Unmet needs for stroke patients based on the social ecological model: protocol for a mixed-methods systematic review

Abstract

Introduction

Stroke is a severe cerebrovascular disease characterised by high morbidity, high recurrence rate, high disability rate, high mortality rate and significant economic burden. The unmet needs of stroke patients are universal and diverse and closely related to their health outcomes.

Methods and analysis

This protocol describes a mixed-methods systematic review to identify unmet needs in stroke patients. A comprehensive search will be performed in the following databases: PubMed, CINAHL, Embase, Web of Science, PsycINFO, CNKI, Wanfang Database and CQVIP. Google Scholar and ProQuest Dissertations & Theses Global were searched as grey literature sources. The search will target studies published in English or Chinese between January 2018 and April 2026. Quantitative, qualitative and mixed-methods study designs will be included. Two independent reviewers will conduct the selection process and cross-check the data extraction. The Mixed-Methods Assessment Tool (2018 version) will be employed to evaluate study quality. The convergent integrated approach and thematic synthesis will be used to synthesise and map extracted data to the social ecological model. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and the Confidence in the Evidence from Reviews of Qualitative Research (GRADE-CERQual) approach will be used for the certainty assessment of evidence.

Ethics and dissemination

Ethical approval is not required for this systematic review, as it will use data extracted exclusively from published studies and other publicly available sources. The findings of this review will be disseminated through publication in a peer-reviewed journal and presentation at relevant academic and clinical conferences.

PROSPERO registration number

CRD420261366175.

STRENGTHS AND LIMITATIONS OF THIS STUDY

• The mixed-methods systematic review methodology will integrate quantitative data with qualitative data, providing a comprehensive understanding of unmet needs for stroke patients.

• Two reviewers will independently screen eligible studies for inclusion, extract data and evaluate the quality of studies and the certainty of evidence, and this review will adhere to the Joanna Briggs Institute methodological framework for mixed-methods systematic reviews to enhance methodological rigour.

• This review will focus on ‘unmet needs’ and exclude studies that assessed needs after stroke but did not explicitly report results regarding ‘unmet needs’.

• This review will exclude studies published before 2018, which may reduce the comprehensiveness of the evidence.

Introduction

Stroke is a severe cerebrovascular disease characterised by high morbidity, high recurrence rate, high disability rate, high mortality rate and significant economic burden.^{1 2} The Global Burden of Disease Study¹ indicated that among non-communicable disorders, stroke remains the second leading cause of death and the third leading cause of death and disability combined in the world. The estimated global cost of stroke is over US$890 billion (0.66% of the global GDP).¹

Stroke patients often experience physical (eg, altered muscle tone, power and sensation),^{3 4} cognitive (eg, memory and attention)^{5 6} or emotional impairments (eg, anxiety and depression)^{7 8} and require partial or full assistance to perform activities of daily living,⁹ which cause significant burden to the person, family unit and society.¹⁰ The treatment and rehabilitation process for stroke patients is lengthy; the risk of recurrence, disease progression and treatment side effects continue to affect patients, which is prone to physiological, psychological and social problems, resulting in the increase of treatment information, economic, continuous care and emotional needs.^{11 12} Unmet needs refers to the persistence of problems, expressed by stroke patients despite receiving some form of poststroke care.¹³ Lee et al¹⁴ indicated that 94% of stroke patients have at least one unmet need, and long-term unmet needs and unmet rehabilitation needs were associated with a lower quality of life. Kuo et al¹⁵ showed that stroke patients continue to experience unmet needs in important areas even 6 months poststroke, and lagged unmet needs were associated with poorer poststroke health outcomes. Therefore, identifying and assessing the unmet needs of stroke patients and providing targeted nursing interventions can help optimise their long-term care.

In 1988, McLeroy et al¹⁶ proposed the social ecological model (SEM) based on Brofenbrenner’s¹⁷ ecological model, which focused on the field of healthcare, particularly those related to health promotion. SEM underscores that individual behaviours are shaped by a dynamic interplay of factors across multiple levels, including intrapersonal (characteristics of the individual such as knowledge, attitudes, behaviour, self-concept, skills, etc), interpersonal (formal and informal social network and social support systems, including the family, work group and friendship networks), institutional (social institutions with organisational characteristics and formal or informal rules and regulations for operation), community (relationships among organisations, institutions and informal networks within defined boundaries) and policy (local, state and national laws and policies) levels.¹⁶ The needs of stroke patients are a multidisciplinary social issue involving medicine, sociology and psychology.¹⁸ Due to its systematic and comprehensive nature, SEM can place stroke patients within their relevant social contexts while analysing the needs at various levels, including individuals, families, communities and policies.

Some systematic reviews have focused on the unmet needs for stroke patients,^{13 19–21} while these reviews provided insights into unmet needs for stroke patients, they were published at an earlier stage with restricted timeliness, and given the ongoing emergence of new evidence, a systematic summary of them is warranted. Additionally, the current reviews have not clearly mapped the unmet needs of stroke patients into a multilevel theoretical framework, which limits our ability to systematically explore the structure of patients’ needs and design theory-driven interventions targeting unmet needs. Furthermore, the existing relevant systematic reviews have exclusively incorporated either qualitative or quantitative studies, without integrating both to facilitate a more profound and comprehensive discussion.

The mixed-methods systematic review is a research methodology that integrates quantitative, qualitative and mixed-methods findings, thereby maximising the extraction of valid evidence and compensating for the informational constraints inherent in single-method research approaches.^{22 23} The objectives of this review are as follows. (1) To describe the range and frequency of unmet needs of stroke patients. (2) Conduct a thematic analysis of the qualitative and quantitative data to report meaningful themes of unmet needs of stroke patients in the framework of SEM, which provides a reference basis for formulating targeted nursing interventions.

Methods and analysis

Study design

A convergent integrated mixed-methods design will be used in this review, employing a thematic approach to synthesise the identified evidence, informed by the Joanna Briggs Institute (JBI) methodological guidance for mixed-method systematic reviews.²⁴ This protocol is guided by the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P)²⁵ (online supplemental file 1).

Eligibility criteria

Inclusion criteria for this review will be defined using the PICo framework (table 1).²⁴ The exclusion criteria will be as follows: (1) studies that assessed needs of stroke survivors but did not explicitly report results regarding ‘unmet needs’; (2) studies for which the full text could not be retrieved; (3) duplicate publications; (4) studies not published in English or Chinese; and (5) study protocols, case reports, conference abstracts and reviews.

Table 1. Inclusion criteria based on the PICo framework.

PICo element	Inclusion criteria
P (population)	Patients with ischaemic or haemorrhagic stroke or transient ischaemic attack
	Age≥18 years old
I (phenomenon of interest)	Unmet needs, including physiological needs, psychological needs, information needs, policy needs, etc
Co (context)	Setting: during hospitalisation, after discharge, community or home
	Study design: quantitative studies (experimental and observational), qualitative studies, mixed-methods studies
	Language: English or Chinese

Search strategy

The systematic search will be conducted using the following databases: PubMed, CINAHL, Embase, Web of Science, PsycINFO, CNKI, Wanfang Database and CQVIP. Google Scholar and ProQuest Dissertations & Theses Global were searched as grey literature sources to improve comprehensiveness and reduce the risk of publication bias. To balance the timeliness and comprehensiveness of the evidence, the search will be limited to studies published between January 2018 and April 2026. The year 2018 is selected as the starting point because the body of evidence on unmet needs among stroke patients published before 2018 had already been systematically identified and comprehensively synthesised in a prior systematic review by Chen et al¹⁹ and Zawawi et al.¹³ Therefore, this review aims to synthesise emerging evidence from the past 8 years (2018–2026) to provide the latest insights into this field, while avoiding unnecessary duplication of existing syntheses.

Search queries were devised using the Boolean operators ‘AND’ and ‘OR’, and the key search concepts were ‘stroke’ and ‘unmet needs’. Details of the search strategies for each database are provided in online supplemental file 2.

Selection process

The literature will be imported into EndNote X9 software for deduplication, initial screening and rescreening of the full text. Two reviewers (HX and HY) will independently screen all the titles and abstracts of the literature identified through the database searches. Discrepancies will be resolved through discussion and consensus, and, if necessary, with the help of a third expert reviewer (BD), who will make the final decision regarding inclusion. The inter-rater agreement will be quantified at the title/abstract screening and full-text review stages using Cohen’s kappa coefficient.²⁶ Kappa values ≤ 0 indicate no agreement; 0.01–0.20 as none to slight; 0.21–0.40 as fair; 0.41–0.60 as moderate; 0.61–0.80 as substantial and 0.81–1.00 as almost perfect agreement.²⁶ The selection process will be documented in appropriate detail to complete the PRISMA flowchart diagram.

Data extraction

Two reviewers (HX and HY) will extract the data independently based on the JBI Mixed-Methods Data Extraction Form.²⁴ Any discrepancies will be resolved through cross-checking and consensus and, when necessary, adjudication by a third reviewer (BD). The following data will be extracted from the included studies: author, publication year, country, study aim, study design, data collection, age, stroke type, time after stroke, setting and phenomena of interest (prevalence of unmet needs and unmet needs type). The data extraction form is provided in online supplemental file 3.

Quality assessment

Two reviewers (HX and HY) will independently assess the quality of the included studies using the Mixed-Methods Appraisal Tool (MMAT) (2018 version)^{27 28} (online supplemental file 4). Disagreements will be resolved through discussion, if required, adjudicated by a third reviewer (BD). The MMAT (2018 version) is a rigorous evaluation tool presented as an assessment list, which can be used to evaluate the quality of five types of studies, including qualitative studies, quantitative randomised controlled trials, quantitative non-randomised studies, quantitative descriptive studies and mixed-method studies.²⁸ The evaluation items for each study type are two screening questions and five specific criteria, with options ‘yes’, ‘no’ or ‘can’t tell’.²⁸ In the MMAT (2018 version), it is discouraged to calculate an overall score from the ratings of each criterion.²⁸ Instead, it is advised to provide a more detailed presentation of the ratings of each criterion, and excluding studies with low methodological quality is usually discouraged.²⁸

Data synthesis and analysis

The convergent integrated approach will be used for this review following the JBI methodology, which refers to a process of combining extracted data from quantitative studies (including data from the quantitative component of mixed-methods studies) and qualitative studies (including data from the qualitative component of mixed-methods studies) and involves data transformation.^{24 29} First, quantitative data should be ‘qualitised’, which requires extracting data from quantitative studies and translating or converting it into ‘textual descriptions’ (themes, categories or narratives) to allow integration with qualitative data.^{24 29} In this study, the specific quantitative data to be qualitised will include the prevalence (proportions of stroke patients reporting unmet needs and the number of unmet needs per patient) and frequency distributions (categories and frequency distribution of unmet needs). When inconsistencies are found between qualitised quantitative findings and qualitative findings, they will be transparently reported in the narrative synthesis, and potential reasons will be explored. Two reviewers will independently generate these interpretive statements by analysing the results sections of the included studies. Consistency will be verified by both reviewers, with any discrepancies resolved through discussion. To ensure the transparency and validity of the data transformation, an auditable conversion log will be created. For each piece of quantitative data extracted, the reviewer will record: (a) the original quantitative data extracted from the study and (b) the corresponding qualitative finding statement generated.

The qualitative data will undergo thematic analysis using NVivo V.15.0 software. Second, combine the ‘qualitised’ quantitative data with the qualitative data to form categories and develop them into themes.^{24 29} Themes will be mapped to the SEM, which will not be used to guide data extraction or synthesis, and it will be applied exclusively after thematic synthesis to organise and present the integrated findings across the five systemic levels. For the theme that could plausibly be assigned to more than one SEM level, it will be designated as a ‘cross-cutting theme’ and reported across the relevant levels, with explicit acknowledgement of its multilevel nature in the narrative synthesis. In addition, if the number of studies included for each subtype is sufficient, we will conduct a subgroup analysis by stroke type to explore potential differences in characteristics of unmet needs across pathological subtypes. Theme coding and classification will be performed independently by two reviewers, with disagreements resolved by discussion and consensus and third-reviewer adjudication when needed.

To assess the overall strength of evidence for our findings, we will employ the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach³⁰ for quantitative outcomes, which assesses the quality of evidence across studies based on five domains (risk of bias, inconsistency, indirectness, imprecision and publication bias). For qualitative findings, we will use the Confidence in the Evidence from Reviews of Qualitative Research (GRADE-CERQual) approach,³¹ which assesses confidence in the evidence based on four components (methodological limitations, coherence, adequacy of data and relevance). The overall confidence in each review finding is rated as high, moderate, low or very low.

Ethics and dissemination

Ethical approval is not required for this systematic review, as it will use data extracted exclusively from published studies and other publicly available sources. The findings of this review will be disseminated through publication in a peer-reviewed journal and presentation at relevant academic and clinical conferences.