Quantitative assessment-based nursing intervention improves bowel function in patients with neurogenic bowel dysfunction after spinal cord injury: Study protocol for a randomized controlled study.

BACKGROUND: The neurogenic bowel dysfunction is a kind of familiar sequelae of the spinal cord injury (SCI), occurring in 70 to 80 percent of the SCI patients. The nursing intervention based on quantitative evaluation is to fully consider and assess the disease condition of patients, implement the personalized programs of nursing intervention, meet the patient's nursing needs to the maximum extent, improve the quality of nursing, and then facilitate the rehabilitation of patients. Our aim is to implement this program to evaluate the impact of this nursing intervention based on quantitative evaluation on the quality of life and bowel function in the neurogenic bowel dysfunction patients after SCI. METHODS: The experiment is a randomized clinical research which will be implemented from May 2021 to October 2021 at the First Affiliated Hospital of Soochow University. The experiment was granted through the Research Ethics Committee of the First Affiliated Hospital of Soochow University (No.100238765). Fifty neurogenic bowel dysfunction patients after SCI confirmed via the imaging are included in this study. The patients with the history of bowel diseases or patients who are unwilling to cooperate with the evaluation will be excluded. The primary outcomes are bowel function recovery and satisfaction of the patients. The secondary outcomes are quality of life evaluated by SF-36 questionnaire. The questionnaire involves physical pain, role physiology, physiological functions, social functions, vitality, general health, mental health and role-motional. RESULTS: Comparison of clinical parameters between the 2 groups will be shown in Table 1. CONCLUSION: Nursing intervention based on the quantitative evaluation can improve the quality of life and recovery of intestinal function for the neurogenic intestinal dysfunction patients after SCI. TRIAL REGISTRATION NUMBER: researchregistry6143.

Abdominal massage plus advice, compared with advice only, for neurogenic bowel dysfunction in MS: a RCT.

BACKGROUND: Between 50% and 80% of people with multiple sclerosis (PwMS) experience neurogenic bowel dysfunction (NBD) (i.e. constipation and faecal incontinence) that affects quality of life and can lead to hospitalisation. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of abdominal massage plus advice on bowel symptoms on PwMS compared with advice only. A process evaluation investigated the factors that affected the clinical effectiveness and possible implementation of the different treatments. DESIGN: A randomised controlled trial with process evaluation and health economic components. Outcome analysis was undertaken blind. SETTING: The trial took place in 12 UK hospitals. PARTICIPANTS: PwMS who had 'bothersome' NBD. INTERVENTION: Following individualised training, abdominal massage was undertaken daily for 6 weeks (intervention group). Advice on good bowel management as per the Multiple Sclerosis Society advice booklet was provided to both groups. All participants received weekly telephone calls from the research nurse. MAIN OUTCOME MEASURES: The primary outcome was the difference between the intervention and control groups in change in the NBD score from baseline to week 24. Secondary outcomes were measured via a bowel diary, adherence diary, the Constipation Scoring System, patient resource questionnaire and the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). RESULTS: A total of 191 participants were finalised, 189 of whom were randomised (two participants were finalised in error) (control group, n = 99; intervention group, n = 90) and an intention-to-treat analysis was performed. The mean age was 52 years (standard deviation 10.83 years), 81% (n = 154) were female and 11% (n = 21) were wheelchair dependent. Fifteen participants from the intervention group and five from the control group were lost to follow-up. The change in NBD score by week 24 demonstrated no significant difference between groups [mean difference total score -1.64, 95% confidence interval (CI) -3.32 to 0.04; p = 0.0558]; there was a significant difference between groups in the change in the frequency of stool evacuation per week (mean difference 0.62, 95% CI 0.03 to 1.21; p = 0.039) and in the number of times per week that participants felt that they emptied their bowels completely (mean difference 1.08, 95% CI 0.41 to 1.76; p = 0.002), in favour of the intervention group. Of participant interviewees, 75% reported benefits, for example less difficulty passing stool, more complete evacuations, less bloated, improved appetite, and 85% continued with the massage. A cost-utility analysis conducted from a NHS and patient cost perspective found in the imputed sample with bootstrapping a mean incremental outcome effect of the intervention relative to usual care of -0.002 quality-adjusted life-years (QALYs) (95% CI -0.029 to 0.027 QALYs). In the same imputed sample with bootstrapping, the mean incremental cost effect of the intervention relative to usual care was £56.50 (95% CI -£372.62 to £415.68). No adverse events were reported. Limitations include unequal randomisation, dropout and the possibility of ineffective massage technique. CONCLUSION: The increment in the primary outcome favoured the intervention group, but it was small and not statistically significant. The economic analysis identified that the intervention was dominated by the control group. Given the small improvement in the primary outcome, but not in terms of QALYs, a low-cost version of the intervention might be considered worthwhile by some patients. FUTURE WORK: Research is required to establish possible mechanisms of action and modes of massage delivery. TRIAL REGISTRATION: Current Controlled Trials ISRCTN85007023 and NCT03166007. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 58. See the NIHR Journals Library website for further project information.

Long-Term Cost-Effectiveness of Transanal Irrigation in Patients with Neurogenic Bowel Dysfunction.

BACKGROUND: People suffering from neurogenic bowel dysfunction (NBD) and an ineffective bowel regimen often suffer from fecal incontinence (FI) and related symptoms, which have a huge impact on their quality of life. In these situations, transanal irrigation (TAI) has been shown to reduce these symptoms and improve quality of life. AIM: To investigate the long-term cost-effectiveness of initiating TAI in patients with NBD who have failed standard bowel care (SBC). METHODS: A deterministic Markov decision model was developed to project the lifetime health economic outcomes, including quality-adjusted life years (QALYs), episodes of FI, urinary tract infections (UTIs), and stoma surgery when initiating TAI relative to continuing SBC. A data set consisting of 227 patients with NBD due to spinal cord injury (SCI), multiple sclerosis, spina bifida and cauda equina syndrome was used in the analysis. In the model a 30-year old individual with SCI was used as a base-case. A probabilistic sensitivity analysis was applied to evaluate the robustness of the model. RESULTS: The model predicts that a 30-year old SCI patient with a life expectancy of 37 years initiating TAI will experience a 36% reduction in FI episodes, a 29% reduction in UTIs, a 35% reduction in likelihood of stoma surgery and a 0.4 improvement in QALYs, compared with patients continuing SBC. A lifetime cost-saving of £21,768 per patient was estimated for TAI versus continuing SBC alone. CONCLUSION: TAI is a cost-saving treatment strategy reducing risk of stoma surgery, UTIs, episodes of FI and improving QALYs for NBD patients who have failed SBC.

Cost-effectiveness of transanal irrigation versus conservative bowel management for spinal cord injury patients.

STUDY DESIGN: Cost-effectiveness analysis following international guidelines and taking the societal viewpoint. OBJECTIVES: To estimate the cost-effectiveness of transanal irrigation using a self-administered irrigation system when compared with conservative bowel management. SETTING: A randomized clinical trial was conducted at five spinal centres situated in Denmark, Germany, Italy, United Kingdom and Sweden. Estimates of resources and unit costs were made for the German health care system. METHODS: Efficacy outcomes were drawn from a randomized controlled trial conducted in 2003-2005. Adult spinal cord-injured patients with neurogenic bowel dysfunction were randomized to 10 weeks with either transanal irrigation using Peristeen Anal Irrigation or to conservative bowel management. Costs were calculated based on results from the clinical trial and on 24 interviews conducted in Germany. Unit costs were obtained from the Federal Statistical Office Germany and product list prices. RESULTS: When comparing outcome measures at termination, transanal irrigation significantly reduced symptoms of neurogenic bowel dysfunction. Product-related costs were higher for transanal irrigation using the self-administered system; however, costs for a carer to help with bowel management and changes/washing due to leakage were lower. For transanal irrigation, costs associated with urinary tract infections and patient time spent were reduced. Thus, the total cost to society is lower when patients use transanal irrigation. The results were shown to be robust in the sensitivity analysis. CONCLUSION: Transanal irrigation using a self-administered system reduces symptoms of neurogenic bowel dysfunction and results in a lower total cost to society than conservative bowel management. SPONSORSHIP: The study was supported by Coloplast A/S.