See instructions on deliverable 2. Relevant articles need to be added. Also articles added in Deliverable 1. Will send PRISMA chart to be utilize instead of the one in deliverable 1.
Deliverable 2 – Results
Deliverable 2 provides results (i.e., study selection) and analysis of individual study information (source information, participant characteristics, research methods, and outcomes) to be included in the systematic review. It is strongly encouraged each study be read and reread (highlight key components) and then appraised. “Strong studies should be given more weight than weaker ones in coming to conclusions about a body of evidence” (Polit & Beck, 2012, pg. 658). There is no consensus on the best approach to assess an individual study for a systematic review, but see in Polit and Beck (2012) an approach to appraise an individual study. At a minimum appraisal of the study design for biases and threats to internal validity; adequate and appropriate sample selection; measurement of variables yielding data that is reliable and valid. Please discuss with Dr. Brown your approach to study appraisal, there are various tools available (see course content).
A table should be developed to organize individual study characteristics with columns (for example: author, study type/objective, quality rating score, sampling/setting, intervention/intervention fidelity, relevance to review/key findings). Tables will vary based on the focus of the systematic review. A systematic review can include meta-analysis but this is not a requirement.
Results section sub-headings to include:
• Study selection (i.e., reporting results of the search from each database, studies included, excluded, duplicates). Describe results with PRISMA flow diagram ( include the n’s) from the study selection process.
• Study characteristics (participants, relevant methodology, and quality).
• Risk of bias within and across studies
• Results of individual studies and intervention effect on outcome of interest. The results should be provided around answers to posed clinical question or domains (using sub-headings) rather than reporting on individual studies.
Folder 2: Relevant Articles
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Folder 2: Relevant Articles (6)
References
Bereznicki, L. R. E., Jackson, S. L., & Peterson, G. M. (2013). Supervised patient self-testing of warfarin therapy using an online system. Journal of Medical Internet Research, 15(7), e138. 10.2196/jmir.2255 Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/23853350
Point-of-care international normalized ratio (INR) monitoring devices simplify warfarin management by allowing selected patients to monitor their own therapy in their homes. Patient self-testing (PST) has been shown to improve the clinical outcomes of warfarin therapy compared to usual care. To compare management of warfarin therapy using PST combined with online supervision by physicians via a custom system with usual warfarin management, which involved laboratory testing and physician dosing. Interested patients were recruited via community pharmacies to participate in a warfarin PST training program. The training involved two sessions covering theoretical aspects of warfarin therapy, use of the CoaguChek XS, and the study website. PST supported by an online system for supervision was associated with improved INR control compared to usual care in a small group of elderly patients. Further research is warranted to investigate the clinical outcomes and cost effectiveness of online systems to support patients monitoring medications and chronic conditions in the home.
Hongsoo Kim, Yeon-Hwan Park, Young-il Jung, Hyoungshim Choi, Seyune Lee, Gi-Soo Kim, . . . Tae-Jin Lee. (2017). Evaluation of a technology-enhanced integrated care model for frail older persons: Protocol of the SPEC study, a stepped-wedge cluster randomized trial in nursing homes. BMC Geriatrics, 1710.1186/s12877-017-0459-7 Retrieved from https://search.proquest.com/docview/1894094759
Background Limited evidence exists on the effectiveness of the chronic care model for people with multimorbidity. This study aims to evaluate the effectiveness of an information and communication technology- (ICT-)enhanced integrated care model, called Systems for Person-centered Elder Care (SPEC), for frail older adults at nursing homes. Methods/Design SPEC is a prospective stepped-wedge cluster randomized trial conducted at 10 nursing homes in South Korea. Residents aged 65 or older meeting the inclusion/exclusion criteria in all the homes are eligible to participate. The multifaceted SPEC intervention, a geriatric care model guided by the chronic care model, consists of five components: comprehensive geriatric assessment for need/risk profiling, individual need-based care planning, interdisciplinary case conferences, person-centered care coordination, and a cloud-based information and communications technology (ICT) tool supporting the intervention process. The primary outcome is quality of care for older residents using a composite measure of quality indicators from the interRAI LTCF assessment system. Outcome assessors and data analysts will be blinded to group assignment. Secondary outcomes include quality of life, healthcare utilization, and cost. Process evaluation will be also conducted. Discussion This study is expected to provide important new evidence on the effectiveness, cost-effectiveness, and implementation process of an ICT-supported chronic care model for older persons with multiple chronic illnesses. The SPEC intervention is also unique as the first registered trial implementing an integrated care model using technology to promote person-centered care for frail older nursing home residents in South Korea, where formal LTC was recently introduced.
Lee, J., Nguyen, A. L., Berg, J., Amin, A., Bachman, M., Guo, Y., & Evangelista, L. (2014). Attitudes and preferences on the use of mobile health technology and health games for self-management: Interviews with older adults on anticoagulation therapy. Journal of Medical Internet Research, 16(7), 1-12. 10.2196/mhealth.3196 Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/25098413
Older adults are at substantial risk for cardiovascular disorders that may require anticoagulation therapy. Those on warfarin therapy report dissatisfaction and reduced quality of life (QOL) resulting from the treatment. However, there is a paucity of research examining the effectiveness of mHealth tools on knowledge, attitudes, and patient satisfaction with treatment, as well as self-management, adherence to therapy, and QOL in older adults with chronic illness conditions requiring long-term warfarin therapy. The objective of the study was to explore the attitudes and preferences of older adults on warfarin therapy regarding the use of mHealth technology and health games to gain skills for self-management. These findings indicate that our older adults on warfarin therapy are interested in mHealth technology specific to warfarin medication management and health games. Further research needs to be done to validate these findings. Elder-friendly designs, technology support, and physical safety using mHealth technology may be useful in this population. These findings can be used to inform a larger study to design and test an elder-centered mHealth technology in this target population. Adapted from the source document.
Nieuwlaat, R., Eikelboom, J., Schulman, S., van Spall, H., Schulze, K., Connolly, B., . . . Connolly, S. (2014). Cluster randomized controlled trial of a simple warfarin maintenance dosing algorithm versus usual care among primary care practices. Journal of Thrombosis and Thrombolysis, 37(4), 435-442. 10.1007/s11239-013-0969-x Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/23877621
Many patients using warfarin are being managed in primary care and typically achieve a lower time in therapeutic range (TTR) for the international normalized ratio (INR) than patients in specialized care. A simple warfarin maintenance dosing tool could assist primary care physicians with improving TTR. We tested whether a simple warfarin maintenance dosing algorithm can improve TTR compared with usual care among Canadian primary care physicians. Primary care practices managing warfarin therapy without an anticoagulation clinic, computer decision support system or patient self-management tools enrolled 10–30 patients with target INR range 2–3. Practices were randomized to manage warfarin maintenance with the algorithm, or as usual in 2009–2010. Primary outcome was the mean individual patient TTR, and was compared between groups with adjustment for clustering within practices. There were 13 practices randomized to the Algorithm and 15 practices to Control, enrolling 240 and 297 patients respectively, with a mean follow-up of 280 days. Mean (standard deviation; SD) TTR before the study was comparable between groups [68 % (SD 26) for usual care vs. 70 % (SD 27) for the algorithm; p = 0.49]. Dosing decisions during the study in the algorithm group were more often in agreement with the algorithm’s recommendations than with usual care (81 vs. 91 %; p < 0.0001). Mean study TTR of the algorithm group was not superior to usual care: [72.1 (SE 1.7) vs. 71.4 % (SE 1.5) respectively; p = 0.73]. The simple warfarin maintenance dosing algorithm did not improve TTR compared with usual care among Canadian primary care practices.
Pirmohamed, M., Burnside, G., Eriksson, N., Jorgensen, A. L., Toh, C. H., Nicholson, T., . . . Wadelius, M. (2013). A randomized trial of genotype-guided dosing of warfarin. The New England Journal of Medicine, 369(24), 2294. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/24251363
The level of anticoagulation in response to a fixed-dose regimen of warfarin is difficult to predict during the initiation of therapy. We prospectively compared the effect of genotype-guided dosing with that of standard dosing on anticoagulation control in patients starting warfarin therapy. We conducted a multicenter, randomized, controlled trial involving patients with atrial fibrillation or venous thromboembolism. Genotyping for CYP2C9*2, CYP2C9*3, and VKORC1 (-1639G→A) was performed with the use of a point-of-care test. For patients assigned to the genotype-guided group, warfarin doses were prescribed according to pharmacogenetic-based algorithms for the first 5 days. Patients in the control (standard dosing) group received a 3-day loading-dose regimen. After the initiation period, the treatment of all patients was managed according to routine clinical practice. The primary outcome measure was the percentage of time in the therapeutic range of 2.0 to 3.0 for the international normalized ratio (INR) during the first 12 weeks after warfarin initiation. A total of 455 patients were recruited, with 227 randomly assigned to the genotype-guided group and 228 assigned to the control group. The mean percentage of time in the therapeutic range was 67.4% in the genotype-guided group as compared with 60.3% in the control group (adjusted difference, 7.0 percentage points; 95% confidence interval, 3.3 to 10.6; P<0.001). There were significantly fewer incidences of excessive anticoagulation (INR ≥4.0) in the genotype-guided group. The median time to reach a therapeutic INR was 21 days in the genotype-guided group as compared with 29 days in the control group (P<0.001). Pharmacogenetic-based dosing was associated with a higher percentage of time in the therapeutic INR range than was standard dosing during the initiation of warfarin therapy.
Terekhov, D., Agapov, V., Kulikov, K., Zadorozhnaya, S., Samitin, V., & Maslyakov, V. (2017). Pacemaker implantation in elderly patients: Safety of various regimens of anticoagulant therapy.9(5), 1467.
To study incidence of hemorrhagic complications after pacemaker implantation in elderly patients receiving antithrombotic therapy with warfarin or uninterrupted dabigatran.126 patients aged 83 [82-85] years who receive continuous antithrombotic therapy after pacemaker implantation, were enrolled in the study. Adverse event data were collected during hospitalization and further 12 weeks.95 subjects (75.4%) received warfarin therapy and 31 subjects (24.6%) received dabigatran. All patients in dabigatran group received 220 mg/day skipping the last dose before a surgery and resumed the drug intake in 36-48 hours after it. Patients of warfarin group underwent surgery if INR was NMT 3; they didn’t stop taking the drug for the duration of operation.No statistically significant differences of hematoma incidence were detected in dabigatran (incidence is 0.065, 95%CI (-0.02–0.15)) and warfarin (incidence is 0.05, 95%CI (0.006–0.01)) groups, p(Fisher)= 0.55. Three cases of nonfatal gastrointestinal bleeding (warfarin group) and 1 similar event in dabigatran group were detected during a follow-up (12 [6; 20] weeks): RR= 0.98 (warfarin group), p(Fisher)=0.68. No statistically significant difference of age, sex composition, history of IHD and diabetes was detected between groups by comparison of individual characteristics of patients whose surgeries were complicated/non-complicated by hematoma formation. Upon that, hematoma formation rate was significantly higher in patients with adjunctive pacemaker muscular fixation: 71.4% vs 31.9% (patients without hematomas), p(Fisher)= 0.045.Incidence of hematoma formation after pacemaker implantation in patients > 75 years receiving warfarin or dabigatran, is the same as in general population of patients treated with anticoagulants. Adjunctive pacemaker muscular fixation is a significant risk factor of hematoma formation.