Antenatal preparation programmes are recommended worldwide to promote a healthy pregnancy and greater autonomy during labor and delivery, prevent physical discomfort and high levels of anxiety. The objective of this study was to evaluate effectiveness and safety of a birth preparation programme to minimize lumbopelvic pain, urinary incontinence, anxiety, and increase physical activity during pregnancy as well as to compare its effects on perinatal outcomes comparing two groups of nulliparous women.A randomized controlled trial was conducted with 197 low risk nulliparous women aged 16 to 40 years, with gestational age ≥ 18 weeks. Participants were randomly allocated to participate in a birth preparation programme  or a control group . The intervention was performed on the days of prenatal visits, and consisted of physical exercises, educational activities and instructions on exercises to be performed at home. The control group followed a routine of prenatal care. Primary outcomes were urinary incontinence, lumbopelvic pain, physical activity, and anxiety. Secondary outcomes were perinatal variables.The risk of urinary incontinence in BPP participants was significantly lower at 30 weeks of pregnancy  and at 36 weeks of pregnancy . Participation in the BPP encouraged women to exercise during pregnancy (p=0.009). No difference was found between the groups regarding to anxiety level, lumbopelvic pain, type or duration of delivery and weight or vitality of the newborn infant.The BPP was effective in controlling urinary incontinence and to encourage the women to exercise during pregnancy with no adverse effects to pregnant women or the fetuses.NCT01155804)Clinicaltrials.gov, ( Antenatal preparation programmes involve several techniques and activities performed by different healthcare professionals. The main aims of antenatal preparation programmes are to promote healthy practices, minimize excessive anxiety and prevent or minimize the discomforts of pregnancy and labor. Such programmes may include educational activities, physical exercise and psychoprophylactic techniques, among others. Despite the fact that such programmes are recommended in different parts of the world, Gagnon and Sandall in a systematic review found no evidence regarding the benefits of general antenatal education for childbirth .The practice of regular physical exercise during pregnancy with the objective of keeping women healthy during pregnancy is recommended by the American College of Obstetricians and Gynecologists (ACOG) , and canInvestigations have been conducted to evaluate whether exercise during pregnancy is able to reduce discomfort resulting from lumbopelvic pain and decrease the occurrence of urinary incontinence. Pennick and Young  in a sysAnxiety during pregnancy has been related to adverse outcomes, such as fetal distress, premature labor, low birth weight, and problems in child development -16. KhiaInformation related to the effect of antenatal preparation programmes on perinatal outcomes is scarce. Some studies have suggested that a shorter duration of labor and a reduction in Cesarean section (C-section) rates is important to improve perinatal outcomes ,18. The The objective of this study was to evaluate the effectiveness and safety of a birth preparation programme (BPP) to minimize lumbopelvic pain, urinary incontinence, anxiety, and increase physical activity during pregnancy, as well as, to compare its effects on perinatal outcomes comparing two groups of nulliparous women.A prospective, randomised, controlled clinical trial was conducted at the Women’s Integral Health Care Hospital (CAISM), University of Campinas (UNICAMP) and four municipal primary healthcare centers in Campinas, São Paulo between June 2009 and September 2011. The study was approved by the Institutional Review Board. The eligible women were recruited at the same time as the first data collection was performed and after the explanation about the study they had a time to consider participation or not. Those who agreed to participate gave their written consent prior to being included in the study.Primary outcomes were: lumbopelvic pain, urinary incontinence (UI), anxiety, and physical activity performed at home.Sample size was calculated based on the occurrence of lumbar pain in a previous study  . The priThe inclusion criteria were: pregnant women with a single fetus, age 16 to 40 years and gestational age 18 to 24 weeks. The exclusion criteria were: pathological conditions prior to pregnancy ; pathological conditions of the pregnancy , contraindications to the practice of physical activity  or indication for elective C-section .st and 5th minute Apgar scores, and perinatal results were obtained from the participants’ medical records. To evaluate the adherence of the intervention group with the exercises to be performed at home, a diary was given to each woman to record the activities performed. The women were instructed to bring the diary back to the clinic on follow-up visits.Data collection during pregnancy was performed on the days of medical visits at: 18–24 weeks of pregnancy at admission to the study; 28–30 weeks of pregnancy  and at 36–38 weeks of pregnancy . Anxiety was evaluated through the state-trait anxiety inventory (STAI), validated for use in Brazil . AnxietyPrior to randomisation, all the participants completed the STAI and the PPAQ, and their sociodemographic and obstetric data were collected. To guarantee that the allocation to groups remained concealed until women were admitted to the study; randomisation was done by opening a sealed, opaque, consecutively numbered envelope containing the information on the group to which the participant was being allocated in accordance with a previously prepared, computer-generated random sequence of numbers. The randomisation was 1:1, and the process and preparation of the envelopes containing the information were carried out by a person who was not directly involved with the study. Participants received only reimbursement of expenses related with participation in the study.The women assigned to the control group participated in educational activities routinely offered at the prenatal clinics where they received prenatal care. These activities consisted of information provided by the nursing staff on breastfeeding, the signs and symptoms of labor and a visit to the delivery ward. During labor, at the maternity ward, non-systematic information on the use of non-pharmacological pain relief techniques was provided by trained physiotherapy, nursing and medical staff.Women of the intervention group participated in the physical and educational activities of the BPP conducted in addition to routine activities offered at the prenatal clinic, on the same days of the prenatal visits, in order to minimize the difficulties women from low resource settings have to attend health education activities organized otherwise. During the meetings of approximately 50 minutes women performed non aerobic exercises of a protocol adapted for pregnancy and designed to attempt to reduce back pain, possibly to help venous return and to prevent UI and minimize anxiety Table . At the During BPP meetings information was provided on the prevention of pain in pregnancy, the role of the pelvic floor in pregnancy, delivery and in the postpartum, the physiology of labor, breathing exercises for delivery, and non-pharmacological pain control techniques during labor. Participants received a guide with the exercises to be performed daily at home, consisting of: pelvic floor muscle training (PFMT) including rapid (30 times) and sustained maximal contractions (20 times holding for 10 seconds), stretching exercises to reduce back pain and exercises to improve venous return in the lower limbs. The women were also encouraged to practice aerobic exercise daily for at least 30 minutes and received written information based on the ACOG guidelines [The activities performed in the BPP were planned and structured specifically for the study and supervised by trained physiotherapists who worked exclusively for the study. The birth preparation programme meetings were held on the same days of prenatal visits on a monthly basis up to 30 weeks of pregnancy, fortnightly between 31 and 36 weeks of pregnancy and weekly from 37 weeks of pregnancy onwards. Meetings were either conducted as open group or individual sessions; the modality depended on the number of women present.t-test were used for the continuous variables and the χ2 test and Fisher’s exact test for the categorical variables. For categorical dependent variables, risk ratios (RR) were calculated, together with their respective 95% confidence intervals (95%CI). For numerical dependent variables, mean differences and their respective 95%CI were also estimated. Significance was established at p<0.05.Analysis was performed according to the group to which participants were assigned, on an intention-to-treat basis. To test the differences between the groups, the Mann–Whitney test and Student’s For the study, 208 eligible pregnant women were identified. Three women refused the invitation to participate and 205 women were randomised into the intervention and control groups. Eight women were excluded post-randomisation. A total of 197 women participated in the study, 97 allocated to the intervention group and 100 to the control group. Figure When compared baseline data, a significant reduction was reported in the number of complaints of UI by the women in the BPP group 41%), whereas in the control group the number of complaints increased at the final evaluation (68%) Table . The num1%, whereAnxiety level was similar in both groups throughout pregnancy, being low/moderate (scores between 20 and 49) in the majority of women at the three evaluations. The Table This study evaluated a birth preparation programme linked to women’s visits to the clinic for prenatal care that included various interventions: general supervised exercise, information on performing aerobic and local exercises at home and educational activities. The main findings showed that a systematically performed programme with clear objectives exerts a positive effect by reducing complaints of UI and increasing the practice of physical exercise throughout pregnancy.In relation to the prevention and control of UI during pregnancy, these findings are in agreement with the results of a systematic review  that shoRegarding the practice of exercise, prevalence studies showed that women do not tend to comply with the guidelines recommended by ACOG for the practice of exercise , performOn the other hand, the BPP had no effect on relieving or preventing lumbopelvic pain. Other studies have shown that specific exercises to reduce pain in the lumbopelvic region were effective when the exercise was supervised and practiced once a week or once a fortnight -34. In tAt the end of pregnancy, anxiety levels may increase as labor approaches . NeverthOne limitation of this study was that the attempt to evaluate adherence by asking the women in the study to complete an exercise diary was not successful since women failed to complete their diaries and consequently it was not possible to perform an analysis of adherence. Also another possible limitation was the loss to follow-up due, in some cases, to the fact that some participants delivered their babies at other facilities and in other cases to the loss of contact with some of the participants, which hampered evaluation of the secondary data. Another limitation may lay on the fact that the study was not blinded, what could have resulted in women giving “right answers” to questions regarding urinary incontinence and practice of physical exercise as a courtesy bias. However, if this was the case, the same could be expected for answers concerning lumbopelvic pain and anxiety, but this did not happen at all.The results of this study may contribute towards improving birth preparation programmes; however, further studies are required to establish the most effective techniques for reducing lumbopelvic pain. Further evaluation also needs to be made of the ideal number of meetings and how frequently they should take place for a programme including different types of interventions.This BPP was effective in preventing and controlling UI and in encouraging women to exercise during pregnancy, while preserving maternal and fetal health; however, the program failed to control lumbopelvic pain, and had no effect on perinatal outcome.This study was approved by the Institutional Review Board of the School of Medicine, State University of Campinas (UNICAMP) under registration number 407/2008 on 24 June 2008. The study was also registered at clinicaltrials.gov (NCT01155804).RCT: Randomized controlled trial; BPP: Birth preparation program; CG: Control group; RR: Risk ratio; CI: Confidence interval; ACOG: the American College of Obstetricians and Gynecologists; CAISM: Women’s integral health care hospital; UNICAMP: University of Campinas; PPAQ: Pregnancy physical activity questionnaire; STAI: State-trait anxiety inventory; PFMT: Pelvic floor muscle training; MET: Metabolic equivalent.The authors declare that they have no competing interests.MAM participated in designing the research project, was involved in the data collection, in the interpretation of the results and writing of the manuscript. MYM participated in designing the research project, interpreting the results and preparing the manuscript. JGC contributed to the final editing of the research project, interpretation of the results and preparation of the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2393/13/154/prepub


Background. In a large randomised controlled trial of acupuncture, counselling, or usual care for depression, we document the acupuncture intervention and explore the relationship between traditional acupuncture diagnosis and outcome. Methods. Patients who were continuing to experience depression were recruited from primary care to the ACUDep trial (n = 755). Practitioners documented for each patient the traditional Chinese medicine diagnosis, the points needled, and additional components of the treatment, such as lifestyle advice, as recommended by the STRICTA guidelines. Results. Over an 18-month period, 23 acupuncturists delivered 2741 treatments to 266 patients, an average of 10 sessions per patient. The primary and secondary zang fu syndromes were identified for 99% of patients. When combining primary and secondary diagnoses, there was a predominant Liver Qi Stagnation cluster (66% of patients) and a Spleen Deficiency cluster (34%). Practitioners sought de qi responses 96% of the time. Lifestyle advice was given to 66% of patients, most commonly dietary. When comparing patient outcomes, no significant differences were found between the two main syndrome clusters. Conclusion. In this large-scale trial, our documentation of diagnosis and treatment provides a useful snapshot of common patterns that patients present with when continuing to experience depression after consulting in primary care. Trials of acupuncture have often been criticised for providing insufficient details of the intervention . It was Acupuncture when practiced according to traditional principles and delivered in routine care is often described as a complex intervention . The mulAccordingly, in this paper we report in depth on the acupuncture intervention that was provided within a large trial of acupuncture and counselling for depression, including the methods used to develop the treatment protocol, the additional processes required given the severity of the depression at baseline, and the relationship between diagnosis and outcome.In a three-arm pragmatic randomised controlled trial, we randomised patients to acupuncture, counseling, and usual care as interventions in the proportions of 2 : 2 : 1, respectively. This trial was designed to evaluate whether referral of people who had consulted in primary care with depression, yet continued to be depressed, and were seeking alternatives would benefit or not from a referral to acupuncturists who practised in the style of traditional Chinese medicine. This trial design is an open one, with no patient blinding, because our research question was not seeking to separate out specific from nonspecific effects but rather to evaluate overall benefit. Eligible participants were 18 or over, had consulted their general practitioner with depression within the past 5 years, and were continuing to experience “moderate” to “severe” depression with a score of 20 or above on the Beck Depression Inventory (BDI-II) at baseline . Ethical approval was obtained in October 2009 .  with at least three-year postqualification experience. Members of the BAcC have completed a three-year  degree level qualification in acupuncture. We documented the gender of participating acupuncturists, the duration of their initial training in acupuncture, and their postqualification years in practice.An acupuncture treatment protocol was established prior to the trial, based on a series of pretrial activities. These activities were developed in a way that was consistent with the Medical Research Council's guidelines on developing and evaluating complex interventions . Firstly Take each patient's history including past medical history, recent medical history, medication usage, and detailed summary of his/her depression and related symptoms. Examine each patient using the TCM diagnostic assessments you find appropriate .zang fu, eight principles, and four levels). Make a diagnosis based on the TCM pattern of differentiation you find appropriate . Note that the treatment principle may vary for each treatment and that these guidelines allow for such variation. Design a treatment strategy that incorporates the treatment principle and that aims to accomplish the treatment objective. Select acupuncture points and adjunctive therapies (see below) that are suitable for each patient's condition and treatment strategy. These may be modified at subsequent treatment sessions as appropriate.Additional therapies that may be used are restricted to the following: cupping, ear seeds, electrical stimulation, moxa or moxa essence, heat lamp, acupressure (not more than 10 minutes).Note that the use of herbs and magnets is not permitted in the trial. Use acupuncture needles that are of the appropriate length and gauge for the points selected and patient being treated. Insert acupuncture needles using your chosen method of insertion and to the depth you determine is appropriate for the point location and patient.de qi). Use needling techniques which correlate with the treatment principle and which elicit the desired response  that supplement each patient's treatment strategy according to the appropriate theory for that therapy. Provide appropriate lifestyle advice according to each patient's needs and your clinical judgement, such that the only advice given is based on acupuncture theory. Note that advice that is not related to acupuncture theory is proscribed. Answer any questions the patients may have about what to expect from acupuncture treatment, their diagnoses, and their prognoses. Where appropriate, explain to each patient about his/her condition from a TCM point of view. Discuss the treatment plan with each patient being sure to include information about the number and frequency of treatments based on his/her needs. Keep in mind that only 12 treatments are funded by the trial and that it is expected that all treatments are completed within 18 weeks of the first treatment. If the patient does not attend a session, please follow the procedures. Discuss and agree on reasonable expectations with each patient regarding his/her acupuncture treatment. Make the patient aware of possible reactions to treatment and that symptoms may worsen initially. Adverse events need to be reported. Record and interpret patients' adverse reactions to acupuncture treatment. Refer patients to their general practitioner or appropriate health care professional if you become concerned about worsening of symptoms or the appearance of new symptoms, or if patients have questions about their prescribed medication. In the event that you become concerned about the safety of your patient, or someone else close to them whom you feel may be at risk, then you must follow the procedures related to suicide intent.  Record the points used, adjunctive therapies, and lifestyle advice in the Acupuncture Treatment Log for each patient at each session. At the last session complete the last page of the log which requests information on patient outcome, as well as details of the theoretical framework(s) that you would define as central to your course of treatment for this patient.The following is a list of processes that the acupuncturists agreed to follow as a guide to their treatment of patients in the trial, while treating patients as closely as possible to how they normally would.To ensure that acupuncturists had the necessary awareness of the level of risk of suicide or self-harm, we asked the acupuncturists to complete the Patient Health Questionnaire (PHQ-9)  with parzang fu syndromes, eight extra vessels, six divisions, five elements, Qi, blood, body fluids, eight principles, four levels, and pathogenic Factors [zang fu syndromes were utilised, we asked practitioners to identify both the primary and the secondary syndromes.The acupuncturists provided up to 12 sessions for each patient usually weekly, with scope for more frequent sessions early in the course of treatment and less frequent in the later stages. Practitioners recorded the overall length of time for each session, including all consulting time. The primary theoretical frameworks of traditional Chinese medicine, which were prespecified within the trial documentation, were  Factors . Where zde qi sensation), and the provision of specific needle stimulation methods. We collected data from each acupuncturist on these aspects of their treatment as an average over all the patients whom they treated in the trial, as well as information on the material of the acupuncture needles they used and their diameter and length.The choice of acupuncture points was determined by each acupuncturist at each session, on the basis that it was driven by traditional acupuncture theory and designed to alleviate the symptom complex defined by the acupuncture diagnosis. Acupuncturists also decided on a patient-by-patient and session-by-session basis the depth of needle insertion, the local response elicited  testing. A probability of In total, 755 participants were recruited and randomised within the ACUDep trial between November 2009 and April 2011. Of these, 302 were allocated to acupuncture. The research team were able to contact only 285 patients within the acupuncture group to organise their first appointment for treatment and 266 received at least one treatment. Patients in the acupuncture group received a total of 2741 treatments. Based on the 302 patients randomised, this equates to a mean take-up of 8 sessions of the 12 allocated per patient. However, with only 266 taking up the offer of acupuncture, this equates to a mean of 10 sessions attended. zang fu syndromes. Practitioners were asked to record all of the theoretical frameworks of traditional Chinese medicine that guided their diagnosis and treatment for each patient . The prezang fu diagnosis, practitioners were asked to record the primary zang fu syndrome. In total 38 syndromes were recorded (zang fu” syndromes. The remaining syndromes were grouped into the 7 categories. The most common cluster of primary syndromes reported was those related to Liver Qi Stagnation (41%), followed by Spleen Deficiency (16%) and Heart Deficiency (8%). For each patient with a recorded . On extrzang fu syndromes were also reported by practitioners. These presented a similar picture to the primary syndromes, with Liver Qi Stagnation providing the most common secondary diagnosis (25%), followed by Spleen Deficiency (18%) and Kidney Deficiency (10%). When accounting for both primary and secondary patterns, 66% of participants were diagnosed with some degree of Liver Qi Stagnation, 34% with some degree of Spleen Deficiency, and 18% with Kidney Deficiency. Secondary Practitioners reported their prescription of acupuncture points for each patient at each session. In total, 246 individual acupuncture points were used across all patients in all sessions. A total of 21,055 point locations were needled, with the 20 most common being listed in de qi response  and used varying methods of stimulation for each patient. The methods used were Tonifying , Reducing  and Even methods . The majority of practitioners sought a n = 2), musculoskeletal stretches (n = 1), and herbal lotion application to reduce swelling and pain (n = 1).The treatment protocol guidelines generated for the trial allowed the use of adjunctive interventions. This was inclusive of additional therapies, lifestyle advice, and nonprotocol interventions. The most commonly used additional therapies were acupressure , moxibustion , and electroacupuncture . Of the 266 patients, 176 (66%) were given some form of lifestyle advice. The most common lifestyle advice given was dietary, which was given to 113 participants (42%). This was followed by exercise advice  and relaxation advice . The most common dietary advice given was for the regulation and tonification of Spleen function, resolving of Damp and Phlegm based pathology, and tonification of Blood and Yin. Practitioners reported that they gave nonprotocol advice to 4 (2%) of the 266 patients, comprising referral to a counsellor or psychologist  or with Spleen Deficiency (n = 43). When comparing the two syndrome clusters in relation to gender using a chi-squared test, a weak trend suggested that women more commonly experienced depression with symptoms related to Spleen Deficiency whereas men's experience of depression was more likely to be related to Liver Qi Stagnation . We found no association between the two syndrome clusters and patient's age, whether they experienced concurrent pain at baseline, baseline PHQ-9 score, whether taking antidepressant medication at the time of recruitment, or whether patients had had any thoughts that they would be better off dead or hurting themselves in some way at the outset. Using ANCOVA we found that the reported change in PHQ-9 scores between baseline and 3 months was not significantly different between the two syndrome clusters (F = 0.197(df2) P = 0.821). Both groups saw an improvement of 5 to 6 points on the PHQ-9 scale.In terms of the two main syndrome clusters, we found some variation in acupuncture points used; see Acupuncturists, when utilising the principles of traditional Chinese medicine, will routinely individualise their treatments because of the inherent variations in their patients. Treatments provided within pragmatic trials of acupuncture usually allow practitioners to vary their treatments in this regard. However, in any clinical trial, we do need a description of the intervention, in order to know what to ascribe any putative outcome to. We have utilised a method of standardisation proposed by Hawe et al. for complex interventions, in which the function and process of the intervention are standardised, thus allowing flexibility in the delivery of treatment, provided it is guided by theory . In thisOur documentation of the syndromes diagnosed by the practitioners adds to our understanding of depression. From the perspective of traditional Chinese medicine, two syndrome clusters were commonly reported among the cohort of people in the trial with depression. The first of these clusters centres on Liver Qi Stagnation and Liver Yang Rising, for which typical symptoms along with depression might include irritability, frustration, restlessness, alternating moods, distension of the hypochondrium, and variations in muscle tension related to stress, especially around the shoulders . The secIn this study, we have relied on self-reports of the practitioners. Data was recorded in detailed logbooks supported by a guidance manual that set out the scope of practice, both of which were developed through a consensus process. We have assumed the accuracy of these self-reports and have no reason to doubt their veracity. In order to gain some assessment of how well the practitioners adhered to the treatment protocol, the logbooks provided the option for the practitioner to vary treatment beyond what was specified in the protocol if the variation was considered essential to the patient's treatment. These variations to the protocol were reported by the practitioners to have occurred five times. While this does in some small way compromise the integrity of the treatments provided, the fact that it happened so rarely in a cohort of 266 patients gives some support to the contention that the treatment protocol allowed practitioners to provide care that was close to their routine practice.With regard to generalisability, we found that 96% of the practitioners in the trial reported applying acupuncture in exactly the same way or similarly compared to their routine practice outside the trial. In terms of styles of practice, 86% of British Acupuncture Council practitioners provide traditional Chinese medicine (TCM) [In this paper, we have reported on 2741 treatments delivered to 266 patients receiving acupuncture from 23 practitioners. The most common syndrome cluster was that of Liver Qi Stagnation, followed by Spleen Deficiency. We found no significant differences in outcome between patients diagnosed to be within these two clusters. We found that 96% of the practitioners in the trial reported applying acupuncture in exactly the same way or similarly compared to their normal practice outside the trial. Full reporting of acupuncture treatment data, such as presented in this paper, enhances interpretation of the trial results.


It is concluded that workers perceive risks, and that they tend to relate risks with the occurrence of occupational accidents as an indicator of the dangerous nature of their work environment.The present study aimed to identify the perceptions of gas station workers about physical, chemical, biological and physiological risk factors to which they are exposed in their work environment; identify types of occupational accidents involving gas station workers and; report the development of a socioenvironmental intervention as a tool for risk communication to gas station workers. A quantitative study was performed with 221 gas station workers in southern Brazil between October and December 2010. Data collection was performed between October to December 2010 via structured interviews. The data were analyzed using SPSS 19.0. The participants identified the following risk types: chemical (93.7%), physical (88.2%), physiological (64.3%) and biological (62.4%). In this sample, 94.1% of gas station workers reported occupational accidents, and 74.2% reported fuel contact with the eyes ( This paper discusses the perceptions of gas station workers of the risks they are exposed to in their work environment. It also presents the occurrence of accidents in this environment and the development of a socioenvironmental intervention as a tool for risk communication (RC) to gas station workers.The motivation for the proposed research came from a literature review about the theoretical approach of risk perception ,2,3. On According to the theoretical orientation this research assumed, the notion of risk perception involves two factors: the magnitude of the potential loss and the probability of its occurrence , in otheRisk perception encompasses both personal and work environment-related ideas and constructs, because to perceive it, you have to believe it . TherefoRC is here understood as an interactive process of exchange of information and opinion among individuals, groups, and institutions . RC can Another theoretical orientation is a classification of different risk factors that the gas station workers are exposed to. Therefore, we used the Act of 16 June 1999  that proetc., which the gas station workers come into contact due the diversity of clients of the local population and immigrants from other regions, characteristics of the port region of the study, the lack of hand hygiene of workers and non-use of individual protective devices. Physiological risk factors are repetitive movements of the same type, such as those performed by employees of gas station to supply the vehicles. These factors can create or worsen occupational diseases and accidents, which depend on the nature of risk, the degree of exposure, a lack of protective measures, work conditions and rhythms and the worker’s function [Physical risk factors to which workers are exposed on gas station include noise from vehicles, extreme air temperatures (hot and cold) during the seasons with extreme temperatures characteristic of the studied region. Chemical risk factors include contact with the fuel, more specifically, with the chemical benzene. Biological risk factors include bacteria, viruses, fungi, function . An occufunction .Gas stations offer favorable conditions for occupational accidents. In this place it is possible to identify health problems related to noise, favoring irritability of the worker; physical stress and decreased hearing acuity , among oFor these reasons, the present study aimed to identify the perceptions of gas station workers about physical, chemical, biological and physiological risk factors to which they are exposed in the work environment; identify types of occupational accidents involving gas station workers and report the development of a socioenvironmental intervention as a tool for RC to gas station workers.This study consisted of two phases. The first phase was a quantitative, exploratory and descriptive study involving gas station workers, conducted in 2010 in Rio Grande . The second phase consisted of the report of a socioenvironmental intervention as a tool for RC to workers enrolled in this study, from the results obtained in the exploratory study, conducted in 2011 in the same region.“Health, Risks and Occupational Diseases: An Integrated Study in Different Work Environments” [This study is a part of a larger research project entitled onments” . It was The study subjects were gas station workers in Rio Grande . Of the 34 gas stations that were invited, 22 agreed to participate. Of the total 340 workers, 221 agreed to participate in the first phase of the study, representing a response rate of 65%. For the second phase, consisting of a socioenvironmental intervention as a tool for RC, all participants of the first phase were asked (221 gas station workers). Although there was insistence for mobilization, nine representatives of three gas stations participated. In addition to the gas station workers, six members of the research group LAMSA also participated, as mediators of the socioenvironmental intervention.The first phase of the study was conducted based on the following questions: how gas station workers perceived the risks to which they are exposed in the work environment and which occupational accidents gas stations reported as incurred by them in the work environment? From the theoretical basis assumed in the study, we assumed the existence of a relationship between risk perception and accident involvement by gas station workers. Data collection was performed between October to December 2010, through a structured interview from a questionnaire composed of mixed questions—open, multiple-choice and single-choice. It is noted that for this study, open questions have not been used, which are to be composed from data sources in future publications.The structured questionnaire had multiple-choice and single-choice questions corresponding with the following variables: participant characteristics ; duration of occupational exposure ; risk perception among workers ; and the occurrence of occupational accidents self-reported by workers.For organization of socioenvironmental intervention, we began with the characterization of the research subjects (structured questionnaire) and scientific research in the literature to support the targeted intervention to the risks in the gas station work environment.The research was structured primarily based on Diseases Work-Related Manual, U.S. EPA. Toxicological Review of Benzene, Act of 16 June 1999, and IARC Monographs on the evaluation of carcinogenic risks to humans and the Prevention Report of RC ,11,22,23After analysis of this data, we decided to structure a plan for a Production Health Workshop, which included the topics: occupational risk generated by chemical, physical, biological and physiological factors; risk perception and occupational accidents, prevention of accidents or health problems. To work out these issues, we focused on the approach of the theme perception of risk factors  to which gas station workers are exposed and accidents arising from the characteristics of the work done by them, through discussion with workers about Personal Protective Devices (PPD) that could minimize the risk exposure of the work environment risks and possible strategies identified by workers to minimize work risks.To finalize the socioenvironmental intervention workers were offered a coffee-break with orange juice, water, biscuit and sandwiches. These foods served to emphasize the dialogue on healthy eating with a focus on increasing the natural body’s defenses.The questionnaire’s reliability was assessed with Cronbach’s alpha, which was 0.96, indicating that variance in the scores is explainable. The Statistical Package for Social Sciences (SPSS) software Version 19.0 was used to organize and analyze the data. We started by descriptive analysis and further inferential analysis was performed. We used Fisher’s exact test to verify the existence of an association between perceived risk and occurrence of accidents. Analyzes the influence of exposure time on the occurrence of occupational accidents and worker’s risk perception were performed using Mann-Whitney test.The sample included 221 workers from 22 (65%) gas stations in a southern Brazilian town. Most workers  were male; 189 (85.9%) were ethnically white; and 115 (52%) were single. Their ages ranged from 19 to 64 years, with an average of 30.25 years (±9.58), and 111 (50.2%) had finished secondary school .The results of the questionnaire on risk perception in the work environment showed that 207 (93.7%) workers identified chemical risks, 195 (88.2%) identified physical risks, 142 (64.3%) identified physiological risks and 138 (62.4%) identified biological risks. Among the risk factors identified, the most frequent was contact with chemical products in the workplace, cited by 176 (79.6%) workers .The self-reported risks were correlated with the duration on the job, and higher rates of risk perception were found among individuals with lower work durations . These rOccupational accidents were reported by 94.1% (208) of the participants . The mosp = 0.012) for contact of fuel with the eyes. For those with longer exposure to fuel, the risk for this type of occupational accident was greater.The self-reported occupational accidents were adjusted for duration of exposure and showed a significant difference (p = 0.05), as did the full set of risks grouped together (p = 0.029).The self-reported  risk factors were adjusted for the occurrence of occupational accidents per risk type and the full set of risks. In the first case, the chemical and biological risks exhibited significant differences . Besides the numerical limit, the socioenvironmental intervention was developed without participation of the workforce managers. Under these circumstances, we consider this as a pilot socioenvironmental intervention for RC which could be repeated with other groups of workers exposed to similar working conditions. Also, as mentioned this practice included the Health Production in Different Work Environments Program (HPDWEP), of LAMSA, School Nursing, Federal University of Rio Grande/Brazil. The HPDWEP consists of a set coordinated actions and continuous shaft in promoting social and environmental health in different work environments, whose environments are included in the study group’s academic LAMSA. The debate during the socioenvironmental intervention is summarized in The socioenvironmental intervention was developed based on the RC concept ,2,3,24. To trigger the development of communication (first step) with the workers who are participating of the intervention, we used the question: What are the risks that you identify in your workplace? We asked that workers imagine their workplace to respond to the question. The responses were expressed in a mural with colors corresponding to the classification of risk factors. This allowed the demonstration of workers through comparisons, considerations and suggestions of the theme. Visualization of risk factors from the colors allowed us to show the predominance of chemical risk factors as the main theme, to continue the RC process. We noted that this was corroborated in other studies as a risk factor of greatest potential hazard to workers’ health in the long term ,28,21,25To continue the communication, we presented the results of this research (second step). This approach focused on returning the perception of risk factors  to which workers are exposed on gas station and accidents arising from the characteristics of their work. Corroborating the findings in the study, references were made by workers who participated in the socioenvironmental intervention, particularly the chemical risk factor. We understand this fact, because this is the most prevalent agent  the gas station workers handle in their daily work. Thus, we used the perception of chemical risk factors, such as a concrete reality of the gas station workers, to develop the sequence of intervention.Communicate continued with a discussion on preventive measures regarding the use of PPD and healthy eating (third step). The debate on this theme is summarized in We concluded with an assessment, in which it was possible identify the importance of socioenvironmental intervention for workers’ health who participated before, because the reporting of workers on the lack of information about workplace risks and reflection of new attitudes about risk prevention, accidents and injuries to health. We provided an explanatory poster about health protective measures, for each participating worker so they could display it at the workplace and encourage their colleagues to implement protective measures to minimize exposure to risk factors.This study contributes to an understanding of the perception of risk factors and the occurrence of occupational accidents among gas station workers. As regards the perception of risk factors that were identified that reported risks in decreasing order are: chemical, physical, physiological and biological. Regarding accidents occurring to gas station workers, we found that the accidental skin contact with fuel  was the most frequently mentioned (91.4%) one and inhalation of fuel was also reported (77.8%). The gas station workers are continually in contact with fuel, depending on the activities they do. They are even more centralized in handling several liters of fuel  and constant inhalation of vapors emitted by vehicles, which can lead to a greater number of accidents of this nature ,15,16. IThe sample in the present study was composed mostly of young, white, male adults, which is consistent with the samples used in other reports ,30. The The findings also suggest that the perception of chemical risk and the occurrence of accidents involving this risk were present more frequently. This risk perception related to the chemical risk and chemical occupational accident, is due to the raw material that the worker handle in their daily work, for example, gasoline . GasolinRegarding chemical risk, 20% of the investigated workers identified chemicals used in their work environment, 17% identified gases derived from fuels, and 14% identified the vapors emitted by cars, for a total of 51% of the sample. In other studies ,17,31, tThis study documented and reported that chemical occupational accidents are frequent among gas station workers that have longer exposure times. In addition, in this study, the exposure time was higher in the case of ‘eye contact with fuel’ chemical occupational accidents. In this occupational accident example, it is known that the absorption capacity of the agent benzene can be increased by contact with the mucosa of the eye and the mouth ,34. SkinSome studies ,26,27 haAnother study  showed tThe present study represents a contribution to the occupational health policy formulated by the Permanent National Commission on Benzene , which sIn addition, Regulating Norm #16, a piece of Brazilian legislation backed by the Ministry of Work and Employment, addresses dangerous activities and operations involving combustible materials, and its Appendix 2 grants a 30% increase in the salaries of workers operating pumps with inflammable liquid fuels and to other gas station workers due to the dangers inherent to their work environment . AnotherAdditionally, physical risk was identified and reported by 88.2% of the present sample, which agrees with another study of gas station workers . The worPhysiological risk was self-reported by 64.3% of workers, who most frequently identified inappropriate posture and repetitive stress. These findings agree with those of another study , in whicBiological risk was identified by 62.4% of workers. The workers indicated that the main contaminating microorganisms were bacteria and viruses, which might be related to their frequent contact with customers, inappropriate hygiene conditions in the work environment and insufficient measures for individual protection ,16,35. RIn the present study, the correlation between chemical and biological factors and occupational accidents was statistically significant. This finding agrees with another study  performeFrom the presented exploratory study, there was a socioenvironmental intervention for gas station workers. The socioenvironmental intervention in the work encourages workers to think about the risk factors in the workplace that can cause illness or accidents. In the specific case of the socioenvironmental intervention described in this study, means were used to encourage workers to visualize ways of minimizing risk factors and, therefore, occupational accidents, is the case of PPD that can be used in the workplace and visualization of strategies for minimization of risk factors. The results of the socioenvironmental intervention indicate that PPD and strategies for minimizing the risk factors reported by gas station workers indicated the concern of workers with chemical risk factor, which confirms the results of the exploratory study.The socioenvironmental intervention performed in this study applied strategies that stimulated workers to minimize individual and collective risks, because it is a process in which workers seize and multiply the knowledge in their work environment, and thus interfering with the collective work conditions.A horizontal intervention technique was applied via a dialogue (communication) between researchers and workers in which the researchers offered spontaneous narratives and posed questions. This experience shows that promoting socioenvironmental interventions facilitates the use of clinical reasoning based on theoretical-scientific elements to help workers: (1) correlate theoretical features with their own empirical observations on the risks present in their environment, (2) reflect and (3) perceive possible prevention measures.Some studies have indicated that workers’ participation in decision making is of paramount importance to their safety and health ,40,41. WIn conclusion, gas station workers realize they are exposed to risk factors, especially chemical risk factors due to their workplace being particularly dangerous. The frequency of occupational accidents tends to a state that allows the perception of risk factors to be realized from the accident to the worker.Such evidence confirms the findings of literature on risk factors that gas station workers face in the workplace and in similar situations to those found in this particular study. This study highlights the importance of review and changes in work conditions at gas stations , like other realities that already exceed the unsanitary conditions. To appropriately address the needs of specific worker subgroups, occupational health professionals must grapple with the complexity that exists within the workforce.We believe that the RC is a participatory process designed to assist individuals or groups to make decisions that will advance their health and well being. Health promotion theorists define empowerment as a multidimensional construct that attends to individual, small group of workers and organizational of health promotion. The strategy of RC constitutes a positive possibility of learning about risk factors and the individual and collective measures to minimize the accidents. Occupational health professionals play an important role in responding to the unique needs of individuals and subgroups that make up a diverse workforce by targeting subgroups with health promotional campaigns and advocating for healthy workplaces. We understand that knowing about workers’ perception about a particular set of occupational hazards, is essential to prepare an effective plan for RC. Thus, our intervention has limits, but is included in HPDWEP. Therefore, the socioenvironmental intervention for RC, was confirmed as a positive strategy to promote the socioenvironmental health of workers in their workplace.


Miguel Sanjoaquin and colleagues describe their experience of setting up an electronic patient records system in a large referral hospital in Blantyre, Malawi. Disease burden in developing countries is difficult to quantify—data are sparse and their quality is difficult to assess.Health care planning and the monitoring and evaluation of interventions are hindered by a lack of systematically collected data.An electronic surveillance system was set up to gather morbidity and mortality data from adult patients in a large referral hospital of Malawi (Surveillance Programme of IN-patients and Epidemiology [SPINE]), serving as a model for other potential sentinel implementation sites.SPINE collects individual-level demographic and clinical data from thousands of admissions, thereby informing patient care, policy planning, and research.We discuss the strengths and weaknesses of establishing these types of systems and the challenges that were overcome to implement SPINE.In low-income countries, a prominent obstacle to the effective planning and delivery of health care is the accurate assessment of the disease burden. Commonly used paper-based systems for recording hospital admissions in countries such as Malawi are cumbersome, of uncertain reliability, and do not lend themselves to regular analysis or feedback to clinical teams or health care planners. The Ministry of Health in Malawi and its partners have been at the forefront of the roll-out of a number of major interventions to reduce the burden of HIV Almost a decade ago a touch screen electronic data system that centralizes outpatient clinical records of patients receiving antiretroviral drugs (ARVs) was introduced in a large referral hospital in southern Malawi, which was subsequently rolled out across the country http://www.ruby-lang.org/en/) and therefore allows the sharing of software packages created in different hospitals and from different initiatives at no added cost. The screens are generated from standard HTML web forms using the touch-screen Toolkit. The electronic medical record (EMR) is a password-protected web-based application developed using completely open source platforms. SPINE is connected to the ARV clinic system, enabling patients registered in either system to be recognized by both. When a patient is discharged from hospital a member of the clinical team looking after the patient records the HIV status, ARV use, primary diagnosis, and up to two secondary diagnoses. For this purpose the electronic system provides a series of user-friendly screens allowing diagnoses to be chosen from a comprehensive list modified from the International Classification of Diseases (ICD-10). The clinician can also formulate a prescription, which is linked to the diagnosis made. The system provides access to a limited past medical history, including previous diagnoses and treatment received. On discharge, a summary of the patient's visit, including the discharge medication is printed on an adhesive label and place in the patient's health passport. This avoids the need for hand written discharge summaries and transcription errors. Terminals are password protected to ensure patient's privacy. When health care workers have to log in, the user initiates a session by scanning the barcoded label on the patient's health passport or hospital notes. The health passport is a document that the vast majority of patients (>90%) carry to be seen at hospital or health centers. If not, they can buy one on entry into the health facility at a token price. The terminals are used for the registration of patients, from whom basic demographic information is collected and if a new patient, a unique barcode identifier is generated. Duplicate registrations are largely avoided through a well-validated cross-checking algorithm that uses critical personal variables such as name, age, sex, and location. The electronic system co-exists with the other standard paper-based data collection activities needed for lab, clinical, and hospital functioning. These serve as data back-up and information is sometimes retrieved from these sources when a backlog happens, due to, for example, prolonged power outages. The long-term plan is to discontinue some of these paper-based data collection activities once SPINE is thought to be stable.The Surveillance Programme of IN-patients and Epidemiology (SPINE), an unrelated system to the one set up in the UK, records information through touch-screen terminals located in the hospital adult internal medical wards. The electronic system is a £200,000 investment that took 8 months to develop and 3 months to implement, including sensitization and training. Coding is based on open source software named Ruby . Performance indicators such as re-admission and mortality rates are being monitored and as more data are accumulated, we will be able to determine whether this system, amid multiple other interventions and changes in medical practice, is having a positive effect.SPINE is based within the Department of Medicine  of Queen Elizabeth Central Hospital (QECH), one of the largest hospitals of Malawi. Previously paper-based recording of hospital visits and admissions through health management information systems (HMIS) at QECH were the norm.SPINE has been operational at QECH since late 2009. It has had a positive uptake from the clinical staff and, at present, most doctors and nurses are conversant with its use and utilize SPINE to make discharges, despite the initially low computer literacy in some cases. A summary of the basic descriptors for the adults admitted during the period January 2010 to July 2011 is provided in The total number of patients admitted by disease condition, the fraction of them that died in hospital, and prevalence of HIV infection is shown in The pattern of disease and the frequency of admissions were markedly influenced by season, highlighting that health planning and clinical assessment will need to take these into account. The Malawi rainy season is typically between December and April, and the cold season between June and August. There was a peak in disease-specific admissions between January and March . MalariaAlthough similar systems are being implemented elsewhere, experience with creating electronic patient record systems in resource-poor settings is still scarce One of the main obstacles in monitoring of the success of international public health targets, including the Millennium Development Goals (MDGs) Currently, clinicians lead data entry into the system. This has the advantage of being a more sustainable approach and promotes a feeling of ownership. Involvement with data entry encourages clinicians to ensure the accuracy of discharge diagnoses and to make use of the medical information. However, in the context of a hospital that sees approximately 250,000 patients a year and admits approximately 25,000 adults, using an electronic system places an extra burden on clinicians and this was the main roadblock in the implementation phase. On average, it is estimated that each discharge takes 2–3 minutes for a clinician conversant with the system. This means that, at least for an interim period, one additional clinical officer and four nurses had to be employed to assist with training, technical support, and some of the discharges. The initial reluctance to use the system diminished over time once SPINE was populated with enough previous admissions for it to be useful for clinicians. Lack of accuracy in the diagnosis and missed discharges are other factors that compromise the integrity and validity of the data. At the time of writing this article, SPINE was capturing over 80% of all discharges. Regarding the quality of data, a number of independent unpublished research studies conducted concurrently have provided an indication of the quality of diagnosis. For example, a study looking into meningitis case-fatality rate showed that 50% of all patients diagnosed with meningitis died, which is compatible with the 36% seen by SPINE. The burden of severe malaria admission was 7% of all admissions as measured by an enhanced surveillance activity and 8% when using SPINE. These electronic tools have also required readily available IT/programming expertise to develop and maintain these relatively sophisticated systems. Failures in the system have occurred and these have the potential to reduce motivation, resulting in additional patients not being discharged through the system.Our experience with SPINE demonstrates that such a system can be successfully used for large-scale surveillance, facilitation of in-patient management, and as a platform for clinical research. SPINE can also be used by the hospital administration for monitoring clinical activity, as an audit tool, and for drug forecasting. Our next steps will be to connect SPINE with the laboratory services. We are developing a robust data reporting system for health authorities and hospital management to have updated information and generating a real-life outbreak alert system using geographical information technology. Other health facilities where the capacity for maintenance exists could also benefit from such systems.


Preterm birth is a major cause of neonatal mortality, responsible for 28% of neonatal deaths overall. The administration of antenatal corticosteroids to women at high risk of preterm birth is a powerful perinatal intervention to reduce neonatal mortality in resource rich environments. The effect of antenatal steroids to reduce mortality and morbidity among preterm infants in hospital settings in developed countries with high utilization is well established, yet they are not routinely used in developing countries. The impact of increasing antenatal steroid use in hospital or community settings with low utilization rates and high infant mortality among premature infants due to lack of specialized services has not been well researched. There is currently no clear evidence about the safety of antenatal corticosteroid use for community-level births., health providers will be trained in essential newborn care for low birth weight babies. The primary outcome is neonatal mortality at 28 days of life in preterm infants.We hypothesize that a multi country, two-arm, parallel cluster randomized controlled trial to evaluate whether a multifaceted intervention to increase the use of antenatal corticosteroids, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, will reduce neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six countries. 102 clusters in Argentina, Guatemala, Kenya, India, Pakistan, and Zambia will be randomized, and around 60,000 women and newborns will be enrolled. Kits containing vials of dexamethasone, syringes, gloves, and instructions for administration will be distributed. Improving the identification of women at high risk of preterm birth will be done by (1) diffusing recommendations for antenatal corticosteroids use to health providers, (2) training health providers on identification of women at high risk of preterm birth, (3) providing reminders to health providers on the use of the kits, and (4) using a color-coded tape to measure uterine height to estimate gestational age in women with unknown gestational age. In both intervention and control clustersClinicalTrials.gov. Identifier: NCT01084096 One of the United Nations Millennium Summit goals is a two-thirds reduction, by 2015, in death among children under 5 years old[The most effective perinatal intervention to reduce neonatal mortality is the administration of antenatal corticosteroids to pregnant women at high risk of preterm birth. A high-There is no evidence of short-term adverse effects of antenatal corticosteroids for the infants. In the subpopulation of PPROM infants, there is no evidence of an increased risk of infection . The risTo date, the trials of maternal corticosteroids have been conducted in hospital settings. There is a need to verify that the safety of corticosteroids would be similar for births occurring at home or in community health centers and where referral systems or advanced care for preterm births are limited.One indicator of the coverage of this intervention is the proportion of preterm babies whose mothers received the antenatal corticosteroids in a defined place and period. Even in high-income countries, a proportion of women at risk of preterm delivery do not receive antenatal corticosteroids because of lost opportunities or advanced labor, yielding an assumption of 80% maximum rates of the intervention for preterm deliveries below 34 weeks of gestational age (GA),7,8. In Why, despite the evidence of the past 30 years, are antenatal corticosteroids still not used routinely in low-middle income countries? There is a need for studies to address the contextual factors that affect the delivery of antenatal corticosteroids and the achievement of high and equitable coverage. The evidence supporting the use of antenatal corticosteroids comes from trials that were conducted in health facilities with neonatal intensive care units. Therefore, there is no clear evidence that the same benefits would be found in settings in which preterm babies could not receive appropriate care, such as primary health care centers or home births. It is likely that some of the following factors are associated with the lack of use: (1) Lack of availability of the drug; (2) Lack of guidelines and local regulations about who can administer injections , who are not allowed to administer injections, attend 40% of the deliveries); (3) Health providers’ lack of knowledge about of the beneficial effects of antenatal corticosteroids and misconceptions that corticosteroids produce adverse effects; (4) Difficulty identifying women at high risk of preterm birth in these settings; (5) Lack of accessibility to an appropriate level of care. At the hospital level in low-middle income countries, the major causes of underuse are the lack of availability of the drug and the lack of an active strategy to promote its use.The effect of antenatal corticosteroids to reduce mortality and morbidity among preterm infants delivered in hospital settings in high-income countries is well-established. HoweverThis is a pragmatic cluster, randomized controlled trial designed to evaluate the effects of a multifaceted intervention that will improve the identification of pregnancies at high risk of preterm birth and will provide and facilitate the appropriate use of corticosteroids to women at risk of preterm delivery, with the goal of reducing neonatal mortality rates among preterm infants in communities with low antenatal corticosteroid use. The intervention will target the health system as whole, not individual patients.Our hypothesis is that the multifaceted intervention will improve the identification and referral of pregnant women at high risk of preterm birth, increase the availability of antenatal corticosteroids and facilitate their appropriate use in eligible women and thus reduce neonatal mortality at 28 days in preterm newborns by 25%. We also hypothesize that the therapy will be safe for women and their newborns. Dexamethasone phosphate is the drug of choice for this study because it is readily available in the participating countries. This drug is used as the standard of care at the hospital level for women at risk of preterm birth at many of the sites. The primary objective will be to evaluate whether a cluster-level multifaceted intervention, including components to improve the identification of pregnancies at high risk of preterm birth and to provide and facilitate the appropriate use of corticosteroids, reduces neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care. The secondary objective is to determine whether the intervention is safe for women and their newborns.The study design is a two-arm, parallel cluster, randomized controlled trial. Clusters will be randomized 1:1 to an intervention group or to a control group. Specifically, the intervention consists of the following: (1) training birth attendants to identify risk factors for preterm birth and to determine eligibility for antenatal corticosteroids (2) using a color-coded tape to measure uterine height to improve the assessment of gestational age (GA), and (3) distributing kits with vials of corticosteroids and unique reuse prevention syringes to all birth attendants for use in the community. Neonatal mortality at 28 days will be measured for all low birth weight (LBW) infants in control and intervention clusters for a period of 18 months. LBW will be used as a proxy for preterm birth because in Global Network sites approximately 15% of the women who delivered at health centers or homes did not know their last menstrual period LMP dates, and 40% of the deliveries occurred at the community level, where ultrasound is not available  is comprised of seven geographical study sites, located in low- and middle-income countries, which function as research units for the various maternal and neonatal studies implemented by the network. Each site has research clusters, with 6 clusters in Argentina, 10 clusters in Zambia, 10 clusters in Guatemala, 20 clusters in Belgaum, India, 20 clusters in Nagpur, India, 20 clusters in Pakistan and 16 clusters in Kenya. Seven GN sites will participate in the ACT study and 102 clusters will be available for the implementation of this protocol. The sizes of the clusters differ across and within the GN sites, but each cluster was selected because it had 300 to 500 deliveries per year per cluster. The GN clusters include both rural and urban settings, with deliveries taking place at home and in health facilities. At this time, 40% of deliveries in the participating clusters occur in home or clinic settings with TBAs.This is an intent-to-treat design and thus all pregnancy outcomes of women who deliver in the study clusters and provide consent will be collected. Cluster-level inclusion criteria include GN clusters with at least 250 deliveries per year that consent to participate. Participant-level inclusion criteria include all pregnant women living in and delivering in the study cluster, and identified as having high risk for preterm birth who are eligible to receive intramuscular corticosteroids and, in settings where it is not the standard of care, provide consent.Data from the Maternal and Neonatal Health Registry (MNH) - a prospective, population-based study of pregnancy outcomes at the seven GN sites - will be used as a baseline to select the clusters and to ensure that the underlying neonatal mortality rates are reasonably balanced across arms through the randomization procedure. The 102The study intervention will be (1) to provide antenatal corticosteroids kits  (2) to improve the identification and referral of women at high risk of preterm birth by training birth attendants to identify eligible women, (3) to post eligibility reminders at health facilities and in the boxes, (4) to measure uterine height with a color-coded tape to estimate GA in women with unknown GA, (5) to improve the administration of antenatal corticosteroids to eligible women by training birth attendants on its administration and encouraging its use through reminders at all primary health care levels and at all health care levels in which women at high risk of preterm birth could be attended.The study will distribute ready-to-use treatment kits containing a full course of antenatal corticosteroids , 4 reuse prevention syringes, 4 pairs of gloves, and detailed instructions on when, how, and to whom to administer antenatal corticosteroids Figure.The kits will be distributed in all health care facilities and delivery settings where eligible women might attend. Once an eligible pregnant woman is identified and has already given her consent, the birth attendant will administer the first dose of corticosteroids intramuscularly. The remaining 3 doses of dexamethasone will be administered at 12-hour intervals, if the delivery has not occurred, by either the same or another birth attendant. After administration of the first dose, the remaining vials will remain with the pregnant woman, along with a reminder for a health provider to administer the remaining doses, in case the woman is referred to another level of care or a different attendant is with her after 12 hours.At the community level, the kits will be stored at the primary health center with the health providers or brought by the birth attendants when attending a home birth to ensure that eligible women have access to the medication. TBAs will be trained to identify pregnant women at high risk of preterm delivery and a communication strategy will be put in place so that a qualified health care provider is promptly informed of the situation.All pregnant women who are between 24 weeks and 36 weeks GA will be eligible to receive antenatal corticosteroids if they present with any of the following: signs of labor, or threatened labor, amniotic fluid leakage, hemorrhage, or hypertension/severe headache.Reminders in poster format will be placed in areas of care Figure. They inSigns of labor, or threatened labor , amniotic fluid leakage , hemorrhage , hypertension (diastolic blood pressure of 90 mmHg or more on two consecutive readings taken at least 4 hours apart or 110 mmHg or more on one reading). In communities where blood pressure cannot be measured, women with eclampsia or signs or imminent eclampsia (e.g. severe headache) will be offered corticosteroids.Treatment  and referral will be recommended for all pregnant women who are between 24 and 36 weeks GA and present with any of the following: Signs oIn some of the study communities, it is expected that an estimation of GA in women with signs of labor or pregnancy complications will not be available. Preliminary data from a previous GN study suggest that misclassification of preterm deliveries is significant. AdditioAs part of the development of the intervention, we conducted a study to test a color-coded tape that we developed to identify preterm pregnancies between 24 and 36 weeks GA through fundal height measurement. Uterine fundal height measured by the color-coded tape will be used as a proxy for GA when reliable GA assessment is not available Figure. The usetrain-the-trainer workshop. Workshop participants will learn how to (1) identify those women eligible for antenatal corticosteroids administration and (2) appropriately use the preterm kit, if legally allowed to administer injections, and (3) refer the woman to a health center or contact a skilled birth attendant when indicated. We will adapt the workshops’ format according to the targeted health providers.All the health providers potentially involved in delivery attendance at intervention clusters will be trained to deliver the intervention during an interactive All birth attendants working in the intervention clusters are eligible for participation in the trial if they provide care to pregnant women, assist in the delivery of babies, and assist the women in caring for their babies. We anticipate that approximately 3,000 birth attendants will be trained. All eligible birth attendants will be fully briefed on the study before training and will be asked to sign a Decline Form if they are not willing to receive the training.Both the intervention and control communities will receive training in Essential Newborn Care for LBW Babies. The purThe primary outcome measure is neonatal mortality at 28 days of life in preterm infants in all clusters. LBW will be used as a proxy for preterm birth because in GN sites approximately 15% of the women who delivered at health centers or homes did not know their LMP dates, and 40% of the deliveries occurred at the community level, where ultrasound is not available. Thus, pragmatically, it is not possible to use gestational age to classify preterm births in these settings.The variable to be used for classifying preterm births needs to be objective and unbiased in both intervention and control clusters. Thus it should be unrelated to the experimental intervention. The color-coded tape Figure is part Birth weight can be measured equally in both intervention and control clusters, and it is unrelated to the intervention. Birth weight measurement in the GN clusters is currently being done with high coverage (90%) and good quality. It is likely that some misclassification with small-for-gestational age (SGA) babies will exist, and that this misclassification can underestimate the real benefit of corticosteroids. But it is a conservative approach that will not introduce bias to the comparison between groups.GN sites have different mean birth weights; those from Asian sites are much lower than those from African and Latin American sites. Using the same birth weight  as a cutoff point at all sites would include a higher proportion of Asian babies, whose mean birth weights are ~2700 g, and most of them would be SGA babies rather than preterm. To avoid this, we will use different cutoff points for each country to select the 10% smallest babies in each GN site. Using data from the MNH study for each GN site, we set a birth weight cutoff point, rounded to 100 g, that would select the smallest 10% of infants as a proxy for preterm births (< 36 weeks GA). Using this rule, the cutoff point for sites in Argentina, Zambia, and Kenya was 2500 g; for sites in Guatemala and Karnataka, India, was 2400 g; and for sites in Nagpur, India, and Pakistan was 2200 g. The overall prevalence of LBW for all sites according to those weight limits is 8.2%, with an 11.4% neonatal mortality at 7 days. A birth weight of 750 g will be used as a cutoff point for the lower birth weight limit for analysis purposes, except for those GN sites where babies with birth weights < 1000 g are considered abortions.th percentile of the site.The primary and secondary outcomes in LBW babies, the outcomes in all infants and their mothers, and the process outcomes (to be measured only in the intervention clusters) are shown in TableOutcome data for the ACT trial will be collected through the existing MNH registry in the GN sites. This registry includes all the outcome variables including data to 42 days postpartum. Forms specific for ACT were developed to collect process outcomes.A weekly data transmission from the research units to the Data Center will be completed using the system and transmission procedures currently in place for GN studies at each site. The data entry software will be programmed to conduct range checks and simple consistency checks of the data. Double data entry verification will be used to check for ID and data errors. An error rate of less than 0.3% is considered acceptable.The Data Management System is password protected. It will require a user ID and password to be entered to ensure that only trained, authorized personnel have access to the data.The primary analysis will compare post-intervention outcomes between intervention and control clusters, controlling for country, using two complementary approaches. First, a cluster-based permutation test that is appropriate for the stratified randomization process be used to develop a formal hypothesis test and interval estimates of the treatment difference between the two arms. A model-based analysis will be used to assess whether the inferences generated by the permutation test are robust enough to control for potential confounders and to describe any evidence of differential treatment effects in the different countries. Although this study is not powered to evaluate treatment by country interactions formally, any evidence of such interactions will be described through the model-based analysis of this primary outcome.An intent-to-treat analytic approach will be used for both the permutation test and for the model-based analyses, in that any cluster assigned to the intervention will be considered treated, whether or not the ACT intervention was delivered in that cluster. Also, both analyses will use country as a blocking or stratification variable in the analysis to reflect the randomization scheme.To facilitate the model-based primary analysis, a detailed analysis of baseline variables of the two groups (intervention and control clusters) will be performed to assess the extent, if any, of baseline imbalances between the two groups of clusters. If baseline differences between the treatment arms are identified, the covariables representing the imbalanced variables will be used for adjusted analyses. Imbalances at the cluster level  can be adjusted in the model-based analysis. Because the primary interest is in the decrease in the marginal neonatal mortality rate at the cluster level, the generalized estimating equations (GEE) method of Liang and Zeger as impleIn addition to the permutation tests and GEE models described above, which focus on marginal risk in the population, we will evaluate the effect of the outcome on subject level risk by modeling the binary outcome using generalized linear mixed models as implemented through the SAS procedure GLIMMIX. In this procedure, cluster will be treated as a random effect, with the cluster-specific risk nested within intervention assumed to have a Gaussian distribution. Again, both the GEE model and the generalized linear mixed model will examine the effects of potential confounders on mortality risk and the heterogeneity of treatment effects across country.Although the primary study outcome is neonatal mortality, a key secondary outcome is rate of antenatal corticosteroid use. The analytic approach for this outcome will be comparable with that described for the primary outcome in that both permutation and model-based analyses will be implemented.The primary results likely will need to be substantiated with a sensitivity analysis of the results to missing outcome data. The need for a detailed sensitivity analysis will depend on the amount of missing data and any intervention-dependent pattern to the missing data. A first step will be to look for patterns by comparing observed characteristics of participants who have missing data with those having complete data. Then, if appropriate, both nonparametric and parametric approaches will be undertaken to evaluate the impact of missing data. Additional details will be provided in the Statistical Analysis Plan.The trial will also examine a number of additional clinical and process measures as secondary outcomes. For each of these outcome measures, descriptive statistics will be computed as described in the introductory paragraphs above. Model-based analyses will then be used to examine the effects of the intervention on each of clinical and process measures. For the clinical measures, GEE models will be used to evaluate the effect of the intervention on marginal risk of the outcome, with results reported for both unadjusted analyses and analyses controlling for covariates that differ across clusters. Also, generalized linear mixed models will be used to examine the effect of the intervention on subject-level risks. Again, results will be reported for both unadjusted and adjusted models.We expect to increase corticosteroids use from less than 10% to at least 50% among preterm births. From the estimates in the systematic review on the effect of corticosteroids on mortality, we expeUsing the MNH registry baseline data, the ICC is estimated to be between 0.01 and 0.05. The estimate was computed using data from 106 MNH registry clusters.This trial will be conducted using all of the clusters from the MNH registry determined to have the local infrastructure to implement the protocol. On the basis of preliminary information from the site investigators, we anticipate between 90 and 100 clusters with at least 250 annual deliveries (average of 400) to be available for the trial. Assuming that between 8% and 9% of deliveries are premature, we anticipate a mean cluster size of between 50 and 75 premature newborns for an 18- to 24-month trial. For 28-day neonatal mortality, a study size of 90 clusters with at least 60 LBW deliveries per cluster will have a power of slightly more than 80% (Type I error rate of 0.05) to detect a decrease of 30% in neonatal mortality from 13% to 9%. For the outcome of antenatal corticosteroid use among LBW infants, a sample size of 90 clusters with 50 events per cluster has a power of greater than 0.99 to see an increase in utilization from a start-rate of 10%–20% or more.The use of antenatal corticosteroids for women at risk of preterm birth is the standard of care in high-income countries as well as at the hospital level for most of the countries participating in the trial. However, at each participating site, the Institutional Review Board (IRB), Ministry of Health, and physicians will be consulted on guidelines for the use of antenatal corticosteroids to ensure that we are in compliance with cultural, medical, and regulatory policies and norms. These drugs do not require regulatory approval in the participating countries, nor do they require approval from the Food and Drug Administration as an investigational new drug because the research is being conducted outside the United States.The protocol and the informed consent documents were submitted and approved by the IRBs and ethics committees of all participating clinical sites and Research Triangle Institute (RTI), as the data center.All participating communities must agree in advance to participate in the study. Community-responsible health authorities will provide their agreement to participate before beginning any activities and will act as cluster ethical guardians. Community education, using forums such as meetings and posters, will inform the community and its authorities about the purpose and procedures of the study. Communities will be informed of their assignment to the control or intervention cluster after randomization.At the individual level, informed consent to collect data and to administer corticosteroids will be requested. Because high risk for preterm birth is frequently an emergency condition , to the extent possible, informed consent to administer corticosteroids will be done during pregnancy for all women enrolled in the MNH registry. For those women eligible for corticosteroids administration who were not asked for consent during pregnancy, consent would be sought with identification of the risk of preterm delivery. In this case, women who present at the community or health center level with signs or symptoms that make them eligible to receive corticosteroids, will be consented only if they are in early labor , or in a clinical condition not evaluated as an extreme emergency .At the hospital-level, where antenatal corticosteroids are the standard of care for women having high risk of preterm birth, eligible women will not require consent.All health providers working in the intervention clusters that are eligible to be trained in the intervention procedures will be invited to receive the training and asked for their signed informed consent.The author(s) declare that they have no have competing interests.P Buekens, J Belizán, F Althabe and E Bergel had the original idea and designed the intervention and the first protocol. F Althabe, P Buekens, J Belizán, A Mazzoni, M Berrueta, J Hemingway-Foday, M Koso-Thomas and E McClure wrote the manuscript, in collaboration with E Chomba, A Garces, S Goudar, B Kodkany, S Saleem, O Pasha, A Patel, F Esamai, W Carlo, N Krebs, R Derman, R Goldenberg, P Hibberd, E Liechty, L Wright, and A Jobe. All authors have given final approval of the manuscript.


Phorusrhacidae was a clade including middle-sized to giant terrestrial carnivorous birds, known mainly from the Cenozoic of South America, but also occurring in the Plio-Pleistocene of North America and the Eocene of Africa. Previous reports of small phorusrhacids in the Paleogene of Europe have been dismissed as based on non-phorusrhacid material.Eleutherornis cotei should be used.we have re-examined specimens of large terrestrial birds from the Eocene (late Lutetian) of France and Switzerland previously referred to gastornithids and ratites and have identified them as belonging to a phorusrhacid for which the name The occurrence of a phorusrhacid in the late Lutetian of Europe indicates that these flightless birds had a wider geographical distribution than previously recognized. The likeliest interpretation is that they dispersed from Africa, where the group is known in the Eocene, which implies crossing the Tethys Sea. The Early Tertiary distribution of phorusrhacids can be best explained by transoceanic dispersal, across both the South Atlantic and the Tethys. Lavocatavis africanaThe Phorusrhacidae  were terrestrial carnivorous birds, ranging in height from about 90 cm to more than 2 m, which are a highly distinctive element of the Cenozoic faunas of South America Aves Linnaeus, 1758Cariamae Fürbringer, 1888Phorusrhacidae Ameghino, 1889Psilopterinae Dolgopol de Saez, 1927Eleutherornis Schaub, 1940Genus Eleutherornis cotei , new combinationDiagnosis: A middle-sized phorusrhacid (height about 1.5 m) showing a combination of basal and derived characters. Trochlea II of the tarsometatarsus is expanded medially as in psilopterines, while the pre-acetabular part of the ilia is more compressed laterally and more closely appressed to the neural spines of the synsacral vertebrae than is usual in psilopterines and more reminiscent of more derived phorusrhacids.Type locality: Fissure filling at Lissieu  .Stratigraphic provenance: Middle Eocene, late Lutetian, MP14 mammalian reference level  (L71). Hypodigm: trochlea III of a tarsometatarsus (L72), phalanges , ungual phalanges .Supplementary material from Lissieu: Trochlea III of a tarsometatarsus , ungual phalanges .Referred material from Egerkingen : anterior part of a pelvis (synsacrum and ilia) (Eh.781); posterior part of a synsacrum (Eh. 782); phalanges , ungual phalanges (Ef. 1001 and unnumbered).No permits were required for the described study, which complied with all relevant regulations.The specimens described in the present study are part of three public paleontological collections  and were collected decades ago. Permission to study them was granted by the curators in charge (as mentioned in the acknowledgments) and all collection numbers are provided in the text. No field work was involved in the present study, therefore no permits were required.Diatryma? cotei  and the general morphology of the trochleae on the tarsometatarsus from Lissieu .The morphology of the ungual phalanges from both Lissieu and Egerkingen. They are strongly recurved and hook-shaped, with grooves along the sides and a well-developed flexor tubercle. As in phorusrhacids, the tubercle is oriented proximally, unlike the condition in raptors, where it is oriented distally. The proximal articular face in the phalanges from Lissieu and Egerkingen widens ventrally as in phorusrhacids  [20]. ThThe strong lateral compression of the anterior part of the pelvis from Egerkingen. As mentioned above, the ilia are closely appressed to the neural spines of the synsacral vertebrae, which is a phorusrhacid character StrigogypsStrigogyps are more compressed laterally and have a less developed flexor tubercle. The only elements among the French and Swiss material that can be compared directly are the ungual phalanges and they are virtually identical. Other elements are compatible in size, indicating a bird roughly the size of the phorusrhacid Patagornis marshi, from the Miocene of Patagonia (height about 1.5 m). In view of the fact that the specimens come from two localities of the same geological age (late Lutetian), which are not very distant geographically (about 300 km) . It had already been suggested Because of the above-mentioned close similarities of the various skeletal elements from Lissieu and Egerkingen, they are referred here to phorusrhacids. Comparison with other Eocene birds from Europe, notably those erroneously referred to phorusrhacids such as  300 km)  and wereEleutherornis cotei can be distinguished from other phorusrhacids by a combination of characters. The tarsometatarsus is reminiscent of the Psilopterinae, a subfamily of mostly relatively small and basal phorusrhacids, by the shape of trochlea II, which is relatively broad and rounded PatagornisPhorusrhacosEleutherornis cotei trochlea II bore a caudal process, as in psilopterines, because that area is broken and worn. Eleutherornis cotei, however, is significantly larger than other psilopterines, being about the size of Patagornis marshi. The cranial part of the pelvis appears to be more compressed laterally than in most psilopterines, notably Procariama, in which the ilia are more divergent and less closely appressed to the neural spines. Although it appears to be relatively basal in some respects, Eleutherornis cotei also shows some derived features (including a relatively large size), resulting in a combination of characters not known in any other representative of the group. It is provisionally placed in the subfamily Psilopterinae mainly because of the characters of the tarsometatarsus.Although it is known from fairly incomplete material, Eleutherornis cotei described in this study come from two sites in Western Europe that are similar in various ways. The French specimens are from a fissure filling at Lissieu (Rhône), a few kilometres north of the city of Lyon , which have been known since the 19Eleutherornis cotei are thus from similar geological settings  and of the same age, viz. late Lutetian (MP14). It is worth noting that the specimens from Lissieu and Egerkingen are currently the only well-attested records of phorusrhacids from Europe. The Palaeogene avian fossil record of Europe is of good quality All the remains referred to For a long time phorusrhacid birds were considered as an essentially South American group, the late Cenozoic North American forms being easily explained by dispersal from South America via the isthmus of Panama during the Great American Biotic Interchange. However, because of the recent discovery of a phorusrhacid in the Eocene of Africa and the description of phorusrhacids from the Middle Eocene of Europe in the present paper, a reappraisal of phorusrhacid biogeography is needed. The topic was already discussed in the 1980s when purported phorusrhacids were reported from the Palaeogene of Europe, but the subject was dropped when it became apparent that the fossils in question belong to other taxonomic groups. It is now possible to reconsider the question on the basis of solid evidence for the presence of phorusrhacids in Europe during a well-defined period of the Eocene, and of the occurrence of the group in the Eocene of Africa.Paleopsilopterus itaboraiensis, from the Palaeocene of Brazil The place of origin of the Phorusrhacidae is a moot point. As already pointed out An unnamed psilopterine from the Vacan (probably early Eocene) of Cañadon Vaca, in Patagonia Lavocatavis africana, from the late Early or early Middle Eocene of Algeria Eleutherornis cotei, from the Middle Eocene  of France and Switzerland.In terms of geological age, these early records of phorusrhacids are thus not very distant from one another and it would be unsafe to draw conclusions about the place of origin of the group simply from its possible earliest occurrence. However, as mentioned above, the European record does not suggest that phorusrhacids were present there before MP14, so that a European origin is unlikely. The situation in Africa is more difficult to assess, because the Palaeogene record of terrestrial birds on that continent is very scanty, and it is not possible at the moment to estimate how long phorusrhacids may have been present on that continent.Lavocatavis was in all likelihood flightless Eleutherornis. Therefore, flight across marine barriers probably cannot explain the dispersal of the African and European phorusrhacids, unless one assumes that they developed flightlessness independently from flying ancestors, a hypothesis that has already been discussed in the case of Lavocatavis and considered unlikely because of complete morphological similarity between the African form and those from South America Eleutherornis. Parallel or convergent evolution can thus be excluded.If, as suggested by their stratigraphic distribution, European phorusrhacids are considered as immigrants from elsewhere rather than having originated on that continent, a first point to be considered is how dispersal may have taken place. The question of the possible flight abilities of some phorusrhacids is important from that point of view. There is no doubt that the larger forms of phorusrhacids, with reached a very large size and had strongly reduced wings, were flightless. Things are less clear for the smaller psilopterines. It has been suggested that psilopterines were able to fly Several possibilities can be suggested for the origin and dispersal of phorusrhacids :Direct dispersal from South America to Europe is unlikely because of distance and lack of likely direct terrestrial connections across the central Atlantic.Dispersal from South America to Europe via North America and a North Atlantic connection has been considered from some groups of terrestrial vertebrates, including phorusrhacids The likeliest origin for the European phorusrhacids is therefore Africa. Dispersal from Africa to Europe in the Eocene involved crossing the Tethys Sea. Several dispersal phases from Africa to Laurasia during the Palaeogene, involving land vertebrates, have been identified or postulated Irrespective of their dispersal from Africa to Europe, whether phorusrhacids originated in Africa or in South America remains uncertain. As noted above, stratigraphic evidence is inconclusive in this respect. The fact that the greatest diversification of phorusrhacids took place in South America has been considered as suggesting a South American origin In the early Tertiary, the South Atlantic was significantly narrower than it is today and large islands subsisted along the now-submerged Walvis Ridge and Rio Grande Rise until the Eocene Transatlantic dispersal, either by island-hopping or drafting on “floating islands” is considered likely for a number of vertebrate groups that occur in both Africa and South America, including burrowing amphisbaenian reptiles A reappraisal of various fossil avian remains from France and Switzerland leads to the conclusion that a quite large flightless bird of the family Phorusrhacidae was present in Europe at the end of the Middle Eocene, apparently after the extinction of another family of large terrestrial birds previously well represented in Europe, the Gastornithidae. The European phorusrhacids were in all likelihood derived from African forms, through dispersal across the Tethys Sea. Current stratigraphic evidence suggests that the presence of phorusrhacids was of short duration, apparently being restricted to the late Lutetian (MP14). During this short time span (perhaps not more than 3 million years