Dataset Information

Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

ABSTRACT: There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes. We designed and implemented a robust and integrated DQA system to sustain high-quality data throughout the trial.We designed the Data Quality Monitoring and Improvement System (DQMIS) to reinforce six dimensions of data quality: accuracy, reliability, timeliness, completeness, precision, and integrity. The DQMIS was comprised of five functional components: 1) a monitoring and evaluation team to support the system; 2) a DQA protocol, including data collection audits and targets, rapid data feedback, and supportive supervision; 3) training; 4) standard operating procedures for data collection; and 5) an electronic data collection and reporting system. Routine audits by supervisors included double data entry, simultaneous delivery observations, and review of recorded calls to patients. Data feedback reports identified errors automatically, facilitating supportive supervision through a continuous quality improvement model.The five functional components of the DQMIS successfully reinforced data reliability, timeliness, completeness, precision, and integrity. The DQMIS also resulted in 98.33% accuracy across all data collection activities in the trial. All data collection activities demonstrated improvement in accuracy throughout implementation. Data collectors demonstrated a statistically significant (p?=?0.0004) increase in accuracy throughout consecutive audits. The DQMIS was successful, despite an increase from 20 to 130 data collectors.In the absence of widely disseminated data quality methods and standards for large RCT interventions in limited-resource settings, we developed an integrated DQA system, combining auditing, rapid data feedback, and supportive supervision, which ensured high-quality data and could serve as a model for future health systems research trials. Future efforts should focus on standardization of DQA processes for health systems research.ClinicalTrials.gov identifier, NCT02148952 . Registered on 13 February 2014.

SUBMITTER: Gass JD

PROVIDER: S-EPMC5590237 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

Gass Jonathon D JD Misra Anamika A Yadav Mahendra Nath Singh MNS Sana Fatima F Singh Chetna C Mankar Anup A Neal Brandon J BJ Fisher-Bowman Jennifer J Maisonneuve Jenny J Delaney Megan Marx MM Kumar Krishan K Singh Vinay Pratap VP Sharma Narender N Gawande Atul A Semrau Katherine K Hirschhorn Lisa R LR

Trials 20170907 1

<h4>Background</h4>There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In th ...[more]

PMID: 28882167

Similar Datasets

Project description:In the absence of adequate social security, out-of-pocket health expenditure compels households to adopt coping strategies, such as utilizing savings, selling assets, or acquiring external financial support (EFS) by borrowing with interest. Households' probability of acquiring EFS and its amount (intensity) depends on its social capital - the nature of social relationships and resources embedded within social networks. This study examines the effect of social capital on the probability and intensity of EFS during health events in Uttar Pradesh (UP), India. The analysis used data from a cross-sectional survey of 6218 households, reporting 3066 healthcare events, from two districts of UP. Household heads (HH) reported demographic, socioeconomic, and health-related information, including EFS, for each household member. Self-reported data from Shortened and Adapted Social Capital Assessment Tool in India (SASCAT-I) was used to generate four unique social capital measures (organizational participation, social support, trust, and social cohesion) at HH and community-level, using multilevel confirmatory factor analysis. After descriptive analysis, two-part mixed-effect models were implemented to estimate the probability and intensity of EFS as a function of social capital measures, where multilevel mixed-effects probit regression was used as the first-part and multilevel mixed-effects linear model with log link and gamma distribution as the second-part. Controlling for all covariates, the probability of acquiring EFS significantly increased (p = 0.04) with higher social support of the HH and significantly decreased (p = 0.02) with higher community social cohesion. Conditional to receiving any EFS, higher social trust of the HH resulted in higher intensity of EFS (p = 0.09). Social support and trust may enable households to cope up with financial stress. However, controlling for the other dimensions of social capital, high cohesiveness with the community might restrict a household's access to external resources demonstrating the unintended effect of social capital exerted by formal or informal social control.

Project description:BackgroundEnsuring the current public health workforce has appropriate competencies to fulfill essential public health functions is challenging in many low- and middle-income countries. The absence of an agreed set of core competencies to provide a basis for developing and assessing knowledge, skills, abilities, and attitudes contributes to this challenge. This study aims to identify the requisite core competencies for practicing health professionals in mid-level supervisory and program management roles to effectively perform their public health responsibilities in the resource-poor setting of Uttar Pradesh (UP), India.MethodsWe used a multi-step, interactive Delphi technique to develop an agreed set of public health competencies. A narrative review of core competency frameworks and key informant interviews with human resources for health experts in India were conducted to prepare an initial list of 40 competency statements in eight domains. We then organized a day-long workshop with 22 Indian public health experts and government officials, who added to and modified the initial list. A revised list of 54 competency statements was rated on a 5-point Likert scale. Aggregate statement scores were shared with the participants, who discussed the findings. Finally, the revised list was returned to participants for an additional round of ratings. The Wilcoxon matched-pairs signed-rank test was used to identify stability between steps, and consensus was defined using the percent agreement criterion.ResultsStability between the first and second Delphi scoring steps was reached in 46 of the 54 statements. By the end of the second Delphi scoring step, consensus was reached on 48 competency statements across eight domains: public health sciences, assessment and analysis, policy and program management, financial management and budgeting, partnerships and collaboration, social and cultural determinants, communication, and leadership.ConclusionsThis study produced a consensus set of core competencies and domains in public health that can be used to assess competencies of public health professionals and revise or develop new training programs to address desired competencies. Findings can also be used to support workforce development by informing competency-based job descriptions for recruitment and performance management in the Indian context, and potentially can be adapted for use in resource-poor settings globally.

Project description:BackgroundPoor patient experiences during delivery leads to delayed presentation at facilities and contributes to poor maternal health outcomes. Person-centered maternity care (PCMC) is a key component of quality. Improving PCMC requires changing the process of care which can be complex and necessitate significant external input, making replication and scale difficult. This study compares the effectiveness two Quality Improvement (QI) intervention phases, one Intensive, one Light-Touch.MethodsWe use a matched case-control design to compare two phases of a QI Intervention targeting PCMC, with three facilities in each. The Intensive phase was introduced into three government facilities where teams were supported to identify, design, and test potential improvements over 12?months. The Light-Touch phase was subsequently introduced in three other government facilities and changes were tracked over six months. We compared the two groups using multivariate linear regression and difference-in-difference models to assess changes in PCMC outcome RESULTS: Both Intensive and Light-Touch arms demonstrated large improvements in PCMC. On a scale from 0 to 100, Intensive facilities increased in PCMC scores from 85.02 to 97.13, while Light-Touch facilities increased from 63.42 to 87.47. For both there was a 'halo' effect, with a similar improvement recorded for the specific improvement activities focused on, as w ell as aspects of PCMC not directly addressed.ConclusionsThis study demonstrates that a short, inexpensive, light-touch and directive intervention can change staff practices and significantly improve the experiences of women during childbirth. It also shows that improvements in a few areas of provider-patient interaction have a 'halo' effect, changing many other aspects of patient-provider interaction at the same time.Trial registrationQI Phase 1 - NCT04208867 . Retrospectively registered. December 19th, 2019. QI Phase 2 - NCT04208841 . Retrospectively registered. December 23, 2019.

Project description:BACKGROUND:The use of medication abortion is increasing rapidly in India, the majority of which is purchased through pharmacies. More information is needed about the quality of services provided by pharmacist about medication abortion, especially barriers to providing high quality information. The goal of this study was to explore the quality of pharmacist medication abortion provision using mixed methods to inform the developed of an intervention for this population. METHODS:Data was collected via convenience sampling using three methods: a quantitative survey of pharmacists (N?=?283), mystery clients (N?=?111), and in-depth qualitative interviews with pharmacist (N?=?11). Quality indictors from the quantitative data from surveys and mystery clients were compared. Qualitative interviews were used to elucidate reasons behind findings from the quantitative survey. RESULTS:Quality of information provided to client purchasing medication abortion was low, especially related to timing and dosing of misoprostol (18% of pharmacists knew correct timing) and side effects (31% not telling any information on side effects). Mystery clients reported lower quality (less correct information) than pharmacists reported about their own behaviors. Qualitative interviews suggested that many barriers exist for pharmacists, including perceptions about what information clients can understand and desire, and also lack of comfort giving certain information to certain types of clients (young women). CONCLUSIONS:It is essential to improve the quality of information given to client purchasing medication abortion from pharmacists. Our findings highlight specific gaps in knowledge and reasons for poor quality information. Differences in guidelines available at that time from the Indian Government, World Health Organization, and the medication abortion boxes may lead to confusion amongst pharmacists and potentially clients. Interventions need to improve both knowledge about medication abortion and also biases in the provision of care.

Project description:BackgroundThe sustainable development goals (SDG) aim at satisfying three-fourths of family planning needs through modern contraceptive methods by 2030. However, the traditional methods (TM) of family planning use are on the rise, along with modern contraception in Uttar Pradesh (UP), the most populous Indian state. This study attempts to explore the dynamics of rising TM use in the state.MethodsWe used a state representative cross-sectional survey conducted among 12,200 Currently Married Women (CMW) aged 15-49 years during December 2020-February 2021 in UP. Using a multistage sampling technique, 508 primary sampling units (PSU) were selected. These PSU were ASHA areas in rural settings and Census Enumeration Blocks in urban settings. About 27 households from each PSU were randomly selected. All the eligible women within the selected households were interviewed. The survey also included the nearest public health facilities to understand the availability of family planning methods. Univariate and bivariate analyses were conducted. Appropriate sampling weights were applied.ResultsOverall, 33.9% of CMW were using any modern methods and 23.7% any TM (Rhythm and withdrawal) at the time of survey. The results show that while the modern method use has increased by 2.2 percentage points, the TM use increased by 9.9 percentage points compared to NFHS-4 (2015-16). The use of TM was almost same across women of different socio-demographic characteristics. Of 2921 current TM users, 80.7% started with TM and 78.3% expressed to continue with the same in future. No side effects (56.9%), easy to use (41.7%) and no cost incurred (38.0%) were the main reasons for the continuation of TM. TM use increased despite a significant increase (66.1 to 81.3%) in the availability of modern reversible methods and consistent availability of limiting methods (84.0%) in the nearest public health facilities.ConclusionInitial contraceptive method was found to have significant implications for current contraceptive method choice and future preferences. Program should reach young and zero-parity women with modern method choices by leveraging front-line workers in rural UP. Community and facility platforms can also be engaged in providing modern method choices to women of other parities to increase modern contraceptive use further to achieve the SDG goals.

Project description:BackgroundIn response to the high levels of maternal nutrition in Uttar Pradesh, Alive & Thrive (A&T) aimed to strengthen the delivery of nutrition interventions through the government antenatal care platform, including leveraging ongoing data collection to improve program delivery and reach (registered at clinicaltrials.gov as NCT03378141). However, we have a limited understanding of providers' experiences and challenges in collecting and using data for decision making.ObjectiveThe aim was to identify barriers and facilitators to the 1) collection of data and 2) use of data for decision making.MethodsIn-depth interviews (n = 35) were conducted among block-level government staff, frontline worker (FLW) supervisors, and A&T staff in 2 districts in Uttar Pradesh. Systematic coding of verbatim transcripts and detailed summaries were undertaken to elucidate themes related to data collection and use. FLW supervisors (n = 103) were surveyed to assess data use experiences.ResultsData were used to understand the reach of maternal nutrition services, estimate the demand for supplements, and guide identification of areas of low FLW performance. About half of supervisors reported using data to identify areas of improvement; however, only 23% reported using data to inform decision making. Facilitators of data collection and use included collaboration between health department officials, perceived importance of block ranking, and monthly review meetings with staff and supervisors to review and discuss data. Barriers to data collection and use included human resource gaps, inadequate technology infrastructure, FLW educational level, political structure, and lack of cooperation between FLWs and supervisors.ConclusionsThe use of data for decision making is critical for supporting intervention planning and providing targeted supervision and support for FLWs. Despite intensive data-collection efforts, the use of data to inform decision making remains limited. Collaboration facilitated data collection and use, but structural barriers such as staff vacancies need to be addressed to improve the implementation of maternal nutrition interventions.

Project description:CONTEXT:Recent randomised controlled trials in Bangladesh and Kenya concluded that household water treatment, alone or in combination with upgraded sanitation and handwashing, did not reduce linear growth faltering or improve other child growth outcomes. Whether these results are applicable in areas with distinct constellations of water, sanitation and hygiene (WaSH) risks is unknown. Analysis of observational data offers an efficient means to assess the external validity of trial findings. We studied whether a water quality intervention could improve child growth in a rural Indian setting with higher levels of circulating pathogens than the original trial sites. METHODS:We analysed a cross-sectional dataset including a microbiological measure of household water quality. All households accessed water from an improved source. We applied propensity score methods to emulate a randomised trial investigating the hypothesis that receipt of drinking water meeting Sustainable Development Goal (SDG) 6.1 quality standards for absence of faecal contamination leads to improved growth. Growth outcomes (stunting, underweight, wasting, and their corresponding Z-scores) were assessed in children 12-23 months of age. For each outcome, we estimated the mean and 95% confidence interval of the absolute risk difference between treatment groups. FINDINGS:Of 1088 households, 442 (40.62%) received drinking water meeting SDG 6.1 standards. The adjusted risk of child underweight was 7.4% (1.3% to 13.4%) lower among those drinking water satisfying SDG 6.1 norms than among controls. Evidence concerning the relationship of drinking water meeting SDG 6.1 norms to length-for-age and weight-for-age was inconclusive, and there was no apparent relationship with stunting or wasting. CONCLUSIONS:In contexts characterised by high pathogen transmission, water quality improvements have the potential to reduce the proportion of underweight children, but are unlikely to impact stunting or wasting. Further research is required to assess how these modelled benefits can best be achieved in real world settings.

Project description:Background:Double fortified salt (DFS) is efficacious in addressing iron deficiency, but evidence of its effectiveness is limited. The few published evaluations do not include details on program implementation, limiting their utility for programmatic decisions. Objectives:We sought to characterize the coverage of a DFS program implemented through the Public Distribution System (PDS) in Uttar Pradesh, India, and understand the drivers of DFS adherence. Methods:After 8 mo of implementation, we surveyed 1202 households in 5 districts and collected data on sociodemographic characteristics, asset ownership, food security, and regular PDS utilization. We defined DFS program coverage as the proportion of PDS beneficiaries who had heard of and purchased DFS, and we defined DFS adherence as DFS use reported by households. We used principal component analysis to create an asset-based index of relative wealth, and we categorized households into higher/lower relative wealth quintiles. We conducted path analyses to examine the drivers of DFS adherence, particularly the mediated influence of household wealth on DFS adherence. The evaluation is registered with 3ie's Registry for International Development Impact Evaluations (RIDIE-STUDY-ID-58f6eeb45c050). Results:The DFS program had good coverage: 83% of respondents had heard of DFS and 74% had purchased it at least once. However, only 23% exclusively used DFS. Respondents had low awareness about DFS benefits and considered DFS quality as poor. Being in a lower household wealth quintile and being food insecure were significant drivers of DFS adherence, and regular PDS utilization acted as a mediator. Adherence was lower in urban areas. Conclusions:We observed significant heterogeneity in DFS implementation as reflected by high coverage and low adherence. Findings from this process evaluation informed the design of an adaptive impact evaluation and provided generalizable insights for ensuring that the potential for impact is realized. Efforts are needed to increase awareness, improve product quality, as well as mitigate against the sensory challenges identified.

Dataset Information

Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

Publications

Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets