Cost consequence analysis of transcutaneous tibial nerve stimulation (TTNS) for urinary incontinence in care home residents alongside a randomised controlled trial.

BACKGROUND: Urinary incontinence (UI) is prevalent in more than half of residents of nursing and residential care homes and can have a detrimental impact on dignity and quality of life. Care homes predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive, safe, low-cost intervention with demonstrated effectiveness for reducing UI in adults. We examined the costs and consequences of delivering TTNS to care home residents in comparison to sham (inactive) electrical stimulation. METHODS: A cost consequence analysis approach was used to assemble and present the resource use and outcome data for the ELECTRIC trial which randomised 406 residents with UI from 37 care homes in the United Kingdom to receive 12 sessions of 30 min of either TTNS or sham (inactive) TTNS. TTNS was administered by care home staff over 6 weeks. Health state utility was measured using DEMQOL-U and DEMQOL-PROXY-U at baseline, 6 weeks and 18 weeks follow-up. Staff completed a resource use questionnaire at baseline, 6 weeks and 18 weeks follow-up, which also assessed use of absorbent pads. RESULTS: HRQoL did not change significantly in either randomised group. Delivery of TTNS was estimated to cost £81.20 per participant, plus training and support costs of £121.03 per staff member. 85% of participants needed toilet assistance as routine, on average requiring one or two staff members to be involved 4 or 5 times in each 24 h. Daily use of mobility aids and other assistive devices to use the toilet were reported. The value of staff time to assist residents to use the toilet (assuming an average of 5 min per resident per visit) was estimated as £19.17 (SD 13.22) for TTNS and £17.30 (SD 13.33) for sham (per resident in a 24-hour period). CONCLUSIONS: Use of TTNS to treat UI in care home residents did not lead to changes in resource use, particularly any reduction in the use of absorbent pads and no cost benefits for TTNS were shown. Managing continence in care homes is labour intensive, requiring both high levels of staff time and use of equipment aids. TRIAL REGISTRATION: ISRCTN98415244, registered 25/04/2018. NCT03248362 (Clinical trial.gov number), registered 14/08//2017.

Long-term effects and costs of pelvic floor muscle training for prolapse: trial follow-up record-linkage study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse affects around 40% of women aged over 50 years. A multicentre parallel group randomised trial (the Pelvic Organ Prolapse PhysiotherapY (POPPY) trial) demonstrated that pelvic floor muscle training (PFMT) was effective in reducing prolapse symptoms compared with no treatment. However, insight into the long-term impact of PFMT on health outcomes and health-service utilisation is scarce. METHODS: This study utilised linkage of Scottish administrative health records to follow-up POPPY trial participants resident in Scotland over 11 years. Mixed effects logistic regression determined the likelihood of receiving further prolapse treatment for those in the PFMT and control groups. Analyses were adjusted for age group, prolapse stage, baseline symptom severity and attitude towards surgery. A cost assessment estimated longitudinal costs to the UK National Health Service (in Scotland) of accessing further prolapse treatment for each trial group. RESULTS: Two hundred and ninety-three women, aged 25 to 79 years, were followed up. One hundred and forty-one women (48.1%) had received further prolapse treatment: 65 (of 149; 43.6%) in the PFMT group compared with 76 (of 144; 52.8%) in the control group. PFMT was associated with a reduction in the odds of any prolapse treatment during follow-up (AOR 0.61; 95% CI 0.37 to 0.99). Total cost of secondary care was £154,544 (GBP) in the PFMT group and £172,549 (GBP) in the control group. CONCLUSIONS: Although PFMT did not lead to significant differences in total costs for further prolapse treatment over a post-intervention period of more than 10 years, it reduced the overall long-term risk of requiring hospital-based treatment for pelvic floor disorders.

Assessment of the Relative Performance of the EQ-5D-3L, ICIQ-UI SF and POP-SS Using Data from the OPAL Trial.

Conducting economic evaluations alongside randomised controlled trials (RCTs) is an efficient way to collect cost-effectiveness data. Generic preference-based measures, such as EQ-5D, are often used alongside clinical data measures in RCTs. However, in the case of female urinary incontinence (UI), evidence of the relative performance of EQ-5D with condition-specific measures such as the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF), measuring severity of UI, and Pelvic Organ Prolapse Symptom Score (POP-SS), measuring severity of prolapse symptoms, is limited. This study employed secondary analysis of outcome measures data collected during the Optimal Pelvic floor muscle training for Adherence Long-term (OPAL) RCT, which compared biofeedback-mediated pelvic floor muscle training to basic pelvic floor muscle training for women with UI. The relative performance of EQ-5D-3L and ICIQ-UI SF, and EQ-5D-3L and POP-SS was assessed for concurrent validity and known-groups validity. Data for 577 women (mean age 48) were available for EQ-5D-3L/ICIQ-UI SF, and 555 women (mean age 47) for EQ-5D-3L/POP-SS. Overall, EQ-5D-3L exhibited very weak association with the ICIQ-UI SF total score, or any subscale. EQ-5D-3L and POP-SS were found to be weakly correlated. EQ-5D-3L was able to distinguish between groups with known differences in severity of UI and also between types of UI. These findings provide useful information to guide researchers in selecting appropriate outcome measures for use in future clinical trials.

Tibial nerve stimulation compared with sham to reduce incontinence in care home residents: ELECTRIC RCT.

BACKGROUND: Urinary incontinence is prevalent in nursing and residential care homes, and has a profound impact on residents' dignity and quality of life. Treatment options are limited in these care contexts and care homes predominantly use absorbent pads to contain incontinence, rather than actively treat it. Transcutaneous posterior tibial nerve stimulation is a non-invasive, safe, low-cost intervention that is effective in reducing urinary incontinence in adults. OBJECTIVE: To determine the clinical effectiveness of transcutaneous posterior tibial nerve stimulation to treat urinary incontinence in care home residents and to determine the associated costs of the treatment. DESIGN: A multicentre, pragmatic, participant and outcome assessor-blind, randomised placebo-controlled trial. SETTING: A total of 37 UK residential and nursing care homes. PARTICIPANTS: Care home residents with at least weekly urinary incontinence that is contained using absorbent pads and who are able to use a toilet/toilet aid with or without assistance. INTERVENTIONS: Residents were randomised (1 : 1) to receive 12 30-minute sessions of transcutaneous posterior tibial nerve stimulation or sham stimulation over a 6-week period. MAIN OUTCOME MEASURES: Primary outcome - change in volume of urine leaked over a 24-hour period at 6 weeks. Secondary outcomes - number of pads used, Perception of Bladder Condition, toileting skills, quality of life and resource use. RESULTS: A total of 408 residents were randomised (transcutaneous posterior tibial nerve stimulation, n = 197; sham stimulation, n = 209); two exclusions occurred post randomisation. Primary outcome data were available for 345 (85%) residents (transcutaneous posterior tibial nerve stimulation, n = 167; sham stimulation, n = 178). Adherence to the intervention protocol was as follows: 78% of the transcutaneous posterior tibial nerve stimulation group and 71% of the sham group received the correct stimulation. Primary intention-to-treat adjusted analysis indicated a mean change of -5 ml (standard deviation 362 ml) urine leakage from baseline in the transcutaneous posterior tibial nerve stimulation group and -66 ml (standard deviation 394 ml) urine leakage in the sham group, which was a statistically significant, but not clinically important, between-group difference of 68-ml urine leakage (95% confidence interval 0 to 136 ml; p = 0.05) in favour of the sham group. Sensitivity analysis supported the primary analysis. No meaningful differences were detected in any of the secondary outcomes. No serious adverse events related to transcutaneous posterior tibial nerve stimulation were reported. Economic evaluation assessed the resources used. The training and support costs for the staff to deliver the intervention were estimated at £121.03 per staff member. Estimated costs for delivery of transcutaneous posterior tibial nerve stimulation during the trial were £81.20 per participant. No significant difference was found between participants' scores over time, or between transcutaneous posterior tibial nerve stimulation and sham groups at any time point, for resident or proxy quality-of-life measures. CONCLUSIONS: The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial showed, in the care home context (with a high proportion of residents with poor cognitive capacity and limited independent mobility), that transcutaneous posterior tibial nerve stimulation was not effective in reducing urinary incontinence. No economic case for transcutaneous posterior tibial nerve stimulation was made by the cost-consequences analysis; however, the positive reception of learning about urinary incontinence for care home staff supports a case for routine education in this care context. LIMITATIONS: Completing 24-hour pad collections was challenging for care home staff, resulting in some missing primary outcome data. FUTURE WORK: Research should investigate transcutaneous posterior tibial nerve stimulation in residents with urgency urinary incontinence to determine whether or not targeted stimulation is effective. Research should evaluate the effects of continence training for staff on continence care in care homes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN98415244 and ClinicalTrials.gov NCT03248362. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 41. See the NIHR Journals Library website for further project information.

Bladder leakage (urinary incontinence) is common among people living in care homes. Most people wear absorbent pads to contain urine leakage, but this does not treat the cause of incontinence. Transcutaneous posterior tibial nerve stimulation is a treatment for the type of incontinence associated with a sudden need to use the toilet (urgency incontinence). Two sticky patches applied to the ankle are connected to a small electrical stimulator. The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial looked at whether or not transcutaneous posterior tibial nerve stimulation can help reduce incontinence for people in care homes. A total of 406 residents from 37 care homes were given transcutaneous posterior tibial nerve stimulation treatment or a dummy treatment for 30 minutes, twice per week for 6 weeks. The amount of urine leaked by each resident was measured over 24 hours by collecting all pads used in a sealable plastic bag and weighing the bag. This happened after the final transcutaneous posterior tibial nerve stimulation or dummy treatment, and again after 3 and 5 months. Residents, family members and care home staff were asked if they thought that the transcutaneous posterior tibial nerve stimulation had any effect and for their views of the treatment. We found no important difference in leakage between residents who had the transcutaneous posterior tibial nerve stimulation and those who had the dummy treatment. There were also no differences in daily pad use, feelings about bladder condition or quality of life. It cost around £120 to train staff to deliver transcutaneous posterior tibial nerve stimulation and around £80 per person to have transcutaneous posterior tibial nerve stimulation treatment. Transcutaneous posterior tibial nerve stimulation had no serious side-effects. Care home residents, even those with severe dementia, found the application of transcutaneous posterior tibial nerve stimulation acceptable. Staff found learning about incontinence helpful, but continence care routines did not change. In summary, the ELECTRIC trial found that for very dependent older people in care homes, transcutaneous posterior tibial nerve stimulation did not reduce urinary incontinence. The findings do not support transcutaneous posterior tibial nerve stimulation use to reduce urinary incontinence in care home environments.

The impact of multimorbidity on foot health outcomes in podiatry patients with musculoskeletal foot pain: a prospective observational study.

BACKGROUND: Multimorbidity is prevalent and adversely affects health outcomes. Foot pain is common and one of the primary reasons for utilisation of podiatry services. At present, little is known about the impact of multimorbidity on foot health and related outcomes following podiatric intervention. The aims of this study were to evaluate whether there is a difference in foot health outcomes following exposure to podiatric foot care for people with and without multimorbidity; and ii) to evaluate whether the presence or absence of multimorbidity affects patients' perceptions of change in foot pain. METHODS: The PROMFoot study is a prospective cohort study of adults with a new episode of foot pain attending the podiatry service within the NHS Greater Glasgow and Clyde health board. Baseline medical comorbidity status (no condition, single condition, multiple conditions), longitudinal data on foot health measured using the Foot Health Status Questionnaire (FHSQ), and patient rating of change scores for foot pain were obtained from the PROMFoot study at baseline, and 3 and 6 months after podiatric intervention. Foot health scores (pain, function, footwear and general foot health) and perceptions of change for foot pain were compared between comorbidity groups. RESULTS: A total of 115 participants (59% female) with a mean age of 55 years were included. Multimorbidity was common, affecting 61 participants (53%); while 28 (24.3%) and 26 (22.6%) reported single or no medical comorbidities respectively. Significantly worse foot health scores for all FHSQ domains were observed for the multimorbidity group at baseline, 3 and 6 months. Change scores for foot pain were similar between groups and demonstrate modest improvements, however multimorbidity group membership was strongly associated with a perceptions of change in foot pain. Multimorbidity was independently associated with poorer foot function outcomes at 3 months, and poorer foot pain and foot function outcomes at 6 months. CONCLUSIONS: Multimorbidity was associated with poor foot health outcomes and lower rates of self-perceived improvement in foot pain over 6 months following podiatric intervention in a sample of patients attending podiatric biomechanics clinics for a new episode of foot pain.

Foot pain and foot health in an educated population of adults: results from the Glasgow Caledonian University Alumni Foot Health Survey.

BACKGROUND: Foot pain is common amongst the general population and impacts negatively on physical function and quality of life. Associations between personal health characteristics, lifestyle/behaviour factors and foot pain have been studied; however, the role of wider determinants of health on foot pain have received relatively little attention. Objectives of this study are i) to describe foot pain and foot health characteristics in an educated population of adults; ii) to explore associations between moderate-to-severe foot pain and a variety of factors including gender, age, medical conditions/co-morbidity/multi-morbidity, key indicators of general health, foot pathologies, and social determinants of health; and iii) to evaluate associations between moderate-to-severe foot pain and foot function, foot health and health-related quality-of-life. METHODS: Between February and March 2018, Glasgow Caledonian University Alumni with a working email address were invited to participate in the cross-sectional electronic survey (anonymously) by email via the Glasgow Caledonian University Alumni Office. The survey was constructed using the REDCap secure web online survey application and sought information on presence/absence of moderate-to-severe foot pain, patient characteristics (age, body mass index, socioeconomic status, occupation class, comorbidities, and foot pathologies). Prevalence data were expressed as absolute frequencies and percentages. Multivariate logistic and linear regressions were undertaken to identify associations 1) between independent variables and moderate-to-severe foot pain, and 2) between moderate-to-severe foot pain and foot function, foot health and health-related quality of life. RESULTS: Of 50,228 invitations distributed, there were 7707 unique views and 593 valid completions (median age [inter-quartile range] 42 [31-52], 67.3% female) of the survey (7.7% response rate). The sample was comprised predominantly of white Scottish/British (89.4%) working age adults (95%), the majority of whom were overweight or obese (57.9%), and in either full-time or part-time employment (82.5%) as professionals (72.5%). Over two-thirds (68.5%) of the sample were classified in the highest 6 deciles (most affluent) of social deprivation. Moderate-to-severe foot pain affected 236/593 respondents (39.8%). High body mass index, presence of bunions, back pain, rheumatoid arthritis, hip pain and lower occupation class were included in the final multivariate model and all were significantly and independently associated with moderate-to-severe foot pain (p < 0.05), except for rheumatoid arthritis (p = 0.057). Moderate-to-severe foot pain was significantly and independently associated lower foot function, foot health and health-related quality of life scores following adjustment for age, gender and body mass index (p < 0.05). CONCLUSIONS: Moderate-to-severe foot pain was highly prevalent in a university-educated population and was independently associated with female gender, high body mass index, bunions, back pain, hip pain and lower occupational class. Presence of moderate-to-severe foot pain was associated with worse scores for foot function, foot health and health-related quality-of-life. Education attainment does not appear to be protective against moderate-to-severe foot pain.

A systematic review of economic evaluations of conservative treatments for chronic lower extremity musculoskeletal complaints.

OBJECTIVE: The aim was to appraise and synthesize studies evaluating the clinical and cost effectiveness of conservative interventions for chronic lower extremity musculoskeletal (MSK) conditions and describe their characteristics, including the type of economic evaluation, primary outcomes and which conditions. METHODS: The search strategy related to economic evaluations of lower limb MSK conditions that used conservative therapies. Eight electronic databases were searched (CENTRAL, MEDLINE, PubMed, EMBASE, CINAHL, PEDro, NHSEED and Proquest), as were the reference lists from included articles. The quality of articles was appraised using a modified version of the economic evaluations' reporting checklist (economic) and The Cochrane Collaboration's tool for assessing risk of bias (clinical). RESULTS: Twenty-six studies were eligible and included in the review. Economic evaluations of conservative interventions for OA or pain affecting the knee/hip (n = 25; 93%) were most common. The main approaches adopted were cost-utility analysis (n = 17; 68%) or cost-effectiveness analysis (n = 5; 19%). Two studies involved interventions including footwear/foot orthoses; for heel pain (n = 1; 4%) and overuse injuries (n = 1; 4%). Fifty per cent of economic evaluations adopted the EQ-5D-3L as the primary outcome measure for quality of life and quality-adjusted life year calculations. CONCLUSION: Economic evaluations have been conducted largely for exercise-based interventions for MSK conditions of the hip and knee. Few economic evaluations have been conducted for other clinically important lower limb MSK conditions. A matrix presentation of costs mapped with outcomes indicated increasing costs with either no difference or improvements in clinical effectiveness. The majority of economic evaluations were of good reporting quality, as were the accompanying clinical studies.