 2 diabetes. Patients and nurses were interviewed separately at the end of the 6-month study period and asked to describe their experience of managing diabetes. The analysis used ethnography and interaction analysis.
In addition to analysis of the recorded consultations and interviews, the number of consultations for each patient and total time spent with nurses and other health professionals were quantified and compared.
Results
This study showed that initial consultations with nurses often incorporated completion of extensive checklists, physical examination, referral to other health professionals and distribution of written material, and were typically longer than consultations with other health professionals. The consultations were driven more by the nurses’ clinical agenda than by what the patient already knew or wanted to know. Interactional analysis showed that protocols and checklists both help and hinder the communication process. This contradictory outcome was also evident at a health systems level: although organisational targets may have been met, the patient did not always feel that their priorities were attended to. Both nurses and patients reported a sense of being overwhelmed arising from the sheer volume of information exchanged along with a mismatch in expectations.
Conclusions
Conscientious nursing work was evident but at times misdirected in terms of optimal use of time. The misalignment of patient expectations and clinical protocols highlights a common dilemma in clinical practice and raises questions about the best ways to balance the needs of individuals with the needs of a health system. Video- recording can be a powerful tool for reflection and peer review.
doi:10.1186/1472-6955-12-20
PMCID: PMC3856446  PMID: 24028348
12.  Health checks on patients 75 years and over in Nottinghamshire after the new GP contract. 
BMJ : British Medical Journal  1992;305(6854):619-621.
OBJECTIVE--To investigate annual health checks for patients of 75 years and over required by the 1990 contract for general practitioners. DESIGN--Visits to practices to collect information on how assessments were organised and carried out; completion of questionnaires for every patient who had been assessed in a sample month, using information provided by the practice records. SETTING--20 general practices in one family health services authority. SUBJECTS--Patients of 75 years and over in 20 general practices. RESULTS--Three practices (15%) had not performed checks. Thirteen practices sent a letter to invite patients to undergo a check. Of these practices, seven followed up non-responders. Two practices visited patients' homes unannounced, and two did checks on an opportunistic basis only. Sixteen practices used a checklist. Sixteen practices involved their practice nurses; at eight of these, doctors also performed checks; in six practices the nurses undertaking the checks had no training in assessing old people. Ten practices assessed more than 75% of their old people in the first year of the new contract. Practices that did not follow up patients who had not responded to the invitation for assessment completed significantly fewer checks. During the sample month, 331 patients were assessed in the 17 practices. 204 new problems were discovered in 143 patients. Significantly more problems per patient were found in inner city areas. CONCLUSIONS--The way health checks were performed varied greatly, both in their organisation and the practices' attitudes. Many old people did not respond to letters asking if they wanted an assessment but very few refused one if followed up. Forty three per cent of those assessed had some unmet need. The number of new problems found per patient may reduce over the next few years if the assessments are successful. The need for annual assessment should be kept under review and adequate resources made available for the needs uncovered. Improved training for practice nurses in assessment is needed. Effectiveness of the checks must be monitored. If most unmet need falls in particular high risk groups it would seem sensible to modify the annual check to target these groups.
PMCID: PMC1883333  PMID: 1393076
13.  Validating child vaccination status in a demographic surveillance system using data from a clinical cohort study: evidence from rural South Africa 
BMC Public Health  2011;11:372.
Background
Childhood vaccination coverage can be estimated from a range of sources. This study aims to validate vaccination data from a longitudinal population-based demographic surveillance system (DSS) against data from a clinical cohort study.
Methods
The sample includes 821 children in the Vertical Transmission cohort Study (VTS), who were born between December 2001 and April 2005, and were matched to the Africa Centre DSS, in northern KwaZulu-Natal. Vaccination information in the surveillance was collected retrospectively, using standardized questionnaires during bi-annual household visits, when the child was 12 to 23 months of age. DSS vaccination information was based on extraction from a vaccination card or, if the card was not available, on maternal recall. In the VTS, vaccination data was collected at scheduled maternal and child clinic visits when a study nurse administered child vaccinations. We estimated the sensitivity of the surveillance in detecting vaccinations conducted as part of the VTS during these clinic visits.
Results
Vaccination data in matched children in the DSS was based on the vaccination card in about two-thirds of the cases and on maternal recall in about one-third. The sensitivity of the vaccination variables in the surveillance was high for all vaccines based on either information from a South African Road-to-Health (RTH) card (0.94-0.97) or maternal recall (0.94-0.98). Addition of maternal recall to the RTH card information had little effect on the sensitivity of the surveillance variable (0.95-0.97). The estimates of sensitivity did not vary significantly, when we stratified the analyses by maternal antenatal HIV status. Addition of maternal recall of vaccination status of the child to the RTH card information significantly increased the proportion of children known to be vaccinated across all vaccines in the DSS.
Conclusion
Maternal recall performs well in identifying vaccinated children aged 12-23 months (both in HIV-infected and HIV-uninfected mothers), with sensitivity similar to information extracted from vaccination cards. Information based on both maternal recall and vaccination cards should be used if the aim is to use surveillance data to identify children who received a vaccination.
doi:10.1186/1471-2458-11-372
PMCID: PMC3118246  PMID: 21605408
14.  Contraindications to progestin-only oral contraceptive pills among reproductive aged women 
Contraception  2012;86(3):199-203.
Background
Progestin-only oral contraceptive pills (POPs) have fewer contraindications to use compared to combined pills. However, the overall prevalence of contraindications to POPs among reproductive aged women has not been assessed.
Study Design
We collected information on contraindications to POPs in two studies: 1) the Self-Screening Study, a sample of 1,267 reproductive aged women in the general population in El Paso, Texas, and 2) the Prospective Study of Oral Contraceptive (OC) Users, a sample of current OC users who obtained their pills in El Paso clinics (n=532) or over the counter (OTC) in Mexican pharmacies (n=514). In the Self-Screening Study, we also compared women’s self-assessment of contraindications using a checklist to a clinician’s evaluation.
Results
Only 1.6% of women in the Self-Screening Study were identified as having at least one contraindication to POPs. The sensitivity of the checklist for identifying women with at least one contraindication was 75.0% (95% CI: 50.6–90.4%), and the specificity was 99.4% (95% CI: 98.8–99.7%). In total, 0.6% of women in the Prospective Study of OC Users reported having any contraindication to POPs. There were no significant differences between clinic and OTC users.
Conclusion
The prevalence of contraindications to POPs was very low in these samples. POPs may be the best choice for the first OTC oral contraceptive in the US.
doi:10.1016/j.contraception.2012.01.008
PMCID: PMC3368072  PMID: 22364816
oral contraceptives; contraindications; self-screening; over-the-counter status
15.  Checking it twice: an evaluation of checklists for detecting medication errors at the bedside using a chemotherapy model 
Quality & Safety in Health Care  2010;19(6):562-567.
Objective
To determine what components of a checklist contribute to effective detection of medication errors at the bedside.
Design
High-fidelity simulation study of outpatient chemotherapy administration.
Setting
Usability laboratory.
Participants
Nurses from an outpatient chemotherapy unit, who used two different checklists to identify four categories of medication administration errors.
Main outcome measures
Rates of specified types of errors related to medication administration.
Results
As few as 0% and as many as 90% of each type of error were detected. Error detection varied as a function of error type and checklist used. Specific step-by-step instructions were more effective than abstract general reminders in helping nurses to detect errors. Adding a specific instruction to check the patient's identification improved error detection in this category by 65 percentage points. Matching the sequence of items on the checklist with nurses' workflow had a positive impact on the ease of use and efficiency of the checklist.
Conclusions
Checklists designed with explicit step-by-step instructions are useful for detecting specific errors when a care provider is required to perform a long series of mechanistic tasks under a high cognitive load. Further research is needed to determine how best to assist clinicians in switching between mechanistic tasks and abstract clinical problem solving.
doi:10.1136/qshc.2009.032862
PMCID: PMC3002832  PMID: 20724398
Medication error; medication safety; checklist; double check; error detection
16.  A Checklist to Improve Patient Safety in Interventional Radiology 
Purpose
To develop a specific RADiological Patient Safety System (RADPASS) checklist for interventional radiology and to assess the effect of this checklist on health care processes of radiological interventions.
Materials and Methods
On the basis of available literature and expert opinion, a prototype checklist was developed. The checklist was adapted on the basis of observation of daily practice in a tertiary referral centre and evaluation by users. To assess the effect of RADPASS, in a series of radiological interventions, all deviations from optimal care were registered before and after implementation of the checklist. In addition, the checklist and its use were evaluated by interviewing all users.
Results
The RADPASS checklist has two parts: A (Planning and Preparation) and B (Procedure). The latter part comprises checks just before starting a procedure (B1) and checks concerning the postprocedural care immediately after completion of the procedure (B2). Two cohorts of, respectively, 94 and 101 radiological interventions were observed; the mean percentage of deviations of the optimal process per intervention decreased from 24 % before implementation to 5 % after implementation (p < 0.001). Postponements and cancellations of interventions decreased from 10 % before implementation to 0 % after implementation. Most users agreed that the checklist was user-friendly and increased patient safety awareness and efficiency.
Conclusion
The first validated patient safety checklist for interventional radiology was developed. The use of the RADPASS checklist reduced deviations from the optimal process by three quarters and was associated with less procedure postponements.
doi:10.1007/s00270-012-0395-z
PMCID: PMC3595473  PMID: 22562482
Checklist; Interventional radiology; Patient safety
17.  Surgical checklists: a systematic review of impacts and implementation 
BMJ Quality & Safety  2013;23(4):299-318.
Background
Surgical complications represent a significant cause of morbidity and mortality with the rate of major complications after inpatient surgery estimated at 3–17% in industrialised countries. The purpose of this review was to summarise experience with surgical checklist use and efficacy for improving patient safety.
Methods
A search of four databases (MEDLINE, CINAHL, EMBASE and the Cochrane Database of Controlled Trials) was conducted from 1 January 2000 to 26 October 2012. Articles describing actual use of the WHO checklist, the Surgical Patient Safety System (SURPASS) checklist, a wrong-site surgery checklist or an anaesthesia equipment checklist were eligible for inclusion (this manuscript summarises all but the anaesthesia equipment checklists, which are described in the Agency for Healthcare Research and Quality publication).
Results
We included a total of 33 studies. We report a variety of outcomes including avoidance of adverse events, facilitators and barriers to implementation. Checklists have been adopted in a wide variety of settings and represent a promising strategy for improving the culture of patient safety and perioperative care in a wide variety of settings. Surgical checklists were associated with increased detection of potential safety hazards, decreased surgical complications and improved communication among operating staff. Strategies for successful checklist implementation included enlisting institutional leaders as local champions, incorporating staff feedback for checklist adaptation and avoiding redundancies with existing systems for collecting information.
Conclusions
Surgical checklists represent a relatively simple and promising strategy for addressing surgical patient safety worldwide. Further studies are needed to evaluate to what degree checklists improve clinical outcomes and whether improvements may be more pronounced in particular settings.
doi:10.1136/bmjqs-2012-001797
PMCID: PMC3963558  PMID: 23922403
Surgery; Checklists; Patient Safety; Teamwork
18.  The WHO surgical safety checklist: survey of patients’ views 
BMJ Quality & Safety  2014;23(11):939-946.
Background
Evidence suggests that full implementation of the WHO surgical safety checklist across NHS operating theatres is still proving a challenge for many surgical teams. The aim of the current study was to assess patients’ views of the checklist, which have yet to be considered and could inform its appropriate use, and influence clinical buy-in.
Method
Postoperative patients were sampled from surgical wards at two large London teaching hospitals. Patients were shown two professionally produced videos, one demonstrating use of the WHO surgical safety checklist, and one demonstrating the equivalent periods of their operation before its introduction. Patients’ views of the checklist, its use in practice, and their involvement in safety improvement more generally were captured using a bespoke 19-item questionnaire.
Results
141 patients participated. Patients were positive towards the checklist, strongly agreeing that it would impact positively on their safety and on surgical team performance. Those worried about coming to harm in hospital were particularly supportive. Views were divided regarding hearing discussions around blood loss/airway before their procedure, supporting appropriate modifications to the tool. Patients did not feel they had a strong role to play in safety improvement more broadly.
Conclusions
It is feasible and instructive to capture patients’ views of the delivery of safety improvements like the checklist. We have demonstrated strong support for the checklist in a sample of surgical patients, presenting a challenge to those resistant to its use.
doi:10.1136/bmjqs-2013-002772
PMCID: PMC4215340  PMID: 25038036
Checklists; Patient safety; Attitudes; Quality improvement; Surgery
19.  Mutans Streptococci Colonization in Relation to Feeding Practices, Age and the Number of Teeth in 6 to 30-Month-Old Children: An in vivo Study 
ABSTRACT
Background: Early childhood caries has been characterized as first affecting the primary maxillary anterior teeth, followed by the involvement of the primary molars. Other terms for dental caries in preschool children, which inappropriately may imply cause for the disease, includes baby bottle tooth decay, nursing caries, milk bottle syndrome, baby bottle caries, nursing bottle mouth and nursing mouth.
Aim: To explore the relationships of feeding practices, age and number of teeth present with mutans streptococci colonization in infants.
Design and setting: A comparative clinical study conducted on 160 children aged from 6 to 30 months in the Department of Pedodontics and Preventive Dentistry, Bapuji Dental College and Hospital in collaboration with Child Health Institute and Research Center and Department of Oral Pathology and Microbiology, Bapuji Dental College and Hospital, Davangere.
Materials and methods: Baseline data collection included: (i) Parents of the infants were asked open ended questions about the baby feeding practices, (ii) The age of the subjects were obtained from the immunization register maintained at Child Health Institute and Research Center and were grouped into group I (6-11 months), group II (12-17 months), group III (18-23 months) and group IV (24-30 months), (iii) Clinical examination of children was done by using mouth mirror and explorer in flash light.6 For each child number and location of erupted teeth was recorded, (iv) Microbial screening for mutans streptococci involved sampling of saliva from each child was performed by placing a sterile wooden tongue blade on the dorsum of the tongue and the number of colony forming units (CFU) were recorded.
Results: According to feeding practices, 34 children were in breastfed category, 39 were in baby bottle category and 87 children reported no bottle usage. Out of 160 children examined, a total 142 children were colonized with mutans streptococci. 18 children were found to be colonized with low colony forming units, 78 children were found to be colonized with moderate colony forming units and 64 children were colonized with high colony forming units. In baby bottle group, all of 39 subjects were reported to have sweetened milk, sugar in the bottle.
Conclusion: Among different feeding practices, all the three subgroups viz breastfed children, children with nursing bottle usage and children with no bottle usage, all have shown mutans streptococci acquisition. But breastfed children have shown least number of high colony forming units, which is increased in the case of children using nursing bottle and is maximum in the children who were neither breastfed nor fed with nursing bottle. Percentage of children colonized with mutans streptococci increases with age and as the number of teeth increase, number of colony forming units were also found to be increasing.
How to cite this article: Sharma R, Prabhakar AR, Gaur A. Mutans Streptococci Colonization in Relation to Feeding Practices, Age and the Number of Teeth in 6 to 30-Month-Old Children: An in vivo Study. Int J Clin Pediatr Dent 2012;5(2): 124-131.
doi:10.5005/jp-journals-10005-1149
PMCID: PMC4148738  PMID: 25206151
Mutans streptococci; Feeding practices; Early childhood caries (ECC); Colony forming units (CFU); Saliva
20.  Acceptance of the WHO Surgical Safety Checklist among surgical personnel in hospitals in Guatemala city 
Background
Studies have highlighted the effects the use of the WHO Surgical Safety Checklist can have on lowering mortality and surgical complications. Implementation of the checklist is not easy and several barriers have been identified. Few studies have addressed personnel’s acceptance and attitudes toward the WHO Surgical Safety Checklist. Determining personnel’s acceptance might reflect their intention to use the checklist while their awareness and knowledge of the checklist might assess the effectiveness of the training process.
Methods
Through an anonymous self- responded questionnaire, general characteristics of the respondents (age, gender, profession and years spent studying or working at the hospital), knowledge of the WHO Surgical Safety Checklist (awareness of existence, knowledge of objectives, knowledge of correct use), acceptance of the checklist and its implementation (including personal belief of benefits of using the checklist), current use, teamwork and safety climate appreciation were determined.
Results
Of the 147 surgical personnel who answered the questionnaire, 93.8% were aware of the existence of the WHO Surgical Safety Checklist and 88.8% of them reported knowing its objectives. More nurses than other personnel knew the checklist had to be used before the induction of anesthesia, skin incision, and before the patient leaves the operating room. Most personnel thought using the WHO Surgical Safety Checklist is beneficial and that its implementation was a good decision. Between 73.7% and 100% of nurses in public and private hospitals, respectively, reported the checklist had been used either always or almost always in the general elective surgeries they had participated in during the current year.
Conclusions
Despite high acceptance of the checklist among personnel, gaps in knowledge about when the checklist should be used still exist. This can jeopardize effective implementation and correct use of the checklist in hospitals in Guatemala City. Efforts should aim to universal awareness and complete knowledge on why and how the checklist should be used.
doi:10.1186/1472-6963-12-169
PMCID: PMC3444374  PMID: 22721269
21.  More Evidence on the Impact of India's Conditional Cash Transfer Program, Janani Suraksha Yojana: Quasi-Experimental Evaluation of the Effects on Childhood Immunization and Other Reproductive and Child Health Outcomes 
PLoS ONE  2014;9(10):e109311.
Background
In 2005, India established a conditional cash transfer program called Janani Suraksha Yojana (JSY), to increase institutional delivery and encourage the use of reproductive and child health-related services.
Objective
To assess the effect of maternal receipt of financial assistance from JSY on childhood immunizations, post-partum care, breastfeeding practices, and care-seeking behaviors.
Methods
We use data from the latest district-level household survey (2007–2008) to conduct a propensity score matching analysis with logistic regression. We conduct the analyses at the national level as well as separately across groups of states classified as high-focus and non-high-focus. We carry out several sensitivity analyses including a subgroup analysis stratified by possession of an immunization card.
Results
Receipt of financial assistance from JSY led to an increase in immunization rates ranging from 3.1 (95%CI 2.2–4.0) percentage points for one dose of polio vaccine to 9.1 (95%CI 7.5–10.7) percentage points in the proportion of fully vaccinated children. Our findings also indicate JSY led to increased post-partum check-up rates and healthy early breastfeeding practices around the time of childbirth. No effect of JSY was found on exclusive breastfeeding practices and care-seeking behaviors. Effect sizes were consistently larger in states identified as being a key focus for the program. In an analysis stratified by possession of an immunization card, there was little to no effect of JSY among those with vaccination cards, while the effect size was much larger than the base case results for those missing vaccination cards, across nearly all immunization outcomes.
Conclusions
Early results suggest the JSY program led to a significant increase in childhood immunization rates and some healthy reproductive health behaviors, but the structuring of financial incentives to pregnant women and health workers warrants further review. Causal interpretation of our results relies on the assumption that propensity scores balance unobservable characteristics.
doi:10.1371/journal.pone.0109311
PMCID: PMC4193776  PMID: 25303078
22.  The Safety of Adult Male Circumcision in HIV-Infected and Uninfected Men in Rakai, Uganda 
PLoS Medicine  2008;5(6):e116.
Background
The objective of the study was to compare rates of adverse events (AEs) related to male circumcision (MC) in HIV-positive and HIV-negative men in order to provide guidance for MC programs that may provide services to HIV-infected and uninfected men.
Methods and Findings
A total of 2,326 HIV-negative and 420 HIV-positive men (World Health Organization [WHO] stage I or II and CD4 counts > 350 cells/mm3) were circumcised in two separate but procedurally identical trials of MC for HIV and/or sexually transmitted infection prevention in rural Rakai, Uganda. Participants were followed at 1–2 d and 5–9 d, and at 4–6 wk, to assess surgery-related AEs, wound healing, and resumption of intercourse. AE risks and wound healing were compared in HIV-positive and HIV-negative men. Adjusted odds ratios (AdjORs) were estimated by multiple logistic regression, adjusting for baseline characteristics and postoperative resumption of sex. At enrollment, HIV-positive men were older, more likely to be married, reported more sexual partners, less condom use, and higher rates of sexually transmitted disease symptoms than HIV-negative men. Risks of moderate or severe AEs were 3.1/100 and 3.5/100 in HIV-positive and HIV-negative participants, respectively (AdjOR 0.91, 95% confidence interval [CI] 0.47–1.74). Infections were the most common AEs (2.6/100 in HIV-positive versus 3.0/100 in HIV-negative men). Risks of other complications were similar in the two groups. The proportion with completed healing by 6 wk postsurgery was 92.7% in HIV-positive men and 95.8% in HIV-negative men (p = 0.007). AEs were more common in men who resumed intercourse before wound healing compared to those who waited (AdjOR 1.56, 95% CI 1.05–2.33).
Conclusions
Overall, the safety of MC was comparable in asymptomatic HIV-positive and HIV-negative men, although healing was somewhat slower among the HIV infected. All men should be strongly counseled to refrain from intercourse until full wound healing is achieved.
Trial registration: http://www.ClinicalTrials.gov; for HIV-negative men, #NCT00047073 and for HIV-positive men, #NCT00047073.
Ron Gray and colleagues report on complications of circumcision in HIV-infected and HIV-uninfected men from two related trials in Uganda, finding increased risk with intercourse before wound healing.
Editors' Summary
Background
Worldwide over 33 million people are thought to be living with HIV, and in the absence of a vaccine, preventing its spread is a major health issue. The World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) estimate that 68% of 2.5 million new infections worldwide in 2007 took place in sub-Saharan Africa, where 76% of 2.1 million AIDS-related deaths also took place.
One of the principal means of person-to-person transmission of HIV is through sex without the protection of a condom. In parts of Africa, male circumcision is performed in infancy or childhood for religious or cultural reasons or is a traditional rite of passage that marks the transition from child to man. Three trials, in South Africa, Kenya, and Uganda, each found that circumcised men were around half as likely as uncircumcised men to contract HIV from HIV-positive female partners. After reviewing the results, WHO and UNAIDS issued joint advice that male circumcision should be promoted for preventing HIV infection in heterosexual men. As male circumcision does not provide complete protection against HIV infection, they advised that it should be promoted in addition to existing strategies of promoting condom use, abstinence, and a reduction in the number of sexual partners.
Why Was This Study Done?
Although earlier studies had shown that adult male circumcision, when performed in Africa under optimal conditions, is a safe procedure for HIV-negative men, it was not known whether it would also be a safe procedure for HIV-positive men. WHO guidelines recommend that HIV-positive men who request the procedure or have a medical need and no contraindications for it should be circumcised. Also, exclusion of HIV-positive men from circumcision programs may result in stigmatization of these men, and discourage participation by men who do not wish to be tested for HIV. Therefore, it is important to know whether the procedure is safe for HIV-positive men.
What Did the Researchers Do and Find?
The authors compared results from two separate clinical trials carried out with identical procedures in rural Rakai, Uganda. The first, which compared the effect of circumcision with no circumcision in HIV-negative men, was one of the three trials that persuaded the WHO and UNAIDS to promote male circumcision as an HIV prevention strategy. The second Rakai trial did the same comparison but in men who were HIV positive and without symptoms. In this present study, the authors used data from both trials to compare the likelihood of surgery-related complications following circumcision for HIV-negative and HIV-positive men.
The trials recruited men aged 15–49, who were randomly assigned to be circumcised either on enrollment or two years later and were followed up to monitor complications related to the procedure, such as infections, as well as wound healing and when the participant first had sex after the operation. Condom use was recorded at enrollment and six months after enrollment.
The researchers found that most complications were infrequent, mild, and comparable in both groups, with moderate-to-severe complications occurring in only 3%–4% of men in each group. However, delayed wound healing was more frequent in HIV-positive men. Complications were more likely among men who had sex before healing was complete; such men were more likely to be HIV-positive and/or married. Similarly, moderate or severe complications were more likely where men had symptoms of sexually transmitted disease at enrollment, although these were treated before surgery, and these men were more likely to be HIV-positive. Six months after enrollment, similar proportions of HIV-positive and HIV-negative men used condoms consistently, but HIV-positive men were more likely to report using condoms inconsistently than HIV-negative men. However, consistent use of a condom increased among the HIV-positive men compared to when they enrolled.
What Do these Findings Mean?
Circumcision in HIV-positive men without symptoms of AIDS has a low rate of complications, although healing is slower than in HIV-negative men. Because of the greater risk of complications if sex is resumed before full healing, both men and their women partners should be advised to have no sex for at least six weeks after the operation. A separately reported analysis from one of these studies found that women partners are more likely to become HIV infected by HIV-positive men who resume sex prior to complete wound healing. Therefore, for protection of both men and their female partners, it is essential to refrain from intercourse after circumcision until the wound has completely healed.
Because the study found no increased risk of surgical complications in HIV-positive men who undergo circumcision, it should not be necessary to screen men with no symptoms of HIV in future circumcision programs. This should reduce the complexity of implementing such programs and reduce any stigma resulting from exclusion, making it likely that more men will be willing to be circumcised. The rise in consistent condom use among HIV-positive men suggests that messages of safe sex are reaching an important target group and changing their behavior, and that circumcision does not make men less likely to use a condom.
The authors also noted that the rates of complications they observed were low compared with those following traditional circumcision procedures. Others have found that circumcision carried out under unsafe conditions has a high rate of complications. The authors of this study comment that the resources and standards of surgery during the trial represented best practice and that to attain similarly low rates of complications—and the confidence of men in the safety of the procedure—there is a need to ensure sufficient resources and high standards of training.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050116.
WHO and the UNAIDS issued a joint report recommending male circumcision for HIV prevention and another on the HIV epidemic worldwide in December 2007
An information pack here on male circumcision and HIV prevention has also been developed jointly by WHO/UNAIDS, the United Nations International Children's Emergency Fund (UNICEF), the United Nations Population Fund (UNFPA), and the World Bank
The University of California San Francisco's HIV InSite provides information on HIV prevention, treatment, and policy
AEGIS is the world's largest searchable database on HIV and AIDS
The National AIDS Trust provides information on HIV prevention
doi:10.1371/journal.pmed.0050116
PMCID: PMC2408615  PMID: 18532873
23.  Laboratory Pre-Participation Screening Examination in a Chiropractic College 
Introduction:
Chiropractic students often serve as subjects in laboratories where they and their classmates practice examinations, various soft tissue techniques, physiological therapeutic modalities, and active rehabilitation. There are contraindications and risks associated with these procedures. This article describes how a procedure was developed to identify potential health concerns and risks that students may face while serving as subjects or performing procedures in clinical skills laboratories.
Methods:
Screening questions and examination procedures were developed through a consensus process. Findings from the screening process determine whether students may engage in full participation or limited participation (precautions) or are prohibited from receiving certain procedures (contraindications). Skills laboratory students and their instructors are informed of any identifiable precautions or contraindications to participation.
Results:
Since its implementation, precautions regarding delivery of manual therapies were found in 4% of those examined and precautions regarding receiving manual therapies in 11.5%. Contraindications to receiving specified manual therapies were found in 8%, and 4% had contraindications to certain physiological therapeutic modalities.
Discussion:
Further work is necessary to improve compliance with follow-up regarding diagnosis of conditions revealed or suspected. Future efforts should address how well students adhered to precautions and contraindications, the nature and frequency of injuries sustained within the laboratories, and what specific measures were taken by faculty to help students with special needs.
Conclusion:
This chiropractic college now has a method to describe potential risks, explain rules of laboratory participation, and obtain consent from each student.
PMCID: PMC3113620  PMID: 21677869
Chiropractic Contraindications; Chiropractic Education; Informed Consent
24.  SMARTS (Systematic Monitoring of Adverse events Related to TreatmentS): The development of a pragmatic patient-completed checklist to assess antipsychotic drug side effects 
Objectives:
Antipsychotic drug side effects are common and can cause stigmatisation, decreased quality of life, poor adherence, and secondary morbidity and mortality. Systematic assessment of anticipated side effects is recommended as part of good clinical care, but is uncommon in practice and patients may not spontaneously report side effects. We aimed to develop a simple patient-completed checklist to screen systematically for potential antipsychotic side effects.
Methods:
The SMARTS checklist was developed over a series of group meetings by an international faculty of 12 experts (including psychiatrists, a general physician and a psychopharmacologist) based on their clinical experience and knowledge of the literature. The emphasis is on tolerability (i.e. assessment of side effects that ‘trouble’ the patient) as subjective impact of side effects is most relevant to medication adherence. The development took account of feedback from practising psychiatrists in Europe, the Middle East and Africa, a process that contributed to face validity.
Results:
The SMARTS checklist assesses whether patients are currently ‘troubled’ by 11 well-established potential antipsychotic side effects. Patients provide their responses to these questions by circling relevant side effects. An additional open question enquires about any other possible side effects. The checklist has been translated into Italian and Turkish.
Conclusions:
The SMARTS checklist aims to strike a balance between brevity and capturing the most common and important antipsychotic side effects. It is appropriate for completion by patients prior to a clinical consultation, for example, in the waiting room. It can then form the focus for a more detailed clinical discussion about side effects. It can be used alone or form part of a more comprehensive assessment of antipsychotic side effects including blood tests and a physical examination when appropriate. The checklist assesses current problems and can be used longitudinally to assess change.
doi:10.1177/2045125313510195
PMCID: PMC3896136  PMID: 24490026
antipsychotics; checklist; rating scale; side effects; tolerability
25.  Decisions to treat or not to treat pneumonia in demented psychogeriatric nursing home patients: development of a guideline 
Journal of Medical Ethics  2000;26(2):114-120.
Non-treatment decisions concerning demented patients are complex: in addition to issues concerning the health of patients, ethical and legal issues are involved. This paper describes a method for the development of a guideline that clarifies the steps to be taken in the decision making process whether to forgo curative treatment of pneumonia in psychogeriatric nursing home patients.
The method of development consisted of seven steps. Step 1 was a literature study from which ethical, juridical and medical factors concerning the patient's health and prognosis were identified. In step 2, a questionnaire was sent to 26 nursing home physicians to determine the relative importance of these factors in clinical practice. In a meeting of nine experienced physicians (step 3), the factors identified in step 2 were confirmed by most of these professionals. To prevent the final guideline being too directive, a concept guideline that included ethical and legal aspects was designed in the form of a "checklist of considerations" (step 4). Experts in the fields of nursing home medicine, ethics and law reviewed and commented on the concept guideline (step 5). The accordingly adapted "checklist of considerations" was tested in a pilot study (step 6), after which all experts endorsed the checklist (step 7).
The resulting "checklist of considerations" structures the decision making process according to three primary domains: medical aspects, patient's autonomy, and patient's best interest (see annex at end of paper).
Key Words: Decision making • medical futility • patient advocacy • pneumonia • practice guidelines • nursing homes
doi:10.1136/jme.26.2.114
PMCID: PMC1733182  PMID: 10786322

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