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Health Systems Research I

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This module was developed at the School of Public Health, University for the Western Cape for the Postgraduate Certificate in Public Health which was offered as a distance learning module between 2001 and 2008. Health Systems Research is an integral part of the vision for a quality, comprehensive, community-based, participatory and equitable system. This module aims to provide an introduction to the kinds of research conducted within a health system, the research designs and methods used, and how to develop a research protocol.

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Health Systems Research I

  1. 1. MultiWorks
  2. 2. Health Systems Research I Health Systems Research I -
  3. 3. Dr Smruti Patel Health Systems Research I -
  4. 4. Health Systems Research I -
  5. 5. o o o SOPH Programme Handbook2008 Health Systems Research I -
  6. 6. Programme Handbook o o o o o Health Systems Research I -
  7. 7. Academic Handbook, 2008. Health Systems Research I Health Systems Research I -
  8. 8. ASSIGNMENT 1 –– Prepare to Investigate a Health Systems Problem (40 marks) SOPH Academic Handbook ASSIGNMENT 2 –– Write a Research Protocol (60 marks) Health Systems Research I -
  9. 9. Programme Handbook SOPH Academic Handbook.Health Systems Research I -
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  14. 14. Introduction toUNIT Health Systems 1T Research Health Systems Research I -
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  17. 17. A nurse is taking down a patient’s medical history, asking questions suchas “Are you on any medication now?”A health worker checking the weight of a childA nurse is showing a bar chart with the number of children immunisedat the clinic. Health Systems Research I -
  18. 18. Define the task/problemPlanning questionsAction Health Systems Research I -
  19. 19. ResponsibilitiesStages in Conducting Research Stage 1 Define the problem Stage 2 Stage 7 Identify research Write the research Stage 3 Stage 6 Review existing information Analyse the data and draw Stage 4 Stage 5 Plan how to answer Collect data your questions Then plan Health Systems Research I -
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  21. 21. (Adapted from Varkevisser et al., 1991,19) Health Systems Research I -
  22. 22. What proportion of X population has X condition?Given condition Y, what proportion of a group seeks care?What type of care is sought?What is the cost of care to the patient, the health care system and society?What proportion of those who obtain care is satisfied with the care obtained?Is treatment or care of Type A more effective than Type B?Is treatment of Type A cheaper than Type B, given similar effectiveness?How well do staff and patients communicate?Why is staff morale low? Health Systems Research I -
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  29. 29. Health Systems Research Designing and Conducting Heath SystemsResearch Projects. Health Systems Research I -
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  31. 31. Availability, Provision and Use ofAntibiotic, Antihypertensive and AntidiabeticDrugs at Public Health Care Level inMauritius. Health Systems Research I -
  32. 32. A Research Protocol Health Systems Research I -
  33. 33. HIV infection, Perinatal outcome, Mother-to-child transmission, AZT, Maternal, Pregnancy,PAIDS, Intervention programme, Neonatal, Developing countries.SUMMARY 3INTRODUCTION 4PROBLEM 5PURPOSE 5LITERATURE REVIEW 5AIM 7OBJECTIVES 7METHODOLOGY 8 Study Design 8 Definition of terms 8 Study Population 9 Generalisability 9 Sample Size 9 Sampling Procedure 9 Data Collection 10 Validity 10 Reliability 10 Data Analysis 10LOGISTICS 11TIME-FRAME 11RESOURCES 11ETHICAL CONSIDERATIONS 11REFERENCES 12 Health Systems Research I -
  34. 34. The relationship between maternal HIV infection and adverse perinatal outcome seems mainly influencedby local determinants and is generally higher in less-developed countries. Whether these outcomes shouldbe attributed to the HIV status of the newborn or to the general health status of the HIV-infected motherremains unclear. The focus of intervention programmes for mother-to-child transmission is obviously toreduce the perinatal transmission rate. However it is also worthwhile to assess what impact such aprogramme has in terms of perinatal outcome, regardless of the HIV status of the neonate. This mini-thesis aims to evaluate the perinatal outcome of HIV-infected women and their neonates, enrolled in adistrict-based prevention programme for mother-to-child transmission (MTCT) in peri-urban Cape Town.This MTCT programme serves as a pilot project for South Africa. Therefore, all outcomes related to thisproject should help to guide policymakers and stakeholders in their decisions around the future ofintervention strategies for perinatal HIV transmission.Mother-to-child transmission of human immunodeficiency virus (HIV) is currently the major cause ofpaediatric acquired immunodeficiency syndrome (PAIDS) in all countries. Over 90% of this type of HIVtransmission occurs in developing countries due to high fertility rates in combination with high HIVprevalence in women of childbearing age (Saba, 1997). World-wide estimates of children infected withHIV by the year 2000, are around 5 million; 80% of these children will live in sub-Saharan Africa(Nesheim, 1996).Since the first cases of perinatally infected children with AIDS were reported in 1983, a lot of researchhas been done to get a better understanding of the dynamics of vertical HIV transmission. It is nowgenerally agreed that there are 3 categories of perinatal transmission according to the timing: in utero,intrapartum and postpartum through breastfeeding. Most studies in this area suggest that more than 50%of perinatal transmission occurs close to the time of delivery (Orloff, 1996). Such findings have been ofgreat importance to guide further research and the planning of intervention strategies to prevent perinatalHIV transmission. So far several prevention strategies have been examined. These include: vaginal lavagewith disinfectants or microbicides, vitamin A supplements for pregnant women, and obstetric practicessuch as elective caesarean section or reduction of invasive procedures (episiotomy, scalp electrodes etc.)(Cohen, 1995; Orloff, 1996). One of the most promising strategies has been the antiretroviral therapy withzidovudine (AZT) during pregnancy, which was studied in the AIDS Clinical Trials Group 076 protocolin 1994 and demonstrated a risk reduction of perinatal HIV transmission by two thirds (CDC, 1998).Unfortunately due to its complexity and cost this regimen was not suitable for implementation in thoseparts of the world where most HIV-infected pregnant women live. In reaction to this, researchers havefocussed on how to simplify and reduce the cost of the 076 protocol without losing its efficacy (Cohen,1995). In March 1998 the preliminary results of a short-term antenatal AZT trial in Thailand werereported, showing a 50 % decrease in transmission risk (CDC, 1998). A recent trial in Uganda introducedthe latest short-term antiretroviral regimen using nevirapine. This intrapartum and neonatal single-doseregimen lowered the risk of HIV transmission by nearly 50% during the first 14-16 weeks of life, in abreastfeeding population. Although the effectiveness of nevirapine was not directly compared with theThai AZT regimen, the simplicity and low cost of the nevirapine regimen could make a difference formany babies born to HIV positive mothers in the less-developed parts of the world (Guay, 1999).South Africa currently experiences a rapid increase in HIV prevalence with marked provincialdifferences. Antenatal surveys for HIV prevalence in 1997 ranged from 6% in the Western Cape to 27%in KwaZulu-Natal. Although the figures for the Western Cape were still low, this province showed thehighest increase of all, by doubling its HIV prevalence in one year. The prevalence for the CapeMetropole was 7,6% in 1997 (Department of National Health and Antenatal Survey). In October 1998 theSouth African Government took a decision that the country was yet unable to implement the provision ofAZT for pregnant HIV positive women (McIntyre, 1999). However in January 1999 a preventionprogramme for mother-to-child transmission (MTCT), using a short-term AZT regimen (similar to theThai regimen), started as a pilot in two Maternity Obstetric Units (MOUs): Michael Mapongwana andSite B, in Khayelitsha, a peri-urban settlement near Cape Town. Monitoring and evaluation of the MTCTprogramme is done under the hospice of the Department of Community Health from the University ofCape Town.There is no doubt about the seriousness of perinatal HIV transmission. Whether the factors influencingthe transmission rate also affect the perinatal outcome of HIV-infected pregnancies is still unclear. In fact Health Systems Research I -
  35. 35. there is a lot of controversy around this subject. While most studies conducted in developing countriesreport an association between maternal HIV infection and adverse perinatal outcome (Temmerman, 1994;Kumar, 1995; Chamiso, 1996; Leroy 1998), studies from developed countries fail to demonstrate such aneffect (Newell, 1997). Whatever the relationship between maternal HIV status, perinatal transmission andperinatal outcome, it is clear that the results are highly influenced by regional circumstances. Knowledgeof the local situation seems crucial for implementation and evaluation of intervention strategies and willhelp to develop further guidelines concerning the prenatal care of HIV-infected pregnancies. So far, therehave been no reports on the impact of maternal HIV-infection on perinatal outcome from South Africa.Furthermore, most studies around this topic in developed as well as developing countries reported theoutcomes of hospital-based trials.This mini-thesis will focus on the perinatal outcome of HIV positive pregnancies as compared to HIVnegative pregnancies in a district-based intervention programme that intends to reduce the burden ofPAIDS in this area. This programme has been implemented in the routine Primary Health Care services ofthe Khayelitsha district. In addition, this study will seek to identify concomitant factors for HIV positivewomen in this population group that may have a negative influence on perinatal outcome.The MTCT programme in Khayelitsha serves as a pilot project. All outcomes related to this programmewill help the stakeholders to make informed decisions about the future of this intervention strategy. Themajor stakeholder is the Provincial Health Department of the Western Cape, which provides the mainfunds for this two-year pilot project. It will also make health workers understand the importance of HIVcounselling for pregnant women and help them to find ways in which they can contribute towards thereduction of adverse perinatal outcomes in HIV-positive women, even in the absence of AZT. Finally theresults of this study could be used to create awareness amongst women of childbearing age concerningthe impact of HIV on perinatal outcome and help them to make informed choices about their own futureand that of their children.Perinatal HIV transmission has been the topic of many researchers in developed as well as developingcountries over the last 15 years. Transmission rates vary considerably among different regions in theworld, ranging from 14% in Europe to almost 50 % in sub-Saharan Africa (Working Group on Mother-To-Child Transmission of HIV, 1995). Explanations for these variations involve several factors. Initialstudies around this topic made use of different methods to calculate and report transmission rates. Thisproblem was addressed during a workshop in 1992 in Belgium, where the use of standard methods wasproposed to make studies in this field more comparable. Other factors that may explain some of theregional differences are breastfeeding practices, nutritional status and disease stage of the mother orconcurrent sexually transmitted diseases (Datta, 1994; Orloff, 1996; Tovo, 1997), all of these oftendetermined by socio-economic circumstances. Obstetric factors such as mode and timing of delivery alsoseem to play a role (European Collaborative Study 1996; Landesman, 1996; Tovo, 1996).Some studies focus on the impact of a specific factor related to perinatal HIV transmission in order toformulate guidelines for prevention. Examples of such studies are the impact of maternal disease stage(Blanche, 1994); vitamin A deficiency (Semba, 1994; Greenberg, 1997; Coutsoudis, 1999); or caesareansection (Kuhn, 1996; European Mode of Delivery Collaboration, 1999). Such aspects are usually studiedwithin a group of known HIV-infected pregnant women.Brocklehurst (1998) reports on the findings of a systematic literature review on the association betweenmaternal HIV-infection and perinatal outcome over the period 1983 - 1996. This review includes 21studies from developing countries and 10 studies from developed countries. All these studies wereconducted with prospective cohorts of pregnant women identified as being HIV-positive duringpregnancy or delivery and a control group of HIV-negative pregnant women. Another prerequisite for thisstudy was that outcome measures had to be pre-specified. Summary odds ratios of the main adverseperinatal outcomes related to maternal HIV infection were reported as follows: spontaneous abortion 4.05(95% CI 2.75-5.96); stillbirth 3.91 (95% CI 2.65-5.77); neonatal mortality 1.10 (95% CI 0.63-1.93);infant mortality 3.69 (95% CI 3.03-4.49); low birthweight 2.09 (95% CI 1.86-2.35) and pre-term delivery1.83 (95% CI 1.63-2.06). The review also highlights that the association between maternal HIV infectionand an adverse perinatal outcome is generally stronger for developing countries compared to developedcountries. Control of confounding was done in some studies by matching the HIV-infected and uninfectedpregnant women for age and parity. Another method to control for confounding was stratification of birthoutcomes by maternal disease stage. Different types of multivariate analyses were also used for the samepurpose. Health Systems Research I -
  36. 36. Studies like those included in the literature review are similar to the scope of this mini-thesis. The focus ison the overall impact of HIV on pregnancy and its outcome, without knowledge of the HIV status of thenewborn, as such test results only become reliable after the first year of life, unless more expensive testmethods are used (Orendi, 1998). Most reports on adverse perinatal outcome of HIV-infected pregnanciescome from less-developed countries, whereby perinatal outcome refers to neonatal as well as maternaloutcome. The following neonatal outcomes have all been associated with a positive maternal HIV status:stillbirth, neonatal death, low Apgar score, low birthweight and prematurity (Aiken, 1992; Temmerman,1994; Kumar, 1995; Taha, 1995; Chamiso, 1996; Leroy, 1998). Whether these outcomes should beattributed to the HIV status of the child or to the general health status of HIV-infected pregnant womenremains unclear (Abrams, 1995; Brocklehurst, 1998). But even if an HIV exposed infant is uninfected, alow birthweight or prematurity in itself increases the risk of perinatal mortality or morbidity (Taha, 1995;Markson, 1996). Apart from adverse neonatal outcomes, there is also evidence that maternal HIVinfection increases the risk of obstetric complications such as premature labour, chorioamnionitis andpostpartum endometritis (Temmerman, 1994; Kumar, 1995; Chamiso, 1996; Orloff, 1996).A retrospective record study was done to assess the association of maternal HIV-infection with lowbirthweight (Markson, 1996). This study design has the advantage that it is easier to include a largersample, which might produce more convincing results.So far, no studies have reported any evidence of an HIV dysmorfic syndrome or specific congenitalabnormalities in children born to HIV-infected women (European Collaborative Study 1994). In additionseveral studies found that HIV-infected children rarely show signs and symptoms of their infection duringthe neonatal period (Abrams, 1995; Nesheim, 1996). Therefore most HIV-infected newborns seemperfectly healthy at birth and only show progress of their disease later in infancy.Most studies in developing countries had larger sample sizes than those conducted in developed countries.This might be one of the underlying reasons why the latter studies fail to demonstrate an impact of HIVon perinatal outcome.Research on maternal HIV infection and transmission has been rather limited in South Africa; moststudies seem to be based on two cohorts of HIV positive pregnant women in Durban. The first reportcomes from a prospective cohort of 229 HIV positive pregnant women. The intermediate HIVtransmission rate of 181 infants born to these women was 34% (95% CI 26-42). Furthermore this studyshowed an increased risk of transmission (RR 1.99; 95% CI 1.18-3.34) for women with lowerhaemoglobin concentrations (< 10 g/dl) during pregnancy and a protective effect from caesarean sectionson vertical transmission (RR 0.46; 95% CI 0.23-0.91) (Bobat, 1996; Kuhn, 1996). The impact ofbreastfeeding on transmission rate, growth and mortality in infants of HIV infected women was studied inthe same cohort. The results of this study showed an increased risk of 15% (CI, 1.8-31.8) for transmissionby breastfeeding compared to formula feeding. A more recent study also conducted in Durban assessedthe effect of vitamin A supplementation to HIV positive pregnant women in terms of transmission rateand birth outcome. This intervention did not appear to be effective in reducing the overall verticaltransmission rate but seemed to have some potential for reducing the incidence of preterm deliveries andthe risk of vertical transmission in these preterm infants (Coutsoudis, 1999)(1). In addition the influenceof infant-feeding patterns on early mother-to-child HIV transmission was assessed in infants born towomen who were part of the vitamin A intervention trial. Outcomes of this study suggest that exclusivebreastfeeding in the first 3 months might not convey any excess risk of HIV transmission over formulafeeding (Coutsoudis, 1999)(2).To establish the impact of maternal HIV-infection on perinatal outcomes in women, who volunteered forantenatal HIV screening and thus enrolled in a short-term AZT prevention programme for mother-to-childtransmission in Khayelitsha. To determine whether there is an association between maternal HIV-infection and mortality outcome (maternal, neonatal and stillbirth). To determine whether there is an association between maternal HIV-infection and maternal and/ or neonatal morbidity. To establish within the group of HIV positive pregnant women the impact of compliance to the AZT regimen ( full, partial or no course of AZT received) , on stillbirth and neonatal mortality and morbidity Health Systems Research I -
  37. 37. To identify concomitant risk factors in HIV-positive pregnant women contributing to adverse perinatal outcome.The study has a descriptive component to meet the first objective. This part will describe the totalmortality outcome (maternal, neonatal and stillbirth) of the short-term AZT prevention programme,during the first year (1999). The study contains an analytic part, based on a retrospective cohort, to meetthe other three objectives. The main advantage of this design compared to a prospective study isfeasibility in terms of time and resources. Because the method is less time consuming it will be possibleto study a larger sample of the population, which might produce more convincing results. A majordisadvantage is the dependency on data that were not collected for research purposes, which might lead toa reduction in the accuracy and completeness of the collected data, and has limitations in terms of follow-up. However, a special monitoring and evaluation system has been devised for the MTCT programme toguarantee that a certain set of data will be available (from a database). For the purpose of this mini-thesis,the advantages of the chosen study design weigh up to the disadvantages.- Gestation: length of pregnancy calculated from the first day of the last menstrual period or first trimester ultra-sound scans when available.- Perinatal outcome: all maternal and neonatal morbidity and mortality outcome- Mortality outcome: - maternal death: any death of a women during pregnancy or within 6 weeks after delivery, unless any relationship to the pregnancy as a cause can be excluded. - still birth: all foetuses born dead after a gestational age of 20 weeks. - neonatal death: all neonates born alive who die within the first 4 weeks.- Maternal morbidity outcome: - mode of delivery (including caesarean section). - sexually transmitted diseases (syphilis, vaginal discharge, herpes or condylomata accuminata) diagnoses during pregnancy. - premature rupture of membranes: rupture of membranes > 1 hour prior to the onset of uterine contractions. - premature labour: the onset of labour before 37 completed weeks of gestation. - chorioamnionitis: woman in labour with a temperature of 38º C or more, without external causes of fever. - postpartum endometritis: record of at least 2 of the following symptoms: temperature > 38º C, foul smelling lochia or uterine tenderness. - postpartum haemorrhage: bleeding from the genital tract which exceeds 1000 ml and which occurs within 24 hours after delivery. - referrals to hospital.- Neonatal morbidity outcome: - pre-term birth: all births before 37 completed weeks of gestation. - intrauterine growth retardation: all live neonates with a birthweight below the 10th percentile for gestational age. - low birthweight: all live neonates with a birthweight below 2500 gram. - Apgar-score. - congenital abnormalities. - any signs or symptoms of disease in the neonate within the first 4 weeks of life. - hospital admissions during the first 4 weeks of life.- AZT regimen: - full: 300 mg BD from 36 weeks gestation until onset of labour and 300 mg every 3 hours from onset of labour until delivery. - partial: any course of AZT containing fewer doses than the full regimen. - no treatment: no AZT doses at all.All pregnant women attending the two MOUs in Khayelitsha, who underwent a voluntary HIV screeningtest during the study period, are eligible to the study.Although the MTCT programme in Khayelitsha is rather unique in South Africa, the results could alsoapply to other populations with a similar HIV prevalence and living under similar circumstances. Health Systems Research I -
  38. 38. The total retrospective cohort will consist of 540 records, 180 cases and 360 controls. This number isbased on an expected adverse perinatal outcome of 15% in a normal population and an estimated riskratio of two, for adverse perinatal outcomes in HIV positive pregnancies (Taha, 1995; Leroy, 1998). Todetermine an association with 80% power and 95% confidence interval, under these circumstancesrequires a minimum number of 480 records according to the WHO Epi info statistical package. The 60extra records are included, taking into account possible loss to follow-up.The sampling frame is systematic, whereby cases and controls are determined by the time/date they comefor their first antenatal visit and consent for a voluntary HIV test. This fist visit links the women to theirrecord.The MOU at site B is at least twice as busy as the MOU at Michael Mapongwana, therefore two third(360) of the study sample will be taken from site B and one-third (180) from Michael Mapongwana. Atsite B, the first 10 women in each month during 1999, who tested HIV positive during the voluntaryantenatal screening will be included as cases. The first 20 women in each month during 1999, who testedHIV negative, will be included as controls. At Michael Mapongwana, the first 5 women who tested HIVpositive and the first 10 women who tested HIV negative in each month will be included in the same way.Record review at two MOUs in Khayelitsha. The following data will be collected from each record: sociodemographic - age, educational level, marital status, number of partners, occupation. medical history - all relevant chronic or acute medical conditions, current medication. obstetric history - parity, miscarriages/ abortions, STDs, VDRL result, haemoglobin level, gestational age at first antenatal visit, total number of antenatal visits, pregnancy induced hypertension or diabetes. obstetric outcome - mode of delivery, gestational age, premature labour, premature rupture of membranes, placenta weight, post partum haemorrhage, chorioamnionitis, post partum endometritis, hospital referrals, maternal death. neonatal outcome - stillbirth, birthweight, Apgar score, congenital malformations, symptoms, diseases or hospital admissions within the first 4 weeks of life, neonatal death. AZT regimen - full, partial or no AZT course received.A pilot study will be conducted to check whether it is possible to obtain the above mentioned data fromthe records.The retrospective character of the study is likely to have an impact on the validity in terms of informationbias. It is not possible to control for inaccuracies in measurements or record keeping, but the bias in therelative risk estimates will be minimal, as the error will be equally distributed between the cases and thecontrols.As with validity, the reliability will also suffer from the retrospective study design. It is unlikely that allhealth workers between the two facilities or even within one facility perform certain measurements in astandardised way or make use of the same measurement tool at all times.But the possible error will be equally distributed over cases as well as controls.Statistics will be analysed using the WHO Epi Info 6 statistical package. Means of quantitative variableswill be compared by a t-test; proportions will be compared with a X -test. Odds ratios and the 95%confidence intervals will be used to measure the strength of associations. Statistical significance will beset at a cut-off level of p < 0.05.Data related to the HIV positive women will be collected from their obstetric records or from the MTCTmonitoring database. Data related to the control group will be collected from the obstetric records. Datarelated to the neonates will be obtained from the records that are given to them at birth. All mortality data Health Systems Research I -
  39. 39. will be retrieved from the annual mortality statistics for Khayelitsha. After collection all data will beentered in a database and made suitable for statistical analysis. The results of the study will be distributedto the Provincial Department, health workers in the participating MOUs and the women of childbearingage in Khayelitsha.Planning phase (literature search, protocol writing): September 1999 - December 1999Data collection phase: January 2000 - March 2000Data analysis: April 2000Report writing: May 2000 - June 2000Handing in mini-thesis: July 2000The student responsible for the mini-thesis will do all necessary data collection; she will need some helpin searching the sample records at the MOUs and the referral institutions. The support of a supervisor willbe required at all stages of the study. The advice of a statistician might be required for the methodssection of the protocol and for the data analysis later on.Although the MTCT programme in itself might give rise to ethical concerns, the programme has beenapproved and started in January 1999. The ethical question to consider for this mini-thesis is whetherconfidentiality of data can be guaranteed. Complete confidentiality is not possible as data collectionallows the investigator to have knowledge of the HIV status of the study population, however in the dataset and analysis these and other results will be linked to record numbers and not to the name of theindividual. The retrospective character of the study does not cause any inconvenience in terms of extravisits, clinical examinations or laboratory tests for the population under study.To obtain ethical approval this protocol will be presented to the ethical committee of the University of theWestern Cape and the health authorities of the Provincial Administration of the Western Cape and theCity of Tygerberg.Abrams EJ, Matheson PB, Thomas PA. et al. (1995) Neonatal predictors of infection status and earlydeath among 332 infants at risk of HIV-1 infection monitored prospectively from birth. 96:451-458.Aiken CGA. (1992) HIV-1 infection and perinatal mortality in Zimbabwe. 67: 595-599.Blanche S, Mayaux MJ, Rouzioux C. et al. (1994) Relation of the course of HIV infection in children andthe severity of the disease in their mothers at delivery. 330: 308-312.Bobat R, Coovadia H, Coutsoudis A. et al. (1996) Determinants of mother-to-child transmission ofhuman immunodeficiency virus type 1 infection in a cohort from Durban, South Africa. 15: 604-610.Bobat R, Moodley D, Coutsoudis A. et al. (1997) Breastfeeding by HIV-1-infected women and outcomein their infants: a cohort study from Durban, South Africa. 11: 1627-1633.Brocklehurst P, French R. (1998) The association between maternal HIV infection and perinatal outcome:a systematic review of the literature and meta-analysis. 105: 836-848.Centers for Disease Control and Prevention (1998) Administration of zidovudine during late pregnancyand delivery to prevent perinatal HIV transmission --Thailand, 1996-1998. 47: 151-154.Chamiso D. (1996) Pregnancy outcome in HIV-1 positive women in Gandhi Memorial Hospital AddisAbaba, Ethiopia. 73: 805-809.Cohen J. (1995) Bringing AZT to poor countries. 269: 624-626.Coutsoudis A, Pillay K, Spooner E. et al. (1999) (1) Randomized trial testing the effect of vitamin Asupplementation on pregnancy outcomes and early mother-to-child HIV-1 transmission in Durban, SouthAfrica. 13: 1517-1524.Coutsoudis A, Pillay K, Spooner E. et al. (1999) (2) Influence of feeding patterns on early mother-to-child transmission of HIV-1 in Durban, South Africa: a prospective cohort study. 354: 471-476.Datta P, Embree JE, Kreiss JK. et al. (1994) Mother -to-child transmission of human immunodeficiencyvirus type 1: report from the Nairobi study. 170: 1134-1140.European Collaborative Study (1994) Perinatal findings in children born to HIV-infected mothers. 101: 136-141.European Collaborative Study (1996) Vertical transmission of HIV-1: maternal immune status andobstetric factors. 10: 1675-1681. Health Systems Research I -
  40. 40. European Mode of Delivery Collaboration (1999) Elective caesarean-section versus vaginal delivery inprevention of vertical HIV-1 transmission: a randomised clinical trial. 353: 1035-1039.Greenberg BL, Semba RD, Vink PE. et al. (1997) Vitamin A deficiency and maternal-infant transmissionof HIV in two metropolitan areas in the United States. 11: 325-332.Guay LA, Musoke P, Fleming T. et al. (1999) Intrapartum and neonatal single-dose nevirapine comparedwith zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET012 randomised trial. 354: 795-802.Kuhn L, Bobat R, Coutsoudis A. et al. (1996) Caesarean deliveries and maternal-infant HIV transmission:results from a prospective study in South Africa. 11:478-483.Kumar RM, Uduman SA, Khurranna AK. (1995) Impact of maternal HIV-1 infection on perinataloutcome. 49: 137-143.Landesman SH, Kalish LA, Burns DN. et al. (1996) Obstetrical factors and the transmission of humanimmunodeficiency virus type 1 from mother to child. 334: 1617-1623.Leroy V, Ladner J, Nyiraziraje M. et al. (1998) Effect of HIV-1 infection on pregnancy outcome inwomen in Kigali, Rwanda, 1992-1994. 12: 643-650.Markson L, Turner BJ, Houchens R. et al. (1996) Association of maternal HIV infection with low birthweight. 13: 227-234.McIntyre J, Gray G. (1999) Mother-to-child transmission of HIV: Where to now? 8Nesheim SR. (1996) The diagnosis and management of perinatal HIV infection.39: 396-410.Newell ML, Thorne C. (1997) Pregnancy and HIV infection in Europe. 421: 10-14.Orendi JM, Geelen SPM, Graeff-Meeder ER de. et al. (1998) Verticale-HIV-1 transmissie. II. HIV-diagnostiek bij het kind. 142: 2724-2728.Orloff SL, Simonds RJ, Steketee RW. et al. (1996) Determinants of perinatal HIV-1 transmission. 39: 386-395.Saba J. (1997) Identification of HIV infection in pregnancy: another era. 421: 65-66.Semba RD, Miotti PG, Chipangwi JD. et al. (1994) Maternal vitamin A deficiency and mother-to-childtransmission of HIV-1. 343: 1593-1597.Taha TE, Dallabetta GA, Canner JK. et al. (1995) The effect of human immunodeficiency virus infectionon birthweight, and infant and child mortality in urban Malawi. 24: 1022-1029.Temmerman M, Chomba EN, Ndinya-Achola J. et al. (1994) Maternal human immunodeficiency virus-1infection and pregnancy outcome. 83: 495-501.Tovo PA, Martino M de, Gabiano C. et al. (1996) Mode of delivery and gestational age influenceperinatal HIV-1 transmission. 11: 88-94.Tovo PA, Gabiano C, Tulisso S. (1997) Maternal clinical factors influencing HIV-1 transmission. 421: 52-55. The protocol is made up of the following headings: Summary The summary presents a brief summary of Introduction Problem Purpose Literature Review Aim Objectives Methodology o Study Design o Definition Of Terms o Study Population o Generalisability Health Systems Research I -
  41. 41. o Sample Size o Sampling Procedure o Data Collection o Validity o Reliability o Data AnalysisLogisticsTime-FrameResourcesEthical ConsiderationsReferencesIntroductionBackground informationThe background information provides some information on the settingof the research, how the research question came about and whois/will be involved in the research.Statement of the problemProblem identification is one of the major tasks for HSR researchersand this section shows how the problem was identified and why itshould prioritised. The problem should be defined and stated in aclear and brief manner.Literature ReviewThe literature review shows what information is already available onthis problem and what methods other researchers have used toanswer the same types of questions.Aims and ObjectivesThe aim of the study states the broad question this research is tryingto answer and should be set out clearly. The aim can then be brokeninto several smaller connected objectives. An objective identifies aspecific and measurable issue that will be achieved by the study.MethodologyDescribes study type, variables, and data collectionSamplingPlan for data collectionPlan for data processing and analysisPretestingEthical considerationsWork PlanA work plan is a schedule, graph or chart that summarises in a clearfashion, the components of a research project and how they fittogether. It should include the various tasks to be performed, whenthe tasks will be performed, who will perform the tasks and the timeeach person will spend on them. Health Systems Research I -
  42. 42. Plans for Dissemination of Results The key to successful Health Systems Research is its impact on policy. It is conducted to highlight needs for change and recommend ways to bring about change. The protocol should show that you have thought through the process of influencing policy and developed a strategy for the best use of your results. Budget The work plan can be used to plan your budget especially in terms of the resources required for each activity. : (1995). Availability, Provision and Use of Antibiotic, Antihypertensive and Antidiabetic Drugs at Public Health Care Level in Mauritius. Geneva: WHO: 5 - 23.1. Health Systems Research I -
  43. 43. Stages in the Development of an HSR ProtocolQuestions to ask Stage ElementWhat is the problem? 1. Statement of the Identify the problemWhy should we study it? Research Problem Prioritise the problem Analyse the problemWhat information is already 2. Literature Review Review the literatureavailable? and other available informationWhy do we want to carry out the 3. Formulation of Set aims andresearch? Aims and objectivesWhat do we hope to achieve? ObjectivesWhat additional data do we need 4. Research Variables andto reach our research Methodology indicatorsobjectives? Study design (typesHow are we going to collect this and approaches)information? Data collection methods - Record reviews - Questionnaires and sampling - Observations - Interviews - Focus group discussions Plan for data collection Plan for data processing and analysis Health Systems Research I -
  44. 44. Who will do what and when? 5. Workplan Personnel TimetableWhat resources do we need to 6. Budget Material support andcarry out this study? equipmentWhat resources do we have? MoneyHow will we present our proposal 7. Proposal Summaryto relevant authorities andfunders? (Adapted from Varkevisser, 1991, p.6). Stages in Developing a Protocol Stage 1 Identify the research problem Stage 2 Stage 7 Review the Write the proposal literature Stage 3 Stage 6 Formulate aims & Draw up the budget objectives Stage 5 Stage 4 Draw up the workplan Choose the research methodology Health Systems Research I -
  45. 45. Designing and Conducting Heath SystemsResearch Projects. Health Systems Research I -
  46. 46. Stage 1 Identify the research problem Stage 2 Stage 7 Review the literatureWrite the proposal Stage 6 Stage 3Draw up the budget Formulate aims & objectives Stage 5 Draw up the workplan Stage 4 Choose the research methodology Health Systems Research I -
  47. 47. TB Problems Health Systems Research I -
  48. 48. Ante-natal Care Problems Health Systems Research I -
  49. 49. Health Systems Research I -
  50. 50. Health Systems Research I -
  51. 51. Health Systems Research I -
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  55. 55. Long waiting times at Lack of drugs in Long distances to thethe clinics the clinics clinics Poor use of ANC services Short opening hours Rude midwives of clinics Poor knowledge and awareness of the benefits of ANC Health Systems Research I -
  56. 56. Helping Health Workers LearnInsufficient awareness of the importance of ANC in the communityWhy?Because local mothersWhy?Because Health Systems Research I -
  57. 57. Health Systems Research I -
  58. 58. This is a poor rural community. There is a low use of ante- natal services in this community, which is resulting in high maternal and perinatal mortality. Local beliefs about the use of traditional birth attendants may act as a barrier towards the use of ante-natal services. There is presently little knowledge about the impact of these beliefs on the use of ANC services. Further research on these beliefs will allow a better understanding and perhaps lead to improved relations between the health services and the TBAs.This community is a poor rural community. There is a low use of ante-natal services in this community, which is resulting in high maternal and perinatal mortality. Health Systems Research I -
  59. 59. Local beliefs about the use of traditional birth attendants may act as abarrier towards the use of ante-natal services.There is presently little knowledge about the impact of these beliefs on theuse of ANC services.Further research on these beliefs will allow a better understanding andperhaps lead to improved relations between the health services and theTBAs. five main components of a problem statement Health Systems Research I -
  60. 60. The Highgate Hospital is a busy teaching hospital serving the whole of Tinsel Town. Patients have been complaining that they have to wait for long periods of time in the outpatient department. Sometimes this leads to the death of patients. There is a need for information to identify the reasons for this long wait, so that these factors can be remedied. The teenage pregnancy prevalence in this community is 20%. It occurs mostly amongst the poorer sections of the community. It leads to increased school dropout and malnourished babies. We do not know why teenagers are becoming pregnant. There is a need to gather information from teenagers about their knowledge of contraception.Community X is a poor rural community. The prevalence of breastfeeding has beendropping over the last few years, leading to increased childhood malnutrition and death.One of the most important causes identified in this community is the low level of knowledgeof breastfeeding amongst young mothers. There is a need to establish what knowledgeyoung mothers have about breastfeeding and where they have received this knowledge.This will assist in developing an educational intervention. Health Systems Research I -
  61. 61. Health Systems Research Designing and Conducting Heath SystemsResearch Projects. Health Systems Research I -
  62. 62. Research Design UNIT 2T Stages in Developing a Protocol Stage 1 Identify the research problem Stage 7 Stage 2 Write the proposal Review the literature Stage 6 Stage 3Draw up the budget Formulate aims & objectives Stage 5 Stage 4 Draw up the workplan Choose the research methodology Health Systems Research I -
  63. 63. Health Systems Research I -
  64. 64. Stage 1 Identify the research problem Stage 7Write the proposal Stage 2 Review the literature Stage 6 Stage 3 Draw up the budget Formulate aims & objectives Stage 5 Stage 4 Draw up the workplan Choose the research methodology Health Systems Research I -
  65. 65. Epidemiology: A Manual for South Africa Using and Referencing Sources Health Systems Research I -
  66. 66. Epidemiology: A Manual for SouthAfrica. Developing a Protocol Stage 1 Identify the research problem Stage 7 Stage 2 Write the proposal Review the literature Stage 6 Stage 3 Draw up the budget Formulate aims & objectives Stage 4 Stage 5 Choose the research methodology Draw up the workplan Health Systems Research I -
  67. 67. The availability and use of drugs in MauritiusMain ResearchFocus Topicintroducing While only few studies exist on the availability and use of drugs in Mauritius,research area &its relevance for many other studies all over the world support the relevance of their research topic.Mauritius Problems in the availability of drugs may start at the central level when the country has limited access to foreign exchange.6 At the lower levels, drug shortages can he caused by inadequate ordering and delivery of drugs, poor stock management, theft, wastage of drugs, and also inappropriate use of drugs. A study in Yemen provides recommendations on how to improve the drug ordering system on the basis of morbidity figures. Wastage of drugs, such as expiry or damage can be the result of poor stock management.7,8 To improve the availability of drugs, Essential Drug Programmes have been introduced in many countries, sometimes with considerable effect, but often still hampered by continued irrational prescribing and dispensing.4 This is discussed below in more detail. A larger number of studies deal with doctors’ prescribing practices in which excessive, inadequate and incorrect prescribing are commonly observed.9,10 Health Systems Research I -
  68. 68. Two most commonly used indicators for rational prescribing at health care levelare the average number of drugs per prescription and the percentage ofprescriptions containing antibiotics or an injection.11 A third indicator is notrelevant in respect of this study. Antibiotics are indeed widely misused: a study inAngola, surveying 27 health units, found that there was an exaggerated use ofantibiotics in the case of a simple diarrhoea. And very often antibiotics were usedas a single dose or for three or less days.12 An evaluative study in Yemenconcluded that the Essential Drug Programme considerably reduced the figures forthe three indicators referred to above. However, despite this reduction in use,antibiotics still appeared to be overused.13A study in Bangladesh in two teaching hospitals showed that 65% of 234 patientsreceived antibiotics. Ninety percent of the prescriptions were on clinical groundsonly. Frequently combination preparations were used which were irrational andpotentially harmful.14 A study in the United States of America showed that 25 to40% of antibiotics were given unnecessarily.15 Misuse of antibiotics brings anunnecessary financial burden on national and individual health budgets. It alsoleads to an increasing drug resistance.16Prescribing of unnecessary expensive brandname products is a burden on nationaland individual financial resources.Overprescribing of antibiotics and other drugs could be due to doctors not beingalways aware of the costs of the drugs they prescribe. The introduction of EssentialDrug Programmes intended to address these problems, has had limited effect. Foreffective implementation of the Essential Drug Programme, the simultaneousintroduction of standard protocol for treatment of common diseases is a must. Inaddition, prescribing guidelines and measures to limit the choice for prescribingshould be developed in consultation with health workers, otherwise co-operation isvery unlikely and even strong protest might be the result.17Some measures suggested by WHO Drug Action Programme to promote rationalprescribing are the:a) prescribing of generic drugs,b) use of standard protocol for common diseases, andc) training of health workers in rational use of drugs.Another method could be to provide feedback to prescribers on the costs of theirprescriptions compared to costs for a standard treatment. Health Systems Research I -
  69. 69. To change doctors prescribing practices, however, appeared difficult. The usualpromotional drive with educational objectives has generally little effect.18 But inAustralia a professionally-run advertising campaign to change doctors preferencefor new broad-spectrum antibiotics to an old more effective penicillin showed quitesuccessful.18Both pharmacy-based studies, as well as household-based studies show thatinappropriate use of drugs, in terms of excessive or wrong use of drugs is alsocommon among consumers, The most common types of misuse of drugs amongconsumers are:19a) non-compliance with health workers prescriptionb) self-medication with prescription drugsc) misuse of antibioticsd) overuse of injectionse) overuse of relatively safe drugs (e.g. painkillers)f) use of inessential combination drugsg) use of needlessly expensive drugsNon-compliance to drug therapy has been extensively investigated. In general,compliance rates vary between 40 to 70%, even in serious conditions.17 A study inZimbabwe found that more than 60% of hypertensive and diabetic patientsattending all out-patient clinic did not understand the disease and the use of themedicines prescribed to them.20 Non-compliance from a medical perspective couldalso be regarded as a patients way to ascertain control over his own disorder.Compliance behaviour can therefore be seen as a dynamic process by whichchanges occur as a result of new information and experience gained by thepatient.21Self medication with prescription drugs is also well documented.10 A study inEthiopia surveying 11700 drug orders in pharmacies in the capital found that 83%were purchased without a prescription, many of which were potentially hazardous.Various studies found that consumers sometimes have very strong preferences forcertain drugs, pressing their doctors to prescribe them antibiotics or injectionswhen they are not indicated.10 Peoples ideas about drug efficacy and diseaseetiology may differ from the biomedical perspective, which can affect the way theyuse the drugs.22 Health Systems Research I -
  70. 70. Overconsumption of drugs by consumers may occur when drugs are provided forfree, as is the case in Mauritius. In several countries user-fees are being introducedfor cost recovery in Primary Health Care. User charges for drugs, however, couldalso result in overprescribing, as it provides a possibility for prescribers to makeextra money. Health Systems Research I -
  71. 71. Main Research Focus The Availability and Use of Drugs in Mauritius Topic 1Introducing research While only few studies exist on the availability and use of drugs in Mauritius,area & its relevance many other studies all over the world support the relevance of their research topic. Problems in the availability of drugs may start at the central level when the Problems country has limited access to foreign exchange.6 At the lower levels, drug shortages can he caused by inadequate ordering and delivery of drugs, poor stock management, theft, wastage of drugs, and also inappropriate use of drugs. A study in Yemen provides recommendations on how to improve the drug ordering system on the basis of morbidity figures. Wastage of drugs, such as expiry or damage can be the result of poor stock management.7,8 Tried solutions & To improve the availability of drugs, Essential Drug Programmes have been introduced in many countries, sometimes with considerable effect, but often their limitations still hampered by continued irrational prescribing and dispensing.4 This is discussed below in more detail. Topic 2 Main problems A larger number of studies deal with doctors’ prescribing practices in which excessive, inadequate and incorrect prescribing are commonly observed.9,10 Two most commonly used indicators for rational prescribing at health care 2 indicators for level are the average number of drugs per prescription and the percentage of rational prescriptions containing antibiotics or an injection.11 A third indicator is not prescribing relevant in respect of this study. Antibiotics are indeed widely misused: a study in Angola, surveying 27 health units, found that there was an Evidence: Angola exaggerated use of antibiotics in the case of a simple diarrhoea. And very often & Yemen studies antibiotics were used as a single dose or for three or less days.12 An evaluative study in Yemen concluded that the Essential Drug Programme considerably reduced the figures for the three indicators referred to above. However, despite this reduction in use, antibiotics still appeared to be overused.13 2 further studies: A study in Bangladesh in two teaching hospitals showed that 65% of 234 Bangladesh, USA patients received antibiotics. Ninety percent of the prescriptions were on clinical grounds only. Frequently combination preparations were used which Broader were irrational and potentially harmful.14 A study in the United States of consequences of America showed that 25 to 40% of antibiotics were given unnecessarily.15 misusing antibiotics Misuse of antibiotics brings an unnecessary financial burden on national and individual health budgets. It also leads to an increasing drug resistance.16 Consequences of Prescribing of unnecessary expensive brandname products is a burden on prescribing national and individual financial resources. brandnames Overprescribing of antibiotics and other drugs could be due to doctors not Possible causes being always aware of the costs of the drugs they prescribe. The introduction of over- of Essential Drug Programmes intended to address these problems, has had prescribing; & limited effect. For effective implementation of the Essential Drug Programme, the simultaneous introduction of standard protocol for treatment of common some solutions diseases is a must. In addition, prescribing guidelines and measures to limit the choice for prescribing should be developed in consultation with health workers, otherwise co-operation is very unlikely and even strong protest might be the result17 Drug WHO measures for rational Another measure prescribing Health Systems Research I -
  72. 72. a) prescribing of generic drugs, b) use of standard protocol for common diseases, and How to change c) training of health workers in rational use of drugs. doctors’’ prescribing Another method could be to provide feedback to prescribers on the costs of practices their prescriptions compared to costs for a standard treatment. To change doctors prescribing practices, however, appeared difficult. The Topic 3 usual promotional drive with educational objectives has generally little effect.18 But in Australia a professionally-run advertising campaign to change Common ways in doctors preference for new broad-spectrum antibiotics to an old more effective which consumers penicillin showed quite successful.18 misuse drugs Both pharmacy-based studies, as well as household-based studies show that inappropriate use of drugs, in terms of excessive or wrong use of drugs is also common among consumers, The most common types of misuse of drugs among consumers are:19 a) non-compliance with health workers prescription b) self-medication with prescription drugs c) misuse of antibioticsCompliance rates d) overuse of injections e) overuse of relatively safe drugs (e.g. painkillers)Why patients f) use of inessential combination drugsdon’’t comply g) use of needlessly expensive drugsHow to change Non-compliance to drug therapy has been extensively investigated. In general,this behaviour compliance rates vary between 40 to 70%, even in serious conditions.17 A study in Zimbabwe found that more than 60% of hypertensive and diabetic patients attending all out-patient clinic did riot understand the disease and the use of the medicines prescribed to them.20 Non-compliance from a medical perspective could also be regarded as a patients way to ascertain control over Problems with his own disorder. Compliance behaviour can therefore be seen as a dynamic self-medication process by which changes occur as a result of new information and experience gained by the patient.21 Self medication with prescription drugs is also well documented.10 A study in Ethiopia surveying 11700 drug orders in pharmacies in the capital found that 83% were purchased without a prescription, many of which were potentially hazardous. Various studies found that consumers sometimes have very strongUser fees, preferences for certain drugs, pressing their doctors to prescribe themoverconsumption & antibiotics or injections when they are not indicated.10 Peoples ideas aboutoverprescribing of drug efficacy and disease etiology may differ from the biomedical perspective,drugs which can affect the way they use the drugs.22 Overconsumption of drugs by consumers may occur when drugs are provided for free, as is the case in Mauritius. In several countries user-fees are being introduced for cost recovery in Primary Health Care. User charges for drugs, however, could also result in overprescribing, as it provides a possibility for prescribers to make extra money. Some measures suggested by WHO Action Programme to promote rational prescribing are the: Health Systems Research I -
  73. 73. This page has been removed from this version.
  74. 74. Health Systems Research I -
  75. 75. Maternal HIV-Infection and Perinatal Outcome: Results of a District-Based PreventionProgramme for Mother-to-Child Transmission in Khayelitsha, Cape Town Broad Research Area Global statistics (Reference) DINGENA KOPPELAAR, 1999 Perinatal HIV transmission has been the topic of many researchers in developed as well as developing countries over the last 15 years. Transmission rates vary considerably among different regions in the world, ranging from 14% in Europe to almost 50 % in sub-Saharan Africa (Working Group on Mother-To-Child Transmission of HIV, 1995). Explanations for these variations involve several factors. Initial studies around this topic made use of different methods to calculate and report transmission rates. This problem was addressed during a workshop in 1992 in Belgium, where the use of standard methods was proposed to make studies in this field more comparable. Other factors that may explain Health Systems Research I -
  76. 76. some of the regional differences are breastfeeding practices, nutritional status and diseasestage of the mother or concurrent sexually transmitted diseases (Datta, 1994; Orloff, 1996;Tovo, 1997), all of these often determined by socio-economic circumstances. Obstetricfactors such as mode and timing of delivery also seem to play a role (EuropeanCollaborative Study 1996; Landesman, 1996; Tovo, 1996).Some studies focus on the impact of a specific factor related to perinatal HIV transmissionin order to formulate guidelines for prevention. Examples of such studies are the impact ofmaternal disease stage (Blanche, 1994); vitamin A deficiency (Semba, 1994; Greenberg,1997; Coutsoudis, 1999); or caesarean section (Kuhn, 1996; European Mode of DeliveryCollaboration, 1999). Such aspects are usually studied within a group of known HIV-infected pregnant women.Brocklehurst (1998), reports on the findings of a systematic literature review on theassociation between maternal HIV-infection and perinatal outcome over the period 1983-1996. This review includes 21 studies from developing countries and 10 studies fromdeveloped countries. All these studies were conducted with prospective cohorts of pregnantwomen identified as being HIV-positive during pregnancy or delivery and a control groupof HIV-negative pregnant women. Another prerequisite for this study was that outcomemeasures had to be pre-specified. Summary odds ratios of the main adverse perinataloutcomes related to maternal HIV infection were reported as follows:spontaneous abortion 4.05 (95% CI 2.75-5.96);stillbirth 3.91 (95% CI 2.65-5.77);neonatal mortality 1.10 (95% CI 0.63-1.93);infant mortality 3.69 (95% CI 3.03-4.49);low birthweight 2.09 (95% CI 1.86-2.35) andpre-term delivery 1.83 (95% CI 1.63-2.06).The review also highlights that the association between maternal HIV infection and anadverse perinatal outcome is generally stronger for developing countries compared todeveloped countries. Control of confounding was done in some studies by matching theHIV-infected and uninfected pregnant women for age and parity. Another method tocontrol for confounding was stratification of birth outcomes by maternal disease stage.Different types of multivariate analyses were also used for the same purpose.Studies like those included in the literature review are similar to the scope of this mini-thesis. The focus is on the overall impact of HIV on pregnancy and its outcome, withoutknowledge of the HIV status of the newborn, as such test results only become reliable afterthe first year of life, unless more expensive test methods are used (Orendi, 1998).Most reports on adverse perinatal outcome of HIV-infected pregnancies come from less-developed countries, whereby perinatal outcome refers to neonatal as well as maternal Health Systems Research I -
  77. 77. outcome. The following neonatal outcomes have all been associated with a positivematernal HIV status: stillbirth, neonatal death, low Apgar score, low birthweight andprematurity (Aiken, 1992; Temmerman, 1994; Kumar, 1995; Taha, 1995; Chamiso, 1996;Leroy, 1998). Whether these outcomes should be attributed to the HIV status of the childor to the general health status of HIV-infected pregnant women remains unclear (Abrams,1995; Brocklehurst, 1998). But even if an HIV exposed infant is uninfected, a lowbirthweight or prematurity in itself increases the risk of perinatal mortality or morbidity(Taha, 1995; Markson, 1996). Apart from adverse neonatal outcomes, there is alsoevidence that maternal HIV infection increases the risk of obstetric complications such aspremature labour, chorioamnionitis and postpartum endometritis (Temmerman, 1994;Kumar, 1995; Chamiso, 1996; Orloff, 1996).A retrospective record study was done to assess the association of maternal HIV-infectionwith low birthweight (Markson, 1996). This study design has the advantage in that it iseasier to include a larger sample, which might produce more convincing results.So far, no studies have reported any evidence of an HIV dysmorfic syndrome or specificcongenital abnormalities in children born to HIV-infected women (European CollaborativeStudy 1994). In addition several studies found that HIV-infected children rarely show signsand symptoms of their infection during the neonatal period (Abrams, 1995; Nesheim,1996). Therefore most HIV-infected newborns seem perfectly healthy at birth and onlyshow progress of their disease later in infancy.Most studies in developing countries had larger sample sizes than those conducted indeveloped countries. This might be one of the underlying reasons why the latter studies failto demonstrate an impact of HIV on perinatal outcome.Research on maternal HIV infection and transmission has been rather limited in SouthAfrica; most studies seem to be based on two cohorts of HIV positive pregnant women inDurban.The first report comes from a prospective cohort of 229 HIV positive pregnant women.The intermediate HIV transmission rate of 181 infants born to these women was 34% (95%CI 26-42). Furthermore this study showed an increased risk of transmission (RR 1.99; 95%CI 1.18-3.34) for women with lower haemoglobin concentrations (< 10 g/dl) duringpregnancy and a protective effect from caesarean sections on vertical transmission (RR0.46; 95% CI 0.23-0.91) (Bobat, 1996; Kuhn, 1996). The impact of breastfeeding ontransmission rate, growth and mortality in infants of HIV infected women was studied inthe same cohort. The results of this study showed an increased risk of 15% (CI, 1.8-31.8)for transmission by breastfeeding compared to formula feeding. Health Systems Research I -
  78. 78. A more recent study also conducted in Durban assessed the effect of vitamin Asupplementation to HIV positive pregnant women in terms of transmission rate and birthoutcome. This intervention did not appear to be effective in reducing the overall verticaltransmission rate but seemed to have some potential for reducing the incidence of pretermdeliveries and the risk of vertical transmission in these preterm infants (Coutsoudis,1999)(1). In addition the influence of infant-feeding patterns on early mother-to-child HIVtransmission was assessed in infants born to women who were part of the vitamin Aintervention trial. Outcomes of this study suggest that exclusive breastfeeding in the first 3months might not convey any excess risk of HIV transmission over formula feeding(Coutsoudis, 1999)(2). Health Systems Research I -
  79. 79. Introduction to Broad Research Area Importance Global statistics Explanations of rate variations: Studies undertaken (6 Refs)Studies on the impact of specificfactors on perinatal HIV Literature review findingstransmission (6 Refs) Who focused on How conducted (Ref) Relating literature review to this research (Ref)Association between maternal HIV infection & neonatal &perinatal outcomes (14 Refs) Study on association between maternal HIV infection & low birthweight (Ref) General findings & conclusions of other studies (3 Refs) Why studies in developing countries don’t show HIV impacting on perinatal outcome Research carried out in S. Africa Main findings - 1st study Main findings - 2nd study (2 Refs) (2 Refs) Health Systems Research I -
  80. 80. Health Systems Research I -
  81. 81. : Using and Referencing Sources Epidemiology: A Manual for SouthAfrica. Health Systems Research I -
  82. 82. et al.Health Systems Research I -
  83. 83. Acta Paediatr Suppl Int J Epidemiol Lancet Science The situation of children and women World Health Forum Health Systems Research I -
  84. 84. Availability, Provision and Use of Antibiotic, Antihypertensiveand Antidiabetic Drugs at Public Health Care Level in Mauritius Maternal HIV-Infection and Perinatal Outcome: Resultsof a District-Based Prevention Programme for Mother-to-Child Transmissionin Khayelitsha, Cape Town . Health Systems Research I -
  85. 85. This page has been removed from this version.
  86. 86. Why do we want to carry out the research?What do we hope to achieve? Stage 1 Identify the research Stage 7 Stage 2Write the proposal Review the literature Stage 6 Stage 3 Draw up the budget Formulate aims & objectives Stage 5 Stage 4 Draw up the workplan Choose the research Health Systems Research I -
  87. 87. Epidemiology: A Manual forSouth Africa Health Systems Research I -
  88. 88. S. Epidemiology: A Manualfor South Africa Health Systems Research I -
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  93. 93. clinicsHealth Systems Research I -
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  96. 96. What additional data do we need to reach our research objectives?How are we going to collect this information? Stage 1 Identify the research problem Stage 7 Stage 2 Write the proposal Review the literature Stage 6 Stage 3 Draw up the budget Formulate aims & objectives Stage 5 Stage 4 Draw up the workplan Choose the research methodology Health Systems Research I -
  97. 97. Designing and Conducting Heath Systems Research Projects.What information are we going to collect in our study in order to meet ourobjectives? Health Systems Research I -
  98. 98. Designing and ConductingHeath Systems Research Projects. Health Systems Research I -
  99. 99. To list the ages of all the children attending an immunisation clinicTo measure the knowledge of mothers about measlesTo measure the number of children admitted with measles to the hospitalTo compare the cost of different TB medicationsTo measure the proportion of obese adults attending a diabetic clinic Identify factors related to the TB services that make them either accessible or not to TB sufferers. Health Systems Research I -
  100. 100. To identify whether there are variations in TB compliance related to theage, gender, area of residence, type of treatment and type of treatmentpoint. Health Systems Research I -
  101. 101. Determine the level of diabetes complications admitted to hospital in the last two years‘the hospital admission of diabetic complications’ Health Systems Research I -
  102. 102. What additional data do we 4. Research Study designneed to reach our research Methodologyobjectives?How are we going to collectthis information? Health Systems Research I -
  103. 103. Designing andConducting Heath Systems ResearchProjects. Health Systems Research I -
  104. 104. Planning Healthy Communities. Planning Healthy Communities. ? South African Medical Journal Designing and Conducting HeathSystems Research Projects. Health Systems Research I -
  105. 105. Non-intervention Intervention Study designs Study types? case-studies ? ? ? Non-intervention Intervention Study designs Case study Cross-sectional Cross-sectional study Cohort Study types Case-control Health Systems Research I -
  106. 106. Health Systems Research I -
  107. 107. Planning Healthy Communities.Planning Healthy Communities. Health Systems Research I -
  108. 108. Health Systems Research I -
  109. 109. ? South African Medical Journal Health Systems Research I -
  110. 110. 1 Individual case studies Health Systems Research I -
  111. 111. 2 Set of individual case studies s3 Community studies4 Social group studies5 Studies of organizations and institutions6 Studies of events, roles and relationshipsFocus 3 Health Systems Research I -
  112. 112. Health Systems Research I -
  113. 113. ( Health Systems Research I -
  114. 114. Case Study Researcher1 Question asking2 Good listening Good3 Adaptiveness and flexibility adaptiveness rigour. Health Systems Research I -
  115. 115. 4 Grasp of the issues interpret5 Lack of bias Health Systems Research I -
  116. 116. What do you ask?How do you ask? Health Systems Research I -
  117. 117. Epidemiology: A Manual for South Africa Health Systems Research I -
  118. 118. UNIT Data Collection 3T How will you collect the information? Whom do you ask? Health Systems Research I -
  119. 119. Health Systems Research I -
  120. 120. What additional data 4. Research Data collection methodsdo we need to reach our Methodology o Record reviewsresearch objectives?How are we going tocollect thisinformation? Health Systems Research I -
  121. 121. . Designing andConducting Heath Systems ResearchProjects. Real World Research Health Systems Research I -
  122. 122. Non-intervention Intervention Study designs Study types Data Collection Methods Data Collection Techniques Data Collection Tools Health Systems Research I -
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  126. 126. Business Day TheCitizen Health Systems Research I -
  127. 127. Health Systems Research I -
  128. 128. Designing and Conducting Heath Systems Research Projects. Health Systems Research I -
  129. 129. Real World Research. Health Systems Research I -
  130. 130. (Adapted from Puoane T, Sanders D, Chopra M et al. Improving the clinical management of malnourished children through participatory Health Systems Research.) Measuring Health and Disease Using Information for EffectiveManagement 1 Health Systems Research I -
  131. 131. Research Methods for Adult Educators. Planning Healthy Communities. TheBusiness Day The Citizen Health Systems Research I -
  132. 132. What additional data do 4. Researchwe need to reach our Methodology Questionnaires and Samplingresearch objectives?How are we going tocollect this information? Health Systems Research I -
  133. 133. Planning Healthy Communities Planning Healthy CommunitiesPlanning Healthy Communities. Planning HealthyCommunities. ResearchMethods in Health: Investigating Health andHealth Services. Health Systems Research I -
  134. 134. Health Systems Research I -
  135. 135. Planning Healthy Communities. Planning HealthyCommunities. Health Systems Research I -
  136. 136. (Adapted from Varkevisser, 1991, p.162) Planning HealthyCommunities. Health Systems Research I -
  137. 137. Do you think that eggs are healthy?How many steps can you climb before stopping for a breath?Can you walk for 1km without stopping?Do you feel contented with life and able to cope well with itsdemands most of the time?How many times a week do you perform physical exercise lastingfor longer than 10 minutes?Do you smoke cigarettes? If you do, how many cigarettes do youusually smoke per day?Do you always use a condom when having sexual intercourse? Health Systems Research I -
  138. 138. Health Systems Research I -
  139. 139. Study Population Study Sample Sampling Frame No Sampling Frame Probability Strategy Non – Probability StrategySimple Random Systematic Random Purposive ConvenienceSampling Sampling Sampling Sampling Planning Healthy Communities. Health Systems Research I -
  140. 140. Health Systems Research I -
  141. 141. all age groups bothsexes? Health Systems Research I -
  142. 142. Studying volunteers onlySampling of registered patients only Health Systems Research I -
  143. 143. Missing cases of short durationSeasonal biasTarmac bias(Adapted from Varkevisser, 1991, p.204-5). • • • Health Systems Research I -
  144. 144. Research Methods in Health:Investigating Health and Health Services. Health Systems Research I -
  145. 145. Designing and Conducting HeathSystems Research Projects. Health Systems Research I -
  146. 146. What additional data do 4. Research Observationswe need to reach our Methodologyresearch objectives?How are we going tocollect this information? Health Systems Research I -
  147. 147. Planning Healthy Communities Research Methods for AdultEducators Health Systems Research I -
  148. 148. Structured UnstructuredFixed FlexibleDefined Not pre-Pre-determined defined, Unpredictable Health Systems Research I -
  149. 149. Health Systems Research I -
  150. 150. Health Systems Research I -
  151. 151. Planning HealthyCommunities. ResearchMethods for Adult Educators. Health Systems Research I -
  152. 152. Health Systems Research I -
  153. 153. This page has been removed from this version.
  154. 154. What additional data do 4. Research Interviewswe need to reach our Methodology Focus group discussionsresearch objectives?How are we going tocollect this information? . Health Systems Research I -
  155. 155. Research Methods for Adult EducatorsPlanning Healthy Communities. Health Systems Research I -
  156. 156. Structured UnstructuredFixed FlexibleDefined Not pre-Pre-determined defined, Unpredictable Health Systems Research I -
  157. 157. in-depth interviews Health Systems Research I -
  158. 158. Designing by Dialogue Research Methods for AdultEducators. Health Systems Research I -
  159. 159. Health Systems Research I -
  160. 160. Health Systems Research I -
  161. 161. Health Systems Research I -
  162. 162. you gradually build rapport with the interviewee(s)The topics should follow logically from each other. be clear about the issues most relevant to health Planning Healthy Communities Health Systems Research I -
  163. 163. Health Systems Research I -
  164. 164. Health Systems Research I -
  165. 165. Designing and Conducting Heath Systems ResearchProjects Planning HealthyCommunities. Health Systems Research I -
  166. 166. (prompt) Were you pleased/shocked/scared/ angry?(probe) So you did/didnt want to get pregnant then?(probe) (If did) Why did you want to get pregnant(probe) Do you still feel that way now?(prompt) Mum, Dad, friend, boyfriend, doctor, teacher?(probe) Where do you usually go if you need information or advice?(prompt) Why not?(probe) Not having sex/using the pill, condoms, etc.(probe) (If using contraception) Why do you think the pill/condometc, didnt work? Health Systems Research I -
  167. 167. (probe) How easy is it? (probe) Whose responsibility do you think it is to make sure you dont get pregnant? (probe) Do you think the guys care? (probe) What would you do to make sure you didnt get pregnant again? Designing by Dialogue Planning Healthy Communities Designing and Conducting Heath SystemsResearch Projects Health Systems Research I -
  168. 168. UNIT Data Analysis, 4T Workplan and Budget Stage 1 Identify the research problem Stage 7 Stage 2 Write the proposal Review the literature Stage 3 Stage 6 Formulate aims & objectives Draw up the budget Stage 4 Stage 5 Choose the STUDY the workplan Draw up SESSIONS research methodology Health Systems Research I -
  169. 169. Health Systems Research I -
  170. 170. What additional data do 4. Research Plan for data collectionwe need to reach our Methodologyresearch objectives?How are we going tocollect this information? Health Systems Research I -
  171. 171. . TheMedical Journal of Australia, Designing andConducting Heath Systems ResearchProjects Health Systems Research I -
  172. 172. The Medical Journal of Australia Health Systems Research I -
  173. 173. Health Systems Research I -
  174. 174. Health Systems Research I -
  175. 175. Health Systems Research I -
  176. 176. Health Systems Research I -
  177. 177. Health Systems Research I -

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