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Quality of IUD services, complications of IUD insertions, secondary data analysis, client follow-ups
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Gehani M, Pal M, Arya A et al. Could EAISI-trained providers provide better quality of IUD services? Results of a secondary data analysis of complications as a proxy indicator [version 2; peer review: 2 approved]. Gates Open Res 2019, 3:1473 (https://doi.org/10.12688/gatesopenres.12997.2)
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Could EAISI-trained providers provide better quality of IUD services? Results of a secondary data analysis of complications as a proxy indicator
[version 2; peer review: 2 approved]
Previously titled: Could trained providers provide better quality of IUD services? Results of a secondary data analysis of complications as a proxy indicator
PUBLISHED 17 Sep 2019
This article is included in the International Conference on Family Planning gateway.
Abstract
Corresponding authors:
Manish Gehani, Sunita Singal
Competing interests:
No competing interests were disclosed.
Grant information:
No funding was needed or availed for conducting this research. Funding for publication of this paper was provided by Bill & Melinda Gates Foundation, under Investment ID OPP1181398.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Copyright:
© 2019 Gehani M et al.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Gehani M, Pal M, Arya A et al. Could EAISI-trained providers provide better quality of IUD services? Results of a secondary data analysis of complications as a proxy indicator [version 2; peer review: 2 approved]. Gates Open Res 2019, 3:1473 (https://doi.org/10.12688/gatesopenres.12997.2)
First published: 24 May 2019, 3:1473 (https://doi.org/10.12688/gatesopenres.12997.1)
Latest published: 04 Mar 2020, 3:1473 (https://doi.org/10.12688/gatesopenres.12997.3)
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Revised Amendments from Version 1
As per the reviewers' comments, limitations of the study and other reasons of complications besides as a result of IUD insertion, were updated. Tables 1 and 2 were combined to better represent the results of descriptive statistics and cross-tabs. We also categorically mentioned that no pregnancy with IUD in-situ was reported in our study.
See the authors' detailed response to the review by Avita Rose Johnson
See the authors' detailed response to the review by Nuriye Ortayli
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of this article available.
Introduction
India is the second most populous country in the world, contributing to 18% of the global population1. In 1952, it became the first country in the developing world to introduce a national family planning program to lower fertility and stabilize population growth2. India’s FP2020 goals aim to drive access, choice, and quality of family planning services. Since first making an FP2020 commitment in 2012, India has continued its efforts to expand the range and reach of contraceptive options through rolling out new contraceptives and delivering a full range of family planning services at all levels. For example, India has integrated family planning into the Reproductive, Maternal, Newborn, Child, and Adolescent Health (RMNCH+A) Strategy3. Increasing awareness and generating demand for family planning services through comprehensive media campaigns have also been prioritized. Reflecting this, data from India’s Demographic and Health Survey revealed that 72% of women reported hearing or seeing a family planning message in the past few months4.
Within the broader commitment to increase access and use of family planning services, a focus of the Government of India has also been to improve access to quality IUD services. It is recognized that ensuring the availability and quality of IUD services can improve family planning uptake, increase modern contraceptive methods use, and reduce unmet need for family planning services. While current use of IUDs among married women is low in India (1.5%), evidence suggests that contraceptive discontinuation rates are lowest for IUD methods (26%), as compared to other methods such as injectables (51%), condoms (47%), and pills (42%)4.
Evidence has shown that ensuring the quality of IUD services can lead to improved client satisfaction, a reduction in complications, continuation of IUD use, and increasing demand of IUD services5. Many factors contribute to the quality of IUD insertions, including the importance of an enabling environment, and assurance that the client’s rights are safeguarded6. In addition, studies have shown that the quality of IUD insertions may also get influenced by the skill level of the provider6. Evidence has also suggested that clients may be significantly more likely to experience IUD complications if they obtained their IUD from untrained providers7. Complications from IUD insertions is of concern given this can lead to unwanted pregnancies8, compromise patient safety9, and impose additional economic burden on the client10. Reduction in IUD complications may also enhance client satisfaction, increase demand for this family planning method and reduce negative beliefs about IUDs within the community9.
Since 2014, the international NGO, EngenderHealth has been providing technical assistance to the Government of India to improve access to quality IUD services. The project, “Expanding Access to IUD Services in India” (EAISI) has been implemented in Gujarat and Rajasthan districts. The interventions under the EAISI project include capacity building of service providers to provide quality IUD services, monitoring their compliance with standard practices, and strengthening the public health system by training administrators. The EAISI project trains public sector service providers in client assessment, counselling skills, IUD insertion and infection prevention practices, as well as ensuring services protect client’s sexual and reproductive health rights. Providers practice their skills on anatomic models and clients.
Estimation of complications of clinical procedures is an important outcome measure, as it has been an established outcome measure of quality of care11. To the best of our knowledge, studies that have investigated the quality of IUD services5,6, have not explored the importance of provider training and the extent to which this may influence the incidence of IUD complications. Given that follow-up information is routinely collected from IUD clients in India, the availability of facility data provided an opportunity to investigate factors associated with IUD complications. The primary aim of the study was to estimate factors associated with IUD complications, including the extent to which provider training influenced the rate of IUD complications. The rate of complications was deemed to serve as a proxy measure of the effectiveness of the EAISI project in reducing complications in the clients who have availed IUD insertion. A secondary aim of the study was also to estimate the magnitude of complications.
Methods
Study design
This study was an analytical retrospective cross-sectional study based on secondary data of follow-ups captured in the intervention facilities of EAISI project between April 2018 and March 2019. This manuscript is written on the basis of the Standardized Reporting of Secondary Data Analysis (STROSA) guidelines12.
Data source
Data for insertions and follow ups are recorded in case records and registers at the facilities. The source of data for this study was the IUD follow-up registers, which were being used for many years for documenting the follow-ups of the reference population consisting of clients who had returned to EAISI intervention facilities for follow-up after IUD insertion. The format of IUD registers mirrored the Government of India guidelines. The data captured in the registers included the identification details of the client, details of IUD insertion, timing of the follow-up visit, as well as findings of the follow-up visits including complications and reason of removal if applicable. The data were owned by the health department of Rajasthan and Gujarat State of India.
Approvals, confidentiality, and data availability
Permission to publish data was obtained from Ministry of Health and Family Welfare, India. In accordance with Declaration of Helsinki, since the study was based on secondary data, institutional ethics approval was not needed. Client privacy was maintained throughout the analysis. No client identifiable data were disclosed. The data has been anonymized without distorting scientific meaning using safe harbor method. The dataset has been deposited in the Harvard Dataverse repository under a CC0 1.0 Universal License13.
Data flow
The data were collected from health facilities every month by EngenderHealth staff. Data were entered into the EAISI project database by data entry operators, as mandated by the Family Planning Department of Ministry of Health and Family Welfare, India. For this analysis, an Excel file was exported from EAISI software for the required period, for the data of the follow-up entries in the software. The data was imported and analyzed using SPSS version 24 by the investigators of the study.
Inclusion and exclusion criteria
The facilities included in the analysis were 138 facilities in Rajasthan (1 sub-district hospital, 130 Community Health Centers, and 7 Primary Health Centers) and 38 facilities in Gujarat (14 district hospitals, 5 sub-district hospitals, 19 community health centers) in which 1306 providers were trained by the EAISI project during the first phase of the project implemented from June 2014 to November 2016. Only clients that returned to the facility for facility-based clinical follow-up were included in the data analysis. Client data was excluded from the analysis if any of the following criteria were met: the client was contacted by phone for a telephonic follow-up, the client was visited at their home by a health provider for home-based follow-up, or the client went to a facility for follow-up other than where she had availed IUD insertion. A full survey of the available data in the targeted facilities for the study period was done by universal sampling.
Analysis unit and variables analysed
The unit of analysis was a client case that was confirmed through clinical follow-up to have experienced complication after IUD insertion. The presence of complication was described as presence of any one or more out of expulsion, infection, and missing strings. This variable served as a proxy indicator for the quality of IUD services14,15. For the analysis, the data were disaggregated according to whether clients had received IUD insertions from providers trained by EngenderHealth versus clients that received IUD insertions from providers that were not trained by EngenderHealth. The latter group included providers that were not formally trained in IUD insertions or had been trained by other institutions.
Other variables that were investigated included the timing of the IUD insertion (post-placental, immediate postpartum, intra-caesarean, interval), timing of follow up after insertion, age, state of residence, and the type of IUD inserted (IUD 380A or IUD 375).
Study size
The study size was determined by the number of entries documented in EAISI software for the study period.
Statistical analysis
A multivariate logistic regression analysis was performed to determine the probability of complications (reference category: no complication) by training status, after controlling for other variables of timing of insertion, timing of follow up after insertion, age, state, and type of IUD inserted. Odds ratio and p value were estimated. Chi square and Nagelkerke R2 values were also estimated. SPSS 24 was used for performing the entire statistical analysis.
Results
Selection of study population
Selection of study population was based on inclusion and exclusion criteria (Figure 1). Of 16,672 clients in the database, 10,747 client records (6,013 in Rajasthan and 4,734 in Gujarat) met the inclusion criteria and were included in the secondary analysis.
Figure 1. Flow chart to show the pathway of the participants in the study.
Descriptive results
Six facilities in Rajasthan and four facilities in Gujarat did not document any follow-up after IUD insertions during the study period due to a lack of follow-up registers and poor documentation practices. The remaining 166 facilities (132 in Rajasthan and 34 in Gujarat) reported that of the 56,733 clients (Rajasthan: 42,231, Gujarat: 14,502) who had availed IUD insertions in these facilities, 10,747 (18.9%) came to the facility for clinical follow-up during the study period. Among these 10,747 clients, 432 (4%) experienced IUD complications: 144 clients experienced expulsions (1.3%), 179 clients had missing strings (1.7%), and 113 clients had infections (1.1%). The sample distribution, according to the different variables, is provided in Table 1. Raw data are available from Harvard Dataverse13.
Table 1. Distribution of clients and proportion of complications.
| Variable | Number of clients (% of total) N=10,747 | Number of complications/n (% of complications) |
|---|---|---|
| State | ||
| Rajasthan | 6013 (56.0%) | 210/6013 (3.5%) |
| Gujarat | 4734 (44.0%) | 222/4734 (4.7%) |
| Training status of providers | ||
| EAISI-trained providers | 5305 (49.4%) | 159/5305 (3%) |
| Other providers | 5442 (50.6%) | 273/5442 (5%) |
| Timing of insertion | ||
| Post-placental | 7112 (66.2%) | 254/7112 (3.6%) |
| Immediate postpartum | 2395 (22.3%) | 112/2395 (4.7%) |
| Intra-caesarean | 498 (4.6%) | 44/498 (8.8%) |
| Interval | 693 (6.4%) | 19/693 (2.7%) |
| Unspecified | 49 (0.5%) | 3/49 (6.1%) |
| Type of IUD | ||
| IUD 375 | 3454 (32.2%) | 113/3454 (3.3%) |
| IUD 380A | 7074 (65.8%) | 310/7074 (4.4%) |
| Unspecified | 219 (2.0%) | 9/219 (4.1%) |
| Time of follow up after insertion | ||
| Within 6 weeks | 3142 (29.2%) | 147/3142 (4.7%) |
| 6 weeks to 6 months | 6440 (59.9%) | 267/6440 (4.1%) |
| More than 6 months | 1114 (10.4%) | 17/1114 (1.5%) |
| Unspecified | 51 (0.5%) | 1/51 (2%) |
| Type of complication experienced* |
Number of complications (% of complications) N=10,747 | |
| Any one complication | 432 (4%) | |
| Expulsions | 144 (1.3%) | |
| Missing strings | 179 (1.7%) | |
| Infections | 113 (1.1%) | |
| Age in years | Mean | Range |
| 24.58 | 16–45 |
Bivariate analyses
Cross-tabulation of various variables with complications reported post insertion is shown in Table 1. Clients in Gujarat reported a higher complication rate (4.7%) compared with those in Rajasthan (3.5%). While 159 complications (3%) were reported among insertions done by EAISI-trained providers, 273 complications (5%) were reported among insertions done by other providers who were either not formally trained or trained by other sources. Missing strings was the most common complication in both the groups and was reported in 1.3% insertions by EAISI-trained providers, and 2.0% insertions by other providers. Incidence of complications varies considerably with timing of insertion – it is highest among intra-caesarian clients (8.8%) followed by immediate post-partum (4.7%), post-placental (3.6%) and lowest among interval IUD clients (2.7%). IUD 380A clients reported higher rate of complications (4.4 %) compared with IUD 375 (3.3%). There is also decline in the frequency of complications according to the time of follow-up, complications are higher among those that were followed-up within 6 weeks of their IUD insertion (4.7%) as compared to clients who were followed-up after six months of insertion (1.5%).
Multivariate analyses
A total of 10,422 cases were included in analysis (χ2 = 82.996, p <0.0005, Nagelkerke R2 0.028) (Table 2). Insertions done by other providers who were either not formally trained or trained by other sources were 55.5% more likely to result in a complication than were insertions done by EAISI-trained providers. Clients receiving IUD 380A were 43.5% more likely than IUD 375 to have a complication. Intra-cesarean clients were 135.7% more likely to report a complication compared with clients having insertions done in the post-placental period. The other two categories of timing of insertion, immediate post-partum and interval, did not have a statistically significant association with incidence of complication. Clients who came for follow-up within 6 weeks of insertion or from 6 weeks to 6 months after insertion were 175% and 178% more likely to report complication than who came more than 6 months post insertion.
Table 2. Multivariate logistic regression of complications post intrauterine device (IUD) insertion by other variables.
| Variable | Odds ratio | 95% CI | p value |
|---|---|---|---|
| State | |||
| Rajasthan* | |||
| Gujarat | 0.996 | 0.772, 1.284 | 0.975 |
| Training status of providers | |||
| EAISI-trained providers* | |||
| Other providers | 1.555 | 1.262, 1.915 | <0.0005 |
| Timing of insertion | |||
| Post-placental* | |||
| Immediate postpartum | 1.189 | 0.909, 1.554 | 0.206 |
| Intra-caesarean | 2.357 | 1.607, 3.459 | <0.0005 |
| Interval | 0.893 | 0.548, 1.458 | 0.652 |
| Type of IUD | |||
| IUD 375* | |||
| IUD 380A | 1.435 | 1.143, 1.801 | 0.002 |
| Time of follow up after insertion | |||
| More than 6 months* | |||
| 6 weeks to 6 months | 2.778 | 1.664, 4.639 | <0.0005 |
| Within 6 weeks | 2.752 | 1.623, 4.665 | <0.0005 |
| Age (continuous variable) | 0.974 | 0.948, 1.002 | 0.068 |
Discussion
This study explored the frequency of complications among IUD clients across two states in India. Our findings highlight the frequency of complications among these women, and also present factors associated with this, including the training of the provider, the type of IUD, timing of the follow-up and timing of the insertion.
Globally, it is estimated that between 2% to 8% of IUD clients will experience missing strings16; 1.6 per 1,000 women/years will have infections17; and between 2 and 10% of IUD clients will experience expulsions in their first year18. Missing strings was the most common complication in insertions by EAISI-trained providers as well as in insertions by non-EASI trained providers. Our evidence data suggest that the occurrence of missing strings, infection and expulsion among our sample were lower than other studies. This is perhaps reflective of the effort the Government of India and EngenderHealth have made to ensure the quality of IUD services.
Our results also illustrate that several factors are associated with the frequency of IUD complications. Of note, complications were significantly more common among clients who obtained their IUD from non-EAISI trained providers, a promising outcome from the EAISI project. These positive findings may reflect several efforts by the project to ensure that the providers are maintaining quality of IUD insertions and counselling of patients. The findings also demonstrate the importance of intensive, hands-on training of providers to build up their clinical skills to provide quality services and reduce post-insertion complications.
The findings that complications were significantly more common among women who returned for follow-up within 6 weeks, possibly reflects that clients noted some type of discomfort, or pain, or noted the expulsion and returned immediately to seek consultation. The finding that complications were significantly more frequent among clients with the IUD 380A has also been observed in other studies19. For example, while a clinical trial evaluating the effectiveness of the copper T 380A and multiload copper 375 (MLCU 375) IUD concluded that both types demonstrated comparable in performances in the first year of use, several issues with the 380A were noted. Clients who received the 380 A had higher discontinuation rates after a year, reported greater abdominal pain during menstruation and bleeding, and higher expulsion and termination rates than the 375 IUD19. The results of this study, and that of others, suggest that additional clinical research may be merited to explore the effectiveness of the copper T 380A in the context of India.
Timing was also significantly associated with complications, with women who received their IUD during the intra-caesarean period. This finding is consistent with other research, which reports unacceptably high expulsion and displacement rates among clients who receive IUDs during the intra-caesarean period. For example, one study observed a 20% expulsion rate among copper IUDs inserted during the intra-caesarean period, within the 12-week follow-up period20. Another study found an IUD expulsion rate at 1 year of 17.6% in post-caesarean section women using the 380A IUD21. The method was viewed by the authors as unacceptable for general use. These findings are of concern, given that the expulsion rates after caesarean delivery could prevent proper healing of the laparotomy wound by leading to a shortened interpregnancy interval, which can lead to significant problems during a subsequent pregnancy22.
The age of the client was not significantly associated with incidence of complications, which contradicts other research that observed significantly higher rates of expulsion among younger women, under the age of 1823. Given that few of our sample comprised of women under the age of 18, and ranged from 16–45 years, with an average age of 25, may explain why no significant differences in age were observed among our sample.
This study had several limitations. Out of the sampled 176 facilities of Phase 1, 10 facilities had no records of follow-up clients. In addition, 81% of clients who had availed insertions from the remaining 166 facilities could not be documented. This was due to a number of reasons, including the low return rate of clients to facilities, poor documentation practices, and/or incomplete documentation. Although providers stress the importance of the need to returning to the facility for a follow-up after 1.5 months, it is apparent from our data that many do not. This lack of follow-up to the facility by the client may be attributable to a number of factors, including economic, geographical and logistical issues24,25. As such, the estimation of complications may be biased towards women who were able to return for follow-up visits. Furthermore, the long-term expulsion rates could not be determined, as the vast majority of clients followed-up within 4 to 6 weeks. Due to resource constraints and incompleteness of secondary data, matched sample could not be assured and a case control study could not be conducted. It is also recognized that complications could also have occurred due to other factors. Infections could also have occurred due to sexually transmitted illnesses. Missing strings could also have happened due to failure of IUD, although no such case was reported in the study. These confounders may have been unevenly distributed among the clients who availed insertions from the EAISI-trained providers or from the other providers. Further, the category of non-EAISI trained providers in this study could have been trained on IUD insertion and related aspects during their pre-service and other post service training which could have masked the effect of IUD training on incidence of complications in our analyses. The limited fields in the hospital registers restricted our ability to control for these confounding variables. Finally, the caveats of the analysis framework were that the data was secondary, and the completeness of data could not be ensured.
Despite these limitations, the study demonstrates a cost-effective method of monitoring the quality of IUD services in healthcare facilities. While the other studies on quality of IUD services have derived data by interviewing providers, interaction with clients, or hospital operations indicators, the data in follow-up registers considered in this study, is filled after clinical evaluation, and carries expert assessment and diagnosis of complication or client’s condition. Since complications at the time of follow-up reflect the overall quality of IUD services including enabling environment, skills and practices of providers, and client satisfaction, this model denotes the effectiveness of IUD services in the real world. This analytical framework can be adopted to evaluate the outcomes of any skill-based training.
Conclusion
Training, follow-up practice and monitoring schemes used by the EAISI project could enhance the skills of the providers and improve the quality of IUD services. Based on this, the EAISI model can be used to scale up trainings to other geographic areas, by government or other partners. Besides this, the use of secondary data is cost-effective method of monitoring quality of IUD services. These findings create grounds for further research and presents feasible model for periodic assessment of the quality of IUD services in FP programs.
To facilitate such secondary analyses, follow-up registers should be made available at all the facilities, documentation practices should be improved, and reporting at facilities should be periodically reviewed. The data generated should be used for decision making and informing the implementers and policy makers, which will go a long way in enhancing quality of services.
Data availability
Harvard Dataverse: Could Trained Providers Provide Better Quality of IUD Services-Results of A Secondary Data Analysis of Complications as a Proxy Indicator”, https://doi.org/10.7910/DVN/JYZP7N13.
Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication).
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Gehani M, Pal M, Arya A et al. Could EAISI-trained providers provide better quality of IUD services? Results of a secondary data analysis of complications as a proxy indicator [version 2; peer review: 2 approved]. Gates Open Res 2019, 3:1473 (https://doi.org/10.12688/gatesopenres.12997.2)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Comments on this article Comments (1)
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Reader Comment 26 Jun 2019John Stover, Avenir Health, Glastonbury, CT, USA26 Jun 2019Reader CommentThis is a useful article that provides evidence that provider training for IUCD staff can reduce the frequency of complications. The results show significant lower post-insertion complications for clients of ... Continue reading
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Alongside their report, reviewers assign a status to the article:
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A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
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However, there are some limitations to the study that are not directly addressed by the authors The main one is a concern about selectivity bias. If I understand correctly, less than 20% of patients who had an IUD inserted came to a facility for a follow-up visit during the study period. What about the other 80%? If we assume that none of them had any complications then the difference between EAISI-trained and other providers would much smaller. If they did not come back because of poor counseling about what to do in the case of complications then the complication rate could be much higher. I would be good to know what proportion of patients who received an IUD from an EAISI-trained provider returned for a follow-up visit and how that compares to other IUCD clients.
In the discussion the authors claim that EAISI is a cost-effective method, but they do not provide any information about the costs of the training compared to other types of training. How do we know it is cost-effective?
However, there are some limitations to the study that are not directly addressed by the authors The main one is a concern about selectivity bias. If I understand correctly, less than 20% of patients who had an IUD inserted came to a facility for a follow-up visit during the study period. What about the other 80%? If we assume that none of them had any complications then the difference between EAISI-trained and other providers would much smaller. If they did not come back because of poor counseling about what to do in the case of complications then the complication rate could be much higher. I would be good to know what proportion of patients who received an IUD from an EAISI-trained provider returned for a follow-up visit and how that compares to other IUCD clients.
In the discussion the authors claim that EAISI is a cost-effective method, but they do not provide any information about the costs of the training compared to other types of training. How do we know it is cost-effective?