Critical Appraisal of Research Evidence Based Project

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

Full APA formatted citation of selected article.

Article #1

Article #2

Article #3

Article #4

Cleland J. G., Louis, A. A., Rigby, A. S., Jannsens, U., Aggie, H. M.,…& Balk, M. (2005), Noninvasive Home Telemonitoring for Patients with Heart Failure at High Risk of Recurrent Admission and Death: The Trans-European Network-Home-Care Management System(TEN-HMS) Study. Journal of the American College of Cardiology, 45(10), 1654-64.

Zhao, Q., Chen, C., Zhang, J., & Fan, X. (2020). Effects of Self-Management Interventions on Heart Failure: Systematic Review and Meta-Analysis of Randomized Controlled Trials. International Journal of Nursing Studies, doi: 10.1016/j.ijnurstu.2020.103689

Inglis, S. C., Clark, R. A., Direkcx, R., Prieto-Merino, D., 7 Cleland, J. (2015). Structured Telephone Support or Non-Invasive Telemonitoring fpr Patients with Heart Failure. Cochrane Database of Systematic Reviews, 10(1), doi: 10.1002/14651858.CD007228.pub3

Srivastava, A., Do, J., Sales, V. L., Ly, S., & Joseph, J. (2018). Impact of Patient-Centered Home Telehealth Program on Outcomes in Heart Failure. Journal of Telemedicine and Telecare, 0(0), 1-6.

Evidence Level *

(I, II, or III)

Level I – the study uses a randomized controlled trial design

Level I – this is a systematic review of 15 randomized controlled trials

Level I – this is a systematic review of 41 published RCTs of either non-invasive home tele-monitoring or structured telephone support

Level II – the study uses a quasi-experimental research design, where there is no random assignment of subjects to either an experimental or control group. Further, here is no manipulation of variables as in a true experimental design as the study is retrospective and the researchers only observe behavior.

Conceptual Framework

Describe the theoretical basis for the study (If there is not one mentioned in the article, say that here).**

There is no conceptual framework mentioned in the article

The theoretical basis is Albert Bandura’s self-efficacy theory, which assets that an individual’s ability to exert control over their social environment and behavior is influenced by how much they believe in their individual capacities.

There is no conceptual framework mentioned in the article

There is no conceptual framework mentioned in the article

Design/Method

Describe the design and how the study was carried out (In detail, including inclusion/exclusion criteria).

Participants were assigned randomly to receive Home Telemonitoring (HTM), Nurse Telephone Support (NTS) and usual care (UC) Consent was obtained after which participants’ baseline was collected. The HTM and NTS were the main points of comparison, with the UC group used as a reference to ascertain whether either NTS or HTM had changed. To be included, one needed to i) have had a hospital admission due to worsening heart failure lasting >48 hours over the past 6 weeks, ii) to be receiving Furosenide at a dose of >=40mg/day (or equivalent, ?1 mg Bumetanide, iii) or ?10mg Torasemide). They also needed to have persistent heart failure symptoms, an LV diastolic dimension >30mm/m (height), and an LV ejection fraction of

The researchers searched the Cochrane, Web of Science, Embase, and PubMed Libraries using combined keywords such as (Congestive Heart Failure or Myocardial Failure or Chronic Heart Failure or cardiac failure or heart failure) AND (self-management or self-administration or self-care or self-monitoring) AND (controlled clinical trial or randomized controlled trial or controlled clinical trial or randomized or randomly). The search yielded a total of 4,977 publications. The inclusion criteria was as follows: i) the interventions in the study were consistent with self-management interventions based on self-efficacy theory, ii) at least one group of participants received routine care while the other received self-management interventions, iii) the study included participants diagnosed with heart failure, and iv) the study was a randomized controlled trial. Studies using cohorts, case studies, qualitative data, and quasi-experimental designs were excluded. The inclusion and exclusion criteria gave rise to 15 randomized controlled trials with a total of 3630 participants

The researchers searched the Cochrane Central Register of Controlled Trials, MedLine, Embase, EBSCO, ProQuest, and TROVE, without applying language limits. The selection criteria included: i) the study wa peer reviewed, ii) the study was an RCT, iii) the study compared structured telephone support or non-invasive home telemonitoring to usual care, and iv) the intervention lasted between four and six weeks. The selection criteria led to 41 published RCTs with a total of 12,192 participants.

The researchers performed a retrospective analysis of the impact of telehealth on the outcomes of heart failure patients. 197 heart failure patients who had successfully completed the home telehealth monitoring program at a medical facility for veterans were placed as the observation group. Their outcomes before joining and upon completing the program were recorded and compared to those of 870 heart failure patients who were not enrolled in the telehealth program. The inclusion/exclusion criteria for the telehealth cohort is as follows: i) the patient has heart disease; ii) patient has had greater than 14 outpatient visits in one year, iii) patient lives in a which the home environment is feasible, and iv) patient can safely operate telehaelth equipment. Conversely, the inclusion/criterion for the control cohort is that a patient has health failure and has been admitted at the facility within the past 30 days.

Sample/Setting

The number and characteristics of

patients, attrition rate, etc.

The initial sample was made up of 426 randomized patients, of whom 85 were randomly assigned to UC, 173 to NTS, and 168 to Home Telemonitoring. Of those assigned to UC, 55 completed the 240-day follow-up while 28 died; 100 of those assigned to NTS also completed the follow-up, with 35 dying; and 106 of those in THM completed the 45—day follow-up with 36 dying. The sample characteristics were as follows: 48% were aged above 70, and the mean Left Ventricular Ejection Fraction (LVEF) was 25 percent, and median Plasma N-Terminal natriuretic peptide was 3,070pg/ml

The sample was made up of a total of 2,630 participants from 15 RCTs. The mean age of the sample was 67 years, with males making up 61.9 percent of the total participants. 5 of the studies were based on the US, 3 in Germany, 2 in Japan, 1 in Australia, and 1 each from the Netherlands, Switzerland, Iran, and Italy. 6 studies delivered interventions by face-to-face methods and telephone, 4 studies used only face-to-face delivery, 4 used telephone only, and 1 used a website. All 15 studies were published between 1995 and 2018, with the duration of intervention ranging from 2months to 12 months.

The sample was made up of 12,192 participants. 25 studies (with 9,332 participants) evaluated structured telephone support, while 16 (with 3,860 participants) evaluated tele-monitoring

The sample was composed of 1,067 participants -197 in the telehealth group and 870 in the control group. The sample was predominantly male (193 in case group and 830 in control)

Major Variables Studied

List and define dependent and independent variables

The independent variable was the mode of patient monitoring, measured by the nominal variables HTM, UC, and NTS. The outcome variable was the risk of hospitalization or death measured by the number of days lost as a result of death or hospitalization from heart failure or other cardiovascular conditions out of the 240 days of follow-up.

The independent variable was self-management intervention. The outcome variables were: heart failure knowledge, quality of life, and heart failure-related hospitalizations. Heart failure knowledge was measured using the Japanese Heart Failure Knowledge scale, the Dutch Heart Failure Knowledge scale, and the Atlanta Heart Failure Knowledge test. Quality of life was measured using the Chronic Heart Failure Questionnaire, MacNew Heart Disease Health-Related QOL Instrument, Iranian Heart Failure QOL Questionnaire, and the Kansas City Cardiomyopathy Questionnaire.

The study sought to review RCTs on structured telephone support or non-invasive home telemonitoring to quantify the effects of the same over and above usual care. The independent variables were Usual Care, Non-Invasive Home Telemonitoring, and Structured Telephone Support. The dependent variables were: all-cause mortality, and total number of hospitalizations of at least three days.

The independent variable is telehealth. Outcome variables included: hospitals admission, average length of stay during admission, emergency room visits and primary care visitors.

Measurement

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

Treatment groups were compared using the two-sample Wilcoxon test. Outcome measures were expressed as difference between means at 95% confidence interval, and were analyzed using the Chi-square and Kruskal-Wallis tests. To measure progression from baseline characteristics, the Cox regression was conducted at 99 and 95% Confidence intervals to measure changes in covariates over the period: beta-blockers, ACE inhibitors, creatinine, urea, Sodium, Hb, diastolic and systolic blood pressure, body mass index, and age.

The I2 statistic and Cochran’s Q test were used to assess heterogeneity of the meta-analysis. P

The I2 statistic was used to assess heterogeneity of the meta-analysis Data was presented as risk ratios (RR) with 95% CI. All-cause mortality and heart failure-related hospitalizations were analyzed using the fixed effects model, while length of stay, quality of life, and heart failure knowledge were analyzed using random effects model

The outcome variables were compared between patients with home telehealth program and those in the control group; as well as within the telehealth group before and after completion of the program. T-tests and Fisher’s exact tests were used to measure differences.

Data Analysis Statistical or

Qualitative findings

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

Over the 240 days of the intervention, fewer days were lost to death or hospitalization among HTM patients as compared to NTS patients (an average of 10.9 days versus 14 days), but the differences were not statistically significant. However, prognosis was still found to be poor – mean PlasmaNT-proBNT, creatinine, and systolic blood pressure had increased, while Sodium levels, Hb, and BMI had fallen across the board.

Three studies, with a total of 142 participants, reported knowledge on heart failure, with the combined results showing self-management interventions to have a significant effect (SMD 0.61, 95%CI, p = 00004). 9 studies, with a total of 1,871 participants, reported on the quality of life, with the results indicating a significant relationship (SMD 0.21, 95% CI, p = 0.03). 4 studies reported on heart failure-related hospitalizations, with a total of 689 participants yielding a significant relationship between self-management interventions and reduced hospitalization rates (SMD 0.41, 95%CI, p= 0.00001). The results

17 studies , with a total of 3,740 participants repoported on non-invasive tele-monitoring and found it to be a significant reducer of all-cause mortality (RR 0.80, p

Total hospital days per patient reduced significantly with enrolment into the telehealth program (2.4±3.5, p

Findings and Recommendations

General findings and recommendations of the research

Home-telemonitoring improves outcomes for heart failure patients by ensuring better organization of care and timely detection of cardiovascular and non-cardiovascular problems. However, best results could be achieved if such monitoring is complemented by regular calls to assess progress.

Self-management interventions including educational programs on disease management, medication, symptom recognition, and diet management have beneficial effects on heart failure knowledge, quality of life and heart failure-related hospitalizations. Effective self-management may help patients to adapt better heart failure knowledge, play a more active role in the management of heart failure, establish a good lifestyle, and reduce hospitalizations. However, more research is needed to study the effectiveness of the same in case of prolonged use.

For heart failure patients, non-invasive telemonitoring and structured telephone support reduced the risk of hospitalization and all-cause mortality. However, more research is needed to study the effectiveness of the same in case of prolonged use.

Patient centered, personalized home telehaelth monitoring in patients with heart failure is successful in reducing adverse health outcomes. However, more research is needed to study the effectiveness of the same in case of prolonged use.

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?

The general worth of the study is that it adds to existing literature in showing the benefits that telehealth monitoring has on patients with heart failure.

The RCT study design increases the objectivity of findings. However, the study does not show the effectiveness of teleheath monitoring in the long-term.

The risk of using telehealth technologies is that it forces primary care providers to be constantly training patients on the use of the technology as it improves. Wrong usage could be misleading, providing inaccurate information and making it difficult to adequately identify health concerns.

The use of telehaelth is nonetheless feasible for my practice, but only if the patient adequately understands how to use the same.

The general worth of this research is that it provides evidence that self-management interventions could improve health outcomes for patients with heart failure, save medical costs, and reduce the economic burden of heart failure on patients and their families.

The greatest strength of the study is the fact that it uses only randomized controlled trials, which enhances the objectivity of results. However, the use of different studies is also its core weakness – these studies have different modes of intervention, contents, tools of evaluation, and there is a publication bias in the quality of life outcome, which could overstate the effectiveness of interventions. Further, the study ignores the long-term effectiveness of self-management interventions.

The risk of implementing the study findings is that it is not clear what self-management interventions yield the best outcomes or are more manageable by different groups of patients. As such, a selected self-management intervention may yield less desirable results than presented in the study.

The study findings are feasible for my practice, but I would recommend that future research be conducted to assess the effectiveness of different self-management interventions on the three outcome variables to make the findings more feasible.

The study provides evidence to support the use of non-invasive telemonitoring and structured telephone support in enhancing the health benefits of patients with heart failure.

The study’s exclusive use of published RCTs increases objectivity of findings. However, the study does not analyze the long-term effects of the above interventions to determine whether the same are equally effective for long-term use.

The greatest risk associated with implementation is that some patients may mistake regular telephone calls by their physician and tele-monitoring activities as an infringement on personal space, and may be willing to comply initially, but more unwilling as time passes by.

The use of structured telephone support and telemonitoring are only feasible for clinical practice if patients and their families adequately understand the importance of engaging in the same.

The study provides evidence that telehealth monitoring of heart failure patients enhances health outcomes for such patients by reducing all-cause mortality and the average length of stay during admission. However, telehaelth did not have any influence on emergency room visits and primary care visitors

The greatest strength is that the researchers obtain their own data and research participants. However, the study is also limiting because given the challenges of a retrospective strategies, the researchers could not assess the impact of patient-centered variables such as the type of HF.