Introduction

Female sterilization is the most popular contraceptive method globally: an estimated 190 million couples rely on the method, which constitutes 30% of the contraceptive method mix worldwide [1]. In India, female sterilization has dominated the contraceptive method mix since the early 1990s, as observed in multiple rounds of the Demographic and Health Surveys from 1991–92 to 2015–16 [2]. Each year nearly 3.5 million women receive sterilization services at public health facilities in India, and the procedure constitutes 67% of India’s contraceptive method mix [2, 3].

Despite the wide use of female sterilization in India, poor quality of sterilization services in public health facilities has been a persistent concern, dating back to the early 1990s. Reported problems include, but are not limited to: inadequate client counselling on alternative long–acting methods, poor interpersonal interactions between service providers and clients, inadequate screening of clients for potential contraindications, poor maintenance of aseptic conditions during surgery, minimal monitoring of clients during and after surgery, and minimal written or verbal instructions offered to clients at discharge [4]. Government targets for female sterilization further exacerbated quality concerns as health workers felt pressured to meet locally imposed targets [5].

In response, Government of India (GoI) adopted a target-free approach in 1996 [5] and issued quality of care standards for female sterilization in 1998–99 [6]. Despite these efforts, evidence of the poor quality of female sterilization services in various states continued [7–10]. In 2005, the Supreme Court of India passed orders to improve the quality of female sterilization procedures. GoI incorporated these directives into the revised quality standards, which also established a quality assurance mechanism and a revised compensation scheme for adverse events, should they occur [11]. Although this led to some improvements, public sector female sterilization services still did not meet the prescribed quality standards [12, 13], resulting in an unacceptable number of deaths, complications, and failures [5, 14]. In 2014, a major shift in the discourse around female sterilization took place when 16 women died after undergoing sterilization surgery in a family planning camp in the state of Chhattisgarh. In the same year, the Supreme Court of India issued directives to make the program target-free and shift the focus from quantity to the quality of procedures [15]. This led to revisions in government guidelines to incorporate evidence-based best practices and quality assurance processes for female sterilization [16, 17]. While India’s current national guidelines are comprehensive and address almost all components of quality in female sterilization services provided in the public health system, they still need to be understood within the context of implementation. Poor technical and managerial capacity, scarcity of trained human resources, and a high client load have put increased pressure on the health system at the state level and below, resulting in underutilization of these guidelines [13].

Any assessment of female sterilization services must be cognizant of the global articulation of quality in the context of family planning. This emphasizes the need to both, maintain safety and incorporate client-centered care, although the latter is not usually accorded equal treatment [18]. The United Nations Committee on Economic, Social and Cultural Rights has defined quality as evidence-based practices that are scientifically and medically appropriate [19].

In light of the history of quality problems with female sterilization in India as well as the current focus on voluntary, client–centered quality family planning services [20, 21], the Maternal and Child Survival Program (MCSP) in India has worked to improve practices pertaining to female sterilization in public health facilities in five states: Assam, Chhattisgarh, Maharashtra, Odisha, and Telangana.

MCSP was a global program focused in 26 high priority-countries, which supported the Government of India in expanding the basket of contraceptive choices, contributing to meet India’s FP 2020 commitments and to universal access to quality contraceptive services. Quality along with respectful client-centered care was the cornerstone of the program.

This study examines whether the program’s package of interventions increased service providers’ adherence to key practices during provision of female sterilization services at public health facilities in two of these states (Chhattisgarh and Odisha). The study was designed to inform program managers and other key stakeholders about critical practices requiring additional attention and resources. It also aimed at adding to the existing knowledge on the ‘know-do gap’. While increased knowledge of health service providers is often seen as a process indicator of improved quality of care, it may not necessarily translate into change in practices in the real-world settings [22–24]. Providers may not ‘do’ as per what they ‘know’. Therefore understanding the know-do gap is a critical step towards developing effective, practical strategies to improve delivery of quality female sterilization services.

Methods

Study design and setting

The study employed a before-and-after quasi-experimental design with a matched comparison arm. It had a quasi-experimental design as the intervention districts for MCSP were selected purposefully and not randomly. The intervention districts were selected in consultation with state officials based on government priorities and poor facility performance on key family planning indicators.

The study was conducted in two of the five states where the MCSP intervention was rolled out–Chhattisgarh and Odisha–where all interventions were implemented with full intensity. To ensure uniformity of assessment, we conducted the study in health facilities where female sterilization procedures were done using the mini-laparotomy (Minilap) approach under sedation and local anesthesia; this was true of all facilities in Chhattisgarh and most facilities in Odisha.

The intervention was implemented in six districts in each state, for a total of 12 intervention districts. In intervention districts, MCSP supported all public health facilities which were designated by the government to provide Fixed Day Static (FDS) female sterilization services. The FDS approach offers regular sterilization services on fixed days throughout the year, performed by trained providers posted in that facility [16]. From among all MCSP-supported public health facilities that employed the minilap procedure in the 12 intervention districts, we randomly selected 12 facilities for the intervention group (3 of 44 facilities in Chhattisgarh and 9 of 108 facilities in Odisha). To form a comparison group, we matched the intervention facilities with 12 FDS facilities from nine districts that were not supported by MCSP, based on the facility’s (1) state, (2) delivery volume, and (3) average monthly female sterilization client load during the three months prior to baseline data collection (Fig 1). At endline, three facilities from the comparison group were replaced, using the same matching criteria, because they no longer performed female sterilization by the Minilap approach.

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Fig 1. Flow chart summarizing the selection of study sites and sample per study site.

https://doi.org/10.1371/journal.pone.0244088.g001

Data collection tools and procedures

The study data came from direct observation of the provision of female sterilization services. Observations were recorded on a structured checklist (S1 Checklist) that included 30 key practices outlined in national guidelines for female sterilization [16]. The practices were categorized into the same four pause points as the CSC. Some key practices were further subdivided into two to five observable steps (Table 1). For such practices, data collectors noted whether each step was performed or not performed. Adherence to a practice was defined as performing all steps in that practice.

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Table 1. Practices and steps observed across the four pause points.

https://doi.org/10.1371/journal.pone.0244088.t001

Data collectors were medical doctors and nursing graduates, and 70% of those who collected data in the baseline round returned for the endline round. Data collectors attended a standardized three-day training prior to each round of data collection, during which the observation checklist and scoring procedures were reviewed. The training included practice sessions during which data collectors filled out the observation checklist while watching simulated procedures using anatomic models. Ensuing discussions of the observations helped standardize the application of the scoring system across data collectors and also clarified doubts and concerns.

Baseline data were collected in April-June 2017 and endline data in November-December 2018. During each survey round, two data collectors (one doctor and one nurse) were assigned to a facility. After obtaining consent from both, the providers and clients, data collectors observed interactions until the target number of observations were reached for each pause point. Nurses observed pause points 1 (admission) and 4 (post-operative care and discharge). Doctors observed pause points 2 (pre-operative assessment) and 3 (surgery).

Results

Of the 12 health facilities in the intervention arm, nine were located in Odisha and three in Chhattisgarh, reflecting the greater number of MCSP-supported facilities in Odisha overall. Two of the 12 were district hospitals, one was a sub-district level hospital, and nine were community health centers. The comparison facilities had the same geographic breakdown and included one district hospital and 11 community health centers.

At baseline, 240 observations were completed for each pause point in both intervention and comparison facilities (Table 2). At endline, 240 observations were completed for each pause point in the intervention facilities. However, fewer endline observations were completed at comparison facilities: 223 observations for pause points 1 and 4, and 214 observations for pause points 2 and 3. The shortfall in the planned sample size was due to personnel changes at two health facilities in the comparison arm: the surgeons who performed female sterilizations at these facilities were transferred and not immediately replaced.

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Table 2. Number of completed observations at baseline and endline, by study arm and pause point.

https://doi.org/10.1371/journal.pone.0244088.t002

Adherence levels for practices observed during pause point 1 (admission) varied widely at baseline. Two practices–urine tests for sugar and albumin and obtaining women’s signatures on consent forms–were nearly universal. At the other extreme, adherence was exceptionally low for abdominal and pelvic examinations in both study arms and remained low at endline (25.4% in the intervention group and 16.6% in the comparison group) (Table 3).

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Table 3. Percent of observations at pause point 1 (admission) in which providers adhered to key practices, by study arm and round of data collection (n = 943).

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Findings suggest the intervention led to improved adherence among six of the 12 practices observed during pause point 1. This included three practices related to women’s medical eligibility for female sterilization, two practices related to client-provider interaction, and one practice related to obtaining informed consent from clients. For five of these practices, the bivariate analysis found that adherence declined significantly at comparison facilities while increasing significantly at intervention facilities. Despite positive changes, considerable room for improvement remained for some practices. For example, providers explained the procedure to the client and encouraged questions in just 40.7% of endline sessions at intervention facilities.

Adherence levels also varied widely at pause points 2 and 3 (pre-operative assessment and surgery). Baseline adherence levels were below 30% for sedation and anesthesia and also for monitoring and documenting vital signs during surgery (Table 4). In contrast, surgeons used sterile gloves, instruments, and drapes, ensured the client had emptied her bladder, and followed recommended surgical technique in over 80% of cases at baseline, limiting the room for improvement. A comparison of the two study arms from baseline to endline shows no significant impact of the intervention on any practices during pause points 2 and 3. The bivariate analysis found that adherence actually fell significantly at intervention sites for four practices.

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Table 4. Percent of observations at pause points 2 and 3 (pre-operative assessment and surgery) in which providers adhered to key practices, by study arm and round of data collection (n = 934).

https://doi.org/10.1371/journal.pone.0244088.t004

At baseline, adherence to all key practices observed during pause point 4 (post-operative care and discharge) was low, ranging from 0 to 45%. In the intervention group, the bivariate analysis showed significant increases in adherence to all practices, while adherence in the comparison group remained static or declined. Changes in three practices in the intervention group were significant in the multivariate analysis: documenting the client’s vitals, checking the surgical dressing, and giving clients a discharge slip or card with written instructions. At endline, however, adherence levels in the intervention group exceeded 50% for only two practices: use of a trolley or wheelchair (63.5%) and discharge slips (86.3%) (Table 5).

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Table 5. Percent of observations at pause point 4 (post-operative care and discharge) in which providers adhered to key practices, by study arm and data collection round (n = 943).

https://doi.org/10.1371/journal.pone.0244088.t005

Discussion

This quasi-experimental study examined the effectiveness of a package of interventions–supported by MCSP and implemented in collaboration with GoI–in improving providers’ adherence to key evidence-based practices during female sterilization services offered at public health facilities in two Indian states. We found that a few of the 30 practices observed were well established prior to the intervention, including hemoglobin and urine testing, using sterile gloves and surgical instruments, and following recommended surgical techniques. However, adherence to many other practices was extremely low at baseline. The package of program-supported interventions (which included a competency-based hands-on training, mentoring, introduction and use of a safety checklist, and a client card) improved adherence to nine practices, including practices related to ascertaining client’s medical eligibility, client-provider interaction, the consent process, and post-surgery care. The greatest improvement was observed in giving women written instructions prior to discharge.

Ascertaining the medical eligibility of women prior to undergoing sterilization surgery requires both laboratory and clinical screening practices. Hemoglobin and urine examinations prior to surgery were completed in most observed cases even at baseline, which is consistent with earlier studies of female sterilization surgeries in public health facilities in India [13, 27, 28]. The intervention also led to more consistent assessments of the client’s medical status. However, it is equally important to ensure that clients comprehend the implications of their decision because female sterilization permanently limits future childbearing. This is central to an informed and voluntary approach to choosing this or (any) other family planning methods. Our study found that less than half of the clients at baseline were assessed for their ability to understand the consequences of accepting a permanent family planning method. This corroborates with the findings of a recent study from India [27], which also reported low adherence to this critical practice. The MCSP intervention led to substantial gains, as providers at intervention facilities assessed the comprehension of four-fifths of women at the endline.

Abdominal and pelvic examination findings provide valuable information on the presence of adhesions or adnexal masses that portend a difficult surgery. At baseline, these exams were conducted in just one-quarter or fewer of observed cases, and the intervention did not improve adherence to this practice. This may have been due to various implementation challenges, including a lack of doctors to perform these examinations, lack of competency to correctly perform and interpret meaningful findings, and lack of private space at facilities’ screening sites. While other steps in screening women for female sterilization can be performed by nursing or paramedical staff (including doctors of the Indian system of medicine), abdominal and pelvic examinations require a medical doctor as per GoI guidelines. It should be noted that routine screening of non-pregnant, asymptomatic women with pelvic exams poses implementation challenges even in high-income countries [29]. From the woman’s perspective, these intimate physical examinations hold the potential for embarrassment, anxiety, and discomfort. Doctors also have anxieties, including a lack of confidence in their clinical findings and fear of alleged misconduct [29].

Respectful care and good client-provider interaction are critical to a woman’s initial decision to adopt a family planning method and later, to adhere to the chosen method of contraception [30]. Effective communication, respect and dignity, and emotional support comprise the three domains of client experience of care in the WHO Quality of Care framework [31]. This study directly measured two critical elements of respectful care: providers interacting directly and respectfully with women and providing them with full explanations of the procedure. Baseline scores for interacting directly with clients and treating them respectfully were surprisingly high (52.1% in the intervention arm and 75% in comparison arm) compared with previous studies in India [4, 13]. This may be due, in part, to providers being aware of the presence of observers and modifying their behaviors accordingly (the Hawthorne effect) [32]. At endline, adherence to this practice dropped significantly in the comparison arm while it improved further in the intervention arm. Similar trends were seen for the practice of explaining the procedure to the client and encouraging her to ask questions, although adherence levels were lower.

Obtaining written consent from women prior to surgery was almost universal, which is similar to findings reported by other studies in India [13, 27, 28, 33]. A likely explanation is that a signed consent form is part of the documentation required for reimbursement of clients and providers. However, studies have reported that little effort goes into ensuring that women actually understand the contents of the consent form and thus make a truly informed decision [13, 28]. Our baseline findings corroborated this concern: less than one-fourth of observed women received an explanation of the contents of the consent form. The practice of explaining the consent form–which includes providing information on other available highly effective long acting reversible methods, the potential for failure, permanence of the procedure, risks of surgery, the lack of protection against sexually transmitted infections, and the choice to opt out of the procedure without losing access to other medical treatment–is central to a client-centered, quality approach to providing family planning and reproductive health care [20]. In India, a national scheme provides a fixed payment to both the client and the field-level worker who accompanies her; it is designed to offset the loss of wages and other out-of-pocket expenses that may be incurred due to sterilization. In this context, it is imperative that a client’s decision to undergo this surgery is well informed and voluntary, free from coercion or the lure of financial incentives. Although the intervention did lead to a significant improvement in explaining the consent form, adherence remained less than 50% at endline, clearly pointing to the need for further improvement. Inadequate staff, even at intervention facilities, posed a major barrier to this process. Fewer staff catering to higher caseloads on FDS days leaves little opportunity for concerned staff to explain the contents of the consent form to every client individually.

The intervention did not have an effect on any of the key practices observed during the pre-operative assessment and surgery (pause points 2 and 3). Adherence to a few of these practices was high at baseline, but adherence to other practices was low at baseline and changed little. For certain practices, such as monitoring and documenting vital signs during surgery, a lack of adequately trained staff in the operating theater may have posed a barrier to adherence. Using pulse oximeters for monitoring vital signs, which is an established standard in the WHO Safe Surgery Checklist, could facilitate adherence to this key practice [34].

Practices around infection prevention and control did not change after the intervention. At endline, for example, changing into proper attire and performing a surgical scrub before entering the operating theater was observed in less than half of cases, while adequate scrubbing of the incision site was observed in less than one-fourth of cases. Literature from around the world points out that improving adherence to infection prevention practices requires modifying entrenched behaviors of healthcare workers and has always been a big challenge [35, 36]. Experts in the field advocate for multimodal approaches that utilize behavior change models, some of which have been effective in modifying behaviors of health service providers in different clinical situations [36]. Our intervention–which focused on imparting knowledge and skills on infection prevention control through the trainings and mentoring–could have benefitted from the inclusion of behavior change strategies.

Consistent improvements were observed in post-surgical care, although not all gains proved significant in the multivariate analysis. Periodic and appropriate monitoring after sterilization is imperative for the timely detection of anesthesia- and/or procedure-related complications. Prior studies in India corroborate our baseline findings showing poor adherence to post-surgery monitoring at public health facilities [4, 13, 27]. The intervention led to significant gains in practices like checking the surgical dressing for soakage and documenting the vital signs of clients before discharge. Despite improvements, however, adherence remained low at endline (less than one-third). Earlier studies have pointed to a lack of nursing staff as the reason for poor adherence to post-operative monitoring [13], and staff shortages may also have played a role in this study. Government reports based on healthcare administrative data point to a lack of nursing and paramedical staff at FDS sites (including community health centers, sub-district/divisional hospitals, and district hospital) in these two states [37].

Notably, the intervention almost tripled the proportion of female sterilization clients who received written instructions prior to their discharge from the facility. Earlier studies in India reported poor adherence to this practice [4, 13], which were confirmed by our baseline findings showing that less than one-third of women were given written instructions prior to discharge. By the endline, that proportion had climbed to 86%. This can be attributed to the introduction of a printed client card at intervention facilities, along with increased emphasis on the importance of giving these instructions during the MCSP program.

To the best of our knowledge, this study is first of its kind from India. A major strength is its use of direct observations of clinical care by senior surgeons and experienced nurses or ANMs. This is considered the gold standard for measuring quality of care [38]. Previous published studies of the quality of female sterilization services in India have relied on record audits or client interviews which are liable to biases.

Both the program and the study were conducted in close coordination with the state health departments, and there were no other quality improvement interventions with similar objectives implemented at the study sites, during course of the study.

However, our study does have certain limitations. Direct observations of service providers may have biased some findings due to the Hawthorne effect, though the observers were trained to make their observations in an as unobtrusive manner as possible Inter-observer variation may have also had an influence on the findings, although rigorous procedures for training data collectors sought to avoid this, including standardized trainings by the same instructors before each round of data collection. In addition, during the course of this study, we were able to retain more than 70% of data collectors from baseline to endline. However, inter-rater reliability was not measured as part of the study. Lastly, three comparison facilities had to be replaced in the endline round of data collection after they stopped performing the minilap procedure, although efforts were made to ensure that the additional facilities were comparable to the others, based on the same matching criteria and there were no quality improvement interventions, with similar objectives as MCSP, being implemented there. There was also a shortfall in the number of observations completed in comparison facilities at endline (874 observations were conducted of the 960 originally planned), but the missing observations were spread relatively evenly across the four pause points. Given these limitations, a degree of caution should be exercised in interpreting the data.

Conclusion

This study highlights the need for quality improvement interventions like the one implemented by MCSP, as adherence to many key practices identified in the Government of India’s standards and guidelines for female sterilization was very low at baseline. Although the package of interventions studied here did improve adherence to certain key practices around admission, post-operative care and discharge, many practices–even those that saw an improvement–remained low at endline. Contextual factors such as insufficient human resources, frequent turn-over of trained staff, and inadequate infrastructure may have blunted the potential impact of the intervention.

Utilization of behavior change models as part of the intervention might have helped improve practices around infection prevention and control. In addition, inclusion of respectful care as an essential aspect of family planning service provision and measures to ensure reduced turn-over of trained staff can further strengthen adherence to best-practices and ensure sustainability of quality improvement initiatives such as MCSP.

Further research is needed to understand factors that can enable more consistent adherence to evidence-based practices in such resource-constrained health facilities.

Supporting information

Acknowledgments

The authors would like to thank India’s Ministry of Health and Family Welfare and USAID for their invaluable support and guidance and to acknowledge Academy of Management Studies, Lucknow, India, which was responsible for data collection. The authors are grateful to the government health officials of the states of Chhattisgarh and Odisha for their support during the study. The authors also extend their sincere thanks to all the people who participated in the study. The authors would also like to thank Adrienne Kols for critically reviewing the manuscript and providing valuable inputs.