Continuum of Care Services for Maternal and Child Health using mobile technology – a health system strengthening strategy in low and middle income countries Improving mental health among people living with HIV: a review of intervention trials in low- and middle-income countries Unravelling the quality of HIV counselling and testing services in the private and public sectors in Zambia Comparison of registered and published intervention fidelity assessment in cluster randomised trials of public health interventions in low- and middle-income countries: systematic review protocol The Influence of “Stock out” on Health-Seeking Behavior of Low Income Women in Uyo Urban, Akwa Ibom State, Nigeria Quality of generic medicines in South Africa: Perceptions versus Reality – A qualitative study Private pharmacy practice and regulation. A randomized trial in Lao P.D.R. Sudden cardiac death in low- and middle-income countries. Got ACTs? Availability, price, market share and provider knowledge of anti-malarial medicines in public and private sector outlets in six malaria-endemic countries Interventions for domestic violence among pregnant women in low- and middle-income countries: a systematic review protocol Recommendations for clinical trials of off-label drugs used to treat advanced-stage cancer. A systematic review of online interventions for mental health in low and middle income countries: a neglected field Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial Evaluation of the Safe Care, Saving Lives (SCSL) quality improvement collaborative for neonatal health in Telangana and Andhra Pradesh, India: a study protocol Panic disorder in public sector primary care: clinical characteristics and illness severity compared with "mainstream" primary care panic disorder. Improving immunization capacity in Ethiopia through continuous quality improvement interventions: a prospective quasi-experimental study The FIDELIS initiative: innovative strategies for increased case finding. Effectiveness of a brief community outreach tobacco cessation intervention in India: a cluster-randomised controlled trial (the BABEX Trial) Improving the outcomes of primary care attenders with common mental disorders in developing countries: a cluster randomized controlled trial of a collaborative stepped care intervention in Goa, India Enhancing Routine Immunization Performance using Innovative Technology in an Urban Area of Nigeria. Economic Analysis of Health Care Technology: A Report on Principles Perceptions and utilization of primary health care services in Iraq: findings from a national household survey Study protocol for a cluster-randomised controlled trial of an NCD access to medicines initiative: evaluation of Novartis Access in Kenya
Background Mobile phone technology is utilized for better delivery of health services worldwide . In low- and -middle income countries mobile phones are now ubiquitous . Thus leveraging mHealth applications in health sector is becoming popular rapidly in these countries . To assess the effectiveness of the Continuum of Care Services ( CCS ) mHealth platform in terms of strengthening the delivery of maternal and child health ( MCH ) services in a district in Bihar , a re source -poor state in India . Methods The CommCare mHealth platform was customized to CCS as one of the innovations under a project funded by the Bill and Melinda Gates Foundation to improve the maternal and newborn health services in Bihar . The intervention was rolled out in one project district in Bihar , during July 2012 . More than 550 frontline workers out of a total of 3000 including Accredited Social Health Activists , Anganwadi Workers , Auxilliary Nurse Midwives and Lady Health Supervisors were trained to use the mHealth platform . The service delivery components namely early registration of pregnant women , three antenatal visits , tetanus toxoid immunization of the mother , iron and folic acid tablet supply , institutional delivery , postnatal home visits and early initiation of breastfeeding were used as indicators for good quality services . The result ant coverage of these services in the implementation area was compared with rest of Bihar and previous year statistics of the same area . The time lag between delivery of a service and its record capture in the maternal and child tracking system ( MCTS ) data base was computed in a r and om sample of 16,000 beneficiaries . The coverage of services among marginalized and non-marginalized castes was compared to indicate equity of service delivery . Health system strengthening was viewed from the angle of coverage , quality , equity and efficiency of services . Results The implementation blocks had higher coverage of all the eight indicator services compared to rest of Bihar and the previous year . There was equity of services across castes for all the indicators . Timely capture of data was also ensured compared to paper-based reporting . Conclusion By virtue of its impact on quality , efficiency and equity of service delivery , health care manpower efficiency and governance , the mHealth inclusion at service provision level can be one of the potential strategy to strengthen the health system People living with HIV ( PLWH ) experience greater psychological distress than the general population . Evidence from high-incomes countries suggests that psychological interventions for PLWH can improve mental health symptoms , quality of life , and HIV care engagement . However , little is known about the effectiveness of mental health interventions for PLWH in low- and middle-income countries ( LMICs ) , where the large majority of PLWH reside . This systematized review aims to synthesize findings from mental health intervention trials with PLWH in LMICs to inform the delivery of mental health services in these setting s. A systematic search strategy was undertaken to identify peer- review ed published papers of intervention trials addressing negative psychological states or disorders ( e.g. depression , anxiety ) among PLWH in LMIC setting s. Search results were assessed against pre-established inclusion and exclusion criteria . Data from papers meeting criteria were extracted for synthesis . Twenty-six papers , published between 2000 and 2014 , describing 22 unique interventions were identified . Trials were implemented in sub-Saharan Africa ( n = 13 ) , Asia ( n = 7 ) , and the Middle East ( n = 2 ) , and addressed mental health using a variety of approaches , including cognitive-behavioral ( n = 18 ) , family-level ( n = 2 ) , and pharmacological ( n = 2 ) treatments . Four r and omized controlled trials reported significant intervention effects in mental health outcomes , and 11 preliminary studies demonstrated promising findings . Among the limited mental health intervention trials with PLWH in LMICs , few demonstrated efficacy .  Mental health interventions for PLWH in LMICs must be further developed and adapted for re source -limited setting s to improve effectiveness Background Despite the substantial investment for providing  HIV counselling and testing ( VCT ) services in Zambia , there has been little effort to systematic ally evaluate the quality of  VCT services provided by various types of health providers . This study , conducted in 2009 , examines  VCT in the public and private sectors including private for-profit and NGO/faith-based sectors in Copperbelt and Luapula . Methods The study used five primary data collection methods to gauge quality of  VCT services  : closed-ended client interviews with clients exiting  VCT sites ; open-ended client interviews ; interviews with facility managers ; review of service statistics ; and an observation of the physical environment for VCT by site .  Over 400 clients and 87 facility managers were interviewed from almost 90 facilities . Sites were r and omly selected and results are generalizable at the provincial level . Results The study shows concerning levels of underperformance in VCT services  across the sectors . It reveals serious underperformance in counselling about key risk-reduction methods . Less than one-third of clients received counselling on reducing number of sexual partners and only approximately 5 % of clients received counselling about disclosing test results to partners . In terms of client profiles , the NGO sector attracts the most educated clients and less educated Zambians seek  VCT  services at very low rates ( 7 % ) . The private for-profit performs equally or sometimes better than other sectors even though this sector is not adequately integrated into the Zambian national response to HIV . Conclusion The private for-profit sector provides  VCT services  on par in quality with the other sectors . Most clients did not receive counselling on partner reduction or disclosure of HIV test results to partners . In a generalized HIV epidemic where multiple concurrent sexual partners are a significant problem for transmitting the disease , risk-reduction methods and discussion should be a main focus of pre-test and post-test counselling Background Cluster r and omised trials ( CRTs ) are a key instrument to evaluate public health interventions , particularly in low- and middle-income countries ( LMICs ) . Fidelity assessment examines study processes to gauge whether an intervention was delivered as initially planned . Evaluation of implementation fidelity ( IF ) is required to establish whether the measured effects of a trial are due to the intervention itself and may be particularly important for CRTs of complex interventions . Current CRT reporting guidelines offer no guidance on IF assessment . We will systematic ally review the scientific literature to study current practice s concerning the assessment of IF in CRTs of public health interventions in LMICs . Methods We will include  CRTs of public health interventions in LMICs that planned or assessed IF in either the trial protocol or the main trial report ( or an associated document ) . Search strategies use Medical Subject Headings ( MESH ) and text words related to CRTs , developing countries , and public health interventions . The electronic data base search was developed first for MEDLINE and adapted for the following data bases : EMBASE , CINAHL , PubMed , and EMB Review s , to identify CRT reports in English , Spanish , or French published on or after January 1 , 2012 . To ensure availability of a study protocol , we will include CRTs reporting a registration number in the abstract . For each included study , we will compare planned versus reported assessment of IF , and consider the dimensions of IF studied , and data collection methods used to evaluate each dimension . Data will be synthesis ed using quantitative and narrative techniques . Risk of bias for individual studies will be assessed using the Cochrane Collaboration Risk of Bias Tool criteria and additional criteria related to CRT methods . We will investigate possible sources of heterogeneity by performing subgroup analysis . This review was not eligible for inclusion in the PROSPERO registry . Discussion Fidelity assessment may be a key tool for making studies more reliable , internally valid , and externally generalizable . This review will provide a portrait of current practice s related to the assessment of intervention fidelity in CRTs and offer suggestions for improvement . Results will be relevant to research ers , those who finance health interventions , and for decision-makers who seek the best evidence on public health interventions The “ Health for All Project ” ( HFAP ) policy in Nigeria was complemented by the National Drug Policy to ensure constant availability of high quality drugs and medical consumables at affordable prices to citizens in public hospitals . Apart from strengthening the utilization of health services , the project also sought to improve health care delivery for the poor who could not afford the high cost of drugs in private clinics and pharmaceutical stores . Employing a survey method with stratified and systematic r and om techniques , the study found failed expectations in the promises of HFAP policy among the 1250 low-income women in Uyo urban . In the face of “ stock out ” where most drugs , pharmaceuticals , and medical supplies are consistently not available for dispensing in public hospitals and health centers poor urban women resorted to alternative health care in prayer houses , herbal homes , patent medicine vendors , health workers homes , and traditional birth attendants . The study reported that stock out in government health facilities result ed in health hazards and the relapse of illnesses as a result of non-adherence to treatment regime and exposure to fake , expired , and adulterated drugs . A renewed commitment in health care delivery in Nigeria is called for if poor women are to be really empowered Background Generic Medicines are an important policy option allowing for access to affordable , essential medicines . Quality of generic medicines must be guaranteed through the activities of national medicines regulatory authorities . Existing negative perceptions surrounding the quality of generic medicines must be addressed to ensure that people use them with confidence . Campaigns to increase the uptake of generic medicines by consumers and providers of healthcare need to be informed by local norms and practice s. This study sought to compare South African consumers ’ and healthcare providers ’ perceptions of quality of generics to the actual quality of selected products . Methods The study was conducted at the local level in three cities of South Africa : Johannesburg , Durban and Cape Town . Purposive sampling was used to recruit consumer participants ( n = 73 ) and r and om sampling used to recruit healthcare providers from public and private sectors ( n = 15 ) . Data were obtained through twelve focus group discussion s with consumers and semi-structured interviews ( n = 15 ) with healthcare providers in order to gain familiarity with perceptions of quality . One hundred and thirty five products comprising paracetamol tablets ( n = 47 ) , amoxicillin capsules ( n = 45 ) and hydrochlorothiazide tablets ( n = 43 ) were source d from public and private sector healthcare providers . These products were subjected to in vitro dissolution , uniformity of weight and identity ( Fourier Transformed Infrared Spectroscopy ) tests using prescribed methods from the British ( 2005 ) and United States Pharmacopeias ( 2006 ) . Results Respondents described drug quality in relation to the effect on symptoms . Procurement and use behavior of healthcare providers was influenced by prior experience , manufacturers ’ names and consumers ’ ability to pay . All formulations passed the in vitro tests for quality . Conclusions This study showed clear differences between perceptions of quality and actual quality of medicines suggesting deficiencies in public engagement by government regarding the implementation of generic medicines policy . Implementation of generic medicines policy requires the involvement of consumers and healthcare providers to specifically address their information gaps and needs OBJECTIVES The objective of this study was to assess the effectiveness of government regulation of private pharmacy practice in a low-income country . METHODS The intervention comprised inspections of the pharmacies , information , and distribution of documents to drug sellers and sanctions . It was implemented at two different intensity levels , active and regular intervention . The methods used to assess the effect of the interventions were interviews with the district drug inspectors , drug sellers and customers , inspection of drug purchases , and indicator surveys of pharmacies . Indicators for pharmacy-specific quality as well as for dispensing quality were developed . RESULTS The main finding was one of strong overall improvements from initially low levels . The improvements were particularly marked by increases in the availability of essential material s for dispensing by 34 % and in order in the pharmacy by 19 % . Information given to customers increased from 35 % to 51 % and the mixing of different drugs in the same package went down from 17 % to 9 % . The pharmacies in the active intervention districts showed greater improvements for four of the six indicators , although statistically significant compared with the regular intervention districts only for the essential material s indicator . CONCLUSIONS It was concluded that the regulatory activities have probably been an important factor behind the service quality improvements . It appeared feasible as well as effective to regulate private pharmacy practice in this particular low-income setting Cardiovascular disease , and the incidence of sudden cardiac death ( SCD ) , will increase significantly in low- and middle-income countries ( LMIC ) . Thus , SCD threatens to become a global public health problem . We present a summary of the current research that has investigated the epidemiology of SCD in LMIC . Few studies of SCD in LMIC exist , and they are of variable method ological quality . Risk factors for SCD are described , taking into account recent global burden of disease and risk factor statistics . We describe 1 proposal for a community-based , prospect i ve , multiple- source methodology for SCD monitoring and surveillance that can be implemented in LMIC . Further research into the epidemiology of SCD in LMIC , using st and ardized methodology , would allow investigators and policy makers to determine the regions , communities , and individuals most at need for SCD prevention . Focusing on SCD and its prevention in LMIC should be a priority for the global health community Background Artemisinin-based combination therapy ( ACT ) is the first-line malaria treatment throughout most of the malaria-endemic world . Data on ACT availability , price and market share are needed to provide a firm evidence base from which to assess the current situation concerning quality -assured ACT supply . This paper presents supply side data from ACTwatch outlet surveys in Benin , the Democratic Republic of Congo ( DRC ) , Madagascar , Nigeria , Ug and a and Zambia . Methods Between March 2009 and June 2010 , nationally representative surveys of outlets providing anti-malarials to consumers were conducted . A census of all outlets with the potential to provide anti-malarials was conducted in clusters sample d r and omly . Results 28,263 outlets were censused , 51,158 anti-malarials were audited , and 9,118 providers interviewed . The proportion of public health facilities with at least one first-line quality -assured ACT in stock ranged between 43 % and 85 % . Among private sector outlets stocking at least one anti-malarial , non-artemisinin therapies , such as chloroquine and sulphadoxine-pyrimethamine , were widely available ( > 95 % of outlets ) as compared to first-line quality -assured ACT ( < 25 % ) . In the public/not-for-profit sector , first-line quality -assured ACT was available for free in all countries except Benin and the DRC ( US$ 1.29 [ Inter Quartile Range ( IQR ) : $ 1.29-$1.29 ] and $ 0.52[IQR : $ 0.00-$1.29 ] per adult equivalent dose respectively ) . In the private sector , first-line quality -assured ACT was 5 - 24 times more expensive than non-artemisinin therapies . The exception was Madagascar where , due to national social marketing of subsidized ACT , the price of first-line quality -assured ACT  ( $ 0.14 [ IQR : $ 0.10 , $ 0.57 ] ) was significantly lower than the most popular treatment ( chloroquine , $ 0.36 [ IQR : $ 0.36 , $ 0.36 ] ) .  Quality -assured ACT accounted for less than 25 % of total anti-malarial volumes ; private-sector quality -assured ACT volumes represented less than 6 % of the total market share . Most anti-malarials were distributed through the private sector , but often comprised non-artemisinin therapies , and in the DRC and Nigeria , oral artemisinin monotherapies .  Provider knowledge of the first-line treatment was significantly lower in the private sector than in the public/not-for-profit sector . Conclusions These st and ardized , nationally representative results demonstrate the typically low availability , low market share and high prices of ACT , in the private sector where most anti-malarials are accessed , with some exceptions . The results confirm that there is substantial room to improve availability and affordability of ACT treatment in the surveyed countries . The data will also be useful for monitoring the impact of interventions such as the Affordable Medicines Facility for malaria Background Violence during pregnancy is a global problem , associated with serious health risks for both the mother and baby . Evaluation of interventions targeted for reducing or controlling domestic violence ( DV ) is still in its infancy , and the majority of findings are primarily from high-income countries ( HICs ) . Therefore , there is an urgent need for generating evidence of DV interventions among pregnant women in low- and middle-income countries ( LMICs ) . Methods Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) guidelines will be employed to structure the review . A comprehensive search will be carried out via electronic data bases including MEDLINE , CINAHL , Scopus , Embase , Web of Science , PsycINFO , and The Cochrane library . Gray literature will also be scrutinized for potential articles . An optimal search strategy has been developed following consultations with subject-matter experts and librarians . This search strategy will be adapted to the different data bases . Experimental studies evaluating DV interventions among pregnant women from LMICs will be included in the review . The review will only include literature written in English . Two review ers will independently screen and assess studies for inclusion in the review . A third author will resolve any discrepancies between the review ers . Risk of bias will be assessed based on the Cochrane risk of bias assessment tool , and overall quality of the evidence will be judged using Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) criteria . Findings will be presented with the narrative synthesis , and if applicable , they will be further quantified using r and om-effects meta- analysis . Effect size , risk ratio for dichotomous variables , and st and ardized mean differences for continuous variables will be calculated for each outcome using Review Manager 5.3 . Discussion Systematic review s to evaluate the efficacy of interventions to address DV within the perinatal context have been limited . Hence , no one intervention has emerged as substantially effective towards addressing perinatal DV and associated health consequences . The evidence generated from this systematic review will inform research ers and policy makers about the effectiveness of existing DV interventions among pregnant women in LMICs and provide recommendations for future research in this area . This in turn will contribute towards violence prevention in LMICs . Systematic review registration PROSPERO PURPOSE To provide recommendations to trialists and sponsors that guide the design and implementation of prospect i ve postapproval clinical trials for oncology drugs used outside US Food and Drug Administration-labeled indications for treatment of late-stage cancers . METHODS A meeting was hosted by the Center for Medical Technology Policy in Baltimore , MD , on November 12 , 2009 . Discussion s during the meeting and key informant interviews were conducted before and after this stakeholder meeting . Peer review by multidisciplinary stakeholders was followed by a public comment period . Input was received from patient advocacy groups , medical oncologists , pharmaceutical companies , the US Food and Drug Administration , Centers for Medicare and Medicaid Services , the National Cancer Institute , foreign government agencies involved in health technology assessment , public and private payers , drug compendia , clinical research entities , statisticians , academics , and the American Society of Clinical Oncology . RESULTS To address the needs of patients and their clinical providers , compendia , payers , and policy makers , recommendations are proposed to guide the design of future prospect i ve trials for off-label use of oncology drugs across four areas : trial design and data analysis , patient and site recruitment , comparators , and outcomes . CONCLUSION The US Food and Drug Administration provides guidance to the pharmaceutical industry and others design ing r and omized clinical trials for regulatory approval . However , a gap exists for postregulatory decision makers , including patients , prescribers , and payers , because regulatory trials do not answer the questions most relevant to them . Therefore , guidance is needed for trials performed in the postapproval environment for these postapproval decision makers Background . Low and middle income countries ( LMICs ) are facing an increase of the impact of mental health problems while confronted with limited re sources and limited access to mental health care , known as the ‘ mental health gap ’ . One strategy to reduce the mental health gap would be to utilize the internet to provide more widely-distributed and low cost mental health care . We undertook this systematic review to investigate the effectiveness and efficacy of online interventions in LMICs . Methods . We systematic ally search ed the data -bases PubMed , PsycINFO , JMIR , and additional sources . MeSH terms , Thesaurus , and free text keywords were used . We included all r and omized controlled trials ( RCTs ) of online interventions in LMICs . Results . We found only three articles reported results of RCTs on  online interventions for mental health conditions in LMICs , but none of these interventions was compared with an active control condition . Also , the mental health conditions were diverse across the three studies . Conclusions . There is a dearth of studies examining the effect of online interventions  in LMICs , so we can not draw a firm conclusion on its effectiveness . However , given the effectiveness of  online interventions in high income countries and sharp increase of internet access in LMICs , online interventions may offer a potential to help reduce the ‘ mental health gap ’ . More studies are urgently needed in LMICs Background Therapeutic hypothermia reduces death and disability after moderate or severe neonatal encephalopathy in high-income countries and is used as st and ard therapy in these setting s. However , the safety and efficacy of cooling therapy in low- and middle-income countries ( LMICs ) , where 99 % of the disease burden occurs , remains unclear . We will examine whether whole body cooling reduces death or neurodisability at 18–22 months after neonatal encephalopathy , in LMICs . Methods We will r and omly allocate 408 term or near-term babies ( aged ≤ 6 h ) with moderate or severe neonatal encephalopathy admitted to public sector neonatal units in LMIC countries ( India , Bangladesh or Sri Lanka ) , to either usual care alone or whole-body cooling with usual care . Babies allocated to the cooling arm will have core body temperature maintained at 33.5 ° C using a servo-controlled cooling device for 72 h , followed by re-warming at 0.5 ° C per hour . All babies will have detailed infection screening at the time of recruitment and 3 Telsa cerebral magnetic resonance imaging and spectroscopy at 1–2 weeks after birth . Our primary endpoint is death or moderate or severe disability at the age of 18 months . Discussion Upon completion , HELIX will be the largest cooling trial in neonatal encephalopathy and will provide a definitive answer regarding the safety and efficacy of cooling therapy for neonatal encephalopathy in LMICs . The trial will also provide important data about the influence of co-existent perinatal infection on the efficacy of hypothermic neuroprotection . Trial registration Clinical Trials.gov , NCT02387385 . Registered on 27 February 2015 ABSTRACT Background : The collaborative quality improvement approach proposed by the Institute for Healthcare Improvement has the potential to improve coverage of evidence -based maternal and newborn health practice s. The Safe Care , Saving Lives initiative supported the implementation of 20 evidence -based maternal and newborn care practice s , targeting labour wards and neonatal care units in 85 public and private hospitals in Telangana and And hra Pradesh , India . Objective : We present a protocol for the evaluation of this programme which aims to ( a ) estimate the effect of the initiative on evidence -based care practice s and mortality ; ( b ) evaluate the mechanisms leading to changes in adherence to evidence -based practice s , and their relationship with context ual factors ; ( c ) explore the feasibility of scaling-up the approach . Methods : The mixed- method evaluation is based on a plausibility design nested within a phased implementation . The 29 non-r and omly selected hospitals comprising wave II of the programme were compared to the 31 remaining hospitals where the quality improvement approach started later . We assessed mortality and adherence to evidence -based practice s at baseline and endline using abstract ion of registers , checklists , observations and interviews in intervention and comparison hospitals . We also explored the mechanisms and drivers of change in adherence to evidence -based practice s. Qualitative methods investigated the mechanisms of change in purpose fully selected case study hospitals . A readiness assessment complemented the analysis of what works and why . We used a difference-in-difference approach to estimate the effects of the intervention on mortality and coverage . Thematic analysis was used for the qualitative data . Discussion : This is the first quality improvement collaborative targeting neonatal health in secondary and tertiary hospitals in a middle-income country linked to a government health insurance scheme . Our process evaluation is theory driven and will refine hypotheses about how this quality improvement approach contributes to institutionalization of evidence -based practice The prevalence of anxiety disorders is increased among low-income individuals , who are more likely to seek mental health care in medical as opposed to specialty setting s because of limited insurance access and restricted availability of public sector mental health re sources . However , little is known about the clinical characteristics and illness severity of anxiety disorders in this setting . We studied the clinical characteristics of  low-income compared with middle-income primary care panic patients .  Clinical , functional , and service use measures obtained at baseline interview in 39 panic disorder patients seen in one public sector medical clinic were compared with 76 patients seen in two middle-income clinics . All patients were participants in a r and omized effectiveness pharmacotherapy trial [ Roy Byrne et al. , Arch Gen Psychiatry 2001;58:869 - 876 ] . Public sector patients were more often older , male , single , unemployed , of lower income , and non-Caucasian ethnicity . They had more severe clinical symptoms , more medical comorbidity , worse physical and role health status , and more emergency room visits . Low income and unemployment accounted for most of the differences in non-anxiety-related measures . However , type of clinic still contributed independently to the greater severity of specific measures of panic/anxiety ( Panic Disorder Severity Scale and Marks Fear Scale scores ) , suggesting that the increased stress and limited social re sources associated with low-income and disadvantaged status may have more specific effects on anxiety than other aspects of psychopathology Background Strong scientific evidence is needed to support low-income countries in building effective and sustainable immunization programs and proactively engaging in global vaccine development and implementation initiatives . This study aim ed to implement and evaluate the effectiveness of system-wide continuous quality improvement ( CQI ) interventions to improve national immunization programme performance in Ethiopia . Methods The study used a prospect i ve , quasi-experimental design with an interrupted time-series analysis to collect data from 781 government health sectors ( 556 healthcare facilities , 196 district health offices , and 29 zonal health departments ) selected from developing and emerging regions in Ethiopia . Procedures included baseline quality assessment of immunization programme and services using structured checklists ; immunization systems strengthening using onsite technical support , training , and supportive supervision interventions in a Plan-Do-Check-Act cycle over 12 months ; and collection and analysis of data at baseline and at the 6th and 12th month of interventions using statistical process control and the t-test . Outcome measures were the coverage of the vaccines pentavalent 3 , measles , Bacillus Calmette – Guérin vaccine ( BCG ) , Pneumococcal Conjugate Vaccine ( PCV ) , as well as full vaccination status ; while process measures were changes in human re sources , planning , service delivery , logistics and supply , documentation , coordination and collaboration , and monitoring and evaluation . Analysis and interpretation of data adhered to SQUIRE 2.0 guidelines . Results Prior to the interventions , vaccination coverage was low and all seven process indicators had an aggregate score of below 50 % , with significant differences in performance at healthcare facility level between developing and emerging regions ( P = 0.0001 ) . Following the interventions , vaccination coverage improved significantly from 63.6 % at baseline to 79.3 % for pentavalent ( P = 0.0001 ) , 62.5 to 72.8 % for measles ( P = 0.009 ) , 62.4 to 73.5 % for BCG ( P = 0.0001 ) , 65.3 to 81.0 % for PCV ( P = 0.02 ) , and insignificantly from 56.2 to 74.2 % for full vaccination . All seven process indicators scored above 75 % in all regions , with no significant differences found in performance between developing and emerging regions . Conclusions The CQI interventions improved immunization capacity and vaccination coverage in Ethiopia , where the unstable transmission patterns and intensity of infectious diseases necessitate for a state of readiness of the health system at all times . The approach was found to empower zone , district , and facility-level health sectors to exercise accountability and share ownership of immunization outcomes . While universal approaches can improve routine immunization , local innovative interventions that target local problems and dynamics are also necessary to achieve optimal coverage SETTING Low-income , high tuberculosis ( TB ) burden countries . OBJECTIVE To compare case finding of new smear-positive pulmonary TB patients in projects funded to apply innovative approaches . DESIGN Prospect i ve application of innovative approaches to case finding within routine services to determine the numbers of additional cases detected and the cost per additional case detected , according to the type of approach applied . RESULTS Between 2003 and 2007 , 51 FIDELIS projects were implemented in 18 countries ; 273,239 cases were reported , of which 85,267 were additional to the number reported in the previous year . The median cost per additional case was US$ 103 . The interventions employed were : 1 ) social mobilisation and information , education and communication ; 2 ) engagement of the private sector ; 3 ) innovative approaches for microscopy services ; 4 ) enhanced or semi-active case finding ; 5 ) health systems strengthening ; and 6 ) use of incentives . None of these was significantly more likely to detect additional cases or to have a lower cost per additional case than any of the others . CONCLUSION While there was a substantial increase in cases detected , at a moderate cost per additional case , we were unable to show that any single intervention had an advantage over the others Background Tobacco use kills half a million people every month , most in low – middle income countries ( LMICs ) . There is an urgent need to identify potentially low-cost , scalable tobacco cessation interventions for these countries . Objective To evaluate a brief community outreach intervention delivered by health workers to promote tobacco cessation in India . Design Cluster-r and omised controlled trial . Setting 32 low-income administrative blocks in Delhi , half government authorised ( ‘ resettlement colony ’ ) and half unauthorised ( ‘ J.J. cluster ’ ) communities . Participants 1213 adult tobacco users . Interventions Administrative blocks were computer r and omised in a 1:1 ratio , to the intervention ( 16 clusters ; n=611 ) or control treatment ( 16 clusters ; n=602 ) , delivered and assessed at individual level between 07/2012 and 11/2013 . The intervention was single session quit advice ( 15 min ) plus a single training session in yogic breathing exercises ; the control condition comprised very brief quit advice ( 1 min ) alone . Both were delivered via outreach , with contact made though household visits . Measurements The primary outcome was 6-month sustained abstinence from all tobacco , assessed 7 months post intervention delivery , biochemically verified with salivary cotinine . Results The smoking cessation rate was higher in the intervention group ( 2.6 % ( 16/611 ) ) than in the control group ( 0.5 % ( 3/602 ) ) ( relative risk=5.32 , 95 % CI 1.43 to 19.74 , p=0.013 ) . There was no interaction with type of tobacco use ( smoked vs smokeless ) . Results did not change material ly in adjusted analyses , controlling for participant characteristics . Conclusions A single session community outreach intervention can increase tobacco cessation in LMIC . The effect size , while small , could impact public health if scaled up with high coverage . Trial registration number IS RCT CN23362894 Background and Objective Common mental disorders ( CMD ) are a leading global burden of disease . Up to 30 % of primary care attenders suffer from these disorders but most do not receive evidence -based drug or psychological treatments . There are no trials of interventions which attempt to integrate these treatments into routine primary care in developing countries . The aims of this trial ( the MANAS Project ) are to evaluate the clinical and cost-effectiveness of a collaborative stepped-care intervention for the treatment of CMD in India . Study Design A cluster r and omized controlled trial will be implemented in the state of Goa , on the west coast of India . Twenty-four primary care facilities , 12 from the government sector and 12 from the private sector , will be enrolled in two consecutive phases . For each sector , facilities will be r and omly allocated within strata defined by urban/rural location , population size and presence of a visiting psychiatrist . Facilities will be r and omly allocated to receive the collaborative stepped care intervention or the enhanced usual care control intervention . Both arms share two components of the intervention , viz . , routine screening , and in the government clinics provision of antidepressants . In addition , the collaborative stepped care arm also provides a range of psychosocial treatments delivered by a specially trained Health Counselor , and supervision by a visiting Psychiatrist .  A total of 3600 primary care attenders who are detected to suffer from a CMD based on a vali date d screening question naire will be recruited . The primary outcome is the proportion of subjects who recover from an ICD10 defined CMD at baseline by 6 months . Additional endpoints at 2 and 12 months will assess the speed and sustainability of achieving the primary outcomes . Other outcomes will include recovery from ICD10 defined depression and incidence of ICD-10 among individuals who were sub-threshold cases at baseline . Economic and disability outcomes will be assessed to estimate incremental cost-effectiveness ratios . Implication sThis will be the first trial of the effectiveness of a complex intervention aim ing to integrate efficacious treatments for CMD into routine primary care in a developing country . If effective , its findings will have relevance to policy makers who wish to scale up treatments for CMD in primary care across the world , but mostly in those countries where specialist mental health services are few . Study Registration The MANAS project is registered through the National Institutes of Health sponsored clinical trials registry and has been assigned the identifier : BACKGROUND Routine Immunization (RI)is known to beone of the most cost-effective public health strategies ever , and a cornerstone among all primary healthcare efforts but has been bedevilledin Low and Middle Income Countries ( LMICs ) in the last two decadesby poor coverage and lack of timeliness -both due , among other factors , to clients forgetting appointments . These setback RI effectiveness from ensuring herd immunity and preventing disease . Across the world , different cost-effective mobile telephone-based reminder systems are currently in use as strategies for improving coverage and compliance in various health interventions .Their application to RI is thereforehighly recommended . OBJECTIVE This study sought to provide evidence validating the need for development and deployment of automated client Reminder-Recall systems for the Nigerian National Routine Immunisation Program and to compare its projected cost withthe cost of a health personnel-based defaulter tracking system . METHODOLOGY A multi-centre , parallel-group , R and omized Controlled Trial was carried outusing multi-stage sampling . Nine hundred and five child-caregivers were followed-upat 8 health facilities in an urban/sub-urban area in South-South Nigeria . Text messagereminders were sent to the Intervention group only , with concurrent weekly data collection , including that for controls , at each of the enrolled health facilities . Recall messages were sent to defaulters and their responses ( presence at immunization session ) assessed the next RI session . Receipt of DPT3 vaccine on or before the 18th week was categorized early , while receiptafter was categorized delayed . RESULTS Clients in the Interventiongroup were1.5times earlier than Controls intheir receipt of DPT3 . Immunization coverage was also 8.7%better in the Interventiongroup . A first year estimate of cost of deploying this strategy was less than a quarter ofthe estimated cost of using home-visits which is the defaulter tracking method currently recommended by regulatory authorities . CONCLUSION Routine immunization performance was significantly better in the Interventiongroup who received SMS reminders compared to the controls who did not . Since this occurred at a cheaper rate than projected costs of home visits , in a habitual stock-out situation , this is ample evidence for health policy-makers in LMICs to leverage the ever exp and ing mobile telecom platforms for future sustainable improvements in routine immunisation performance and even other disease control efforts in Nigeria Preamble Although economic outcomes research is an evolving field in health services research , there are correct and incorrect ways to conduct and report on economic outcomes studies . Research practice s that help to minimize real or perceived bias will increase the quality and usefulness of such studies for those who sponsor , publish , and use them . Because of public concerns about the potential for bias in the design , analysis , and reporting of economic analyses of health care technology , we formed a task force to develop principles to enhance the credibility of these studies . The Task Force on Principles for Economic Analysis of Health Care Technology included participants from academia , the pharmaceutical industry , the public sector , and private research organizations . As health care re sources become increasingly constrained , the information used to make re source allocation decisions must be as reliable , valid , and free of bias as possible . Getting it right at the level at which economic results are produced will help to protect consumers and will advance the health of the public . Bias stems from two broad categories : lack of appropriate independence for research ers and lack of consensus about methods . We focused heavily on the first of these categories for two major reasons . First , few have yet considered the unique issues of research er independence in economic outcomes research [ 1 , 2 ] . Second , other investigators have begun to consider and define proper methods for economic outcomes work ( an area of considerable controversy ) [ 3 - 5 ] . We also looked closely at the requirements for the reporting of economic analyses , which are intended to ensure method ologic transparency and accountability . The Need for Voluntary Guidelines Widespread use of economic analysis as part of the development of pharmaceutical , biotechnologic , and medical devices is relatively new . To date , many economic analyses of health care have focused on pharmaceutical agents , and many such studies have been funded by pharmaceutical companies . Results of these economic outcomes studies are used by medical technology firms to support the pricing and marketing of new interventions and to influence national health care systems and third-party payers in their development of coverage and payment decisions . Managed care organizations , hospitals , and government-subsidized health care programs rely on economic analysis of medical technology to help make formulary purchasing and utilization decisions . Physicians may use the results of these analyses to help guide treatment and prescription decisions . Health care economic outcomes projects are sponsored and conducted by pharmaceutical , biotechnologic , and medical device companies ; government agencies ; nonprofit foundations ; academic investigators ; and private research and consulting firms . The st and ards and methods used to evaluate the safety and efficacy of pharmaceutical products in r and omized , controlled trials have evolved over 50 years of collaboration among research ers in private , public , and academic setting s. Compared with those established to ensure the safety and efficacy of clinical trials , the principles and methods for the conduct of economic studies of health care technology are far less developed . Problems of conduct , reporting , and bias exist in all types of research [ 6 - 14 ] . In response , codes of conduct , such as those developed by the American Federation for Clinical Research and the Institute of Medicine , have been developed for many scientific disciplines [ 15 - 24 ] . These are good models on which to base principles of conduct for economic outcomes analysis . Although many published principles apply to economic studies , others should be modified and new ones should be developed to guide the conduct and reporting of economic outcomes analyses . Economic outcomes research requires unique guidelines for the following reasons : 1 ) As a field , it continues to evolve and is often misunderstood by end users ; 2 ) peer review of it requires special expertise that often exceeds the capabilities of review ers and scientific journals ; 3 ) it often uses secondary data and requires that many assumptions be made [ for example , attribution of a dollar cost to a unit of re source use ] ; 4 ) it offers unique method ologic choices , such as which types of costs to include ( direct , indirect , intangible , induced ) , which perspective to apply ( that of society , payer , provider , patient ) , which design to adopt ( cost- identification , costbenefit , cost-effectiveness , costutility ) , from where to obtain costs [ indemnity data base , managed care or capitated data base , hospital cost systems , Medicare , Medicaid ] , and whether to collect re source consumption data prospect ively or retrospectively through various modeling techniques ; and 5 ) economic studies play an increasingly important role in health care decision making because of increasing financial constraints throughout the health care industry . The financial and medical implication s of decision making done on the basis of these studies , coupled with the lack of widely accepted guidelines about the conduct and reporting of economic analyses , undermine the credibility of this research . A major issue is that the primary source of funding for this research is often the primary financial beneficiary of positive study results . Unfortunately , even valid studies done under the best of circumstances may be suspect [ 25 - 29 ] . This has led at least one major journal to conclude that these analyses should be viewed much like editorials or review articles are viewed in terms of potential for conflicts of interest [ 30 ] . We developed the guidelines reported here after extensive consultation with experts from the public , private , and academic sectors . We recommend that research ers and sponsors adhere to these guidelines , and we suggest they state publicly within their manuscripts that they have done so . End users , including journal editors and readers , consumers , and social decision makers , may then feel more secure in accepting the results of the research , while recognizing that intensive critique of the research will always be necessary . Operations of the Task Force The Task Force on Principles for Economic Analysis of Health Care Technology was initiated and organized by faculty from the Leonard Davis Institute ( LDI ) Center for Health Policy of the University of Pennsylvania . However , because not all LDI faculty were involved , this paper does not represent an official LDI position statement . The Task Force was funded by a coalition of pharmaceutical companies ( Appendix A ) . Funding was also requested ( but not obtained ) from various government and private foundations . All funding was provided in the form of unrestricted research grants or gifts to the University of Pennsylvania . Guidelines derive their credibility in part from the composition of the panel that creates them and the process by which they are developed . C and i date s for participation in the Task Force from the private sector and the academic research community were identified by the frequency with which they were cited in the health economics literature , which was obtained using a MEDLINE search of literature related to economic analyses of medical technology published between 1983 and 1992 . Approximately 15 members attended each meeting . Minutes were distributed after each meeting and approved by all members present . Members from the sponsoring pharmaceutical companies and the academic organizers rotated so that they numbered three and one , respectively , at the table for each formal Task Force meeting . Several professional and governmental organizations , including the Institute of Medicine , the Agency for Health Care Policy and Research , the Food and Drug Administration ( FDA ) , the Health Care Financing Administration , the Centers for Disease Control and Prevention , and a managed care organization , were asked to suggest persons who might participate . In addition , other organizations with a stake in economic analyses were each asked to suggest a person who , because of his or her professional background , had extensive knowledge of or experience with economic analyses . An academic pharmacist , an academic research er , a private research er , an ethicist and patient advocate , and an attorney specializing in medical ethics rounded out the Task Force ( Appendix B ) . Two members withdrew from participation . A small audience consisting of industry sponsors , academic organizers , staff , and a few other interested parties were invited to each meeting and allowed to comment . Four formal meetings of the Task Force were held in Philadelphia during 1993 and 1994 , and the most substantial work was done by various subcommittees between these meetings . The three main subcommittees were titled Ethical Conduct , Responsibility and Control ( the findings of these two subcommittees were later merged into one report ) , and Reporting Requirements for Economic Evaluations ( Appendix C ) . The Task Force was assisted by a professional facilitator . Although Task Force members sought consensus wherever possible on the key issues , consensus was not forced and recommendations were issued only when substantial agreement existed among the members . Task Force members were not asked to formally represent any organization . Formal endorsement of the final document was not sought . Copies of this report will be distributed to all organizations that were asked to suggest a participant and to other parties who responded to announcements placed in The New Engl and Journal of Medicine , Scrip , and the Pink Sheet . The Task Force findings will also be reported at academic conferences , medical profession meetings , and appropriate trade conventions . Findings and Recommendations Valid approaches to economic analyses can be defined ; acceptable methods can be differentiated from unacceptable ones . Bias in economic research stems from two major sources : lack of appropriate independence for Background After many years of sanctions and conflict , Iraq is rebuilding its health system , with a strong emphasis on the traditional hospital-based services . A network exists of public sector hospitals and clinics , as well as private clinics and a few private hospitals . Little data are available about the approximately 1400 Primary Health Care clinics ( PHCCs ) staffed with doctors . How do Iraqis utilize primary health care services ? What are their preferences and perceptions of public primary health care clinics and private primary care services in general ? How does household wealth affect choice of services ? Methods A 1256 household national survey was conducted in the catchment areas of r and omly selected PHCCs in Iraq . A cluster of 10 households , beginning with a r and omly selected start household , were interviewed in the service areas of seven public sector PHCC facilities in each of 17 of Iraq 's 18 governorates . A question naire was developed using key informants . Teams of interviewers , including both males and females , were recruited and provided a week of training which included field practice . Teams then gathered data from households in the service areas of r and omly selected clinics . Results Iraqi participants are generally satisfied with the quality of primary care services available both in the public and private sector . Private clinics are generally the most popular source of primary care , however the PHCCs are utilized more by poorer households . In spite of free services available at PHCCs many households expressed difficulty in affording health care , especially in the purchase of medications . There is no evidence of informal payments to secure health services in the public sector . Conclusions There is widespread satisfaction reported with primary health care services , and levels did not differ appreciably between public and private sectors . The public sector PHCCs are preferentially used by poorer population s where they are important providers . PHCC services are indeed free , with little evidence of informal payments to providers Introduction Novartis recently launched Novartis Access , an initiative to provide a basket of reduced price medicines for non-communicable diseases ( NCDs ) to be sold through the public and private non-profit sectors in programme countries . This study will evaluate the impact of Novartis Access on the availability and price of NCD medicines at health facilities and households in Kenya , the first country to receive the programme . Methods and analysis This study will be a cluster-r and omised controlled trial . 8 counties in Kenya will be r and omly assigned to the intervention or control group using a covariate constrained r and omisation method to maximise balance on demographic and health characteristics . In intervention counties , public and private non-profit health facilities will be able to order Novartis Access NCD medicines from the Mission for Essential Drugs and Supplies ( MEDS ) . Data will be collected from a r and om sample of 384 health facilities and 800 households at baseline , midline after 1-year of intervention , and end-line after 2 years . Quarterly surveillance data will also be collected from health facilities and a sub sample of households through phone-based interviews . Households will be eligible if at least one resident has been previously diagnosed and prescribed a medicine for an NCD addressed by Novartis Access , including hypertension and diabetes . The primary outcomes will be availability and price of NCD medicines at health facilities , and availability , price , and expenditures on NCD medicines at households . Impacts will be estimated using intention-to-treat analysis . Ethics and dissemination This protocol was approved by the Institutional Review Boards at Strathmore University and at Boston University . Informed consent will be obtained from all participants at the start of the trial . The findings of the trial will be disseminated through peer- review ed journals , international conferences , and meetings and events organised with local stakeholders . Trial registration number NCT02773095
Authors ' conclusions Training probably improves quality of care ( i.e. adherence to recommended practice ) , regulation may improve quality of care , and we are uncertain about the effects of co‐ordination on quality of private for‐profit healthcare services in LMICs .
Background Governments use different approaches to ensure that private for‐profit healthcare services meet certain quality st and ards .
Such government guidance , referred to as public stewardship , encompasses government policies , regulatory mechanisms , and implementation strategies for ensuring accountability in the delivery of services .
However , the effectiveness of these strategies in low‐ and middle‐income countries ( LMICs ) have not been the subject of a systematic review .
Objectives To assess the effects of public sector regulation , training , or co‐ordination of the private for‐profit health sector in low‐ and middle‐income countries .