EVIDENCE BASED TABLE

Author(s) and year

Research

Question/Purpose

Study Aims

Study

Design

Sample size (n), setting, and population characteristics

Independent and

dependent

Variable (s)

Results

Evidence Strength & Quality Rating

(JHNEBP), include

limitations/strengths

How the articles answer the PICO

Student Initials

Roseanne D. Dobkin, Sarah L. Mann, Michael A. Gara, Alejandro Interian, Kailyn M. Rodriguez, Matthew Menza (2020).

It was to see if patients with depression and Parkinson's disease (PD) can effectively alleviate their depressive symptoms significantly more than treatment as usual (TAU) alone with telephone-based cognitive-behavioral treatment (T-CBT) and TAU together (Dobkin et al., 2020).

It aims to use T-CBT as a way to get through access obstacles to multidisciplinary, evidence-based care and reduce depression in patients with PD, which is considered a need that is not often taken care of. It also aims to take advantage of telemedicine to extend the reach of evidence-based, PD-based depression treatment, and its great benefits for PD self-management. With T-CBT, patients with PD can benefit from their own home, and they do not have to live near any mental health services (Dobkin et al., 2020).

A randomized controlled trial

There were 72 people with PD and depression whose ages ranged from 59-75 years old. There were 35 males and 37 females. They were randomized into 37 people doing T-CBT and TAU together, which is the intervention, with 35 people doing only TAU, the control group. The setting was the Departments of Neurology and Psychiatry at Rutgers–Robert Wood Johnson Medical School. Between August 2015 and September 2017 from the Departments of Neurology and Psychiatry at Rutgers–Robert Wood Johnson Medical School, local PD support groups, and Fox Trial Finder (a clinical trial match tool), participants were found and recruited. When the last evaluation finished in June 2018, follow-up finished for patients as well (Dobkin et al., 2020).

The independent variables are T-CBT plus TAU and TAU alone. The primary dependent variable is the Hamilton Depression (HAM-D) Rating Score, which measures depressive symptoms. The secondary outcomes are anxiety and quality of life scores.

T-CBT and TAU together greatly improved mood (HAM-D) compared to TAU over the course of the trial ( F4,249 = 14.89, p < 0.0001) ( tables 2 and 3 and figure 2). Treatment effects ( p < 0.0001) were maintained at 6-month follow-up ( p < 0.0001). Self-reported depressive symptoms (BDI) (F4,244 = 5.07, p < 0.001), anxiety (HAM-A) (F4,249 = 8.63, p < 0.0001), and quality of life (SF-36 MCS) (F4,241 = 3.62, p = 0.007) had significant improvements (Dobkin et al., 2020). Depression and anxiety decreased while quality of life increased. Effects were consistent through 6-month follow-up (tables 2 and 3) (Dobkin et al., 2020).

This is Level 1, quality A research. A randomized controlled trial is one of the most top levels of research to find the relationship between the intervention and focused outcomes. This article provides consistent results with a sufficient sample size, adequate control, and definitive conclusions. Results are valid and reliable even after a 6 month follow-up.Strengths and limitations are clearly stated in the article. Here are the article’s limitations. One of them is that results may not apply well to people with advanced PD. The second one is that an existing practice control was used to compare the T-CBT results to the current care standard, and TAU may boost effect sizes relative to other kinds of comparison conditions. The third one is that it’s not doable to fully separate the effects of T-CBT from broad factors, such as therapeutic relationship, time, and attention, that can very well impact all psychotherapy outcomes (Dobkin et al., 2020). This would lower the chances of T-CBT being the major factor, but based on the study results, the T-CBT intervention seemed to have more of an impact that would lower the chances of the broad factors being more of a contribution. Fourth, this study had an a priori test of T-CBT's effectiveness at lowering negative thoughts, a key treatment target, but it was not made to assess the relative contributions of specific components of the intervention (e.g., cognitive, behavioral, and caregiver engagement strategies) or other clinical factors (e.g., antidepressant medication status) to the end treatment effect, which will be the focus of future dismantling studies (Dobkin et al., 2020). Fifth, even though 41% of T-CBT participants got to or went over the study criteria of depression “much improved” (CGI-I ≤ 2), and mean HAM-D scores lowered more than 1.5 standard deviations (SDs) in the T-CBT group, there were still reports of post-residual symptoms. This applies to the other tools and results. Finally, while remote delivery of interdisciplinary PD services is expanding and being seen as critical for advancing care, limitations stay on insurance coverage for telemental health services like T-CBT (Dobkin et al., 2020). Reimbursement may also be hard to achieve based on patients’ eligibilities of telehealth. In addition to the quality rating strengths, here are other strengths of the article. It helps the promise of telemedicine to extend the reach of evidence-based, PD depression treatment, and its grand benefits for PD self-management, into usual neurologic care. It addresses some generalizability questions related to the objective of spreading access to PD depression care. It makes access more equitable to people who don’t live near mental health services or other medical centers. The interventions statistically significantly achieve the desired results and increase the likelihood of the intervention being applicable to many more patients with PD (Dobkin et al., 2020).

Despite quality of life not being the primary outcome, it was positively improved in patients with PD, along with a reduction in depression and anxiety thanks to T-CBT, which is the supportive therapy in this case. T-CBT combined with TAU, the standard practice, had a statistically significant effect on all three outcomes of the study. Reductions in depression and anxiety would also greatly improve quality of life compared to just basic practice alone. In this article, it would be TAU, the control variable.

LL

W.M. Michael Schuepbach, Lisa Tonder, Alfons Schnitzler, Paul Krack, Joern Rau, Andreas Hartmann, Thomas D. Hälbig, Fanny Pineau, Andrea Falk, Laura Paschen, Stephen Paschen, Jens Volkmann, Haidar S. Dafsari, Michael T. Barbe, Gereon R. Fink, Andrea Kühn, Andreas Kupsch, Gerd-H. Schneider, Eric Seigneuret, Valerie Fraix, Andrea Kistner, P. Patrick Chaynes, Fabienne Ory-Magne, Christine Brefel-Courbon, Jan Vesper, Lars Wojtecki, Stéphane Derrey, David Maltête, Philippe Damier, Pascal Derkinderen, Friederike Sixel-Döring, Claudia Trenkwalder, Alireza Gharabaghi, Tobias Wächter, Daniel Weiss, Marcus O. Pinsker, Jean-Marie Regis, Tatiana Witjas, Stephane Thobois, Patrick Mertens, Karina Knudsen, Carmen Schade-Brittinger, Jean-Luc Houeto, Yves Agid, Marie Vidailhet, Lars Timmermann, Günther Deuschl (2019).

It was to see if deep brain stimulation (DBS) of the subthalamic nucleus (STN) for Parkinson's disease (PD) with early motor complications can greatly improve quality of life (QOL) of patients compared to best medical treatment (BMT) (Schuepbach et al., 2019).

One study aim is to see how DBS impacts QOL in patients with different 39-Item Parkinson's Disease Questionnaire summary index (PDQ-39-SI) baseline scores. It seems that those with little baseline scores between 0-30 get less benefits out of DBS compared to those who surpass that score. The other study aim is to continue evaluating the effect of DBS on quality of life of PD patients throughout the future.

A prospective randomized controlled trial

There were 151 people with Parkinson’s disease and impaired quality of life from an EARLYSTIM’S study 2 years ago. The patients were under 61 years of age and had a decent response to levadopa, but had early to advanced motor complications for at least 3 years. This article follows up the results of that study 2 years later. The setting is not stated in this article. 124 people did the main intervention that is STN-DBS, while 127 people did the best medical treatment, which is the control group intervention (Schuepbach et al., 2019).

The independent variables are deep brain stimulation (DBS) and best medical treatment (BMT). The dependent variable is quality of life.

Quality of life significantly improved more in the main intervention group (STN-DBS p < 0.001, medical group p < 0.001) than in patients in the medical control group (p = 0.0262 for interaction) (figure 1). (Schuepbach et al., 2019).

This is Level 1, quality B research. A randomized controlled trial is one of the most top levels of research to determine the relationship of cause and effect. The results are reasonably consistent with a more than sufficient sample size and a control group. The conclusions are fairly definitive since the intervention seems to work better on those with more advanced baseline PDQ-39-SI scores than those with less baseline PDQ-39-SI scores. Here are the limitations of the article. First, the study targeted many people under 61 years of age with a more than average response to levadopa. With that in mind, it’s likely that adults over the age of 61 may not benefit too much. Second, DBS may not be too helpful in those with little to no response for levodopa. Third, the lack of associations of age, disease duration, and disease severity with the change of QOL after STN-DBS leaves only baseline PDQ-39-SI scores as a predictor QOL change. Fourth, those with less severe PD may get less out of the treatments. As for the strengths in addition to the quality rating strengths, the results are valid and reasonably consistent throughout the 2 years. The correlations between DBS and baseline scores are stronger than those between the control. The study proves to work in patients with more advanced PD.

In this article, DBS (the supportive therapy), combined with BMT (the standard practice), had a statistically significant effect in terms of improving QOL compared to BMT alone. The effect improved for 2 years.

LL

Adriano Zanardi da Silva, Vera Lúcia Israel

The purpose of the study was to determine the effectiveness of dual-task aquatic exercises in a heated pool to stimulate the situations of corporal instability and improve functional mobility, balance, and gait of individuals with Parkinson's disease.

The study aims to verify the effects of a dual-task aquatic exercises program on the functional mobility, balance, and gait of individuals with PD.

A randomized, single-blind trial was used.

The sample size was 36 individuals with PD recruited in January 2016 by convenience and willingness at The Association of Parkinson's Disease Patients, Paraná - Brazil. The 28 participants who met the inclusion criteria were assigned randomly to experimental and control groups. However, after randomization, 25 individuals (14 intervention and 11 control group) completed the study with a sample loss of greater than 20%. Males and females with a clinical diagnosis of idiopathic PD were considered eligible.

The independent variable was a dual-task aquatic exercise program. The dependent variable is functional mobility, balance, and gait improvement.

This study is a level 1 of quality B evidence.

Strengths: The study is a Randomized control trial and a sufficient sample size using GPower 3.1 software to calculate the minimum sample of 30 individuals with an effect size of 0.25 on a probability distribution F. The research ethics committee approved the study, conforms to all CONSORT guidelines, and reports all required information. They used the Shapiro-Wilk test to evaluate the contribution pattern and used ANOVA for repeated measures. They evaluated the study in three sessions (at the beginning of the intervention (AS1), three months later in the study (AS2), and three months after the intervention program (AS3)).

Limitations:

RA

Muhammad Kashif1, Ashfaq Ahmad, Muhammad Ali Mohseni Bandpei, Syed Amir Gilani, Asif Hanif and Humaira Iram

RA

Sangarapillai, K., Norman, B. M., & Almeida, Q. J. (2021).

The purpose of this study was to investigate the effects of boxing and sensory exercise on motor symptoms of Parkinson's disease

The study aims to look into how boxing and sensory exercise affect Parkinson's disease motor symptoms.

Double-blinded parallel-group randomized controlled trial (RCT). The type of study was an intervention study.

The study used independent t-tests to assess group comparability at pre-assessment. A 2-factor mixed repeated-measures ANOVA was used to explore the primary outcome measure (UPDRS-III) using 2 groups and 3 evaluation times. Repeated-measures ANOVA was used to explore secondary outcome measures. Pairwise comparisons of within and between were explored. Significant interactions were followed up with Tukey's post hoc, and the alpha level was set at .05 for all analyses

The sample size was approximately 40 total participants randomly assigned to intervention 1 and 2 exercise groups (20 per group). The population was mainly composed of individuals with idiopathic Parkinson’s; no additional comorbid neurological disorders, from the Movement Disorders Research and Rehabilitation Center, Wildrid Laurie University; only those who consented took part in the study

The independent variable was the type of exercise intervention (boxing or sensory). The dependent variable was motor symptoms of Parkinson's disease, measured using the UPDRS-III and unbiased computerized gait data

The study used independent t-tests to assess group comparability at pre-assessment. A 2-factor mixed repeated-measures ANOVA was used to explore the primary outcome measure (UPDRS-III) using 2 groups and 3 evaluation times. Repeated-measures ANOVA was used to explore secondary outcome measures. Pairwise comparisons of within and

The study found that both boxing and sensory exercise interventions led to significant improvements in motor symptoms of Parkinson's disease, as measured by the UPDRS-III and unbiased computerized gait data. Specifically, both groups showed significant improvements in UPDRS-III scores at post-intervention and washout periods compared to pre-assessment. Additionally, both groups showed significant improvements in gait parameters, including stride length and stride velocity. There were no significant differences between the two groups in terms of improvement in motor symptoms

This is a level I study of good quality evidence strength.

Strengths: The study design was a randomized controlled trial, which is a strong design for evaluating the efficacy of an intervention. The study’s strengths also stem from the use of a multimodal exercise program, the inclusion of various measures of feasibility, safety, and efficacy, and the stratification of participants by sex and Hoehn and Yahr stage.

Limitations: The sample size was small, and the study was limited by the short duration of the intervention and the lack of blinding of participants and assessors.

This article relates to the PICO question because it provides moderate evidence for the feasibility and safety of a high-intensity exercise boot camp for persons with Parkinson's disease and suggests potential benefits for balance, gait, and quality of life.

CA

Li, K., Xu, S., Wang, R., Zou, X., Liu, H., Fan, C., ... & Wu, H. (2023).

The purpose of this study is to investigate the efficacy and safety of combining electroacupuncture with conventional pharmacological treatment for motor dysfunction and constipation in patients with Parkinson's disease.

The aim of this study is to determine whether electroacupuncture combined with traditional pharmaceutical treatment is safe and effective in treating motor impairment and constipation in Parkinson's disease patients.

Randomized controlled multi-center trial

The study used the entire randomization feature of SAS to construct computer-generated random sequences. The intention-to-treat (ITT) analysis population was the primary population for efficacy and safety analyses. Missing data on the primary outcome were assumed to be missing at random and imputed using the multiple imputation method.

Sensitivity analysis was conducted based on patients with complete outcome data (per-protocol, PP), and subgroup analysis was implemented to explore the differences of change of UPDRS score from baseline to week 12 between the EA group and control group by sex and age.

Statistical analysis was performed by applying SAS 9.4 software with a two-tailed P value of less than 0.05 considered statistically significant.

The normality distribution of quantitative variables was assessed based on the "Shapiro-Wilk" results, with a P value >0.05 indicating that the quantitative variable was normally distributed. The data were described as means and standard deviations (SD) or as the median and interquartile range (IQR) for quantitative variables. The data were described by frequency counts and proportions (rate) for qualitative variables.

The sample size included 166 patients with Parkinson's disease from 7 hospitals in China. The mean age of the patients was 63.5 years, and the majority were male (62.7%). The patients had a mean disease duration of 5.6 years and a mean UPDRS score of 32.1.

The independent variable was the use of electroacupuncture in combination with conventional pharmacological treatment.

The dependent variables were changes in the Unified Parkinson's Disease Rating Scale (UPDRS) scores and bowel movement frequency.

The study found that the use of electroacupuncture in combination with conventional pharmacological treatment significantly improved motor function and bowel movement frequency in patients with Parkinson's disease compared to conventional treatment alone. The mean change in UPDRS score from baseline to week 12 was significantly greater in the electroacupuncture group than in the control group (mean difference -4.2, 95% CI -6.1 to -2.3, P<0.001). The mean change in bowel movement frequency from baseline to week 12 was also significantly greater in the electroacupuncture group than in the control group (mean difference 0.5, 95% CI 0.2 to 0.8, P=0.001). No serious adverse events were reported in either group.

The study provides level I evidence, which is the highest level of evidence. The quality of the evidence is rated as high.

Strengths: The study was a well-designed randomized controlled trial with a large sample size and a low risk of bias. The study adhered to the Consolidated Standards of Reporting Trials (CONSORT) and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines for reporting randomized trials.

Limitations: However, the study was conducted in China, and the results may not be generalizable to other populations. Additionally, the study did not include a sham acupuncture group, which limits the ability to determine the specific effects of electroacupuncture

This article relates to the pico question because electroacupuncture can stimulate nerve function in PD patients, which promotes peristalsis and hence prevents constipation

CA

Tamplin, J., Morris, M. E., Marigliani, C., Baker, F. A., & Vogel, A. P. (2019).

The study's purpose is to investigate the effectiveness of a singing intervention on speech and communication in people with Parkinson's

The aim of this study is to determine whether singing can improve speech and communication in Parkinson's patients.

Randomized controlled trial.

The sample size is 75 participants, with an average age of 74 years and 61% male. The population characteristics are people with Parkinson's disease.

The independent variable is the singing intervention (ParkinSong) and the control group. The dependent variables are speech intelligibility and communication ability.

The study found that the Parkin Song program was effective in improving speech intelligibility in people with Parkinson's disease. The results showed were statistically significant between-group difference in speech intelligibility as measured by SIT scores (P = .027). The decrease in intelligibility for monthly controls was statistically significantly different from that for weekly controls (P = .001), monthly singers (P ≤ .001), and weekly singers (P < .001). The average overall baseline intelligibility measured by the SIT was around 90% for the sample as a whole. Additionally, there was a statistically significant between-group difference in perceptual intelligibility consensus ratings (P = .001). The decrease in intelligibility for monthly controls was statistically significantly different from that for weekly controls (P = .001), monthly singers (P ≤ .001), and weekly singers (P < .001). However, the authors note that participants selected their group (ParkinSong or control), which created selection bias. It is possible that the degree of improvement in the weekly ParkinSong participants was a result of the higher dosage or expertise of the facilitators or a combination of both. A large-scale randomized controlled trial is needed to deal with the limitations of selection bias yielded in this study.

The level of evidence strength for this study is Level I with high quality evidence.

Strengths: The study used a randomized controlled trial design and included a large sample size. The study also used validated outcome measures and reported interrater reliability.

Limitations: However, the study has some limitations, including the lack of blinding of participants and therapists, the use of self-reported outcome measures, and the relatively short follow-up period of 3 months. Additionally, the study only included participants from Australia, which may limit the generalizability of the findings to other populations.

This article relates to the pico question because singing intervention on speech and communication in people with parkinsons helps relax muscle and release tension in the back and neck

LT

Landers, M. R., Navalta, J. W., Murtishaw, A. S., Kinney, J. W., & Richardson, S. P. (2019).

The study's purpose was to explore the feasibility, safety, and efficacy of a multimodal exercise program and its potential impact on disease-modifying mechanisms in persons with Parkinson's

This study aims to investigate the viability, security, and effectiveness of a multimodal exercise program as well as its possible influence on disease-modifying processes in Parkinson's disease patients.

Randomized controlled trial (RCT). The type of study was an intervention study.

The sample size was 32 participants (16 in each arm). The population characteristics were persons with Parkinson's disease who were able to walk independently and had no contraindications to exercise.

The independent variable was the type of exercise program (HIBC vs. UC).

The dependent variables were various measures of feasibility, safety, and efficacy, including attendance, aerobic intensity, strengthening, attrition, intrinsic motivation, balance, gait, and quality of life.

The study found that the high-intensity multimodal exercise boot camp (HIBC) was better at attaining CDC guidelines (P = 0.013) and spent more minutes in higher-intensity exercise per week (P < 0.001) compared to the usual care (UC) arm. There were no differences in adverse events (P = 0.419) between the two groups.

The HIBC arm experienced significant improvements in 7 out of 31 outcomes, while the UC arm experienced significant improvements in 3 out of 31 outcomes. The outcomes that showed significant improvements in the HIBC arm included balance, endurance and fatigue, motor activity, strength, mental health, and quality of life. The outcomes that showed significant improvements in the UC arm included endurance and fatigue, strength, and quality of life.

Brain-derived neurotrophic factor (BDNF) improved significantly for both groups from pre- to post-tests (Ps ≤ 0.041), indicating that exercise can increase BDNF levels in individuals with PD. An improved anti-inflammatory response was observed for both groups, suggesting that exercise may have anti-inflammatory effects in individuals with PD.

Overall, the study suggests that HIBC is feasible, safe, and produces a signal of efficacy relative to UC across a wide breadth of outcomes in individuals with PD. However, further research is needed to confirm these findings and determine the long-term effects of HIBC participation on individuals with PD.

This is a level I study of good quality evidence, strength and quality.

Strengths: The study design was a randomized controlled trial, which is a strong design for evaluating the efficacy of an intervention. The study’s strengths also stem from the use of a multimodal exercise program, the inclusion of various measures of feasibility, safety, and efficacy, and the stratification of participants by sex and Hoehn and Yahr stage.

Limitations: The sample size was small, and the study was limited by the short duration of the intervention and the lack of blinding of participants and assessors.

Overall, the study provides moderate evidence for the feasibility and safety of a high-intensity exercise boot camp for persons with Parkinson's disease and suggests potential benefits for balance, gait, and quality of life.

They article relates to the Pico question because multimodal exercise program helps PD patients in improve and maintain physical and cognitive function.

LT