Alternative Treatments for Recurrent Bacterial Vaginosis

Alternative Treatments for Recurrent Bacterial Vaginosis
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Alternative Treatments for Recurrent Bacterial Vaginosis
Women are constantly at risk for bacterial vaginosis (BV), especially during their reproductive years (Buttaro, Trybulski, Polgar-Bailey, & Sandberg-Cook, 2017). BV is caused by changes in the vaginal flora caused mainly by anaerobic bacteria (Onderdonk, Delaney, & Fichorova, 2016). However, the cause of the microbial change is not fully understood causing a reduction in treatment efficacy (Sobel et al., 2019). Intrauterine uterine devices (IUDs), douching, and sexual intercourse are said to increase the risk of recurrent BV (Bilardi et al., 2016). In developed countries, approximately 10 to 30% of heterosexual women are affected by BV, while the prevalence in bisexual women ranges between 20 and 50% (Marshall, 2015). Healthcare providers have heavily relied on oral metronidazole for the standard treatment of care for BV (Heczko et al., 2015). Intravaginal route is another method of metronidazole administration for treating BV. The route of administration is usually selected based on the patient’s insurance coverage and patient’s preference (Heczko et al., 2015). Failed treatments from both oral and intravaginal metronidazole resulted in re-emergence of BV shortly after therapy was discontinued (Sobel et al., 2019). Studies have shown that after BV treatment with oral or intravaginal metronidazole 50–70% of women experience recurrence within 4–6 weeks and almost 70% within 90 days (Hakimi et al., 2018). The purpose of this paper is to analyze treatment options for BV and identify the best alternative medication regimens to prevent recurrent BV after failed treatment with both either oral and intravaginal metronidazole.
BV occurs when an anaerobic bacterium enters the vaginal area and replicates. Large quantities of the bacterium replace Lactobacillus, a normal hydrogen peroxide- producing protective organism, causing a low number of Lactobacillus in the vagina (Marshall, 2015). When bacterial flora alters the pH in the vagina and increases the pH above 4.5, symptoms develop. The anaerobe bacteria then release amines which produces a “fishy” malodorous thick vaginal discharge, which is more distinct after sexual intercourse and during menses because of the alkaline nature of semen and blood (Buttaro et al., 2017). Although BV is not considered a sexually transmitted infection (STI), BV is considered sexually associated (Buttaro et al., 2017). The inefficiency of oral metronidazole has caused women to repeatedly suffer from the malodorous symptoms of BV causing themselves to isolate themselves because of feelings of embarrassment resulting from a strain on their self-esteem and sexual relationships (Bilardi et al., 2016). Frustration is commonly felt, as the condition typically recurs within one to two months after treatment for many women (Buttaro et al., 2017). Women suffer not only physically, but also emotionally during the presence of this condition and frustration increases with each reoccurrence. The high prevalence among women showcases the significance of analyzing BV and finding effective methods for treating as well as preventing recurrence after the first occurrence.
In addition to the disturbing physical and emotional symptoms of BV, there are other negative effects of recurrent BV. Repeated treatments can become very costly and cause a financial burden (Peebles, Velloza, Balkus, McClelland, & Barnabas, 2019). For example, women with BV are at increased risk for acquiring human immunodeficiency virus (HIV) and certain STIs such as gonorrhea, chlamydia, and herpes simplex virus type 2 (Buttaro et al., 2017). The cost of treatment of linked conditions associated with BV such as HIV and STIs would further put a woman into a financial burden. Untreated HIV and STIs can be very detrimental to one’s health. According to Bilardi et al. (2016), the reoccurrence rate of BV is nearly 50% and there is a gap in the research to determine if sexual intercourse is the leading cause of reoccurrence in BV. Other negative outcomes are linked to BV include miscarriages and pre-term delivery (Rani, Rao, Grisha, Sharma, & Usha, 2017). BV negatively affects women in a multitude of ways that become very overwhelming to cope with because it affects them physically, socially, and psychologically. The need to identify and analyze other treatment options that could lead to successful treatment of BV after the initial treatment is needed for better patient outcomes and decrease recurrence rates.
The potential value of seeking possible alternative regimens that will aid the reduction of the reoccurrence rate of BV after failed treatment with oral or intravaginal metronidazole will benefit women worldwide. This project would highly benefit women repeatedly affected by BV, potential women that may encounter this recurrent condition, and healthcare providers. Healthcare providers will be to help their patients with this challenging condition in hopes of better patient outcomes and patient satisfaction. The approach of finding alternatives treatments will benefit healthcare providers and national health bodies to realize a reduced prevalence of BV and associated conditions such as HIV, STIs, miscarriages and preterm births (Rani et al., 2017). Finding alternative treatments that reduce recurrence will contribute to achieving national health goals and better outcomes for patients. This review of the literature will address the following research question in PICO format: In women with recurrent bacterial vaginosis, what is the best alternative treatment method in comparison to failed oral and intravaginal metronidazole therapy to decrease recurrence?
Theoretical Framework
The Theory of Uncertainty of Illness created by Merle Mishel (1990) will be the primary theoretical framework that will inform and serve as a guide in this literature review. The theory consists of four primary components: antecedents generating uncertainty, coping with uncertainty, appraisal of uncertainty and adaption to the illness (Zhang, 2017). According to Mishel (1990), antecedents of uncertainty include patterns of disease symptoms, familiarity with the disease, and congruency. The Theory of Uncertainty of Illness further embodies considering the cognitive capacity of the patients which include the provision of information by healthcare professionals because a new diagnosis of bacterial vaginosis can result in uncertainty when patients are not familiar with the condition; for example, symptoms and treatment options or when their anticipation is not consistent with the experience. Uncertainty influences how a patient interprets the illness (Mishel, 1990).
With regard to the appraisal of uncertainty, the stressor or disease can be perceived as danger or opportunity, which may influence patients coping strategies. When the stressor is seen as a danger, this affects the outcome negatively and vice versa regarding an opportunity. Coping is both mental and physical effort that a patient contributes towards the management of the bacterial vaginosis disease (Clayton, Dean, & Mishel, 2018). When the uncertainty is perceived as an opportunity, patients use buffering strategies such as selective ignoring and neutralization, which change their appraisal of uncertainty, leading to better medical outcomes (Zhang, 2017). Finally, adaptation is a component in Mishel’s theory that focuses on the ability of a patient to achieve a new balance and adjust to the new illness-related experience. With effective coping strategies, Mishel argues that adaptation to the illness is achieved successfully (Mishel, 1990). Similar to other patients, individuals with bacterial vaginosis show high levels of uncertainty and increased physical symptoms. As such, the theory will be used to organize the rationale regarding the best treatment method for decreasing the recurrence of this disease.
Alternative Treatments for Recurrent Bacterial Vaginosis
Methods
This literature review is based on quality studies obtained from CINAHL, EMBASE, PUBMED, Cochrane Library, and MEDLINE. Keywords used for the search of the articles include bacterial vaginosis, recurrence, metronidazole, treatment, and alternative. Inclusion criteria were article that were: peer-reviewed, within the past five years, primary research, about the treatment of recurrent BV, and written in English. Exclusion criteria included articles that are first occurrence of BV and successful treatments of metronidazole. The scholarly project focused on the research of nine quantitative articles and one qualitative article. The clinical outcomes from various studies explored for alternative treatment for recurrent BV will be synthesized, and recommendations on the best method will be provided. Findings from this research are essential for health care providers as they help in the identification of the most effective strategy that can be used to ensure safety and quality care for patients with BV.
Synthesis of Literature
This review proposes the use of evidence-based research to investigate and determine an ultimate intervention method that is needed to treat and prevent BV. The goal of the literature review is to synthesize and compare the outcomes from the reviews, and thus, determine the most effective intervention method for treating and preventing the recurrence of BV.
High Dose Treatments. Vitamin D is an essential component to one’s body regarding the immune system, as it acts as a stimulant in the elimination of pathogens and immune response. Low levels of vitamin D have been linked to the increasing prevalence of BV; a study done by Turner et al. (2015) examined the effect on women taking high supplementation of vitamin D concurrently with oral metronidazole for the treatment of BV. About 90% of African American, Hispanic, and Asian women are found to be below the recommended levels of the U.S. Institute of Medicine (IOM) and postulated that this contributed to their lowered immune system ability to defend against BV. Additionally, the study (Turner et al., 2015) focused on African American, Hispanic, and Asian women with the hypothesis that increasing their vitamin D levels would prevent them from reoccurring BV. However, the high dose of vitamin D supplementation showed no effect in the decrease of recurrent BV, and only showed higher levels of vitamin D (Turner et al., 2015).
Sobel et al. (2019) used high dose intravaginal metronidazole to treat recurrent BV after failed treatment with standard of care of oral metronidazole. The use of high dose intravaginal metronidazole therapy in the treatment of BV did not significantly improve reoccurrence rates compared to oral metronidazole therapy. The high dose intravaginal metronidazole treatment led to a slightly longer remission period of 10 days after a women’s menstrual cycle in 68% amongst its sample group. After the completion of a high dose of metronidazole treatment, 83% of the reoccurrence of BV occurred post menses (Sobel et al., 2019). The increased reoccurrence showed that menses has a significant impact on the reoccurrence of BV. Additionally, those women with longer menstrual cycles had a higher rate of reoccurring BV, irrespective of the high dose metronidazole and standard of care treatment. While high dose metronidazole has a higher remission rate than the standard of care oral metronidazole therapy, it was still ineffective in preventing recurrence (Sobel et al., 2019).
A similar approach was done by McClelland et al. (2015) who examined the dual therapy of high-dose intravaginal metronidazole and miconazole. Miconazole is an antifungal that is commonly used to treated other vaginal infections such as vulvovaginal candidiasis (VCC) and has shown effectiveness in reducing the reoccurrence of VCC when used weekly. This study examined if the monthly use of a combined intravaginal suppository of metronidazole 750 mg and miconazole 200 mg for a year, which acted as a suppressive regimen of BV recurrence. The dual regimen did show a reduction in the reoccurrence of BV within 12 months. Also, the adverse effects of the treatment were considered low; for example, only 14 side effects of respiratory infection occurred compared to 24 in their placebo treatment. The use of high dose intravaginal metronidazole and miconazole is an effective and safe alternative to use to suppress the recurrence of BV over a prolonged period (McClelland et al., 2015). However, this study did not show if recurrence occurred after the 12-month treatment stopped, making it hard to distinguish if this is an effective treatment of decreasing recurrence rate.
The use of high dose intravaginal metronidazole therapy contributes to improving recurrent rates; however, this treatment regimen only prolongs remission up to ten days (Sobel et al., 2019) while the combination therapy of high dose intravaginal metronidazole and miconazole (McClelland et al., 2015) has better efficacy due to its effective duration of 12 months. The use of high dose vitamin D treatment showed zero prevention of BV reoccurrence when using high dose therapy treatment (Turner et al., 2015). Additionally, oral metronidazole is known as the standard of care for BV at this time, however, it is associated with a 69-80% recurrence rate within 12 months (Sobel et al., 2019). Promotion of using intravaginal metronidazole administration versus oral administration may be favorable for alternative treatments when used to treat and prevent the reoccurrence of BV, as it has shown to be beneficial, as seen with high dose intravaginal metronidazole and when combined with other treatment methods, such as miconazole, the effectiveness of treatment increases in BV (McClelland et al., 2015). Therefore, more studies need to determine if there is a preferred route for metronidazole administration for better effectiveness when treating BV.
Probiotics. Probiotics inhibit the growth of harmful bacteria as they act to enhance the immune system with their antioxidant, detoxifying, and anti-inflammatory properties. The use of intravaginal probiotics in the treatment of recurrent BV to decrease recurrent rates was studied by Hakimi et al., 2018). The administration of intravaginal probiotic gel with adjuvant oral metronidazole tablets and was shown to improve the efficacy of treatment of BV. The use of daily intravaginal probiotic gel (Trifolium vag) and oral metronidazole tablets three times per day for seven days was studied by Hakimi et al. (2018). Comparing the prebiotic gel and placebo groups in terms of satisfaction with treatment showed 94% in the intervention group were satisfied and 6% were dissatisfied in the control group after 90 days of initial treatment (Hakimi et al., 2018). This treatment therapy not only resulted in satisfying results from participants but also was demonstrated as an effective treatment of recurrent BV over a longer period of at least three months compared to one to two months with the standard metronidazole. The intervention group that used the prebiotic intravaginal gel with adjuvant oral metronidazole recorded a 76% probability of preventing the re-emergence of BV. As well as the probiotic component, the direct application of the prebiotic intravaginal treatment versus oral route was more effective in reducing recurrence (Hakimi et al., 2018).
In another study done by Bohbot et al. (2018) a different probiotic, Lactobacillus crispatus, was studied in the treatment of reoccurring BV. L. crispatus was prepared and inserted vaginally for 14 days for a duration of two menstrual cycles. The use of L. crispatus significantly reduced the reoccurrence of BV by 79.5% compared to the placebo and increased the time before the recurrence of BV by 28% (Bohbot et al., 2018). Along with the previous study with intravaginal probiotics (Hakimi et al., 2018), the use of probiotics has shown effective results decreasing the recurrence rate of BV with a longer remission period of at least three months compared to one to two months with the standard metronidazole.
The use of probiotics has many beneficial effects on health. Studies about oral probiotics like Bacillus coagulans done by Rani et al. (2017) and prOVag done by Heczko et al. (2015) demonstrated lowered the recurrent rates of BV. Probiotics have an efficiency rate ranging from 75%- 87% in treating and preventing the reoccurrence of BV (Rani et al., 2017). The researchers from the study done by Rani et al. (2017) analyzed the use of probiotic B. coagulans in the reduction of BV reoccurrence. Metronidazole and metronidazole with B. coagulans were compared and found that metronidazole + B. coagulans had a higher success rate of 86.6% in preventing the reoccurrence of BV. Probiotics greatly enhance the treatment of recurrent BV and significantly reduced the symptoms associated with the disease. Although other studies of intravaginal route administration (Sobel et al., 2019; McClelland et al., 2015) showed more effectiveness than the oral administration, oral metronidazole with oral B. coagulans treatment was also still effective (Rani et al., 2017).
The addition of probiotics significantly improved the ability of the standard oral metronidazole therapy to prevent the reoccurrence of BV (Rani et al., 2017; Heczko et al., 2015). The supplementation of probiotics of prOVag containing 3 strains of Lactobacillus strains was examined when used simultaneously with oral metronidazole. The supplementation PrOVag led to reduced pH levels and increased the number of Lactobacillus, resulting in a decrease reoccurrence rate of 76% in BV (Heczko et al., 2015). The study consisted of 578 participants (Heczko et al., 2015), making it a larger sample size than similar studies. The use of targeted probiotics enhances the treatment of BV and reduces its reoccurrence significantly.
The literature review has shown that the use of oral metronidazole therapy alone is ineffective in preventing the reoccurrence of BV. However, probiotics, together with metronidazole, has a higher efficiency rate of preventing the re-emergence of bacterial vaginosis. Probiotic B. Coagulans had an 86.6% success rate (Rani et al., 2017), prOVag probiotics had a 76% efficiency (Heczko et al., 2015), and probiotic vaginal gel had a 76% efficacy (Hakimi et al., 2018). Advanced Practice Nurses (APNs) and other healthcare providers can recommend the administration of these probiotics along with metronidazole to treat and prevent bacterial vaginosis re-emergence.
Herbal. The use of herbal therapy has been used for alternative treatments for a variety of medical conditions like cardiovascular and women’s health. Garlic contains allein, a protective barrier with antibacterial effects. When that protective barrier gets crushed, allein gets converted to allicin which disrupts oxidation of thiol group of bacteria enzymes and the synthesis of bacterial RNA, proteins, and enzymes. Oral preparations of garlic have found to be as effective as metronidazole when in the treatment of the STI, trichomonas vaginalis (Mohammadzadeh, Dolatian, Jorjani, Majd, & Borumandnia, 2015). Also, garlic preparation vaginal cream was found to be effective in the treatment of vaginal candidiasis (Mohammadzadeh et al., 2015). In this particular study, the addition of garlic tablets was used twice a day for seven days with oral metronidazole and examined its effects in the treatment of reducing the recurrence rate of BV (Mohammadzadeh et al., 2015). The study revealed showed lower side effects due to garlic’s natural properties. Garlic supplementation tablets had an efficacy rate of 63.3% compared to standard oral metronidazole therapy and also revealed a significant improvement of 70% in reducing the reoccurrence of BV compared to the standard oral metronidazole alone (Mohammadzadeh et al., 2015). Herbal medications continue to gain popularity as they continue to demonstrate beneficial effects in the treatment of medical conditions.
Myrtus communis is an herbal plant that has been used to treat herpes and inflammation of nasal passages and has shown to also inhibit the growth Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli (Masoudi, Kopaei, & Miraj, 2016). The use of metronidazole intravaginal gel consisting of Myrtus (Myrtus communis) extract for the treatment of BV was studied to identify its effects on the treatment of recurrent BV (Masoudi et al., 2016). The use of combined metronidazole intravaginal gel with Myrtus extract daily for five-days was more effective than using metronidazole alone. The use of metronidazole intravaginal gel alone had a 30% recurrence rate of BV within three weeks of completion of treatment. The combination of metronidazole intravaginal gel and Myrtus extract reduced the reoccurrence of bacterial vaginosis by 70% compared to oral metronidazole. This herbal supplementation revealed its effectiveness in the reduction rates of BV due to its antibacterial, anti-inflammatory, and analgesic component. Additionally, the studies done by Hakimi et al.(2018) and Masoudi et al. (2016) have shown that metronidazole alone was ineffective in preventing the re-emergence of bacterial vaginosis and that additional treatment of probiotic and Myrtus can help reduce the reoccurrence rate of BV.
Critique of the Literature
APNs need to use the current best practice when caring for patients. The skills to determine whether a research article is a credible source and if its applicability to practice are essential to clinical practice. Knowing how to critique an article is fundamental for APNs as it helps in determining whether the research is robust and reliable. An article written by Coughlan et al. (2007) offers a systematic approach for quantitative research review that APNs apply to demystify processes, decode terminologies, and adequately critique an article. Whereas the article by Coughlan et al. (2007) focuses on critiquing a qualitative article, the authors note that there are fundamental differences in approach to research between quantitative and qualitative data. Coughlan et al. (2007) suggest that evaluating the two research methods demands diverse approaches. This critique will cover both quantitative and qualitative reviews.
Quantitative Literature
Coughlan et al. (2007) will be used as a guide to critiquing nine quantitative studies. Below are the elements influencing the credibility, integrity, and robustness of a research.
Purpose/research problem. The purpose of a study guides researcher on what they should address in a study (Coughlan et al., 2007). The step helps in setting a base for the consecutive steps during quantitative analysis. The purpose of the studies was identified in all nine studies. The researchers analyzed the prevalence of BV and alternative treatments after failed medication either through oral or intravaginal metronidazole. The researchers evaluated the effect of the intervention of the study and its effect on treating recurrent BV. Bohbot et al. (2018) and Masoudi et al. (2016) focused on the effects of intravaginal probiotics, while Hakimi et al. (2018) looked at the effects of intravaginal prebiotics with adjunct oral metronidazole. McClelland et al. (2019) examined the effect of high dose intravaginal combinations of metronidazole and miconazole. In contrast, Sobel et al. (2019) studied the effects of high dose intravaginal metronidazole. The use of oral probiotics was studied by Heczko et al. (2015) and Rani et al. (2017); however, Rani et al. (2017) added adjunct oral metronidazole. Other researchers, such as Mohammadzadeh et al. (2015), delved into the use of garlic and oral metronidazole, while Turner et al. (2015) studied a high supplementation dose of vitamin D in the treatment of recurrent BV.
Logical consistency. Coughlan et al. (2007) stipulated that quantitative critique must analyze the logical consistency in the study. All nine studies had good flow; the logical consistencies of the studies were clear and linked, starting with an abstract, to the introduction, the purpose of the study, literature review, methodology, results, discussion, and conclusion. All nine studies were well organized and had headings and subheadings to guide readers.
Literature review. The literature review segments of all of the nine studies under review demonstrated an appropriate depth and breadth of BV. Each study offered a balanced analysis of the literature, except Sobel et al. (2019) and McClelland et al. (2019), who discussed the literature minimally. Therefore, in these articles, the reader must research further to understand the concepts being studied. Meanwhile, Bohbot et al. (2018) effectively compared several other clinical studies regarding the use of probiotics and L. crispatus to justify or support the need for the study. The other seven studies presented supportive details of the topic of research and compared and contrasted similar studies to identify research gaps. The majority of the studies mentioned in the literature review were published within the last five years. However, some articles included were published over eight years ago, such as those of Heczko et al. (2015), Masoudi et al. (2016), McClelland et al. (2019), Turner et al., 2015, and Rani et al. (2017). According to Coughlan et al. (2007), the use of old references may be necessary when there is a lack of research and to give the article some historical information and present data. All the articles used about 20-30 sources in their literature review, except for the study done by Rani et al. (2017), who only used eight articles, and of those eight articles, four being 18, 19, 24, and 26 years old. All studies except Rani et al. (2017) used mainly primary sources in their literature review. The other eight studies utilized secondary data, scholarly journals, government publications, and academic books. All nine studies provided keywords to conduct their search, but none of the articles mentioned information about which databases were consulted. The two of the nine studies (Sobel et al., 2019; McClelland et al., 2019) did not provide a rich introduction with keywords to grasp the reader’s attention, compared to the other seven studies.
Theoretical framework. The theoretical framework is used as a guide for a study to set boundaries (Coughlan et al., 2007). None of the quantitative studies discussed a theoretical framework in their research. The purpose of a theoretical framework is to guide a researcher in identifying the connection between variables and highlighting potential gaps. Consequently, all nine studies might have missed critical explanations and directions.
Aims/objectives/research question/hypotheses. Based on Coughlan et al. (2007), the use of the aims, objectives, research questions, and hypotheses are dependent upon the type of research. These terms can also refer to the purpose of the research or research problem and can include aims and objectives as well. The study conducted by Mohammadzadeh et al. (2015) specifically had a section with its subheading “objectives” that explained the objectives of the study. All nine studies clearly stated the aims or purposes which were consistent with my PICO question of: In women with recurrent bacterial vaginosis, what is the best alternative treatment method in comparison to failed oral and intravaginal metronidazole therapy to decrease recurrence? All nine studies focused on an alternative treatment for BV after failed treatment with metronidazole.
Sample. In the nine articles, the target population was identified. Participants were recruited from a clinic or hospital setting. All participants had a history of recurrent BV from failed treatment through the standard oral or intravaginal metronidazole. Seven of the nine studies adopted probability sampling because they were randomized investigations, and the other two were prospective studies (Rani et al., 2017; Sobel et al., 2019). Sample sizes were calculated using 80% power (Bohbot et al., 2018; McClelland et al., 2019; Mohammadzadeh et al., 2015; Turner et al., 2015). The two of the prospective studies (Rani et al., 2017; Sobel et al., 2019) based their sample size on participants who tested positive for recurrent BV. The study by Masoudi et al. (2016) did not clarify the sample size. The study done by Hakimi et al. (2018) had the fewest number of participants (44), followed by Masoudi et al. (2016), whose sample size was 80; Sobel et al. (2019) had 90 participants. The studies may have overly represented a small subgroup of the target population because of having a small sample size (Coughlan et al., 2007). The highest number of participants was 578 in the study done by Heczko et al. (2015), and all of the other studies had a sample size ranging between 120-234 participants. The majority of the studies had large sample sizes that reduce the risk of errors (Heczko et al., 2015; Sobel et al., 2019; Masoudi et al., 2016; McClelland et al., 2019; Turner et al., 2015; Rani et al., 2017).
Inclusion and exclusion criteria were clearly stated in each study. All of the articles had the same inclusion criteria; participants were heterosexual women aged between 18 and 45. Other studies had additional inclusion where participants had to be married (Hakimi et al., 2018; Masoudi et al., 2016), HIV seronegative (McClelland et al., 2019), and agreeing to several restrictions during the study like to abstain from sex and alcohol 24-48 hours following each treatment (McClelland et al., 2019; Sobel et al., 2019). All articles presented extensive exclusion criteria, with several studies listing about 20 and more specific criteria (Hakimi et al., 2018; McClelland et al., 2019; Heczko et al., 2015; Mohammadzadeh et al., 2015; Sobel et al., 2019). Typical exclusion criteria among all nine studies are not limited to pregnancy, breastfeeding, and current antibiotic use.
Ethical considerations. Ethical consideration is a critical practice, especially in cases where humans are participants. According to Coughlan et al. (2007), a credible quantitative review must concentrate on the moral principles of the study. The moral principles include autonomy, beneficence, justice, and non-maleficence. In all nine studies, participants signed consent forms; however, they did not mention whether independence was not granted. The study by McClelland et al. (2019) had their participants signed a second consent once they were eligible and agreed to enroll in the trail. None of the studies discussed if confidentiality was broken. Not all participants were protected from harm; two studies mentioned harm to their respondents. The research by Turner et al. (2015) stated adverse effects from the high supplementation of vitamin D. Adverse effects included dry mouth, vaginal discharge, and itching in the control group. In Hakimi et al. (2018), the prebiotic gel group, 30% reported suprapubic pain, but in the placebo group, 8% reported suprapubic pain. All of the research clearly stated their study were granted permission either by an ethics committee (Bohbot et al., 2018; Heczko et al., 2015; Masoudi et al., 2016; Mohammadzadeh et al., 2015; Rani et al., 2017), research committee (Hakimi et al., 2018; McClelland et al., 2019), or by the Institutional Review Board (Sobel et al., 2019; Turner et al., 2015).
Operational definitions. Indeed, to allow readers to understand the concept of the study entirely, the authors must define terms and concepts used in the research. All of the nine articles explained specific terms and ideas that are essential for their study and linked those terms throughout the study. For example, the authors must explain the four Amsel’s criteria to understand how a participant is diagnosed with BV. Each of the nine articles explained this term in detail to allow readers to have basic knowledge of the topic being studied.
Methodology. Each study clearly stated the research design. The articles included eight randomized blind (single, double, and triple) studies (Bohbot et al., 2018; Hakimi et al., 2018; Heczko et al., 2015; Masoudi et al., 2016; McClelland et al., 2019; Mohammadzadeh et al., 2015; Turner et al., 2015). Five studies were controlled clinical trials (Heczko et al., 2015; Masoudi et al., 2016; McClelland et al., 2019; Mohammadzadeh et al., 2015; Turner et al., 2015). Two of the nine studies were cohort studies (Bohbot et al., 2018; Heczko et al., 2015). Three of the nine were prospective studies (Bohbot et al., 2018; Rani et al., 2017; Sobel et al., 2019). One pilot study was done by Sobel et al. (2019).
Data collection. As mentioned by Coughlan et al. (2007), questionnaires are the most common method of data collection and was adopted by Masoudi et al. (2016), McClelland et al. (2019), Mohammadzadeh et al. (2015), and Turner et al. (2015). Hakimi et al. (2018) stated the questionnaires focused on demographic and obstetrics history. All nine studies used clinical examination that included vaginal swabbing at follow up visits as the preferred method of data collection. Besides, Bohbot et al. (2018) used telephone calls to gather data to determine the compliance of medications. Turner et al. (2015) used blood draws to collect data as well.
Instrument design. There were several instrument designs mentioned in the nine studies. For example, a common instrument used in the studies was the Amsel’s criteria. The Amsel criteria are applied in diagnosing bacterial vaginosis. The criteria are deemed particularly helpful in situations where the diagnostician’s microscopic experience, time, or availability of microscope tools may be a limiting factor. Masoudi et al. (2016) effectively outlined how the use of the Amsel’s criteria diagnosed BV. After the treatment, a study was administered and participants were instructed to have a follow-up visit in the clinic or hospital for vaginal swabbing by speculum. The contents from the vaginal swabbing would then be tested to diagnosis the presence of BV by meeting at least three of the four Amsel’s criteria. The Amsel’s criteria include the following four: homogenous vaginal discharge, vaginal ph >4.5, positive amine tests findings, and the presence of clue cells in wet smear observed under microscopy (Heczko et al., 2015). The lack of the four Amsel criteria or the presence of only one criterion was indicted the treatment’s success. The study by Bohbot et al. (2018) used the contents from the vaginal swab and used a scale called the Nugent score to determine the diagnosis of BV. However, in this study, minimal information about the Nugent score was mentioned; only information mentioned about the Nugent scale was a score of seven confirmed the diagnoses of BV (Bohbot et al., 2018). Gram-staining was also used by Heczko et al. (2015) and McClelland et al. (2019), in which both studies outlined each step of the process.
Validity/reliability. In this regard, to ensure accurate results, the instruments used in research must be valid and reliable. Coughlan et al. (2007) explain validity as an instrument having the ability to measure properly, and reliability refers to the instrument’s ability to consistently and accurately measure phenomena. For example, in the study by Heczko et al. (2015) was conducted in several clinical centers in southern Poland using the same protocol to ensure the study consistency. The research by Mohammadzadeh et al. (2015) provided a good explanation of how validity and reliability were tested in the study. To achieve the test validity of questionnaires and checklists was applied. Besides, to achieve observation validity, a researcher was trained by microbiologists, who confirmed the diagnosis. To determine intra-observer reliability, Kappa statistics were used for measuring agreement. Moreover, to determine pH meter reliability, five samples were prepared by a research unit, and PH was measured with the same results. McClelland et al. (2019) showed that all laboratory staff passed the Microbicide Trial Network vaginal wet preparation proficiency test before the start of the study and annually after to ensure proper handling of instruments to get accurate results.
Data analysis and results. According to Coughlan et al. (2007), data analysis remains one of the complex sections of quantitative research because it analyses data collected using the compound language. There are different tactics, which are crucial in ensuring that readers can understand the language applicable and can find the answers to the study questions. The articles utilized different data analysis methods. The studies done by McClelland et al. (2019) and Sobel et al. (2019) used tests, such as the Mantel-Haenszel, Fisher’s exact unpaired, and ANOVA tests.
Coughlan et al. (2007) stated at least 50% of the sample is required to be included in a study to avoid bias and serves as an essential element in considering generalizability in research. In the study by Bohbot et al. (2018), the response rate was 92%, 100% in Hakimi et al. (2018), 27% in Heczko et al. (2015), 93% in McClelland et al. (2019), 86% in Mohammadzadeh et al. (2015), 61% in Sobel et al. (2019), and 53% in the study done by Turner et al. (2015). Two studies (Masoudi et al., 2016; Rani et al., 2017) did not state the number of participants that completed the study.
In the results section, Heczko et al. (2015) confirmed BV/AV microbiologically in 241 participants, who continuously undertook the trial. The study showed that prOVag significantly lengthened the duration for clinical relapse of BV/AV signs and symptoms up to 51%. Besides, probiotic utilization also maintained and reduced low Nugent and vaginal pH score, as well as increased vaginal Lactobacillus counts based on standard treatment. Mohammadzadeh et al. (2015) reported that Amsel’s criteria were considerably reduced after treatment with metronidazole or garlic. Therapeutic effects realized from garlic on BV were the same as those of metronidazole. Significant differences were noted between garlic and metronidazole as far as side effects are concerned; metronidazole was linked to more complications. Rani et al. (2017) reported that oral supplementation with probiotics could be an efficient treatment approach for BV. Prolonged oral therapy would be effective regardless of vaginal ascension, intestinal passage, and growth of lactobacilli needing a long time. Masoudi et al. (2016) showed significant differences resulting from therapeutic responses; the results revealed that the combination of M. communis and metronidazole had higher efficiency. On the other hand, Sobel et al. (2019) reported that HDM realized short-term remission in 68% of patients, which recurred after SOC. Patients having prolonged dybiosis before symptomatic recurrence had a higher likelihood of recurrence after subsequent HDM. Hakimi et al. (2018) found no significant differences between the two groups as far as social and personal characteristics, laboratory markers, or clinical complaints. Healing rate on the 10th day based on Nugent and Amsel criteria was 30% in the control group and 76% in the intervention group. Turner et al. (2015) revealed that BV prevalence among women given vitamin D was considerably similar to the placebo between the 4th and 12th weeks. Vitamin D supplementation reduced BV recurrence. Bohbot et al. (2018) showed that during the treatment period, 41% of the patients had at least a recurrence in the placebo group against 20.5% in the Lc group. All the results from the nine articles under review are well presented and informed by rich data gathered by the researchers. The section is properly linked to the adopted methodology and delineates results from the intervention and control groups. There is a clear attempt to contrast and compare outcomes from the control and the intervention groups in their treatments. The results are consistent with known facts about BV and add value to treatment and management of vaginosis across different populations.
Discussion. Each of the nine articles linked the literature review and purpose of the study. In the studies by Heczko et al. (2015), McClelland et al. (2019), and Rani et al. (2017), the hypothesis was supported by the study. For example, Heczko et al. (2015) hypothesized the use of oral probiotic with oral metronidazole would reduce the recurrence rates of BV and this was proved. Strengths, limitations, future research, or implications were not discussed in Bohbot et al. (2018), Heczko et al. (2015), and Masoudi et al. (2016). Only strengths and limitations were included in Hakimi et al. (2018), yet these were minimal, with no supporting details. Turner et al. (2015) expressed that one of the strengths of their study in that it differs from many interventions relying on self-reports, which reflected in the blood levels that were drawn. Mohammadzadeh et al. (2015) only discussed one strength of the study that the use of the herbal alternative is a possible alternative for the treatment of recurrent BV. Rani et al. (2017) discussed limitations, including the study being preliminary with a small number of participants and an open trial. Implications of the study by Rani et al. (2017) included when treating BV; clinicians should consider not just the physical symptoms, but also the distressing psychosocial frustration experienced by women. Sobel et al. (2019) discussed future research and limitations, such as a single geographic site of enrollment and a disproportionally low percentage of Caucasian participants; hence, the study is not generalizable. McClelland et al. (2019) discussed the strengths, limitations, and future research. In addition to McClelland et al. (2019), the inclusion of both high-risk women and general population women from Africa and North America supports the generalizability of the findings. The study McClelland et al. (2019) also concluded to be safe, well-tolerated, and significantly reduced the recurrence of BV.
References. All nine studies listed their references accurately and acknowledged every source used in the paper to enhance academic integrity. The references were organized on a different page, and all critical information about the authors, study titles, names of journals, volumes, and page-ranges were indicated appropriately.
Qualitative Literature
According to Coughlan et al. (2007), qualitative analysis is more challenging to critique compared to quantitative research but still crucial for APNs to have the skills to explore credibility. The article by Coughlan et al. (2007) exemplifies the step by step critique of qualitative research and has been used to critique the study done by Bilardi et al. (2016).
Statement of the phenomenon of interest. In the study, the researchers failed to articulate their phenomenon of interest clearly. A novice to research may not know the definition of the phenomenon of interest, which entails what researchers to understand, predict, explain, or describe. There was no research question stated in the study.
Purpose/significance of the study. The purpose of the study is stated clearly: To explore women’s recurrent BV management approaches and clinical care experiences to inform and improve the clinical management of BV.
Literature review. A literature review was done that discussed in detail basic foundational knowledge of BV, current issues of BV recurrences, and standard treatment of BV, which were all supported with sources from the literature review. The literature review consisted of 34 sources, many of which are from medical journals, making it a well-researched topic. The majority of the sources were published within the last five years, but a few sources dated 22 years ago. However, the information from these sources gave the study a historical context. The literature review focused on studies exploring women’s experiences in the clinical management of BV and the use of other remedies meeting the philosophical underpinnings of the research, which also help build the robustness.
Theoretical framework. A social constructionist approach was chosen as the framework for the study. This theoretical framework is an appropriate approach as social constructionism attempts to address the nature of reality (Andrews, 2012). In this study, the experiences of women were explored concerning realities of recurrent BV. Unfortunately, the framework was not described.
Method and philosophical underpinnings. The philosophical approach was identified as the use of semi-structured interviews to allow women to share their personal experiences of recurrent BV, management, as well as exploring clinical areas of interest. In this regard, semi-structured interviews, which are a fixed set of questions with no pre-determined responses, were utilized (Grove et al., 2015). Semi-structured interviews were used to allow the researchers to collect specific data needed for the study while enabling participants to share their thoughts, ideas, and perceptions of their experiences of recurrent BV and clinical management of BV.
Sample. The sample method and size were clearly stated. Women were purposively sampled to allow for a broad sample of women, including heterosexual, single women in a relationship, women who had experienced high and low numbers of current BV and women from several recruitment locations. Purposive sampling was appropriate for this study. Purposive sampling focuses on insight, description, and understanding of a phenomenon with selected participants, and permits researchers to gain an in-depth understanding of experiences (Grove et al., 2015). Thirty-five women participated in the study. Women suitable for informing research were aged between 18 and 45 years old, had two or more occurrences of BV in the past five years, and can read and write English.
Ethical considerations. All 35 women in the study were provided with consent in plain language to be read and sign or give verbal consent if the interview was done via telephone. Verbal consent was then recorded for record-keeping. There was no information on whether participants were given the nature of the research, except the participants were given the consent form, which was not detailed either. There was nothing stating participants were harmed in any way by the study or confidentially was broken. There was no statement about how the researchers obtained the confidentiality of the participants. The Alfred Hospital Ethics Committee granted ethical permission.
Data collection/data analysis. Women were recruited from the largest sexual health clinic in Victoria, Australia, and high case loaded clinics. Data collection was done by face to face or telephone interviews, and asking 15 semi-structured questions about demographic, sexual behavior, diagnosis, and treatment before seeking responses regarding their knowledge of BV of their first diagnosis of BV versus their subsequent diagnoses of BV. Then questions regarding experiences of their first versus recurrent experiences, the impact of BV of them on an emotional, social, sexual, work, and religious standpoint were also asked. Lastly, questions about beliefs of the causes of BV, use of any home remedies, use of antibiotics, and clinical management of BV were included. All interviews were conducted within three months. The strategies used to analyze the data were stated clearly. For example, thematic analysis and data coded using primarily segmented approaches were used for data analysis. Transcripts were imported into a program for data management, and other transcripts were evaluated individually by two researchers to verify coding and themes. The software was used to analyze demographic, sexual history, and diagnosis and treatment data. Saturation was not stated in the study. Saturation is met when additional sampling provides no new information, only redundancy of collected data, which indicates their sample size could have been more appropriate once saturation was reached to determine adequate data. Through saturation, the researchers could have been reasonably assured that extended data gathering would produce the same results, as well as confirm emerging conclusions and themes. In this context, when a researcher claims the collection of enough information to realize study purpose, they ought to report when, how, and the extent to which saturation is achieved.

Trustworthiness. Trustworthiness was established in the study by having the interviews transcribed into transcripts. Having transcripts will allow other researchers to audit and follow the researcher to the findings.
Trustworthiness in the documentation. There is a correlation between the research steps and the aim of the study. The study follows in a logical manner starting from introduction, methods, ethics statement, synopsis of methods, results, discussion, strengths, limitations, and future implications to keep the reader guided.
Procedural trustworthiness. The researchers use purposive sampling to give a broad sample of participants from a population to reduce bias. The researchers also used semi-structured interviews to gain in-depth information to minimize misinterpretations.
Ethical rigour. Confidential was taken into consideration in the study when sharing specific quotes by participants in the results. These participants were labeled as “participant #, age.” No other information was used for identification. However, no other methods of confidentiality were mentioned in the study, which is a weakness of the study.
Credibility. Credibility was illustrated through common themes analyzed by the researchers from the interviews of the 35 participants. For example, when women were asked about women’s experience of clinical management of BV, common answers included insensitive/dismissive attitudes, misdiagnosis and inappropriate diagnostic approaches, no advice, and frustration. Besides, the authors provided numerous direct quotes from participants proving the themes analyzed by the researchers are consistent and relatable.
Dependability. The steps of the study would be challenging to reproduce if another researcher was to follow the study because minimal information was given about the data analysis. However, having transcripts allows researchers to audit and follow the steps of the research and draw similar conclusions. The overall findings would still conclude with a negative experience of recurrent BV.
Transferability. The findings of this study can be applied outside the context of the study situation because even though its focus is aimed at a specific condition and experience, it can apply to other people experiencing other health conditions with high recurrence rates owing to the fact failed treatments with no alternative treatments have yet been determined. One of the implications of this study is for clinicians to not only treat physical symptoms but as well as psychosocial as chronic conditions can take a toll on one’s mental health.
Confirmability. The study did not mention that an audit trail was conducted, so other researchers cannot agree that the author’s conclusions are logical. Only when other researchers can review the audit trail, they can agree with the author’s conclusions (Grove et al., 2015). However, transcripts were made and analyzed for data, which the researchers can demonstrate how they arrived at their conclusions and interpretations of the research.
Goodness. The principle of goodness can be found in all stages of this study, as supported by the literature review, data collection, results, and discussion. This principle allowed this study to become more robust. Even the aim of the study is appropriate since it seeks to improve the clinical management of BV.
Findings/discussion. The findings of the study were presented appropriately. The findings were represented in multiple themes with supportive data from the research. Also, numerous direct quotes from participants were provided in each theme. The findings supported what was already known about the phenomenon and supportive of the other studies mentioned in the literature review of women’s experiences of recurrent BV. The original purpose of the study had been adequately addressed and also concluded additional detailed information on women’s experiences of recurrent BV. For example, the various home remedies women used to treat symptoms of BV were extensive like salt and vinegar baths, internal and external use of yogurt, garlic, and inserting tampons soaked in various products. Although, in the end, these self-help remedies were not successful in treating BV, they were done because participants did not have good experiences with clinical management.
Conclusions/implications and recommendations. The importance and implications of the findings were identified. For example, gaining a better understanding of women’s experiences and management of BV allows the opportunity to improve clinical management and diagnostic approaches. Another implication is to increase the understanding among clinicians of the psychosocial impact of recurrent BV on women’s lives will go a long way toward addressing concerns of BV. Another implication mentioned was the use of evidence-based advice regarding the use of home remedies as some of the remedies mentioned in the study can be damaging to the body. There were no recommendations stated in the study of how the research findings can be developed.
References. The sources used in the research were accurately referenced. The references are listed alphabetically and all information included. The sources consulted by the researchers are relevant and duly acknowledged.
Gaps in the Literature
The literature showed that the primary cause of bacterial vaginosis is anerobic bacteria, but the cause of microbial alteration has not been identified making successful treatment of recurrent BV challenging (Bilardi et al., 2016). Multiple studies showed revealed of the use of probiotics as adjunct therapy has a remarkable reduction of recurrent bacterial vaginosis. The use of probiotic therapy may be used in the future, however, no specific probiotic has been recommended for standard use (Marshall, 2015). More studies are needed to show significant evidence to determine which probiotic(s) are the most effective in the treatment of recurrent BV. Studies also need to distinguish whether the use of oral or intravaginal probiotics effect efficacy in treatment of recurrent BV. Since recurrent rates occurs within just weeks after initiation of treatment of metronidazole additional studies are needed to conclude if the use of probiotics alone are effective enough to replace the standard treatment of metronidazole or probiotics are recommended to be used as an adjunct and if probiotic use is to be administered only during active treatment or for long-term therapy prophylactically to reduce the recurrence of BV (Sobel et al., 2019).
Oral administration of metronidazole surpasses the digestive system and ascend into the infected vaginal area, which I believe to reduce its efficiency and strength in combating bacterial vaginosis allowing the bacterium to survive and later regenerate, leading to a second reoccurrence (Sobel et al., 2019). Concerns of oral metronidazole of being inefficient due to the pathway the medication has to travel reaching the targeted area, while the direct application of intravaginal metronidazole alone increased the efficiency of recurrence (Masoudi et al., 2016). There is a need to compare the efficacy of different routes medication administration of oral versus intravaginally therapy in decreasing recurrence rate of BV. Furthermore, it was found that increasing the dose of the metronidazole drug in high dose metronidazole intravaginally therapy still showed returned of BV symptoms within 10 days post menses (Sobel et al., 2019). Compared to conventional oral metronidazole therapy, the intravaginal route of drug administration remarkably decreased the reoccurrence of bacterial vaginosis (Sobel et al., 2019). Currently both routes of administration are acceptable methods of treatment, however, there is no preferred route, more evidence is needed if one route is more effective over the other. Additionally, if studies determine there is a preferred route, further studies are needed if the preferred route has same efficacy in all women or is there an exception with women who has a history of frequent vaginal infections, STIs, HIV, births, miscarriages, weight, race, vaginal hygiene, and sex practices. There are many more factors that needs to be further evaluated when determining the best alternative treatment to minimize the recurrence rate of BV. More studies need to further evaluate whether if replacing metronidazole or adding an adjunct therapy with metronidazole is the best treatment for decreasing recurrence in BV.
Implications for Further Research
The Implication for Nursing Practice
The literature review has shown that the use of conventional oral metronidazole therapy alone is ineffective in preventing the reoccurrence of bacterial vaginosis. However, probiotics, together with metronidazole, has a higher efficiency rate of preventing the re-emergence of bacterial vaginosis. Probiotic B. Coagulans had an 86.6% success rate (Rani et al., 2017), prOVag probiotics had a 76% efficiency (Heczko et al., 2015), and probiotic vaginal gel had a 76% efficacy (Hakimi et al., 2018). Advanced Practice Nurses (APNs) and other healthcare providers can recommend the administration of these probiotics along with metronidazole to treat and prevent bacterial vaginosis re-emergence.
The research showed the importance of healthcare providers following up with the patients to ensure signs of re-emergence are detected and treated early. The literature review showed many studies focused on the physical symptoms or discomfort of bacterial vaginosis and overlook the psychosocial sequel women go through. Therefore, APNs and other healthcare providers should acknowledge one’s mental well-being. It is recommended that APNs should have a good understanding of the management of BV and have more compassion with women experiencing recurrence of BV to improve better patient outcomes (Bilardi et al., 2016). The literature review also detailed that bacterial vaginosis led to social changes such as isolation (Bilardi et al., 2016). Primary care offices, women’s health offices, and OBGYN offices should create awareness on the bacterial vaginosis disease and how it affects not only physically, but also psychosocially. The approach will significantly contribute to the women’s social acceptance and reduced stigmatization irrespective of the embarrassing symptoms.
Conclusion
The paper focused on investigating the best treatment method in comparison to metronidazole to decrease recurrence in women with recurrent bacterial vaginosis. Bacterial vaginosis affects a large number of women during their reproductive age. The disease is caused by the alteration of the vaginal flora that leads release of amines which causes a fishy foul odor discharge. Previous studies have shown that after BV treatment with metronidazole 50–70% of women experience recurrence within 4–6 weeks and almost 70% within 90 days (Hakimi et al., 2018). Although healthcare providers perceive BV as a minor condition, it is very common. With recurrence rates very high, women become very frustrated due to the challenges of recurrence in nature which impacts their emotional, sexual, and social lives (Rani et al., 2017). Therefore, APNs and healthcare provider must acknowledge all effects BV has in their patients from a physical and emotional standpoint. APNs and other healthcare providers can educate their patients about the pathophysiology of BV and to recommend safe practices to help prevent BV, such as the harmful effects of douching, use perfume soaps, and engaging in safer sex practices.
Metronidazole has been used as the standard of treatment, however due to its high reoccurrence rate brings concerns whether if metronidazole alone is still the best treatment option available. BV has been linked with increased linked of HIV, STIs, miscarriages, and pre-term deliveries, so the need for alternative treatments is imperative to prevent reoccurrence (Rani et al., 2017). This review of the literature investigated the use of a variety of treatments such as high dose of vitamin D and metronidazole, a variety of probiotics, and herbal supplements such as Myrtus plant and garlic to detect if these treatment regimens decreases the recurrence in BV. Based on the review of the literature the use of probiotics appears have the most remarkable effect on decreasing recurrent rates of BV. However, the use of probiotics is said offer the best additional treatment option (Rani et al., 2017). There is a need for more studies to focus on the use of probiotics focusing on probiotics replaces standard metronidazole or use an adjunct therapy. With many probiotics available, determination on the best probiotic needs be further studied along with the which route of administration if most effective. Furthermore, if this the use of probiotics is appropriate for all women despite their histories of infections, comorbidities, history of given birth, race, and weight. Bacterial vaginosis remains a challenging condition to treat with its high recurrence shortly after failed treatment with metronidazole causing women with great frustration. With ongoing studies, the determination of a better treatment for recurrent BV in the near future.
 
References
Andrews, Tom. (2012). What is social constructionism? Grounded Theory Review: An International Journal, 11(1)
Buttaro, T.M., Trybulski, J., Polgar-Bailey, & Sandberg-Cook, J. (2017). Primary care: A collaborative practice (5th edition). St. Louis, MO: Elsevier.
Bilardi, J., Walker, S., McNair, R., Mooney-Somers, J., Temple-Smith, M., Bellhouse, C., & Bradshaw, C. (2016). Women’s management of recurrent bacterial vaginosis and experiences of clinical care: A qualitative study. PLoS One, 11(3), e0151794.
Bohbot, J.M., Darai, E., Bretelle, F., Brami, G., Daniel, C., & Cardot, J.M. (2018). Efficacy and safety of vaginally administered lyophilized lactobacillus crispatus IP 174178 in the prevention of bacterial vaginosis recurrence. Journal of Gynecology Obstetrics and Human Reproduction, 47(2), 81-86.
Clayton, M.F., Dean, M., & Mishel, M. (2018). Theories of uncertainty in illness. Middle Range Theory for Nursing, 49-82.
Coughlan, M., Cronin, P., & Ryan, F. (2007). Step-by-step guide to critiquing research. Part I: Quantitative research. British Journal of Nursing, 16(2), 658-663.
Grove, S., Gray, J, & Burns, N. (2015) Understanding nursing research building an evidence- based practice. St. Louis, MO. Elsevier Saunders.
Hakimi, S., Farhan, F., Farshbaf-Khalili, A., Dehghan, P., Javadzadeh, Y., Abbasalizadeh, S., & Khalvati, B. (2018). The effect of prebiotic vaginal gel with adjuvant oral metronidazole tablets on treatment and recurrence of bacterial vaginosis: A triple-blind randomized controlled study. Archives of Gynecology and Obstetrics, 297(1), 109-116.
Heczko, P.B., Tomusiak, A., Adamski, P., Jakimiuk, A.J., Stefański, G., Mikołajczyk-Cichońska, A., & Strus, M. (2015). Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: A randomised, double-blind, placebo-controlled trial. BMC Women’s Health, 15(1). doi:10.1186/s12905-015-0246-6
Marshall, A.O. (2015). Managing recurrent bacterial vaginosis: Insights for busy providers. Sexual Medicine Reviews, 3(2), 88-92.
Masoudi, M., Kopaei, M.R., & Miraj, S. (2016). A Comparison of the efficacy of metronidazole vaginal gel and myrtus (myrtus communis) extract combination and metronidazole vaginal gel alone in the treatment of recurrent bacterial vaginosis. Journal of Phytomedicine, 7(2), 129-136. doi:10.7860/jcdr/2016/17211.7392
McClelland, R.S., Balkus, J.E., Lee, J., Anzala, O., Kimani, J., Schwebke, J., & Kavak, L. (2015). Randomized trial of periodic presumptive treatment with high-dose intravaginal metronidazole and miconazole to prevent vaginal infections in HIV-negative women. Journal of Infectious Diseases, 211(12), 1875-1882. doi:10.1093/infdis/jiu818
Mishel, M.H. (1990). Reconceptualization of the uncertainty in illness theory. Image: The Journal of Nursing Scholarship, 22(4), 256-262.
Mohammadzadeh, F., Dolatian, M., Jorjani, M., Alavi Majd, H., & Borumandnia, N. (2015). comparing the therapeutic effects of garlic tablet and oral metronidazole on bacterial vaginosis: A randomized controlled clinical trial. Iranian Red Crescent Medical Journal, 16(7). doi:10.5812/ircmj.19118
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Onderdonk, A.B., Delaney, M.L., & Fichorova, R.N. (2016). Human microbiome during bacterial vaginosis. Clinical Microbiology Reviews, 29(2), 223-238. doi:10.1128/cmr.00075-15
Peebles, K., Velloza, J., Balkus, J.E., McClelland, R. S., & Barnabas, R.V. (2019). High global burden and costs of bacterial vaginosis: A systematic review and meta-analysis. Sexually Transmitted Diseases, 46(5), 304-311.
Plummer, E., Garland, S., Bradshaw, C., Law, M., Vodstrcil, L., Hocking, J., &Tabrizi, S. (2017). Molecular diagnosis of bacterial vaginosis: Does adjustment for total bacterial load or human cellular content improve diagnostic performance? Journal of Microbiological Methods, 133, 66-68. doi:10.1016/j.mimet.2016.12.024
Rani, V.U., Rao, S.R., Grisha, P., Sharma, A.V., & Usha, M.S. (2017). The efficacy of probiotic B. coagulans (SNZ-1969) tablets in the treatment of recurrent bacterial vaginosis. International Journal of Probiotics and Prebiotics, 12(4).
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Scholarly Project, Part 2

Directions:

1. To complete the NUR 820 Scholarly Project, Part 2 the student will:
a. Explore qualitative and/or quantitative methods used for evidence-based practice
b. Synthesize clinical nursing knowledge
c. Translate research findings into practice settings.
2. This scholarly project will be in the form of an integrative review, systematic review, or other scholarly project approved by the faculty advisor.
3. The student’s scholarly work must demonstrate the following:
a. A succinctly articulated analysis and synthesis of the topic that addresses a problem relevant to the Advanced Practice Nurse in the primary care or outpatient setting
b. Clear presentation of the methodological approach taken and critique of the found primary sources, and other peer-reviewed evidence (meta-syntheses, meta-analyses, Cochrane collection)
4. The following sections will be included:
a. Title:
i. Clear and concise title reflective of the research focus.
b. Abstract
c. Introduction:
i. Based on evidence and leading to the research topic includes a statement of the research problem, the purpose of the study, rationale for the study, potential value of the study, and a clearly stated research question using PICO(T) format.
d. Theoretical Framework:
i. The student describes the theory used to organize their thinking about the issue and serves as a conceptual context for the study.
e. Synthesis of the Literature:
i. In the literature review, the student demonstrates a strong grasp of the knowledge of the existing literature in the research area of interest by synthesizing and integrating selected articles.
f. Critique of the Literature
g. Gaps in the Literature
h. Implications for Further Research
i. Implications for Practice
j. Conclusion:
i. The paper concludes with a summary of the paper, findings from the evidence, and thoughts about the topic of paper.
a. Final Submission:
i. Title
ii. Introduction
iii. Theoretical Framework
iv. Synthesis of the Literature
v. Critique of the Literature
vi. Gaps in the Literature
vii. Implications for Further Research
viii. Implications for Practice
ix. Conclusion
5. Must be written in APA 6th ed. guidelines.
6. No minimum or maximum length to this assignment. Value quality versus quantity!
7. Refer to the course syllabus for the late policy on written assignments.

Student: ____________________________________________________

Faculty: ____________________________________________________ Date: ____________________

Scholarly Project, Part 2
Final Submission Rubric
Criteria Exemplary Acceptable
Needs Improvement Comments
Abstract
Abstract is a succinct paragraph clearly describing all elements of the project. Abstract is concise and clearly reflects the focus of the scholarly project
(5 pts) Abstract reflects the focus of the paper. Abstract does not adhere to APA format.
(3-4 pts)
Abstract does not reflect the focus of the scholarly paper.
(0-2 pts)
Title
Title reflects the main idea of the paper and variables under investigation Title is concise and clearly reflects the focus of the scholarly paper. Title adheres to APA format.
(5 pts)

Title reflects the focus of the paper. Title does not adhere to APA format.
(3-4 pts) Title does not reflect the focus of the scholarly paper.
(0-2 pts)
Introduction
A clearly articulated introduction based on evidence and leading to the research topic. The introduction also includes the following:
• A statement of the research problem
• The purpose of the study
• Rationale for the study
• Potential value of the study
• Clearly stated research question using PICO(T) format
A clear, comprehensive introduction to the topic including all required elements.
(5 pts) Superficial introduction to the topic. All required elements present.
(3-4 pts) Lacks an introduction or introduction is incomplete.
(0-2 pts)

Theoretical Framework
Describe a theory used to organize thinking about the topic and serves as a conceptual context for the study.
Accurate and thorough description of a theory that aligns with the context of the scholarly paper.
(10 pts)

Superficial description of a theory. Theory aligns with the context of the scholarly paper.
(5-9 pts) Theoretical framework absent, or is not linked to the focus of the paper
(0-4 pts)
Critique of the Literature
• A comprehensive critical analysis of the rigor of selected studies that is according to the recommended Qualitative, Quantitative, and/or Mixed-Methods critique guidelines.

Exemplary work is comprehensive and includes all required elements outlined in the rubric and demonstrates a strong understanding of research concepts.
(20 pts)

Acceptable work includes all required elements outlined in the rubric, minimal or no bias, is clearly articulated, and demonstrates basic knowledge of the content area.
(10-19 pts) Work needing improvement or unacceptable lacks required elements, is poorly articulated, and demonstrates bias and/or limited knowledge of content area.
(0-9 pts)
Synthesis of Literature
• Project type is clearly identified or other approved scholarly project format.
• Describe types of studies used in the review; specify search strategies
• Identify how the quality of studies was evaluated; describe approach to analysis of studies.
• Theoretical framework identified and application to project described.
• Synthesize common themes.
• Discuss evidence in terms of the original research question, the research problem, and the theoretical framework.
• Draws inferences from the results of synthesis.
• Articulates overall conclusions from the body of literature on the research topic.
Exemplary work is comprehensive and includes all required elements outlined in the rubric, is clearly articulated, is bias-free, and demonstrates a strong understanding of the content area.
(20 pts)

Acceptable work includes all required elements outlined in the rubric, minimal or no bias, is clearly articulated, and demonstrates basic knowledge of the content area.
(10-19 pts) Work needing improvement or unacceptable lacks required elements, is poorly articulated, and demonstrates bias and/or limited knowledge of content area.
(0-9 pts)
Gaps in the Literature
• Discussion occurs concerning gaps in the research literature (i.e., areas that has not yet been explored or is under-explored.
• This could be a population or sample (size, type, location, etc.), research method, data collection and/or analysis, or other research variables or conditions. Exemplary work is comprehensive and includes all required elements outlined in the rubric, is clearly articulated, is bias-free, and demonstrates a strong understanding of the content area.
(5 pts)
Acceptable work includes all required elements outlined in the rubric, minimal or no bias, is clearly articulated, and demonstrates basic knowledge of the content area.
(3-4 pts) Work needing improvement or unacceptable lacks required elements, is poorly articulated, and demonstrates bias and/or limited knowledge of content area.
(0-2 pts)
Implications for Further Research
• Discussion occurs concerning the impact that your synthesis of the literature might have on future research or policy decision. Exemplary work is comprehensive and includes all required elements outlined in the rubric, is clearly articulated, is bias-free, and demonstrates a strong understanding of the content area.
(5 pts)

Acceptable work includes all required elements outlined in the rubric, minimal or no bias, is clearly articulated, and demonstrates basic knowledge of the content area.
(3-4 pts) Work needing improvement or unacceptable lacks required elements, is poorly articulated, and demonstrates bias and/or limited knowledge of content area.
(0-2 pts)
Implications for Practice
• Discussion occurs concerning the impact that your synthesis of the literature might have upon individuals who work in your field of study.
• Implications for practice also involve discussing how information from your study might be delivered to practitioners Exemplary work is comprehensive and includes all required elements outlined in the rubric, is clearly articulated, is bias-free, and demonstrates a strong understanding of the content area.
(5 pts)
Acceptable work includes all required elements outlined in the rubric, minimal or no bias, is clearly articulated, and demonstrates basic knowledge of the content area.
(3-4 pts) Work needing improvement or unacceptable lacks required elements, is poorly articulated, and demonstrates bias and/or limited knowledge of content area.
(0-2 pts)
Conclusion
• Remind the reader of the purpose
of the paper, summarize the main
points, and inform the reader of
the significance (the take-away) of the paper.

A comprehensive conclusion that synthesizes the content of the paper and demonstrates the importance of the topic and contents of the paper.
(5 pts)

The conclusion includes all required elements but lacks detail, or some required elements are missing.
(3-4 pts)
Lacks a conclusion, or conclusion not clear.
(0-2 pts)

Academic Standards
• Ideas are arranged logically, they flow smoothly from one to another, and they are clearly linked to each other. Headings are used and the reader can easily follow the line of reasoning.
• Scholarly writing includes use of APA format and correct grammar, spelling, and writing mechanics. APA formatted paper is well-organized with use of Level 1 and Level 2 headings. Rules of grammar, punctuation, and sentence structure are followed. Spelling is correct and professional language is used. Required sources are appropriately cited and referenced
(10 points)
Generally, well written and organized with few grammatical, punctuation, spelling, sentence structure, and/or APA errors. Required sources are appropriately cited and referenced.
(5-9 points)

Poorly organized or lacks headings. Numerous grammatical, punctuation, spelling, and sentence structure errors. Poor use of APA format. Lacks required sources.
(0-4 points)

Total: