A study protocol for integrating outpatient services at the primary health care level as part of the universal health coverage benefit package within the national health insurance program of Pakistan through private health facilities.

Introduction and aim: Pakistan has a mixed-health system where up to 60% of health expenditures are out of pocket. Almost 80% of primary healthcare (PHC) facilities are in the private sector, which is deeply embedded within the country's health system and may account for the unaffordability of healthcare. Since 2016, the existing national health insurance program or Sehat Sahulat Program (SSP), has provided invaluable coverage and financial protection to the millions of low-income families living in Pakistan by providing inpatient services at secondary and tertiary levels. However, a key gap is the non-inclusion of outpatient services at the PHC in the insurance scheme. This study aims to engage a private provider network of general practitioners in select union councils of Islamabad Capital Authority (ICT) of Pakistan to improve access, uptake, and satisfaction and reduce out-of-pocket expenditure on quality outpatient services at the PHC level, including family planning and reproductive health services. Methods and analysis: A 24-month research study is proposed with a 12-month intervention period using a mixed method, two-arm, prospective, quasi-experimental controlled before and after design with a sample of 863 beneficiary families from each study arm, i.e., intervention and control groups (N = 1726) will be selected through randomization at the selected beneficiary family/household level from four peri-urban Union Councils of ICT where no public sector PHC-level facility exists. All ethical considerations will be assured, along with quality assurance strategies. Quantitative pre/post surveys and third-party monitoring are proposed to measure the intervention outcomes. Qualitative inquiry with beneficiaries, general practitioners and policymakers will assess their knowledge and practices. Conclusion and knowledge contribution: PHC should be the first point of contact for accessing health services and appears to serve as a programmatic engine for universal health coverage (UHC). The research aims to study a service delivery model which harnesses the private sector to deliver an essential package of health services as outpatient services under SSP, ultimately facilitating UHC. Findings will provide a blueprint referral system to reduce unnecessary hospital admissions and improve timely access to healthcare. A robust PHC system can improve population health, lower healthcare expenditure, strengthen the healthcare system, and ultimately make UHC a reality.

An assessment of facility readiness for comprehensive abortion care in 12 districts of Pakistan using the WHO Service Availability and Readiness Assessment tool.

Although Pakistan's Essential Package of Health Services was recently updated to include therapeutic and post-abortion care, little is known about current health facility readiness for these services. This study assessed the availability of comprehensive abortion care, and readiness of health facilities to deliver these services, within the public sector in 12 districts of Pakistan. A facility inventory was completed in 2020-2021 using the WHO Service Availability and Readiness Assessment, with a newly developed abortion module. A composite readiness indicator was developed based on national clinical guidelines and previous studies. Just 8.4% of facilities reported offering therapeutic abortion, while 14.3% offered post-abortion care. Misoprostol (75.2%) was the most common method provided by facilities that offer therapeutic abortion, followed by vacuum aspiration (60.7%) and dilatation and curettage (D&C) (59%). Few facilities had all the readiness components required to deliver pharmacological or surgical therapeutic abortion, or post-abortion care (<1%), but readiness was higher in tertiary (22.2%) facilities. Readiness scores were lowest for "guidelines and personnel" (4.1%), and slightly higher for medicines and products (14.3-17.1%), equipment (16.3%) and laboratory services (7.4%). This assessment highlights the potential to increase the availability of comprehensive abortion care in Pakistan, particularly in primary care and in rural areas, to improve the readiness of health facilities to deliver these services, and to phase out non-recommended methods of abortion (D&C). The study also demonstrates the feasibility and utility of adding an abortion module to routine health facility assessments, which can inform efforts to strengthen sexual and reproductive health and rights.

Assessing Effectiveness of Multipurpose Voucher Scheme to Enhance Contraceptive Choices, Equity, and Child Immunization Coverage: Results of an Interventional Study from Pakistan.

BACKGROUND: Pakistan has a high total fertility and unmet contraceptive need and is the fifth most populous country. This research aims to assess the effectiveness of a subsidized, multi-purpose voucher intervention to enhance the client-provider interaction for improved contraceptive counseling resulting in a potential increase in the modern methods uptake, continued use, and its impact on equity through better targeting, while increasing uptake of postnatal care and child immunization among women from the lowest two wealth quintiles in rural and urban communities of Punjab province, Pakistan. METHODS: We used a quasi-experimental design with pre- and post-phases in intervention and control sites in Punjab province (August 2012-March 2015). To detect a 20% increase in modern contraceptive prevalence rate compared to baseline, 1276 women were enrolled in each arm. Difference-in-differences (DID) estimates are reported for key variables. Absolute and relative index of inequality including concentration curves and concentration index are used to describe the magnitude and extent of equity. RESULTS: With no net increase in modern contraception use, the intervention area, however, reported a low modern method discontinuation rate. Vaccination rates for BCG increased significantly by 14%, and 5% each for DPT, HBV, and measles. Concentration index and slope index of inequalities for first-time use of modern contraceptives, knowledge of contraceptives, receiving ANC, and delivery at health facilities were negative, indicating that the use of these services was more concentrated among the disadvantaged in intervention areas than the wealthy counterparts. CONCLUSION: This Greenstar-led multiple voucher model did not significantly increase modern contraceptive use in the intervention study area but positively impacted equity. The integrated approach combining contraception with child immunization led to an increase in immunization coverage. It will be important for public policy decision-makers to assess the usefulness of this approach, as a long-term provision of free contraceptive services may lead to dependency in targeted communities.

Are family planning vouchers effective in increasing use, improving equity and reaching the underserved? An evaluation of a voucher program in Pakistan.

BACKGROUND: Low modern contraceptive prevalence rate and high unmet need in Pakistan aggravates the vulnerabilities of unintended pregnancies and births contributing to maternal morbidity and mortality. This research aims to assess the effectiveness of a free, single-purpose voucher approach in increasing the uptake, use and better targeting of modern contraceptives among women from the lowest two wealth quintiles in rural and urban communities of Punjab province, Pakistan. METHODS: A quasi-interventional study with pre- and post-phases was implemented across an intervention (Chakwal) and a control district (Bhakkar) in Punjab province (August 2012-January 2015). To detect a 15% increase in modern contraceptive prevalence rate compared to baseline, 1276 women were enrolled in each arm. Difference-in-Differences (DID) estimates are reported for key variables, and concentration curves and index are described for equity. RESULTS: Compared to baseline, awareness of contraceptives increased by 30 percentage points among population in the intervention area. Vouchers also resulted in a net increase of 16% points in current contraceptive use and 26% points in modern methods use. The underserved population demonstrated better knowledge and utilized the modern methods more than their affluent counterparts. Intervention area also reported a low method-specific discontinuation (13.7%) and high method-specific switching rates (46.6%) amongst modern contraceptive users during the past 24 months. The concentration index indicated that voucher use was more common among the poor and vouchers seem to reduce the inequality in access to modern methods across wealth quintiles. CONCLUSION: Vouchers can substantially expand contraceptive access and choice among the underserved populations. Vouchers are a good financing tool to improve equity, increase access, and quality of services for the underserved thus contributing towards achieving universal health coverage targets.

Assessment of modern contraceptives continuation, switching and discontinuation among clients in Pakistan: study protocol of 24-months post family planning voucher intervention follow up.

BACKGROUND: Pakistan has the second highest fertility rate in South Asia and its increasing population growth presents a significant challenge for country's path to progress and development. Modern contraceptive methods only account for a slow-rising 26% of use in Pakistan which is further lowest in the underserved areas (< 20%), with a high unmet need for family planning (20%). The David and Lucile Packard Foundation USA and Pakistan funded two operational research projects from 2012 to 2015, that employed a Demand-side Financing (DSF) approach testing the effectiveness of single and multi-purpose voucher schemes in increasing access and uptake of FP services and products among the women of two-lowest income quintiles in the Punjab province of Pakistan. The present paper presents a study protocol which intends to assess the longer term impact of these two voucher intervention programs among married women of reproductive age (MWRA) who received contraceptive services through vouchers. METHODS: This will be a mixed methods study using qualitative and quantitative approaches. A quantitative cross sectional survey will measure the contraceptive uptake among voucher users, included in the endline survey and to examine the attitudes and behaviour of women with respect to contraceptive continuation, switching and discontinuation 24 months post intervention in two districts of Chakwal and Faisalabad in Punjab province of Pakistan. Qualitative in-depth interviews will be conducted with FP service providers operating in intervention areas and with key policy makers in the public sector to examine and document the service provider perspective on sustainability on contraceptive practices and behaviour in the post project closure period within the intervention areas. DISCUSSION: Globally, there is almost negligible direct evidence on the assessment of longer-term impact of a demand-side financing programs using free or subsidized vouchers for family planning services especially during post-intervention period or when donor money runs out. The findings of this study will help fill the knowledge gap in the context of sustainability issues post-intervention and will provide information to policy makers to develop and plan contraceptive services in the target area to sustain the positive behaviour change in the population.

Engaging with community-based public and private mid-level providers for promoting the use of modern contraceptive methods in rural Pakistan: results from two innovative birth spacing interventions.

BACKGROUND: Family planning (FP) interventions aimed at reducing population growth have negligible during the last two decades in Pakistan. Innovative FP interventions that help reduce the growing population burden are the need of the hour. Marie Stopes Society--Pakistan implemented an operational research project--'Evidence for Innovating to Save Lives', to explore effective and viable intervention models that can promote healthy timing and spacing of pregnancy in rural and under-served communities of Sindh, Punjab and Khyber Pakhtunkhwa provinces of Pakistan. METHODS: We conducted a quasi-experimental (pre- and post-intervention with control arm) study to assess the effectiveness of each of the two intervention models, (1) Suraj model (meaning 'Sun' in English), which uses social franchises (SF) along with a demand-side financing (DSF) approach using free vouchers, and (2) Community Midwife (CMW) model, in promoting the use of modern contraceptive methods compared to respective controls. Baseline and endline cross-sectional household surveys were conducted, 24 months apart, by recruiting 5566 and 6316 married women of reproductive age (MWRA) respectively. We used Stata version 8 to report the net effect of interventions on outcome indicators using difference-in-differences analysis. Multivariate Cox proportional hazard regression analysis was used to assess the net effect of the intervention on current contraceptive use, keeping time constant and adjusting for other variables in the model. RESULTS: The Suraj model was effective in significantly increasing awareness about FP methods among MWRA by 14% percentage points, current contraceptive use by 5% percentage points and long term modern method--intrauterine device (IUD) use by 6% percentage points. The CMW model significantly increased contraceptive awareness by 28% percentage points, ever use of contraceptives by 7% percentage points and, IUD use by 3% percentage points. Additionally the Suraj intervention led to a 35% greater prevalence (prevalence ratio: 1.35, 95% CI: 1.22-1.50) of contraceptive use among MWRA. CONCLUSION: Suraj intervention highlights the importance of embedding subsidized FP services within the communities of the beneficiaries. The outcomes of the CMW intervention also improved the use of long-term contraceptives. These findings indicate the necessity of designing and implementing FP initiatives involving local mid-level providers to expand contraceptive coverage in under-served areas.

Continuation rates and reasons for discontinuation of intra-uterine device in three provinces of Pakistan: results of a 24-month prospective client follow-up.

BACKGROUND: Long-acting reversible contraceptives, such as the intrauterine device (IUD), remain underutilised in Pakistan with high discontinuation rates. Based on a 24-month prospective client follow-up (nested within a larger quasi-experimental study), this paper presents the comparison of two intervention models, one using private mid-level providers branded as "Suraj" and the other using community midwives (CMWs) of Maternal Newborn and Child Health Programme, for method continuation among IUD users. Moreover, determinants of IUD continuation and the reasons for discontinuation, and switching behaviour were studied within each arm. METHODS: A total of 1,163 IUD users, 824 from Suraj and 339 from the CMW model, were enrolled in this 24-month prospective client follow-up. Participants were followed-up by female community mobilisers physically every second month to ascertain continued IUD usage and to collect information on associated factors, switching behaviour, reasons for discontinuation, and pregnancy occurrence. The probabilities of IUD continuation and the risk factors for discontinuation were estimated by life table analysis and Cox proportional-hazard techniques, respectively. RESULTS: The cumulative probabilities of IUD continuation at 24 months in Suraj and CMW models were 82% and 80%, respectively. The difference between the two intervention areas was not significant. The probability distributions of IUD continuation were also similar in both interventions (Log rank test: χ(2) = 0.06, df = 1, P = 0.81; Breslow test: χ(2) = 0.6, df = 1, P = 0.44). Health concerns (Suraj = 57.1%, CMW = 38.7%) and pregnancy desire (Suraj = 29.3%, CMW = 40.3%) were reported as the most prominent reasons for IUD discontinuation in both intervention arms. IUD discontinuation was significantly associated with place of residence in Suraj and with age (15-25 years) in the CMW model. CONCLUSION: CMWs and private providers are equally capable of providing quality IUD services and ensuring higher method continuation. Pakistan's National Maternal Newborn and Child Health programme should consider training CMWs and providing IUDs through them. Moreover, private sector mid-level providers could be engaged in promoting the use of IUDs.

Family planning in Pakistan: applying what we have learned.

Despite six decades of government and private sector programs, CPR in Pakistan is among the lowest in the region. This article reviews published and grey literature to understand why despite sufficient time and usually sufficient funding, CPR remains low in Pakistan. This paper looks beyond the usual factors of quality of services, coverage and supplies and management issues to examine how family planning may be improved in Pakistan. Based on analysis of the Pakistan Demographic Health Survey 2006-7, the public sector provides around a third of FP services, while NGOs and private providers another 15%. More than half of all family planning users buy their methods directly from stores. Within the government, the services cost 5-8 fold more than the private sector. Nearly a fifth of pregnancies end in an abortion suggesting the role of abortions as a key FP method. This together with a high unmet need pose the question: why is there such low uptake of FP services in the country. To explain this lack of uptake, we explore the limitations of the public sector in providing services, the lack of effect of religious beliefs, of abundant, yet misdirected funding and gaps in demand creation. The increasing role of NGOs and donors in filling the void left by the public sector is discussed. Suggestions are provided about improving public and private sector services including better information gathering and use in defining needs, measuring results and creating demand for FP.

From contraceptive prevalence to family planning service users: implications for policy and programmes.

INTRODUCTION: Contraceptive prevalence rate (CPR) is a widely accepted measure of maternal health and uptake of family planning (FP) services. However, the overall CPR obscures the actual utilization of FP services due to over-representation of long-term methods. This study used CPR from 2007 to arrive at and compare the number of actual number of women who availed different FP services in order to understand issues and gaps in FP services in Pakistan. METHODS: This study used secondary data from the Pakistan Demographic and Health Survey 2006-7 estimate the CPR and modern method mix for 2007.These were then multiplied by the estimated number of married women of reproductive age (MWRA) to arrive at the actual numbers of women using specific FP methods and utilizing FP services in a given year. RESULTS: In 2007 the CPR was 30% overall and 22% for modern methods. However, the number of women availing FP services decreased to 12% when adjusted for FP users who had availed services in the past 12 months. Within this "service mix", self-procurement of FP commodities directly from stores without a advice from a health provider constitutes around 37% of all FP "services" and the public sector accounts for another 33%. Condoms are the commonest method served, accounting for over half of all "services". CONCLUSIONS: The bulk of FP is self-procured and the service mixed is skewed towards client controlled methods that do not require medical advice. Thus, lack of quality for contraceptive services that require some form of supportive healthcare services and counselling may be a bottleneck to improving CPR.

Effectiveness, safety, and tolerability of powdered Nigella sativa (kalonji) seed in capsules on serum lipid levels, blood sugar, blood pressure, and body weight in adults: results of a randomized, double-blind controlled trial.

OBJECTIVE: The seed extracts from Nigella sativa is used by Unani physicians of traditional medicine (Hakims or Tabibs) and Ayurvedic practitioners (Vaids) in the treatment of several medical disorders including dyslipidemia, obesity, and hypertension. It is, therefore, important to prove or disprove the effectiveness, safety, and tolerability of powdered N. sativa (Kalonji) seed in capsules on serum lipid levels, blood sugar, blood pressure, and body weight in adults. DESIGN: The study design was a randomized, double-blind trial. SETTINGS/LOCATION: Conducted at Aga Khan University Hospital, Karachi, from February 2006 to January 2007. SUBJECTS: Half of the respondents received powdered N. sativa (Kalonji) seed in capsule and the rest received a placebo. INTERVENTION/OUTCOME: Baseline and after-intervention variables recorded were the following: body-mass index, waist-hip ratio, blood pressure, fasting blood sugar, serum lipids, serum alanine aminotransferase, and serum creatinine. RESULTS: One hundred and twenty-three (123) patients were recruited. Sixty-four (64) and 59 patients were randomized to the intervention and the control arms, respectively. Thirty-nine (39) patients in the intervention group and 34 in the control group completed the study. Favorable impact of powdered N. sativa (Kalonji) seed in capsule was noted on almost all variables, but results were not statistically significant because of small sample size. CONCLUSIONS: Favorable impact of powdered N. sativa (Kalonji) seed in capsule was noted on almost all variables, but results were not statistically significant. A larger study with adequate sample size is recommended.

Attributes of an effective clinical teacher: a survey on students' and teachers' perceptions.

OBJECTIVE: To identify the attributes of effective clinical teacher, using a self-filled survey questionnaire, that students and faculty value most, and to compare the opinion of student and faculty regarding the same. STUDY DESIGN: Cross-sectional study. PLACE AND DURATION OF STUDY: The Aga Khan University Hospital (AKUH), Karachi from October 2006 to January 2007. SUBJECT AND METHODS: Clinical faculty at AKUH and students in clinical years were included in this survey after taking their written informed consent. Data were collected through a structured questionnaire administered to all participants. Responses were compared. RESULTS: A total of 119 students in clinical years (3, 4 and 5) and 89 faculties involved in clinical teaching responded to the questionnaire. The most important attributes in faculty's and students' perspective were knowledge, interest in teaching and clinical competency. In students and faculty perspective, the fourth and fifth attributes were good communication skills and being non-judgmental. CONCLUSION: Students in clinical years and clinical teachers valued knowledge, interest in teaching and clinical competency as the most important attributes for an effective clinical teacher. There were various areas of agreement and disagreement between faculty and students about attributes of effective clinical teacher.

Metabolic syndrome: frequency and gender differences at an out - patient clinic.

OBJECTIVE: To determine the frequency of metabolic syndrome among patients attending an out-patient clinic of a teaching hospital and to compare the clinical features regarding metabolic syndrome among males and females. STUDY DESIGN: Cross-sectional study. PLACE AND DURATION: Aga Khan University Hospital (AKUH), Executive and Family Medicine Clinics, from December 2004 to April 2005. PATIENTS AND METHODS: All adults, above 25 years, attending the clinics for an executive check-up and giving informed consent were included in the study. Data was collected through a structured questionnaire administered to those eligible to participate. Metabolic syndrome was defined according to ATP-III guidelines. RESULTS: There were 250 participants in this study. Mean age of study participants was 48.94 (SD10.62) years, while approximately two-thirds, 157 (62.8%), were male. Metabolic syndrome (those who had 3 or more risk factors) was present in 35.2% of adults. Fasting blood sugar level was raised in 36.4% of study participants while significant number of participants (78.8%) had a body mass index (BMI) >or= 25 (p = 0.02). CONCLUSION: Frequency of metabolic syndrome was significantly high in this study with preponderance of males and prevalence similar to that observed in developed countries. Majority of patients had obesity and high fasting blood sugar levels. Males demonstrated higher levels of triglycerides and low levels of high-density lipoprotein (HDL) compared to females while blood pressure reading was observed to be the same in both males and females.

Implementation of good clinical practice guidelines in vaccine trials in developing countries.

The practicalities when applying the ICH GCPs (International Conference on Harmonization 1996 Good Clinical Practices [EU, MHLW, FDA. International Conference on Harmonization Guideline for Good Clinical Practice; 1997] in less developed countries (ldcs) are seldom discussed and we found no guidelines as how to "adapt" them. Below we illustrate how ICH GCP principles can be implemented in different settings. We have recently conducted in Asia (Hechi, China; Karachi, Pakistan; Hue, Vietnam; North Jakarta, Indonesia and Kolkata, India) large-scale cluster-randomized effectiveness evaluations of the Vi polysaccharide typhoid fever vaccine (Vi PS project) among approximately 200,000 individuals(1)[Acosta CJ, Galindo CM, Ali M, Abu-Elyazeed R, Ochiai RL Danovaro-Holliday MC et al. A multi-country cluster randomized controlled effectiveness evaluation to accelerate the introduction of Vi polysaccharide typhoid vaccine in developing countries in Asia: rationale and design. TMIH 2005;10(12):1219-1228]. There is no doubt on the importance of ICH GCP in its contribution to ethical and scientifically sound clinical research. However, when the ICH GCP is implemented in ldcs some considerations must be made in order to adequately tailor them. Vaccine trials in ldcs are a frequent setting for such challenges because of the increased global interest conducting health research in such countries. The ICH GCP principles are discussed below within the framework of this recent typhoid fever vaccine study experience.

Lessons and implications from a mass immunization campaign in squatter settlements of Karachi, Pakistan: an experience from a cluster-randomized double-blinded vaccine trial [NCT00125047].

OBJECTIVE: To determine the safety and logistic feasibility of a mass immunization strategy outside the local immunization program in the pediatric population of urban squatter settlements in Karachi, Pakistan. METHODS: A cluster-randomized double blind preventive trial was launched in August 2003 in 60 geographic clusters covering 21,059 children ages 2 to 16 years. After consent was obtained from parents or guardians, eligible children were immunized parenterally at vaccination posts in each cluster with Vi polysaccharide or hepatitis A vaccine. Safety, logistics, and standards were monitored and documented. RESULTS: The vaccine coverage of the population was 74% and was higher in those under age 10 years. No life-threatening serious adverse events were reported. Adverse events occurred in less than 1% of all vaccine recipients and the main reactions reported were fever and local pain. The proportion of adverse events in Vi polysaccharide and hepatitis A recipients will not be known until the end of the trial when the code is broken. Throughout the vaccination campaign safe injection practices were maintained and the cold chain was not interrupted. Mass vaccination in slums had good acceptance. Because populations in such areas are highly mobile, settlement conditions could affect coverage. Systemic reactions were uncommon and local reactions were mild and transient. Close community involvement was pivotal for information dissemination and immunization coverage. CONCLUSION: This vaccine strategy described together with other information that will soon be available in the area (cost/effectiveness, vaccine delivery costs, etc) will make typhoid fever control become a reality in the near future.