discussion. response
RANDOMIZED TRIALS IN EPIDEMIOLOGY
discussion. response
RANDOMIZED TRIALS IN EPIDEMIOLOGY
Respond to
two colleagues in one or more of the following ways:
· Ask a probing question, substantiated with additional background information, evidence, or research.
· Share an insight from having read your colleagues’ postings, synthesizing the information to provide new perspectives.
· Offer and support an alternative perspective using readings from the classroom or from your own research in the Walden Library.
· Validate an idea with your own experience and additional research.
· Make a suggestion based on additional evidence drawn from readings or after synthesizing multiple postings.
· Expand on your colleagues’ postings by providing additional insights or contrasting perspectives based on readings and evidence.
PEER #1
Clinical trials are usually tightly controlled in terms of eligibility, delivery of the intervention, and monitoring of outcomes. A clinical trial is termed a randomized controlled trial (RCT), which is most appropriate for testing narrow hypotheses regarding vaccines, treatments, or individuals’ behavior change (Friis & Sellers, 2021).
Select Article: Phase III Randomized Controlled Trial of eRAPID: eHealth Intervention During Chemotherapy
Link:
The data of this study trial was collected between January 22, 2015, and June 11, 2018. 782 patients were identified. Ninety-two were ineligible, 182 of 690 fully eligible patients declined participation (26.4%), and 508 of 690 patients (73.6%) consented and were randomly assigned to Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) program (Absolom et al., 2021). eRAPID is a weekly online symptom reporting system. This trial aimed to evaluate the potential benefits of eRAPID for patients and clinicians when added to usual care (UC) during chemotherapy in a population of predominantly early-stage cancer treated with curative intent (Absolom et al., 2021). The total number of participants in usual care adding eRAPID intervention was 256, and the total number of participants in the usual care group was 252; the total number of patients in this trial was 508 with consent.
Purpose
eRAPID is an online eHealth system for patients to self-report symptoms during cancer treatment. The hypothesis was that adding eRAPID in usual care (UC) would improve symptom control, reduce hospital contacts or emergency admissions, and increase patient self-efficacy in managing side effects. This trial evaluated the impact of eRAPID on symptom control, healthcare use, patient self-efficacy, and quality of life (QOL) in a patient population treated predominantly with curative intent (Absolom et al., 2021).
Study population
This trial targets cancer patients on treatment therapy for colorectal, breast, or gynecological cancers. Patients were eligible if they planned to receive chemotherapy for colorectal, breast, or gynecological cancers, had internet access at home or via mobile devices, were fluent in English, did not participate in clinical trials with patient-reported outcome measures (PROMS), and did not exhibit cognitive dysfunction (Absolom et al., 2021).
Length of the trial
18 weeks was selected as the primary endpoint, with 6 and 12 weeks being secondary endpoints. Patient outcome was measured at 6, 12, and 18 weeks.
Data collection methods
The primary outcome was symptom control measured by using the Functional Assessment of Cancer Therapy Scale-General Physical Well-Being subscale (FACT-PWB, scores 0-28, high scores = better symptoms) (Absolom et al., 2021). All data are collected online, however, all outcome PROMs at 6, 12, and 18 weeks were completed in both arms on paper to ensure equality in mode of outcomes assessment. Baseline questionnaires were completed prior to random assignment (Absolom et al., 2021).
Outcome measures
The measurements were analyzed every 6 weeks for 18 weeks to compare the two groups’ primary outcomes on physical well-being (deteriorated, stable, and improved), process of care, and patient self-efficacy. Multivariable mixed-effects repeated-measures models were used for analyses (Absolom et al., 2021).
Results and conclusions
At 18 weeks, eRAPID patients reported better self-efficacy (P = .007) and better health on EQ5D-VAS (P = .009). Average patient compliance with weekly symptom reporting was 64.7%. Patient adherence was associated with clinician’s data use and improved at 12 weeks. Moreover, real-time monitoring with electronic patient-reported outcomes improved physical well-being (6 and 12 weeks) and self-efficacy (18 weeks) in a patient population predominantly treated with curative intent without increasing hospital workload (Absolom et al., 2021).
Ethical issues associated with the study
All participants were given full consent; all the data were collected online without patients’ detailed information. All participant’s answers and responses to the questionnaires are protected. One of the ethical considerations of ethical issues in randomized controlled trials is determining what constitutes “usual care” and implications for trial reporting, identifying relevant risks from trial participation, and determining what constitutes minimal risk (Nicholls et al., 2019). Considering the participant’s age and ability to use devices to report symptoms weekly, it might be a challenge in the geriatric population. On the other hand, patients should receive education on self-reporting potential adverse reaction symptoms immediately during treatment/therapy, whether with usual care or adding on eRAPID; the outcome from the two groups might indicate that patient education and treatment complications provided to patients were lacking during clinic visits. Furthermore, because the usual care (UC) group data was collected by paper documentation, it raised concerns about the accuracy and possible documentation errors during collection.
How did this research study benefit from its experimental design? What was achieved by randomization that might not otherwise have been achieved?
This study demonstrated the benefit of using a digital symptom monitoring system for patients. Utilizing eRAPID with usual care is a way to closely monitor adverse reactions during treatment and report them immediately to receive rapid treatment, improving quality of life and treatment outcomes. Using the chance to divide people into groups means that the groups will be similar and that the effects of the treatments they receive can be compared more fairly. At the time of the randomized clinical trial, the best treatment is unknown (National Cancer Institute). However, because the study trial is designed to compare and find the best intervention, randomized controlled trials in cancer research have played a remarkable role in the past five decades, even though there are some concerns of sponsorship bias and most of the results are mostly positive (Del Paggio et al., 2021). No doubt, randomized controlled trials in cancer research have provided the most valuable resources and data that would improve cancer treatments and therapies and further positively impact patients’ care outcomes and quality of life.
References
Absolom, K., Warrington, L., Hudson, E., Hewison, J., Morris, C., Holch, P., Carter, R., Gibson, A., Holmes, M., Clayton, B., Rogers, Z., McParland, L., Conner, M., Glidewell, L., Woroncow, B., Dawkins, B., Dickinson, S., Hulme, C., Brown, J., & Velikova, G. (2021). Phase iii randomized controlled trial of erapid: Ehealth intervention during chemotherapy.
Journal of Clinical Oncology,
39(7), 734–747.
to an external site.
Del Paggio, J. C., Berry, J. S., Hopman, W. M., Eisenhauer, E. A., Prasad, V., Gyawali, B., & Booth, C. M. (2021). Evolution of the randomized clinical trial in the era of precision oncology.
JAMA Oncology,
7(5), 728.
to an external site.
Friis, R. H., & Sellers, T. (2021).
Epidemiology for public health practice (6th ed.). Jones & Bartlett Learning.
Nci dictionary of cancer terms. (n.d.). National Cancer Institute.
to an external site.
Nicholls, S. G., Carroll, K., Zwarenstein, M., Brehaut, J. C., Weijer, C., Hey, S. P., Goldstein, C. E., Graham, I. D., Grimshaw, J. M., McKenzie, J. E., Fergusson, D. A., & Taljaard, M. (2019). The ethical challenges raised in the design and conduct of pragmatic trials: An interview study with key stakeholders.
Trials,
20(1).
to an external site.
PEER #2
Randomized Trail in Epidemiology
The Article: Optimizing PMTCT Adherence by Treating Depression in Perinatal Women with HIV in South Africa: A Pilot Randomized Controlled Trial.10.1007/s12529-022-10071-z
Purpose of the Randomized Control Trial (RCT)
The study aims to evaluate the effectiveness of improving medication adherence and depression among women with human immunodeficiency (HIV) by utilizing several interventions. The intervention content was problem-solving with depression, stigmas associated with HIV, social support, and medication adherence.
Study Population
Two hundred seventy-four patients were approached in the clinic, and 266 were screened for eligibility. Of these, 34 (13%) were eligible and interested in participating, and 23 of those 34 (67.6%) enrolled. Fourteen participants were randomized to the intervention arm, and nine were randomized to the control arm. (Psaros et al., 2022) The study included twenty-three Black South African (SA) pregnant women ages 18-45, in the third trimester, with gestation greater than 28 weeks, diagnosed with (HIV) and on antiviral therapy (ART), with self-reporting MDD.
Study Duration
The trial length was conducted during pregnancy, immediately post-pregnancy, and three months posttreatment and included a qualitative exit interview.
Data Collection Methods
To assess medication adherence, depression, HIV stigma score, and women’s social support, several different methods were used. Medication adherence to ART during the previous month was measured through a composite score developed by Lu and colleagues. Current and past MDD was calculated using the 17-item Major Depressive Episode module of the Mini International Neuropsychiatric Interview (MINI). HIV-related stigma was measured at baseline, posttreatment, and 3-month follow-up using the HIV/AIDS Stigma Instrument–People Living with AIDS (HASI-P). A modified version of the Duke-UNC Functional Social Support Questionnaire assessed participants’ emotional, informational, and tangible support networks at baseline, posttreatment, and 3-month follow-up. (Psaros et al., 2022)
The participants provided feedback and suggestions for future intervention in their exit interview.
Outcomes Measure
Nineteen of 23 participants (82.6%; 7 control, 12 intervention) met the criteria for MDD on the MINI at baseline. Posttreatment, two of the 17 participants who completed the study (11.8%) met for MDD on the MINI, and both were in the control arm. At 3-month follow-up, one participant was in the control arm (10% of all participants who completed this final assessment), and none in the intervention arm met the MINI criteria for MDD. (Psaros et al., 2022) The intervention was, therefore, not associated with increases in ART adherence compared to the control. No significant main effects emerged.
Ethical Issues Associated with The Study
These women have several vulnerabilities: pregnancy, depression, HIV, poverty, and little social support, which raises questions about whether they were appropriate for this study. They were given patient education, medication regimen management, convenient medication administration, reminders, and psychotherapies. However, ethical approval was obtained for the study; these women were compensated for transportation, and each session raises questions about their motivation for medication adherence or monetary benefits. The control group was only given one session of problem-solving, which is questionable if that is enough support for a poor, depressed pregnant woman with HIV. I’m afraid I have to disagree that the control design can’t support it. Lastly, this was a small sample size. To be effective in random control trials, researchers needed larger samples.
References
Friis, R. (2021). Experimental Study Design. In T. Sellers (Ed.),
Epidemiology for Public Health Practice (6th ed., pp. 24–51). Jones & Bartlett Learning.
Psaros, C., Stanton, A. M., Raggio, G. A., Mosery, N., Goodman, G. R., Briggs, E. S., Williams, M., Bangsberg, D., Smit, J., & Safren, S. A. (2022). Optimizing pmtct adherence by treating depression in perinatal women with HIV in South Africa: A pilot randomized controlled trial.
International Journal of Behavioral Medicine,
30(1), 62–76.
to an external site.
