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Implementation fidelity of intravenous ferric carboxymaltose administration for iron deficiency anaemia in pregnancy: a mixed-methods study nested in a clinical trial in Nigeria

Implementation Science Communications volume 5, Article number: 81 (2024) Cite this article

Abstract

Background

Iron deficiency anaemia is common among pregnant women in Nigeria. The standard treatment is oral iron therapy, which can be sub-optimal due to side effects. Intravenous ferric carboxymaltose (FCM) is an evidenced-based alternative treatment with a more favourable side effect profile requiring administration according to a standardized protocol. In this study, we assessed the fidelity of administering a single dose of FCM according to protocol and identified factors influencing implementation fidelity.

Methods

We used a mixed-method approach with a sequential explanatory design nested in a clinical trial across 11 facilities in Lagos and Kano States, Nigeria. Guided by a conceptual framework of implementation fidelity, we quantitatively assessed adherence to protocol by directly observing every alternate FCM administration, using an intervention procedure checklist, and compared median adherence by facility and state. Qualitative fidelity assessment was conducted via in-depth interviews with 14 skilled health personnel (SHP) from nine purposively selected health facilities, using a semi-structured interview guide. We analyzed quantitative data using descriptive and inferential statistics in Stata and used thematic analysis to analyze the transcribed interviews in NVivo.

Results

A total of 254 FCM administrations were observed across the 11 study sites, with the majority in secondary (63%), followed by primary healthcare facilities (PHCs) (30%). Overall, adherence to FCM administration as per protocol was moderate (63%) and varied depending on facility level. The lowest level of adherence was observed in PHCs (36%). Median, adherence level showed significant differences by facility level (p = 0.001) but not by state (p = 0.889). Teamwork and availability of protocols are facilitation strategies that contributed to high fidelity. However, institutional/ logistical barriers are contextual factors that influenced the varied fidelity levels observed in some facilities.

Conclusions

Collaborative teams and access to operating protocols resulted in high fidelity in some facilities. However, in some PHCs, fidelity to FCM was low due to contextual factors and intervention complexities, thereby influencing the quality of delivery. In Nigeria, scale-up of FCM will require attention to staff strength, teamwork and availability of administration protocols, in order to optimize its impact on anaemia in pregnancy.

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Background

Iron deficiency anaemia (IDA) is the leading cause of anaemia in pregnancy (AIP) globally [1], contributing to up to 25–45% of AIP in Nigeria [2]. This condition can be categorized as mild, with a haemoglobin (Hb) concentration of 10–10.9 g/dl, moderate with Hb of 7.0–9.9 g/dl, and severe with Hb < 7.0 g/dl [3]. To reduce the high risk of fetomaternal morbidity and mortality [2, 4] associated with this condition in low- and middle-income countries (LMICs), the World Health Organization recommends daily oral iron as prophylaxis and therapeutic using low and higher doses, respectively [3, 5]. However, higher doses are associated with significant gastrointestinal adverse events [6, 7], which result in intolerance and poor adherence in up to 70% of pregnant women [8,9,10,11].

Ferric carboxymaltose (FCM), is a dextran-free intravenous (IV) iron therapy which is typically used when oral iron therapy is ineffective either from poor adherence, lack of tolerance, lack of absorption, side effect or a need for quick correction of low haemoglobin (Hb) levels [6]. FCM is widely used as an alternative for treating moderate to severe IDA in pregnancy, especially in high-income countries (HICs) [6, 12]. However, it has only recently been the subject of clinical trials in LMICs, including Nigeria and Malawi [13, 14]. Despite the positive results of these trials, the nature of administration of IV FCM, as well as the timing and severity of adverse events related to it, are very different to that of oral iron [6]. As such, there is a need to adequately` train skilled health personnel (SHP), i.e., doctors and nurses, to safely administer this intervention and manage any reactions that may occur during or after administration [6, 15, 16].

Fidelity can be described as how closely an intervention like FCM is administered according to the protocol [17]. Fidelity is a crucial outcome for researchers planning on translating evidence-based interventions (EBIs) into day-to-day practice [17]. High fidelity can enable the maintenance of the intended effect of EBIs, even if delivered in a different context [18]. Additionally, fidelity assessment helps to distinguish between the EBI’s actual effects and variations in its implementation [19]. Therefore, for any EBI like FCM to be successfully and safely administered, evaluating the adherence to the protocol, the dose, and the quality of intervention delivery is crucial [17].

While there is a general recommendation for IV iron as a treatment option for AIP, there are currently no established guidelines for administering IV iron to pregnant women in Nigeria [20]. It is important to support the IV iron recommendation with feasible standardized protocols for safe and accurate administration. Healthcare facilities that attain high implementation fidelity might develop the capacity to adopt and integrate FCM into routine practice.

However, there is insufficient evidence on the implementation fidelity of this EBI in LMICs [21]. To address this evidence gap, the objective of this study was to assess the fidelity of SHP in administering FCM safely to treat moderate to severe IDA in pregnancy and to understand factors which influence implementation fidelity within the setting of a clinical trial in Nigeria.

Methods

Study design and setting

This mixed-method study of sequential explanatory design consisted of two phases: a quantitative followed by a qualitative phase [22]. In the quantitative phase, data on each component of the administration of FCM were collected and analyzed. Findings from this analysis informed the subsequent qualitative sampling, data collection, and analysis. This study was nested in the context of an open-label hybrid study of IV versus oral iron for iron deficiency anaemia in pregnant women in Nigeria (IVON) [23]. We used the Standards for Reporting Implementation Studies (StaRI) checklist to report our findings (Additional file I) [24].

This study was conducted in IVON trial sites in the two most populous States in Nigeria: Kano and Lagos [25]. Nigeria is a country of > 200 million inhabitants, with an estimated seven million births each year [26] and a high maternal mortality ratio of 917 per 100,000 live births [27]. These two states are situated in the North-Western (Kano) and South-Western (Lagos) parts of Nigeria [26] with varying antenatal care utilization rates (Kano: 73% and Lagos: 90%) [28]. The prevalence of AIP in Kano is approximately 47%, while in Lagos, it is 50% [26]. We conducted the study across the three levels of the healthcare system namely primary, secondary, and tertiary [25]. Primary healthcare (PHC) provides basic maternal healthcare services at the community level, while secondary and tertiary facilities provide comprehensive and advanced maternal healthcare [29]. These facilities included two PHCs in Lagos and three PHCs in Kano, and two secondary and one tertiary facilities in each state.

Conceptual framework

We adapted the modified Carroll et al. conceptual framework for implementation fidelity (CFIF) to assess the implementation fidelity, henceforth referred to as fidelity, of FCM administration across different levels of healthcare facilities [30,31,32]. According to CFIF, implementation fidelity is the measurement of adherence (e.g., the extent to which those delivering an intervention adhere to its original design) which is influenced by factors including facilitation strategies, intervention complexity, delivery quality, and participant responsiveness. We measured adherence quantitatively using its subcategories (content, coverage, dose, and duration) and evaluated qualitatively the influencing factors. The different fidelity components and measurement methods are defined in more detail in Table 1.

Table 1 Elements of implementation fidelity for FCM administration adapted from Carroll et al. elements and modified by Hasson Henna
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Implementation strategies

The SHP who administered FCM were skilled research nurses (employed by the trial), facility-based nurses who assisted the research nurses as needed, and medical doctors specializing in fetomaternal care. The trial organized a theoretical and practical training session to ensure that all SHP could administer FCM and perform basic life support. The trial also provided treatment protocols/standard operating procedure (SOP), counselling guidelines and charts to simplify the calculation of the dose of FCM. An algorithm was developed to facilitate step-by-step administration processes [33], which was further used to train the SHP and ensure consistency in FCM administration across all trial facilities (Additional file II). Emergency drugs (e.g. adrenaline and hydrocortisone) and resuscitation materials were provided by the IVON research team to each facility to manage anaphylactic reactions in the unlikely event that they occurred. During the implementation phase of the 16-month trial, six monthly refresher training sessions (four in all), quarterly monitoring, and monthly feedback were provided by IVON to all SHP involved in the trial in all 11 facilities (Table 2).

Table 2 Illustrating implementation strategies that facilitated implementation outcome
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Data collection tools and sources

To assess the fidelity of FCM administration (Table 3), the following four tools were used:

  1. 1.

    Intervention procedure checklist: A checklist was developed to assess the adherence (content) of the FCM administration (Additional file III). The IVON trial treatment manual, FCM administration package insert, and a literature search on the safe administration of IV iron guided the initial development of the checklist [34,35,36,37]. The checklist was then divided into smaller, sequenced steps, resulting in a 12-item (components) standardized intervention procedure checklist. Subsequently, 10 essential components critical to safely administering IV iron were identified. The first component included nine sub-components comprised of resuscitation medications and materials. This checklist was confirmed through SHP and core research team feedback, ensuring content validity.

  2. 2.

    FCM administration chart: We used an intervention chart to track FCM administration details, including participant identifiers (study ID and study site name), dose, vital sign checks (temperature, oxygen saturation, respiratory rate, pulse rate and blood pressure), and administration duration. The intervention chart was developed to record the details of each administration procedure including the starting and ending time of the administration, the cadre of SHP involved, and the intervals for vital signs checks. These vital signs were conducted before administration, two minutes into the administration, immediately after, and 30 min post-administration. Additionally, the chart was used to record the clinical state of the participants throughout the administration process and at the time of discharge.

  3. 3.

    Enrolment data: To confirm the proportion of eligible participants who received FCM administration, we measured coverage using the IVON trial enrolment data on Research Electronic Data Capture (REDCap) [38, 39].

  4. 4.

    Topic guide: Using the CFIF, a semi-structured topic guide with four sections was developed to understand factors influencing adherence in this study. This guide was utilized for qualitative data collection via in-depth interviews (IDIs) among purposively selected SHP.

Table 3 Illustrating data collection sources for implementation fidelity elements
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Recruitment procedure

In the IVON trial, all 11 facilities were involved in the implementation of FCM. For this study, we used a systematic sampling technique (every alternate FCM administration) to select FCM administration to assess adherence to the study protocol. The target sample size was 264, out of which the first ten administrations were used to pilot the intervention procedure checklist. A total of 254 observations of FCM administrations, ranging from nine to 58 per facility, were included in the analysis.

Qualitatively, to gain insight into the factors influencing adherence to FCM administration protocols, we purposively selected facilities with low and high adherence and high antenatal patient attendance (compared to the number of available SHP). To determine data sufficiency, we relied on the concept of information power [40] based on the study objective, the specificity of the sample, and the high-quality input from different perspectives [24].

Data collection

Quantitative phase

We assessed adherence to content through direct non-participant observation with the intervention procedure checklist. To do this, we trained seven neutral research assistants to use the checklist, and to document and interpret observations accurately. Each element of adherence was rated by the observers as done, partially done, or not done. Data were collected between August 9, 2021, and December 29, 2022, and entered directly into REDCap (Vanderbilt University, Nashville, Tennessee, US) using an electronic device (tablet).

Qualitative phase

We developed a four-section interview guide based on the findings from the quantitative aspect of this study and insights from previous studies on barriers to administering FCM (Additional file IV) [15, 16]. We piloted the guide before data collection and made necessary adjustments based on the responses of the SHPs.

The first author (ORA) and two other interviewers (research assistants) trained in qualitative data collection methods conducted the IDIs with SHP in selected healthcare facilities. We chose IDIs as they provided a practical opportunity for one-on-one discussions with the SHP involved in the intervention [41, 42]. IDIs were conducted over the phone at the convenience of the SHP in those facilities to create a comfortable and non-judgemental environment. We interviewed 14 SHP purposively selected from nine facilities between May and October 2023 in English between 40 and 90 min. We ensured the accuracy and clarity of intended meanings by repeating responses to participants. All interviews were audio-recorded and transcribed verbatim.

Data analysis

Quantitative data analysis

The number of FCM observations per facility level was presented using descriptive statistics in frequencies and percentages. Percentages for the sub-elements of adherence (content, coverage, dose, and duration) were presented, including the 10 essential components for content. The nine sub-components of the first component were added and then divided by nine to create a proportion completed. Adherence per protocol was also calculated as a proportion, and this was defined as all 18 essential components from the intervention procedure checklist (content) in addition to dose and duration.

The level of adherence per facility level was examined using Pearson’s Chi-square test. We utilized the Shapiro–Wilk test to test for normality distribution. Median and interquartile ranges were used to present adherence levels for non-normally distributed data by components.

The adherence levels per facility level for each sub-element were categorized as high (between 80–100%), moderate (between 51–79%), and low (between 0–50%) based on insights from published studies [43, 44]. The Kruskal–Wallis test was utilized to identify significant differences between adherence levels per facility level and state, and a p-value of less than 0.05 was considered significant. A post hoc test was conducted utilizing the Bonferroni-Dunn test to determine the exact facility type with a statistically significant difference. With further analysis, we identified and selected healthcare facilities purposively for qualitative data collection. We analyzed our data using Stata version 17.0 statistical software (StataCorp LLC, College Station, Texas, US).

Qualitative data analysis

The modified CFIF framework informed our analysis, which focused on implementation fidelity [30,31,32]. All transcribed interviews were reviewed for accuracy and completeness and analyzed using thematic analysis [45, 46]. ORA and COJ, two qualitatively trained researchers, coded a subset of the transcript independently using a deductive approach to create a codebook, which was applied to the rest of the dataset. Next, we developed, reviewed, and refined our themes and sub-themes to accurately reflect the dataset's meaning. The analysis was conducted with the aid of a computer-assisted qualitative data analysis software, NVivo 12 Plus (QSR International, Memphis, Tennessee, US).

Data integration

We prioritized the initial quantitative findings and used the qualitative findings to provide further explanation. Ultimately, we integrated quantitative and qualitative results in the interpretation phase of the findings [47]. Data from FCM administration observation and IDIs with SHP were quantitatively and qualitatively triangulated to ascertain convergence. Convergence was defined as general agreement between data sets.

Ethical considerations

Ethical approval was obtained from the National Health Research Ethics Committee of Nigeria (NHREC/01/01/2007- 17/01/2021), Health Research and Ethics Committees of the Lagos University Teaching Hospital (ADM/DCST/HREC/APP/3971) and Aminu Kano Teaching Hospital, Kano State (NHREC/28/01/2020/AKTH/EC/2955).

Social approvals were obtained from Lagos State Health Service Commission (LSHSC/2222/VOLIII), Lagos State Primary Health Care Board (LS/PHCB/MS/1128/VOL.VII/100) and Ministry of Health, Kano State (MOH/Off/797/T.1/2102). We obtained verbal consent from SHP before each phase of the study. Patient safety was ensured by avoiding interruptions during the observation process. Audio recordings before data collection began only after obtaining verbal permission from the SHP.

Results

Quantitative findings

Characteristics of FCM administration observations

The 254 observed administrations of FCM to pregnant women in the 11 trial facilities were conducted by 42 unique SHP. Mirroring the distribution of participants in the clinical trial, the majority of the observations were conducted at secondary healthcare facilities (63%), followed by PHCs (30%), and 7% in tertiary facilities. One hundred and twenty-four FCM administrations were observed in Lagos state (49%) and 130 (51%) in Kano state.

Adherence in implementation fidelity

There was a high level of adherence to each of the ten essential components (content). Ensuring the availability of FCM had the highest adherence (100%) and ensuring the availability of resuscitation materials such as oxygen masks had the lowest adherence (73%). When comparing the median adherence levels among the states, we found no significant difference (p = 0.889). However, the detailed results are not presented in Table 4 below. The median adherence level for PHC was 97.8 (IQR = 81.1,100), 100 in secondary (IQR = 100,100), and 100 in tertiary facilities (IQR = 100,100) (Table 4). The level of adherence per facility level was significant (p < 0.001), with median adherence levels which statistically differed by facility level (p = 0.001). There was a statistically significant difference in adherence levels between PHC and secondary facilities (p < 0.001), and between PHC and tertiary facilities (p < 0.001), but no difference between secondary and tertiary facilities (p = 0.394). All eligible participants (coverage measure) received FCM (100%). The level of adherence to dose (99.6%) and duration (95.3%) were high.

Table 4 Adherence for content, dose, and duration by facility level and overall (n = 254 FCM administrations)
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Adherence level to protocol

The level of adherence to protocol was highest in tertiary facilities (84.2%) and lowest in PHCs (36.0%) (p < 0.001). Overall, the level of complete adherence to protocol was moderate (66.5%) (Fig. 1).

Fig. 1
figure 1

Level of adherence to protocol per facility level and overall (n: no of FCM administrations per facility)

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Further data stratification by facility levels and States revealed that ensuring the availability of resuscitation drugs and materials at the point of administration (component 1) as the most affected component with incomplete adherence to content across all three healthcare facility levels (Table 4). Adherence levels to this component ranged from 37.2% to 100.0% across the facility levels in both states, with statistically significant differences between PHC and secondary facilities (p < 0.001) and PHC and tertiary facilities (p < 0.001) (Table 5). Components 3 (patient counselling), 6 (perform baseline vital signs) and 10 (post-administration vital signs check) were the next most common contributors to incomplete adherence (Table 5).

Table 5 Essential components with the lowest adherence level by facility type and state
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Four facilities had varied adherence levels (from low to high): PHC facilities #2 and #3 in Kano, secondary facility #1 in Lagos and tertiary facility in Kano (PHC #3 – > PHC #2 – > SHF #1 – > TF). In contrast, PHC facilities #1 (93.8%) and #2 (95.0%) in Lagos, secondary facility #2 in Lagos (100%) and secondary facility #2 in Kano (99.7%) had the highest adherence levels.

Qualitative findings

Three main themes primarily influenced the level of adherence to FCM administration (content) in this study namely teamwork is key to sustained high fidelity, readily available charts and protocols are needed for high fidelity and institutional/logistical barriers negatively influenced fidelity. The third theme was further divided into three sub-themes to describe the institutional barriers as influencing factors of fidelity. These themes and sub-themes were mapped to all but one of the elements of the modified CFIF (Table 6).

Table 6 Themes and sub-themes mapped into five factors that influenced the implementation fidelity of FCM administration using the modified CFIF
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Teamwork is key to sustained high fidelity

For most SHP, administering FCM to pregnant women was a simple procedure that closely followed standard clinical practice. However, to administer FCM as intended, teamwork was deemed to be of utmost importance. According to some SHP who had sustained high fidelity levels throughout the trial, teamwork was critical to administer FCM as intended. They reported encountering many challenges that could have negatively influenced FCM level. Nonetheless, they overcame these challenges by effectively working as a team despite dealing with high patient flow and a limited workforce.

“I have very hard-working research nurses… they have tried, so it is teamwork. Every one of us participated very well and put in our best, which is why you see such improvement, such performance”. Medical Officer, Female, Secondary Healthcare Facility #2, Kano

One of the research nurses in PHC #2 Lagos emphasized the importance of teamwork when administering FCM, especially when there is more than one administration to be made. She shared her experience of a time when she had to administer FCM to three eligible pregnant women with a challenge to monitor them at once. However, the administration process became much easier when the facility nurse joined her to assist. According to her, they attended to one pregnant woman at a time and then moved on to the next until all three pregnant women had received their FCM. This approach enabled them to complete the administration process as intended.

Readily available charts and protocols needed for high fidelity

According to SHP in highly adherent facilities, the readily availability of charts and protocols contributed to their high performance. Most influential was the availability of charts, which were pasted on the wall for easy access when needed.

“You know, as a team, we decided to follow a step-by-step method, so I’m always looking at the chart on the wall, and that was how I was doing until I became so familiar with it. Even after that, I visit the chart whenever I want to administer the IV iron (FCM”. Research Nurse, Female, Secondary Healthcare Facility #2, Lagos

Institutional/logistical barriers negatively influenced fidelity

Institutional/logistical barriers negatively influenced the adherence of most SHP to components 1,3, 6 and 10 as intended.

Ensuring the availability of resuscitation materials at the point of administration

Component 1 (availability of resuscitation materials at the point of administration) was not delivered as intended at several sites. Non-proximity between the storage area for resuscitation drugs/ materials and where FCM was administered created an issue. They overcame this challenge after discussions with the IVON research team, when storage space was provided within the FCM administration area.

Space was why ensuring the availability of resuscitation materials at the point of administration was difficult to implement as planned at the initial phase of the trial. I mentioned space because where we used it was not totally ours. We didn't get a place to keep the resuscitating drugs…so we had to keep them on another floor and go up and down the stairs to bring them when needed…so it was not easy at all because it was only me at that initial phase… but with time they provided us with a cupboard to use. And we started having our things close as instructed, making the administration more straightforward." Research Nurse, Female, Secondary Healthcare Facility #1, Lagos

For some SHP in the tertiary and PHC facility levels, component 1 was not adhered to as intended because they were aware that the resuscitation drugs and materials were readily accessible and stored in a secured place. Therefore, they felt it unnecessary to check the availability of these drugs at the point of every administration as per the protocol.

High HCP workload expedited conduct of counselling and baseline observations

Even though the SHP were adequately trained to counsel the pregnant women on the process of FCM administration just before the procedure, the high SHP workload in the facilities influenced their complete adherence to this component. Therefore, counselling pregnant women (component 3) as intended became challenging. According to a nurse in PHC #2, Lagos, the one-on-one counselling before FCM administration might be rushed through due to the pressure to administer FCM to many eligible pregnant women at the same time. From the perspective of another SHP, challenges to adhering to this component as intended occurred when:

“… there are so many patients to administer FCM to at the same time, and usually, in such instances, the patients want to go home on time, and the SHP are also trying their best not to delay them, so further verbal counselling may not be very adequate, you might actually miss some things…” Medical officer, Female, Primary Healthcare Facility #1, Lagos

Furthermore, the high SHP workload was used to explain why component 6 (to perform baseline vital signs check) was not completely adhered to. Although most SHP performed this task, a few found it challenging, citing forgetfulness and heavy workload as the reasons why. However, SHP at a high-fidelity facility in Kano overcame this challenge by complementing their workforce's capacity with the number of patients receiving FCM daily. This strategy resulted in decreased waiting time, agitation, and anxiety for both SHP and pregnant women.

Prolonged patient waiting time influenced post administration observation

According to some SHP, incomplete adherence to component 10 (post-administration vital signs check) was due to the prolonged waiting time for pregnant women to receive their scheduled routine antenatal care (ANC) services. For these SHP, ANC service infrastructure and organization were primarily responsible for the lengthy ANC waiting period, thereby making the pregnant women already agitated and exhausted to complete the entire administration process. Consequently, some pregnant women declined further observation of vital signs immediately after administration, considering it a time-consuming and unnecessary step.

“Yes, the issue with this observation is more of time-consuming, i.e., before you send patients for screening, scanning and everything, the time has already gone, and the patient will start complaining, so I think this is why they (SHP) rush through this aspect and finish everything so they can discharge the patient to go home…" Research Nurse, Female, Primary Healthcare Facility #2, Kano

Discussion

Our study used a mixed-method approach to assess the degree to which SHP adhered to FCM administration. We found that the fidelity level to IV iron implementation was moderate, which varied by facility level (the lowest level attained in PHCs). The most compromised component was ensuring the availability of resuscitation drugs and materials at the point of administration. Our findings showed that teamwork and the availability of charts and protocols contributed to high fidelity. However, institutional / logistical barriers contributed to low to moderate fidelity levels at the facility level.

This moderate level of fidelity in our study was consistent with other quantitative studies and meta-analyses conducted by Durlak et al. [48]. According to the authors, it is impractical to expect complete or near complete adherence as favourable results have been attained at 60%, with few studies reaching above 80% [48]. Additionally, as stated in their review and similar to our study findings, providers in the same study settings have marked variations, usually with differences when comparing the lowest and highest fidelity levels [48]. Their report highlights the diverse levels of fidelity that we observed across different healthcare facility levels in our study (high in tertiary, moderate in secondary and low in PHCs).

It is worth noting that fidelity in most secondary and some primary facilities in our study was high. One facilitation strategy that worked well was collaborative teamwork. Teamwork behaviours exhibited by these SHP were communication of work plans, working in parallel and coordination of FCM administration among team members [49]. The effect of this strategy was consistent with the findings of a study conducted in a real-world setting where an intervention implementation was scaled up across a national healthcare system [50]. It is imperative to note that for the SHP to be fully committed to teamwork as a strategy and to sustain their engagement, it is crucial for the facilities to provide feedback and support at a managerial level as a source of motivation for the SHP [49].

Another strategy that enabled fidelity in our study was the availability and consistent use of protocols and charts, which fostered self-efficacy and, hence, positive participants’ responsiveness, which influenced and enabled the extent to which FCM was administered as intended [30]. Our research findings are similar to the findings from previous studies where program resources and treatment manuals positively influenced their fidelity level [51, 52]. This approach has been proven effective in enabling SHP to apply standardized interventions continuously and accurately to several patients [53].

Fidelity monitoring and feedback are just as critical as facilitation strategies, which have proven effective in overcoming contextual challenges [54, 55] For example, in our study, the use of these strategies overcame the lack of designated space that hindered adherence to ensuring the availability of resuscitation drugs and materials at the point of administration. This approach was similarly effective in previous studies demonstrating the effectiveness of using a standardized strategy to promote high fidelity to EBIs [56, 57] However, despite the availability of designated space, some SHP in some facilities in our study failed to adhere to this component due to their varying perceptions of its delivery. This attitude resulted in low fidelity, which supports Carroll et al.'s statement that more facilitation strategies do not necessarily mean excellent implementation [30]. Although the SHP' attitude resulted in low fidelity, their reasons are practical and realistic, which explains why this component may not be adhered to as intended outside the research-controlled environment. It is of note to acknowledge that adhering to an essential component can become more challenging when implementing EBIs like FCM in real-world settings [58]. On the positive side, the constant availability of and access to resuscitation materials and drugs facilitated emergency readiness before the administration of the intervention, as recommended [36]. However, we must caution that SHP may assume that these resources are always available, even when not, which can lead to life-threatening situations in the event of adverse events.

Unlike the secondary facilities and some PHCs that have a high-fidelity level, a few PHCs in our study had a low to moderate fidelity level primarily due to institutional factors in the process of ANC service delivery. This contextual factor has been linked to insufficient SHP [59]. Generally, the Nigerian healthcare system has one of the lowest health workforce densities (20.1 per 10,000 population), far below the least recommended workforce density of 44.5/10,000 [60]. This shortage of SHP disproportionately affects PHC facilities and the country's northern region, where Kano state is located [61, 62]. This disparity in the HCP-patient ratio led to prolonged patient waiting periods [63,64,65], resulting in dissatisfaction with the ANC service delivery, mostly in Kano State as observed in our study. Our study found that these prolonged patient waiting periods led to expedited conduct of some essential components and, hence, partial adherence. In line with our findings, it is clear from previous studies that a limited workforce is vital to implementation fidelity, highlighting the need for lasting solutions [66, 67].

Implementing EBIs like FCM in a new setting requires fidelity to the original protocol, but adaptation might also be necessary for the intervention to work and be sustainable [48, 55]. However, controversy still surrounds the balance between fidelity and adaptation [48]. In other words, some authors believe measuring adaptation is necessary when evaluating fidelity [48], while others consider adaptation a lack of implementation success [30, 48]. In our study, the SHP tried to balance following the intervention protocol with adapting it to suit the unique challenges in their facilities. This conduct resulted in some essential intervention components being expedited to address issues like long patient wait times. This expedited conduct was a reactive (adaptation) response to improve the fit of FCM administration to pregnant women [48, 55, 68]. On the other hand, facilities that successfully implemented FCM with high fidelity used planned adaptation strategies, a deliberate attempt to enhance and sustain high fidelity [55]. For instance, the SHP timed the administration of FCM based on workforce capacity and volume of eligible recipients to overcome infrastructural constraints like inadequate human resources and high workload.

Implications for future practice and research

The findings of our study emphasize the importance of taking practical steps to ensure the high fidelity of FCM administrations in Nigeria's healthcare system. Firstly, it is crucial to introduce strategies to alleviate the excessive workload of SHP, such as health talk-focused videos or AI-powered tools [64, 69]. These tools can assist SHP in educating and counselling pregnant women about their health, including IV iron therapy. Furthermore, it is essential to ensure adequate provision of SHP [65], which could reduce the effect of increased workload, reduce waiting times for pregnant women, and improve their responsiveness to receiving FCM as intended [61, 64]. Additionally, task sharing and task shifting, with sufficient training, should be considered to reduce the impact of FCM administration workload on SHP [70].

Secondly, there is a need to consider the appropriate timing to administer FCM in our day-to-day practice. In our study, we administered FCM during routine ANC services to minimize additional hospital visits to pregnant women outside their scheduled ANC appointments. However, facilities' structure and delivery of ANC services impacted fidelity to protocol. To achieve and sustain high fidelity in real-world settings, we recommend administering FCM on an outpatient basis in specific locations like the lying-in-ward or daycare units [71,72,73,74]. Lastly, the SHP need more than an assumption but to be intentional about ascertaining emergency readiness, which is paramount before any IV iron (FCM) administration [36]. Even though the risk of severe adverse reactions to FCM is rare (> 1/10 000 to < 1/1000) [6], SHP need to be aware of the significance of the criticality of such reactions and trained on adequate preparations in case such an eventuality occurs [34].

In our study, we identified the factors that influenced fidelity to FCM in a research setting. Therefore, implementation studies must evaluate adherence to FCM, implement targeted strategies [75] and balance adherence and adaptability in a real-world setting [51]. Our checklists may not have accounted for the unique facility-specific or individualized needs and situations surrounding FCM administration. Thus, future studies on similar assessments should consider this factor to promote the scalability and sustainability of IV iron use and fidelity in Nigeria [48, 76].

Strengths and limitations

To the best of our knowledge, this is the first study in Nigeria to assess and evaluate the fidelity of facilities to IV iron (FCM) administration. We utilized a mixed-method approach through the CFIF guidelines to understand the impact of various factors on the achieved level of fidelity, consistent with the theory of compensatory mechanisms [32]. We established the content validity of our intervention procedure checklist using findings from the literature, including experimental studies, expert agreement and HCP feedback [77]. The triangulation of different data sources improved convergent validity and reliability [78]. Due to this study's pragmatic conduct, we had no control over how the ANC services are delivered in day-to-day practice. However, the intervention was administered in a supplemented environment, which might not have accurately reflected the actual needs relevant to the fidelity of FCM in the present Nigeria healthcare system. Nevertheless, our detailed report enhanced trustworthiness and ease of replicability for future research in similar settings [33, 77]. There is the possibility that the SHP in facilities with high fidelity might have changed their behaviour because they are aware of being observed [79] However, it is unlikely that their awareness influenced the fidelity level throughout the study period due to institutional challenges [33, 78]. Furthermore, because we observed every other FCM administration, SHP may become habituated and less likely to notice being observed. Additionally, there is the possibility of bias in our data collection method [80], the risk of which was reduced by engaging skilled and neutral research assistants.

Conclusions

Our study aimed to evaluate SHP adherence to implementing FCM and identify the factors that influenced this adherence. Our findings revealed that while fidelity levels were moderate generally, they varied across facility types. However, some PHCs, all secondary and tertiary centres that effectively utilized facilitation strategies, had high fidelity. Unfortunately, a few PHCs had low adherence due to intervention complexities and contextual factors. To ensure high fidelity, targeted strategies are necessary, including providing adequate SHP to reduce heavy workloads and patient waiting times and ultimately improve FCM implementation quality. Further research conducted in a real-world setting could help identify and test these facilitation strategies and improve healthcare facilities' adaptability.

Availability of data and materials

The datasets utilized and/or analyzed during the index study will be made available by the corresponding author upon request.

Abbreviations

FCM:

Ferric carboxymaltose

SHP:

Skilled health personnel

PHC:

Primary health centres

IDA:

Iron deficiency anaemia

AIP:

Anaemia in pregnancy

IV:

Intravenous

pH:

Potential of hydrogen

Hb:

Haemoglobin

HICs:

High income countries

LMICs:

Low and middle-income countries

IVON-IV:

Versus oral iron for Iron Deficiency Anaemia in Pregnant Nigerian Women

StaRI:

Standards for Reporting Implementation Studies

CFIF:

Conceptual framework for implementation fidelity

SOP:

Standard operating procedure

REDCap:

Research Electronic Data Capture

IDIs:

In-depth interviews

IC:

Intervention complexities

FS:

Facilitation strategies

QA:

Quality of administration

PR:

Participants responsiveness

C:

Context

IVF:

Intravenous fluid

IQR:

Interquartile range

ANC:

Antenatal care

References

  1. Karami M, Chaleshgar M, Salari N, Akbari H, Mohammadi M. Global Prevalence of Anemia in Pregnant Women: A Comprehensive Systematic Review and Meta-Analysis. Matern Child Health J. 2022;26(7):1473–87.

    Article  PubMed  Google Scholar 

  2. Ugwu NI, Uneke CJ. Iron Deficiency Anemia in Pregnancy in Nigeria-A Systematic Review. Niger J Clin Pract. 2020 [cited 2022 Sep 21];23(7):889–96. Available from: https://pubmed.ncbi.nlm.nih.gov/32620715

  3. WHO. Haemoglobin Concentrations for the Diagnosis of Anaemia and Assessment of Severity. Geneva: WHO; 2011. https://iris.who.int/handle/10665/85839.

  4. Zeisler H, Dietrich W, Heinzl F, Klaritsch P, Humpel V, Moertl M, et al. Prevalence of iron deficiency in pregnant women: A prospective cross-sectional Austrian study. Food Sci Nutr. 2021;9(12):6559–65.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  5. World Health Organization. WHO recommendations on antenatal care for a positive pregnancy experience. 2016 Nov [cited 2022 Nov 9]. Available from: https://www.who.int/publications-detail-redirect/9789241549912

  6. Pavord S, Daru J, Prasannan N, Robinson S, Stanworth S, Girling J. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol [Internet]. 2020;188(6):819–30. Available from: https://www.gradeworkinggroup.org

  7. Benson CS, Shah A, Frise MC, Frise CJ. Iron deficiency anaemia in pregnancy: A contemporary review. Obstet Med. 2021;14(2):67–76. https://doi.org/10.1177/1753495X20932426.

  8. Balarajan Y, Ramakrishnan U, Özaltin E, Shankar AH, Subramanian SV. Anaemia in low-income and middle-income countries. The Lancet. 2011;378(9809):2123–35.

    Article  Google Scholar 

  9. Dhanani JV, Ganguly BP, Chauhan LN. Comparison of efficacy and safety of two parenteral iron preparations in pregnant women. J Pharmacol Pharmacother. 2012;3(4):314–9.

    Article  PubMed  PubMed Central  Google Scholar 

  10. Tolkien Z, Stecher L, Mander AP, Pereira DIA, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: A systematic review and meta-analysis. PLoS ONE. 2015;10(2):e0117383. https://doi.org/10.1371/journal.pone.0117383.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Auerbach M, Gafter-Gvili A, Macdougall IC. Intravenous iron: a framework for changing the management of iron deficiency. Lancet Haematol. 2020;7(4):e342–50. https://doi.org/10.1016/S2352-3026(19)30264-9.

  12. Froessler B, Collingwood J, Hodyl NA, Dekker G. Intravenous ferric carboxymaltose for anaemia in pregnancy. BMC Pregnancy Childbirth. 2014;14(1):115.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Bosede Bukola Afolabi; Ochuwa Adiketu Babah; Titilope A. Adeyemo; Mobolanle Balogun; Aduragbemi Banke-Thomas; Ajibola I. Abioye et al. Intravenous versus oral iron for anaemia among pregnant Nigerian women (IVON): an open-label randomised controlled trial. Lancet Glob Health. 2024.

  14. Pasricha SR, Mwangi MN, Moya E, Ataide R, Mzembe G, Harding R, et al. Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trial. Lancet. 2023; 13;401 (10388): 1595–1609. https://doi.org/10.1016/S0140-6736(23)00278-7.

  15. Akinajo OR, Babah OA, Banke-Thomas A, Beňová L, Sam-Agudu NA, Balogun MR, et al. Acceptability of IV iron treatment for iron deficiency anaemia in pregnancy in Nigeria: a qualitative study with pregnant women, domestic decision-makers, and health care providers. Reprod Health. 2024;21(1):22. https://doi.org/10.1186/s12978-024-01743-y.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Manda-Taylor L, Kufankomwe M, Chatha G, Chipeta E, Mamani-Mategula E, Mwangi MN, et al. Perceptions and experiences of intravenous iron treatment for anaemia in pregnancy in Malawi: a formative qualitative study. Gates Open Res. 2024;8(6):66. https://doi.org/10.12688/gatesopenres.13631.2.

    Article  Google Scholar 

  17. Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, et al. Outcomes for implementation research: Conceptual distinctions, measurement challenges, and research agenda. Administration and Policy in Mental Health and Mental Health Services Research. 2011;38(2):65–76.

    Article  PubMed  Google Scholar 

  18. Pérez D, Van der Stuyft P, Zabala MC, Castro M, Lefèvre P. A modified theoretical framework to assess implementation fidelity of adaptive public health interventions. Implementation Science. 2016;11(1):91.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Toomey E, Hardeman W, Hankonen N, Byrne M, McSharry J, Matvienko-Sikar K, et al. Focusing on fidelity: narrative review and recommendations for improving intervention fidelity within trials of health behaviour change interventions. Health Psychol Behav Med. 2020;8(1):132–51. https://doi.org/10.1080/21642850.2020.1738935.

  20. Afolabi BB, Ogunbode OO, Ezechi OC, Ogu RN, Agboghoroma CO, Aboyeji AP, et al. Management and the Prevention of Anaemia in Pregnancy: SOGON Clinical Practice Guidelines. Trop J Obstet Gynaecol. 2023;41(2):64–9.

    Google Scholar 

  21. Prang KH, Mamani-Mategula E, Verbunt E, Chipeta E, Ataide R, Mwangi M, et al. An implementation research programme to support an intravenous iron intervention for pregnant women with moderate and severe anaemia in Malawi: study protocol. Implement Sci Commun. 2022; 3(1). Available from: https://implementationsciencecomms.biomedcentral.com/articles/https://doi.org/10.1186/s43058-022-00299-x

  22. Ivankova NV, Creswell JW, Stick SL. Using Mixed-Methods Sequential Explanatory Design: From Theory to Practice. Field Methods. 2006;18(1):3–20.

    Article  Google Scholar 

  23. Afolabi BB, Babah OA, Akinajo OR, Adaramoye VO, Adeyemo TA, Balogun M, et al. Intravenous versus oral iron for iron deficiency anaemia in pregnant Nigerian women (IVON): study protocol for a randomised hybrid effectiveness-implementation trial. Trials. 2022;23(1):763. Available from: https://trialsjournal.biomedcentral.com/articles/https://doi.org/10.1186/s13063-022-06690-2

  24. Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, et al. Standards for Reporting Implementation Studies (StaRI): Explanation and elaboration document. BMJ Open. 2017;7(4):e013318.

    Article  PubMed  PubMed Central  Google Scholar 

  25. Ademiluyi IA, Aluko-Arowolo SO. Infrastructural distribution of healthcare services in Nigeria: An overview. Journal of Geography and Regional Planning. 2009;2(5):104–10. Available from: http://www.academicjournals.org/JGRP

  26. National Population Commission Nigeria. National Demographic and Health Survey. Nigeria 2018. The DHS Program. 2018;1–748. Available from: https://dhsprogram.com/pubs/pdf/F

  27. World Health Organization. Trends in maternal mortality 2000 to 2020: estimates by WHO, UNICEF, UNFPA, World Bank Group and UNDESA/Population Division. 2023. Available from: https://www.who.int/publications-detail-redirect/9789240068759

  28. National Bureau Of Statistics. Statistical Report On Women And Men In Nigeria. 2021 Aug. Available from: https://nigerianstat.gov.ng/download/1241062

  29. Ogu RN, Ntoimo LFC, Okonofua FE. Perceptions of women on workloads in health facilities and its effect on maternal health care A multi-site qualitative study in Nigeria A multi-site qualitative study in Nigeria. Midwifery. 2017;55:1–6. https://doi.org/10.1016/j.midw.2017.08.008.

    Article  CAS  PubMed  Google Scholar 

  30. Carroll C, Patterson M, Wood S, Booth A, Rick J, Balain S. A conceptual framework for implementation fidelity. Implement Sci. 2007;2(1):40.

    Article  PubMed  PubMed Central  Google Scholar 

  31. Hasson H. Systematic evaluation of implementation fidelity of complex interventions in health and social care. Implement Sci. 2010;3(5):67. https://doi.org/10.1186/1748-5908-5-67.

    Article  Google Scholar 

  32. Hasson H, Blomberg S, Dunér A. Fidelity and moderating factors in complex interventions: A case study of a continuum of care program for frail elderly people in health and social care. Implement Sci. 2012;7(1):23.

    Article  PubMed  PubMed Central  Google Scholar 

  33. Mowbray CT, Holter MC, Teague GB, Bybee D. Fidelity Criteria: Development, Measurement, and Validation. Am J Eval. 2003;24(3):315–40.

    Article  Google Scholar 

  34. Rampton D, Folkersen J, Fishbane S, Hedenus M, Howaldt S, Locatelli F, et al. Hypersensitivity reactions to intravenous iron: Guidance for risk minimization and management. Haematologica. 2014;99(11):1671–6.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  35. (Ferric carboxymaltose) Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/5910/smpc/print

  36. Drug Safety Update. Intravenous iron and serious hypersensitivity reactions: strengthened recommendations. MHRA. 2013;7(1). https://www.mhra.gov.uk.

  37. Pasricha SR, Mwangi MN, Moya E, Ataide R, Mzembe G, Harding R, et al. Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trial. The Lancet. 2023;401(10388):1595–609.

    Article  CAS  Google Scholar 

  38. Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, et al. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019;95:103208. https://doi.org/10.1016/j.jbi.2019.103208.

  39. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)-A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.

    Article  PubMed  Google Scholar 

  40. Malterud K, Siersma VD, Guassora AD. Sample Size in Qualitative Interview Studies: Guided by Information Power. Qual Health Res. 2016;26(13):1753–60.

    Article  PubMed  Google Scholar 

  41. Moen K, Middelthon AL. Qualitative Research Methods. Research in Medical and Biological Sciences: From Planning and Preparation to Grant Application and Publication. 2015;23:321–78.

    Article  Google Scholar 

  42. McGrath C, Palmgren PJ, Liljedahl M. Twelve tips for conducting qualitative research interviews. Med Teach. 2019;41(9):1002–6.

    Article  PubMed  Google Scholar 

  43. Nurjono M, Shrestha P, Ang IYH, Shiraz F, Yoong JSY, Toh SAES, et al. Implementation fidelity of a strategy to integrate service delivery: learnings from a transitional care program for individuals with complex needs in Singapore. BMC Health Serv Res. 2019;19(1):177.

    Article  PubMed  PubMed Central  Google Scholar 

  44. Ghimire A, Mahendradhata Y, Paudel S, Yonzon CL, Bhuvan KC, Sharma S, et al. Implementation fidelity of tuberculosis preventive therapy for under five children exposed to sputum smear positive pulmonary tuberculosis in Kaski district, Nepal: An implementation research. PLoS ONE. 2022;17(2):e0263967. https://doi.org/10.1371/journal.pone.0263967.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  45. Nowell LS, Norris JM, White DE, Moules NJ. Thematic Analysis: Striving to Meet the Trustworthiness Criteria. Int J Qual Methods. 2017;16(1):1609406917733847.

    Article  Google Scholar 

  46. Byrne D. A worked example of Braun and Clarke’s approach to reflexive thematic analysis. Qual Quant. 2022;56(3):1391–412.

    Article  Google Scholar 

  47. Schoonenboom J, Johnson RB. How to Construct a Mixed Methods Research Design. Kolner Z Soz Sozpsychol. 2017;69(2):107–31.

    Article  PubMed  PubMed Central  Google Scholar 

  48. Durlak JA, DuPre EP. Implementation matters: A review of research on the influence of implementation on program outcomes and the factors affecting implementation. Am J Community Psychol. 2008;41(3–4):327–50.

    Article  PubMed  Google Scholar 

  49. Frykman M, Von Thiele SU, Athlin ÅM, Hasson H, Mazzocato P. The work is never ending: Uncovering teamwork sustainability using realistic evaluation. J Health Organ Manag. 2017;31(1):64–81.

    Article  PubMed  Google Scholar 

  50. Byrne BE, Faiz OD, Bottle A, Aylin P, Vincent CA. A Protocol is not Enough: Enhanced Recovery Program-Based Care and Clinician Adherence Associated with Shorter Stay After Colorectal Surgery. World J Surg. 2021;45(2):347–55.

    Article  PubMed  Google Scholar 

  51. Toomey E, Matthews J, Hurley DA. Using mixed methods to assess fidelity of delivery and its influencing factors in a complex self-management intervention for people with osteoarthritis and low back pain. BMJ Open. 2017;7(8):e015452.

    Article  PubMed  PubMed Central  Google Scholar 

  52. Kladouchou V, Papathanasiou I, Efstratiadou EA, Christaki V, Hilari K. Treatment integrity of elaborated semantic feature analysis aphasia therapy delivered in individual and group settings. Int J Lang Commun Disord. 2017;52(6):733–49.

    Article  PubMed  Google Scholar 

  53. Siner JM, Connors GR. Protocol-Based Care versus Individualized Management of Patients in the Intensive Care Unit. Semin Respir Crit Care Med. 2015;36(6):870–7.

    Article  PubMed  Google Scholar 

  54. Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, et al. A refined compilation of implementation strategies: Results from the Expert Recommendations for Implementing Change (ERIC) project. Implementation Science. 2015;10(1):21.

    Article  PubMed  PubMed Central  Google Scholar 

  55. Strehlenert H, Hedberg Rundgren E, Sjunnestrand M, Hasson H. Fidelity to and Adaptation of Evidence-based Interventions in the Social Work Literature: A Scoping Review. The British Journal of Social Work. 2023; bcad170, https://doi.org/10.1093/bjsw/bcad170

  56. McMahon SA, Muula AS, De Allegri M. “I wanted a skeleton … they brought a prince”: A qualitative investigation of factors mediating the implementation of a Performance Based Incentive program in Malawi. SSM Popul Health. 2018;1(5):64–72.

    Article  Google Scholar 

  57. Kimber M, Barac R, Barwick M. Monitoring Fidelity to an Evidence-Based Treatment: Practitioner Perspectives. Clin Soc Work J. 2019;47(2):207–21.

    Article  Google Scholar 

  58. Cohen DJ, Crabtree BF, Etz RS, Balasubramanian BA, Donahue KE, Leviton LC, et al. Fidelity Versus Flexibility. Translating Evidence-Based Research into Practice. Am J Prev Med. 2008;35(5 Suppl): S381–9. https://doi.org/10.1016/j.amepre.2008.08.005.

  59. Kang S, Das MK, Ajisegiri WS, Abimbola S, Gebresilassie Tesema A, Odusanya OO, et al. ``We just have to help’’: Community health workers’ informal task-shifting and task-sharing practices for hypertension and diabetes care in Nigeria. 2023 Jan. https://doi.org/10.3389/fpubh.2023.1038062.

  60. World Health Organization. World health statistics 2016: monitoring health for the SDGs, sustainable development goals. World Health Organization website (www.who.int) [Internet]. 2016;1–136. Available from: https://www.who.int/docs/default-source/gho-documents/world-health-statistic-reports/world-heatlth-statistics-2

  61. Abimbola S, Olanipekun T, Schaaf M, Negin J, Jan S, Martiniuk ALC. Where there is no policy: governing the posting and transfer of primary health care workers in Nigeria. International Journal of Health Planning and Management. 2017;32(4):492–508.

    PubMed  Google Scholar 

  62. Zurn P, Zapata T, Okoroafor SC. The importance of strengthening the health workforce in Nigeria to improve health outcomes. J Public Health. 2021;43(1):i1–3. https://doi.org/10.1093/pubmed/fdab012.

    Article  CAS  Google Scholar 

  63. Adamu H, Oche M. Determinants of patient waiting time in the general outpatient department of a tertiary health institution in North Western Nigeria. Ann Med Health Sci Res. 2013;3(4):588.

    Article  PubMed  PubMed Central  Google Scholar 

  64. Okonofua FE, Ogu RN, Ntoimo LF, Gana M, Okike ON, Durodola A, et al. Where do delays occur when women receive antenatal care? A client flow multi-site study in four health facilities in Nigeria. Ghana Med J. 2018;52(1):8–14.

    Article  PubMed  PubMed Central  Google Scholar 

  65. Akinyinka MR, Adebayo BI, Wright KO, Adeniran A. Client waiting time in an urban primary health care centre in Lagos. Journal of Community Medicine and Primary Health Care. 2016;28(1):17–24.

    Google Scholar 

  66. Mehjabeen S, Matin M, Gupta R Das, Sutradhar I, Mazumder Y, Kim M, et al. Fidelity of kangaroo mother care services in the public health facilities in Bangladesh: a cross-sectional mixed-method study. Implement Sci Commun. 2021;2(1):115.

  67. Gedlu T, Dessie KG, Birhanu N, Tessema S, Deti T, Mekonnen ZA, et al. Implementation fidelity and challenges of optimal cold chain management in Assossa district health system, Benshangul-Gumuz region, Western Ethiopia. Ethiop. J. Health Dev. 2021;35(SI-3):03-08. https://www.ajol.info/index.php/ejhd/article/view/217884.

  68. Low LL, Rahim FIAB, Hamzah NAR, Ismail MS. Process evaluation of enhancing primary health care for non-communicable disease management in Malaysia: Uncovering the fidelity & feasibility elements. PLoS ONE. 2021;1:16.

    Google Scholar 

  69. Alowais SA, Alghamdi SS, Alsuhebany N, Alqahtani T, Alshaya AI, Almohareb SN, et al. Revolutionizing healthcare: the role of artificial intelligence in clinical practice. BMC Med Educ. 2023;23:689. https://doi.org/10.1186/s12909-023-04698-z.

    Article  PubMed  PubMed Central  Google Scholar 

  70. Federal Ministry Of Health. Task-Shifting And Task-Sharing Policy For Essential Health Care Services In Nigeria Federal Ministry Of Health. 2014 Aug. http://www.health.gov.ng/doc/TSTS.pdf

  71. Barrera M and SD. “Implementation of an Outpatient Iron Infusion Clinic: Alternative Approach to Treat Iron Deficiency Anemia in Pregnancy”. 2020. Available from: https://digitalcommons.fiu.edu/cnhs-studentprojects/4

  72. Kriplani A, Mahey R, Dash BB, Kulshreshta V, Agarwal N, Bhatla N. Intravenous iron sucrose therapy for moderate to severe anaemia in pregnancy. 2013. Available from: https://pubmed.ncbi.nlm.nih.gov/24056559

  73. Calvet X, Ruíz MÀ, Dosal A, Moreno L, López M, Figuerola A, et al. Cost-Minimization Analysis Favours Intravenous Ferric Carboxymaltose over Ferric Sucrose for the Ambulatory Treatment of Severe Iron Deficiency. PLoS One. 2012;7(9):e45604.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  74. Lucas S, Garg M. Intravenous iron: an update. Intern Med J. 2024;54(1):26–34. https://doi.org/10.1111/imj.16184.

    Article  CAS  PubMed  Google Scholar 

  75. Curran GM, Landes SJ, McBain SA, Pyne JM, Smith JD, Fernandez ME et al. Reflections on 10 years of effectiveness-implementation hybrid studies. 2022 Dec. Available from: https://www.frontiersin.org/articles/https://doi.org/10.3389/frhs.2022.1053496/full

  76. Grooten L, Fabbricotti IN, Devroey D, Vrijhoef HJM. Assessment of the implementation fidelity of a strategy to scale up integrated care in five European regions: a multimethod study. BMJ Open. 2020;10(3):e035002.

    Article  PubMed  PubMed Central  Google Scholar 

  77. Feely M, Seay KD, Lanier P, Auslander W, Kohl PL. Measuring Fidelity in Research Studies: A Field Guide to Developing a Comprehensive Fidelity Measurement System. Child Adolesc Soc Work J. 2018;35(2):139–52.

    Article  Google Scholar 

  78. Sprange K, Mountain G, Craig C. Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: A randomised controlled trial. BMJ Open. 2021;11(4):e043478.

    Article  PubMed Central  Google Scholar 

  79. Horner S, Rew L, Torres R. Enhancing Intervention Fidelity: A Means of Strengthening Study Impact. J Spec Pediatr Nurs. 2006;11(2):80–9. https://doi.org/10.1111/j.1744-6155.2006.00050.x.

    Article  PubMed  PubMed Central  Google Scholar 

  80. Girard JM, Cohn JF. A Primer on Observational Measurement. Assessment. 2016;23(4):404–13.

    Article  PubMed  PubMed Central  Google Scholar 

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Acknowledgements

We sincerely appreciate the IVON trial team, the research assistants, and the pregnant women for their support and hard work.

Funding

Open access funding provided by Karolinska Institute. The main trial titled “Intravenous versus oral iron for iron deficiency anaemia in pregnant Nigerian women (IVON)” is an open-label, randomized controlled trial funded by the Bill & Melinda Gates Foundation (BMGF) Grant (Investment ID INV-017271).

Author information

Authors and Affiliations

  1. Department of Obstetrics and Gynaecology, Lagos University Teaching Hospital, Lagos, Idi-Araba, Nigeria

    Opeyemi R. Akinajo, Ochuwa A. Babah & Bosede Bukola Afolabi

  2. Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden

    Opeyemi R. Akinajo, Kristi Sidney Annerstedt & Ochuwa A. Babah

  3. Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

    Opeyemi R. Akinajo, Ochuwa A. Babah & Lenka Beňová

  4. Department of Obstetrics and Gynaecology, Faculty of Clinical Sciences, College of Medicine, University of Lagos, Lagos, Idi-Araba, Nigeria

    Opeyemi R. Akinajo, Ochuwa A. Babah & Bosede Bukola Afolabi

  5. Centre for Clinical Trials and Implementation Science (CCTRIS), College of Medicine, University of Lagos, Lagos, Idi-Araba, Nigeria

    Opeyemi R. Akinajo, Aduragbemi Banke-Thomas, Ochuwa A. Babah, Mobolanle R. Balogun & Bosede Bukola Afolabi

  6. Maternal, Adolescent, Reproductive and Child Health (MARCH), Centre, London School of Hygiene and Tropical Medicine, London, UK

    Aduragbemi Banke-Thomas

  7. Brooks Insights Limited, Abuja, FCT, Nigeria

    Chisom Obi‑Jeff

  8. Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK

    Chisom Obi‑Jeff

  9. International Research Center of Excellence, Institute of Human Virology Nigeria, Abuja, Nigeria

    Nadia A. Sam-Agudu

  10. Global Pediatrics Program and Division of Infectious Diseases, Department of Pediatrics, University of Minnesota Medical School, Minneapolis, Minnesota, USA

    Nadia A. Sam-Agudu

  11. Department of Community Health & Primary Care, College of Medicine, University of Lagos, Lagos, Nigeria

    Mobolanle R. Balogun

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  1. Opeyemi R. Akinajo
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  2. Kristi Sidney Annerstedt
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  9. Bosede Bukola Afolabi
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Contributions

ORA, BBA, KSA, AB-T and LB were involved in the conceptualization of the research ideas, reviewed and approved the research title and proposal, and supervised the research. NASA, OAB and MRB were involved in conceptualizing the IVON trial project ideas and protocol writing. ORA, KSA and AB-T were involved in developing interview guides. ORA was involved in training research assistants and data collection. ORA and COJ coded the qualitative dataset. ORA, AB-T, KSA, COJ, LB and BBA performed and interpreted data analysis. ORA, NASA, OAB and MRB were involved in research monitoring activities. NASA mentored ORA in the implementation science aspect of the IVON trial. BBA was the Principal Investigator of the IVON trial from which this study was extracted. ORA prepared the research manuscript under the supervision of KSA, AB-T, LB, and BBA, with contributions from COJ, NASA, OAB, and MRB. All authors endorsed the last version of the manuscript for publication.

Corresponding author

Correspondence to Opeyemi R. Akinajo.

Ethics declarations

Ethics approval and consent to participate

Ethical approval was obtained from National (NHREC/01/01/2007- 17/01/2021), Lagos State (LSHSC/2222/VOLIII), Kano State (MOH/Off/797/T.1/2102), Health Research and Ethics Committees of the Lagos University Teaching Hospital (ADM/DCST/HREC/APP/3971), and Aminu Kano Teaching Hospital, Kano State (NHREC/28/01/2020/AKTH/EC/2955). Verbal consent was taken from all participants before each interview.

Consent for publication

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Akinajo, O.R., Annerstedt, K.S., Banke-Thomas, A. et al. Implementation fidelity of intravenous ferric carboxymaltose administration for iron deficiency anaemia in pregnancy: a mixed-methods study nested in a clinical trial in Nigeria. Implement Sci Commun 5, 81 (2024). https://doi.org/10.1186/s43058-024-00609-5

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Implementation Science Communications

ISSN: 2662-2211