@article{82a5f611d47643fd891280cd248002c0,
title = "Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: A randomized controlled trial",
abstract = "AIM: The aim was to determine whether specialist-led habit training using Habit Training with Biofeedback (HTBF) is more effective than specialist-led habit training alone (HT) for chronic constipation and whether outcomes of interventions are improved by stratification to HTBF or HT based on diagnosis (functional defaecation disorder vs. no functional defaecation disorder) by radio-physiological investigations (INVEST).METHOD: This was a parallel three-arm randomized single-blinded controlled trial, permitting two randomized comparisons: HTBF versus HT alone; INVEST- versus no-INVEST-guided intervention. The inclusion criteria were age 18-70 years; attending specialist hospitals in England; self-reported constipation for >6 months; refractory to basic treatment. The main exclusions were secondary constipation and previous experience of the trial interventions. The primary outcome was the mean change in Patient Assessment of Constipation Quality of Life score at 6 months on intention to treat. The secondary outcomes were validated disease-specific and psychological questionnaires and cost-effectiveness (based on EQ-5D-5L).RESULTS: In all, 182 patients were randomized 3:3:2 (target 384): HT n = 68; HTBF n = 68; INVEST-guided treatment n = 46. All interventions had similar reductions (improvement) in the primary outcome at 6 months (approximately -0.8 points of a 4-point scale) with no statistically significant difference between HT and HTBF (-0.03 points; 95% CI -0.33 to 0.27; P = 0.85) or INVEST versus no-INVEST (0.22; -0.11 to 0.55; P = 0.19). Secondary outcomes showed a benefit for all interventions with no evidence of greater cost-effectiveness of HTBF or INVEST compared with HT.CONCLUSION: The results of the study at 6 months were inconclusive. However, with the caveat of under-recruitment and further attrition at 6 months, a simple, cheaper approach to intervention may be as clinically effective and more cost-effective than more complex and invasive approaches.",
author = "Christine Norton and Sybil Bannister and Lesley Booth and Brown, {Steve R} and Samantha Cross and Sandra Eldridge and Christopher Emmett and Ugo Grossi and Mary Jordan and Jon Lacy-Colson and James Mason and John McLaughlin and Rona Moss-Morris and Scott, {S Mark} and Natasha Stevens and Shiva Taheri and Taylor, {Stuart A} and Yan Yiannakou and Knowles, {Charles H}",
note = "Funding Information: The Cochrane Review concluded that there was {\textquoteleft}insufficient evidence to allow any firm conclusions regarding the efficacy and safety of biofeedback for the management of people with CC{\textquoteright} and a need for {\textquoteleft}well‐designed RCTs with adequate sample sizes, validated outcome measures (especially patient‐reported outcome measures) and long‐term follow‐up{\textquoteright}. The CapaCiTY (chronic constipation treatment pathway) I trial sought to address these gaps. This trial was part of a broader UK National Institute of Health Research funded research programme funded by the NIHR (PGfAR: RP‐PG‐0612‐20001) [ 20 ]. The CapaCiTY programme addressed several questions pertinent to the development of a cost‐conscious pathway of care to help reduce healthcare expenditures by appropriately sequencing the care provided, while targeting more expensive therapies at those most likely to benefit. Funding Information: This study was funded by the UK National Institutes of Health Research as part of the CapaCiTY programme grant for applied research (RP-PG-0612-20001). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. A proportion of patients with constipation (population 1%–2%) suffer chronic and disabling symptoms [1] and may be referred for specialist diagnostics and management, including habit training and biofeedback (HTBF). Termed chronic constipation (CC), first-line conservative treatments such as diet and lifestyle advice and laxatives frequently fail to address symptoms adequately in this group [2]. Hospital-based bowel re-training programmes, sometimes including focused biofeedback and psychosocial support, may therefore be trialled. A range of cohort studies [3], randomized controlled trials (RCTs) [4–9], reviews [10], guidelines [11] and a meta-analysis [12] attest to the general success of this approach. However, opinion varies greatly concerning the complexity of intervention required and UK survey evidence indicates that there is remarkable variability of practice [13]. More complex forms of therapy include instrument-based biofeedback learning techniques [3–9]. Favoured in the United States, and by about half of UK centres [13], these provide direct visual computer-based biofeedback of pelvic floor activity. While small RCTs suggest an additive value of biofeedback over habit training alone in the management of selected patient subgroups of CC, for example those with a {\textquoteleft}functional defaecation disorder{\textquoteright} (dyssynergic defaecation) [5, 14–16], there have been no multicentre or adequately powered RCTs in unselected patients despite the uncertainty having significant resource implications. Most publications advocating biofeedback have come from specialist centres with considerable {\textquoteleft}investment{\textquoteright} in these techniques with much less favourable reports when biofeedback is used as the disinvested comparator to a surgical intervention [17, 18]. The 2014 Cochrane Review {\textquoteleft}Biofeedback for treatment of chronic idiopathic constipation in adults{\textquoteright} [19] extracted efficacy data from 17 eligible RCTs including 931 participants. The authors considered 16 trials to be of high risk of bias. Inclusion criteria, notably CC versus defined {\textquoteleft}functional defaecation disorder{\textquoteright} (dyssynergic defaecation) and choice of outcome measure and comparator (standard care, sham biofeedback or range of alternative interventions including drugs and surgery) varied greatly between trials. Most trials had small sample sizes (median 60 participants [range 21–119]) and some, including the largest study (whose comparator was surgery) [18], had levels of attrition of up to 50% at primary outcome. The Cochrane Review concluded that there was {\textquoteleft}insufficient evidence to allow any firm conclusions regarding the efficacy and safety of biofeedback for the management of people with CC{\textquoteright} and a need for {\textquoteleft}well-designed RCTs with adequate sample sizes, validated outcome measures (especially patient-reported outcome measures) and long-term follow-up{\textquoteright}. The CapaCiTY (chronic constipation treatment pathway) I trial sought to address these gaps. This trial was part of a broader UK National Institute of Health Research funded research programme funded by the NIHR (PGfAR: RP-PG-0612-20001) [20]. The CapaCiTY programme addressed several questions pertinent to the development of a cost-conscious pathway of care to help reduce healthcare expenditures by appropriately sequencing the care provided, while targeting more expensive therapies at those most likely to benefit. The aims of the current study were (i) to determine whether standardized specialist-led habit training plus pelvic floor re-training using HTBF is more clinically effective than standardized specialist-led habit training alone (HT) at 6 months{\textquoteright} follow-up; (ii) to determine whether outcomes of such specialist-led interventions are improved by stratification to HTBF or HT, based on prior knowledge of anorectal and colonic pathophysiology using standardized radio-physiological investigations (INVEST). Funding Information: This study was funded by the UK National Institutes of Health Research as part of the CapaCiTY programme grant for applied research (RP‐PG‐0612‐20001). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Publisher Copyright: {\textcopyright} 2023 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.",
year = "2023",
month = nov,
doi = "10.1111/codi.16738",
language = "English",
volume = "25",
pages = "2243--2256",
journal = "Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland",
issn = "1462-8910",
publisher = "Wiley",
number = "11",
}