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1.  Lessons Learned From Managing a Prospective, Private Practice Joint Replacement Registry: A 25-year Experience 
Background
In 1984, we developed a private practice joint replacement registry (JRR) to prospectively follow patients undergoing THA and TKA to assess clinical and radiographic outcomes, complications, and implant survival. Little has been reported in the literature regarding management of this type of database, and it is unclear whether and how the information can be useful for addressing longer-term questions.
Questions/purposes
We answered the following questions: (1) What is the rate of followup for THA and TKA in our JRR? (2) What factors affect followup? (3) How successful is this JRR model in capturing data and what areas of improvement are identified? And (4) what costs are associated with maintaining this JRR?
Methods
We collected clinical data on all 12,047 patients having primary THA and TKA since 1984. Clinical and radiographic data were collected at routine followup intervals and entered into a prospective database. We searched this database to assess the rate of successful followup and data collection and to compare the effect of patient variables on followup. Costs related to database management were evaluated.
Results
Followup was poor at every time interval after surgery, with a tendency for worsening over time. Patients with a complication and those younger than 70 years tended to followup with greater frequency. There were difficulties with data capture and substantial expenses related to managing the database.
Conclusions
Our findings highlight the difficulties in managing a JRR. Followup is poor and data collection is often incomplete. Newer technologies that allow easier tracking of patients and facilitate data capture may streamline this process and control costs.
Electronic supplementary material
The online version of this article (doi:10.1007/s11999-012-2541-y) contains supplementary material, which is available to authorized users.
doi:10.1007/s11999-012-2541-y
PMCID: PMC3549191  PMID: 22948525
2.  Clinical outcomes of patients with isolated femoral shaft fractures treated with S.I.G.N interlock nails versus Cannulated Interlock Intramedullary nails 
Journal of Orthopaedics  2013;10(4):182-187.
Objective
The S.I.G.N (Surgical Implant Generation Network Inc.) solid intramedullary nail is originally designed for tibial shaft fractures and is currently being used for femoral shaft fractures as an extended use. The nail is used in developing nations such as the Philippines, as an alternative for those who could not afford the commercially available nails. The main objective of the study is to determine whether there is a difference in clinical outcomes of patients with isolated femoral shaft fractures in Philippine General Hospital, treated with S.I.G.N intramedullary nails versus Cannulated intramedullary nails, from year 2007 to 2012.
Population
A total of 175 patients fulfilled the inclusion criteria based from reviews of censuses, in-patient and OPD charts of the trauma section of the Department of Orthopedics, Philippine General Hospital. The Surgical Implant Generation Network (S.I.G.N) Fracture Care On-line Database was also screened for patients to be included in the study. A total of 68 patients were able to follow-up, with 48 patients in the S.I.G.N group and 20 patients for the Cannulated group.
Main outcome measures
The dependent variables of the study are radiographic and clinical union, knee range of motion, weight bearing status, and complications.
Results
The subjects were divided into patients operated with S.I.G.N nails and with Cannulated Interlock Intramedullary nails. For the S.I.G.N group, the mean age is 32.1 years and mean follow-up is 40.75 weeks post-op. The Cannulated group has a mean age of 27.9 years and mean follow-up of 35.85 weeks post-op. Radiographic union rate for the S.I.G.N group is 68.8% while for the Cannulated group is 80%. Clinical union and full weight bearing status of patients are 100% in both groups. There is no significant difference with the number of patients with full range of motion in both groups: (S.I.G.N: 85%; Cannulated: 90%). Complication rates are also non-significant (S.I.G.N: 12.5%; Cannulated: 5%).
Conclusions
There is no significant difference between patients with isolated femoral shaft fractures treated with S.I.G.N. Interlock Intramedullary nail versus Cannulated Interlock Intramedullary nail in terms of Clinical and radiographic union, weight bearing, knee range of motion and complication rate.
doi:10.1016/j.jor.2013.09.003
PMCID: PMC3849246  PMID: 24396239
Femur fractures; SIGN nails; Cannulated nails
3.  Injuries in Developing Countries—How Can We Help?: The Role of Orthopaedic Surgeons 
Each year nearly 5 million people worldwide die from injuries, approximately the number of deaths caused by HIV/AIDS, malaria, and tuberculosis combined. Ninety percent of these injuries occur in developing countries and that number is growing. Road traffic accidents account for 1.2 million of these 5 million deaths. For each death from trauma, three to eight more are permanently disabled. Orthopaedic surgeons should consider the victims of this epidemic by using their ability and capacity to treat these injuries. SIGN (Surgical Implant Generation Network, Richland, WA, USA) builds local surgical capability in developing countries by providing training and equipment to surgeons for use in treating the poor. It assists in treating long-bone fractures by using an intramedullary nail interlocking screw system. C-arm imaging, unavailable in many of these hospitals, is not necessary to accomplish interlocking. Surgery is performed primarily by local surgeons who record their cases on the SIGN surgical database. Discussion of these reports provides a means of communication and education among surgeons. This database demonstrates the capability of these surgeons. It also demonstrates that the SIGN intramedullary nail is safe for use in the developing world as it has been successful in treating 36,000 trauma patients.
doi:10.1007/s11999-008-0387-0
PMCID: PMC2584284  PMID: 18685912
4.  Steppingstones to the implementation of an inhospital fracture and dislocation registry using the AO/OTA classification: compliance, completeness and commitment 
Background
Musculoskeletal trauma represents a considerable global health burden, however reliable population-based incidence data are scarce. A fracture and dislocation registry was established within a well-defined population. An audit of the establishment process, feasibility of the registry work and report of the collected data is given.
Methods
Demographic data, fracture type and location, mode of treatment, and the reasons for the secondary procedures were collected and scored using recognized systems, such as the AO/OTA classification and the Gustilo-Anderson classification for open fractures. The reporting was done in the operation planning program by the involved orthopaedic surgeon. Both inpatient and day-case procedures were collected. Data were collected prospectively from 2006 until 2010. Compliance among the surgeons and completeness and accuracy of the data was continuously assured by an orthopaedic surgeon.
Results
During the study period, 39 orthopaedic surgeons were involved in the recording of a total of 8,188 procedures, consisting of primary treatment of 4,986 long bone fractures, 467 non long bone fractures, 123 dislocations and 2,612 secondary treatments. In the study period 532 fractures or dislocations were treated at least once for one or more serious complications. For the index year of 2009, a total of 5710 fractures or dislocations were treated in the emergency department or hospitalized, of which the 1594 (28%) were treated at the inpatient or day-case operation rooms, thus registered in the FDR. Quality assurance, educational incentives and continuous feedback between coders and controller in the integrated electronic system are available and used through the features of the electronic database.
Conclusions
Implementing an integrated registry of fractures and dislocations with the electronic hospital system has been possible despite several users involved. The electronic system and the data controller provide for completeness and validity. The FDR has become an indispensable tool for the department for planning and education and will serve as a prerequisite for the conduct and execution of future prospective trials within the department. Further, other departments with similar electronic patient files may fairly easily adopt this system for implementation.
doi:10.1186/1757-7241-18-54
PMCID: PMC2976727  PMID: 20955572
5.  Road Trauma in Teenage Male Youth with Childhood Disruptive Behavior Disorders: A Population Based Analysis 
PLoS Medicine  2010;7(11):e1000369.
Donald Redelmeier and colleagues conducted a population-based case-control study of 16-19-year-old males hospitalized for road trauma or appendicitis and showed that disruptive behavior disorders explained a significant amount of road trauma in this group.
Background
Teenage male drivers contribute to a large number of serious road crashes despite low rates of driving and excellent physical health. We examined the amount of road trauma involving teenage male youth that might be explained by prior disruptive behavior disorders (attention deficit hyperactivity disorder, conduct disorder, oppositional defiant disorder).
Methods and Findings
We conducted a population-based case-control study of consecutive male youth between age 16 and 19 years hospitalized for road trauma (cases) or appendicitis (controls) in Ontario, Canada over 7 years (April 1, 2002 through March 31, 2009). Using universal health care databases, we identified prior psychiatric diagnoses for each individual during the decade before admission. Overall, a total of 3,421 patients were admitted for road trauma (cases) and 3,812 for appendicitis (controls). A history of disruptive behavior disorders was significantly more frequent among trauma patients than controls (767 of 3,421 versus 664 of 3,812), equal to a one-third increase in the relative risk of road trauma (odds ratio  =  1.37, 95% confidence interval 1.22–1.54, p<0.001). The risk was evident over a range of settings and after adjustment for measured confounders (odds ratio 1.38, 95% confidence interval 1.21–1.56, p<0.001). The risk explained about one-in-20 crashes, was apparent years before the event, extended to those who died, and persisted among those involved as pedestrians.
Conclusions
Disruptive behavior disorders explain a significant amount of road trauma in teenage male youth. Programs addressing such disorders should be considered to prevent injuries.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In the latest World Health Organization (WHO) global burden of disease list, road traffic crashes are currently ranked eighth but are predicted to take fourth place by 2030 (by which time, road traffic deaths are likely to increase by more than 80% in developing countries and to decrease by nearly 30% in industrialized countries.) Every year, road traffic crashes kill an estimated 1.2 million people world-wide and injure or disable a further 20–60 million. Furthermore, the economic consequences of road traffic crashes account for about 2% of the gross national product of the entire global economy.
90% of road traffic deaths occur in developing countries where pedestrians, cyclists, and users of two-wheel vehicles (scooters, motorbikes) are the most vulnerable. In industrialized countries, teenage male drivers are the single most risky demographic group, with an incidence of road traffic crashes of twice that of the population average. Also, male teenagers are sometimes a hazard to other road users and contribute to more fatalities in older pedestrians than older drivers. Furthermore, teenage male drivers involved in serious crashes can have ongoing health care needs but are often resistant to standard road safety advice.
Why Was This Study Done?
Previous studies have suggested that disruptive behavior disorders might contribute to the risk of road traffic crashes in male teenagers but methodological problems with these studies make these results unclear. Given the importance of this topic, authorities have called for more research into the full range of behavioral disorders and relevant populations. This study attempted to avoid the methodological problems of previous studies and to rigorously assess whether disruptive behavior disorders predispose male teenagers to road traffic crashes.
What Did the Researchers Do and Find?
The researchers conducted a 7-year population-based case-control study in Ontario, Canada of consecutive male teenagers aged between 16 and 19 years who were admitted to a hospital due to a road traffic crash, including those who were pedestrians. For the controls, the researchers used consecutive males in the same age range who were admitted to the same hospitals during the same time interval for acute appendicitis (which is common and generally unrelated to traumatic injury). For each participant in the study, the authors used universal health care databases in Canada's single-payer health care system to identify relevant psychiatric diagnoses (attention deficit hyperactivity disorder, conduct disorder, and oppositional defiant disorder) during the decade before admission.
During the study period, 3,421 male teenagers were admitted to hospital as the result of a road traffic crash and 3,812 male teenagers were admitted to hospital for appendicitis. A history of disruptive behavior disorders was significantly more frequent among male teenagers admitted for road traffic crashes than controls (767 of 3,421 versus 664 of 3,812) giving an odds ratio 1.37. This higher risk was still present after the researchers adjusted for possible confounding factors (such as age, social status, and home location) and accounted for about one-in-20 road traffic crashes, including male teenagers who had died and those involved as pedestrians.
What Do These Findings Mean?
The results of this study suggest that disruptive behavior disorders explain a significant amount of road traffic crashes experienced in male teenagers. Overall, attention deficit hyperactivity disorder, conduct disorder, and oppositional defiant disorder are associated with about a one-third increase in the risk of a road traffic crash (which is similar to the relative risk among individuals treated for epilepsy.) As in previous studies in this area, some methodological problems may affect the interpretation of these findings. As this study did not document who was “at fault,” an alternative interpretation might be that behavioral disorders impair a teenager's ability to avoid a mishap initiated by someone else. Most importantly, the observed increase in risk as pedestrians indicates that male teenagers who abstain from driving do not escape the danger of road traffic crashes.
The researchers stress that any increased risk of road traffic crashes associated with disruptive behavior disorders in male teenagers does not justify withholding a driver's license, especially as many such disorders can be effectively treated or, indeed, because it does not address the issue of the increased risk for those teenagers who were pedestrians. Instead, they suggest that disruptive behavior disorders could be considered as contributors to road traffic crashes—analogous to seizure disorders and some other medical diseases. Therefore, greater attention by primary care physicians, psychiatrists, and community health workers might be helpful since interventions can perhaps reduce the risk including medical treatments and avoidance of distractions.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000369.
The World Health Organization has information on road traffic crashes
The US National Institutes of Health has information about behavior disorders in children as well as UK-based Kids Development
The Ontarion Ministry of Transportation has information on annual roadway collisions in Ontario
doi:10.1371/journal.pmed.1000369
PMCID: PMC2981585  PMID: 21125017
6.  Electronic Data Capture for Registries and Clinical Trials in Orthopaedic Surgery: Open Source versus Commercial Systems 
Background
Collection and analysis of clinical data can help orthopaedic surgeons to practice evidence based medicine. Spreadsheets and offline relational databases are prevalent, but not flexible, secure, workflow friendly and do not support the generation of standardized and interoperable data. Additionally these data collection applications usually do not follow a structured and planned approach which may result in failure to achieve the intended goal.
Questions/purposes
Our purposes are (1) to provide a brief overview of EDC systems, their types, and related pros and cons as well as to describe commonly used EDC platforms and their features; and (2) describe simple steps involved in designing a registry/clinical study in DADOS P, an open source EDC system.
Where are we now?
Electronic data capture systems aimed at addressing these issues are widely being adopted at an institutional/national/international level but are lacking at an individual level. A wide array of features, relative pros and cons and different business models cause confusion and indecision among orthopaedic surgeons interested in implementing EDC systems.
Where do we need to go?
To answer clinical questions and actively participate in clinical studies, orthopaedic surgeons should collect data in parallel to their clinical activities. Adopting a simple, user-friendly, and robust EDC system can facilitate the data collection process.
How do we get there?
Conducting a balanced evaluation of available options and comparing them with intended goals and requirements can help orthopaedic surgeons to make an informed choice.
Electronic supplementary material
The online version of this article (doi:10.1007/s11999-010-1469-3) contains supplementary material, which is available to authorized users.
doi:10.1007/s11999-010-1469-3
PMCID: PMC3049639  PMID: 20635174
7.  Acute management and outcome of multiple trauma patients with pelvic disruptions 
Critical Care  2012;16(4):R163.
Introduction
Data on prehospital and trauma-room fluid management of multiple trauma patients with pelvic disruptions are rarely reported. Present trauma algorithms recommend early hemorrhage control and massive fluid resuscitation. By matching the German Pelvic Injury Register (PIR) with the TraumaRegister DGU (TR) for the first time, we attempt to assess the initial fluid management for different Tile/OTA types of pelvic-ring fractures. Special attention was given to the patient's posttraumatic course, particularly intensive care unit (ICU) data and patient outcome.
Methods
A specific match code was applied to identify certain patients with pelvic disruptions from both PIR and TR anonymous trauma databases, admitted between 2004 and 2009. From the resulting intersection set, a retrospective analysis was done of prehospital and trauma-room data, length of ICU stay, days of ventilation, incidence of multiple organ dysfunction syndrome (MODS), sepsis, and mortality.
Results
In total, 402 patients were identified. Mean ISS was 25.9 points, and the mean of patients with ISS ≥16 was 85.6%. The fracture distribution was as follows: 19.7% type A, 29.4% type B, 36.6% type C, and 14.3% isolated acetabular and/or sacrum fractures. The type B/C, compared with type A fractures, were related to constantly worse vital signs that necessitated a higher volume of fluid and blood administration in the prehospital and/or the trauma-room setting. This group of B/C fractures were also related to a significantly higher presence of concomitant injuries and related to increased ISS. This was related to increased ventilation and ICU stay, increased rate of MODS, sepsis, and increased rate of mortality, at least for the type C fractures. Approximately 80% of the dead had sustained type B/C fractures.
Conclusions
The present study confirms the actuality of traditional trauma algorithms with initial massive fluid resuscitation in the recent therapy of multiple trauma patients with pelvic disruptions. Low-volume resuscitation seems not yet to be accepted in practice in managing this special patient entity. Mechanically unstable pelvic-ring fractures type B/C (according to the Tile/OTA classification) form a distinct entity that must be considered notably in future trauma algorithms.
doi:10.1186/cc11487
PMCID: PMC3580753  PMID: 22913820
8.  Trauma Care in Germany: An Inclusive System 
Background
Development of trauma systems is a demanding process. The United States and Germany both have sophisticated trauma systems. This manuscript is a summary of political, economic, and medical changes that have led to the development of both trauma systems and the current high-quality standards.
Questions/purposes
We specifically asked three questions: (1) What tasks are involved in developing a modern trauma system? (2) What is the approach to achieve this task? (3) Do these systems work?
Methods
We conducted a systematic review of relevant articles by searching electronic databases (PubMed, Embase, Cochrane library) using the following search terms: “trauma system”, “polytrauma”, “trauma networks”, and “trauma registry”. Of 2573 retrieved manuscripts, the authors made a personal selection of studies. A personal study selection from our experiences was added when their contribution to the topic was judged important.
Results
Worldwide, similar tasks concerning trauma care have to be addressed. In most societies, traffic accidents and firearm-related injuries contribute to a high number of trauma victims. The German approach has been to decrease the number of accidents through injury prevention and to provide better care by establishing an emergency medical system. For in-hospital treatment, clinical care has constantly improved and a close interaction with members from the American Association for the Surgery of Trauma and the Orthopaedic Trauma Association has helped a great deal to achieve these improvements. The German healthcare system was developed as a powerful healthcare tool covering patients from injury to rehabilitation. In addition, trauma and injury research has been strengthened to deal with various questions of trauma care.
Conclusions
Organized injury prevention programs and systematized professional patient care can address the issues associated with the global burden of trauma. These trauma systems require constant monitoring and improvement.
doi:10.1007/s11999-013-2967-x
PMCID: PMC3734420  PMID: 23633181
9.  Epidemiological Trends of Spine Trauma: An Australian Level 1 Trauma Centre Study 
Global Spine Journal  2013;3(2):75-84.
Knowledge of current epidemiology and spine trauma trends assists in public resource allocation, fine-tuning of primary prevention methods, and benchmarking purposes. Data on all patients with traumatic spine injuries admitted to the Alfred Hospital, Melbourne between May 1, 2009, and January 1, 2011, were collected from the Alfred Trauma Registry, Alfred Health medical database, and Victorian Orthopaedic Trauma Outcomes Registry. Epidemiological trends were analyzed as a general cohort, with comparison cohorts of nonsurvivors versus survivors and elderly versus nonelderly. Linear regression analysis was utilized to demonstrate trends with statistical significance. There were 965 patients with traumatic spine injuries with 2,333 spine trauma levels. The general cohort showed a trimodal age distribution, male-to-female ratio of 2:2, motor vehicle accidents as the primary spine trauma mechanism, 47.7% patients with severe polytrauma as graded using the Injury Severity Score (ISS), 17.3% with traumatic brain injury (TBI), the majority of patients with one spine injury level, 7% neurological deficit rate, 12.8% spine trauma operative rate, and 5.2% mortality rate. Variables with statistical significance trending toward mortality were the elderly, motor vehicle occupants, severe ISS, TBI, C1–2 dissociations, and American Spinal Injury Association (ASIA) A, B, and C neurological grades. Variables with statistical significance trending toward the elderly were females; low falls; one spine injury level; type 2 odontoid fractures; subaxial cervical spine distraction injuries; ASIA A, B, and C neurological grades; and patients without neurological deficits. Of the general cohort, 50.3% of spine trauma survivors were discharged home, and 48.1% were discharged to rehabilitation facilities. This study provides baseline spine trauma epidemiological data. The trimodal age distribution of patients with traumatic spine injuries calls for further studies and intervention targeted toward the 46- to 55-year age group as this group represents the main providers of financial and social security. The study's unique feature of delineating variables with statistical significance trending toward both mortality and the elderly also provides useful data to guide future research studies, benchmarking, public health policy, and efficient resource allocation for the management of spine trauma.
doi:10.1055/s-0033-1337124
PMCID: PMC3854579  PMID: 24436855
spine trauma; epidemiology; demographics; spinal injury characteristics; neurological status; registry; prevention
10.  Presentation and outcome of traumatic spinal fractures 
Background:
Motor vehicle crashes and falls account for most of the spine fractures with subsequent serious disability.
Aim:
To define the incidence, causes, and outcome of spinal fractures.
Materials and Methods:
Data were collected retrospectively from trauma registry database of all traumatic spinal injuries admitted to the section of trauma surgery in Qatar from November 2007 to December 2009.
Results:
Among 3712 patients who were admitted to the section of trauma surgery, 442 (12%) injured patients had spinal fractures with a mean age of 33.2 ± 12 years. The male to female ratio was 11.6:1. Motor vehicle crashes (36.5%) and falls from height (19.3%) were the leading causes of cervical injury (P = 0.001). The injury severity score ranged between 4 and 75. Nineteen percent of cases with cervical injury had thoracic injury as well (P = 0.04). Lumber injury was associated with thoracic injury in 27% of cases (P < 0.001). Combined thoracic and lumber injuries were associated with cervical injury in 33% of cases (P < 0.001). The total percent of injuries associated with neurological deficit was 5.4%. Fifty-three cases were managed surgically for spine fractures; 14 of them had associated neurological deficits. Overall mortalityrate was 5%.
Conclusions:
Spine fractures are not uncommon in Qatar. Cervical and thoracic spine injuries carry the highest incidence of associated neurological deficit and injuries at other spinal levels. Young males are the most exposed population that deserves more emphasis on injury prevention programs in the working sites and in enforcement of traffic laws.
doi:10.4103/0974-2700.102381
PMCID: PMC3519044  PMID: 23248500
Cord injury; fracture; spine; trauma; Qatar
11.  TRAUMA IN TANZANIA: Researching Injury in a low-Resource Setting  
The prevalence of surgical trauma as a global public health hazard has been severely neglected. Trauma surgeons in Uganda and Canada have developed the Kampala Trauma Score (KTS), a trauma severity index specific to east African contexts. Hospitals in Tanzania have begun to use this tool to measure their own trauma management protocols in order to measure the validity of this index regionally. This study sought to enhance analysis of data collected through the KTS, by highlighting the efficacy and the lacunae of this registry through evaluation of the data quality of one ongoing round of data collection at an orthopaedic emergency room in Dar es Salaam, Tanzania. The data was screened for missing values that would have impact on prediction of clinical evolution and also analysed for contradictory evidence. Interviews were conducted with data collectors on the main challenges involved in data gathering and analysis for this project. Analysis of the initial round of data collection confirms road accidents cause the most trauma in Dar es Salaam, with pedestrians being particularly vulnerable. However, critical sources of information such as serious injury scores and two-week followup were inconsistently recorded, thereby limiting outcome measurement. The lack of research resources, both financial and human, had a major impact on the ability to sustain the data collection. While the results of this study demonstrate the public health value of having a mechanism to record trauma, research capacity must be supported in low-resource settings in order to enhance clinical care to accident and injury patients.
PMCID: PMC2997249  PMID: 21152331
Surgery; trauma; global health; data quality; research capacity
12.  First Diagnosis and Management of Incontinence in Older People with and without Dementia in Primary Care: A Cohort Study Using The Health Improvement Network Primary Care Database 
PLoS Medicine  2013;10(8):e1001505.
Robert Grant and colleagues used the British THIN primary care database to determine rates of first diagnosis of urinary and faecal incontinence among people aged 60–89 with dementia compared with those without dementia, and the use of medication or indwelling catheters for urinary incontinence in those with and without dementia.
Please see later in the article for the Editors' Summary
Background
Dementia is one of the most disabling and burdensome diseases. Incontinence in people with dementia is distressing, adds to carer burden, and influences decisions to relocate people to care homes. Successful and safe management of incontinence in people with dementia presents additional challenges. The aim of this study was to investigate the rates of first diagnosis in primary care of urinary and faecal incontinence among people aged 60–89 with dementia, and the use of medication or indwelling catheters for urinary incontinence.
Methods and Findings
We extracted data on 54,816 people aged 60–89 with dementia and an age-gender stratified sample of 205,795 people without dementia from 2001 to 2010 from The Health Improvement Network (THIN), a United Kingdom primary care database. THIN includes data on patients and primary care consultations but does not identify care home residents. Rate ratios were adjusted for age, sex, and co-morbidity using multilevel Poisson regression.
The rates of first diagnosis per 1,000 person-years at risk (95% confidence interval) for urinary incontinence in the dementia cohort, among men and women, respectively, were 42.3 (40.9–43.8) and 33.5 (32.6–34.5). In the non-dementia cohort, the rates were 19.8 (19.4–20.3) and 18.6 (18.2–18.9). The rates of first diagnosis for faecal incontinence in the dementia cohort were 11.1 (10.4–11.9) and 10.1 (9.6–10.6). In the non-dementia cohort, the rates were 3.1 (2.9–3.3) and 3.6 (3.5–3.8).
The adjusted rate ratio for first diagnosis of urinary incontinence was 3.2 (2.7–3.7) in men and 2.7 (2.3–3.2) in women, and for faecal incontinence was 6.0 (5.1–7.0) in men and 4.5 (3.8–5.2) in women. The adjusted rate ratio for pharmacological treatment of urinary incontinence was 2.2 (1.4–3.7) for both genders, and for indwelling urinary catheters was 1.6 (1.3–1.9) in men and 2.3 (1.9–2.8) in women.
Conclusions
Compared with those without a dementia diagnosis, those with a dementia diagnosis have approximately three times the rate of diagnosis of urinary incontinence, and more than four times the rate of faecal incontinence, in UK primary care. The clinical management of urinary incontinence in people with dementia with medication and particularly the increased use of catheters is concerning and requires further investigation.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Globally, more than 35 million people have dementia, brain disorders that are characterized by an irreversible decline in cognitive functions such as language and memory. Alzheimer's disease and other forms of dementia mainly affect older people and, because people are living longer than ever, experts estimate that by 2050 more than 115 million people will have dementia. The earliest sign of dementia is usually increasing forgetfulness but, as the disease progresses, people gradually lose their ability to deal with normal daily activities such as dressing, they may become anxious or aggressive, and they may lose control of their bladder (urinary incontinence), bowels (bowel or fecal incontinence), and other physical functions. As a result, people with dementia require increasing amounts of care as the disease progresses. Relatives and other unpaid carers provide much of this care—two-thirds of people with dementia are cared for at home. However, many people with dementia end their days in a care or nursing home.
Why Was This Study Done?
Incontinence in people with dementia is distressing for the person with dementia and for their carers and often influences decisions to move individuals into care homes. However, little is known about the diagnosis and treatment of urinary and/or fecal incontinence among people with dementia living at home. This information is needed to help policymakers commission the services required for this section of society and insurers recognize the needs such patients have, as well as helping to raise clinicians' awareness of the issue. In this cohort study (an investigation that compares outcomes in groups of people with different characteristics), the researchers use data routinely collected from general practices (primary care) in the UK to determine the rate of first diagnosis of urinary and fecal incontinence in elderly patients with and without dementia and to find out whether a diagnosis of dementia affects the rate of use of drugs or of indwelling urinary catheters (tubes inserted into the bladder to drain urine from the body) for the treatment of urinary incontinence.
What Did the Researchers Do and Find?
The researchers extracted data collected between 2001 and 2010 on incontinence for nearly 55,000 people aged 60–89 with a diagnosis of dementia (the dementia cohort) and for more than 200,000 individuals without a diagnosis of dementia (the non-dementia cohort) from The Health Improvement Network (THIN) primary care database, which includes anonymized consultation records from nearly 500 UK general practices. In the dementia cohort, the rates of first diagnosis of urinary incontinence were 42.3 and 33.5 per 1,000 person-years at risk among men and women, respectively. In the non-dementia cohort, the corresponding rates were 19.8 and 18.6. The rates of first diagnosis of fecal incontinence were 11.1 and 10.1 in the dementia cohort, and 3.1 and 3.6 in the non-dementia cohort among men and women, respectively. After adjusting for age, sex and other diseases, the adjusted rate ratio for the first diagnosis of urinary incontinence in people with dementia compared to people without dementia was 3.2 in men and 2.7 in women; for fecal incontinence, it was 6.0 in men and 4.5 in women; the adjusted rate ratio was 2.2 for both men and women for drug treatment of urinary incontinence and 1.6 in men and 2.3 in women for use of indwelling urinary catheters.
What Do These Findings Mean?
These findings indicate that, in primary care in the UK, dementia is associated with a three-fold higher rate of diagnosis of urinary incontinence and a greater than four-fold higher rate of diagnosis of fecal incontinence. Moreover, the authors suggest that some aspects of clinical management of urinary continence vary between people with and without dementia. In particular, the use of indwelling urinary catheters appears to be more common among people with dementia than among people without dementia, increasing the risk of infection. Thus, health care practitioners providing care for people with dementia may be prioritizing ease of management over risk avoidance, a possibility that requires further investigation. Although the accuracy of these findings is limited by certain aspects of the study design (for example, the THIN database does not identify which patients are living in care homes), they nevertheless suggest that policymakers and insurers involved in planning and providing services for people with dementia living at home need to provide high levels of help with incontinence, including the provision of advice and support for carers.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001505.
The UK not-for-profit organization Alzheimers Society provides information for patients and carers about dementia, including information on coping with incontinence and personal stories about living with dementia
The US not-for-profit organization Alzheimers Association also provides information for patients and carers about dementia and about incontinence, and personal stories about dementia
The UK National Health Service Choices website provides information (including personal stories) about dementia, urinary incontinence, and bowel incontinence
MedlinePlus provides links to further resources about dementia, urinary incontinence and fecal incontinence (in English and Spanish)
The International Continence Society and the International Consultation on Urological Diseases provide independent advice on products to manage incontinence
More information about the THIN database is available
doi:10.1371/journal.pmed.1001505
PMCID: PMC3754889  PMID: 24015113
13.  Dissecting Inflammatory Complications in Critically Injured Patients by Within-Patient Gene Expression Changes: A Longitudinal Clinical Genomics Study 
PLoS Medicine  2011;8(9):e1001093.
By studying gene expression changes over time in a cohort of trauma patients, Keyur Desai and colleagues identify genes and pathways strongly associated with longer-term complications, which could lead to improved outcome prediction in the first 80 hours after injury.
Background
Trauma is the number one killer of individuals 1–44 y of age in the United States. The prognosis and treatment of inflammatory complications in critically injured patients continue to be challenging, with a history of failed clinical trials and poorly understood biology. New approaches are therefore needed to improve our ability to diagnose and treat this clinical condition.
Methods and Findings
We conducted a large-scale study on 168 blunt-force trauma patients over 28 d, measuring ∼400 clinical variables and longitudinally profiling leukocyte gene expression with ∼800 microarrays. Marshall MOF (multiple organ failure) clinical score trajectories were first utilized to organize the patients into five categories of increasingly poor outcomes. We then developed an analysis framework modeling early within-patient expression changes to produce a robust characterization of the genomic response to trauma. A quarter of the genome shows early expression changes associated with longer-term post-injury complications, captured by at least five dynamic co-expression modules of functionally related genes. In particular, early down-regulation of MHC-class II genes and up-regulation of p38 MAPK signaling pathway were found to strongly associate with longer-term post-injury complications, providing discrimination among patient outcomes from expression changes during the 40–80 h window post-injury.
Conclusions
The genomic characterization provided here substantially expands the scope by which the molecular response to trauma may be characterized and understood. These results may be instrumental in furthering our understanding of the disease process and identifying potential targets for therapeutic intervention. Additionally, the quantitative approach we have introduced is potentially applicable to future genomics studies of rapidly progressing clinical conditions.
Trial Registration
ClinicalTrials.gov NCT00257231
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Trauma—a serious injury to the body caused by violence or by an accident—is a major global health problem. Every year, events that include traffic collisions, falls, blows, and fires cause injuries that kill more than 5 million people (9% of annual global deaths). Road traffic accidents alone are responsible for 1.3 million deaths a year and, if current trends continue, will be the fifth leading cause of death worldwide by 2030. Moreover, in many countries, including the US, trauma is the number one killer of individuals aged 1–44 y. Trauma can kill people rapidly through loss of blood or serious physical damage to internal organs, but it can also lead to localized infections and to sepsis, an infection of the bloodstream that is characterized by an amplified, body-wide (systemic) inflammatory response. Inflammation—redness, pain, and swelling—is an immune system response that normally provides protection against infections, but systemic inflammation can result in multiple organ failure (MOF) and death.
Why Was This Study Done?
Inflammatory complications of trauma are responsible for more than half of late trauma deaths, but at present it is impossible to predict which patients with major injuries will recover and which will spiral down into MOF and death, because the biological processes that underlie post-injury inflammatory complications are poorly understood. If the changes in gene expression (the process that converts the information encoded in genes into functional proteins) that accompany systemic inflammation could be elucidated, it might be possible to improve the diagnosis of MOF and to develop better treatments for post-trauma inflammatory complications. In this prospective, longitudinal clinical genomics study (part of the Inflammation and Host Response to Injury multi-disciplinary research program [IHRI]), the researchers developed an approach to associate early within-patient gene expression changes with later clinical outcomes. A prospective study is one in which patients with a specific condition are enrolled and then followed to see how various factors affect their outcomes; a longitudinal study analyzes multiple samples taken at different times from individual patients; a clinical genomics study investigates how genes and gene expression affect clinical outcomes.
What Did the Researchers Do and Find?
The researchers followed 168 patients for up to 28 d after they experienced blunt-force trauma (injuries caused when the human body hits or is hit by a large object such as a car). Using a molecular biology tool called a DNA microarray, they determined gene expression patterns in leukocytes (a type of immune system cell) isolated from multiple blood samples collected from each patient during the first few days after injury. Using clinical information collected by trained nurses, they organized the patients into five outcome categories based on a measure of MOF known as the Marshall score. Finally, they developed a statistical method (an analysis framework) to associate the early changes in gene expression with clinical outcomes.
A quarter of the patients' genes showed early expression changes that were associated with longer-term post-injury inflammatory complications. Among the associations revealed by this analysis, down-regulation (reduced expression) of MHC-class II genes (which encode proteins involved in antigen presentation, the process by which molecules from foreign invaders are presented to immune cells to initiate an immune response) and up-regulation of genes encoding components of the p38 MAPK signaling pathway (which helps to drive inflammatory responses) between 40 and 80 h post-injury were particularly strongly associated with longer-term post-injury complications and provided the strongest discrimination between patient outcomes.
What Do These Findings Mean?
The statistical approach used in this study to link the early changes in gene expression that occur after trauma to clinical outcomes provides a detailed picture of genome-wide gene expression responses to trauma. These findings could help scientists understand why some patients develop inflammatory complications of trauma while others do not, and they could help to identify those patients most at risk of developing complications. They could also help to identify targets for therapy, although further studies are needed to confirm and extend these findings. Importantly, the quantitative approach developed by the researchers for analyzing associations between within-patient gene changes over time and clinical outcomes should provide more robust predictions of outcomes than single measurements of gene expression and could be applicable to genomic studies of other rapidly progressing clinical conditions.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001093.
More details about the Inflammation and Host Response to Injury research program are available; the program's website includes a link to an article that explains how genomics can be used to understand the inflammatory complications of trauma
The World Health Organization provides information on injuries and on violence and injury prevention (in several languages)
The US National Institutes of Health has a factsheet on burns and traumatic injury in the USA
The US Centers for Disease Control and Prevention has information on injury and violence prevention and control
MedlinePlus provides links to further resources on injuries
doi:10.1371/journal.pmed.1001093
PMCID: PMC3172280  PMID: 21931541
14.  Missed upper cervical spine fracture: clinical and radiological considerations 
Objective:
This report presents a case of missed upper cervical spine fracture following a motor vehicle accident and illustrates various clinical and radiographic considerations necessary in the evaluation of post traumatic cervical spine injuries. Specific clinical signs and symptoms, as well as radiographic clues should prompt the astute clinician to suspect a fracture even when plain film radiographs have been reported as normal.
Clinical features:
A 44-year-old male was referred for an orthopaedic consultation for assessment of headaches following a high speed head-on motor vehicle accident eleven weeks prior to his presentation. Cervical spine radiographs taken at an emergency ward the day of the collision were reported as essentially normal.
Subsequent radiographs taken eleven weeks later revealed a fracture through the body of axis with anterior displacement of atlas. A review of the initial radiographs clearly demonstrated signs suggesting an upper cervical fracture.
Intervention and outcome:
Initially the patient was prescribed a soft collar which he wore daily until an orthopaedic consultation eleven weeks later. Fifteen weeks following trauma, the patient was considered for surgical intervention, due to persistent headaches associated with the development of neurological signs suggestive of early onset of cervical myelopathy.
Conclusion:
Cervical spine fractures can have disastrous consequences if not detected early. A thorough clinical and radiological evaluation is essential in any patient presenting with a history of neck or head trauma. Repeated plain film radiographs are imperative in the event of inadequate visualization of the cervical vertebrae. When in doubt, further imaging studies such as computed tomography or magnetic resonance imaging are required to rule out a fracture.
Images
PMCID: PMC2485171
upper cervical fracture; odontoid fracture; cervical spine trauma; chiropractic
15.  Risk Factors for Infection after 46,113 Intramedullary Nail Operations in Low- and Middle-income Countries 
World Journal of Surgery  2012;37(2):349-355.
Background
The fields of surgery and trauma care have largely been neglected in the global health discussion. As a result the idea that surgery is not safe or cost effective in resource-limited settings has gone unchallenged. The SIGN Online Surgical Database (SOSD) is now one of the largest databases on trauma surgery in low- and middle-income countries (LMIC). We wished to examine infection rates and risk factors for infection after IM nail operations in LMIC using this data.
Methods
The SOSD contained 46,722 IM nail surgeries in 58 different LMIC; 46,113 IM nail operations were included for analysis.
Results
The overall follow-up rate was 23.1 %. The overall infection rate was 1.0 %, 0.7 % for humerus, 0.8 % for femur, and 1.5 % for tibia fractures. If only nails with registered follow-up (n = 10,684) were included in analyses, infection rates were 2.9 % for humerus, 3.2 % for femur, and 6.9 % for tibia fractures. Prophylactic antibiotics reduced the risk of infection by 29 %. Operations for non-union had a doubled risk of infection. Risk of infection was reduced with increasing income level of the country.
Conclusions
The overall infection rates were low, and well within acceptable levels, suggesting that it is safe to do IM nailing in low-income countries. The fact that operations for non-union have twice the risk of infection compared to primary fracture surgery further supports the use of IM nailing as the primary treatment for femur fractures in LMIC.
doi:10.1007/s00268-012-1817-4
PMCID: PMC3553402  PMID: 23052810
16.  Characteristics of Pediatric Trauma Transfers to a Level I Trauma Center: Implications for Developing a Regionalized Pediatric Trauma System in California 
Background
Since California lacks a state-wide trauma system, there are no uniform inter-facility pediatric trauma transfer guidelines across local emergency medical services (EMS) agencies in California. This may result in delays in obtaining optimal care for injured children.
Objectives
This study sought to understand patterns of pediatric trauma patient transfers to the study trauma center as a first step in assessing the quality and efficiency of pediatric transfer within the current trauma system model. Outcome measures included clinical and demographic characteristics, distances travelled, and centers bypassed. The hypothesis was that transferred patients would be more severely injured than directly admitted patients, primary catchment transfers would be few, and out-of-catchment transfers would come from hospitals in close geographic proximity to the study center.
Methods
This was a retrospective observational analysis of trauma patients ≤18 years of age in the institutional trauma database (2000–2007). All patients with a trauma International Classification of Diseases – 9th revision (ICD-9) code and trauma mechanism who were identified as a trauma patient by EMS or emergency physicians were recorded in the trauma database, including those patients who were discharged home. Trauma patients brought directly to the emergency department (ED), and patients transferred from other facilities to the center, were compared. A geographic information system was used to calculate the straight-line distances from the referring hospitals to the study center, and to all closer centers potentially capable of accepting inter-facility pediatric trauma transfers.
Results
Of 2,798 total subjects, 16.2% were transferred from other facilities within California; 69.8% of transfers were from the catchment area, with 23.0% transferred from facilities ≤10 miles from the center. This transfer pattern was positively associated with private insurance (risk ratio [RR] 2.05; p < 0.001), and negatively associated with age 15–18 years (RR 0.23; p = 0.01) and injury severity score (ISS)>18 (RR 0.26; p < 0.01). The out-of-catchment transfers accounted for 30.2% of the patients, and 75.9% of these non-catchment transfers were in closer proximity to another facility potentially capable of accepting pediatric inter-facility transfers. The overall median straight-line distance from non-catchment study hospitals to the study center was 61.2 miles (IQR 19.0–136.4), compared to 33.6 miles (interquartile range [IQR] 13.9–61.5) to the closest center. Transfer patients were more severely injured than directly admitted patients (p < 0.001). Out-of-catchment transfers were older than catchment patients (p < 0.001); ISS >18 (RR 2.06; p < 0.001) and age 15–18 (RR 1.28; p < 0.001) were predictive of out-of-catchment patients bypassing other pediatric-capable centers. Finally, 23.7% of pediatric trauma transfer requests to the study institution were denied due to lack of bed capacity.
Conclusions
From the perspective an adult Level I trauma center with a certified pediatric intensive care unit, delays in definitive pediatric trauma care appear to be present secondary to initial transport to non-trauma community hospitals within close proximity of a trauma hospital, long transfer distances to accepting facilities, and lack of capacity at the study center. Given the absence of uniform trauma triage and transfer guidelines across state EMS systems, there appears to be a role for quality monitoring and improvement of the current inter-facility pediatric trauma transfer system, including defined triage, transfer, and data collection protocols.
doi:10.1111/j.1553-2712.2010.00926.x
PMCID: PMC3059150  PMID: 21122022
17.  Femoral Stress Fractures Associated With Long-term Bisphosphonate Treatment 
Background
Recent studies have described unique clinical and radiographic characteristics of femoral stress fractures or low-energy fractures associated with long-term bisphosphonate therapy. However, it is unclear whether these fractures require subsequent surgery after the initial treatment.
Questions/purposes
We performed a cohort analysis of bisphosphonate-associated femoral stress fractures to (1) confirm the unique clinical and radiographic findings compared with existing literature, (2) determine whether any patients with completed fractures had no preexisting transverse stress fracture lines, (3) assess the need for additional surgical procedures, and (4) determine whether the hospital length of stay (LOS) differed for patients with prophylactic fixation of stress fractures versus fixation of completed fractures.
Methods
We retrospectively reviewed 16 patients with 24 diaphyseal and subtrochanteric femoral stress fractures (14) or low-energy fractures (10) who had been on bisphosphonates for 3 to 10 years. Data included demographics, symptoms, medication history, radiographic characteristics, treatment parameters, LOS, and outcome. Minimum followup was 9 months (average, 44.0 months; median, 31 months; range, 9–112 months).
Results
All patients had clinical and radiographic findings similar to those reported in the literature. Two of four patients sustained completed fractures after radiographs failed to reveal transverse lateral fracture lines. None of the 14 prophylactically treated impending fractures progressed or required additional surgery; however, in five of 10 femurs treated after fracture completion, six additional surgeries were performed. The average hospital LOS was shorter in patients who underwent prophylactic fixation (3.8 days) than in patients treated for completed fractures (5.6 days).
Conclusions
Bisphosphonate-associated stress fractures and completed fractures are unique, possessing subtle characteristic radiographic features. Completed fractures may occur through the thickened bone in the absence of an appreciable transverse stress fracture line. Our observations suggest prophylactic reconstruction nail fixation may avoid fracture completion and may be associated with a shorter hospital LOS and less morbidity than treatment of completed fractures.
Level of Evidence
Level IV, diagnostic study. See the Guidelines for Authors for a complete description of levels of evidence.
Electronic supplementary material
The online version of this article (doi:10.1007/s11999-011-2194-2) contains supplementary material, which is available to authorized users.
doi:10.1007/s11999-011-2194-2
PMCID: PMC3270181  PMID: 22125247
18.  Internet-Based Device-Assisted Remote Monitoring of Cardiovascular Implantable Electronic Devices 
Executive Summary
Objective
The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions.
Clinical Need: Condition and Target Population
Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD.
Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities.
Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs.
Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however, increases the risk of SCD five-fold, regardless of aetiology. Patients with HF who remain highly symptomatic despite optimal drug therapy are sometimes also treated with CRT devices.
With an increasing prevalence of age-related conditions such as chronic HF and the expanding indications for ICD therapy, the rate of ICD placement has been dramatically increasing. The appropriate indications for ICD placement, as well as the rate of ICD placement, are increasingly an issue. In the United States, after the introduction of expanded coverage of ICDs, a national ICD registry was created in 2005 to track these devices. A recent survey based on this national ICD registry reported that 22.5% (25,145) of patients had received a non-evidence based ICD and that these patients experienced significantly higher in-hospital mortality and post-procedural complications.
In addition to the increased ICD device placement and the upfront device costs, there is the need for lifelong follow-up or surveillance, placing a significant burden on patients and device clinics. In 2007, over 1.6 million CIEDs were implanted in Europe and the United States, which translates to over 5.5 million patient encounters per year if the recommended follow-up practices are considered. A safe and effective RMS could potentially improve the efficiency of long-term follow-up of patients and their CIEDs.
Technology
In addition to being therapeutic devices, CIEDs have extensive diagnostic abilities. All CIEDs can be interrogated and reprogrammed during an in-clinic visit using an inductive programming wand. Remote monitoring would allow patients to transmit information recorded in their devices from the comfort of their own homes. Currently most ICD devices also have the potential to be remotely monitored. Remote monitoring (RM) can be used to check system integrity, to alert on arrhythmic episodes, and to potentially replace in-clinic follow-ups and manage disease remotely. They do not currently have the capability of being reprogrammed remotely, although this feature is being tested in pilot settings.
Every RMS is specifically designed by a manufacturer for their cardiac implant devices. For Internet-based device-assisted RMSs, this customization includes details such as web application, multiplatform sensors, custom algorithms, programming information, and types and methods of alerting patients and/or physicians. The addition of peripherals for monitoring weight and pressure or communicating with patients through the onsite communicators also varies by manufacturer. Internet-based device-assisted RMSs for CIEDs are intended to function as a surveillance system rather than an emergency system.
Health care providers therefore need to learn each application, and as more than one application may be used at one site, multiple applications may need to be reviewed for alarms. All RMSs deliver system integrity alerting; however, some systems seem to be better geared to fast arrhythmic alerting, whereas other systems appear to be more intended for remote follow-up or supplemental remote disease management. The different RMSs may therefore have different impacts on workflow organization because of their varying frequency of interrogation and methods of alerts. The integration of these proprietary RM web-based registry systems with hospital-based electronic health record systems has so far not been commonly implemented.
Currently there are 2 general types of RMSs: those that transmit device diagnostic information automatically and without patient assistance to secure Internet-based registry systems, and those that require patient assistance to transmit information. Both systems employ the use of preprogrammed alerts that are either transmitted automatically or at regular scheduled intervals to patients and/or physicians.
The current web applications, programming, and registry systems differ greatly between the manufacturers of transmitting cardiac devices. In Canada there are currently 4 manufacturers—Medtronic Inc., Biotronik, Boston Scientific Corp., and St Jude Medical Inc.—which have regulatory approval for remote transmitting CIEDs. Remote monitoring systems are proprietary to the manufacturer of the implant device. An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer’s devices.
All Internet-based device-assisted RMSs have common components. The implanted device is equipped with a micro-antenna that communicates with a small external device (at bedside or wearable) commonly known as the transmitter. Transmitters are able to interrogate programmed parameters and diagnostic data stored in the patients’ implant device. The information transfer to the communicator can occur at preset time intervals with the participation of the patient (waving a wand over the device) or it can be sent automatically (wirelessly) without their participation. The encrypted data are then uploaded to an Internet-based database on a secure central server. The data processing facilities at the central database, depending on the clinical urgency, can trigger an alert for the physician(s) that can be sent via email, fax, text message, or phone. The details are also posted on the secure website for viewing by the physician (or their delegate) at their convenience.
Research Questions
The research directions and specific research questions for this evidence review were as follows:
To identify the Internet-based device-assisted RMSs available for follow-up of patients with therapeutic CIEDs such as PMs, ICDs, and CRT devices.
To identify the potential risks, operational issues, or organizational issues related to Internet-based device-assisted RM for CIEDs.
To evaluate the safety, acceptability, and effectiveness of Internet-based device-assisted RMSs for CIEDs such as PMs, ICDs, and CRT devices.
To evaluate the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted RMSs for CIEDs compared to usual outpatient in-office monitoring strategies.
To evaluate the resource implications or budget impact of RMSs for CIEDs in Ontario, Canada.
Research Methods
Literature Search
The review included a systematic review of published scientific literature and consultations with experts and manufacturers of all 4 approved RMSs for CIEDs in Canada. Information on CIED cardiac implant clinics was also obtained from Provincial Programs, a division within the Ministry of Health and Long-Term Care with a mandate for cardiac implant specialty care. Various administrative databases and registries were used to outline the current clinical follow-up burden of CIEDs in Ontario. The provincial population-based ICD database developed and maintained by the Institute for Clinical Evaluative Sciences (ICES) was used to review the current follow-up practices with Ontario patients implanted with ICD devices.
Search Strategy
A literature search was performed on September 21, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from 1950 to September 2010. Search alerts were generated and reviewed for additional relevant literature until December 31, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Inclusion Criteria
published between 1950 and September 2010;
English language full-reports and human studies;
original reports including clinical evaluations of Internet-based device-assisted RMSs for CIEDs in clinical settings;
reports including standardized measurements on outcome events such as technical success, safety, effectiveness, cost, measures of health care utilization, morbidity, mortality, quality of life or patient satisfaction;
randomized controlled trials (RCTs), systematic reviews and meta-analyses, cohort and controlled clinical studies.
Exclusion Criteria
non-systematic reviews, letters, comments and editorials;
reports not involving standardized outcome events;
clinical reports not involving Internet-based device assisted RM systems for CIEDs in clinical settings;
reports involving studies testing or validating algorithms without RM;
studies with small samples (<10 subjects).
Outcomes of Interest
The outcomes of interest included: technical outcomes, emergency department visits, complications, major adverse events, symptoms, hospital admissions, clinic visits (scheduled and/or unscheduled), survival, morbidity (disease progression, stroke, etc.), patient satisfaction, and quality of life.
Summary of Findings
The MAS evidence review was performed to review available evidence on Internet-based device-assisted RMSs for CIEDs published until September 2010. The search identified 6 systematic reviews, 7 randomized controlled trials, and 19 reports for 16 cohort studies—3 of these being registry-based and 4 being multi-centered. The evidence is summarized in the 3 sections that follow.
1. Effectiveness of Remote Monitoring Systems of CIEDs for Cardiac Arrhythmia and Device Functioning
In total, 15 reports on 13 cohort studies involving investigations with 4 different RMSs for CIEDs in cardiology implant clinic groups were identified in the review. The 4 RMSs were: Care Link Network® (Medtronic Inc,, Minneapolis, MN, USA); Home Monitoring® (Biotronic, Berlin, Germany); House Call 11® (St Jude Medical Inc., St Pauls, MN, USA); and a manufacturer-independent RMS. Eight of these reports were with the Home Monitoring® RMS (12,949 patients), 3 were with the Care Link® RMS (167 patients), 1 was with the House Call 11® RMS (124 patients), and 1 was with a manufacturer-independent RMS (44 patients). All of the studies, except for 2 in the United States, (1 with Home Monitoring® and 1 with House Call 11®), were performed in European countries.
The RMSs in the studies were evaluated with different cardiac implant device populations: ICDs only (6 studies), ICD and CRT devices (3 studies), PM and ICD and CRT devices (4 studies), and PMs only (2 studies). The patient populations were predominately male (range, 52%–87%) in all studies, with mean ages ranging from 58 to 76 years. One study population was unique in that RMSs were evaluated for ICDs implanted solely for primary prevention in young patients (mean age, 44 years) with Brugada syndrome, which carries an inherited increased genetic risk for sudden heart attack in young adults.
Most of the cohort studies reported on the feasibility of RMSs in clinical settings with limited follow-up. In the short follow-up periods of the studies, the majority of the events were related to detection of medical events rather than system configuration or device abnormalities. The results of the studies are summarized below:
The interrogation of devices on the web platform, both for continuous and scheduled transmissions, was significantly quicker with remote follow-up, both for nurses and physicians.
In a case-control study focusing on a Brugada population–based registry with patients followed-up remotely, there were significantly fewer outpatient visits and greater detection of inappropriate shocks. One death occurred in the control group not followed remotely and post-mortem analysis indicated early signs of lead failure prior to the event.
Two studies examined the role of RMSs in following ICD leads under regulatory advisory in a European clinical setting and noted:
– Fewer inappropriate shocks were administered in the RM group.
– Urgent in-office interrogations and surgical revisions were performed within 12 days of remote alerts.
– No signs of lead fracture were detected at in-office follow-up; all were detected at remote follow-up.
Only 1 study reported evaluating quality of life in patients followed up remotely at 3 and 6 months; no values were reported.
Patient satisfaction was evaluated in 5 cohort studies, all in short term follow-up: 1 for the Home Monitoring® RMS, 3 for the Care Link® RMS, and 1 for the House Call 11® RMS.
– Patients reported receiving a sense of security from the transmitter, a good relationship with nurses and physicians, positive implications for their health, and satisfaction with RM and organization of services.
– Although patients reported that the system was easy to implement and required less than 10 minutes to transmit information, a variable proportion of patients (range, 9% 39%) reported that they needed the assistance of a caregiver for their transmission.
– The majority of patients would recommend RM to other ICD patients.
– Patients with hearing or other physical or mental conditions hindering the use of the system were excluded from studies, but the frequency of this was not reported.
Physician satisfaction was evaluated in 3 studies, all with the Care Link® RMS:
– Physicians reported an ease of use and high satisfaction with a generally short-term use of the RMS.
– Physicians reported being able to address the problems in unscheduled patient transmissions or physician initiated transmissions remotely, and were able to handle the majority of the troubleshooting calls remotely.
– Both nurses and physicians reported a high level of satisfaction with the web registry system.
2. Effectiveness of Remote Monitoring Systems in Heart Failure Patients for Cardiac Arrhythmia and Heart Failure Episodes
Remote follow-up of HF patients implanted with ICD or CRT devices, generally managed in specialized HF clinics, was evaluated in 3 cohort studies: 1 involved the Home Monitoring® RMS and 2 involved the Care Link® RMS. In these RMSs, in addition to the standard diagnostic features, the cardiac devices continuously assess other variables such as patient activity, mean heart rate, and heart rate variability. Intra-thoracic impedance, a proxy measure for lung fluid overload, was also measured in the Care Link® studies. The overall diagnostic performance of these measures cannot be evaluated, as the information was not reported for patients who did not experience intra-thoracic impedance threshold crossings or did not undergo interventions. The trial results involved descriptive information on transmissions and alerts in patients experiencing high morbidity and hospitalization in the short study periods.
3. Comparative Effectiveness of Remote Monitoring Systems for CIEDs
Seven RCTs were identified evaluating RMSs for CIEDs: 2 were for PMs (1276 patients) and 5 were for ICD/CRT devices (3733 patients). Studies performed in the clinical setting in the United States involved both the Care Link® RMS and the Home Monitoring® RMS, whereas all studies performed in European countries involved only the Home Monitoring® RMS.
3A. Randomized Controlled Trials of Remote Monitoring Systems for Pacemakers
Two trials, both multicenter RCTs, were conducted in different countries with different RMSs and study objectives. The PREFER trial was a large trial (897 patients) performed in the United States examining the ability of Care Link®, an Internet-based remote PM interrogation system, to detect clinically actionable events (CAEs) sooner than the current in-office follow-up supplemented with transtelephonic monitoring transmissions, a limited form of remote device interrogation. The trial results are summarized below:
In the 375-day mean follow-up, 382 patients were identified with at least 1 CAE—111 patients in the control arm and 271 in the remote arm.
The event rate detected per patient for every type of CAE, except for loss of atrial capture, was higher in the remote arm than the control arm.
The median time to first detection of CAEs (4.9 vs. 6.3 months) was significantly shorter in the RMS group compared to the control group (P < 0.0001).
Additionally, only 2% (3/190) of the CAEs in the control arm were detected during a transtelephonic monitoring transmission (the rest were detected at in-office follow-ups), whereas 66% (446/676) of the CAEs were detected during remote interrogation.
The second study, the OEDIPE trial, was a smaller trial (379 patients) performed in France evaluating the ability of the Home Monitoring® RMS to shorten PM post-operative hospitalization while preserving the safety of conventional management of longer hospital stays.
Implementation and operationalization of the RMS was reported to be successful in 91% (346/379) of the patients and represented 8144 transmissions.
In the RM group 6.5% of patients failed to send messages (10 due to improper use of the transmitter, 2 with unmanageable stress). Of the 172 patients transmitting, 108 patients sent a total of 167 warnings during the trial, with a greater proportion of warnings being attributed to medical rather than technical causes.
Forty percent had no warning message transmission and among these, 6 patients experienced a major adverse event and 1 patient experienced a non-major adverse event. Of the 6 patients having a major adverse event, 5 contacted their physician.
The mean medical reaction time was faster in the RM group (6.5 ± 7.6 days vs. 11.4 ± 11.6 days).
The mean duration of hospitalization was significantly shorter (P < 0.001) for the RM group than the control group (3.2 ± 3.2 days vs. 4.8 ± 3.7 days).
Quality of life estimates by the SF-36 questionnaire were similar for the 2 groups at 1-month follow-up.
3B. Randomized Controlled Trials Evaluating Remote Monitoring Systems for ICD or CRT Devices
The 5 studies evaluating the impact of RMSs with ICD/CRT devices were conducted in the United States and in European countries and involved 2 RMSs—Care Link® and Home Monitoring ®. The objectives of the trials varied and 3 of the trials were smaller pilot investigations.
The first of the smaller studies (151 patients) evaluated patient satisfaction, achievement of patient outcomes, and the cost-effectiveness of the Care Link® RMS compared to quarterly in-office device interrogations with 1-year follow-up.
Individual outcomes such as hospitalizations, emergency department visits, and unscheduled clinic visits were not significantly different between the study groups.
Except for a significantly higher detection of atrial fibrillation in the RM group, data on ICD detection and therapy were similar in the study groups.
Health-related quality of life evaluated by the EuroQoL at 6-month or 12-month follow-up was not different between study groups.
Patients were more satisfied with their ICD care in the clinic follow-up group than in the remote follow-up group at 6-month follow-up, but were equally satisfied at 12- month follow-up.
The second small pilot trial (20 patients) examined the impact of RM follow-up with the House Call 11® system on work schedules and cost savings in patients randomized to 2 study arms varying in the degree of remote follow-up.
The total time including device interrogation, transmission time, data analysis, and physician time required was significantly shorter for the RM follow-up group.
The in-clinic waiting time was eliminated for patients in the RM follow-up group.
The physician talk time was significantly reduced in the RM follow-up group (P < 0.05).
The time for the actual device interrogation did not differ in the study groups.
The third small trial (115 patients) examined the impact of RM with the Home Monitoring® system compared to scheduled trimonthly in-clinic visits on the number of unplanned visits, total costs, health-related quality of life (SF-36), and overall mortality.
There was a 63.2% reduction in in-office visits in the RM group.
Hospitalizations or overall mortality (values not stated) were not significantly different between the study groups.
Patient-induced visits were higher in the RM group than the in-clinic follow-up group.
The TRUST Trial
The TRUST trial was a large multicenter RCT conducted at 102 centers in the United States involving the Home Monitoring® RMS for ICD devices for 1450 patients. The primary objectives of the trial were to determine if remote follow-up could be safely substituted for in-office clinic follow-up (3 in-office visits replaced) and still enable earlier physician detection of clinically actionable events.
Adherence to the protocol follow-up schedule was significantly higher in the RM group than the in-office follow-up group (93.5% vs. 88.7%, P < 0.001).
Actionability of trimonthly scheduled checks was low (6.6%) in both study groups. Overall, actionable causes were reprogramming (76.2%), medication changes (24.8%), and lead/system revisions (4%), and these were not different between the 2 study groups.
The overall mean number of in-clinic and hospital visits was significantly lower in the RM group than the in-office follow-up group (2.1 per patient-year vs. 3.8 per patient-year, P < 0.001), representing a 45% visit reduction at 12 months.
The median time from onset of first arrhythmia to physician evaluation was significantly shorter (P < 0.001) in the RM group than in the in-office follow-up group for all arrhythmias (1 day vs. 35.5 days).
The median time to detect clinically asymptomatic arrhythmia events—atrial fibrillation (AF), ventricular fibrillation (VF), ventricular tachycardia (VT), and supra-ventricular tachycardia (SVT)—was also significantly shorter (P < 0.001) in the RM group compared to the in-office follow-up group (1 day vs. 41.5 days) and was significantly quicker for each of the clinical arrhythmia events—AF (5.5 days vs. 40 days), VT (1 day vs. 28 days), VF (1 day vs. 36 days), and SVT (2 days vs. 39 days).
System-related problems occurred infrequently in both groups—in 1.5% of patients (14/908) in the RM group and in 0.7% of patients (3/432) in the in-office follow-up group.
The overall adverse event rate over 12 months was not significantly different between the 2 groups and individual adverse events were also not significantly different between the RM group and the in-office follow-up group: death (3.4% vs. 4.9%), stroke (0.3% vs. 1.2%), and surgical intervention (6.6% vs. 4.9%), respectively.
The 12-month cumulative survival was 96.4% (95% confidence interval [CI], 95.5%–97.6%) in the RM group and 94.2% (95% confidence interval [CI], 91.8%–96.6%) in the in-office follow-up group, and was not significantly different between the 2 groups (P = 0.174).
The CONNECT Trial
The CONNECT trial, another major multicenter RCT, involved the Care Link® RMS for ICD/CRT devices in a15-month follow-up study of 1,997 patients at 133 sites in the United States. The primary objective of the trial was to determine whether automatically transmitted physician alerts decreased the time from the occurrence of clinically relevant events to medical decisions. The trial results are summarized below:
Of the 575 clinical alerts sent in the study, 246 did not trigger an automatic physician alert. Transmission failures were related to technical issues such as the alert not being programmed or not being reset, and/or a variety of patient factors such as not being at home and the monitor not being plugged in or set up.
The overall mean time from the clinically relevant event to the clinical decision was significantly shorter (P < 0.001) by 17.4 days in the remote follow-up group (4.6 days for 172 patients) than the in-office follow-up group (22 days for 145 patients).
– The median time to a clinical decision was shorter in the remote follow-up group than in the in-office follow-up group for an AT/AF burden greater than or equal to 12 hours (3 days vs. 24 days) and a fast VF rate greater than or equal to 120 beats per minute (4 days vs. 23 days).
Although infrequent, similar low numbers of events involving low battery and VF detection/therapy turned off were noted in both groups. More alerts, however, were noted for out-of-range lead impedance in the RM group (18 vs. 6 patients), and the time to detect these critical events was significantly shorter in the RM group (same day vs. 17 days).
Total in-office clinic visits were reduced by 38% from 6.27 visits per patient-year in the in-office follow-up group to 3.29 visits per patient-year in the remote follow-up group.
Health care utilization visits (N = 6,227) that included cardiovascular-related hospitalization, emergency department visits, and unscheduled clinic visits were not significantly higher in the remote follow-up group.
The overall mean length of hospitalization was significantly shorter (P = 0.002) for those in the remote follow-up group (3.3 days vs. 4.0 days) and was shorter both for patients with ICD (3.0 days vs. 3.6 days) and CRT (3.8 days vs. 4.7 days) implants.
The mortality rate between the study arms was not significantly different between the follow-up groups for the ICDs (P = 0.31) or the CRT devices with defribillator (P = 0.46).
Conclusions
There is limited clinical trial information on the effectiveness of RMSs for PMs. However, for RMSs for ICD devices, multiple cohort studies and 2 large multicenter RCTs demonstrated feasibility and significant reductions in in-office clinic follow-ups with RMSs in the first year post implantation. The detection rates of clinically significant events (and asymptomatic events) were higher, and the time to a clinical decision for these events was significantly shorter, in the remote follow-up groups than in the in-office follow-up groups. The earlier detection of clinical events in the remote follow-up groups, however, was not associated with lower morbidity or mortality rates in the 1-year follow-up. The substitution of almost all the first year in-office clinic follow-ups with RM was also not associated with an increased health care utilization such as emergency department visits or hospitalizations.
The follow-up in the trials was generally short-term, up to 1 year, and was a more limited assessment of potential longer term device/lead integrity complications or issues. None of the studies compared the different RMSs, particularly the different RMSs involving patient-scheduled transmissions or automatic transmissions. Patients’ acceptance of and satisfaction with RM were reported to be high, but the impact of RM on patients’ health-related quality of life, particularly the psychological aspects, was not evaluated thoroughly. Patients who are not technologically competent, having hearing or other physical/mental impairments, were identified as potentially disadvantaged with remote surveillance. Cohort studies consistently identified subgroups of patients who preferred in-office follow-up. The evaluation of costs and workflow impact to the health care system were evaluated in European or American clinical settings, and only in a limited way.
Internet-based device-assisted RMSs involve a new approach to monitoring patients, their disease progression, and their CIEDs. Remote monitoring also has the potential to improve the current postmarket surveillance systems of evolving CIEDs and their ongoing hardware and software modifications. At this point, however, there is insufficient information to evaluate the overall impact to the health care system, although the time saving and convenience to patients and physicians associated with a substitution of in-office follow-up by RM is more certain. The broader issues surrounding infrastructure, impacts on existing clinical care systems, and regulatory concerns need to be considered for the implementation of Internet-based RMSs in jurisdictions involving different clinical practices.
PMCID: PMC3377571  PMID: 23074419
19.  Treatment of Infections in Young Infants in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis of Frontline Health Worker Diagnosis and Antibiotic Access 
PLoS Medicine  2014;11(10):e1001741.
Anne C. C. Lee and colleagues assess the factors affecting access to treatment for neonatal and infant infections in low- and middle-income countries by conducting a systematic review and meta-analysis of frontline health worker diagnosis and access to antibiotics.
Please see later in the article for the Editors' Summary
Background
Inadequate illness recognition and access to antibiotics contribute to high case fatality from infections in young infants (<2 months) in low- and middle-income countries (LMICs). We aimed to address three questions regarding access to treatment for young infant infections in LMICs: (1) Can frontline health workers accurately diagnose possible bacterial infection (pBI)?; (2) How available and affordable are antibiotics?; (3) How often are antibiotics procured without a prescription?
Methods and Findings
We searched PubMed, Embase, WHO/Health Action International (HAI), databases, service provision assessments (SPAs), Demographic and Health Surveys, Multiple Indicator Cluster Surveys, and grey literature with no date restriction until May 2014. Data were identified from 37 published studies, 46 HAI national surveys, and eight SPAs. For study question 1, meta-analysis showed that clinical sign-based algorithms predicted bacterial infection in young infants with high sensitivity (87%, 95% CI 82%–91%) and lower specificity (62%, 95% CI 48%–75%) (six studies, n = 14,254). Frontline health workers diagnosed pBI in young infants with an average sensitivity of 82% (95% CI 76%–88%) and specificity of 69% (95% CI 54%–83%) (eight studies, n = 11,857) compared to physicians. For question 2, first-line injectable agents (ampicillin, gentamicin, and penicillin) had low variable availability in first-level health facilities in Africa and South Asia. Oral amoxicillin and cotrimoxazole were widely available at low cost in most regions. For question 3, no studies on young infants were identified, however 25% of pediatric antibiotic purchases in LMICs were obtained without a prescription (11 studies, 95% CI 18%–34%), with lower rates among infants <1 year. Study limitations included potential selection bias and lack of neonatal-specific data.
Conclusions
Trained frontline health workers may screen for pBI in young infants with relatively high sensitivity and lower specificity. Availability of first-line injectable antibiotics appears low in many health facilities in Africa and Asia. Improved data and advocacy are needed to increase the availability and appropriate utilization of antibiotics for young infant infections in LMICs.
Review Registration
PROSPERO International prospective register of systematic reviews (CRD42013004586).
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Neonatal mortality—death that occurs during the first 28 days of life—accounts for nearly half of all the deaths that occur in children before they reach their fifth birthday. Worldwide, nearly 3 million neonatal deaths occur every year. Three bacterial infections—sepsis (infection of the bloodstream), pneumonia (infection of the lungs), and meningitis (infection of the brain's protective covering)—are responsible for nearly a quarter of all neonatal deaths. Babies born in low- and middle-income countries (LMICs) are at particularly high risk of developing neonatal bacterial infections because the risk factors for these infections, which include maternal infections and unhygienic delivery care, are more common in LMICs than in high-income countries. Babies born in LMICs are also at a high risk of dying from bacterial infections because access to appropriate medical care and antibiotics is often poor.
Why Was This Study Done?
To reduce neonatal deaths from bacterial infections in LMICs, health care experts need to identify the factors that limit access to medical care and antibiotics in these countries. Are babies dying because health care providers fail to diagnose neonatal bacterial infections, because antibiotics are not available in first-line health facilities, or for some other reason? In this systematic review and meta-analysis, the researchers investigate access to treatment for neonatal bacterial infections in LMICs by first asking whether frontline health workers in LMICs can accurately diagnose bacterial infections in neonates and young infants (babies less than 2 months old). Next, they ask whether antibiotics for treating neonatal infections are available and affordable in LMICs. Finally, they ask how often antibiotics are procured for young children (children up to the age of 5 years) without a prescription. A systematic review uses pre-defined criteria to identify all the research on a given topic; meta-analysis uses statistical methods to combine the results of several studies.
What Did the Researchers Do and Find?
The researchers identified 37 published studies, 46 surveys of drug availability and affordability in LMICs (Health Access International databases), and eight surveys of the capacity of health facilities in LMICs to provide quality health care services (service provision assessments) that met their inclusion criteria. Meta-analysis of six studies indicated that a combination of simple clinical signs for the diagnosis of bacterial infection in children predicted very severe disease in young infants with a sensitivity of 87% and a specificity of 62% (“sensitivity” indicates the percentage of true positives detected by a test; “specificity” indicates the percentage of healthy people that a test correctly identifies as healthy) compared to a physician's diagnosis with laboratory testing. Meta-analysis of eight studies indicated that frontline health workers (for example, community health workers) diagnosed very severe disease (including possible bacterial infection) in young infants with a sensitivity of 82% and a specificity of 69% compared to trained physicians. The national surveys analyzed indicated that first-level (primary) health facilities in Africa and South Asia had low, variable stocks of recommended first-line injectable antibiotics and that the cost of these drugs was high. By contrast, some oral antibiotics were widely available at low cost in most regions. Finally, meta-analysis of 11 studies indicated that, in LMICs, 25% of antibiotic purchases for the treatment of young children were obtained without a prescription.
What Do These Findings Mean?
These findings suggest that trained frontline health workers should be able to identify most young infants who have possible bacterial infections in LMICs but may also diagnose bacterial infections in many young infants who are not infected. This may lead to the inappropriate use of antibiotics and facilitate the emergence of antibiotic resistance. These findings also show that the availability and affordability of first-line injectable antibiotics is low in many health facilities in Africa and Asia. The lack of neonatal-specific data on illness recognition, antibiotic formulations and availability, and other aspects of this systematic review and meta-analysis are likely to limit the accuracy of these findings. Nevertheless, the researchers suggest that, to decrease the neonatal death toll in LMICs, governments, policymakers, and the pharmaceutical industry need to work together to improve the diagnosis of neonatal bacterial infections and to increase the availability, affordability, and appropriate use of antibiotics for the treatment of these infections.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001741.
WHO provides information on global efforts to reduce global child mortality and on ending preventable neonatal deaths (available in several languages)
The United Nations Children's Fund (UNICEF) works for children's rights, survival, development, and protection around the world; it provides information on global efforts to reduce child mortality , and its Childinfo website provides detailed statistics about neonatal survival and health; its “Committing to Child Survival: A Promise Renewed” webpage includes links to its 2013 progress report and to videos about ending preventable child deaths
The WHO has published a report entitled UN Commission on Life Saving Commodities for Women and Children
The Healthy Newborn Network (NHH) is an online community of more than 80 partner organizations that addresses critical knowledge gaps in newborn health; its website includes information on neonatal infections in LMICs
Kidshealth, a resource provided by the not-for-profit Nemours Foundation, has information for parents on neonatal infections (in English and Spanish)
The MedlinePlus Encyclopedia has a page on neonatal sepsis (in English and Spanish)
A personal story about fatal neonatal bacterial meningitis is available on the website of Meningitis UK, a not-for-profit organization; the site also includes a survivor story
doi:10.1371/journal.pmed.1001741
PMCID: PMC4196753  PMID: 25314011
20.  Exercise Protocol for the Treatment of Rotator Cuff Impingement Syndrome 
Journal of Athletic Training  2010;45(5):483-485.
Abstract
Reference/Citation:
Kuhn JE. Exercise in the treatment of rotator cuff impingement: a systematic review and a synthesized evidence-based rehabilitation protocol. J Shoulder Elbow Surg. 2009;18(1):138–160.
Clinical Question:
What is the role of exercise in the treatment of rotator cuff impingement syndrome (RCIS), and what evidence-based exercises can be synthesized into a criterion-standard exercise rehabilitation protocol?
Data Sources:
Investigations were identified by PubMed, Ovid, the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, American College of Physicians Journal Club, and Database of Abstracts of Reviews of Effects. The search terms included shoulder, impingement, rotator cuff, rehabilitation, physical therapy, physiotherapy, and exercise. Additional searches were performed with bibliographies of retrieved studies.
Study Selection:
To qualify for inclusion, studies had to be level 1 or level 2 (randomized controlled trials); had to compare rehabilitation interventions, such as exercise or manual therapy, with other treatments or placebo; had to include validated outcome measures of pain, function, or disability; and had to be limited to individuals with diagnosed impingement syndrome. Impingement syndrome was determined by a positive impingement sign per Neer or Hawkins criteria, or both. Articles were excluded if they addressed other shoulder conditions (eg, calcific tendinosis, full-thickness rotator cuff tears, adhesive capsulitis, osteoarthritis), addressed postoperative management, were retrospective studies or case series, or used other outcome measures.
Data Extraction:
An evidence-based journal club of 9 faculty members and fellows reviewed the articles and extracted and tabulated the data. Individual outcomes for pain, range of motion (ROM), strength, and function were organized. Intragroup and between-groups outcomes were assessed for the effectiveness of treatment, and statistical outcomes were recorded when available. Clinical importance was determined when statistical value was P < .05 and the effect size or difference between treatments was 20% or more. Sixa major categories were created to organize the components of the physical therapy programs used in each study: ROM, flexibility and stretching, strengthening techniques, therapist-driven manual therapy, modalities, and schedule. Components from these categories were used to create a synthesized physical therapy program.
Main Results:
The searches identified 80 studies, of which 11 met the inclusion criteria. In 5 studies, the diagnosis of RCIS was confirmed using an impingement test consisting of lidocaine injected into the subacromial space and elimination of pain with the impingement sign. Randomization methods were used in 6 studies, and blinded, independent examiners were involved in follow-up data collection in only 3 studies. Validated outcome measures were used in all studies. Follow-up was very good in 10 studies and was less than 90% in only 1 study. The specific exercise programs varied among studies. However, general treatment principles were identified among the different studies and included frequency, ROM, stretching or flexibility, strengthening, manual therapy (joint and/or soft tissue mobilizations), modalities, and others.
The findings indicated that exercise improves outcomes of pain, strength, ROM impairments, and function in patients with impingement syndrome. In 10 studies, investigators reported improvements in pain with supervised exercise, home exercise, exercise associated with manual therapy, and exercise after subacromial decompression. Of the 6 studies in which researchers compared pre-exercise pain with postexercise pain, 5 demonstrated that exercise produced statistically significant and clinically important reductions in pain. Two studies demonstrated improvements in pain when comparing exercise and control groups. In 1 study, investigators evaluated bracing without exercise and found no difference in pain between the brace and exercise groups. Investigators evaluated exercise combined with manual therapy in 3 studies and demonstrated improvement in pain relief in each study and improvement in strength in 1 study. In most studies, exercise also was shown to improve function. The improvement in function was statistically significant in 4 studies and clinically meaningful in 2 of these studies. In 2 studies, researchers compared supervised exercise with a home exercise program and found that function improved in both groups but was not different between groups. This finding might have resulted from a type II statistical error. In 4 studies, researchers did not find differences between acromioplasty with exercise and exercise alone for pain alone or for outcomes of pain and function.
Conclusions:
Findings indicated that exercise is beneficial for reducing pain and improving function in individuals with RCIS. The effects of exercise might be augmented with implementation of manual therapy. In addition, supervised exercise might not be more effective than a home exercise program. Many articles had methodologic concerns and provided limited descriptions of specific exercises, which made comparing types of exercise among studies difficult. Based on the results, Kuhn generated a physical therapy protocol using evidence-based exercise that could be used by clinicians treating individuals with impingement syndrome. This evidence-based protocol can serve as the criterion standard to reduce variables in future cohort and comparative studies to help find better treatments for patients with this disorder.
doi:10.4085/1062-6050-45.5.483
PMCID: PMC2938321  PMID: 20831395
function; subacromial impingement; rehabilitation
21.  Incidence of Radiographic Cam-Type Impingement in Young Patients (<50) After Femoral Neck Fracture Treated with Reduction and Internal Fixation 
HSS Journal  2013;9(2):113-117.
Background:
Cam-type femoral impingement is caused by structural abnormalities of the hip and is recognized as a cause of degenerative hip arthritis. Identifiable etiologies of this structural abnormality include congenital malformation, pediatric hip disease, and malunion of femoral neck fractures after internal fixation.
Purpose:
The purpose of this study was to determine the prevalence of radiographic impingement in healed Orthopaedic Trauma Association (OTA) type 31B fractures treated with reduction and internal fixation.
Methods:
Seventy OTA 31B hip fractures treated with internal fixation were identified from our institutional trauma database and radiographs were retrospectively reviewed for signs of impingement. Mean follow-up was 53 months after fracture. Alpha angle, Mose templates, and femoral head retroversion were the measurements used to determine impingement.
Results:
The overall prevalence of any sign of radiographic impingement was 75%. Alpha angle was elevated in 32 hips (46%), asphericity was present in 46 femoral heads (65%), and femoral head retroversion was present in 26 hips (37%). The rates were highest in displaced subcapital fractures (OTA 31B-3) with a 63% (13/19) prevalence of elevated alpha angle, 68% (14/19) prevalence of asphericity, and 47% (10/19) prevalence of retroversion.
Conclusions:
Prevalence of radiographic signs of impingement in this population is higher than expected based on population-based controls. Surgeons must be vigilant about reduction and fixation of femoral neck fractures. Malunion should be recognized as early intervention may be beneficial in improving long-term outcomes.
doi:10.1007/s11420-012-9325-5
PMCID: PMC3757494  PMID: 24426855
femoroacetabular impingement; femoral neck fracture; alpha angle; cam lesion
22.  Preventing and Treating Lower Extremity Stress Reactions and Fractures in Adults 
Journal of Athletic Training  2006;41(4):466-469.
Reference/Citation: Rome K, Handoll HH, Ashford R. Interventions for preventing and treating stress fractures and stress reactions of bone of the lower limbs in young adults. Cochrane Database Syst Rev.20052:CD000450. Update from Gillespie WJ, Grant I. Interventions for preventing and treating stress fractures and stress reactions of bone of the lower limbs in young adults. Cochrane Database Syst Rev.20002: CD000450.
Clinical Question: Do evidence-based interventions exist for the prevention and treatment of stress reactions and stress fractures in young active adults?
Data Sources: This systematic review is an update of the original article, which was published in 2000. The authors conducted a literature review of computerized databases that included the Cochrane Musculoskeletal Injuries Group Specialized Register (April 2004), the Cochrane Central Register of Controlled Trials, MEDLINE (1966 to September 2004), EMBASE (1988 to 2004, week 36), CINAHL (1982 to 2004, September, week 1), Index to Theses (1990 to 2004), and Dissertation Abstracts (1990 to 2004). In addition, the authors searched the Current Controlled Trials at http://www.controlled-trials.com (June 2004, week 1) and the United Kingdom National Research Registrar at http://www.update-software.com/national/ (to issue 1, 2004) for current or recently completed studies. They also reviewed the British Journal of Podiatry, International Journal of Podiatric Biomechanics, Physiotherapy, and the Australian Journal of Podiatric Medicine for relevant studies. Furthermore, they contacted the Medical Departments of Defense Forces in Europe and North America to identify unpublished or unlisted military studies. Reference lists of all identified studies and Cochrane reviews were also investigated. The computer search strategy included 61 separate entries and included such terms as stress fractures, stress reactions, shin splints, overuse, athletic injuries, cumulative trauma disorders, running, and randomized controlled trial. The 3 authors of this updated review independently selected new articles for inclusion. Furthermore, the 12 articles that were included in the original systematic review were also reevaluated to ensure they met the defined inclusion criteria.
Study Selection: To qualify for inclusion, studies had to be randomized or quasirandomized control trials, involve interventions to prevent or treat lower extremity stress reactions and fractures, and include physically active adults (adolescence to middle age) who were involved in athletics or military training. Clinical and radiographic (bone scan or x-ray) evidence of a lower extremity stress reaction or stress fracture was also required for inclusion of treatment-based studies. Specifically, skeletal overuse injuries are considered the result of a cumulative and repetitive process that produces initial microstructural changes or stress reactions that are identified by bone scans or magnetic resonance imaging but not conventional radiographs. If cumulative stresses continue, structural changes are visualized on radiographs and are referred to as stress fractures. In addition, research studies involving the treatment of medial tibial stress syndrome or shin splints were excluded. Desired outcome measures for treatment studies included return to training time, return to normal physical activity, functional performance, quality of life measures, resource management (eg, costs, health care visits, diagnostic procedures), adverse effects, and compliance.
The inclusion criteria for stress fracture prevention studies were similar, except that the authors did not have to provide radiographic evidence of a stress fracture or stress reaction. Prevention studies included a combination of the following outcome measures: occurrence and location of stress fracture, stratification of diagnosis, incidence of other lower limb injuries, complications and adverse effects of prevention techniques, resource management, and compliance with the prevention strategy.
Data Extraction: At least 2 reviewers independently extracted the demographic and outcome data from the newly identified studies, and 1 author verified the data and results from the 12 studies included in the 2000 Cochrane review. Inconsistencies from the original review and data from all new studies were also checked by an additional reviewer. All 3 reviewers then independently evaluated the quality of inclusion studies using a quality scoring scheme ( Table). The categories considered included randomization or group allocation (A), intention-to-treat analysis (B), examiner blinding (C), comparison of experimental and control groups at baseline (D), use of a placebo treatment (E), clearly defined subject inclusion and exclusion criteria (F), and methods of outcome assessments (G). Items A through F were scored from 0 to 2 and item G from 0 to 3, for a total “best” quality assessment score (QAS) of 15. Inconsistencies among reviewers' QAS scores were resolved by discussion and with the aid of a discrepancies form.
Main Results: Search criteria identified 24 new studies since the previous review, 8 of which fulfilled the inclusion criteria. In addition, 4 of the 12 studies included in the original 2000 review were excluded. Three were excluded as a result of insufficient indication of subject or group randomization or quasirandomization, and the fourth excluded study included subjects with the diagnosis of medial tibial stress syndrome. Overall, 16 studies were included.
The authors of 13 studies focused on prevention, and 3 groups evaluated the treatment of stress fractures and reactions. The average number of subjects for prevention and treatment studies, respectively, was 1091 (range = 206 to 3025) and 34 (range = 21 to 60). All 13 prevention studies involved military personnel who performed physical training over a 9-to-14–week period. Quality assessment scores for prevention studies ranged from 4 to 10 (mean score = 7). In 9 prevention studies, the effectiveness of insoles or orthoses was evaluated, and the QAS for these studies ranged from 4 to 9 (mean = 6.2). The investigators in 4 studies assessed “shock-absorbing” insoles or orthoses in shoes or boots versus a control (shoes or boots alone), and an additional 5 groups compared insoles and orthoses against one another. One study's authors also evaluated military training in a modified high-top shoe versus standard military boots (QAS = 8). Two groups assessed the influence of pre-exercise stretching (QAS = 8 and 9, respectively), and one investigated the effects of calcium supplementation (QAS = 10).
In none of the prevention studies were adequate randomization and concealment of treatment before group allocation (item A) accomplished, and the researchers in 3 studies randomized groups (team or platoon) instead of individual participants. Attrition rates exceeded 50% in 2 studies, and missing subjects' data were unaccounted for in the final analysis of 3 studies (item B, intention-to-treat analysis). Also, in only 2 of 13 studies were examiners blinded to group assignment (item C). Radiographic (bone scan or x-ray) evidence for diagnostic confirmation of a stress reaction or fracture was used in 12 studies. The method of diagnosis (item G) was based solely on clinical examination or a self-report questionnaire in 2 studies, and diagnostic methods were not described in 2 studies.
Overall fewer osseous stress injuries were reported in the experimental groups for all 4 studies comparing military personnel in “shock absorbing insoles” with controls (no insoles). However, none of these 4 studies demonstrated a statistically significant reduction in lower extremity overuse osseous injuries. In addition, statistically significant results were reported in only 1 of 5 studies that compared various orthoses and insoles. The authors reported a significant reduction in tibial stress fractures for soldiers wearing custom-made semirigid or soft-foot orthoses versus those wearing standard insoles (relative risk = 0.46, 95% confidence interval = 0.22 to 0.93). In a follow-up study, no significant difference in stress fracture rates was seen between subjects who wore custom-made semirigid orthoses and those who wore biomechanical soft orthoses, thus precluding the ability to identify one best design for stress fracture reduction. No significant stress fracture or lower extremity injury rate differences were seen between the control and experimental groups involved in lower extremity stretching studies. Participants taking calcium supplements did not demonstrate a significant reduction in stress fractures (tibial only) versus controls. The differences among the prevention studies prohibited pooling of the data and subsequent meta-analysis. Authors of all 3 treatment studies investigated the effects of a pneumatic ankle foot orthosis (Aircast Corp, Summit, NJ). Follow-up for outcome measures ranged from 78 days to 6 months. Two studies were conducted with military recruits, and the other was conducted with competitive and recreational athletes (n = 18, age range = 18 to 45 years). Treatment QASs ranged from 7/15 to 11/ 15, with an average score of 9.3/15. Proper randomization (item A) and evaluator blinding (item C) were confirmed in 1 of the 3 treatment studies. Data pooled from all 3 studies reached statistical significance for mean number of days until returning to full activities (weighted mean difference with brace versus without brace = −33.39 days, 95% confidence interval = −44.18 to −22.59 days).
Conclusions: Currently, no solid evidence-based interventions to prevent lower extremity stress reactions or fractures exist. Limited evidence suggests that “shock absorbing” insoles may reduce the overall incidence of lower extremity osseous injuries in military personnel. Unfortunately, research does not support the best design for inserts or footwear modifications. There is also insufficient evidence to determine if pre-performance stretching or calcium supplementation offers added protection from lower extremity osseous overuse injuries. Initial evidence supports the use of a pneumatic brace and early mobilization for the treatment of tibal stress reactions and fractures, but additional studies are required to validate these findings. Further investigation concerning the prevention and treatment of lower extremity stress fractures is needed and would assist researchers in establishing and clarifying evidence-based intervention guidelines. Future randomized control trials that clearly define (ie, provide clinical and radiographic evidence for) the diagnosis of a stress fracture or reaction, implement appropriate randomization, and use intervention and outcome measures (functional and performance measurements) that are appropriate for active adults would assist this ongoing and necessary process.
PMCID: PMC1748425  PMID: 17273474
athletic injuries; outcomes assessment
23.  Determinants of Mortality in Chest Trauma Patients 
Background:
Chest trauma is an important trauma globally accounting for about 10% of trauma admission and 25-50% of trauma death. Different types and severity of chest trauma in different subsets of patients with varying associated injuries result in differing outcomes measured with mortality. Early mitigation of poor prognostic factors could result in improved outcome, therefore the need to know such factors or determinants of mortality in chest trauma patients.
Patients and Methods:
Retrospective and prospective analysis of demographic details, socio-economic, clinical details, modified early warning signs (MEWS) score on presentation, investigation findings, treatment and outcome of chest trauma patients who presented to our cardiothoracic surgery unit was undertaken. Data were collected and were analyzed using WINPEPI Stone Mountain, Georgia: USD Inc; 1995 statistical software.
Results:
A total 149 patients with thoracic trauma were studied over a 5 year period constituting 40% of the unit workload. There were 121 males and 28 females (81.2% vs. 18.8%; m: f = 4:1) with age range from 7 to 76 years (mean: 37.42 ± 12.86 years) and about 55% aged 45 years or below and more blunt trauma than penetrating trauma (65.1% vs. 34.9%), but no statistical significance amongst the groups on outcome analysis. Sub-grouping of the 149 patients according to their on-admission MEWS score shows that 141 patients had scores of 9 and less and all survived while the remaining eight had scores >9 but all died. As independent variables, age, sex and type of chest injury did not prove to be correlated with mortality with P values of 0.468, 1.000 and 1.000 respectively. However presence of associated extra thoracic organ injury, high on-admission MEWS score >9, delayed presentation with injury to presentation interval longer than 24 h, and severe chest injury as characterized by bilateral chest involvement correlated positively with mortality with P values of 0.0003, 0.0001, 0.0293 and 0.0236 respectively.
Conclusion:
Associated extra thoracic organ injury, high on-admission MEWS score >9, late presentation beyond 24 h post trauma and severe chest injury with bilateral chest involvement were found to be determinants of mortality in chest trauma.
doi:10.4103/1117-6806.127107
PMCID: PMC3953631  PMID: 24665200
Chest trauma; determinants; mortality
24.  Donor Funding for Newborn Survival: An Analysis of Donor-Reported Data, 2002–2010 
PLoS Medicine  2012;9(10):e1001332.
With recent increases in development assistance money for maternal and child health, Catherine Pitt and colleagues examine whether foreign aid specifically for newborns has changed, whether it's on par with the burden of newborn deaths worldwide, and how such funding can be tracked.
Background
Neonatal mortality accounts for 43% of global under-five deaths and is decreasing more slowly than maternal or child mortality. Donor funding has increased for maternal, newborn, and child health (MNCH), but no analysis to date has disaggregated aid for newborns. We evaluated if and how aid flows for newborn care can be tracked, examined changes in the last decade, and considered methodological implications for tracking funding for specific population groups or diseases.
Methods and Findings
We critically reviewed and categorised previous analyses of aid to specific populations, diseases, or types of activities. We then developed and refined key terms related to newborn survival in seven languages and searched titles and descriptions of donor disbursement records in the Organisation for Economic Co-operation and Development's Creditor Reporting System database, 2002–2010. We compared results with the Countdown to 2015 database of aid for MNCH (2003–2008) and the search strategy used by the Institute for Health Metrics and Evaluation. Prior to 2005, key terms related to newborns were rare in disbursement records but their frequency increased markedly thereafter. Only two mentions were found of “stillbirth” and only nine references were found to “fetus” in any spelling variant or language. The total value of non-research disbursements mentioning any newborn search terms rose from US$38.4 million in 2002 to US$717.1 million in 2010 (constant 2010 US$). The value of non-research projects exclusively benefitting newborns fluctuated somewhat but remained low, at US$5.7 million in 2010. The United States and the United Nations Children's Fund (UNICEF) provided the largest value of non-research funding mentioning and exclusively benefitting newborns, respectively.
Conclusions
Donor attention to newborn survival has increased since 2002, but it appears unlikely that donor aid is commensurate with the 3.0 million newborn deaths and 2.7 million stillbirths each year. We recommend that those tracking funding for other specific population groups, diseases, or activities consider a key term search approach in the Creditor Reporting System along with a detailed review of their data, but that they develop their search terms and interpretations carefully, taking into account the limitations described.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In 1990, 12 million children—most of them living in developing countries—died before they reached their fifth birthday. Faced with this largely avoidable loss of young lives, in 2000, world leaders set a target of reducing under-five mortality (deaths) to one-third of its 1990 level by 2015 as Millennium Development Goal 4 (MDG4); this goal, together with seven others, aims to eradicate extreme poverty globally. In recent years, progress towards reducing child mortality has accelerated but remains insufficient to achieve MDG4, in part, because progress towards reducing neonatal mortality—deaths during the first 28 days of life—has been particularly slow. Neonatal deaths now account for a greater proportion of global child deaths than in 1990—43% of the 7 million children who died before their fifth birthday in 2011 died during the neonatal period. The major causes of neonatal deaths are complications of preterm and term delivery and infections. Simple interventions such as improved hygiene at birth and advice on breastfeeding can substantially reduce neonatal deaths.
Why Was This Study Done?
To achieve MDG4, more must be done to prevent deaths among newborn babies. One reason that progress in reducing neonatal mortality is slow could be insufficient donor funding (aid) for newborn health. Previous analyses by, for example, Countdown to 2015 (which tracks coverage levels for health interventions that reduce maternal, newborn, and child mortality) indicate that donor funding has increased for maternal, newborn, and child health over the past decade, but how much of this aid directly benefits newborns is unknown. Here, the researchers develop a method for tracking aid flows for newborns and examine changes in this flow over the past decade by applying their new strategy to the Organisation for Economic Co-operation and Development (OECD) Creditor Reporting System (CRS) Aid Activity database. This database collects information about official development assistance for health given (disbursed) to developing countries by member countries of the OECD Development Assistance Committee, international organizations, and some private donors.
What Did the Researchers Do and Find?
The researchers developed a comprehensive set of search terms related to newborn survival by piloting it on the Countdown to 2015 official development assistance database, which covers the years 2003–2008. They then used their list of 24 key terms to search the CRS database from 2002 (the first year for which relatively complete disbursement data are available) to 2010 (the most recent year for which data are available) and classified each retrieved project according to whether its funding activities aimed to benefit newborns exclusively or to improve the health of other population groups as well. The researchers found that key terms related to newborns were rare in disbursement records before 2005 but that their frequency increased markedly thereafter. The total value of non-research disbursements (aid provided for programmatic or advocacy activities) that mentioned any newborn search terms increased from US$38.4 million in 2002 to US$717.1 million in 2010. The value of non-research projects that exclusively benefitted newborns fluctuated; in 2010, it was $US5.7 million. Finally, the US and United Nations Children's Fund (UNICEF) provided the largest value of non-research funding mentioning newborns and exclusively benefitting newborns, respectively.
What Do These Findings Mean?
These findings indicate that the value of aid disbursements mentioning newborns or an activity likely to benefit newborns increased 20-fold between 2002 and 2010 and constituted an increasing proportion of aid for maternal, newborn, and child health. Although this increase may partly reflect increased detail in aid disbursement reporting, it is also likely to reflect an increase in donor attention to newborn survival. The accuracy of these findings is likely to be affected by limitations in the search strategy and in the CRS database, which does not capture aid flows from emerging donors such as China or from many private foundations. Moreover, because these findings take no account of domestic expenditure, they do not provide a comprehensive estimate of the value of resources available in developing countries for newborn health. Nevertheless, investment in newborn survival is unlikely to be commensurate with global newborn mortality. Thus, an expansion of programmatic funding from donors as well as increased governmental support for newborn health in developing countries is urgently needed to catalyze the scale-up of cost-effective interventions to save newborn lives and to meet MDG4.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001332.
The United Nations Childrens Fund (UNICEF) works for children's rights, survival, development, and protection around the world; it provides information on Millennium Development Goal 4 and its Childinfo website provides detailed statistics about child survival and health, including the 2012 report of UN Inter-agency Group of Child Mortality Estimation; its Committing to Child Survival: a Promise Renewed webpage includes links to its 2012 progress report, to a video about progress made in reducing child deaths worldwide, and to stories about child survival in the field
The World Health Organization has information about Millennium Development Goal 4 and about maternal, newborn, child, and adolescent health (some information in several languages)
Countdown to 2015 provides additional information on maternal, newborn, and child survival, including its 2012 report Building a Future for Women and Children
The Healthy Newborn Network (HNN) is a community of more than 70 partner organizations addressing critical knowledge gaps for newborn health providing recent data on newborn survival and analyses of country programs
Information on and access to the Organisation for Economic Co-operation Development Creditor Reporting System Aid Activities database is available
Further information about the Millennium Development Goals is available
doi:10.1371/journal.pmed.1001332
PMCID: PMC3484125  PMID: 23118619
25.  Perineal care 
Clinical Evidence  2011;2011:1401.
Introduction
Over 85% of women having a vaginal birth suffer some perineal trauma. Spontaneous tears requiring suturing are estimated to occur in at least a third of women in the UK and US, with anal sphincter tears in 0.5% to 7% of women. Perineal trauma can lead to long-term physical and psychological problems.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of intrapartum surgical and non-surgical interventions on rates of perineal trauma? What are the effects of different methods and materials for primary repair of first- and second-degree tears and episiotomies? What are the effects of different methods and materials for primary repair of obstetric anal sphincter injuries (third- and fourth-degree tears)? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 38 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: active pushing, spontaneous pushing, and sustained breath-holding (Valsalva) method of pushing; continuous support during labour; conventional suturing; different methods and materials for primary repair of obstetric anal sphincter injuries; episiotomies (midline and mediolateral incisions); epidural analgesia; forceps; methods of delivery ("hands-on" method, "hands poised"); water births; non-suturing of muscle and skin (or perineal skin alone); passive descent in the second stage of labour; positions (supine or lithotomy positions, upright position during delivery); restrictive or routine use of episiotomy; sutures (absorbable synthetic sutures, catgut sutures, continuous sutures, interrupted sutures); and vacuum extraction.
Key Points
Over 85% of women having a vaginal birth suffer some perineal trauma. Spontaneous tears requiring suturing are estimated to occur in at least one third of women in the UK and US, with anal sphincter tears in 0.5% to 7% of women.Risk factors include first vaginal delivery, large or malpositioned baby, older or white mother, abnormal collagen synthesis, poor nutritional state, and forceps delivery.
Perineal trauma can lead to long-term physical and psychological problems. Up to 10% of women continue to have long-term perineal pain; up to 25% will have dyspareunia or urinary problems, and up to 10% will report faecal incontinence.
Restricting routine use of episiotomy reduces the risk of posterior perineal trauma. Using episiotomies only when there are clear maternal or fetal indications increases the likelihood of maintaining an intact perineum, and does not increase the risk of third-degree tears.
We don't know whether pain or wound dehiscence are less likely to occur with midline episiotomy compared with mediolateral incision. Midline incisions may be more likely to result in severe tears, although we can't be sure about this.
Instrumental delivery increases the risk of perineal trauma. The risk of instrumental delivery is increased after epidural analgesia. Vacuum extraction reduces the rate of severe perineal trauma compared with forceps delivery, but increases the risk of cephalhaematoma and retinal haemorrhage in the newborn.
Continuous support during labour reduces the rate of assisted vaginal births, and thus the rate of perineal trauma.
The "hands-poised" delivery method is associated with lower rates of episiotomy, but increased rates of short-term pain and manual removal of the placenta. Likewise, an upright position during delivery is associated with lower rates of episiotomy, but no significant difference in overall rates of perineal trauma.
Non-suturing of first- and second-degree tears (perineal skin and muscles) may be associated with reduced wound healing up to 3 months after birth. However, leaving the perineal skin alone unsutured (vagina and perineal muscles sutured) reduces dyspareunia and may reduce pain at up to 3 months.
Absorbable synthetic sutures for repair of first- and second-degree tears and episiotomies are less likely to result in long-term pain than catgut sutures. Rapidly absorbed synthetic sutures reduce the need for suture removal. Continuous sutures reduce short-term pain.
Early primary overlap repair for third- and fourth-degree anal sphincter tears seems to be associated with lower risks for faecal urgency and anal incontinence symptoms than end-to-end approximation.
We don't know whether immersion in water during the first or second stage of labour has any effect on rates of perineal trauma or whether passive descent is better than active pushing.
It is unclear whether the sustained breath holding (Valsalva) method is more effective at reducing rates of perineal trauma compared with exhalatory or spontaneous pushing.
PMCID: PMC3275301  PMID: 21481287

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