EBP Poster

1.

Study Purpose,

Author(s) and year

Study Design

Sample size (n) and population characteristics

Independent and dependent variable(s)

Statistical tests/models

Results

Evidence Strength & Quality Rating

(JHNEBP), include limitations/strengths

Student Initials

1.

Article 1 Title;

Hybrid effectiveness-implementation trail of guided relaxation and acupuncture for chronic sickle cell disease pain

Study purpose/Aim: To evaluate the effectiveness of guided relaxation and acupuncture as compared with usual care in decreasing pain in people with sickle cell disease (SCD) and to explore the implementation of these interventions in clinical practice.

The study used a SMART design/model to evaluate the effectiveness of the interventions. The data were analyzed using qualitative data organizing software to code the data. The study also used Q-learning to explore moderating variables and develop decision rules for more extensive tailoring of therapy combinations.

Authors

.Doorenbos, A. Z., Schlaeger, J. M., deMartelly, V. A., Burke, L. A., Boyd, A. D., Knisely, M. R., ... & Ezenwa, M. O. (2023).

Randomized Control Trial

The study included 360 adults with SCD who reported chronic pain and were recruited from two academic medical centers in the United States. They were randomly assigned to three intervention groups,although the number of participants in each group was not mentioned. The sample was diverse in terms of age, sex, race, and ethnicity, with 48% of patients identified as African American, 24% Hispanic or Latino, 20% Caucasian, and 8% Asian or Pacific Islander.

The independent variables were guided relaxation and acupuncture, as compared with usual care.

The dependent variables were pain intensity.

No statistical tests were used in this study. However, the study used a SMART design/model combined with Consolidated Framework for Implementation Research (CFIR) to plan, execute, and evaluate associated implementation processes. The data was analyzed using qualitative data organizing software to code the data. The study also used Q-learning to explore moderating variables and develop decision rules for more extensive tailoring of therapy combinations.

The study found that acupuncture was effective in reducing pain intensity in patients with SCD. At 6 weeks, patients randomized to the acupuncture group had greater decreases in pain and pain catastrophizing compared with patients randomized to usual care.

The study provides level I A evidence with high-quality evidence, as the study used a SMART design to evaluate the effectiveness of the interventions and explored the implementation of these interventions in clinical practice.

Strengths:

-The use of diverse samples enhances the generalizability of results.

-The use of validated outcome measures, and the use of a SMART design helped researchers to determine the most effective intervention sequences..

-Power analysis was used to determine enough sample size.

-As a gold standard for providing strong evidence, participants were randomly assigned to groups.

-As a result of the use of controlled groups, it can be argued that the observed results are not just a result of chance.

Limitations:

-The study used a short follow-up period.

-Participants and providers were not blinded which is a threat to the internal validity of this study.

-Small sample size which could make generalization difficult.

CT

2

Acupuncture for pediatric sickle cell pain management: A promising non-opioid therapy

The study's purpose/Aim: To evaluate the use of acupuncture for pediatric sickle cell pain management. After the interventions were introduced to the patients, statistical software SAS® 9.3 was used for analysis to determine the effect of acupuncture on pain levels

AUTHORS

Tsai, S. L., Bombacie, M., Licursi, M., Qian, Y., Stiles, G. M., & Lee, M. T. (2020).

Retrospective- Observational study.

The sample size (n) is 24 patients who received 90 acupuncture treatments. The population characteristics include a median age of 17.5 years, 15 females, 9 males, 37.5% African American, 50% Hispanic, and 12.5% of other ethnicity/races.

The independent variable is the use of acupuncture for pain management in pediatric sickle cell patients. The dependent variables include pain scores and pre- and post-acupuncture presenting pain location.

The statistical software SAS® 9.3 was used for analysis. However, no specific statistical tests/models were mentioned in the article.

Acupuncture was associated with a statistically significant reduction in pain scores in pediatric sickle cell patients. The median pain score decreased from 7 (interquartile range [IQR] 6-8) to 4 (IQR 2-6) on the 10-point Verbal Pain Scale (p<0.001) and from 2 (IQR 2-4) to 1 (IQR 0-2) on the 4-point Verbal Pain Scale (p<0.001). The most common presenting pain locations were the back (29.2%), chest (25%), and bilateral knee/thigh (20.8%). No adverse events were reported during or after acupuncture treatment.

The level of evidence strength III and the quality of evidence is good.

Strengths

-The strengths of this study include the use of a large sample size. Sampling errors are less likely to occur with larger sample sizes.

Limitations

-The retrospective design of the study limits the ability to establish causality and the generalizability of the findings to other populations.

-Additionally, the lack of a control group limits the ability to compare the effectiveness of acupuncture to other pain management strategies.

CT

3.

Article 3 Title

A retrospective review of acupuncture use for the treatment of pain in sickle cell disease patients

Study Purpose/Aim This retrospective study describes the use of acupuncture for adult sickle cell patients in a single institution and its effect on pain levels. Pain severity was assessed using the 0–10 Numeric Pain Rating Scale immediately before and after each acupuncture session, patients were asked by the acupuncturist to rate the severity of their pain symptoms on a 0–10 scale, ranging from 0 for “no pain symptoms” to 10 for “worst pain symptoms”. The acupuncturist then documented the pain rating into their progress notes for each of the sessions. Statistical difference for pain intensity was measured using pair t-test methods.

Authors

(Kit Lu1, M. Jennifer Cheng2, Xiaoying Ge2, Ann Berger2, Dihua Xu4, Gregory J. Kato3, and Caterina P Minniti3 2015)

A retrospective observational study..

The sample size is 47. Out of the 47 patients referred for acupuncture by the pain and palliative team, 42 had sickle cell anemia (HbSS) (89%) and 5 had hemoglobin SC disease (11%). 19 participants were males and 28 were females. Over half of the patients (51%) reported more than 3 sites of pain.

The independent variable was the use of acupuncture treatment whereas the dependent variable was pain score reported by the participants.

Statistical difference for pain intensity was measured using pair t-test methods.

Of the 47 patients, eleven patients received only outpatient acupuncture treatment for chronic pain, and four patients received both inpatient and outpatient treatments, the rest declined the service. For the 15 patients who agreed and received acupuncture treatment there was a significant reduction of reported pain score immediately after acupuncture treatment with an average pain reduction of 2.1 points on the numeric pain scale (p< 0.0001) by the end of three acupuncture sessions. Duration of acupuncture treatment was not mentioned.

The strength of the study is level III, and the quality of evidence is good (B).

Strengths:

- Per FDA regulations, acupuncture needles were sterile, nontoxic, and labeled for single use by a licensed, NIH-credentialed acupuncture consultant. This erases any co-founders that might be a cause of soreness and bruising thereby otherwise increasing pain for the patients and threatening internal validity of the study.

-The study provided good conclusions and enough recommendations for future research.

Limitations:

-Limitations of this study are its retrospective nature. Already existing records were used which could lead to information biases.

-Secondly, documentation on why a number of the patients who were referred for acupuncture declined its service was not provided, and whether their pain symptoms were comparable to the patients who chose to undergo acupuncture was not provided. Those patients could have been used as a control group for the study.

- Third, the number of individuals included in the study was relatively small, and this decreases generalizability of results.

NA

4.

Article 4 Title

Acupuncture for pain management in children with sickle cell disease

Purpose/Aim: This study describes and evaluates

children with SCD who received acu

puncture in either inpatient or outpatient and its consequent effect on pain levels.

Pre and post-acupuncture pain scores and, session level data was collected. Summary statistics were also provided for the difference in pre/post acupuncture pain scores. In order to account for multiple sessions per person, repeated measures analyses were used to assess whether the average difference in pain score was significantly different from 0.

Authors

(L.A. Mahmood, et al. 2020)

A Retrospective observational study.

The sample size was 12

The average age of the patients was 16.85 years.

9 of them were females and 3 were males. The most common genotype was HbSS. Eight of 12 the patients had a history of psychological concerns ranging from general

anxiety and stress related to their medical condition, major depression,

conversion disorder and adjustment disorder.

Independent variable was the use of acupuncture treatment and the dependent variable was the pain levels reported by participants.

Models used to develop diagnostic criteria for the patient’s chronic pain were

AAPT criteria of chronic pain in SCD (Analgesic,

Anesthetic, and Addiction Clinical Trial Translations Innovations Op

portunities and Networks-American Pain Society Pain Taxonomy

(AAPT). However, no statistical tests were used in this study.

Of the 11 patients who gave a subjective rating of their session, 100 % felt it was a good experience with

73 % specifically expressing improvement in pain levels or feeling good after

the session. The average difference in

pain scores from pre- to post-acupuncture session was 0.933 with a

standard deviation of 1.03 by the end of 33 sessions. However, the duration of the treatment was not provided.

The strength of the study is level III, and the quality of evidence is good (B).

Strengths

-This study has reasonably consistent results, fairly definitive conclusions; reasonably consistent recommendations based on previous literature.

Limitations

-limitations of the study include its retrospective nature; incomplete pain scores due to missing data.

-No control; The absence of a control group makes it impossible to confidently determine which changes or outcomes relate to the intervention acupuncture versus others.

-Sample size was too small and no power analysis was used to determine sample size.. Through a power analysis, researchers can estimate the sample size required based on statistical procedures.

NA

5

Title of the article 5 :

Developing an Implementation Blueprint for the NIH HEAL Initiative GRACE Trial: Perspectives on Acupuncture and Guided Relaxation for Chronic Sickle Cell Disease Pain.

Authors

Knisely, M. R., Rivera, E., deMartelly, V. A., Abdulkadir, A., Doorenbos, A. Z., Ezenwa, M. O., ... & Patil, C. L. (2023).

Purpose/Aim: To explore perspectives of people living with sickle cell disease (SCD) and determine whether the use of acupuncture decreased their pain levels or not.The interviewers conducted up to 33 semi structured interviews and with the help of the GRACE trial model, assessments of how patients responded to the intervention in relation to pain levels was done.

Qualitative research design (Semi Structured interviews)

33 semi-structured interviews with people with SCD (sickle cell disease). Participants self-identified as African American or black. Aged between 18 to 66 years.

Independent variable- Acupuncture and Guided Relaxation treatment

Dependent: Sickle cell Disease pain levels

GRACE Trial, Hybrid Effectiveness Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain was the model used for analysis of how patients responded to the interventions in this study.

Participants were not able to give a definitive answer on whether acupuncture decreased their pain or not. Many patients did not ask for more information about acupuncture. A 24-year-old patient in particular commented on the duration of therapy and was not sure of the outcome of the acupuncture therapy.

Level III, quality B. As a qualitative study, sample and data collection and presentation procedure are properly identified. The study strength is the use of the model tool (GRACE trial) with an identified theme that assessed how patients responded to each intervention.

Limitations or weaknesses included a small sample size, which makes the application of the finding shallow.

FS

6

Title of article 6

Acupuncture for chronic pain in adults with sickle cell disease

Authors

Li, H., Patil, C. L., Molokie, R. E., Njoku, F., Steffen, A. D., Doorenbos, A. Z., & Schlaeger, J. M. (2021).

Purpose/Aim: To assess the feasibility and acceptability of performing acupuncture to treat chronic pain in adults with SCD. All participants received a standardized 18 point protocol with needle insertion starting superiorly and moving inferiorly. After the tenth acupuncture , the participants completed the data collection tools, and this was analyzed by the researchers.

Mixed method - prospective pilot study

A total of 6 participants enrolled, were > 18 years of age with a mean age of 52.5, and were all black. However, one participant did not complete the study due to COVID-19. Participants Acupuncture was to be administered twice per week for 5 weeks, for 30 min per session for a total of 10 treatments. Inclusion was based on SCD chronic pain and above 18 years.

Independent variable was acupuncture therapy.

Dependent:

Sickle Cell Disease chronic pain level

Models used; Standards for Reporting of Controlled Trials Acupuncture (STRICTA) guidelines.

All participants experienced pain relief after acupuncture. Not all agreed to use acupuncture treatment in the future. Only two participants managed to complete all ten sessions. All participants reported a reduction in pain. The scores include −7.1 for Pain intensity, −9.9 for pain interference, −6.8 for sleep disturbance, −4.6 for anxiety, −1.6 for depression, and anger −1.0. The mean acceptance score was 82%

Level III, Quality B

Strengths

-The study's strength can be tagged to the proper alignment of qualitative and quantitative results, followed by the acupuncture protocol with ten sessions that provided a conclusive finding.

Limitations

However, the study's limitation or weakness is its small sample size, which narrows the application of its results. Not all participants finished the ten sessions as required by the program. Thus, the finding is only based on two who completed it successfully, which makes the whole study inconclusive.

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7

Title of the article 7 : Acupuncture as an Adjunctive Treatment for Pain in Hospitalized Children With Sickle Cell Disease (Stremtan et al 2021).

The purpose/Aim of this study is to assess the acceptability of acupuncture as a supplementary treatment and investigate its effects on pain-related outcomes among sickle cell disease patients who are hospitalized for acute pain management. This review examines a pilot study on patients with severe chronic pain (SCD) aged 9-20, who were randomized into an intervention group or a control group. The study used a self-reported survey through a TEI-SF (nine items that were scored using a five-point scale, where one strongly disagreed and five strongly agreed) and NRS to assess the severity of pain response using NRS “0- 10 “where zero is no pain and 10 is the most severe pain after acupuncture.

Single center pilot study

A pilot study was conducted with a total of 29 participants enrolled from the Children's National Hospital. Of these, 10 individuals served as controls and 19 were assigned to receive acupuncture (intervention group. In both the intervention group (n=19), and control group (n=10), there were no significant differences between the groups in patients’ parameters like age, gender, and number of hospitalizations. Also, all patients had short acting oral opioids to use as needed for the management of sickle cell disease pain.

The i ndependent variable was the use of acupuncture.

The dependent variable was level of pain score 0-10 where zero is no pain and 10 is severe pain, and the acceptability and satisfaction of acupuncture by using Treatment Evaluation Inventory Short Form( TEI-SF).

Descriptive analysis was conducted on the continuous variables of the patient's data in both the acupuncture and control groups using the Mann-Whitney test. The Pearson chi-square test was used to evaluate the categorical variable between the groups. Data was analyzed using “SAS for Windows version 9.4 ( SAS Institute Inc., Cary, NC)”. A two-sided test with a significant level of 0.05 was used thought all the data analysis

Participants in the acupuncture group (n=19) and control group (n=10) were comparable, and there were no significant differences between the groups in the demographic characteristics. However, there were comparable and clinically significant differences between the acupuncture and control group. Acupuncture demonstrated a high acceptance rate of 66% and was well-tolerated, exhibiting no adverse effects. The practice of acupuncture showed a significant correlation with a decrease in pain levels (6.84−5.51; P < 0.001). The group that got acupuncture had a shorter total duration of hospital stay (with a median of 3.74 days compared to 4.6 days) and a reduced rate of readmission within 30 days (15% compared to 30%). 16 (89%) expressed agreement with the notion that acupuncture is an acceptable modality of pain management, and 17 (94%) indicated their willingness to utilize acupuncture as a means of managing sickle cell disease (SCD)-related pain.

The strength of the study is level III, and the quality of evidence is B: Good

Strength:

This study has a reasonable outcome in the study.

· The findings of this study exhibit a satisfactory level of consistency, which can be attributed to the implementation of certain controls.

· The study exhibits an acceptable degree of consistency in its recommendations, which are derived from comprehensive literature reviews that encompass a range of scientific findings.

Limitation:

This article does not have the power analysis to estimate the minimum number of sample sizes, and it has a small sample size.

The study does not use a randomization method of group allocation into the control and intervention groups.

The generalizability of the study is not applicable for patients who have SCD-related pain due to the small sample size.

HB

8

Title of the article 8:

Acupuncture for Pain Management in Pediatric Patients with Sickle Cell Disease

The purpose/Aim of the study was to review the recent studies on the use of acupuncture as a pain management method for pediatric patients with sickle cell disease who are experiencing acute pain episodes.

To evaluate acupuncture as an effective method of pain relief, the author systematically reviewed a scholarly article published from 2011 to 2021. Five articles were selected for review on the utilization of acupuncture treatment to relieve pain in children who are diagnosed with SCD. The descriptive statistical analysis method was applied to review the article. The study used a self-reported survey and NRS to assess the severity of pain responses after acupuncture.

Author (Krystal Plonski, 2022)

Systematic article review study

A systematic examination of scholarly articles published from 2011 to 2021 was undertaken to assess the existing literature on the utilization of acupuncture or acupressure as a form of treatment for pain management in pediatric patients diagnosed with sickle cell disease (SCD). The main searching words from the database were “acupuncture”, “acupuncture therapy”, “acupressure”, “sickle cell anemia”, “anemia”, “sickle cell”, “acupuncture analgesia”, “pain”, and “pain management”. The Ovid Medline, EMBASE, and CINAHL databases were utilized for this comprehensive search, and nine articles were found. Of the nine articles, five were used for the reviewed study because these articles focused on the utilization of acupuncture as a method for managing acute pain in the pediatric population affected by sickle cell disease.

The independent variable of the study was acupuncture treatment,

The dependent variable measured by the studies utilized was the level of pain experienced.

The study was a meta article analysis. No other statistical test/models were mentioned.

The first article showed the statistical significance of pain decreased by 2.1 across all treatment settings without any adverse effects. The average score before acupuncture was 6.17 +/− 2.73, and the average score after acupuncture was 5.23 +/− 2.46.This means that there was an average difference of 0.933 points with a standard deviation of 1.03 (p < 0.0001).

In the second article, 72% of the patients agreed that integrative therapies are an effective approach for treating sickle cell disease (SCD) pain, and 84% of the patients expressed their willingness to utilize acupuncture. However, 32% of the participants acknowledged the possibility of experiencing discomfort.

In the third article, the reduction of pain by 1.33 points (19.4%) was statistically significant with 89% indicating that acupuncture was an acceptable way of treating pain and 100 % of participants had positive experiences with acupuncture.

The finding of the last article reported that acupuncture resulted in a reduction of pain by one point on a numerical scale, with around 66% of patients reporting alleviation of both pain and anxiety following acupuncture intervention.

The strength of evidence is level IV, and the quality of evidence is B: Good

Strength:

-The study conducts a rational and relevant search of scientific databases, yielding consistent results across multiple studies.

- It supports its conclusions with a reasonable degree of certainty and recognizes both its strengths and limitations, along with recommendations for future research.

-Consistent recommendations come from the study's comprehensive literature evaluation, which incorporates thoughtful references to scientific literature.

Limitation:

The study does not have a sufficient number of well-defined studies .

Systematic review of the article is not from randomized control trial experiment studies. Because pain was measured in different easy, its possible the studies were not all measuring the same dependent variable

HB

9

Article 9: title

Acupuncture Alleviates Pain and Improves Quality of Life in Patients with Sickle Cell Disease

Tyler J Barrett, Andrew Pucka, Brandon Reyes, Seethal A Jacob, Andrew RW O'Brien, Richard Harris, Steven Harte, Ying Wang (2022)

Purpose: A randomized controlled clinical trial investigating acupuncture pain management in Pts with SCD

Randomized control study

At time of publishing 41 pts with SCD with a total anticipated enrollment of 75

Pts were between the ages of 14-73 that are single blind randomized into acupuncture (treatment) or sham acupuncture (Control). Recruiting settings and methods were not mentioned.

Independent: administration of 10 acupuncture treatments for 5 weeks

Dependent variables: Pt self report of pain intensity with Promise-29 self report

Neuropathic pain score was assessed by Paindetect survey.

Biomarkers of pain were collected but not published.

A paired two sample T- test was used to compare pre-treatment outcomes at baseline and again post treatment.

Pain intensity (P 0.022) and neuropathic pain symptoms (P 0.0002) were reduced post treatment in experimental groups.

Level IA due to being a well-designed randomized control trial with a systematic review of the literature

Quality A due to having very definitive conclusions that agree with the results of other studies research studies

Limitations: the number of study participants was small and did not have a previous study to determine the necessary size.

Strengths: The randomization and blinding make the study high quality. This would make an excellent pilot for a larger study.

IC

10

Article 10 title

Acupuncture for Sickle Cell Pain Management in a Pediatric Emergency Department, Hematology Clinic, and Inpatient Unit

Shiu-Lin Tsai, Douglas McDaniel, Katherine Taromina, and Margaret T. Lee

(21 Dec 2015)

Purpose/Aim: A retrospective chart review comparing the 1 Patients experience with acupuncture treating his symptomatology

Case study

N = 1 16 year old Hispanic male with SCD receiving care from an inner-city children's hospital pediatric emergency department (PED), hematology clinic, and inpatient unit over the course of 3 years.

This Pts chart was reviewed for reported pain during his visits over this 3 year period from 2012 to 2015 during which he received 58 acupuncture treatments.

Independent variable was the amount of time the Pt had been receiving acupuncture

Dependent variable: amount of reported pain by the patients

This study was a retrospective chart review comparing before and after scores.

No other statistical models were mentioned

On a 1- 10 scale with 10 being the worst pain experienced the on average was 2.3 or 2.2 points lower when receiving inpatient or outpatient acupuncture treatment respectively.

During the time he was receiving “maintenance acupuncture” the frequency of PED and inpatient admission visits dropped by 80%.

Level III C

Level III: This is a case study following 1 Pt as they receive our treatment intervention. It has a limited literature review. There is a correlation but not causal relationships can be concluded

C: this case study lacks a literature review and is there for class C

The Strengths: this study takes a longitudinal view of acupuncture care not found in most other studies found in our literature review.

Weaknesses: Given this is a case study it does not indicate causation. It lacks sufficient participants to generate support conclusions drawn from its data.

IC