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Background: Total laryngectomy with or without adjuvant (chemo)radiation often induces speech, swallowing and neck and shoulder problems. Speech, swallowing and shoulder exercises may prevent or diminish these problems. The aim of the present paper is to describe the study, which is designed to investigate the effectiveness and cost-utility of a guided self-help exercise program built into the application "In Tune without Cords" among patients treated with total laryngectomy.Methods/design: Patients, up to 5 years earlier treated with total laryngectomy with or without (chemo)radiation will be recruited for participation in this study. Patients willing to participate will be randomized to the intervention or control group (1:1). Patients in the intervention group will be provided access to a guided self-help exercise program and a self-care education program built into the application "In Tune without Cords". Patients in the control group will only be provided access to the self-care education program. The primary outcome is the difference in swallowing quality (SWAL-QOL) between the intervention and control group. Secondary outcome measures address speech problems (SHI), shoulder disability (SDQ), quality of life (EORTC QLQ-C30, QLQ-H&N35 and EQ-5D), direct and indirect costs (adjusted iMCQ and iPCQ measures) and self-management (PAM). Patients will be asked to complete these outcome measures at baseline, immediately after the intervention or control period (i.e. at 3 months follow-up) and at 6 months follow-up.Discussion: This randomized controlled trial will provide knowledge on the effectiveness of a guided self-help exercise program for patients treated with total laryngectomy. In addition, information on the value for money of such an exercise program will be provided. If this guided self-help program is (cost)effective for patients treated with total laryngectomy, the next step will be to implement this exercise program in current clinical practice.Trial Registration: NTR5255 Protocol version 4 date September 2015. [ABSTRACT FROM AUTHOR]

Aim: To develop a Web-based self-care program for patients after total laryngectomy according to a participatory design approach. Methods: We conducted a needs assessment with laryngectomees (n = 9) and their partners (n = 3) by means of a focus group interview. In 4 focus group sessions, a requirement plan was formulated by a team of health care professionals (n = 10) and translated into a prototype. An e-health application was built including illustrated information on functional changes after total laryngectomy as well as video demonstrations of skills and exercises. Usability of the prototype was tested by end users (n = 4) and expert users (n = 10). Interviews were held to elicit the intention to use and the desired implementation strategy. Results: Six main self-care topics were identified: (1) nutrition, (2) tracheostomy care, (3) voice prosthesis care, (4) speech rehabilitation, (5) smell rehabilitation, and (6) mobility of head, neck, and shoulder muscles. Expert users expressed concerns regarding tailored exercises, indicated a positive intent to implement the intervention in routine care, and expressed a need for guidance when implementing the intervention. End users and expert users appreciated the content completeness and multimedia-based information built into the application. Conclusion: The participatory design is a valuable approach to develop a self-care program to help meet users' needs. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effectiveness of a guided self-help exercise program on swallowing, speech, and shoulder problems in patients treated with total laryngectomy (TL).Materials and Methods: This randomized controlled trial included patients treated with TL in the last 5 years. Patients were randomized into the intervention group (self-help exercise program with flexibility, range-of-motion and lymphedema exercises and self-care education program) or control group (self-care education program). Both groups completed measurements before and 3 and 6-months after randomization. The primary outcome was swallowing problems (SWAL-QOL). Secondary outcomes were speech problems (SHI), shoulder problems (SDQ), self-management (patient activation: PAM) and health-related quality of life (HRQOL: EORTC QLQ-C30/H&N35). Adherence was defined as moderate-high in case a patient exercised >1 per day. Linear mixed model analyses were conducted to investigate the effectiveness of the intervention and to investigate whether neck dissection, treatment indication (primary/salvage TL), time since treatment, severity of problems, and preferred format (online/booklet) moderated the effectiveness.Results: Moderate-high adherence to the exercise program was 59%. The intervention group (n = 46) reported less swallowing and communication problems over time compared to the control group (n = 46) (p-value = 0.013 and 0.004). No difference was found on speech, shoulder problems, patient activation and HRQOL. Time since treatment moderated the effectiveness on speech problems (p-value = 0.025): patients within 6 months after surgery benefitted most from the intervention. Being treated with a neck dissection, treatment indication, severity of problems and format did not moderate the effectiveness.Conclusion: The guided self-help exercise program improves swallowing and communication.Trial Registration: NTR5255. [ABSTRACT FROM AUTHOR]

Purpose: Our aim was to develop consensus on the definition and operationalization of communicative participation (CP) in 2- to 8-year-old children with language disorders (LDs). A clear definition and operationalization can facilitate the discussion about children’s communication problems in daily life between parents and professionals. Method: In an online Delphi study, anonymized thoughts and opinions were collected on the definition and operationalization of CP in young children with LD. The 47 Delphi panel members were Dutch parents, young adults with LDs, teachers and assistants, speech-language pathologists, clinical linguists, and clinical researchers. Thematic content analysis was used to develop a concept definition and items operationalizing CP. The Delphi panel rated the suitability of concept definitions using a 7-point Likert scale. Concept definitions were revised with feedback from the Delphi panel until consensus was achieved. The Delphi panel rated items on how well they operationalize CP, using the same Likert scale. Results: The majority (79%) of the Delphi panel indicated that the essence of CP was captured by the definition: “CP is understanding and being understood in a social context, by applying verbal and non-verbal communication skills.” In addition, 33 behavioral items were developed. Conclusion: This study resulted in strong consensus on the definition of CP between Dutch parents and professionals. Items were developed that can inform speech-language pathologists on the type of questions to ask a child’s parents or teacher when discussing CP. Further research is needed on how the items can best be used in clinical practice. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to investigate the feasibility of an online self-care education program supporting early rehabilitation of patients after total laryngectomy (TLPs) and factors associated with satisfaction.Methods: Health care professionals (HCPs) were invited to participate and to recruit TLPs. TLPs were informed on the self-care education program "In Tune without Cords" (ITwC) after which they gained access. A study specific survey was used (at baseline T0 and postintervention T1) on TLPs' uptake. Usage, satisfaction (general impression, willingness to use, user-friendliness, satisfaction with self-care advice and strategies, Net Promoter Score (NPS)), sociodemographic, and clinical factors were analyzed.Results: HCPs of 6 out of 9 centers (67% uptake rate) agreed to participate and recruited TLPs. In total, 55 of 75 TLPs returned informed consent and the baseline T0 survey and were provided access to ITwC (73% uptake rate). Thirty-eight of these 55 TLPs used ITwC and completed the T1 survey (69% usage rate). Most (66%) TLPs were satisfied (i.e., score ≥7 (scale 1-10) on 4 survey items) with the self-care education program (mean score 7.2, SD 1.1). NPS was positive (+5). Satisfaction with the self-care education program was significantly associated with (higher) educational level and health literacy skills (P = .004, P = .038, respectively). No significant association was found with gender, age, marital status, employment status, Internet use, Internet literacy, treatment modality, time since total laryngectomy, and quality of life.Conclusion: The online self-care education program ITwC supporting early rehabilitation was feasible in clinical practice. In general, TLPs were satisfied with the program. [ABSTRACT FROM AUTHOR]

Objectives: The guided self-help exercise program called In Tune without Cords (ITwC) is effective in improving swallowing problems and communication among patients treated with a total laryngectomy (TL). This study investigated the cost-utility and cost-effectiveness of ITwC.Materials and Methods: Patients within 5 years after TL were included in this randomized controlled trial. Patients in the intervention group (n = 46) received access to the self-help exercise program with flexibility, range-of-motion and lymphedema exercises, and a self-care education program. Patients in the control group (n = 46) received access to the self-care education program only. Healthcare utilization (iMCQ), productivity losses (iPCQ), health status (EQ-5D-3L, EORTC QLU-C10D) and swallowing problems (SwalQol) were measured at baseline, 3- and 6-months follow-up. Hospital costs were extracted from medical files. Mean total costs and effects (quality-adjusted life-years (QALYs) or SwalQol score) were compared with regression analyses using bias-corrected accelerated bootstrapping.Results: Mean total costs were non-significantly lower (-€685) and QALYs were significantly higher (+0.06) in the intervention compared to the control group. The probability that the intervention is less costly and more effective was 73%. Sensitivity analyses with adjustment for baseline costs and EQ-5D scores showed non-significantly higher costs (+€119 to +€364) and QALYs (+0.02 to +0.03). A sensitivity analysis using the QLU-C10D to calculate QALYs showed higher costs (+€741) and lower QALYs (-0.01) and an analysis that used the SwalQol showed higher costs (+€232) and higher effects (improvement of 6 points on a 0-100 scale).Conclusion: ITwC is likely to be effective, but possibly at higher expenses.Trial Registration: NTR5255. [ABSTRACT FROM AUTHOR]