Phil Edwards , Ian Roberts , Peter Sandercock , Chris Frost
{"title":"Follow-up by mail in clinical trials: does questionnaire length matter?","authors":"Phil Edwards , Ian Roberts , Peter Sandercock , Chris Frost","doi":"10.1016/j.cct.2003.08.013","DOIUrl":null,"url":null,"abstract":"<div><p>In large clinical trials where outcome assessment is possible using questionnaires, it may be more cost-effective to mail them to patients than to conduct interviews in-person. However, nonresponse to mailed questionnaires reduces the effective sample size and can introduce bias. We conducted a systematic review and meta-analysis of randomized controlled trials evaluating the effect of questionnaire length on response rates. We searched 14 electronic bibliographic databases, the reference lists of relevant trials, and we contacted the authors of eligible trials to ask about unpublished data. For each trial identified, we used logistic regression to estimate the odds ratio for response per one page increase in the number of pages included in the questionnaire. We pooled the regression coefficients in a random effects meta-analysis. Heterogeneity among the coefficients was assessed using a chi-square test at a 5% significance level. We specified a priori that the reduction in the odds of response per one page increase would be greatest among trials comparing relatively short questionnaires. We used meta regression to examine the relationships between the regression coefficients, the length of the questionnaires used in each trial, and other study characteristics. A total of 38 randomized controlled trials were identified where participants were allocated to questionnaires of differing lengths and where the number of pages used was known. There was significant heterogeneity between the regression coefficients estimated from each trial. In meta regression, most of the heterogeneity was explained by variation in the length of the questionnaires used in each trial. Among trials in which the shortest questionnaire was a postcard, the odds of response were more than halved for each additional page used (0.39; 95% CI 0.34 to 0.45). In the remaining trials, pooled effect sizes were much smaller. In trials of one page compared with either two or three pages, the odds of response per one page increase was 1.01 (95% CI 0.82 to 1.24). For one page compared with four or more pages, and for two or more pages compared with longer alternatives, the odds ratios per one page increase were 0.90 (95% CI 0.83 to 0.98) and 0.98 (95% CI 0.96 to 0.99), respectively. There were no statistically significant associations between trial results and other study characteristics. It appears that response can be increased by using a shorter questionnaire. Moderate changes to the length of shorter questionnaires will be more effective than moderate changes to the length of longer questionnaires. If a choice of follow-up questionnaire exists for a clinical trial, the shorter one should be used. If a new follow-up questionnaire is to be designed, it should be made as short as possible without compromising the data collection requirements of the trial.</p></div>","PeriodicalId":72706,"journal":{"name":"Controlled clinical trials","volume":"25 1","pages":"Pages 31-52"},"PeriodicalIF":0.0000,"publicationDate":"2004-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.cct.2003.08.013","citationCount":"150","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Controlled clinical trials","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0197245603001387","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 150
Abstract
In large clinical trials where outcome assessment is possible using questionnaires, it may be more cost-effective to mail them to patients than to conduct interviews in-person. However, nonresponse to mailed questionnaires reduces the effective sample size and can introduce bias. We conducted a systematic review and meta-analysis of randomized controlled trials evaluating the effect of questionnaire length on response rates. We searched 14 electronic bibliographic databases, the reference lists of relevant trials, and we contacted the authors of eligible trials to ask about unpublished data. For each trial identified, we used logistic regression to estimate the odds ratio for response per one page increase in the number of pages included in the questionnaire. We pooled the regression coefficients in a random effects meta-analysis. Heterogeneity among the coefficients was assessed using a chi-square test at a 5% significance level. We specified a priori that the reduction in the odds of response per one page increase would be greatest among trials comparing relatively short questionnaires. We used meta regression to examine the relationships between the regression coefficients, the length of the questionnaires used in each trial, and other study characteristics. A total of 38 randomized controlled trials were identified where participants were allocated to questionnaires of differing lengths and where the number of pages used was known. There was significant heterogeneity between the regression coefficients estimated from each trial. In meta regression, most of the heterogeneity was explained by variation in the length of the questionnaires used in each trial. Among trials in which the shortest questionnaire was a postcard, the odds of response were more than halved for each additional page used (0.39; 95% CI 0.34 to 0.45). In the remaining trials, pooled effect sizes were much smaller. In trials of one page compared with either two or three pages, the odds of response per one page increase was 1.01 (95% CI 0.82 to 1.24). For one page compared with four or more pages, and for two or more pages compared with longer alternatives, the odds ratios per one page increase were 0.90 (95% CI 0.83 to 0.98) and 0.98 (95% CI 0.96 to 0.99), respectively. There were no statistically significant associations between trial results and other study characteristics. It appears that response can be increased by using a shorter questionnaire. Moderate changes to the length of shorter questionnaires will be more effective than moderate changes to the length of longer questionnaires. If a choice of follow-up questionnaire exists for a clinical trial, the shorter one should be used. If a new follow-up questionnaire is to be designed, it should be made as short as possible without compromising the data collection requirements of the trial.
在大型临床试验中,可以使用问卷来评估结果,将问卷邮寄给患者可能比亲自面谈更具成本效益。然而,对邮寄问卷的不回应减少了有效样本量,并可能引入偏见。我们对随机对照试验进行了系统回顾和荟萃分析,以评估问卷长度对应答率的影响。我们检索了14个电子书目数据库,检索了相关试验的参考文献列表,并联系了符合条件的试验的作者询问未发表的数据。对于确定的每个试验,我们使用逻辑回归来估计问卷中每增加一页的响应的优势比。我们在随机效应荟萃分析中汇总了回归系数。使用卡方检验在5%显著性水平下评估系数之间的异质性。我们先验地指出,在比较相对较短的问卷的试验中,每增加一页,应答几率的减少将是最大的。我们使用元回归来检验回归系数、每次试验中使用的问卷长度和其他研究特征之间的关系。总共确定了38个随机对照试验,参与者被分配到不同长度的问卷,并且使用的页数是已知的。每个试验估计的回归系数之间存在显著的异质性。在meta回归中,大多数异质性可以用每次试验中使用的问卷长度的变化来解释。在最短的问卷是一张明信片的试验中,每增加一页,回应的几率就会减少一半以上(0.39;95% CI 0.34 ~ 0.45)。在其余的试验中,合并效应量要小得多。在一页的试验中,与两页或三页的试验相比,每一页的反应几率增加1.01 (95% CI 0.82至1.24)。与四页或更多页相比,一页或更多页与更长的替代方案相比,每页的优势比分别增加0.90 (95% CI 0.83至0.98)和0.98 (95% CI 0.96至0.99)。试验结果与其他研究特征之间没有统计学上的显著关联。似乎可以通过使用更短的问卷来增加反应。适度改变较短问卷的长度比适度改变较长问卷的长度更有效。如果临床试验存在随访问卷的选择,则应使用较短的问卷。如果要设计新的随访问卷,应在不影响试验数据收集要求的情况下尽可能短。