Abstract
Background:
This study will assess the effects of high quality nursing care (HQNC) on psychological outcomes (PCO) in patients with chronic heart failure (CHF).
Methods:
We will carry out a through search in 7 databases: PUBMED, EMBASE, Cochrane Library, Web of Science, Chinese Biomedical Literature Database, WANGFANG, and China National Knowledge Infrastructure. Eligibility criteria will be randomized controlled trials on assessing effects of HQNC on PCO in patients with CHF. Cochrane risk of bias evaluation will be utilized for methodological quality.
Results:
This proposed study will summarize a rational synthesis of current evidence for HQNC on PCO in patients with CHF.
Conclusion:
The results of this study will provide convinced evidence for judging the effects of HQNC on PCO in patients with CHF.
Keywords: chronic heart failure, effect, high-quality nursing care, psychological outcome, randomized controlled trial
1. Introduction
Chronic heart failure (CHF) has become a global epidemic disorder, and it impacts about 26 million populations around the world.[1–4] Such disorder often significantly affects quality of life and brings a tremendous burden for both patients’ family and the society.[5–8] It has been estimated that its prevalence was 0.9%, and the mortality was 19.5% annually in China.[9] In addition, the CHF motility was 17.4% in Europe,[10] and 31.4% in United States each year.[11] Previous studies found significant associations of psychological outcomes (PCO) with CHF.[12–17] Thus, it is very important to manage PCO in patients with CHF in clinical practice.
Several clinical studies have reported that high-quality nursing care (HQNC) has been utilized to manage PCO in patients with CHF.[18–22] However, no study has systematically assessed the effects and safety of HQNC on PCO in patients with CHF, and its effects are still inconclusive. Therefore, the present study will investigate the effects and safety of HQNC on PCO in patients with CHF.
2. Methods
2.1. Study registration
This study protocol has been registered on PROSPERO (CRD42019140638). It has been reported abiding to the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols statement guidelines.
2.2. Eligibility criteria for study selection
2.2.1. Types of studies
All available randomized controlled trials (RCTs) about the use of HQNC on PCO in patients with CHF will be included. Other studies such as case reports, case series, noncontrolled studies, and non-RCTs will be excluded.
2.2.2. Types of participants
We will include studies on patients that have been diagnosed as PCO in patients with CHF without any restrictions of age, sex, and ethnicity.
2.2.3. Type of interventions
The experimental intervention must be HQNC for PCO in patients with CHF.
The control intervention can be any therapies, except HQNC.
2.2.4. Type of outcomes
The primary outcomes are depression and anxiety. They can be measured by Hamilton Depression Rating Scale or Hamilton Anxiety Rating Scale or any other tools.
The secondary outcomes comprise of pain intensity, health-related quality of life, and adverse events. Pain intensity can be assessed by visual analog scale or other scales. Health-related quality of life can be evaluated by 36-Item Short Form Survey, or any other tools. Additionally, any expected or unexpected adverse events will also be measured.
2.3. Strategy of literature searches
Relevant studies will be independently and comprehensively searched in PUBMED, EMBASE, Cochrane Library, Web of Science, Chinese Biomedical Literature Database, WANGFANG, and China National Knowledge Infrastructure. The searched items will be utilized as follows: HQNC, PCO, and CHF. The detailed search strategies in Cochrane Library are exerted in Table 1, and will be adapted similarly in other databases.
Table 1.
Search strategy used in Cochrane Library database.
Relevant reviews will also be searched. In addition, we will also filter relevant journals and magazines to identify literature to avoid missing any other potential studies.
2.4. Data collection
2.4.1. Study selection
Two authors will independently import relevant studies obtained from all searched records into Endnote X7. After excluding duplications, the same 2 authors will independently assess the titles and abstracts of the searched trials and remove unqualified records. Then, the full text of remaining studies will be read carefully to judge if they meet final eligibility criteria. Any differences generated between 2 authors will be solved via discussion with the help of another author. The study selection procedure is showed in a flow chart in Fig. 1.
Figure 1.
Process of study selection.
2.4.2. Data extraction
Data will be independently collected from the eligible studies by 2 authors. Any divergences on data collection between 2 authors will be judged by a third author through discussion. The following information will be collected: title, authors, year of publication, sample size, patient characteristics, study setting, study methods, treatment details, comparators, outcome measurements, and follow-up details. We will contact primary authors for the above mentioned data if they are unclear, ambiguous, or insufficient.
2.5. Assessment of risk of bias
Methodological quality of all eligible studies will be assessed according to the Cochrane risk of bias by 2 independent authors. Any discrepancies between 2 authors will be solved by discussion with a third author if it is necessary. The tool includes 7 aspects, and each item will be further divided into 3 levels of low, unclear, and high risk of bias.
2.6. Measures of treatment effect
For continuous data, we will apply mean difference or standardized mean difference and 95% confidence intervals (CIs). For dichotomous data, we will use risk ratio and 95% CIs.
2.7. Assessment of heterogeneity
We will assess the heterogeneity with the use of I2 test. I2 ≤50% may represent reasonable heterogeneity, and a fixed-effect model will be utilized. I2 >50% may represent significant heterogeneity, and a random-effect model will be applied.
2.8. Data synthesis
All analysis will be performed using RevMan 5.3 software. We will select a fixed-effect model or a random-effect model to merge the outcome indicators based on the results of heterogeneity test. If there is reasonable heterogeneity (I2 ≤50%), a meta-analysis will be carried out. If there is significant heterogeneity or after subgroup analysis (I2 >50%), we will report a narrative summary instead of data pooled and meta-analysis.
2.9. Subgroup analysis
The following subgroup analysis will be explored the potential sources of the heterogeneity in accordance with different study characteristics, treatments, controls, and outcome measurements.
2.10. Sensitivity analysis
We will perform sensitivity analysis to assess the robustness of pooled results by taking away low quality studies.
2.11. Publication bias
We will carry out funnel plot[23] and Egger regression[24] to analyze the existence of publication bias if more than 10 studies are included.
2.12. Ethics and dissemination
We will utilize publicly available data from previous published studies; hence, no ethical approval is needed. We will disseminate the results of this study through publication at a peer-reviewed journal or conference proceedings.
3. Discussion
To the best of our knowledge, this study will be the first study to systematically assess the effects of HQNC on PCO in patients with CHF. First, the results of this study will provide objective statistics for further studies on HQNC. Second, the results of this study will provide references for both clinicians and patients in the invention of HQNC on PCO in patients with CHF. Third, the results of this study may provide alternative intervention of PCO in patients with CHF to the policy makers. Therefore, this study may summarize most recent clinical evidence helping clinicians make decisions on clinical practice for the treatment of PCO in patients with CHF.
Author contributions
Conceptualization: Xiao-Qing Li.
Data curation: Xiao-Qing Li.
Formal analysis: Xiao-Qing Li.
Investigation: Xiao-Qing Li.
Methodology: Xiao-Qing Li.
Project administration: Xiao-Qing Li.
Resources: Xiao-Qing Li.
Software: Xiao-Qing Li.
Supervision: Xiao-Qing Li.
Validation: Xiao-Qing Li.
Visualization: Xiao-Qing Li.
Writing – original draft: Xiao-Qing Li.
Writing – review & editing: Xiao-Qing Li.
Footnotes
Abbreviations: CHF = chronic heart failure, CIs = confidence intervals, HQNC = high-quality nursing care, PCO = psychological outcome, RCTs = randomized controlled trials.
How to cite this article: Li XQ. Effects of high quality nursing care on psychological outcomes in patients with chronic heart failure. Medicine. 2019;98:41(e17351).
Funding: This study is partly supported by Shaanxi Science and Technology Department Science and Technology Development Plan Project (2014K11-02-04-09). The funder did not take part in any sections of this study.
The authors report no conflicts of interest.
References
- [1].Butler J. An overview of chronic heart failure management. Nurs Times 2012;108:16–20. [PubMed] [Google Scholar]
- [2].Azad N, Lemay G. Management of chronic heart failure in the older population. J Geriatr Cardiol 2014;11:329–37. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [3].Chivite D, Franco J, Formiga F. Chronic heart failure in the elderly patient. Rev Esp Geriatr Gerontol 2015;50:237–46. [DOI] [PubMed] [Google Scholar]
- [4].Ambrosy AP, Fonarow GC, Butler J, et al. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol 2014;63:1123–33. [DOI] [PubMed] [Google Scholar]
- [5].Ewen S, Nikolovska A, Zivanovic I, et al. Chronic heart failure: new insights. Dtsch Med Wochenschr 2016;141:1560–4. [DOI] [PubMed] [Google Scholar]
- [6].Kempf T, Bavendiek U, Bauersachs J. New pharmacologic therapies for chronic heart failure. Internist (Berl) 2017;58:990–9. [DOI] [PubMed] [Google Scholar]
- [7].Nikolaou M, Chrysohoou C, Georgilas TA, et al. Management of iron deficiency in chronic heart failure: practical considerations for clinical use and future directions. Eur J Intern Med 2019;65:17–25. [DOI] [PubMed] [Google Scholar]
- [8].Gao WQ, Meng XD, Sun Z. Efficacy of tolvaptan for chronic heart failure: Study protocol for a systematic review of randomized controlled trial. Medicine (Baltimore) 2019;98:e14540. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [9].Chen WW, Gao RL, Liu LS, et al. Summary of Chinese cardiovascular disease report 2016. Chin Circ J 2017;32:521–30. [Google Scholar]
- [10].Ponikowski P, Voors AA, Anker SD, et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail 2016;18:891–975. [DOI] [PubMed] [Google Scholar]
- [11].Bharmal M, Gemmen E, Zyczynski T, et al. Resource utilisation, charges and mortality following hospital inpatient admission for congestive heart failure among the elderly in the US. J Med Econ 2008;11:397–414. [DOI] [PubMed] [Google Scholar]
- [12].Herrmann-Lingen C. Chronic heart failure and depression. Internist (Berl) 2018;59:445–52. [DOI] [PubMed] [Google Scholar]
- [13].Bordoni B, Marelli F, Morabito B, et al. Depression and anxiety in patients with chronic heart failure. Future Cardiol 2018;14:115–9. [DOI] [PubMed] [Google Scholar]
- [14].Olano-Lizarraga M, Oroviogoicoechea C, Errasti-Ibarrondo B, et al. The personal experience of living with chronic heart failure: a qualitative meta-synthesis of the literature. J Clin Nurs 2016;25:2413–29. [DOI] [PubMed] [Google Scholar]
- [15].Pelle AJ, Gidron YY, Szabó BM, et al. Psychological predictors of prognosis in chronic heart failure. J Card Fail 2008;14:341–50. [DOI] [PubMed] [Google Scholar]
- [16].Yohannes AM, Willgoss TG, Baldwin RC, et al. Depression and anxiety in chronic heart failure and chronic obstructive pulmonary disease: prevalence, relevance, clinical implications and management principles. Int J Geriatr Psychiatry 2010;25:1209–21. [DOI] [PubMed] [Google Scholar]
- [17].Riegel B, Lee CS, Dickson VV, et al. Self care in patients with chronic heart failure. Nat Rev Cardiol 2011;8:644–54. [DOI] [PubMed] [Google Scholar]
- [18].Bennett SJ, Pressler ML, Hays L, et al. Psychosocial variables and hospitalization in persons with chronic heart failure. Prog Cardiovasc Nurs 1997;12:4–11. [PubMed] [Google Scholar]
- [19].Tsay SL, Chao YF. Effects of perceived self-efficacy and functional status on depression in patients with chronic heart failure. J Nurs Res 2002;10:271–8. [DOI] [PubMed] [Google Scholar]
- [20].Brännström M, Ekman I, Norberg A, et al. Living with severe chronic heart failure in palliative advanced home care. Eur J Cardiovasc Nurs 2006;5:295–302. [DOI] [PubMed] [Google Scholar]
- [21].Clark AP, McDougall G, Riegel B, et al. Health status and self-care outcomes after an education-support intervention for people with chronic heart failure. J Cardiovasc Nurs 2015;304 suppl 1:S3–13. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [22].Bekelman DB, Allen LA, McBryde CF, et al. Effect of a collaborative care intervention vs usual care on health status of patients with chronic heart failure: the CASA randomized clinical trial. JAMA Intern Med 2018;178:511–9. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [23].Sutton AJ, Duval SJ, Tweedie RL, et al. Empirical assessment of effect of publication bias on meta-analyses. BMJ 2000;320:1574–7. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [24].Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629–34. [DOI] [PMC free article] [PubMed] [Google Scholar]