key: cord-0890707-gha57azj authors: Stephenson, John; Haywood, Annette; Bond, Michael; Gillibrand, Warren; Bissell, Paul; Holding, Eleanor; Holt, Rachel title: Health‐related outcomes in patients enrolled on surgical and non‐surgical routes in a weight management service date: 2022-02-04 journal: Health Sci Rep DOI: 10.1002/hsr2.501 sha: 0620e0c72a25c78475b69893eaad9f71a77215fc doc_id: 890707 cord_uid: gha57azj BACKGROUND AND AIMS: This study evaluates a specialist weight management service and compares outcomes in participants referred to the service undergoing either surgery or non‐surgical routes to support weight loss. METHODS: Four hundred and forty eight participants were assessed on various weight‐related outcomes (body mass index [BMI], psychological distress, quality of life, nutrition, weight‐related symptoms, physical activity) on referral to the service and on discharge. The effect of group (surgery or non‐surgery) and time in the service were facilitated by doubly multivariate analyses of variance models. RESULTS: Between referral and discharge, participants improved significantly on a combination of outcomes (P < .001) and on each outcome assessed individually. The magnitude of overall improvement was moderate (partial‐η(2) = 0.141). Individual improvement components varied; including a moderate reduction of 3.2% in the BMI outcome measure and a substantive gain of 64.6% in quality of life. Participants on non‐surgical routes performed significantly better than participants on surgical routes on a linear combination of outcomes (P < .001) and on all outcomes except nutrition; with an effect of route small‐to‐moderate in magnitude (partial‐η(2) = 0.090). CONCLUSIONS: Weight management services are successful in achieving weight management‐related outcomes in the short‐ and long‐term, with large overall improvements between referral and discharge averaged over all participants observed. Non‐surgical routes appear to confer benefits between referral and discharge compared to surgical routes. Current research and evidence-based practice guidelines offer various treatments and care pathways for reducing obesity, 3 Similar results were reported in a review by Alkharaiji et al 7 ; who found in a review of 19 studies (including 1 randomized controlled trial) that 11 reported reductions in BMI 6 months after baseline, with reductions ranging from 0.8 to 3.3 kg/m 2 . However, the lack of a comparator group in the majority of studies included in both of these reviews makes it impossible to know in these cases what would have happened without the intervention of weight management services. Furthermore, an unacknowledged, contemporary critique of behavior change in clinical weight management services is its over-reliance on self-regulationbased approaches. 8 Sarwer and Polonsky 9 identified multiple facets constituting the psychosocial burden of obesity; finding a positive association between obesity and poor mental health, possibly mediated by stigma and experience of discrimination, body image, and low self-esteem among other factors. The study also promoted the value of psychological assessment and follow-up for weight reduction programmes including bariatric surgery. The Covid-19 pandemic is known to have affected the extent of the prevalence of obesity, with consequent implications for incidence rates of type 2 diabetes and other conditions. A study of 46 000 adults 10 at high risk of type 2 diabetes revealed the existence of small but clinically significant increases in mean body weight in people as a result of the pandemic. Differential effects were also observed, with those younger than 65 years, female, and in the two quintiles of greatest deprivation experiencing increases in baseline weight compared with pre-pandemic levels which were more than twice as large as differences observed in the total sample. Surgical interventions (eg, Roux-en-Y gastric bypass or sleeve gastrectomy) with people with obesity have demonstrated consistent effects in initiating and maintaining weight loss. These effects are generally found to be greater than weight losses achieved by participants on non-surgical routes. Booth et al 11 studied long-term effects of enrolment on a Tier 4 service, finding a reduction in incidence of Type 2 diabetes in 80% in participants who had surgery, compared to controls. Gloy et al 12 However, bariatric surgery is not suitable for all, and is usually only considered when other treatments have failed. It is generally considered for those with a BMI greater than 40 kg/m 2 , or for those obesity-related diseases such as Type 2 diabetes. 14 Updated NICE guidance 3 for clinical assessment and management of obesity stated that bariatric surgery is the option of choice (instead of lifestyle interventions or drug treatment) for adults with a BMI ≥50 kg/m 2 , when other interventions have not been effective. Weight loss in surgical routes can occur through physically restricting amounts and types of food eaten, and can result in the occurrence or exacerbation of disordered eating habits. Dixon et al 15 report physiological factors relating to early satiation and prolonged satiety following a meal which reduce energy intake and lead to sustained changes in energy balance. Long-term outcome data remains equivocal. Furthermore, additional medical costs arising from surgical intervention and follow-up care appointments may exceed the costs of long-term behavioral change support. However, it is difficult to determine an exact comparison of long-term monetary costs, which would need to account for costs of co-morbidities arising from weight, weight loss, and the interventions and treatment received. Wise 16 studied data from 18 283 procedures conducted by the National Bariatric Surgery Registry, concluding that the procedure is cost-effective, without providing specific costing information. Educational and psychosocial interventions have received less attention than surgical-based routes, but may evaluate relatively well, especially when used to initiate and persevere with lifestyle changes, including computer-based online interventions. [17] [18] [19] Current advice proposes that first-line interventions should focus on lifestyle measures, with diet and exercise change at the core. 20 The Tier 3 service in REDACTED is a specialist multi-disciplinary service (including weight management advisers, a psychologist, and dietician) provided by REDACTED NHS Foundation Trust. It provides intensive individualized assessment and intervention for those with severe and complex obesity. The aim of the programme is weight loss and participants can be supported to make lifestyle changes to lose weight for up to 2 years. Participants must have tried other weight-reduction services and support at lower tiers of intervention, and meet BMI and health criteria, to be referred. A weight management adviser works intensively with the participant and provides support to adopt and implement lifestyle behavior change. Weight management support is provided for up to 2 years, within NHS England requirements, and participants undergoing non-surgical routes will typically spend up to 2 years with the service. Surgical and non-surgical routes are available for participants registered with the service. All participants enter the service in the same way and the route is selected depending on the outcome at an initial psychological assessment in which management of psychological factors related to obesity, engagement, eating and activity behaviors are evaluated. Based on this, and discussion with the multidisciplinary team, an individually tailored weight management plan is developed with the patient. A weight management adviser will then use this plan to work intensively (usually fortnightly for the first 3 months and monthly thereafter) with the patient to support him/her to make lifestyle changes to initiate Discharge measures are given and recorded at point of discharge from the service for participants on both the lifestyle change and bariatric surgery routes. For those having surgery, discharge is at the point when the participant is referred through to Tier 4 surgical team by their GP to wait for an outpatient appointment with the surgical team: that is, they are not yet "accepted for surgery" but are en route to the next stage having completed the required amount of time within the Tier 3 service to meet commissioning guidance. There is no certainty that surgery actually takes place at this stage. Participants are able to swap from the surgical to non-surgical route at any stage during the programme. After discharge back to their GP, participants are signposted to appropriate community facilities/offers along the way in order for them to maintain weight loss. This service was originally commissioned by Public Health, and maintains close links with system approaches to obesity across health and social care in their integrated care system. The clinical multidisciplinary team are part of shaping core approaches and messages to support interventions across a pathways of services in conjunction with commissioners who are investing in other approaches; for example, to improve access to green spaces and affordable healthy food options, support for debt and housing and the development of cooking skills and working with local employers, hospitality sector, and schools to shape environmental influences. Although existing literature is concerned with comparative assessments of surgical and non-surgical routes, the current study advances available knowledge by concurrently analyzing, and adjusting for, a time-related effect over a wider raft of health measures. The aim of this research was to compare outcomes in a retrospective, nonrandomized quasi-experimental study in participants referred to a specialist Tier 3 weight management service who receive treatment through one of two routes: 1. Support for long-term lifestyle change to maintain weight loss (non-surgical route); 2. Referral for assessment, support to make lifestyle changes and preparation for surgery (surgical route). These comparisons are facilitated by hypotheses tests of flatness (ie, whether, independent of route, participants have the same average responses to a collection of outcomes measured at different time points), equality of levels (ie, whether participants following different routes score differently from each other on average) and parallelism (ie, the existence of a differential effect over time). This research pertains to the model of delivery at the time of the conduct of the research. The service is currently working to a slightly different set of criteria and operational delivery. Records of all participants who had engaged with the Tier 3 service from May 2012 onwards were identified, and from this group those who last had contact with the service more than 2 years previously and were still living, were selected for inclusion. The end cut-off was set as the original intention was to report follow-up self-reported data from people had left the service at least 2 years previously, to understand the long-term effects of their involvement when compared to the questionnaire we sent out. In fact, due to low response rates, a decision was subsequently made to exclude follow-up data from the reporting. were considered to be primary outcomes on an equal footing; the physical activity survey, which yielded categorical outcomes, was analyzed separately as a secondary measure. Self-reported outcomes were always assessed face-to-face; either in clinic or at home for assessment and key review points. Protocols were put in place to reduce measurement error. Measurements from GP records were provided at baseline and re-checked at assessment on calibrated measuring scales and height measures, so each referral measures were taken and checked at least twice at assessment. Measures of change in weight over time were taken at least every 3 weeks during the programme and trends tracked in online patient records, with any anomalies checked and re-checked as needed. All measures were recorded by the Tier 3 Service multi-disciplinary team, with consent for use of data for research purposes obtained as part of the consent procedure on patient referral. Blocks of 12 weeks were selected as the timeframe for the length of programme components. This timeframe is standard for behavior change programmes: NICE 23 advises that programmes (which should be multicomponent, addressing diet, activity, and behavior change) should last for at least 12 weeks, with sessions at least weekly or fortnightly to be of sufficient length and intensity to support behavior change that will lead to weight loss for a proportion of participants. All outcomes were selected on the basis of their clinical importance. Bushnell The sample was summarized descriptively. To address the wider aspiration of assessment of indicators for service improvement, an analysis plan was conducted in which the effect of key factors on a combination of outcomes; followed by more detailed analysis of specific outcomes. This procedure acknowledges that obesity is activated and sustained by multi-dimensional influences with pro- All statistical analyses were conducted using IBM SPSS statistical software (Version 26). 25 Ethical approval for this study were obtained from the REDACTED Research Ethics Committee in December 2017 (REC reference 17/SW/0084). No amendments were subsequently sought to the project. No participants were directly involved in the study. Follow-up univariate ANOVAs revealed timepoint to be significantly associated at the 5% significance level with all outcome measures, with substantive effects observed with respect to all outcomes. The follow-up ANOVAs also revealed route to be significantly associated at the 5% significance level with all outcome measures except CORE-OM and nutrition, and the interaction to be significantly associated at the 5% significance level with BMI, OWLQOL scores and nutrition. Hence the change between referral and discharge was strongly significant with respect to all outcomes, with significant reductions in BMI, CORE-OM and WRSM; and significant gains in OWLQOL and nutrition scores. All these effects represent positive benefits over the period of enrolment with the Tier 3 service between referral and discharge. Route comparisons revealed significant differences with respect to all outcomes except CORE-OM and nutrition; with lower BMI values and WRSM scores, and higher OWLQOL scores reported in the non-surgical group. All these effects represent better performance in the non-surgical group. Differential effects observed with respect to the outcomes of OWLQOL, nutrition, and BMI limit the level of interpretation that can be placed on main effects considered in isolation. However, the presence of a substantive differential effect was observed only with respect to nutrition scores; in which the betterperforming lifestyle group at referral is overtaken by the surgery group by the point of discharge. Model parameters are summarized in Table 2 . The pattern of activity between discharge and referral differed across the two routes, with neither showing obviously higher levels: participants on the surgical route were more likely to be lightly active on discharge than non-surgery participants; whereas participants on the non-surgical route were more likely to be either inactive, or moderately active. Somers' d statistic for asymmetric ordinal measures was calculated to be 0.107, which was statistically significant at the 5% significance level (P = .029). The principal finding of this study is that programme route is significantly associated with several weight-related outcomes in a large cohort of people with obesity and morbid obesity; with the primary outcomes of QoL, BMI and WRSM revealed to be better for participants on non-surgical routes than for participants on surgical routes. A secondary finding is that between referral and discharge, participants improved significantly on all measures, regardless of specific route. The outcome profiles in the surgical and non-surgical groups summarized in Table 1 and nutrition score at discharge (P < .005), with females scoring better than males on nutrition and worse on QoL and WRSM. Age was revealed to be significantly associated with WRSM at discharge (P = .005) and nutrition score at discharge (P < .001), with older patients scoring better than younger patients on nutrition and worse on WRSM. It is acknowledged that not all the measures were fully validated or tested for test-retest reliability: the nutrition score and the physical activity category were unvalidated locally produced measures. However, both were constructed using expert advice and recommendations. Furthermore, the physical activity questionnaire, which did not yield numerical results was considered to be a secondary outcome. Another possible limitation of this work is that it does not inform about the relative importance of these variables in Service adoption. This is important, as poor "reach" is a major issue affecting most weight management services. Cost-utility analyses and other economic evaluations were not included in the parameters of this study. However, such evaluations are clearly of importance in today's, resource-restricted healthcare systems. NICE guidelines 3 cite research which shows a health benefit to bariatric surgery, in terms of weight reduction and reduced co-morbidities. It is concluded that the enrolment on the programme has clear health benefits, with significant and substantive improvements observed between referral and discharge from the service. Limited additional benefit between referral and discharge is conferred by enrolment on a non-surgical, rather than a surgical route. While further research is required to establish whether this edge is maintained post-discharge, a successful non-surgical route in terms of costs, dietary issues and procedural implications of bariatric surgery may represent an attractive alternative to surgery with implications for the wider commissioning of services. This manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained. The data that support the findings of this study are available from the corresponding author upon reasonable request. Stephenson https://orcid.org/0000-0002-7902-1837 Annette Haywood https://orcid.org/0000-0002-5824-3043 Michael Bond https://orcid.org/0000-0003-4634-8240 Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence National Institutes of Health Impact of commissioning weight-loss surgery for bariatric participants Obesity: identification, assessment and management. 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