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. 2023 Sep 1;18(9):e0290996. doi: 10.1371/journal.pone.0290996

Did the evidence-based intervention (EBI) programme reduce inappropriate procedures, lessen unwarranted variation or lead to spill-over effects in the National Health Service?

Joel Glynn 1,*, Timothy Jones 1,2, Mike Bell 2,3, Jane Blazeby 3, Christopher Burton 4, Carmel Conefrey 5, Jenny L Donovan 5, Nicola Farrar 5, Josie Morley 1, Angus McNair 5,6, Amanda Owen-Smith 1, Ellen Rule 7, Gail Thornton 5, Victoria Tucker 8, Iestyn Williams 9, Leila Rooshenas 5, William Hollingworth 1
Editor: Dirceu Henrique Paulo Mabunda10
PMCID: PMC10473535  PMID: 37656701

Abstract

Background

Health systems are under pressure to maintain services within limited resources. The Evidence-Based Interventions (EBI) programme published a first list of guidelines in 2019, which aimed to reduce inappropriate use of interventions within the NHS in England, reducing potential harm and optimising the use of limited resources. Seventeen procedures were selected in the first round, published in April 2019.

Methods

We evaluated changes in the trends for each procedure after its inclusion in the EBI’s first list of guidelines using interrupted time series analysis. We explored whether there was any evidence of spill-over effects onto related or substitute procedures, as well as exploring changes in geographical variation following the publication of national guidance.

Results

Most procedures were experiencing downward trends in the years prior to the launch of EBI. We found no evidence of a trend change in any of the 17 procedures following the introduction of the guidance. No evidence of spill-over increases in substitute or related procedures was found. Geographic variation in the number of procedures performed across English CCGs remained at similar levels before and after EBI.

Conclusions

The EBI programme had little success in its aim to further reduce the use of the 17 procedures it deemed inappropriate in all or certain circumstances. Most procedure rates were already decreasing before EBI and all continued with a similar trend afterwards. Geographical variation in the number of procedures remained at a similar level post EBI. De-adoption of inappropriate care is essential in maintaining health systems across the world. However, further research is needed to explore context specific enablers and barriers to effective identification and de-adoption of such inappropriate health care to support future de-adoption endeavours.

Introduction

Health systems are under pressure to maintain services and introduce novel interventions within limited budgets. Before the COVID-19 pandemic, there were approximately 170 million elective operations globally each year [1]. However, some established elective procedures may be inappropriate or considered ‘low value’ in certain circumstances. ‘Low value’ is defined as interventions where the costs outweigh the benefits in some or all patients [2, 3]. This may be the result of more effective procedures entering the health system or research identifying procedures that offer little or no benefit relative to alternatives including conservative management or no intervention. For example, research has found that several common elective orthopaedic procedures lack high quality evidence of benefit [4]. Across the world it is common for surgical procedures to have lower regulation for adoption compared to other health interventions such as pharmaceuticals and medical implants which may result in over adoption of “low value” care [5, 6]. De-adoption is the process of stopping or reducing an existing clinical practice. International efforts such as the ‘Choosing Wisely’ initiative actively promote the identification and de-adoption of unnecessary medical tests, treatments, and procedures [7]. This is essential for the financial sustainability of healthcare systems. Inappropriate use of procedures has opportunity costs, diverting resources from other, more effective, care. However, attempts to reduce established healthcare interventions often fail [810]. In the English National Health Service (NHS), local health budget holders (known, until 1st July 2022, as clinical commissioning groups) developed evidence-based, but often divergent, policies regulating access to surgical interventions for their populations [11]. This is likely to be one factor resulting in variation in geographical access to surgery in England [12]. In 2019, NHS England and the Academy of Medical Royal Colleges (AoMRC) launched the Evidence-Based Interventions (EBI) Programme [13]. The EBI programme aimed to identify interventions that are being used in inappropriate circumstances and should either be stopped or limited to patients who would benefit most. Inappropriate here meaning the risks and costs of surgery outweigh the benefits. The EBI programme’s primary aim was to reduce the use of inappropriate health care interventions, thereby reducing potential harm and optimising the use of limited resources [13]. However, the additional objectives of reducing unwarranted geographical variation and encouraging shared patient-clinician decision making have become more prominent as the EBI programme has evolved [14]. Seventeen surgical procedures were initially identified in April 2019; of these, EBI recommended that four (category 1 procedures) should not be routinely funded and the remaining 13 (category 2 procedures) should only be offered to patients who meet specific clinical criteria. The EBI programme targeted a reduction in category 1 procedures to “near zero” and approximately a 65% reduction in category 2 procedures by April 2020, a total reduction of approximately 128,000 procedures per year [13]. The list of 17 procedures were selected in an iterative process from a much larger list collated by ’expert working groups’ utilising clinical evidence from bodies such as NICE, the ‘Choosing Wisely’ programme, academic studies and local CCG work. The procedures are presented in Table 1. The full details of the procedures, clinical criteria, and the selection process, have been published in detail elsewhere [13]. Alongside the publication of list one as statutory guidance, the EBI programme also set individual reduction targets for each CCG. Monitoring of progress towards these targets was made available through an online dashboard. The programme also recommended that reimbursement tariff payments be reduced to zero for category one procedures and that all category two procedures require a prior approval process by their CCG [13].

Table 1. Trend changes following EBI for ’list one’, related and substitute procedures.

Trend change coefficients (Confidence intervals)
Procedurea EBI procedures Related procedures b Substitute procedures c
Category 1
A. Snoring Surgery in the Absence of Sleep Apnoea 0.80 (0.60 to 1.06) 0.57* (0.34–0.98) -
B. D&C for Heavy Menstrual Bleeding 1.03 (0.82 to 1.29) - -
C. Knee Arthroscopy for Osteoarthritis 1.08 (0.91 to 1.29) 1.12* (1.05–1.21) -
D. Injection for Non-specific Low Back Pain 1.04 (0.91 to 1.18) 0.96 (0.87–1.08) 0.98 (0.98–1.01)
Category 2
E. Breast Reduction Surgery 0.92 (0.66 to 1.28) 1.23* (1.07–1.41) -
F. Removal of Benign Skin Lesions 1.01 (0.92 to 1.11) - -
G. Grommets for Glue Ear in Children 0.96 (0.81 to 1.14) 0.95 (0.78–1.16) 1.10 (0.98–1.23)
H. Tonsillectomy for Recurrent Tonsillitis 1.02 (0.90–1.15) 0.96 (0.80–1.15) 1.10 (0.89–1.35)
I. Haemorrhoid Surgery 1.01 (0.90 to 1.15) - 1.00 (0.89–1.13)
J. Hysterectomy for Heavy Menstrual Bleeding 1.00 (0.95 to 1.16) 1.13 (0.91–1.40) 0.98 (0.91–1.06)
K. Chalazia Removal 1.11 (0.94 to 1.32) 1.16* (1.06–1.28) -
L. Decompression for shoulder pain 1.12 (0.97 to 1.29) 1.05 (0.94 to 1.18) 0.90 (0.50–1.63)
M. Carpal Tunnel Syndrome Release 1.05 (0.95 to 1.15) - -
N. Dupuytrens Contracture Release 0.93 (0.81 to 1.08) - -
O. Ganglion Excision 1.13 (0.97 to 1.31) - -
P. Trigger Finger Release 0.99 (0.88 to 1.01) 1.03 (0.97–1.01) -
Q. Varicose Vein Interventions 0.96 (0.82 to 1.12) - -

a Full details of the procedures and the clinical criteria are available in the EBI list one guidelines document [13]

b Values omitted as procedures are <10% of the EBI defined procedure counts.

c Missing values represent no inpatient or outpatient substitutes identified. All substitute procedures and codes in supplementary materials (S1 File)

Coefficients interpreted as incident rate ratios i.e. 0.80 would mean the trend was 80% of the pre- EBI trend *significant at *5% level

Anderson et al. [15] provided a robust initial evaluation of the EBI list one guidance using a single difference-in-differences analysis aggregating 16 of the 17 procedures. They concluded that the EBI programme did not accelerate ‘disinvestment’ when analysing the programme as a whole. Disinvestment in their work was defined as the withdrawal of health care resources from existing practices deemed to deliver no or low health gain for their cost [15]. Our work extends this research by: (1) evaluating whether the EBI programme successfully promoted de-adoption in any of the 17 individual surgical procedures by analysing procedures individually; (2) evaluating whether the EBI programme reduced geographic variation in procedure rates across England; and (3) exploring potential ‘spill-over’ effects on related or substitute procedures. Given expected restriction in therapeutic options, ‘spill-over’ effects refer to any concurrent increases or decreases in the use of other similar procedures for the same medical conditions.

Methods

Data sources

All data were extracted from the Hospital Episode Statistics Admitted Patient Care (HES-APC) or Outpatient (HES-OP) datasets [16]. HES-APC is a routinely collected dataset that records all episodes of care delivered to patients admitted to acute hospitals in England. HES presents data as patient episodes of care referring to periods of care under a single consultant. Therefore, an individual patient may have more than one episode of care within the dataset we analyse, but their procedure would not be counted twice. HES-APC records up to 24 procedures per episode captured as Office of Population Censuses and Surveys (OPCS-4) codes and up to 20 diagnoses defined by International Classification of Disease (ICD-10) codes which we used to identify eligible episodes of care [17, 18]. These diagnosis and procedure codes are used to reimburse hospital trusts, or private care funded by the NHS, for treatments provided. Therefore, they are considered accurate and are widely used in research [16]. HES-OP captures all specialist outpatient consultations at acute hospitals in England. Increasingly, minor procedures are being performed in outpatient clinics rather than involving a hospital admission. Therefore, we included HES-OP procedures if they represented more than 10% of the total performed interventions. Primary diagnosis is poorly recorded in HES-OP (>95% missing), therefore we assumed the same percentage of EBI defined, related, and cancer procedures (explained below) present in the inpatient dataset. Both HES datasets include care at NHS hospitals and NHS-funded patients treated in independent sector hospitals.

Eligible episodes

Hospital episodes were eligible if they took place between 1st April 2010 and 31st March 2020. We used the EBI programme’s definition for each procedure, which was based on the relevant procedure code(s) being recorded as the primary procedure and combined with specific diagnosis codes identifying the targeted patient group [13].

To explore ‘spill-over’ effects we extracted episodes containing procedures that were potentially ‘related to’ or ‘substitutes for’ the EBI procedures. Related procedures were defined as an episode of care that had the targeted EBI primary procedure code(s) but with a non-EBI diagnosis (i.e. a type of within unit spill-over in the INTENTS framework [19]). For example, the EBI procedure knee arthroscopy relates to the treatment of osteoarthritis, this procedure is also commonly undertaken for ‘internal derangement of the knee’, these procedures are not target by EBI and therefore are captured as related procedures in our analyses. Substitute procedures were defined as different primary procedures which could be used as an alternative to the EBI procedure to treat the same patient group (i.e. a type of between unit spill-over [19]). For example, increased use of more invasive procedures to remove haemorrhoids (e.g. rubber band ligation). To identify potential substitute procedures, using existing contacts, we met with 11 specialist surgeons with expertise in one or more of the 17 EBI procedures. EBI procedures, related procedures, and substitute procedure episodes were mutually exclusive categories. However, appropriate or measurable substitute procedures were not identified for all EBI procedures, and related procedures were only analysed if they constituted a significant (>10%) proportion of the total number of the related EBI procedure performed. All codes for data extraction are available in the S1 File.

Statistical analysis

All analyses were completed in Stata version 16 or 17 statistical software.

Trend analyses

Individual hospital episodes were aggregated into monthly admission counts and used as the dependent variable in the regression models, assuming that episodes with the same admission date and patient ID represent a single admission. A dummy variable categorised the month as either before (pre-April 2019) or after EBI. We controlled for the seasonality of procedure rates by including two dummy variables for the summer (June, July, August) and winter months (November, December, January). The model was offset using population estimates, provided by the Office for National Statistics (ONS), to control for changes in population size over the study period [20].

For each procedure, we generated scatter plots of total procedures per month over the 10-year period. From visual inspection of the scatter plots we decided to limit the regression analyses to the 2 years prior and 11 months after the EBI programme launch (i.e. 1st April 2018 to 29th February 2020). This captured the immediate pre-intervention trend and excluded longer-term, often non-linear, trends in the 9 years before EBI. We also excluded procedures after 29th February 2020, given the onset of the COVID-19 pandemic hugely diminished procedure rates form March 2020 onwards.

We used an interrupted time series (ITS) analysis utilising segmented Poisson regression models to compare trends in pre- and post-EBI procedure rates. This was implemented in Stata using a GLM regression with a Poisson family and log link function. We hypothesised a gradual rather than immediate change in procedure rates (i.e. a change in the slope rather than a step change in procedure rates) following the implementation of the EBI programme. Visual inspection of scatter plots supported this hypothesis. To account for autocorrelation in the regression models we used Newey-West standard errors, assuming a maximum lag of 2 months [21, 22].

Geographic variation analysis

In the geographic variation analyses we clustered hospital admissions by CCG (using April 2019 boundaries) based on patient residence captured in HES (i.e. lower-super output areas (LSOAs)) [23]. Indirectly age-sex standardised procedure rates per 100,000 population were calculated for each CCG for the two financial years before the EBI programme (2017/18 and 2018/19) and the 11 months after the EBI programme (March 2019 to February 2020) [24]. The national age-sex specific rates for each time period were applied to the age-sex specific CCG population to calculate expected CCG procedure counts. Expected and observed procedures were aggregated by EBI category (i.e. category 1 and 2). Variation in the ratio of observed to expected procedure counts by CCG in each time period were estimated using the systematic component of variance (SCV) [2527]. The SCV statistic (equation1 in S1 File) indicates the amount of variation between CCGs after adjusting for chance variation. We generated 95% confidence intervals around the SCV values using bootstrapping and the percentile method [28].

Sensitivity analysis

We assessed the impact of the EBI programme’s list one consultation period (July 2018- April 2019). To do this we explored trends changes at the release of the consultation document for the EBI programme in July 2018, and whether this was followed by any further change once fully implemented in April 2019. Secondly, we assessed if there was any difference in results using a longer run-in period (36-months) before the EBI programme. Thirdly, we assessed whether there was an immediate step change in procedure rates for category 1 EBI procedures.

Results

Procedure counts

Aggregating across the 17 EBI procedures, there were 447,227 procedures in 2017/18, 433,159 in 2018/19 (3.2% reduction) and 403,739 in 2019/20 (6.8% reduction, including March 2020). By far the most frequently performed procedure was the removal of benign skin lesions with 655,219 from April 2017 to April 2020. The least frequent procedure was snoring surgery with 1,836 procedures over the 3 years, and the median procedure was grommets for glue ear in children with 31,020 procedures over the three years.

For the majority of the procedures, rates were clearly declining across the 10 years of data before the publication of the first EBI guidance. The gradient and timing of these declines varied between procedures (Figs 1–17 in S1 File) and in a minority of procedures, such as Dupuytren’s contracture release and the removal of benign skin lesions, there was no obvious decline before the EBI programme. There were no procedures displaying a consistent increase in rates before the EBI programme.

The regression analyses showed no significant changes in procedure rate trends after the introduction of the EBI programme for all 17 procedures (Table 1). For example, tonsillectomy rates (Fig 1) steadily declined from 50 per 100,000 in 2017/18 to 46 per 100,000 in 2018/19 and 37 per 100,000 in the 11 months after EBI. Across all category one (not to be routinely commissioned) and category two procedures (commissioned only when specific criteria are met), there were 43 and 327 procedures per 100,000 in 2017/18 respectively, falling to 32 and 298 per 100,000 in 2018/19 and 23 and 259 per 100,000 in the 11 months after EBI (excision of benign skin lesions are excluded given very large numbers).

Fig 1. Monthly procedure counts with interrupted time series model prediction lines.

Fig 1

Related and spillover procedures

There was little evidence of spillover effects on related and substitute procedures (Table 1). In general, trend changes in these procedures were not significant and had point estimates in the same direction as the point estimate for the associated EBI procedure. Related procedure rates for knee arthroscopy for osteoarthritis, breast reduction surgery and chalazion removal (see S1 File for details on procedures and codes) were significantly higher post-EBI than would have been predicted based on pre-EBI trends. The remaining related procedures showed no significantly different trend following the publication of the guidance. The six procedures with identified inpatient or outpatient substitute procedures showed no evidence of spill-over effects (Table 1).

Geographic variation analyses

Variation in procedure rates between CCGs was consistently higher in category one compared to category two procedures between April 2016 and Feb 2020 (Table 2). Both category one and two procedures showed no evidence of reduced geographical variation post EBI. In fact, geographic variation (measured by SCV scores) was higher following EBI for both category one and two procedures, although confidence intervals were overlapping and wide (Table 2). There was little discernible pattern of higher procedure rates in particular regions of the country (Fig 2). In the 11 months after the launch of the EBI programme, the top 25% of CCGs, by adjusted procedure rates, were providing 3,808 more category 1 procedures and 26,209 more category 2 procedures than expected based on the age and sex distribution of their population.

Table 2. Variance in procedure rates by EBI category and financial year.

Financial Year EBI Category One SCV (CI) EBI Category Two SCV (CI)
2017–18 58.8 (40.5–80.4) 3.8 (3.1–4.6)
2018–19 53.1 (36.4–71.9) 4.5 (3.5–5.4)
2019–20 64.0 (40.9–91.8) 4.9 (3.9–6.1)

Fig 2. Variation in the percentage of observed category one and two procedures compared to expected by CCG in 2019–20.

Fig 2

Discussion

Main findings

We found little evidence that the EBI programme achieved its aim to reduce the number of surgical interventions through publishing nationwide guidance on appropriate use. The majority of the selected procedures exhibited declining procedure rates in the years before the publication of the EBI criteria and all pre-existing trends continued after the publication of the EBI guidelines in April 2019. Given that the EBI programme had limited additional impact on already declining trends, it is unsurprising that there was limited evidence of a spillover effect on related or substitute procedures. We also found no evidence that the publication of national guidance reduced variation in the number of procedures performed between CCGs compared to pre-EBI variation.

Comparisons with similar studies

In accordance with Anderson et al. [15], we found no evidence of an impact of the EBI programmes list one on procedure rate trends [15]. Furthermore, we demonstrated that no individual procedure showed an associated reduction in procedure rates following EBI. Adding further to Anderson et al. [15], we explored whether the EBI programme had reduced geographical variation, even if overall levels continued to fall at similar rates. Potentially, national guidance could have resulted in some localities relaxing stricter pre-existing clinical policies to match the EBI guidelines while others were tightening or implementing guidelines for the first time. We also explored ‘spill-over’ effects hypothesising the number of related or substitute procedures may increase as access to EBI defined procedures is restricted. These are important considerations for the EBI, and other, programmes as there could be a warranted or unwarranted increase in the use of more expensive or resource intensive treatment options, or inappropriate use of procedures beyond their evidence-based indication. We used an ITS analysis in contrast to the difference in differences method used by Anderson et al. [15]. Difference in differences require a comparison group of similar procedures not affected by EBI. Anderson et al. [15] use EBI list two interventions as a comparison group not target by EBI at the time of analysis. However, there are important difference between the list one and list two procedures. List two included procedures that were not already reducing and less widely agreed upon as ‘low value’ compared to list one. Therefore, in the absence of a clear comparator, we decided the ITS would be an appropriate approach and the assumption of a continuing trend to be plausible.

De-adoption of medical procedures presents different challenges to the adoption of novel health care [29]. Programmes such as ‘Choosing Wisely’ and the National Institute of Health and Care Excellence (NICE) “do not do” recommendations have similarly struggled to implement changes into practice [30, 31]. A number of reviews have explored the barriers and enablers to the success of de-adoption programmes such as EBI [2932]. Incorporating strategies to promote de-adoption amongst the relevant clinicians has been associated with successful de-adoption. Examples of such strategies included making changes to clinical documentation, computer alerts, and education, mainly in the context of primary care [3032]. Applying multiple strategies is associated with greater success and there is currently little evidence that patient level approaches to de-adoption, such as cost sharing, are successful, although these approaches have not been explored in much published work [31].

Strengths and limitations

Our study is the first to explore whether the EBI programme had ‘spill-over’ effects on other types of NHS surgical care not specifically targeted by the programme, and to examine geographical variation before and after the programme. By examining each of the procedures individually, we were able to explore whether or not the EBI programme led to successful de-adoption from some procedures while making little headway with others.

The EBI list one procedures are predominantly undertaken in an inpatient or outpatient hospital setting which is captured by the routine HES datasets. As the HES datasets are mandatory and include all hospital care provided for NHS-funded patients our results should provide an accurate reflection of the impact of the EBI programme on its intended target, publicly funded healthcare. Some of the most minimally invasive procedures could have been provided in a primary care setting. However, this is not expected to be common and unlikely to mask any substantial effect of the EBI programme on procedure rates.

Our analyses were limited to 11 months post-EBI due to the emergence of the COVID-19 pandemic in March 2020. Therefore, we were not able to assess whether the EBI programme had any longer-term impact on procedure counts or variation beyond 11 months. There may be some delay between EBI publication and impact due to patients being placed on waiting lists for surgery pre-EBI but not receiving surgery until post-EBI, and for guidance to be adopted into practice. Before COVID-19 waiting times were increasing, although the majority of patients did not wait more than 18 weeks for elective treatment [33]. ITS is susceptible to bias due to unmeasured external shocks, many of these will be specific to one procedure (e.g. publication of a paper supporting or questioning efficacy). If it occurs, the bias could either inflate or deflate the apparent effect of EBI. If EBI were generally effective, and yet (as we have observed) procedure rate trends did not change post-EBI, that would imply either one general external shock post-EBI that has counteracted the effect of EBI or seventeen specific external shocks have had the same counterbalancing effect for each procedure. Whilst we cannot exclude these possibilities, a simpler explanation and one that is in line with previous research [15]. using different methods, is that the EBI programme did not achieve its objectives to reduce unnecessary healthcare or geographical disparities in access to care.

We were not able to explore spill-over effects elsewhere in the health system. For example, restricted access to NHS surgical care may increase the proportion of patients who seek surgical care through the private sector. Other patients may receive more non-surgical care for their symptoms through NHS primary and community care providers. HES Outpatient data has very poorly captured diagnoses, with less than 95% of interactions having a diagnosis code. Therefore, we had to estimate diagnoses and exclusions based on percentages observed in the HES-APC dataset, which may be inaccurate. Our variation analyses adjusted for the key variables of population size, age and sex, but there may be other factors such as amount of private provision that may be associated with the number of procedures within CCG areas.

Implications for policy

The majority of procedures included in EBI’s list one guidelines were already on a downward trajectory prior to their publication. Many of the procedures had prominent randomised clinical trials providing evidence of limited effectiveness and cost-effectiveness of these interventions in certain patient groups prior to the launch of list one [34, 35]. It is plausible that commissioners and clinicians were already aware of, and acting on, this evidence. Also, in many CCGs procedure counts were already low limiting the scope for the additional impact for the EBI programme. It may therefore be counterproductive to begin de-adoption programmes for procedures with already existing downward trends. This is particularly the case if recent evidence has questioned the efficacy of established procedures and if many local commissioning polices already restrict access. A simple monitoring of rates may be more appropriate in these cases. Identification of new areas for de-adoption that extend beyond the ‘usual suspects’ may have resulted in greater impacts. Questions remain around what constitutes an effective ‘starting point’ for the identification of candidates for de-adoption, particularly given that de-adoption initiatives themselves have resource implications. Previous rigorously developed de-adoption initiatives, such as the ‘Sustainability in Health care by Allocating Resources Effectively’ (SHARE) disinvestment programme in Australia, have also struggled to show impact: of 19 procedures identified for potential disinvestment, only one was taken forward for potential implementation. Reasons for rejecting candidate procedures revolved around lack of local relevance, or later realisation that de-adoption efforts had been already initiated or even concluded [36, 37]. There is an argument for future de-adoption identification and prioritisation exercises to pay explicit attention to whether candidates have a history of de-adoption attempts. If only to learn from barriers or facilitators to activity reduction, and better assess whether further injection of resource is worthwhile relative to pursuit of other, novel candidates. De-adoption initiatives that seek to reduce activity, whether local (e.g. SHARE) or national (e.g. the EBI programme), need to consider the cost and resources required to run such programmes.

It is also apparent that, at least in the short term, publishing statutory national guidelines does not automatically result in standardisations in care, as variation in procedure rates, taking account of population sizes, age and sex, were not reduced. This highlights the important role of evidence-based implementation in the success of programmes like EBI.

Future research

This work is part of a mixed methods analyses of the EBI programme. We are conducting concurrent qualitative work with clinicians, patients and commissioners and will explore the delivery, impact, and acceptability of the EBI programme’s list one and two guidance. Building on the findings of this work, this qualitative analyses will be able to shed light on why little differences in procedure trends were found following EBI, including barriers to the implantation of these policies. We will also be expanding our analyses of ‘spill-over’ effects by exploring the impact of EBI on the wider treatment pathway including the impact within primary care. It is plausible that restriction in the use of surgical treatment for these conditions will have impacts on consultations, treatments, and referrals within primary care.

Since 2019 the EBI programme has published a second list of recommendations including 31 interventions. This subsequent lists go beyond elective surgery to include screening, diagnostic tests, changes to referral pathways, and increasing the prominence of shared decision making, that could result in fewer interventions. We will extend our analyses to examine the impact of the EBI programme’s second list of procedures. It is plausible that different approaches or strategies work in different contexts, and this is why applying multiple strategies appears to have a better chance of success. Understanding what strategies work in which contexts would be helpful in targeting interventions [32]. Our project aims to synthesis findings from our quantitative and qualitative work and present these to stakeholders including patients, clinicians, commissioners, and national policy leads with a view to co-producing recommendations to optimise future de-adoption efforts.

Conclusion

The EBI programme’s first set of national guidelines on appropriate criteria for elective surgical care has had little success in their aim of further reducing unnecessary healthcare or minimising geographical disparities in access to care. The overall number of procedures fell, however pre-existing downward trends mean we cannot attribute this to the EBI programme. De-adoption of low-value care is essential in maintaining health systems across the world. We need to better understand the enablers and barriers to effective de-adoption to support future de-adoption endeavours.

Supporting information

S1 File

(DOCX)

S1 Data

(XLSX)

Acknowledgments

We thank the specialist surgeons and consultants that identified potential substitute secondary care procedures.

Data Availability

This study is based in part on data from the Hospital Episode Statistics (HES) obtained from NHS Digital (previously the Health and Social Care Information Centre), re-used with the permission of The Health & Social Care Information Centre, and is not publicly available. The data are provided by patients and collected by the NHS as part of their care and support. HES data can be accessed via NHS Digital (https://digital.nhs.uk/services/data-access-request-service-dars). The authors confirm that others would be able to access or request these data in the same manner as themselves. The authors also confirm that they did not have any special access or request privileges that others would not have.

Funding Statement

This project is funded by the NIHR Health and Social Care Delivery Research Programme (NIHR130547). TJ’s time is supported by the National Institute for Health and Care Research Applied Research Collaboration West (NIHR ARC West). The views expressed in this article are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Decision Letter 0

Christian Gericke

14 Mar 2023

PONE-D-22-30207Did the evidence-based intervention (EBI) programme reduce inappropriate procedures, lessen unwarranted variation or lead to spill-over effects in the National Health Service?PLOS ONE

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Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: I Don't Know

Reviewer #2: I Don't Know

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Reviewer #1: Yes

Reviewer #2: No

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Reviewer #2: Yes

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5. Review Comments to the Author

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Reviewer #1: Thank you for the opportunity to review this piece on the (in)effectiveness of the EBI programme. It is well written and presented and adds to the important literature on -de-implementation.

A previous analysis (by another group) has already assessed the global impacts of the programme, so in a sense this is a ‘subgroup’ analysis looking at individual elements, as well as adding useful analyses including the effects on variation across the country. I think there is clear added value.

Given that the previous analysis has been done by an entirely different group, I think a more explicit comparison (and a clearer sense of the differences in methods between the two papers) would also be helpful for readers. I have not read the other paper but it appears it used a ‘differences in differences’ model as opposed to the ITS design here, and it was not clear to me why the methods varied (and I assume the former design would be stronger, all other things being equal?). That might be explained more clearly in the current paper given the overlap.

I think a short description (maybe in a Box) of the procedures and clinical criteria could be provided – not everyone will have the capacity to seek out additional references and I would prefer that the paper is self-contained.

I would also like a little more on the mechanisms of the EBI – the Discussion suggests it involved ‘publishing nationwide guidance’ but that sounded quite passive? Is it plausible that the methods used would have the sort of impacts that they were looking for, especially in the context of overall reductions over time?

There is a useful new framework for ‘spill over’ (see Francetic et al in Implementation Science Communications - https://implementationsciencecomms.biomedcentral.com/articles/10.1186/s43058-022-00280-8). I am from that group so something of a competing interest, but I wondered if the current paper might benefit linking the work to that framework if it added value.

I am not a statistician so am not able to judge the technical quality of the analyses but they seemed rigorous and I found them clearly described.

The description of the numbers of procedures on page 10 would benefit from percentages and I would link those frequencies to Table 1 so that readers could judge the volume alongside the data on changes.

A minor issue, but I found the term ‘increased trend’ a bit confusing on page 13, and ‘strong evidence’ a bit vague. It would help to tighten the language – I assume ‘strong’ evidence relates to conventional significance? Does ‘increased trend’ imply significance?

Is power an issue for any of these analyses? I assume for high volumes it is not, but what about lower volumes and subgroups by CCG? Are any of the analyses insufficiently precise because of numbers, or are the lower N still enough for confidence to detect policy relevant changes? Is there a sense of what size a policy related change would be to anchor the analyses?

I did struggle with the suggestion in the discussion that the EBI may have had a role in continuing downward trends. How is that plausible given the data? Additionally, is the ITS even capable of assessing such an effect – the section on the ITS on page 17 suggests that this is not the case anyway? I felt that was a ‘reach’ and would prefer to see that removed unless they can justify it more clearly.

In the discussion of the ITS on page 17, I am not sure why the lack of control group is moderated by analyses over 17 procedures. If the design is flawed then multiple uses of the same design is not going to provide any protection (see Marion Campbell’s ‘red sock in a white wash’ analogy for bias). Maybe I am missing the logic but this did not seem plausible to me. I am happy with the ITS though (although interested in why Anderson used ‘differences in differences’).

There is an interesting conclusion that ‘de-adoption programmes are essential’. I understand the sentiment, although one interpretation is that wider, non-programmatic changes are leading to reductions, whereas a specific programme to drive change added nothing. I wonder if the conclusion needed changing to better reflect the actual results that they present?

Reviewer #2: Thank you for this paper which undoubtedly adds to the literature about the challenges of deimplementation. Please find some comments and suggestions below. In general, I think some additional information on the methods and the "so what" of your findings would improve the manuscript further before publication.

Background

Line 85: NHS England and Improvement -> a bit confusing as it stands for readers outside the UK (two separate entities? NHS England and NHS Improvement?)

Line 94: 17 surgical procedures were initially identified -> how? And how were the EBI recommendations reached?

Line 101: Substantial -> would be good to have a clearer understanding of extent (e.g. in %)

Lines 106-107: how is the first task different from what Anderson et al. had already done?

Methods

Line 118: up to 24 procedures per person/case?

Line 119: how you identified eligible episodes of care is not fully clear, consider elaborating with 1-2 lines

Line 120: consider defining episode of care for this article. Is the data linked/linkable across datasets/settings on an individual patient basis? Please describe the data and how you used it for your research questions a bit more.

Line 139 onwards: consider providing an example here as well as you do below for the substitute procedures. For readers not versed in EBI, it is not necessarily intuitive why an EBI procedure code with a non-EBI diagnosis is a related procedure.

Line 145: met with 11 surgeons -> when, selected how, how did you collect information from them etc. (see above about describing data and method. approach a bit more)

Line 149: how did you set the 10% threshold (rationale)?

Line 161: write out ONS, potentially explain its function

Line 169-170: COVID-19 impact on procedures -> would it make sense to discuss a bit more in the discussion if these reductions in case numbers mean reduction of low-value procedures or increased unmet need?

Line 172: analysis instead of analyses

Line 197: Please check if there is a word missing... if "EBI list one" is a thing, perhaps good to explain what.

Results

Line 207: might it make sense to comment on the likely full year value for 2019/2020?

Line 210: good that you provide the range, any chance of getting a sense of distribution too without going to the Annex?

Lines 222 onwards: consider rephrasing this period, it is a bit difficult to read.

Lines 239-240: would be useful to comment on why same direction and not significant are equated here.

Discussion:

Line 292: move the reference bracket to line 291 after "al."

Line 311-316: for readers not familiar with the EBI, it would be good to understand better what if any implementation tools accompanied the EBI and comment on potential alternatives among the ones you describe here. it would be important to reflect on this as the best possible evidence-based recommendation may not affect outcomes if not actively disseminated, and even then other barriers play a role. I think the paper would benefit from a bit more input from the literature on these issues in the discussion.

Lines 328-330: does this mean you actually had a national sample? perhaps good to add on representativity of data in the methods.

Lines 352-354: This needs to be moved to methods and get a bit more detail.

Line 359: analysed instead of identified?

Line 360-362: polish style a bit (now procedures comes up twice in short interval)

Line 366 onwards: should that not be coupled with monitoring efforts to recognise if deimplementation levels are/become satisfactory, though? From what point onwards is a downward trend considered sufficient evidence of a process of deadoption?

Line 372: well-developed de-adoption ->this is a valuation for which you (rightly) do not provide evidence here. Consider rigorously developed, or successful, as alternatives.

Lines 386-389 -> indeed. How, though? It would be good to end with your views on how this can be achieved, e.g. solutions to low-value care

Lines 403-404 -> update as now already beyond that point

Lines 407-410 -> yes! see previous comment onlines 386 onwards. Consider rearranging the discussion a bit to strengthen this narrative and make it more easily visible

Line 418: we need to BETTER understand (I think there is already knowledge on this, but you are right that we need to increase/strengthen it and its application)

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Reviewer #1: Yes: Peter Bower

Reviewer #2: No

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Decision Letter 1

Dirceu Henrique Paulo Mabunda

21 Aug 2023

Did the evidence-based intervention (EBI) programme reduce inappropriate procedures, lessen unwarranted variation or lead to spill-over effects in the National Health Service?

PONE-D-22-30207R1

Dear Dr. Joel Dominic Glynn

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Kind regards,

Dirceu Henrique Paulo Mabunda, M.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #3: (No Response)

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: (No Response)

Reviewer #3: Yes

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: (No Response)

Reviewer #3: Yes

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4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: (No Response)

Reviewer #3: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

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Reviewer #1: (No Response)

Reviewer #3: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: (No Response)

Reviewer #3: Thank you for the opportunity to read this revised manuscript. The manuscript is well written and clear, and the methods used are appropriate. The authors have responded to the comments of the two previous reviewers in a rigorous and pertinent manner.

There is no point of making some additional comments at this stage. I am only making the following (not mandatory) suggestions that the authors might consider if they think they can help further assess the internal validity of the results.

Please find these optional suggestions below.

Trend analysis:

-The authors used an interrupted time series analysis utilising segmented Poisson regression models to compare trends in pre- and post-EBI procedure rates. Such model is based on a restrictive mean-variance equality assumption. How was the choice of using a Poisson model made over other options such as the Negative Binomial regression model? Did the authors performed for instance a Likelihood Ratio test?

- Did the authors examine the possibility of non-linear trends (as the presence of such trends might explain why no significant linear trends were identified)?

- The interpretation of the regression results regarding the ‘related’ procedures is a bit puzzling to me. When discussing their main findings, the authors explain that there is “limited evidence of a spillover effect on related or substitute procedures” (lines 318-322). However, looking at the results, we see that four out of ten related procedures show a significant trend post-intervention. Doesn’t this mean something (although no significant trends post-intervention were found for the EBI procedures)?

- In the study limitation, the authors mention that “there may be some delay between EBI publication and impact due to patients being placed on waiting lists for surgery pre-EBI but not receiving surgery until post-EBI, and for guidance to be adopted into practice”. This hypothesis might be directly tested in the model by changing the point in time considered (i.e., April 2019) to another time point considered plausible by the authors.

Geographic variation analysis:

- Although I understand that using the CSV is relevant since it is not affected either by extreme values or by the random variability within each region, why not also use other standard indicators of geographic disparities such as the extremal quotient (the ratio of the highest regional rate to the lowest), the interquartile ratio (the ratio of the 75th to the 25th percentile) or the coefficient of variation (the standard deviation divided by the mean)? These might help assess the robustness of the results.

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

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Reviewer #1: Yes: Peter Bower

Reviewer #3: No

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Acceptance letter

Dirceu Henrique Paulo Mabunda

25 Aug 2023

PONE-D-22-30207R1

Did the evidence-based intervention (EBI) programme reduce inappropriate procedures, lessen unwarranted variation or lead to spill-over effects in the National Health Service?

Dear Dr. Glynn:

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on behalf of

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Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 File

    (DOCX)

    S1 Data

    (XLSX)

    Attachment

    Submitted filename: Response to Reviewers.docx

    Data Availability Statement

    This study is based in part on data from the Hospital Episode Statistics (HES) obtained from NHS Digital (previously the Health and Social Care Information Centre), re-used with the permission of The Health & Social Care Information Centre, and is not publicly available. The data are provided by patients and collected by the NHS as part of their care and support. HES data can be accessed via NHS Digital (https://digital.nhs.uk/services/data-access-request-service-dars). The authors confirm that others would be able to access or request these data in the same manner as themselves. The authors also confirm that they did not have any special access or request privileges that others would not have.


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