Isaacs Talia, Hunt Daniel, Ward Danielle, Rooshenas Leila, Edwards Louisa
University of Bristol, Graduate School of Education, Bristol, United Kingdom.
J Med Internet Res. 2016 Sep 26;18(9):e256. doi: 10.2196/jmir.6374.
Type 2 diabetes is a serious, pervasive metabolic condition that disproportionately affects ethnic minority patients. Telehealth interventions can facilitate type 2 diabetes monitoring and prevent secondary complications. However, trials designed to test the effectiveness of telehealth interventions may underrecruit or exclude ethnic minority patients, with language a potential barrier to recruitment. The underrepresentation of minorities in trials limits the external validity of the findings for this key patient demographic.
This systematic review examines (1) the research reporting practices and prevalence of ethnic minority patients included in telehealth randomized controlled trials (RCTs) targeting type 2 diabetes and the trial characteristics associated with recruiting a high proportion of minority patients, and (2) the proportion of included RCTs that report using English language proficiency as a patient screening criterion and how and why they do so.
Telehealth RCTs published in refereed journals targeting type 2 diabetes as a primary condition for adults in Western majority English-speaking countries were included. Ethnically targeted RCTs were excluded from the main review, but were included in a post hoc subgroup analysis. Abstract and full-text screening, risk of bias assessment, and data extraction were independently conducted by two reviewers.
Of 3358 records identified in the search, 79 articles comprising 58 RCTs were included. Nearly two-thirds of the RCTs (38/58) reported on the ethnic composition of participants, with a median proportion of 23.5% patients (range 0%-97.7%). Fourteen studies (24%) that included at least 30% minority patients were all US-based, predominantly recruited from urban areas, and described the target population as underserved, financially deprived, or uninsured. Eight of these 14 studies (57%) offered intervention materials in a language other than English or employed bilingual staff. Half of all identified RCTs (29/58) included language proficiency as a participant-screening criterion. Language proficiency was operationalized using nonstandardized measures (eg, having sufficient "verbal fluency"), with only three studies providing reasons for excluding patients on language grounds.
There was considerable variability across studies in the inclusion of ethnic minority patients in RCTs, with higher participation rates in countries with legislation to mandate their inclusion (eg, United States) than in those without such legislation (eg, United Kingdom). Less than 25% of the RCTs recruited a sizeable proportion of ethnic minorities, which raises concerns about external validity. The lack of objective measures or common procedures for assessing language proficiency across trials implies that language-related eligibility decisions are often based on trial recruiters' impressionistic judgments, which could be subject to bias. The variability and inconsistent reporting on ethnicity and other socioeconomic factors in descriptions of research participants could be more specifically emphasized in trial reporting guidelines to promote best practice.
PROSPERO International Prospective Register of Systematic Reviews: CRD42015024899; http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42015024899 (Archived by WebCite at http://www.webcitation.org/6kQmI2bdF).
2型糖尿病是一种严重的、普遍存在的代谢性疾病，对少数族裔患者的影响尤为严重。远程医疗干预可以促进2型糖尿病的监测并预防继发性并发症。然而，旨在测试远程医疗干预效果的试验可能招募不足或排除少数族裔患者，语言可能是招募的一个潜在障碍。少数族裔在试验中的代表性不足限制了针对这一关键患者群体的研究结果的外部有效性。
本系统评价考察了（1）针对2型糖尿病的远程医疗随机对照试验（RCT）中纳入少数族裔患者的研究报告做法和患病率，以及与招募高比例少数族裔患者相关的试验特征；（2）纳入的RCT中报告将英语语言能力作为患者筛选标准的比例，以及他们这样做的方式和原因。
纳入在西方以英语为主要语言的国家的同行评审期刊上发表的、将2型糖尿病作为主要研究对象的成人远程医疗RCT。针对特定种族的RCT被排除在主要评价之外，但纳入了事后亚组分析。两名评审员独立进行摘要和全文筛选、偏倚风险评估及数据提取。
在检索到的3358条记录中，纳入了79篇文章，其中包含58项RCT。近三分之二的RCT（38/58）报告了参与者的种族构成，患者的中位数比例为23.5%（范围为0%-97.7%）。14项研究（24%）纳入了至少30%的少数族裔患者，这些研究均来自美国，主要从城市地区招募，且将目标人群描述为服务不足、经济贫困或未参保人群。这14项研究中有8项（57%）提供了非英语语言的干预材料或雇佣了双语工作人员。所有纳入的RCT中有一半（29/58）将语言能力作为参与者筛选标准。语言能力采用非标准化的衡量方法（如具备足够的“语言流利度”），只有三项研究说明了因语言原因排除患者的理由。
各研究在RCT中纳入少数族裔患者的情况存在很大差异，在有立法要求纳入少数族裔的国家（如美国），参与率高于没有此类立法的国家（如英国）。不到25%的RCT招募了相当比例的少数族裔，这引发了对外部有效性的担忧。各试验中缺乏评估语言能力的客观方法或通用程序，这意味着与语言相关的入选决定往往基于试验招募者的主观判断，可能存在偏差。试验报告指南可以更具体地强调研究参与者描述中种族和其他社会经济因素的变异性和不一致性报告，以促进最佳实践。
PROSPERO国际前瞻性系统评价注册库：CRD42015024899；http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42015024899（由WebCite存档于http://www.webcitation.org/6kQmI2bdF）
