Results of the Diaphragmatic Plication Database: 10 Years' Experience.

BACKGROUND: Unilateral diaphragmatic paralysis or paresis (UDP) in adults is an often overlooked disease which relevantly impairs the patient's lung function and quality of life. Particularly in idiopathic UDP, there is no evidence for conservative therapy and only little evidence for surgical therapy. METHODS: The method involves retrospective single-center analysis of patients with UDP persistent for at least 1 year who were operated by diaphragmatic resection, plication, and augmentation with a polypropylene mesh. The patients were tested for lung and diaphragmatic function, six-minute walk test (6MWT), and blood gas analysis before, 3 and 12 months after surgery. RESULTS: In total, 85 patients received surgery for UDP. The most frequent reasons for UDP were idiopathic (67%), iatrogenic (mainly cardiac and cervical spine surgery; 24%), and trauma (9%). The mean operation time was 84 ± 24 minutes, the length of hospital stay 8.4 ± 3.9 days, chest tubes were removed after 11.7 ± 4.1 days. Overall morbidity was 42%, mortality 0%. Forced expiratory volume in one second (FEV1) in supine position improved by 12.4% absolute, vital capacity by 11.8% absolute, and sniff nasal inspiratory pressure by 1.4 kPa 12 months after surgery (p <0.001 each). Total lung capacity increased by 6.8% absolute at 12 months (p = 0.001) The 6MWT distance improved by 45.9 m at 3 months and 50.9 m at 12 months (p = 0.001, each). CONCLUSION: Surgical therapy for UDP is highly effective in the long term. The superiority over conservative treatments needs to be evaluated prospectively with standardized physiotherapeutic protocols. FEV1 in supine position and 6MWT are easy to perform tests and represent statistically and patient-relevant outcomes.

Development of the Diaphragmatic Paralysis Questionnaire: a simple tool for patient relevant outcome.

OBJECTIVES: Measurement tools of health-related quality of life (HRQL) that are specific for the underlying disorder are inevitably needed to assess HRQL changes following specific treatment strategies. The aim of the current study was to develop a questionnaire assessing HRQL in patients with unilateral diaphragmatic paresis. METHODS: Firstly, topics of health impairments covering physical, psychological, social and functional aspects were predefined by a physician expert panel to ensure face validity. Secondly, all predefined topics were rated by a patient group with unilateral diaphragmatic paresis (untreated: n = 11; postoperative: n = 9) using a 5-point Likert scale ranging from 'not relevant at all' (-2) to 'absolutely relevant' (+2) to guarantee content validity. Thirdly, only relevant topics (0 to +2) were used for item development, while non-relevant items (<0) were not subject for item development. RESULTS: In total, 20 patients rated a total of 43 topics covering a broad spectrum of health impairment. 21 were considered as relevant for item development. Items are answered on a 5-point Likert scale ranging from 'completely untrue' (-2) to 'always true' (+2). The Diaphragmatic Paralysis Questionnaire (DPQ) Summary Score ranges from 0 (worst HRQL) to 100 (best HRQL). Finally, the German DPQ was professionally translated and transculturally adapted into English, Italian, Dutch, French, Greek and Spanish, using translation/back-translation procedures. CONCLUSIONS: The DPQ is the first diseases-specific HRQL measure developed for patients with diaphragmatic paresis. In addition, the DPQ is available in 7 languages free of charge for non-profit purposes. CLINICAL TRIAL REGISTRATION: German clinical trials register: DRKS00017056.