Cost-effectiveness of surgery versus cast immobilization for adults with a bicortical fracture of the scaphoid waist : an economic evaluation of the SWIFFT trial.

AIMS: The aim of the Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) was to determine the optimal treatment for adults with a bicortical undisplaced or minimally displaced fracture of the waist of the scaphoid, comparing early surgical fixation with initial cast immobilization, with immediate fixation being offered to patients with nonunion. METHODS: A cost-effectiveness analysis was conducted to assess the relative merits of these forms of treatment. The differences in costs to the healthcare system and quality-adjusted life years (QALYs) of the patients over the one-year follow-up of the trial in the two treatment arms were estimated using regression analysis. RESULTS: Our base case analysis found that patients randomized to early surgical fixation had statistically significantly higher mean costs to the NHS of £1,295 more than for the cast immobilization arm (p < 0.001), primarily due to the cost of surgery. They also had a marginally better quality of life, over the period, of 0.0158 QALYs; however, this was not statistically significant (p = 0.379). The mean combined cost per additional QALY was £81,962, well above the accepted threshold for cost-effectiveness used in the UK and internationally. The probability of early surgery being cost-effective in this setting was only 5.6%. CONCLUSION: Consistent with the clinical findings of SWIFFT, these results indicate that initial cast immobilization of minimally displaced scaphoid fractures, with immediate fixation only offered to patients with nonunion, is the optimal form of treatment, resulting in comparable outcomes with less cost to the healthcare system. Cite this article: Bone Joint J 2021;103-B(7):1277-1283.

Surgical treatments compared with early structured physiotherapy in secondary care for adults with primary frozen shoulder: the UK FROST three-arm RCT.

BACKGROUND: Frozen shoulder causes pain and stiffness. It affects around 10% of people in their fifties and is slightly more common in women. Costly and invasive surgical interventions are used, without high-quality evidence that these are effective. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of three treatments in secondary care for adults with frozen shoulder; to qualitatively explore the acceptability of these treatments to patients and health-care professionals; and to update a systematic review to explore the trial findings in the context of existing evidence for the three treatments. DESIGN: This was a pragmatic, parallel-group, multicentre, open-label, three-arm, randomised superiority trial with unequal allocation (2 : 2 : 1). An economic evaluation and a nested qualitative study were also carried out. SETTING: The orthopaedic departments of 35 hospitals across the UK were recruited from April 2015, with final follow-up in December 2018. PARTICIPANTS: Participants were adults (aged ≥ 18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation in the affected shoulder to < 50% of the opposite shoulder, and with plain radiographs excluding other pathology. INTERVENTIONS: The inventions were early structured physiotherapy with a steroid injection, manipulation under anaesthesia with a steroid injection and arthroscopic capsular release followed by manipulation. Both of the surgical interventions were followed with post-procedural physiotherapy. MAIN OUTCOME MEASURES: The primary outcome and end point was the Oxford Shoulder Score at 12 months post randomisation. A difference of 5 points between early structured physiotherapy and manipulation under anaesthesia or arthroscopic capsular release or of 4 points between manipulation under anaesthesia and arthroscopic capsular release was judged clinically important. RESULTS: The mean age of the 503 participants was 54 years; 319 were female (63%) and 150 had diabetes (30%). The primary analyses comprised 473 participants (94%). At the primary end point of 12 months, participants randomised to arthroscopic capsular release had, on average, a statistically significantly higher (better) Oxford Shoulder Score than those randomised to manipulation under anaesthesia (2.01 points, 95% confidence interval 0.10 to 3.91 points; p = 0.04) or early structured physiotherapy (3.06 points, 95% confidence interval 0.71 to 5.41 points; p = 0.01). Manipulation under anaesthesia did not result in statistically significantly better Oxford Shoulder Score than early structured physiotherapy (1.05 points, 95% confidence interval -1.28 to 3.39 points; p = 0.38). No differences were deemed of clinical importance. Serious adverse events were rare but occurred in participants randomised to surgery (arthroscopic capsular release,n = 8; manipulation under anaesthesia,n = 2). There was, however, one serious adverse event in a participant who received non-trial physiotherapy. The base-case economic analysis showed that manipulation under anaesthesia was more expensive than early structured physiotherapy, with slightly better utilities. The incremental cost-effectiveness ratio for manipulation under anaesthesia was £6984 per additional quality-adjusted life-year, and this intervention was probably 86% cost-effective at the threshold of £20,000 per quality-adjusted life-year. Arthroscopic capsular release was more costly than early structured physiotherapy and manipulation under anaesthesia, with no statistically significant benefit in utilities. Participants in the qualitative study wanted early medical help and a quicker pathway to resolve their shoulder problem. Nine studies were identified from the updated systematic review, including UK FROST, of which only two could be pooled, and found that arthroscopic capsular release was more effective than physiotherapy in the long-term shoulder functioning of patients, but not to the clinically important magnitude used in UK FROST. LIMITATIONS: Implementing physiotherapy to the trial standard in clinical practice might prove challenging but could avoid theatre use and post-procedural physiotherapy. There are potential confounding effects of waiting times in the trial. CONCLUSIONS: None of the three interventions was clearly superior. Early structured physiotherapy with a steroid injection is an accessible and low-cost option. Manipulation under anaesthesia is the most cost-effective option. Arthroscopic capsular release carries higher risks and higher costs. FUTURE WORK: Evaluation in a randomised controlled trial is recommended to address the increasing popularity of hydrodilatation despite the paucity of high-quality evidence. TRIAL REGISTRATION: Current Controlled Trials ISRCTN48804508. 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. 24, No. 71. See the NIHR Journals Library website for further project information.

Frozen shoulder occurs when the soft tissue envelope around the shoulder joint becomes inflamed, scarred and contracted, making movement painful and stiff. It affects around 1 in 10 people and is more common in women. Most patients are treated in the community. Those who do not improve are offered treatments in hospital. This includes costly and invasive surgical options. It is unclear which treatment provides the best patient outcomes and is cost-effective. UK FROST (UK FROzen Shoulder Trial) comprised 503 patients (from 35 UK hospitals) who randomly received one of three commonly offered treatments for frozen shoulder: early physiotherapy to restore movement, including a steroid injection for pain reliefmanipulation under anaesthesia, to stretch and tear the tight capsule to restore movement, and a steroid injection followed by physiotherapyarthroscopic capsular release, which uses keyhole surgery, including manipulation, to restore movement, followed by physiotherapy with pain medication. No important differences were found between the three treatments in shoulder function or pain at 12 months. Fewer patients who received arthroscopic capsular release required further treatment, and patients who received arthroscopic capsular release had slightly better shoulder function and pain outcomes than those who received the manipulation procedure or early physiotherapy. This improvement, however, was unlikely to be of clinical benefit to patients. Arthroscopic capsular release had slightly higher risks and substantially higher costs. Six serious complications were reported in patients who received arthroscopic capsular release (mostly owing to co-existing health problems) and two were reported in patients who received manipulation under anaesthesia. Physiotherapy was the least expensive treatment, but patients who received manipulation under anaesthesia had slightly better general health than those who received physiotherapy. Early physiotherapy with steroid injection could be accessed quicker than the surgical alternatives. Manipulation under anaesthesia cost more than physiotherapy but provided the best value for money. Patients in the study wanted early access to medical help to improve their shoulder problems.

Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial.

BACKGROUND: Manipulation under anaesthesia and arthroscopic capsular release are costly and invasive treatments for frozen shoulder, but their effectiveness remains uncertain. We compared these two surgical interventions with early structured physiotherapy plus steroid injection. METHODS: In this multicentre, pragmatic, three-arm, superiority randomised trial, patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK. Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder. Participants were randomly assigned (2:2:1) to receive manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy. In manipulation under anaesthesia, the surgeon manipulated the affected shoulder to stretch and tear the tight capsule while the participant was under general anaesthesia, supplemented by a steroid injection. Arthroscopic capsular release, also done under general anaesthesia, involved surgically dividing the contracted anterior capsule in the rotator interval, followed by manipulation, with optional steroid injection. Both forms of surgery were followed by postprocedural physiotherapy. Early structured physiotherapy involved mobilisation techniques and a graduated home exercise programme supplemented by a steroid injection. Both early structured physiotherapy and postprocedural physiotherapy involved 12 sessions during up to 12 weeks. The primary outcome was the Oxford Shoulder Score (OSS; 0-48) at 12 months after randomisation, analysed by initial randomisation group. We sought a target difference of 5 OSS points between physiotherapy and either form of surgery, or 4 points between manipulation and capsular release. The trial registration is ISRCTN48804508. FINDINGS: Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55%) were randomly assigned. At 12 months, OSS data were available for 189 (94%) of 201 participants assigned to manipulation (mean estimate 38·3 points, 95% CI 36·9 to 39·7), 191 (94%) of 203 participants assigned to capsular release (40·3 points, 38·9 to 41·7), and 93 (94%) of 99 participants assigned to physiotherapy (37·2 points, 35·3 to 39·2). The mean group differences were 2·01 points (0·10 to 3·91) between the capsular release and manipulation groups, 3·06 points (0·71 to 5·41) between capsular release and physiotherapy, and 1·05 points (-1·28 to 3·39) between manipulation and physiotherapy. Eight serious adverse events were reported with capsular release and two with manipulation. At a willingness-to-pay threshold of £20 000 per quality-adjusted life-year, manipulation under anaesthesia had the highest probability of being cost-effective (0·8632, compared with 0·1366 for physiotherapy and 0·0002 for capsular release). INTERPRETATION: All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences. Therefore, none of the three interventions were clinically superior. Arthoscopic capsular release carried higher risks, and manipulation under anaesthesia was the most cost-effective. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Surgical fixation compared with cast immobilisation for adults with a bicortical fracture of the scaphoid waist: the SWIFFT RCT.

BACKGROUND: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. Immediate surgical fixation of this fracture has increased. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of surgical fixation with cast treatment and early fixation in adults with scaphoid waist fractures that fail to unite. DESIGN: Multicentre, pragmatic, open-label, parallel two-arm randomised controlled trial with an economic evaluation and a nested qualitative study. SETTING: Orthopaedic departments of 31 hospitals in England and Wales recruited from July 2013, with final follow-up in September 2017. PARTICIPANTS: Adults (aged ≥ 16 years) presenting within 2 weeks of injury with a clear, bicortical fracture of the scaphoid waist on plain radiographs. INTERVENTIONS: Early surgical fixation using Conformité Européenne-marked headless compression screws. Below-elbow cast immobilisation for 6-10 weeks and urgent fixation of confirmed non-union. MAIN OUTCOME MEASURES: The primary outcome and end point was the Patient-Rated Wrist Evaluation total score at 52 weeks, with a clinically relevant difference of 6 points. Secondary outcomes included Patient-Rated Wrist Evaluation pain and function subscales, Short Form questionnaire 12-items, bone union, range of movement, grip strength, complications and return to work. RESULTS: The mean age of 439 participants was 33 years; 363 participants were male (83%) and 269 participants had an undisplaced fracture (61%). The primary analysis was on 408 participants with valid Patient-Rated Wrist Evaluation outcome data for at least one post-randomisation time point (surgery, n = 203 of 219; cast, n = 205 of 220). There was no clinically relevant difference in the Patient-Rated Wrist Evaluation total score at 52 weeks: the mean score in the cast group was 14.0 (95% confidence interval 11.3 to 16.6) and in the surgery group was 11.9 (95% confidence interval 9.2 to 14.5), with an adjusted mean difference of -2.1 in favour of surgery (95% confidence interval -5.8 to 1.6; p = 0.27). The non-union rate was low (surgery group, n = 1; cast group, n = 4). Eight participants in the surgery group had a total of 11 reoperations and one participant in the cast group required a reoperation for non-union. The base-case economic analysis at 52 weeks found that surgery cost £1295 per patient more (95% confidence interval £1084 to £1504) than cast treatment. The base-case analysis of a lifetime-extrapolated model confirmed that the cast treatment pathway was more cost-effective. The nested qualitative study identified patients' desire to have a 'sense of recovering', which surgeons should address at the outset. LIMITATION: There were 17 participants who had initial cast treatment and surgery for confirmed non-union, which in 14 cases was within 6 months from randomisation and in three cases was after 6 months. Three of the four participants in the cast group who had a non-union at 52 weeks were not offered surgery. CONCLUSIONS: Adult patients with an undisplaced or minimally displaced scaphoid waist fracture should have cast immobilisation and suspected non-unions immediately confirmed and urgently fixed. Patients should be followed up at 5 years to investigate the effect of partial union, degenerative arthritis, malunion and screw problems on their quality of life. TRIAL REGISTRATION: Current Controlled Trials ISRCTN67901257. 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. 24, No. 52. See the NIHR Journals Library website for further project information.

Fracture of the scaphoid bone (one of eight small bones in the wrist) is common in young active people. It is caused by a fall on the hand or the hand being suddenly forced backwards. The usual treatment is to rest the wrist in a plaster cast for 6­10 weeks and allow the broken bone to heal. In 1 in 10 cases in which the fracture is treated in a plaster cast, the bone does not heal and an operation is needed. In the operation, the broken bone is held still with a screw. In the last few years, it has become more common to fix the broken bone with a screw in the first few days after injury, instead of resting the wrist in a plaster cast. It is not clear if fixing the bone early with a screw, compared with resting the wrist in a cast, gives better outcomes for patients and if one treatment is better value for money for the NHS. In this study, 439 adult patients agreed either to have surgery to hold the broken scaphoid with a special screw or to have the wrist held still in a plaster cast (with surgery offered after 6 weeks to those who were still not healed). The decision about which treatment to use was made using randomisation, which is similar to tossing a coin. Patients reported their own wrist pain and function at 6, 12, 26 and 52 weeks. Information was also collected on general health, bone healing, grip strength and range of movement, complications from treatment and costs. No important differences were found in patients' wrist pain and function at 52 weeks. The bone did not heal properly in four patients in the surgery group or in nine patients in the plaster cast group at 52 weeks. For one of these patients in the surgery group and four of these patients in the plaster cast group, the bone did not join at all. Eight patients in the surgery group had further surgery following their initial operation to fix their wrist, and one patient in the cast group required repeated surgery because the bone did not join at all. The overall cost of treating with a plaster cast was lower than that of early surgery. Therefore, the findings of the study suggest that a plaster cast should be used initially and that the bone should be immediately fixed with a screw if it does not heal.

Occupational advice to help people return to work following lower limb arthroplasty: the OPAL intervention mapping study.

BACKGROUND: Hip and knee replacements are regularly carried out for patients who work. There is little evidence about these patients' needs and the factors influencing their return to work. There is a paucity of guidance to help patients return to work after surgery and a need for structured occupational advice to enable them to return to work safely and effectively. OBJECTIVES: To develop an occupational advice intervention to support early recovery to usual activities including work that is tailored to the requirements of patients undergoing hip or knee replacements. To test the acceptability, practicality and feasibility of this intervention within current care frameworks. DESIGN: An intervention mapping approach was used to develop the intervention. The research methods employed were rapid evidence synthesis, qualitative interviews with patients and stakeholders, a prospective cohort study, a survey of clinical practice and a modified Delphi consensus process. The developed intervention was implemented and assessed during the final feasibility stage of the intervention mapping process. SETTING: Orthopaedic departments in NHS secondary care. PARTICIPANTS: Patients who were in work and intending to return to work following primary elective hip or knee replacement surgery, health-care professionals and employers. INTERVENTIONS: Occupational advice intervention. MAIN OUTCOME MEASURES: Development of an occupational advice intervention, fidelity of the developed intervention when delivered in a clinical setting, patient and clinician perspectives of the intervention and preliminary assessments of intervention effectiveness and cost. RESULTS: A cohort study (154 patients), 110 stakeholder interviews, a survey of practice (152 respondents) and evidence synthesis provided the necessary information to develop the intervention. The intervention included information resources, a personalised return-to-work plan and co-ordination from the health-care team to support the delivery of 13 patient and 20 staff performance objectives. To support delivery, a range of tools (e.g. occupational checklists, patient workbooks and employer information), roles (e.g. return-to-work co-ordinator) and training resources were created. Feasibility was assessed for 21 of the 26 patients recruited from three NHS trusts. Adherence to the defined performance objectives was 75% for patient performance objectives and 74% for staff performance objectives. The intervention was generally well received, although the short time frame available for implementation and concurrent research evaluation led to some confusion among patients and those delivering the intervention regarding its purpose and the roles and responsibilities of key staff. LIMITATIONS: Implementation and uptake of the intervention was not standardised and was limited by the study time frame. Evaluation of the intervention involved a small number of patients, which limited the ability to assess it. CONCLUSIONS: The developed occupational advice intervention supports best practice. Evaluation demonstrated good rates of adherence against defined performance objectives. However, a number of operational and implementation issues require further attention. FUTURE WORK: The intervention warrants a randomised controlled trial to assess its clinical effectiveness and cost-effectiveness to improve rates and timing of sustained return to work after surgery. This research should include the development of a robust implementation strategy to ensure that adoption is sustained. STUDY REGISTRATION: Current Controlled Trials ISRCTN27426982 and PROSPERO CRD42016045235. 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. 24, No. 45. See the NIHR Journals Library website for further project information.

Hip and knee replacements are regularly carried out for patients who work. There is a lack of evidence about these patients' needs and how they return to work. Guidance to enable return to work after surgery is limited. There is, therefore, a need for structured occupational advice to help these patients. The aim of this project was to develop a multidisciplinary occupational advice intervention for this patient population and assess if it could be delivered. The study also aimed to make recommendations about its further assessment in a clinical trial. The study combined different methods of research (quantitative and qualitative) to identify the population likely to benefit, their current care, and the outcomes important to patients and health-care professionals. All of the information gathered was mapped through a framework (intervention mapping), which included a consensus process with stakeholders to develop the intervention. The intervention delivery was assessed for a small number of patients across orthopaedic departments, employer organisations and primary care networks. The study involved 154 patients, 110 stakeholders (general practitioners, surgeons, employers and health professionals/nurses) and a survey of current care (152 respondents) to develop the intervention. The intervention included information resources, a personalised return-to-work plan and co-ordination from the health-care team to support the delivery of 33 patient and staff performance objectives. To support delivery, a range of tools (e.g. occupational checklists, patient workbooks and employer information), roles (e.g. return-to-work co-ordinator) and training resources were created. The intervention was assessed in 26 patients and staff, and showed high rates of adherence to the defined performance objectives. The overall results demonstrated that the occupational advice intervention developed for hip and knee replacement patients is deliverable. The intervention warrants further research to assess its clinical effectiveness and cost-effectiveness as a tool to improve rates and timing of sustained return to work after surgery.

Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial.

BACKGROUND: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. The use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non-surgical management. The SWIFFT trial compared the clinical effectiveness of surgical fixation with cast immobilisation and early fixation of fractures that fail to unite in adults with scaphoid waist fractures displaced by 2 mm or less. METHODS: This pragmatic, parallel-group, multicentre, open-label, two-arm, randomised superiority trial included adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs. An independent remote randomisation service used a computer-generated allocation sequence with randomly varying block sizes to randomly assign participants (1:1) to receive either early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group). Randomisation was stratified by whether or not there was displacement of either a step or a gap of 1-2 mm inclusive on any radiographic view. The primary outcome was the total patient-rated wrist evaluation (PRWE) score at 52 weeks after randomisation, and it was analysed on an available case intention-to-treat basis. This trial is registered with the ISRCTN registry, ISRCTN67901257, and is no longer recruiting, but long-term follow-up is ongoing. FINDINGS: Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men) were randomly assigned to the surgery group (n=219) or to the cast immobilisation group (n=220). Of these, 408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group). 16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks. There was no significant difference in mean PRWE scores at 52 weeks between the surgery group (adjusted mean 11·9 [95% CI 9·2-14·5]) and the cast immobilisation group (14·0 [11·3 to 16·6]; adjusted mean difference -2·1 [95% CI -5·8 to 1·6], p=0·27). More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]). The number of participants who had a medical complication was similar between the two groups (four [2%] in the surgery group and five [2%] in the cast immobilisation group). INTERPRETATION: Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery. This treatment strategy will help to avoid the risks of surgery and mostly limit the use of surgery to fixing fractures that fail to unite. FUNDING: National Institute for Health Research Health Technology Assessment Programme.

The Relevant Perspective of Economic Evaluations Informing Local Decision Makers: An Exploration in Weight Loss Services.

Since 2013, obesity services in the UK National Health Service (NHS) have focused on a tiered structure, with tiers 3 (specialist weight management services) and 4 (primarily bariatric surgery) commissioned by Clinical Commissioning Groups (CCGs) and widely reported as cost effective and recommended by national guidelines. However, CCGs have been reluctant to fully conform to the guidance. We explore how the different evaluative perspective of those generating evidence from local decision makers has contributed to this failure of the CCGs to provide services considered cost effective. We explore four elements where the conventional economic evaluation framework, as applied by the National Institute for Health and Care Excellence (NICE), differ from the reality faced by local decision makers: the cost-effectiveness threshold, the implications of decision uncertainty and budgetary excess, the valuation of future costs and outcomes, and the scope of included costs. We argue that the failure of the conventional framework to reflect the reality faced by local decision makers is rendering much of the existing literature and guidance inappropriate to the key commissioners. Our analysis demonstrates that it is not reasonable to assume that the framework of economic evaluation used to inform national guidance applies to local decision makers, such as in the commissioning of weight loss services. This failure is likely to apply to the majority of cases where evidence is generated to inform national decision makers but commissioning is at a local level.

Cost-effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery: Learning from 15,856 patients.

BACKGROUND: Patients undergoing emergency abdominal surgery are exposed to a high risk of death. A quality improvement (QI) programme to improve the survival for these patients was evaluated in the Enhanced Peri-Operative Care for High-risk patients (EPOCH) trial. This study aims to assess its cost-effectiveness versus usual care from a UK health service perspective. METHODS: Data collected in a subsample of trial participants were employed to estimate costs and quality-adjusted life years (QALYs) for the QI programme and usual care within the 180-day trial period, with results also extrapolated to estimate lifetime costs and QALYs. Cost-effectiveness was estimated using incremental cost-effectiveness ratios (ICERs). The probability of being cost-effective was determined for different cost-effectiveness thresholds (£13,000 to £30,000 per QALY). Analyses were performed for lower-risk and higher-risk subgroups based on the number of surgical indications (single vs multiple). RESULTS: Within the trial period, QI was more costly (£467) but less effective (-0.002 QALYs). Over a lifetime, it was more costly (£1395) and more effective (0.018 QALYs), but did not appear to be cost-effective (ICER: £77,792 per QALY, higher than all cost-effectiveness thresholds; probability of being cost-effective: 28.7%-43.8% across the thresholds). For lower-risk patients, QI was more costly and less effective both within trial period and over a lifetime and it did not appear to be cost-effective. For higher-risk patients, it was more costly and more effective, and did not appear cost-effective within the trial period (ICER: £158,253 per QALY) but may be cost-effective over a lifetime (ICER: £14,293 per QALY). CONCLUSION: The QI programme does not appear cost-effective at standard cost-effectiveness thresholds. For patients with multiple surgical indications, this programme is potentially cost-effective over a lifetime, but this is highly uncertain.

Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): a stepped-wedge cluster-randomised trial.

BACKGROUND: Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients. METHODS: We did a stepped-wedge cluster-randomised trial of patients aged 40 years or older undergoing emergency open major abdominal surgery. Eligible UK National Health Service (NHS) hospitals (those that had an emergency general surgical service, a substantial volume of emergency abdominal surgery cases, and contributed data to the National Emergency Laparotomy Audit) were organised into 15 geographical clusters and commenced the QI programme in a random order, based on a computer-generated random sequence, over an 85-week period with one geographical cluster commencing the intervention every 5 weeks from the second to the 16th time period. Patients were masked to the study group, but it was not possible to mask hospital staff or investigators. The primary outcome measure was mortality within 90 days of surgery. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN80682973. FINDINGS: Treatment took place between March 3, 2014, and Oct 19, 2015. 22 754 patients were assessed for elegibility. Of 15 873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. Eight patients in the usual care group and nine patients in the QI group were not included in the analysis because of missing primary outcome data. The primary outcome of 90-day mortality occurred in 1210 (16%) patients in the QI group compared with 1393 (16%) patients in the usual care group (HR 1·11, 0·96-1·28). INTERPRETATION: No survival benefit was observed from this QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. Future QI programmes should ensure that teams have both the time and resources needed to improve patient care. FUNDING: National Institute for Health Research Health Services and Delivery Research Programme.

The impact of pre and perinatal lifestyle factors on child long term health and social outcomes: a systematic review.

To understand the full extent of the impact of a trial, it is important to consider the long-term consequences of outcomes beyond the trial follow-up period, especially for early year's interventions. A systematic review of the literature associated with the long-term consequences of four key outcomes from the Building Blocks trial, specifically, low birth weight, smoking during pregnancy, interval to subsequent pregnancy and A&E attendance or inpatient admission was conducted. These factors were guided by the funders, the Department of Health, as being of particular interest in the UK context. Relevant studies were identified from a number of sources including large databases, reference checking and citation searching. The search yielded 3665 papers, 43 of which were considered appropriate for inclusion. Of these, 29 were relating to smoking during pregnancy, 13 to low birth weight, 0 to A&E attendances during early childhood and 1 to short (< 2 years) interval to subsequent pregnancy. Consistent associations were found between maternal smoking during pregnancy and the effects this has on children's health, educational attainment and likelihood of engaging in problem behaviour and criminal activity in later life. Low birth weight was also found to impact on children's long-term health and cognitive development. Subsequent pregnancies within two years of the previous birth were linked with increased likelihood of pre-term birth and neonatal death. Only minimal evidence was identified regarding the consequences of a short interval to second pregnancy and of child A&E and outpatient attendances. Given that these outcomes have been identified by the UK Department of Health as of particular interest for UK benefit, investment of research in these areas is recommended to establish a clearer picture of both short and long-term consequences.

United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial.

BACKGROUND: Frozen shoulder (also known as adhesive capsulitis) occurs when the capsule, or the soft tissue envelope around the ball and socket shoulder joint, becomes scarred and contracted, making the shoulder tight, painful and stiff. It affects around 1 in 12 men and 1 in 10 women of working age. Although this condition can settle with time (typically taking 1 to 3 years), for some people it causes severe symptoms and needs referral to hospital. Our aim is to evaluate the clinical and cost-effectiveness of two invasive and costly surgical interventions that are commonly used in secondary care in the National Health Service (NHS) compared with a non-surgical comparator of Early Structured Physiotherapy. METHODS: We will conduct a randomised controlled trial (RCT) of 500 adult patients with a clinical diagnosis of frozen shoulder, and who have radiographs that exclude other pathology. Early Structured Physiotherapy with an intra-articular steroid injection will be compared with manipulation under anaesthesia with a steroid injection or arthroscopic (keyhole) capsular release followed by manipulation. Both surgical interventions will be followed with a programme of post-procedural physiotherapy. These treatments will be undertaken in NHS hospitals across the United Kingdom. The primary outcome and endpoint will be the Oxford Shoulder Score (a patient self-reported assessment of shoulder function) at 12 months. This will also be measured at baseline, 3 and 6 months after randomisation; and on the day that treatment starts and 6 months later. Secondary outcomes include the Disabilities of Arm Shoulder and Hand (QuickDASH) score, the EQ-5D-5 L score, pain, extent of recovery and complications. We will explore the acceptability of the different treatments to patients and health care professionals using qualitative methods. DISCUSSION: The three treatments being compared are the most frequently used in secondary care in the NHS, but there is uncertainty about which one works best and at what cost. UK FROST is a rigorously designed and adequately powered study to inform clinical decisions for the treatment of this common condition in adults. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Register, ID: ISRCTN48804508 . Registered on 25 July 2014.

An evaluation of the costs and consequences of Children Community Nursing teams.

AIMS: Recent years have seen an increasing shift towards providing care in the community, epitomised by the role of Children's Community Nursing (CCN) teams. However, there have been few attempts to use robust evaluative methods to interrogate the impact of such services. This study sought to evaluate whether reduction in secondary care costs, resulting from the introduction of 2 CCN teams, was sufficient to offset the additional cost of commissioning. METHODS: Among the potential benefits of the CCN teams is a reduction in the burden placed on secondary care through the delivery of care at home; it is this potential reduction which is evaluated in this study via a 2-part analytical method. Firstly, an interrupted time series analysis used Hospital Episode Statistics data to interrogate any change in total paediatric bed days as a result of the introduction of 2 teams. Secondly, a costing analysis compared the cost savings from any reduction in total bed days with the cost of commissioning the teams. This study used a retrospective longitudinal study design as part of the transforming children's community services trial, which was conducted between June 2012 and June 2015. RESULTS: A reduction in hospital activity after introduction of the 2 nursing teams was found, (9634 and 8969 fewer bed days), but this did not reach statistical significance. The resultant cost saving to the National Health Service was less than the cost of employing the teams. CONCLUSION: The study represents an important first step in understanding the role of such teams as a means of providing a high quality of paediatric care in an era of limited resource. While the cost saving from released paediatric bed days was not sufficient to demonstrate cost-effectiveness, the analysis does not incorporate wider measures of health care utilisation and nonmonetary benefits resulting from the CCN teams.

A discrete choice experiment to explore patients' willingness to risk disease relapse from treatment withdrawal in psoriatic arthritis.

The objective of this study is to assess patient preferences for treatment-related benefits and risk of disease relapse in the management of low disease states of psoriatic arthritis (PsA). Focus groups with patients and a literature review were undertaken to determine the characteristics of treatment and symptoms of PsA important to patients. Patient preferences were assessed using a discrete choice experiment which compared hypothetical treatment profiles of the risk and benefits of treatment withdrawal. The risk outcome included increased risk of disease relapse, while benefit outcomes included reduced sickness/nausea from medication and changes in health-related quality of life. Each patient completed 12 choice sets comparing treatment profiles. Preference weights were estimated using a logic regression model, and the maximum acceptable risk in disease relapse for a given improvement in benefit outcomes was elicited. Final sample included 136 patients. Respondents attached the greatest importance to eliminating severe side effects of sickness/nausea and the least importance to a change in risk of relapse. Respondents were willing to accept an increase in the risk of relapse of 32.6 % in order to eliminate the side effects of sickness/nausea. For improvements in health status, the maximum acceptable risk in relapse was comparable to a movement from some to no sickness/nausea. The study suggests that patients in low disease states of PsA are willing to accept greater risks of relapse for improvements in side effects of sickness/nausea and overall health status, with the most important benefit attribute being the elimination of severe sickness or nausea.

Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) protocol: a pragmatic multi-centre randomised controlled trial of cast treatment versus surgical fixation for the treatment of bi-cortical, minimally displaced fractures of the scaphoid waist in adults.

BACKGROUND: A scaphoid fracture is the most common type of carpal fracture affecting young active people. The optimal management of this fracture is uncertain. When treated with a cast, 88 to 90 % of these fractures unite; however, for the remaining 10-12 % the non-union almost invariably leads to arthritis. The alternative is surgery to fix the scaphoid with a screw at the outset. METHODS/DESIGN: We will conduct a randomised controlled trial (RCT) of 438 adult patients with a "clear" and "bicortical" scaphoid waist fracture on plain radiographs to evaluate the clinical effectiveness and cost-effectiveness of plaster cast treatment (with fixation of those that fail to unite) versus early surgical fixation. The plaster cast treatment will be immobilisation in a below elbow cast for 6 to 10 weeks followed by mobilisation. If non-union is confirmed on plain radiographs and/or Computerised Tomogram at 6 to 12 weeks, then urgent surgical fixation will be performed. This is being compared with immediate surgical fixation with surgeons using their preferred technique and implant. These treatments will be undertaken in trauma units across the United Kingdom. The primary outcome and end-point will be the Patient Rated Wrist Evaluation (a patient self-reported assessment of wrist pain and function) at 52 weeks and also measured at 6, 12, 26 weeks and 5 years. Secondary outcomes include an assessment of radiological union of the fracture; quality of life; recovery of wrist range and strength; and complications. We will also qualitatively investigate patient experiences of their treatment. DISCUSSION: Scaphoid fractures are an important public health problem as they predominantly affect young active individuals in the more productive working years of their lives. Non-union, if untreated, can lead to arthritis which can disable patients at a very young age. There is a rapidly increasing trend for immediate surgical fixation of these fractures but there is insufficient evidence from existing RCTs to support this. The SWIFFT Trial is a rigorously designed and adequately powered study which aims to contribute to the evidence-base to inform clinical decisions for the treatment of this common fracture in adults. TRIAL REGISTRATION: The trial is registered with the International Standard Randomised Controlled Trial Register ( ISRCTN67901257 ). Date registration assigned was 13/02/2013.

Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial.

BACKGROUND: Many countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children. The Family Nurse Partnership (FNP) is a licensed intensive home-visiting intervention developed in the USA and introduced into practice in England that involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained family nurses. We aimed to assess the effectiveness of giving the programme to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth. METHODS: We did a pragmatic, non-blinded, randomised controlled, parallel-group trial in community midwifery settings at 18 partnerships between local authorities and primary and secondary care organisations in England. Eligible participants were nulliparous and aged 19 years or younger, and were recruited at less than 25 weeks' gestation. Field-based researchers randomly allocated mothers (1:1) via remote randomisation (telephone and web) to FNP plus usual care (publicly funded health and social care) or to usual care alone. Allocation was stratified by site and minimised by gestation (<16 weeks vs ≥16 weeks), smoking status (yes vs no), and preferred language of data collection (English vs non-English). Mothers and assessors (local researchers at baseline and 24 months' follow-up) were not masked to group allocation, but telephone interviewers were blinded. Primary endpoints were biomarker-calibrated self-reported tobacco use by the mother at late pregnancy, birthweight of the baby, the proportion of women with a second pregnancy within 24 months post-partum, and emergency attendances and hospital admissions for the child within 24 months post-partum. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN23019866. FINDINGS: Between June 16, 2009, and July 28, 2010, we screened 3251 women. After enrolment, 823 women were randomly assigned to receive FNP and 822 to usual care. All follow-up data were retrieved by April 25, 2014. 304 (56%) of 547 women assigned to FNP and 306 (56%) of 545 assigned to usual care smoked at late pregnancy (adjusted odds ratio [AOR] 0·90, 97·5% CI 0·64-1·28). Mean birthweight of 742 babies with mothers assigned to FNP was 3217·4 g (SD 618·0), whereas birthweight of 768 babies assigned to usual care was 3197·5 g (SD 581·5; adjusted mean difference 20·75 g, 97·5% CI -47·73 to 89·23. 587 (81%) of 725 assessed children with mothers assigned to FNP and 577 (77%) of 753 assessed children assigned to usual care attended an emergency department or were admitted to hospital at least once before their second birthday (AOR 1·32, 97·5% CI 0·99-1·76). 426 (66%) of 643 assessed women assigned to FNP and 427 (66%) 646 assigned to usual care had a second pregnancy within 2 years (AOR 1·01, 0·77-1·33). At least one serious adverse event (mainly clinical events associated with pregnancy and infancy period) was reported for 310 (38%) of 808 participants (mother-child) in the usual care group and 357 (44%) of 810 in the FNP group, none of which were considered related to the intervention. INTERPRETATION: Adding FNP to the usually provided health and social care provided no additional short-term benefit to our primary outcomes. Programme continuation is not justified on the basis of available evidence, but could be reconsidered should supportive longer-term evidence emerge. FUNDING: Department of Health Policy Research Programme.

A randomised controlled trial of three or one breathing technique training sessions for breathlessness in people with malignant lung disease.

BACKGROUND: About 90 % of patients with intra-thoracic malignancy experience breathlessness. Breathing training is helpful, but it is unknown whether repeated sessions are needed. The present study aims to test whether three sessions are better than one for breathlessness in this population. METHODS: This is a multi-centre randomised controlled non-blinded parallel arm trial. Participants were allocated to three sessions or single (1:2 ratio) using central computer-generated block randomisation by an independent Trials Unit and stratified for centre. The setting was respiratory, oncology or palliative care clinics at eight UK centres. Inclusion criteria were people with intrathoracic cancer and refractory breathlessness, expected prognosis ≥3 months, and no prior experience of breathing training. The trial intervention was a complex breathlessness intervention (breathing training, anxiety management, relaxation, pacing, and prioritisation) delivered over three hour-long sessions at weekly intervals, or during a single hour-long session. The main primary outcome was worst breathlessness over the previous 24 hours ('worst'), by numerical rating scale (0 = none; 10 = worst imaginable). Our primary analysis was area under the curve (AUC) 'worst' from baseline to 4 weeks. All analyses were by intention to treat. RESULTS: Between April 2011 and October 2013, 156 consenting participants were randomised (52 three; 104 single). Overall, the 'worst' score reduced from 6.81 (SD, 1.89) to 5.84 (2.39). Primary analysis [n = 124 (79 %)], showed no between-arm difference in the AUC: three sessions 22.86 (7.12) vs single session 22.58 (7.10); P value = 0.83); mean difference 0.2, 95 % CIs (-2.31 to 2.97). Complete case analysis showed a non-significant reduction in QALYs with three sessions (mean difference -0.006, 95 % CIs -0.018 to 0.006). Sensitivity analyses found similar results. The probability of the single session being cost-effective (threshold value of £20,000 per QALY) was over 80 %. CONCLUSIONS: There was no evidence that three sessions conferred additional benefits, including cost-effectiveness, over one. A single session of breathing training seems appropriate and minimises patient burden. TRIAL REGISTRATION: Registry: ISRCTN; TRIAL REGISTRATION NUMBER: ISRCTN49387307; http://www.isrctn.com/ISRCTN49387307 ; registration date: 25/01/2011.

The effectiveness and cost-effectiveness of the Family Nurse Partnership home visiting programme for first time teenage mothers in England: a protocol for the Building Blocks randomised controlled trial.

BACKGROUND: The Nurse Family Partnership programme was developed in the USA where it is made available to pregnant young mothers in some socially deprived geographic areas. The related Family Nurse Partnership programme was introduced in England by the Department of Health in 2006 with the aim of improving outcomes for the health, wellbeing and social circumstances of young first-time mothers and their children. METHODS / DESIGN: This multi-centre individually randomised controlled trial will recruit 1600 participants from 18 Primary Care Trusts in England, United Kingdom. The trial will evaluate the effectiveness of Family Nurse Partnership programme and usual care versus usual care for nulliparous pregnant women aged 19 or under, recruited by 24 weeks gestation and followed until the child's second birthday. Data will be collected from participants at baseline, 34-36 weeks gestation, 6, 12, 18 and 24 months following birth. Routine clinical data will be collected from maternity, primary care and hospital episodes statistics. Four primary outcomes are to be reported from the trial: birth weight; prenatal tobacco use; child emergency attendances and/or admissions within two years of birth; second pregnancy within two years of first birth. DISCUSSION: This trial will evaluate the effectiveness and cost effectiveness of the Family Nurse Partnership in England. The findings will provide evidence on pregnancy and early childhood programme outcomes for policy makers, health professionals and potential recipients in three domains (pregnancy and birth, child health and development, and parental life course and self-sufficiency) up to the child's second birthday. TRIAL REGISTRATION: Trial registration number: ISRCTN23019866.

Cost-effectiveness of supported self-management for CFS/ME patients in primary care.

BACKGROUND: Nurse led self-help treatments for people with chronic fatigue syndrome/myalgic encephalitis (CFS/ME) have been shown to be effective in reducing fatigue but their cost-effectiveness is unknown. METHODS: Cost-effectiveness analysis conducted alongside a single blind randomised controlled trial comparing pragmatic rehabilitation (PR) and supportive listening (SL) delivered by primary care nurses, and treatment as usual (TAU) delivered by the general practitioner (GP) in North West England. A within trial analysis was conducted comparing the costs and quality adjusted life years (QALYs) measured within the time frame of the trial. 296 patients aged 18 and over with CFS/ME diagnosed using the Oxford criteria were included in the cost-effectiveness analysis. RESULTS: Treatment as usual is less expensive and leads to better patient outcomes compared with Supportive Listening. Treatment as usual is also less expensive than Pragmatic Rehabilitation. PR was effective at reducing fatigue in the short term, but the impact of the intervention on QALYs was uncertain. However, based on the results of this trial, PR is unlikely to be cost-effective in this patient population. CONCLUSIONS: This analysis does not support the introduction of SL. Any benefits generated by PR are unlikely to be of sufficient magnitude to warrant recommending PR for this patient group on cost-effectiveness grounds alone. However, dissatisfaction with current treatment options means simply continuing with 'treatment as usual' in primary care is unlikely to be acceptable to patients and practitioners. TRIAL REGISTRATION: The trial registration number is IRCTN74156610.

Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of home delivered pragmatic rehabilitation-a programme of gradually increasing activity designed collaboratively by the patient and the therapist-and supportive listening-an approach based on non-directive counselling-for patients in primary care with chronic fatigue syndrome/myalgic encephalomyelitis or encephalitis (CFS/ME). DESIGN: Single blind, randomised, controlled trial. SETTING: 186 general practices across the north west of England between February 2005 and May 2007. PARTICIPANTS: 296 patients aged 18 or over with CFS/ME (median illness duration seven years) diagnosed using the Oxford criteria. INTERVENTIONS: Participants were randomly allocated to pragmatic rehabilitation, supportive listening, or general practitioner treatment as usual. Both therapies were delivered at home in 10 sessions over 18 weeks by one of three adult specialty general nurses who had received four months' training, including supervised practice, in each of the interventions. GP treatment as usual was unconstrained except that patients were not to be referred for systematic psychological therapies during the treatment period. Main outcome measures The primary clinical outcomes were fatigue and physical functioning at the end of treatment (20 weeks) and 70 weeks from recruitment compared with GP treatment as usual. Lower fatigue scores and higher physical functioning scores denote better outcomes. RESULTS: A total of 257 (87%) of the 296 patients who entered the trial were assessed at 70 weeks, the primary outcome point. Analysis was on an intention to treat basis, with robust treatment effects estimated after adjustment for missing data using probability weights. Immediately after treatment (at 20 weeks), patients allocated to pragmatic rehabilitation (n=95) had significantly improved fatigue (effect estimate -1.18, 95% confidence interval -2.18 to -0.18; P=0.021) but not physical functioning (-0.18, 95% CI -5.88 to +5.52; P=0.950) compared with patients allocated to treatment as usual (n=100). At one year after finishing treatment (70 weeks), there were no statistically significant differences in fatigue or physical functioning between patients allocated to pragmatic rehabilitation and those on treatment as usual (-1.00, 95% CI -2.10 to +0.11; P=0.076 and +2.57, 95% CI 3.90 to +9.03; P=0.435). At 20 weeks, patients allocated to supportive listening (n=101) had poorer physical functioning than those allocated to treatment as usual (-7.54, 95% CI -12.76 to -2.33; P=0.005) and no difference in fatigue. At 70 weeks, patients allocated to supportive listening did not differ significantly from those allocated to treatment as usual on either primary outcome. CONCLUSIONS: For patients with CFS/ME in primary care, pragmatic rehabilitation delivered by trained nurse therapists improves fatigue in the short term compared with unconstrained GP treatment as usual, but the effect is small and not statistically significant at one year follow-up. Supportive listening delivered by trained nurse therapists is not an effective treatment for CFS/ME. Trial registration International Standard Randomised Controlled Trial Number IRCTN74156610.