Evidence-Based Project Part 3 Critical Appraisal of Research

Critical Appraisal Tool Worksheet Template

Evaluation Table

Use this document to complete the evaluation table requirement of the Module 4 Assessment, Evidence-Based Project, Part 4A: Critical Appraisal of Research

Evidence-Based Project Part 4A Critical Appraisal of Research

Full APA formatted citation of selected article. Article #1 Article #2 Article #3 Article #4
Fiellin, D., Pantalon, M., Chawarski, M., Moore, B., Sullivan, L., O’Connor, P., & Schottenfeld, R. (2006). Counseling plus Buprenorphine-Naloxone Maintenance Therapy for Opioid Dependence. The New England Journal of Medicine, 355(4), 365–374. https://doi.org/https://doi org.ezp.waldenu

library.org/ 10.1056/NEJ

Moa055255

Joe, G. W., Simpson, D., Dansereau, D. F., & Rowan Szal, G. A. (2001). Relationships between counseling rapport and drug abuse treatment outcomes. Psychiatric Services, 52(9), 1223–1229. https://doi.

org/ps psychiatry

online org.ezp.

waldenulib

rary.org/doi/f ull/10.1176/appi.

ps.52.9.1223

Maglione, M. A., Raaen, L., Chen, C., Azhar, G., Shahidinia, N., Shen, M., Maksabedian, E., Shanman, R. M., Newberry, S., & Hempel, S. (2018). Effects of medication-assisted treatment (mat) for opioid use disorder on functional outcomes: A systematic review. Journal of Substance Abuse Treatment, 89, 28–51. Garland, E., Hanley, A., Kline, A., & Cooperman, N. (2019). Mindfulness-Oriented Recovery Enhancement reduces opioid craving among individuals with opioid use disorder, and chronic pain in medication-assisted Treatment: Ecological momentary assessments from a stage 1 randomized controlled trial. Drug & Alcohol Dependence, 203 61–65.

https://doi.

org/ezp.wa ldenulibrary.

org/10.10 16/j.drugalcdep.2019 .07.007

Evidence Level *(I, II, or III)  Level I Level III Level II Level I
Conceptual Framework Describe the theoretical basis for the study (If there is not one mentioned in the article, say that here).** There is no identified conceptual framework. The purpose of this study was to look at the relationship between counselor rapport and drug misuse treatment results. What are the effects of medication-assisted therapy for opiate use disorder on functional outcomes compared to waitlist, placebo, treatment without medication, or any other comparator such as naltrexone? There is no identified conceptual framework.
Design/Method Describe the design and how the study was carried out (In detail, including inclusion/exclusion criteria). The experiment was a randomized controlled study that continued for twenty-four weeks. The chi-square test, a statistical analysis, was also employed to evaluate variations as required in the research study. This study used a mixed-method approach. According to a urine test, the researchers are able to estimate the frequency of illicit opiate use recurrence as well as the maximum number of consecutive weeks of abstinence. Inclusion-All patients fulfilled the requirements for opioid dependency, and opioid-agonist maintenance therapy was abode by all patients.Exclusion- Patients who were dependent on drugs, alcohol, and suicidal ideation, clinical depression, or psychosis were all eliminated. Because the study included two cohorts of patients, the research approach employed in this study was quantitative. A statistical analysis utilizing logistic equations showed the importance of counselor rapport as a predictor of drug use and delinquency concerning treatment retention in the index. Therapy, treatment and satisfaction was obtained following the index treatment.

Inclusion-

Two cohorts of patients hospitalized for outpatient methadone therapy were included in the study.

Thirty randomized controlled trials and ten clinical studies met the inclusion criteria after a thorough search and 1521 full-text publication screenings. Inclusion criteria: Adults 18 years or older. Exclusion criteria: Pregnant women This study’s research technique was a hybrid method. The researchers utilized randomized clinical trials and ecological momentary assessments (EMA). Ecological Momentary Assessment (EMA) gathers data via real-time accounts of daily events. OUD and chronic pain participants (N = 30) were indiscriminately allocated to conventional therapy for eight weeks. Each participant underwent up to 112 random EMA evaluations throughout the eight-week course of treatment. This study used multilevel models to examine how positive affect and craving are linked.

Inclusion criteria: Individuals with OUD who were: English-speaking; 18 years old or older; had been admitted to MMT during the previous year; and had chronic non-cancer pain.

The exclusions were Anyone under the age of 18 who cannot understand English, as well as anyone suffering from persistent cancer pain.

Sample/Setting  The number and characteristics ofpatients, attrition rate, etc. Sample size:166Settings: Outpatient treatment options include three distinct treatment modalities. Every week or every three weeks, patients may pick up their medicine.Standard medical management, which comprised of direct guided, medical treatment centered therapy.

Enhanced management method was similar, but each therapy session was longer.

Sample: 577 patients. Split into two cohorts Setting: Patients chosen from four municipalities.Cohort 1: Sample size: 354 participants were enrolled in a community-based outpatient program run by a nonprofit organization.

Race: White: 115 African American: 56 Hispanic: 151 Not specified: 18

Gender: Male:243 Female:111 Marital status: Never married: 50. Married: 171. Separated divorced, or widowed:133

Full-time or part-time employment: 163

Drug intake: Spirits everyday 109 Marijuana weekly 84 Cocaine alone weekly 89 Speedball weekly 107

Cohort 2:

Sample size: comprised of 223 individuals who had applied to an outpatient methadone treatment program that was not publicly funded. In exchange for participating in this trial, these patients will get a year of free treatment. Race: White: 49 African American: 33 Hispanic: 137 Not specified: 5 Gender: Male:140 Female:83

Marital status: Never married: 49. Married:66

Separated, divorced, or widowed:108

Full-time or part-time employment: 71

Drug intake: Alcohol daily: 37 Marijuana weekly:25 Cocaine alone weekly:30 Speedball weekly:37

Settings: The investigations were conducted in outpatient settings. Outpatient phases were available for MAT studies that began in different settings; for example, jail and followed individuals after they were discharged. Total Sample: N=30Women: (n = 15) -Average of 50.4 Race: African American 52% Whites 36.68% non-white Hispanics 20%. Education: Almost one-third of those who took part had less than a high school diploma (30 percent).Categories of pain:

Regular reports of pain condition (40%) with a mean pain intensity of 5.3 (SD=2.7). In addition, 70% of individuals reported using heroin in the previous 30 days, along with cocaine (23%), marijuana (23%), opioids (16%), stimulants (13%), and benzodiazepines (9%). (9 percent).

MMT was given for a median of 7 months (range: 1 month to 35 years). All groups had comparable demographic and clinical baselines. 6 (SD=1.6) treatment sessions One participant dropped out after five sessions.

Two individuals in the TAU dropped out of MMT.

Major Variables Studied List and define dependent and independent variables Dependent Variables: Relapse rates are lower, and the length of sobriety is longer.

Independent Variables: A combination of therapy and FDA-approved medicine is used to treat opiate addiction.

Dependent Variables: Relapse rates are lower, and the period of abstinence is longer.Independent Variables: Opioid addiction treatment that involves both counselling and FDA-approved medicines. Dependent Variables: Relapse rates are lower, and the period of abstinence is longer.Independent Variables: All qualifying trials tested methadone, buprenorphine with or without naloxone, or naltrexone. Studies examining non-US-approved MAT treatments, such as morphine or heroin, were omitted. Only studies of opiate detoxification without follow-up were eliminated.

 

Dependent Variables: Relapse rates are lower, and the period of abstinence is longer.Independent Variables: Medicines-assisted treatment treats opiate addiction with both therapy and FDA-approved medication.
Measurement Identify primary statistics used to answer clinical questions (You need to list the actual tests done). Following treatment, self-reported opioid use dropped from 5.3 to 1.1 days per week (0.9 to 1.3).They were compared using chi-square and evaluation of variation. The Kaplan–Meier product-limit method and the log-rank test were used to evaluate the percentage of patients who completed the experiment. The prevalence of illicit opioid usage was studied using mixed-model Analysis. We also looked at the greatest rate of abstinence, patient satisfaction throughout treatment, utilization of health and social services, and adherence to buprenorphine-naloxone. Treatment retention, satisfaction with therapy, and post-index treatment status were studied using logistic regression. In addition, patients’ evaluations of treatments at months 3, 6, 9, and 12 were used to calculate treatment satisfaction. The five components: consumer satisfaction, place, total quality, meeting time of the session, and was it organized and well operated. Therapy retention was defined as one year of treatment. One hundred thirty-four patients (38%) in cohort 1 and 167 patients (47%) in cohort 2 met the treatment retention requirements.Patients who satisfied this condition received a 1, whereas those who did not received a 0. In two separate reviews, study-level data was abstracted, and the studies’ quality was graded. Meta-analyses used Hartung-Knapp random-effects models. The GRADE method was used to evaluate the evidence’s quality. Studies were required to measure results in all individuals or monitor for the inclusion or exclusion of events in all participants who were involved. Studies that only documented individual adverse events for a subset of participants were omitted. Random EMA data was linearly analyzed using multilevel modeling with a maximum likelihood estimate of missing data. The significant impacts of (MORE vs. TAU), Time, and the Group X Time interaction were of interest. With a random intercept and a chi-square test of change in the -2LL fit statistics, repeated effects covariance was assessed (diagonal and AR1).Because participants could report as many desires as they wanted and at any frequency, time was highly variable in these models, all desire and control analyses choose to concentrate on Group’s direct effect rather than the Group X Time interaction.
Data Analysis Statistical or Qualitative findings(You need to enter the actual numbers determined by the statistical tests or qualitative data). The average proportion of opioid-negative urine specimens was 44 percent for conventional medical care and once-weekly drug administration. In addition, 40% for traditional/ enhance medical treatment meeting three times weekly drug administration. Overall three therapies were linked with considerable decreases in the frequency of illicit opioid use compared to baseline, but there were no big variation between the treatments. The retention rates and backgrounds of the cohorts vary. In cohort 1, 142 patients (40 percent) discontinued therapy by the sixth month, whereas only 134 patients (38 percent) remained for a year. However, in the second cohort, 133 patients (60 percent) stayed in therapy for a year. There were no substantial statistical data to back up a patient undergoing MAT and how it impacts day-to-day functioning. MORE participants reported significantly greater decreases in opioid desire (44 percent) and opioid urge (50 percent ) compared to TAU participants, B=- 0.019 p.0001. 3.2.2. Pain Group X Time B=-.007 (SE =.003), p =.025, but not pain intensity, p >.10. Group X Time B =.010 (SE =.004), p =.017. 3.2.4.
Findings and Recommendations General findings and recommendations of the research Illicit drug usage was tracked on a weekly basis using patient-reported frequency of drug use and urine tests. Urinalyses for opioids and cocaine were performed using a semiquantitative homogeneous enzyme immunoassay. They screened all patients for oxycodone and methadone since the number of individuals misusing prescribed opioids rose over the experiment. At week 12, a questionnaire adapted from a previously published one was used to assess patient satisfaction. Nineteen items were assessed on a 5-point Likert scale, with a higher score indicating more satisfaction and a maximum score of 95. In logistic regression studies, counseling rapport outperformed treatment retention, satisfaction with therapy, and post-index treatment status. Evidence-Based Project Part 4A Critical Appraisal of Research Most functional outcomes had poor or  low evidence quality. Overall, the amount of data does not support strong conclusions concerning MAT’s impact on functional outcomes. Studies investigating functional impacts would add to the literature. Using MMT, this study evaluated the effects of MORE on EMAs of opioid desire, pain, and emotional experience. In comparison to TAU, MORE involvement was linked with substantial decreases in immediate opiate desire, physical intensity, and tension, as well as improvements in life satisfaction. Furthermore, while MORE participants reported more in event-contingent wanting reports, the strength of these desires was decreased.
Appraisal and Study Quality  Describe the general worth of this research to practice.

What are the strengths and limitations of study?

What are the risks associated with implementation of the suggested practices or processes detailed in the research?

What is the feasibility of use in your practice?

Buprenorphine substantially reduced the frequency of illicit opioid use from baseline through induction and maintenance. The research has limitations. Despite the adequate sample size, failure to follow up was not taken into consideration. We can’t rule out clinically meaningful changes since the confidence intervals are so large. Evidence-Based Project Part 4A Critical Appraisal of Research The study’s worth demonstrated that the theory was correct. The researcher thought that stronger counseling rapport is associated with better drug-use and criminality results at follow-up even after adjusting for treatment length and contentment with therapy. StrengthsIn this research, counseling rapport was shown to predict post–index treatment outcomes. A greater counseling rapport was linked with better drug use and criminality results, even after controlling for treatment length, satisfaction with therapy, and potential return for further treatment.

Limitations

Counselors must have access to a variety of environments and receive training in order to learn how to create therapeutic rapport.

Strengths: This review has several strong points with an a priori research design, double study selection, data abstraction, and comprehensive quality-of-evidence assessments. Limitations: One-fifth of MAT research that met the study design criteria produced findings in cognitive, physical, occupational social/behavioral, or neurological. whereas 324 reports were eliminated because they did not disclose any functional outcomes. Strengths: MORE individuals reported being 1.3 times more able to regulate urges than TAU participants. Limitations: The current study had limitations in measuring the persistence of desire alterations, pain, and mood after eight weeks of therapy.
  Key findings 

 

 

The crucial outcomes (length of opioid usage, quantity of negative opioid urine specimens, and total number of weeks of illicit opioid abstinence) did not differ significantly among the three parties. Patients who scored low on counseling rapport fared considerably worse. More than twice as many people with poor counseling rapport had a cocaine-positive urine test, reported cocaine use, participate in unlawful acts, or arrested. The inability to conduct meta analyses was hampered by the minimal number of research reporting specified functional outcome indicators. The majority of data comes from methadone, buprenorphine, or buprenorphine plus naloxone trials. Furthermore, due to a shortage of participants, the majority of controlled trials had a moderate to high risk of bias. Using MMT, this study evaluated the effects of MORE on EMAs of opioid desire, pain, and emotional experience. The findings largely confirmed the study hypotheses, which showed that, compared to TAU, MORE involvement was related with statistically significant decreases in immediate opioid desire, pain discomfort, and stress, along with increases in beneficial impact from beginning to end. While MORE individuals reported more cravings, they were lower in intensity, and involvement was linked with considerably higher self-control over desires..
  Outcomes 

 

 

The research was carried out in an urban, scientifically linked medical center. Future practices will need to examine the consequences of this study in terms of resources, particularly for criteria screening and nurse staffing. Our findings has ramifications for clinical treatment and practice as well. Many patients might benefit from effective care in a primary care, office-based environment with weekly counseling and drug distribution. After accounting for treatment retention, counseling rapport predicted cocaine positive urine and arrests. Therapy satisfaction and post-index treatment status, as in cohort 1. Counseling rapport was also a significant predictor of heroin use in cohort 2. Unfortunately, the flaws in the corpus of data make it impossible to draw solid conclusions regarding the MAT’s impact on functional outcomes or variations across drug kinds. Some studies comparing MAT patients to OUD patients who did not get MAT; found that MAT had a substantial positive impact on criminal behavior. Days of opioid usage and time in MMT will be examined as outcomes in a forthcoming Stage 2 RCT of MORE. To establish if an intervention can prevent relapse by altering important antecedents and precipitants of relapse, future research could utilize EMA.
General Notes/Comments Patients were more likely to continue taking medicine if services were more easily available. The participants also believed that treatment improved their care. This study supports previous psychotherapy research on the significance of having counseling in addition to medication. Evidence-Based Project Part 4A Critical Appraisal of Research Evidence-based treatments were utilized to establish a baseline of therapy for those who suffer from substance misuse. In terms of evidence-based techniques, the material presented was resourceful therapy.

 Part 3B: Evidence-Based Best Practices Based on your appraisal, suggest a best practice that emerges from the research you reviewed. Briefly explain the best practice

The opioid problem in the United States is becoming increasingly severe. There have been 750k drug overdose deaths since 1999 (Centers for Disease Control and Prevention, 2018). Medication-Assisted Therapy MAT has been shown to be safe, cost efficient, and successful in reducing criminal behavior. According to the Centers for Disease Control and Prevention (CDC), prescription opioid abuse costs the United States $78.5 billion per year, including healthcare expenditures, lost productivity, rehabs, and criminal police involvement. Support for this dual approach to opioid use disorder OUD therapy comes from the American Society of Addiction Medicine, the National Council for Behavioral Health, and patient advocacy organizations. Evidence-Based Project Part 4A Critical Appraisal of Research

Dependency on opioids has resulted in a far much bigger problem in which millions of people have become addicted to the drug, while many more die due to overdose. The objective of this paper is to determine approaches to eliminate or lessen the addiction to opioids in patients suffering from Opioid Use Disorder. Opioids have been critical in pain relief, but some individuals have been misusing them to the point that questioning their usability has become imperative. The balance between pain management using opioids and its misuse is already a thin line. This research will, therefore, work on the hypothesis that there are better alternatives to treating OUD for the millions of patients who are addicted to opioids.

The theory thus states:  Buprenorphine-Naloxone can be used effectively to treat opioid addiction. Buprenorphine-Naloxone treatment has the capability to cut off the patient’s addiction to opioids. MAT has been shown to reduce opiate usage, overdose fatalities, criminal activities, and infectious illness. In addition, MAT enhances social functioning and treatment adherence. In this instance, the effectiveness of the treatment technique selected determines the success of controlling the opioid crisis in America.

References for Evidence-Based Project Part 4A Critical Appraisal of Research

Critical Appraisal Tool Worksheet Example 2

Critical Appraisal

Critical appraisal is the fourth of the six steps of evidence-based practice to appraise the selected evidence. This critical appraisal serves two main purposes: to assess the evidence for its closeness to the truth or the actual occurrence in the population and to assess the evidence for usefulness in application to practice. My clinical issue of interest was the use of probiotics in the treatment of gastrointestinal symptoms associated with antibiotics use. Eight journal articles from peer-reviewed journals were selected for early steps of critical appraisal. In this critical appraisal, four of the eight articles with varying methodologies and levels of evidence are appraised and evaluated.

Part 3 A: Evaluation Table

Full APA formatted citation of the selected article. Article #1 Article #2 Article #3 Article #4
Skrzydto-Radomańska, B., Prozorow-Król, B., Cichoż-Lach, H., Majsiak, E., Bierła, J. B., Kanarek, E., Sowińska, A., &Cukrowska, B. (2021). The effectiveness and safety of multi-strain probiotic preparation in patients with diarrhea-predominant irritable bowel syndrome: A randomized controlled study. Nutrients13(3), 756. https://doi.org/10.

3390/nu13030756

Hibberd, A. A., Yde, C. C., Ziegler, M. L., Honoré, A. H., Saarinen, M. T., Lahtinen, S., Stahl, B., Jensen, H. M., &Stenman, L. K. (2019). Probiotic or synbiotic alters the gut microbiota and metabolism in a randomized controlled trial of weight management in overweight adults. Beneficial Microbes10(2), 121–135. https://doi.

org/10.

3920/BM

2018.0028

Rui, X., & Ma, S.-X. (2020). A retrospective study of probiotics for the treatment of children with antibiotic-associated diarrhea. Medicine, 99(23), e20631. https://doi.org/10.1097/

MD.00000000

00020631

Arnold, L. E., Luna, R. A., Williams, K., Chan, J., Parker, R. A., Wu, Q., Hollway, J. A., Jeffs, A., Lu, F., Coury, D. L., Hayes, C., &Savidge, T. (2019). Probiotics for gastrointestinal symptoms and quality of life in autism: A placebo-controlled pilot trial. Journal of Child and Adolescent Psychopharmacology29(9), 659–669. https://

doi.org/

10.1089/cap.

2018.0156

Evidence Level *(I, II, or III)

 

This is an evidence level I study (Randomized Controlled Study). The study is evidence Level I (Randomized Controlled Trial). Evidence Level III (Observational/non-experimental study). Evidence Level I (A Placebo-Controlled Randomized Pilot Trial).
Conceptual Framework Describe the theoretical basis for the study (If there is no one mentioned in the article, say that here).** The study aimed at determining whether the use of a multi-strain probiotic in adults with irritable bowel syndrome that predominantly presents with diarrhea was effective and safe. The research purposed to determine if changes in the gut microbiota attributed to probiotic or symbiotic use were associated with the earlier observed clinical benefits of controlling energy metabolism and body fat mass in overweight adult individuals. The objective of this study was to determine the safety and benefits of probiotics, particularly live combined Bacillus subtilis and Enterococcus faecium granules with multivitamins, when used in the management of children with diarrhea attributed to antibiotics. The conceptual framework of the research was to analyze gastrointestinal (GI) symptoms in regards to targeted probiotic use with expected effect on the quality of life in autistic spectrum disorders.
Design/MethodDescribe the design and how the study was carried out (In detail, including inclusion/exclusion criteria). The study adopted a randomized controlled study which is a type of experimental study. Adult patients with the aforementioned condition were randomly selected into two groups. One group was set to receive a multi-strain probiotic for eight weeks whereas the second group was a control group receiving a placebo for a similar duration. The two groups were observed for anticipated outcomes such as changes in the severity of symptoms and clinical improvement based on the IBS severity scoring system and Global improvement score. A randomized controlled trial of protocol compliant participants was randomly assigned one of the four groups of interventions including a group receiving a placebo and observed for 6 months. Plasma and fecal samples were collected from these individuals at baseline, 2 months, 4 months, 6 months, and one-month post-intervention. These samples were then examined for fecal microbiota composition and metabolites and the correlation with obesity-related clinical outcomes was established. This retrospective observational study analyzed children with antibiotic-associated diarrhea. These were randomly allocated into two groups; one intervention group receiving standard treatment with probiotics and the other group being the control group thus receiving only the routine care. The treatment for both groups lasted for 7 days. The duration of diarrhea, the number of days required dressing, the severity of abdominal pain, the consistency of stool, and any noted adverse occurrence were all measures used to assess the safety and effectiveness of the treatment. A controlled randomized pilot trial was conducted on children of age between 3 to 12 years with preexisting autism spectrum disorders, anxiety, and gastrointestinal symptoms were randomly allocated into two groups of probiotic crossovers for eight weeks with and in-between three-week washout. One group received a placebo/probiotic sequence whereas the other had a probiotic/placebo sequence. A mixed analysis was then employed to assess the primary and secondary outcomes.
Sample/Setting  

The number and characteristics of

patients, attrition rate, etc.

The study sample consisted of 51 patients with diarrhea-predominant inflammatory bowel disease who were randomly selected from 76 patients meeting the inclusion criteria of greater than 175 points based on the IBS-SSS score. The study population was from a larger clinical study of healthy adults who were either overweight or obese of whom a total of 134 protocol compliant individuals were selected for the study. The study was conducted in Jiamusi University First Affiliated Hospital whereby participants were 72 children between the age of five to eleven years diagnosed with AAD with no other preexisting gastrointestinal illness. The study involved 13 children aged between 3 and 12 years who had ASD, gastrointestinal symptoms, and anxiety.
Major Variables Studied 

List and define dependent and independent variables

The independent variable was the multi-strain probiotic treatment for the intervention group and the placebo for the control group. The dependent variables under observation in both groups included improvement or changes in the severity of IBS symptoms with specific attention to the pain intensity, quality of life, and presence of adverse events in the study participants. The independent variable in this study was probiotic Bifidobacterium animalis subspecies lactis 420 and the placebo used which were Litesse ultra polydextrose and microcrystalline cellulose. The dependent variables were the fecal microbiota or gut flora composition and metabolites and correlation with waist-hip ratio. The independent variables in this particular study were the probiotics used which included live combined Bacillus subtilis and Enterococcus faecium granules when added or not added to standard treatment of AAD in children. The dependent variables were the diarrhea duration in days, daily dressing number needed, the severity of abdominal pain, consistency of stool whether normal, liquid or constipated, and any experienced adverse outcome all of which were used to determine the safety and effectiveness of the probiotic. The independent variable was VISBIOME which is a probiotic formulation with eight species majorly Lactobacillus and a placebo administered to study subjects. The dependent variables were health benefits with Pediatric quality of life inventory GI module as the primary outcome and parent-rated anxiety scale for autism spectrum disorder, analysis of microbiota, and parent-chosen target symptoms as the secondary outcomes.
Measurement 

Identify primary statistics used to answer clinical questions (You need to list the actual tests done).

The inflammatory bowel syndrome severity scoring system (IBS-SSS) and IBS Global Improvement scale were used to assess improvement in the severity of symptoms in diarrhea-predominant IBS. Fecal and blood samples were obtained from participants from which outcomes of fecal microbiota components and metabolites were assessed. Change in the ratio of waist-to-hip in addition to the waist area fat mass was also observed for change. The outcome measurements after interventions were either primary or secondary and included the diarrhea duration in days, daily dressing number needed, severity of abdominal pain based on visual analog pain score, consistency of stool based on the Bristol stool scale, and any experienced adverse outcome. PedsQL, PRAS-ASD, and parent-selected target symptoms were measures used to assess the outcome of the probiotic/placebo treatment.
Data Analysis Statistical orQualitative findings

(You need to enter the actual numbers determined by the statistical tests or qualitative data).

After eight weeks of intervention, it was noted that the probiotic led to a statistically significant improvement from baseline in the IBS symptom severity (165.8 +/- 78.9 IBS-SSS score), pain severity, and quality of life in comparison to placebo (105+/-60.2 IBS-SSS). In regards to the IBS-GIS, the group that received the probiotic also reported improved symptoms in contrast to the group receiving the placebo both at the fourth (p=0.04) and twelfth (p=0.003) week of intervention. However, there was no difference in the occurrence of adverse events between the two study groups. Probiotic use when compared with placebo resulted in altered gut microbiota by causing increasing some such as Lactobacillus, and Akkermansia and reducing some such as Paraprevotella. Metabolites such as glycoursodeoxycholic acid were also reduced by probiotic use. This caused a negative correlation between waist-hip ratio and waist fat mass thus improving clinical obesity-related outcomes. Probiotic treatment reduced the diarrhea duration (p<.01), the number of daily dressings (p<.01), the degree of pain in the abdomen (p<.01), and the consistency of stool (p<.01). Furthermore, no adverse events were reported. From the 77% retention rate of participants, there were no statistically significant outcomes in PedsQL and PRAS-ASD despite probiotic use showing greater Lactobacillus retention and better improvement as compared to placebo.
Findings and Recommendations 

General findings and recommendations of the research

The multi-strain probiotic was found to significantly improve IBS symptoms and thus is beneficial to the patient in addition to its safety and good tolerance. The altered gut microorganism contributing to the protective gut barrier and metabolites caused a negative correlation with waist-hip ratio and waist fat mass thus improving clinical obesity-related outcomes. Probiotic treatment greatly reduces the severity of AAD and thus should be considered in individuals with this condition. The retaining of Lactobacillus with probiotic use leads to improvement and is thus beneficial.
Appraisal and Study Quality 

 

Describe the general worth of this research to practice.

What are the strengths and limitations of the study?

What are the risks associated with the implementation of the suggested practices or processes detailed in the research?

What is the feasibility of use in your practice?

Findings were statistically significant and thus can be feasible in clinical practice due to the demonstrated benefits with support from other similar studies. The study demonstrates the role of gut microbiota in improving weight management in overweight management and hence can be considered as one of the weight reduction strategies. Statistically significant findings from this study may justify the use of probiotic AAD. More studies may be required especially in the other age groups for wider coverage. Since the findings from this study were generally statistically insignificant, there is a need to do a repeat study using a larger study group to present more accurate findings.
  

Key findings

 

 

 

Improved IBS symptoms from probiotic use. Probiotic use alters the gut microbiota together with its metabolism which contributes to weight reduction and improvement in gastrointestinal barrier function. There was an improvement in symptoms and shortened duration of illness with probiotic use in AAD. Probiotics when used in ASD with gastro-intestinal symptoms led to abundant Lactobacillus which may contribute to symptom and quality of life improvement.
  

Outcomes

 

 

 

The probiotic is safe and beneficial in its use for the management of IBS-D. Probiotic consumption can successfully lead to clinical benefits of controlling energy metabolism and body fat mass in overweight adult individuals. Probiotics safely and effectively treated antibiotic-associated diarrhea. The findings were not statistically significant. Thus, conclusions on the safety and effectiveness of probiotics in ASD cannot be sufficiently drawn.
General Notes/Comments This study has remarkable data with clear evidence of the correlation between probiotic use and improvement in IBS-D symptoms. There are a few lapses in this study that should be considered in future studies. An experimental study can be considered in the future to further support the findings. This study still has gaps due to the small sample size. A larger study population can be considered in the future to represent a true picture of the findings.

Part 3B: Critical Appraisal of Research

The above evaluation table summarized the findings of individual evidence-based sources that addressed various sections of my clinical inquiry that was in the form of a PICOT question. Two sources were high-level evidence sources that included systematic reviews while the other sources ranked lower in the hierarchy. Systematic reviews have the findings more validity because systematic reviews consolidate the findings from various relevant and valid sources and organize their findings by following a systematic process (Melnyk & Fineout-Overholt, 2018).

From the above evaluation, I can conclude that probiotic use improves systems of irritable bowel symptoms. They enhance weight reduction by alteration in microbiota and their metabolism. Probiotics use among patients with antibiotics associated diarrhea also alleviates these symptoms. Gastrointestinal symptoms also improve among children with gastrointestinal symptoms in atrial septal defects. No study evaluated the contraindications for use of these agents among impatient with gastrointestinal symptoms

The best practice, therefore, would include the prescription of antibiotics among patients with gastrointestinal symptoms especially diarrhea that would be associated with disturbance in the balance between microbiota and pathogenic bacteria in the gut. The decision to prescribe these agents or not is solely made based on clinical reasoning and decision making based on appropriate evaluations. Best practice may consider probiotic use among patients with antibiotic-associated diarrhea, irritable bowel symptoms,

Conclusion

The above best practice statement is backed up by evaluated data for reliable and scholarly sources that are recent and thus credible. Further studies should evaluate when not to use these agents in the indicated patients. Otherwise, they can be considered safe and effective. Data on their efficacies were not evaluated.

Evidence-Based Project Part 3 Critical Appraisal of Research References

Arnold, L. E., Luna, R. A., Williams, K., Chan, J., Parker, R. A., Wu, Q., Hollway, J. A., Jeffs, A., Lu, F., Coury, D. L., Hayes, C., &Savidge, T. (2019). Probiotics for gastrointestinal symptoms and quality of life in autism: A placebo-controlled pilot trial. Journal of Child and Adolescent Psychopharmacology29(9), 659–669. https://doi.org/10.1089/cap.2018.0156

Hibberd, A. A., Yde, C. C., Ziegler, M. L., Honoré, A. H., Saarinen, M. T., Lahtinen, S., Stahl, B., Jensen, H. M., &Stenman, L. K. (2019). Probiotic or synbiotic alters the gut microbiota and metabolism in a randomized controlled trial of weight management in overweight adults. Beneficial Microbes10(2), 121–135. https://doi.org/10.3920/BM2018.0028

Melnyk, B. M., & Fineout-Overholt, E. (2018). Evidence-based practice in nursing & healthcare: A guide to best practice (4th ed.). Lippincott Williams and Wilkins.

Skrzydto-Radomańska, B., Prozorow-Król, B., Cichoż-Lach, H., Majsiak, E., Bierła, J. B., Kanarek, E., Sowińska, A., &Cukrowska, B. (2021). The effectiveness and safety of multi-strain probiotic preparation in patients with diarrhea-predominant irritable bowel syndrome: A randomized controlled study. Nutrients13(3), 756. https://doi.org/10.3390/nu13030756

Rui, X., & Ma, S.-X. (2020). A retrospective study of probiotics for the treatment of children with antibiotic-associated diarrhea. Medicine, 99(23), e20631. https://doi.org/10.1097/MD.0000000000020631

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