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Comparison of telehome care interventions in controlling chronic obstructive pulmonary disease (COPD) and its complications: a protocol for systematic review and meta-analysis | |||||||||||||
| Critical Comments in Biomedicine | |||||||||||||
| Article 5, Volume 2, Issue 2 - Serial Number 4, September 2021 PDF (1.94 M) | |||||||||||||
| Document Type: Article | |||||||||||||
| DOI: https://doi.org/10.18502/ccb.v2i2.7395 | |||||||||||||
| Authors | |||||||||||||
| Zohreh Shoyukhi1; Arezoo Dehghani2; Hamidreza Dehghan* 3 | |||||||||||||
| 1MSc student of Health Technology Assessment ,Consultation Center for Secondary Researches, Data Mining, and Knowledge Transfer in Health and Medical Sciences, Shahid Sadoughi University of Medical Sciences, Yazd, Iran | |||||||||||||
| 2Health Information Management, Department of Health Information Technology and Management, Health Technology Assessment and Medical Informatics Research Center, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.. | |||||||||||||
| 3Research Center for Health Technology Assessment and Medical Informatics, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran | |||||||||||||
| Abstract | |||||||||||||
| Background: Chronic obstructive pulmonary disease (COPD) is considered the fourth main cause of mortality worldwide, affecting 10% of adults aged up to 40 years. Due to the growing elderly population and smoking, the global burden of COPD is expected to increase in the general population. Telemedicine may help patients with COPD to decrease exacerbation episodes and the associated costs. Moreover, Telehomecare (THC) may be considered as an alternative to cut down hospitalization costs and increase the patients’ comfort. Objectives: This study explains the methodology of a systematic review and meta-analysis designed to evaluate the impact of THC interventions on the control and management of COPD and its complications. Methods: To review all published studies comparing THC interventions in controlling COPD and its complications, all studies published in PubMed, Google Scholar, Scopus, ISI Web of Science, Cochrane databases, HTA EED, DARE, Embase, SID, Magiran will be searched until the end of 2021. Randomized controlled trials (RCTs), cluster RCTs, controlled clinical trials comparing telehealth with standard monitoring of COPD patients were included. Independent reviewers will review the abstracts and full-texts of all relevant studies for eligibility, risk of bias, and data extraction using structured forms. The meta-analysis will be performed for adequately homogenous studies regarding their populations, interventions, and objectives. Conclusion: The results of this systematic review and meta-analysis will provide useful information on the impacts of THC on COPD control. The evidence provided by this systematic review can be helpful for clinical specialists, public health policymakers, and the general population. | |||||||||||||
| Keywords | |||||||||||||
| Telemedicine; Chronic Obstructive Pulmonary Disease; Meta-Analysis; Systematic Review | |||||||||||||
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Introduction The Global Initiative for Chronic Obstructive Lung Disease (GOLD) defines chronic obstructive pulmonary disease (COPD) as a common disease characterized by the persistent airflow limitation of the lungs, which can be prevented and treated. Moreover, COPD is a naturally progressive condition in which chronic inflammatory responses to noxious gases are enhanced in both the airways and the lungs [1]. Respiratory exacerbation may occur due to the airflow limitation. COPD exacerbation is defined as an acute deterioration of the respiratory symptoms [2] adversely affecting patients’ health status, often leading to hospital admission. In this regard, telehealthcare (THC) can reduce disease complications, hospitalization costs, and the need for contact with health services, especially in middle-income to low-income countries [3]. Telemedicine is a widespread concept, including the health information exchange and transmission using electronic devices. It can provide health services using information and communication technology (ICT) between patients and the health care experts, which is helpful in health monitoring and management [4]. This respiratory disease is a major consumer of health care resources, mostly due to its exacerbation. In COPD patients, telemedicine may help to decrease the exacerbation episodes and their costs. Moreover, providing healthcare at home may be considered as an alternative to cut down hospitalization costs and increase the patients’ comfort [5, 6]. One of the remarkable aspects of THC is telemonitoring, which plays a very important role in managing COPD patients. Telemonitoring is defined as using ICT for information exchange between patients and health experts. In telemonitoring, healthcare providers usually become informed of the patient’s health status using a communication system installed in the patient’s home through the regular entry of the required information. The entered information is transferred to a central system of data management in a real-time manner, which is designed to systematically monitor the patient's health status according to personal care protocols [7-9]. Using pre-programmed intelligent functions, the device will alarm if the patient's condition exceeds certain limitations and provide decision support to the patient or the health care team. The health care team can monitor the patient’s data remotely and respond quickly if necessary. Telemonitoring encourages the patients to manage their disease through providing regular patient monitoring by professional resource efficiency investment and remote interventions. Patient empowerment for effective self-monitoring prevents disease exacerbation, injury, and hospital admission if supplemented by consistent telemonitoring [10, 11]. To the best of the authors' knowledge, no systematic review has been conducted in this field; therefore, this study aimed to provide a comprehensive review of THC in patients with COPD and its impact on disease management. Method This protocol is reported based on the Preferred Reporting Items for Systematic review and Meta-analysis Protocols PRISMA-P checklist 2015. General and specific objectives The main purpose of this study is to summarize the evidence related to the comparison of THC interventions in controlling COPD and its complications. The specific objectives include determining the effect of THC interventions on the results of COPD Assessment Test (CAT), Forced Expiratory Volume 1 (FEV1) index results, depression, mortality, the health-related quality of life, the quality of life specific to the disease Study eligibility Participants Patients who received THC interventions for COPD management or formed the control arm in THC studies. Intervention Telehomecare including telemonitoring, telerehabilitation,telemanagement, tele-education, and teleconsultation (televisit) Comparisons Usual care Outcomes Improvement in CAT, improvement in lung test results, depression prevention, mortality reduction, reduction of direct and indirect disease cost, reduction of patient visits and hospitalizations, and quality of life improvement. Type of studies Randomized controlled trials (RCTs), clustered RCTs, controlled clinical trials (CCTs) or non-randomized clustered trials, and interrupted time-series studies. Search strategy Electronic databases To review all published studies comparing THC interventions in COPD and its complications, PubMed, Google Scholar, Scopus, Web of Science, CRD Cochrane databases, HTA EED, DARE, Embase, SID will be searched until the end of 2021 (Table 1). Table 1. The search strategy designed to find related publications in PubMed
Manual search The reference lists of the selected studies and systematic reviews will be reviewed in the full-text reading phase to find additional studies. In this step, the full texts of the relevant articles will be reviewed to exclude irrelevant articles. The details of the reasons for exclusion will be recorded. PRISMA flow diagram for studies will be documented. Finally, the automatic part of EndNote software will be used to find duplicate studies and delete them. Data collection and analysis Selection of studies Titles and abstracts of the studies will be independently reviewed by two authors. Data extraction and management Microsoft Excel will be used to prepare a data extraction form. The following information about each included article was independently extracted by two authors: the name of the first author, publication year, location of study, sample size and gender (male/female), mean age, study design, intervention duration, intervention type, and findings. Exclusion criteria The following studies will be excluded: 1. Studies published in languages other than English and Persian 2. Studies with no interventions, including systematic review protocols, systematic reviews, experimental and pre-experimental studies, etc. 3. Studies not reporting the number of participants in control and treatment groups 4. Studies lacking information required for analysis Dealing with missing data In case of missing data, the corresponding author will send an email three times, one week apart, to request the relevant data. In case of no response after three times, the study will be excluded. Quality assessment Given the study will be performed on clinical trial articles, the JADAD checklist will be used to evaluate the quality of the reviewed studies. In evaluating the quality of the articles based on the Newcomer criteria, the articles received a score ranging from 0 to 7 points, with a higher score indicating higher quality [12,13]. Data analysis After data extraction, a meta-analysis will be performed if possible. The STATA software version 16 [StataCorp. 2019. Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC, USA] will be used to analyze and aggregate the results of the selected studies, and forest plots will be generated. The mean changes in the quantitative results [such as respiratory or lung test results, CAT test results, and complication mean difference (MD)] in the control and intervention groups will be extracted to determine the differences as the effect size for meta-analysis. A random-effects model considering the diversity between studies will be used to perform the meta-analyses. Assessment of heterogeneity I-squared (I2) statistic and Chi-square tests will be used to investigate the heterogeneity between studies. The value of I2 ranges from 0 to 100. An I2 value of 0-25, 25-50, 50-75, and 75-100 indicates no heterogeneity, weak heterogeneity, relatively high heterogeneity, and high heterogeneity, respectively. As for the Chi-square test, a P-value of less than 0.1 will be considered as significant heterogeneity. In case of high heterogeneity among studies, subgroup analysis or meta-regression will be used to find the source(s) of heterogeneity. Subgroup analysis Subgroup analysis based on the following variables will be performed to investigate the possible source of heterogeneity:
Sensitivity analysis Sensitivity analysis will be used to evaluate the strength of the overall results. Meta-bias: It will be evaluated whether the RCT protocol was published before study enrollment to determine the reporting bias and selective outcome reporting (outcome reporting bias). To evaluate the possible bias resulting from a small sample size (i.e., the usefulness of the intervention in smaller studies), the fixed effect estimate will be compared with the random-effects model. P values of less than or equal to 0.05 were considered significant. Publication bias Any potential publication bias will be assessed using a funnel plot diagram in addition to Begg's modified stratified correlation test and Egger's asymmetry regression test. Discussion This study will be conducted to compare THC interventions in controlling and managing COPD and its complications. This study will contribute to future studies by identifying the target populations who accept THC and the identification of feasible interventions. Finally, the current systematic review will help modify technological interventions to meet COPD patients' needs more effectively. This systematic review and meta-analysis will provide useful information on the impacts of THC on COPD control. The evidence provided by the results of systematic reviews can be helpful for clinical specialists, public health policymakers, and the general population. Acknowledgment The authors wish to thank Shahid Sadoughi University of Medical Sciences and Health Services for funding this study. Authors’ Contribution HRD is the leading author and guarantor. ZSH and AD planned the study and led the drafting and revising of the manuscript. HRD, ZSH, and AD contributed to drafting and revising the manuscript. All authors approved the submitted version of the manuscript. Funding Source This project was funded by Shahid Sadoughi University of Medical Sciences (1398/10/9-7022). The funders had no role in designing of the study, data collection, data analysis, data interpretation, or manuscript drafting. Conflict of Interest The authors declare that there is no conflict of interest. | |||||||||||||
| References | |||||||||||||
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[1] Rabe KF. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. GOLD executive summary. Am J Respir Crit Care Med. 2007;176:532-55 [2] O'Donnell DE, Parker CM. COPD exacerbations . 3: Pathophysiology. Thorax. 2006;61:354-61. 10.1136/ thx.2005.041830. [3] Lewis T, Synowiec C, Lagomarsino G, Schweitzer J. E-health in low-and middle-income countries: findings from the Center for Health Market Innovations. Bulletin of the World Health Organization. 2012;90:332-40 [4] Qaddoumi I, Bouffet E. Supplementation of a successful pediatric neuro-oncology telemedicine-based twinning program by e-mails. Telemedicine and e-Health. 2009;15:975-82 [5] Bourbeau J, Echevarria C. Models of care across the continuum of exacerbations for patients with chronic obstructive pulmonary disease. Chronic respiratory disease. 2020;17:1479973119895457 [6] Bollmeier SG, Hartmann AP. Management of chronic obstructive pulmonary disease: A review focusing on exacerbations. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists. 2020;77:259-68. 10.1093/ajhp/zxz306. [7] Ambrosino N, Vagheggini G, Mazzoleni S, Vitacca M. Telemedicine in chronic obstructive pulmonary disease. Breathe (Sheffield, England). 2016;12:350-6. 1183/20734735.014616. [8] Jensen MH, Cichosz SL, Hejlesen OK, Toft E, Nielsen C, Grann O, et al. Clinical impact of home telemonitoring on patients with chronic obstructive pulmonary disease. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2012;18:674-810. 1089/ tmj.2012.0003. [9] Kruse C, Pesek B, Anderson M, Brennan K, Comfort H. Telemonitoring to Manage Chronic Obstructive Pulmonary Disease: Systematic Literature Review. JMIR medical informatics. 2019;7:e11496. 10.2196/ 11496. [10] Ventola CL. Mobile devices and apps for health care professionals: uses and benefits. P & T : a peer-reviewed journal for formulary management. 2014;39:356-64 [11] Mathioudakis AG, Janner J, Moberg M, Alonso-Coello P, Vestbo J. A systematic evaluation of the diagnostic criteria for COPD and exacerbations used in randomised controlled trials on the management of COPD exacerbations. ERJ open research. 2019;5: 00136-2019 [12] Moher, D., Jadad, A. R., Nichol, G., Penman, M., Tugwell, P., & Walsh, S. (1995). Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Controlled clinical trials, 16(1), 62-73. [13] Moher, D., Jadad, A. R., & Tugwell, P. (1996). Assessing the quality of randomized controlled trials: current issues and future directions. International journal of technology assessment in health care, 12(2), 195-208. | |||||||||||||
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