Klaske van Sluis

Interaction of functional and participation issues on quality of life 95 to Atos Medical clients from different countries to investigate the hidden needs and complaints of total laryngectomized patients. We were able to use the ob- tained responses for our analysis. Thus, with the aforementioned physical and social consequences of the TL procedure in mind, we developed the following re- search question: What relation exists between demographic characteristics and reported Quality of Life (r-QoL) ratings of total laryngectomized individuals and their self-reported participation and functional issues? 6.2 Materials and methods 6.2.1 Questionnaire An online questionnaire was developed by Atos Medical AB (Malmö, Sweden) and ReD Associates (Copenhagen, Denmark) with input from the Netherlands Cancer Institute. The scope of the questionnaire was to assess the impact of TL on daily life and examine the use of medical devices, experienced functional and participation issues, and possible hidden needs regarding medical devices for the rehabilitation after TL. A pilot version of the questionnaire was send via email by Atos Medical AB to a cohort of 250 TL clients in the United States of America, with a response rate of 12%. Based on the pilot, adjust- ments were made. The final version of the online questionnaire consisted of 26 main questions regarding demographic information (not obligatory) and prod- uct use of the respondents, experienced overall health and independence, and experienced functional and participation issues. The final questionnaire was sent out via email by Atos Medical AB to 8119 clients in nine countries; the United Kingdom, United States, Germany, France, Sweden, the Netherlands, Brazil, Italy, and Spain. All approached Atos Medical clients were treated with TL and older than 18 years. One reminder-email was sent out and the ques- tionnaire was available online for three weeks. The data were collected by ReD Associates and made available to the Netherlands Cancer Institute. 6.2.2 Statistical analysis The responses of the questionnaire were analyzed anonymously by the Nether- lands Cancer Institute using the statistical package R (version 3.5.1.). Respon- dents from the pilot study ( n =29) were excluded from the analysis, resulting in a cohort of n =1705. As primary outcome measure the relation between the reported quality of life (r-QoL) ratings and the reported participation and func- tional issues was tested. As secondary outcome measure the relations between demographics and participation and functional issues were tested. A linear model was selected with the "step" function (setting direction “both”) in R using the Bayesian Information Criterion [20]. The relative importance of the themes was determined with the “calc.relimp” function (setting type “first”) [21].