Background. Psychological symptoms such as depression and anxiety are quite common among stroke survivors and have great negative impacts on patients. Objective. To develop a care bundle through reviewing and integrating care strategies for psychological symptoms after stroke and then improve the bundle by Delphi study. Methods. A structured search of the literature was performed to identify studies evaluating interventions for stroke patients with psychological symptoms such as depression and anxiety. Two trained researchers screened papers through the titles, abstracts, and full-texts independently. All studies complying with the eligibility criteria were appraised using quality assessment tools. Related interventions with evaluated evidence levels formed the preliminary bundle. Afterward, the Delphi study was carried out to improve the bundle, and the experts were contacted by e-mail. Ten clinical experts specialized in stroke and psychological rehabilitation were recruited. The reliability of experts was represented by the effective response rate and authority coefficient (Cr). The consensus was deemed to be reached when the mean score for item importance is all equal or above 3.50 and the coefficient of variation (CV) is all equal or below 0.20. The Kendall coefficient W test was adopted to evaluate the consensus on agreement among the experts as well. Data analysis was performed using SPSS V.22.0. Results. Through a systematic evidence summary and two-round Delphi study, the items that were given high scores and got consensus by experts were chosen for the bundle. The iDAME bundle consisted of five interventions eventually: maintaining Interaction, tailored Diet, Acupressure, mindfulness Meditation, and physical Exercise. Conclusion. The development of an evidence-based and consensus-based iDAME bundle which integrated western and traditional Chinese medicine intervention was described. Evidence summary made the bundle become scientific, while the Delphi study made it more maneuverable. Based on these results, the bundle would be potentially implemented in stroke patients for their psychological symptoms.
1. Introduction
Psychological symptoms are quite common among stroke survivors, such as depression, anxiety, apathy, and bipolar disorder [1]. An updated systematic review and meta-analysis found that the prevalence of poststroke depression was 31%∼33% [2], and 55% of patients might have depressive symptoms within 15 years after stroke [3]. The prevalence of anxiety within 10 years after stroke was 17%∼24%, and 57% of stroke patients might experience anxiety symptoms during this period [4]. It indicates that the adverse psychological symptoms of stroke patients occur in the long term and are persistent. Furthermore, psychological symptoms after stroke have great negative impacts on patients, such as self-efficacy reduction, rehabilitation stagnation, and much more heavy economic burden from the extended LOS (i.e., length of hospital stay) [5, 6].
At present, the management of psychological symptoms after stroke can be subdivided into pharmaceutical and nonpharmaceutical management. Common drugs used in clinical treatment include selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), a noradrenergic and specific serotonergic antidepressant (NaSSA), tricyclic antidepressants (TCAs), Wuling capsule (traditional Chinese medicine), and Shugan Jieyu capsule (traditional Chinese medicine) [7]. Though pharmaceutical treatments have a significant effect, most of them are accompanied by serious gastrointestinal reactions, liver or neurological damage, and other side effects. Current nonpharmaceutical management mainly includes physical therapy, psychotherapy, and traditional Chinese medicine treatment technology. Repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) were applied to the treatment of psychological symptoms after stroke. A meta-analysis by Shen et al. analyzed a total of 1764 stroke patients in 22 randomized controlled trials and found that rTMS was effective for poststroke depression [8]. Bucur and Papagno demonstrated the efficacy and safety of tDCS and rTMS in stroke patients with psychological symptoms [9]. Exercise therapy such as muscle strengthening, mobilization exercise, and aerobic treadmill training was also confirmed that could provide positive contributions to mood improving after stroke through some clinical trials [10, 11]. Cognitive behavior therapy (CBT), behavioral activation therapy (BAT), problem-solving therapy (PST), mindfulness-based intervention (MBI), interpersonal therapy (IPT), and motivational interviewing (MI) are effective psychotherapies for mood disorders after stroke, suitable for patients of poor medication compliance and adverse drug reactions [7]. The effectiveness of traditional Chinese medicine treatment technology (e.g., acupuncture, moxibustion, and acupressure) and other adjuvant treatments such as music therapy, meditation, relaxation exercise, and mind-body exercise (e.g., Taichi, Qigong, and yoga) are also demonstrated and have the potential for clinical promotion [7, 12, 13]. However, the contributing factors of psychological symptoms are complex and various, and comprehensive interventions should be worked out. The existing combinations of interventions are empirical and lack of evidence-based. Hence, a synthesis of the existing literature to develop a care bundle for stroke patients with psychological symptoms is required.
A care bundle is a set of evidence-based or self-evident good-practice-based interventions for a defined patient population and care setting [14]. It is a concept proposed by the Institute for Healthcare Improvement (IHI), which refers to combining and integrating evidence-based treatments and nursing measures into a set of intervention program, so as to achieve the goal of treating clinical diseases and improve the quality of care and patients’ outcomes [15]. The combination of multiple intervention measures is often more efficient and beneficial than the single performed alone.
In this study, we present the development of a poststroke psychological symptom care bundle called iDAME. iDAME is the abbreviation of maintaining Interaction, tailored Diet, Acupressure, mindfulness Meditation, and physical Exercise. These five interventions were obtained through evidence summary and two-round Delphi. The formation of the whole bundle is evidence-based; it not only combines the best available evidence but also attaches the importance to the individual clinical experience. The best evidence, practical experience, and patient’s actual condition are comprehensively considered in medical decision making to achieve the transition from evidence to practice effectively.
2. Materials and Methods
2.1. Evidence Summary
2.1.1. Literature Search
According to the 6S evidence resource pyramid model [16], related practical guidelines, evidence summaries, expert consensus, systematic reviews, and clinical trials for the management of poststroke psychological symptoms were retrieved.
To obtain empirical studies on the management of poststroke psychological symptoms, a comprehensive search of multiple databases from January 2010 to May 2019 was conducted, including SinoMed, Wan Fang Database, Chinese National Knowledge Infrastructure (CNKI), PubMed, EMBASE, CINAHL, Web of Science, JBI, and Cochrane (Table 1). In addition, the relevant clinical practice guideline websites were also searched, such as the Scottish Intercollegiate Guidelines Network (SIGN), the National Institute for Health and Care Excellence (NICE), the Registered Nurses’ Association of Ontario, Canada (RNAO), American Heart Association/American Stroke Association (AHA/ASA), Neurocritical Care Society (NCS), European Stroke Organisation (ESO), Royal College of Physicians (RCP), National Stroke Foundation (NSF), and Royal Dutch Society for Physical Therapy (KNGF) using the search terms “stroke,” “cerebrovascular accident,” “psychological disorder,” “psychological symptom,” “mental problem,” “emotional problem,” and “mood stress.” Reference lists of relevant articles were cross-checked and pertinent journals were hand searched for articles. The inclusion criteria were (1) studies written in English and Chinese and (2) studies that involved psychological symptoms in the context of the poststroke period and addressed any aspect of care. The exclusion criteria were (1) duplicates, review articles, and unpublished manuscripts and (2) studies that did not report poststroke psychological symptoms in their findings.
JBI
#1 Stroke or hemiplegia or “cerebrovascular disease” or “cerebral arterial thrombosis” or “Ischemic stroke”
#2 depression or anxiety
#3 yr = “2010-Current”
#1 and #2 and #3
Cochrane
#1 Stroke or strokes or hemiplegia or “brain infarction” or “cerebrovascular disease” or CVD or “cerebrovascular attack” or “cerebrovascular accident” or “cerebrovascular accidents” or CVA or “brain vascular accident” or “brain vascular accidents” or “acute cerebrovascular accident” or “cerebrovascular apoplexy” or “cerebrovascular stroke” or “cerebrovascular strokes” or “acute stroke” or “acute strokes” or “cerebral strokes” or “cerebral stroke” or “cerebral arterial thrombosis” or “Ischemic stroke”
#2 Psychological or Psychology or “psychological disorders” or “psychological disorder” or “psychological stress” or “psychological health” or “Psychological symptom” or “Psychological symptoms” or “psychological problem” or “psychological problems” or mental or “mental health” or “mental symptoms” or “mental symptom” or “mental disorder” or “mental disorders” or “mental problem” or “mental problems” or “mental stress” or emotional or emotion or “emotional stress” or “emotional symptoms” or “emotional symptom” or “emotional disorder” or “emotional disorders” or “emotional problem” or “emotional problems” or “emotional health” or mood or “mood disorders” or “mood disorder” or “mood health” or “mood stress” or “mood symptom” or “mood symptoms” or “mood problem” or “mood problems” or affectivity or affective or “affective disorder” or “affective disorders” or “affective health” or “affective stress” or “affective problem” or “affective problems” or “affective symptom” or “affective symptoms” or depression or “depression symptom” or “depression symptoms” or “depression disorder” or “depression disorders” or anxiety or “anxiety symptom” or “anxiety symptoms” or “anxiety disorder” or “anxiety disorders”
#3 “Randomized controlled trial ” or ”Randomized controlled trials” or RCT or RCTs or “systematic review” or “systematic reviews” or meta-analysis or guideline or guidelines or consensus
#4 2010-current
#1 and #2 and #3 and #4
Pubmed
#1 Stroke[Title/Abstract] OR strokes[Title/Abstract] OR hemiplegia[Title/Abstract] OR “brain infarction” [Title/Abstract] OR “cerebrovascular disease” [Title/Abstract] OR CVD[Title/Abstract] OR “cerebrovascular attack” [Title/Abstract] OR “cerebrovascular accident” [Title/Abstract] OR “cerebrovascular accidents” [Title/Abstract] OR CVA[Title/Abstract] OR “brain vascular accident” [Title/Abstract] OR “brain vascular accidents” [Title/Abstract] OR “acute cerebrovascular accident”[Title/Abstract] OR “cerebrovascular apoplexy”[Title/Abstract] OR “cerebrovascular stroke” [Title/Abstract] OR “cerebrovascular strokes” [Title/Abstract] OR “acute stroke” [Title/Abstract] OR “acute strokes” [Title/Abstract] OR “cerebral strokes” [Title/Abstract] OR “cerebral stroke” [Title/Abstract] OR “cerebral arterial thrombosis” [Title/Abstract] OR “Ischemic stroke” [Title/Abstract]
#2 Psychological[Title/Abstract] OR Psychology[Title/Abstract] OR “psychological disorders” [Title/Abstract] OR “psychological disorder” [Title/Abstract] OR “psychological stress” [Title/Abstract] OR “psychological health”[Title/Abstract] OR “Psychological symptom” [Title/Abstract] OR “Psychological symptoms” [Title/Abstract] OR “psychological problem” [Title/Abstract] OR “psychological problems” [Title/Abstract] OR mental[Title/Abstract] OR “mental health” [Title/Abstract] OR “mental symptoms” [Title/Abstract] OR “mental symptom” [Title/Abstract] OR “mental disorder” [Title/Abstract] OR “mental disorders” [Title/Abstract] OR “mental problem” [Title/Abstract] OR “mental problems “ [Title/Abstract] OR “mental stress” [Title/Abstract] OR emotional[Title/Abstract] OR emotion[Title/Abstract] OR “emotional stress” [Title/Abstract] OR “emotional symptoms” [Title/Abstract] OR “emotional symptom” [Title/Abstract] OR “emotional disorder” [Title/Abstract] OR “emotional disorders” [Title/Abstract] OR “emotional problem” [Title/Abstract] OR “emotional problems” [Title/Abstract] OR “emotional health” [Title/Abstract] OR mood[Title/Abstract] OR “mood disorders” [Title/Abstract] OR “mood disorder” [Title/Abstract] OR “mood health” [Title/Abstract] OR “mood stress” [Title/Abstract] OR “mood symptom” [Title/Abstract] OR “mood symptoms” [Title/Abstract] OR “mood problem” [Title/Abstract] OR “mood problems” [Title/Abstract] OR affectivity[Title/Abstract] OR affective[Title/Abstract] OR “affective disorder” [Title/Abstract] OR “affective disorders” [Title/Abstract] OR “affective health” [Title/Abstract] OR “affective stress” [Title/Abstract] OR “affective problem” [Title/Abstract] OR “affective problems” [Title/Abstract] OR “affective symptom” [Title/Abstract] OR “affective symptoms” [Title/Abstract] OR depression[Title/Abstract] OR “depression symptom” [Title/Abstract] OR “depression symptoms” [Title/Abstract] OR “depression disorder” [Title/Abstract] OR “depression disorders” [Title/Abstract] OR anxiety[Title/Abstract] OR “anxiety symptom” [Title/Abstract] OR “anxiety symptoms” [Title/Abstract] OR “anxiety disorder” [Title/Abstract] OR “anxiety disorders” [Title/Abstract]
#3 ”Randomized controlled trial ” [Title/Abstract] OR “Randomized controlled trials” [Title/Abstract] OR RCT[Title/Abstract] OR RCTs[Title/Abstract] OR “systematic review” [Title/Abstract] OR “systematic reviews” [Title/Abstract] OR meta-analysis[Title/Abstract] OR guideline[Title/Abstract] OR guidelines[Title/Abstract] OR consensus[Title/Abstract])
#4 Publication date from 2010/01/01
#1 and #2 and #3 and #4
Web of science
#1 TITLE : Stroke or strokes or hemiplegia or “brain infarction” or “cerebrovascular disease” or CVD or “cerebrovascular attack” or “cerebrovascular accident” or “cerebrovascular accidents” or CVA or “brain vascular accident” or “brain vascular accidents” or “acute cerebrovascular accident” or “cerebrovascular apoplexy” or “cerebrovascular stroke” or “cerebrovascular strokes” or “acute stroke” or “acute strokes” or “cerebral strokes” or “cerebral stroke” or “cerebral arterial thrombosis” or “Ischemic stroke”
#2 TITLE : Psychological or Psychology or “psychological disorders” or “psychological disorder” or “psychological stress” or “psychological health” or “Psychological symptom” or “Psychological symptoms” or “psychological problem” or “psychological problems” or mental or “mental health” or “mental symptoms” or “mental symptom” or “mental disorder” or “mental disorders” or “mental problem” or “mental problems” or “mental stress” or emotional or emotion or “emotional stress” or “emotional symptoms” or “emotional symptom” or “emotional disorder” or “emotional disorders” or “emotional problem” or “emotional problems” or “emotional health” or mood or “mood disorders” or “mood disorder” or “mood health” or “mood stress” or “mood symptom” or “mood symptoms” or “mood problem” or “mood problems” or affectivity or affective or “affective disorder” or “affective disorders” or “affective health” or “affective stress” or “affective problem” or “affective problems” or “affective symptom” or “affective symptoms” or depression or “depression symptom” or “depression symptoms” or “depression disorder” or “depression disorders” or anxiety or “anxiety symptom” or “anxiety symptoms” or “anxiety disorder” or “anxiety disorders”
#3 TITLE: “Randomized controlled trial ” or ”Randomized controlled trials” or RCT or RCTs or “systematic review” or “systematic reviews” or meta-analysis or guideline or guidelines or consensus
#4 Timespan: 2010-2019. Indexes: SCI-EXPANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH, ESCI, CCR-EXPANDED, IC
#1 and #2 and #3 and #4
Embase
#1 Stroke or hemiplegia or “cerebrovascular disease” or “cerebral arterial thrombosis” or “Ischemic stroke”
#2 depression or anxiety
#3 yr = “2010”
#1 and #2 and #3
CINAHL
#1 TI ( Stroke or strokes or hemiplegia or “brain infarction” or “cerebrovascular disease” or CVD or “cerebrovascular attack” or “cerebrovascular accident” or “cerebrovascular accidents” or CVA or “brain vascular accident” or “brain vascular accidents” or “acute cerebrovascular accident” or “cerebrovascular apoplexy” or “cerebrovascular stroke” or “cerebrovascular strokes” or “acute stroke” or “acute strokes” or “cerebral strokes” or “cerebral stroke” or “cerebral arterial thrombosis” or “Ischemic stroke”
#2 TI ( Psychological or Psychology or “psychological disorders” or “psychological disorder” or “psychological stress” or “psychological health” or “Psychological symptom” or “Psychological symptoms” or “psychological problem” or “psychological problems” or mental or “mental health” or “mental symptoms” or “mental symptom” or “mental disorder” or “mental disorders” or “mental problem” or “mental problems” or “mental stress” or emotional or emotion or “emotional stress” or “emotional symptoms” or “emotional symptom” or “emotional disorder” or “emotional disorders” or “emotional problem” or “emotional problems” or “emotional health” or mood or “mood disorders” or “mood disorder” or “mood health” or “mood stress” or “mood symptom” or “mood symptoms” or “mood problem” or “mood problems” or affectivity or affective or “affective disorder” or “affective disorders” or “affective health” or “affective stress” or “affective problem” or “affective problems” or “affective symptom” or “affective symptoms” or depression or “depression symptom” or “depression symptoms” or “depression disorder” or “depression disorders” or anxiety or “anxiety symptom” or “anxiety symptoms” or “anxiety disorder” or “anxiety disorders”
#3 AB (“Randomized controlled trial” or ”Randomized controlled trials” or RCT or RCTs or “systematic review” or “systematic reviews” or meta-analysis or guideline or guidelines or consensus)
#4 2010–2019
#1 and #2 and #3 and #4