Improving the time to ileostomy closure following an anterior resection for rectal cancer in the UK.

AIM: Delayed closure of ileostomy following an anterior resection for rectal cancer in the UK is common. The aims of this study were (i) to investigate the variation in patient pathways between hospitals, (ii) to identify the key learning points from units with the shortest time to closure and (iii) to develop guidance for a pathway to minimize delay in ileostomy closure. METHOD: This was a mixed methods study. Thirty-eight colorectal units in the UK completed a short online survey. Nine colorectal units in Wales filled in an additional, expanded version of the survey. Semi-structured interviews were performed with clinicians from the six best performing units in terms of timely ileostomy closure. The optimal pathway suggested is based on the best evidence available and the Association of Coloproctology of Great Britain and Ireland guidelines. RESULTS: Qualitative analysis revealed that 5% of units (n = 2) have a local target time for ileostomy closure. Of all units, 90% (n = 34) would consider implementing a pathway if guidelines were developed. In-depth interviews highlighted the importance of a multidisciplinary approach, a dedicated coordinator to facilitate timely booking, and consensus on whether closure should be performed before or after adjuvant chemotherapy. CONCLUSION: There is a lack of national guidance in timing of contrast studies and ileostomy closure. Key aspects to consider are better information at consent regarding stoma closure timing, a dedicated person to track patients and the planning of contrast studies at discharge from initial surgery. With a dedicated approach closure of ileostomy within 10-12 weeks is feasible for most units.

Quality of life benefits from arrhythmia ablation: A longitudinal study using the C-CAP questionnaire and EQ5D.

AIMS: To investigate long-term efficacy of cardiac ablation for symptomatic arrhythmia by gathering generic and arrhythmia-related quality of life data using patient-reported outcome measures before and after ablation. METHODS: Consecutive patients undergoing cardiac ablation procedures at three sites in the United Kingdom were enrolled (n = 561). Data were collected at baseline, at 8-16 weeks, and 12 months after the ablation with responses from 390 patients received at all three time points. Nonparametric tests were used to identify any changes in patient outcomes due to nonnormal data. RESULTS: There were significant improvements in symptom severity, impact on life scores, EQ-5D-5L indices, and visual analogue score (VAS) scores at pre- versus 3 months and at preablation versus 1 year. Impact on life score showed additional improvement at 1 year versus 3 months, while improvements in symptom severity, EQ-5D-5L indices, and VAS scores continued to be maintained between 3 months and 1 year. CONCLUSION: Cardiac ablation provides patients with arrhythmias relief from symptoms, and results in an improvement in quality of life. Improvements observed at 3 months are maintained at 1 year follow-up.

Questions remain regarding the long-term efficacy of cardiac ablation. We enrolled 561 consecutive patients undergoing ablation procedures at three UK sites. Data were collected at baseline, and at 3 and 12 months. Improvement in symptoms was reported following treatment, with patients continuing to maintain or show continued improvement at 1 year.

Cardiff cardiac ablation patient-reported outcome measure (C-CAP): validation of a new questionnaire set for patients undergoing catheter ablation for cardiac arrhythmias in the UK.

PURPOSE: To formally test and validate a patient-reported outcome measure (PROM) for patients with cardiac arrhythmias undergoing catheter ablation procedures in the UK [Cardiff Cardiac Ablation PROM (C-CAP)]. METHODS: A multicentre, prospective, observational cohort study with consecutive patient enrolment from three UK sites was conducted. Patients were sent C-CAP questionnaires before and after an ablation procedure. Pre-ablation C-CAP1 (17 items) comprised four domains: patient expectations; condition and symptoms; restricted activity and healthcare visits; medication and general health. Post-ablation C-CAP2 (19 items) comprised five domains including change in symptoms and procedural complications. Both questionnaires also included the generic EQ-5D-5L tool (EuroQol). Reliability, validity, and responsiveness measures were calculated. RESULTS: A total of 517 valid pre-ablation and 434 post-ablation responses were received; questionnaires showed good feasibility and item acceptability. Internal consistency was good (Cronbach's alpha >0.7) and test-retest reliability was acceptable for all scales. C-CAP scales showed high responsiveness (effect size >0.8). Patients improved significantly (p < 0.001) following ablation across all disease-specific and global scales. Minimal clinically important difference was calculated. Improvement beyond the smallest detectable change of 9 points (symptom severity scale), 3 points (frequency and duration of symptoms scale), and 8 points (impact on life scale) indicates an important change. Amendments to the C-CAP questionnaires were identified through the validation process and made to produce the final tools. CONCLUSIONS: The final C-CAP questionnaires are valid, reliable, and responsive tools for measuring symptom change, impact, and expectations in patients undergoing ablation for cardiac arrhythmias. C-CAP questionnaires provide a tool with disease-specific and generic domains to explore how cardiac ablation procedures in the UK impact upon patients' lives.

Living on a knife edge-the daily struggle of coping with symptomatic cardiac arrhythmias.

BACKGROUND: In 2010 a retrospective audit was undertaken to assess the viability of using PROMs in patients with symptomatic cardiac arrhythmias having undergone percutaneous arrhythmia ablation. A response rate of 74 % was achieved, with finding suggesting that arrhythmia patients reported a significant impact on their work, social and family life. AIMS: To conduct a qualitative cross sectional survey to understand patients' perspectives of how cardiac arrhythmias affect their daily lives, as part of a program to develop a Patient Reported Outcome Measure (PROM). METHOD: Twenty five patients aged 18 or over, diagnosed with a variety of symptomatic cardiac arrhythmias referred for a cardiac ablation procedure took part in cognitive interviews. These aimed to inform the development of a patient reported outcome measure and to determine factors important to this patient group. Common themes were identified using content analysis. RESULTS: Participants reported that symptoms of their arrhythmia caused them considerable problems and impacted adversely on their quality of life in many ways. This extended through daily routine, work and social activities and also to friends and family, with fear and anxiety being significant factors for most responders. Patients felt their illness was poorly understood, even by health professionals, and often reported that they felt isolated, lacking support and information. CONCLUSION: Symptomatic cardiac arrhythmias are a source of debilitating and life limiting symptoms, having a negative impact on quality of life. Symptoms and related complications are relevant across different arrhythmia substrates and patient groups. TRIAL REGISTRATION: The study is registered on the Clinical Trials website, Identifier NCT01672528.

Establishing content validity in a novel patient reported outcome measure for cardiac arrhythmia ablation patients.

AIM: Preliminary content validity testing of a UK Patient Reported Outcome Measure (PROM) for use in cardiac arrhythmia patients undergoing ablation treatment. METHODS: Twenty five patients diagnosed with symptomatic cardiac arrhythmias participated in qualitative interviews to obtain their perspective of a draft PROM. As part of the process to establish preliminary content validity, patients were asked to complete the questionnaires and to identify missing and redundant items within the PROM, while also reviewing the instructions and formatting. The questionnaires were updated iteratively to reflect patient feedback. RESULTS: Recurring themes were identified during qualitative interviews leading to improvements to the tool. Following modification of the PROM, based on patient feedback, subjects reported that the tool was fully inclusive and easy to comprehend. Patients found the instructions and layout of the tool acceptable and easy to use. CONCLUSION: Qualitative patient interviews are an important part of PROM tool development. In the case of this cardiac ablation PROM, it enabled end users to assess the tool for inclusivity and accessibility, and to ensure that it addressed concerns important to the patient. Cognitive interviews were able to obtain patients' perspectives to establish face validity and content validity of the PROM. This is part of a process which will ensure that this disease-specific PROM measures cardiac arrhythmia patient symptoms and impact on patients' lives accurately and sensitively. The next study will use the PROM prospectively in over 450 arrhythmia patients to prospectively validate the tool. CONDENSED ABSTRACT: Patients diagnosed with symptomatic cardiac arrhythmias provided feedback through cognitive interviews to facilitate improvements in a new disease specific PROM establishing preliminary face and content validity.

Patient reported outcome measures for cardiac ablation procedures: a multicentre pilot to develop a new questionnaire.

AIM: To assess the feasibility of administering Patient Reported Outcomes Measures (PROMs) in patients treated with ablation for cardiac arrhythmias, and to conduct the first stage of development and testing of a new PROM tool. METHODS AND RESULTS: A new tool was developed by a multidisciplinary team and tested alongside an adaptation of the patient perception of arrhythmia questionnaire (PPAQ) and EQ-5D-5L in a multicentre retrospective audit involving 791 consecutive cardiac arrhythmia patients treated with catheter ablation at three UK centres over 13 months. Data were recorded in the National Cardiac Rhythm Management Database, part of the National Institute for Cardiovascular Outcomes Research. The response rate was 71.9% (n = 569). Patients reported significant improvements across all outcomes and impacts, with reductions in symptoms of 51.7% (heart racing), 33.9% (fatigue) 31.8% (heart flutters), 43.5% (dizziness), 38.6% (breathlessness), 44.2% (chest pressure), 33.1% (trouble concentrating), 15.9% (headache), 28.3% (neck pressure), and 23.4% (fainting) (P < 0.001). The mean number of social days affected reduced by 7.49 days/month (P < 0.001); mean work/school days affected/month reduced by 6.26 (P < 0.001); mean GP/hospital visits reduced by 1.36 days/month (P < 0.001). The procedure met patient expectations in 72% of responders. CONCLUSIONS: The high response rate suggests that the use of PROMs in this patient group is feasible, with rates equalling those of the National PROMs Programme. The results showed that patients experienced significant improvements in their quality of life following ablation, while feedback allowed the tools to be improved. Further work is required to validate these tools; however, the findings suggest that PROMs could be useful in the audit of ablation techniques.