Longitudinal study of use and cost of subacromial decompression surgery: the need for effective evaluation of surgical procedures to prevent overtreatment and wasted resources.

OBJECTIVES: To illustrate the need for better evaluation of surgical procedures, we investigated the use and cost of subacromial decompression in England over the last decade compared with other countries and explored how this related to the conduct and outcomes of randomised, placebo-controlled clinical trials. DESIGN: Longitudinal observational study using Hospital Episode Statistics linked to Payment by Results tariffs in England, 2007/2008 to 2016/2017. SETTING: Hospital care in England; Finland; New York State, USA; Florida State, USA and Western Australia. PARTICIPANTS: Patients with subacromial shoulder pain. INTERVENTIONS: Subacromial decompression. MAIN OUTCOME MEASURES: National procedure rates, costs and variation between clinical commissioning groups in England. RESULTS: Without robust clinical evidence, the use of subacromial decompression in England increased by 91% from 15 112 procedures (30 per 100 000 population) in 2007/2008, to 28 802 procedures (52 per 100 000 population) in 2016/2017, costing over £125 million per year. Rates of use of subacromial decompression are even higher internationally: Finland (131 per 100 000 in 2011), Florida State (130 per 100 000 in 2007), Western Australia (115 per 100 000 in 2013) and New York State (102 per 100 000 in 2006). Two randomised placebo-controlled trials have recently (2018) shown the procedure to be no more effective than placebo or conservative approaches. Health systems appear unable to avoid the rapid widespread use of procedures of unknown effectiveness, and methods for ceasing ineffective treatments are under-developed. CONCLUSIONS: Without good evidence, nearly 30 000 subacromial decompression procedures have been commissioned each year in England, costing over £1 billion since 2007/2008. Even higher rates of procedures are carried out in countries with less regulated health systems. High quality randomised trials need to be initiated before widespread adoption of promising operative procedures to avoid overtreatment and wasted resources, and methods to prevent or desist the use of ineffective procedures need to be expedited.

[Cost-effectiveness of local steroid combined with therapeutic exercise in subacromial impingement syndrome]. / Costo-efectividad de esteroides locales combinados con ejercicio terapéutico en síndrome de pinzamiento subacromial.

BACKGROUND: The most common cause of injury is shoulder impingement syndrome. Management includes physical therapy, analgesics, steroids and surgery. The aim of the study was to determine the cost-effectiveness of using steroids combined with therapeutic exercise at home in the chronic impingement syndrome. METHODS: Clinical trial randomized in 30 people with subacromial impingement syndrome underwent two treatments: steroid and at home rehabilitation booklet evaluated at the first and fourth week through UCLA Shoulder rating scale. RESULTS: We studied 17 men (56.7 %) and 13 women (43.3 %), mean age was 42.87 years. Group 2 earned greater improvement in UCLA Shoulder rating scale 18.87 at baseline and 27.60 at the end. With 30.27 accumulated disability days for group 1, and 14.80 for group 2. CONCLUSIONS: The combination of local steroids with therapeutic exercise is more effective clinically and declining disability compared to conventional physical therapy.

INTRODUCCIÓN: la causa de lesión de hombro más frecuente es el síndrome de pinzamiento subacromial. Su manejo incluye fisioterapia, analgésicos, esteroides y cirugía. El objetivo de este trabajo fue determinar el costo-efectividad del uso de esteroides combinado con ejercicio terapéutico en casa en el síndrome de pinzamiento subacromial (SIS). MÉTODOS: ensayo clínico aleatorizado en 30 trabajadores con síndrome de pinzamiento subacromial sometidos a dos tratamientos: esteroide con folleto de rehabilitación en casa y terapia de rehabilitación convencional, ambos grupos evaluados a la primera y cuarta semana mediante la escala de hombro de UCLA. RESULTADOS: estudiamos a 17 hombres (56.7%) y 13 mujeres (43.3%), con edad media de 42.87 años (9.133 DE). El grupo 2 obtuvo mayor mejoría en la escala de evaluación del hombro de la UCLA con una puntuación de 18.87 al inicio y 27.60 al final. Con 30.27 días acumulados de incapacidad para el grupo 1 y 14.80 para el grupo 2. CONCLUSIONES: la combinación de esteroides locales con ejercicio terapéutico es más efectivo clínicamente y reporta una disminución en el número de incapacidades en comparación con la terapia física convencional.

Rising trends in surgery for rotator cuff disease in Western Australia.

BACKGROUND: Increasing rates of surgery for rotator cuff disease have been reported in the past decade in a number of countries worldwide. Rising surgery rates do not correspond with equivalent increases in shoulder pain prevalence. The aims of the study were: to investigate trends in population-adjusted surgical rates for rotator cuff disease in Western Australia (WA) from 2001 to 2013; to compare population-adjusted arthroscopic surgical trends between (i) private versus public hospital setting; (ii) sex and (iii) different age groups; and to evaluate rising health care costs associated with arthroscopic surgical rates for rotator cuff disease. METHODS: Numbers and costs for surgical procedures for rotator cuff disease performed in WA were extracted from the WA Department of Health database for the 13-year period, 2001-2013. RESULTS: Rising surgical trends were demonstrated with arthroscopic subacromial decompression (ASAD) and arthroscopic reconstruction showing large proportional increases of 108.7 and 68.4%, respectively. Increasing trends were mostly linear across private and public hospital settings, gender groups and different age groups. The rise in consumer price index-adjusted costs for ASAD in private and public hospitals was 273.7 and 320.8%, respectively, and for arthroscopic reconstruction 220.2 and 472.5%, respectively. CONCLUSION: The substantial increase in arthroscopic surgery rates for rotator cuff disease and associated costs in WA over the period 2001-2013 is in spite of evidence that surgical outcomes are no different to exercise interventions. Conservative treatments should be recommended as an initial treatment choice, to arrest escalating health care costs.

Does arthroscopic subacromial decompression improve quality of life.

INTRODUCTION: There has been a significant rise in the volume of subacromial decompression surgery performed in the UK. This study aimed to determine whether arthroscopic subacromial decompression improves health related quality of life in a cost effective manner. METHODS: Patients undergoing arthroscopic subacromial decompression surgery for impingement were enrolled between 2012 and 2014. The Oxford shoulder score and the EQ-5D™ instruments were completed prior to and following surgery. A cost-utility analysis was performed. RESULTS: Eighty-three patients were eligible for the study with a mean follow-up duration of 15 months (range: 4-27 months). The mean Oxford shoulder score improved by 13 points (95% confidence interval [CI]: 11-15 points). The mean health utility gain extrapolated from the EQ-5D™ questionnaire improved by 0.23 (95% CI: 0.16-0.30), translating to a minimum cost per QALY of £5,683. CONCLUSIONS: Subacromial decompression leads to significant improvement in function and quality of life in a cost effective manner. This provides justification for its ongoing practice by appropriately trained shoulder surgeons in correctly selected patients.

Subacromial impingement syndrome and pain: protocol for a randomised controlled trial of exercise and corticosteroid injection (the SUPPORT trial).

BACKGROUND: Subacromial impingement syndrome is the most frequent cause of shoulder problems which themselves affect 1 in 3 adults. Management commonly includes exercise and corticosteroid injection. However, the few existing trials of exercise or corticosteroid injection for subacromial impingement syndrome are mostly small, of poor quality, and focus only on short-term results. Exercise packages tend to be standardised rather than individualised and progressed. There has been much recent interest in improving outcome from corticosteroid injections by using musculoskeletal ultrasound to guide injections. However, there are no high-quality trials comparing ultrasound-guided and blind corticosteroid injection in subacromial impingement syndrome. This trial will investigate how to optimise the outcome of subacromial impingement syndrome from exercise (standardised advice and information leaflet versus physiotherapist-led exercise) and from subacromial corticosteroid injection (blind versus ultrasound-guided), and provide long-term follow-up data on clinical and cost-effectiveness. METHODS/DESIGN: The study design is a 2x2 factorial randomised controlled trial. 252 adults with subacromial impingement syndrome will be recruited from two musculoskeletal Clinical Assessment and Treatment Services at the primary-secondary care interface in Staffordshire, UK. Participants will be randomised on a 1:1:1:1 basis to one of four treatment groups: (1) ultrasound-guided subacromial corticosteroid injection and a physiotherapist-led exercise programme, (2) ultrasound-guided subacromial corticosteroid injection and an advice and exercise leaflet, (3) blind subacromial corticosteroid injection and a physiotherapist-led exercise programme, or (4) blind subacromial corticosteroid injection and an advice and exercise leaflet. The primary intention-to-treat analysis will be the mean differences in Shoulder Pain and Disability Index (SPADI) scores at 6 weeks for the comparison between injection interventions and at 6 months for the comparison between exercise interventions. Although independence of treatment effects is assumed, the magnitude of any interaction effect will be examined (but is not intended for the main analyses). Secondary outcomes will include comparison of long-term outcomes (12 months) and cost-effectiveness. A secondary per protocol analysis will also be performed. DISCUSSION: This protocol paper presents detail of the rationale, design, methods and operational aspects of the SUPPORT trial. TRIAL REGISTRATION: Current controlled trials ISRCTN42399123.

A mixed methods study to evaluate the clinical and cost-effectiveness of a self-managed exercise programme versus usual physiotherapy for chronic rotator cuff disorders: protocol for the SELF study.

BACKGROUND: Shoulder pain is the third most common reason for consultation with a physiotherapist and up to 26% of the general population might be expected to experience an episode at any one time. Disorders of the shoulder muscles and tendons (rotator cuff) are thought to be the commonest cause of this pain. The long-term outcome is frequently poor despite treatment. This means that many patients are exposed to more invasive treatment, e.g. surgery, and/or long-term pain and disability.Patients with this disorder typically receive a course of physiotherapy which might include a range of treatments. Specifically the value of exercise against gravity or resistance (loaded exercise) in the treatment of tendon disorders is promising but appears to be under-used. Loaded exercise in other areas of the body has been favourably evaluated but further investigation is needed to evaluate the impact of these exercises in the shoulder and particularly the role of home based or supervised exercise versus usual treatment requiring clinic attendance. METHODS/DESIGN: A single-centre pragmatic unblinded parallel group randomised controlled trial will evaluate the effectiveness of a self-managed loaded exercise programme versus usual clinic based physiotherapy. A total of 210 study participants with a primary complaint of shoulder pain suggestive of a rotator cuff disorder will be recruited from NHS physiotherapy waiting lists and allocated to receive a programme of self-managed exercise or usual physiotherapy using a process of block randomisation with sealed opaque envelopes. Baseline assessment for shoulder pain, function and quality of life will be undertaken with the Shoulder Pain & Disability Index, the Patient Specific Functional Scale and the SF-36. Follow-up evaluations will be completed at 3, 6 and 12 months by postal questionnaire. Both interventions will be delivered by NHS Physiotherapist's.An economic analysis will be conducted from an NHS and Personal Social Services perspective to evaluate cost-effectiveness and a qualitative investigation will be undertaken to develop greater understanding of the experience of undertaking or prescribing exercise as a self-managed therapy. TRIAL REGISTRATION NUMBER: ISRCTN84709751.

Economic evaluations in shoulder pathologies: a systematic review of the literature.

BACKGROUND: Economic evaluations provide decision makers with a tool for reducing health care costs because they assess both the costs and consequences of health care interventions. This study reviewed the quality of published economic evaluations for shoulder pathologies. MATERIALS AND METHOD: A MEDLINE search was conducted to identify articles published from 1980 to 2010 that contained "cost" or "economic" combined with terms for several shoulder disorders and treatments. We selected studies that fit the definition of 1 of the 4 routinely performed economic evaluations: cost-minimization, cost-effectiveness, cost-utility, and cost-benefit analyses. Study quality was determined by measuring adherence to 6 established health economic principles, as described in the literature. RESULTS: The search retrieved 942 studies. Of these, 32 were determined to be economic evaluations, and 53% of the economic evaluations were published from 2005 to 2010. Only 8 of the 32 studies (25%) adhered to all 6 health economic principles. Publication in a nonsurgical journal (P < .05) or in more recent years (P < .01) was significantly associated with higher quality. CONCLUSION: Future health care resource allocation will likely be based on the economic feasibility of treatments. Although the number and quality of economic evaluations of shoulder disorders have risen in recent years, the current state of the literature is poor. Given that availability of such data may factor in private and public reimbursement decisions, there is a clear demand for more rigorous economic evaluations.

Taping patients with clinical signs of subacromial impingement syndrome: the design of a randomized controlled trial.

BACKGROUND: Shoulder problems are a common complaint of the musculoskeletal system. Physical therapists treat these patients with different modalities such as exercise, massage, and shoulder taping. Although different techniques have been described, the effectiveness of taping has not yet been established. The aim of this study is to assess the effectiveness and cost-effectiveness of usual physical therapy care in combination with a particular tape technique for subacromial impingement syndrome of the shoulder compared to usual physical therapy care without this tape technique in a primary healthcare setting. METHODS AND DESIGN: An economic evaluation alongside a randomized controlled trial will be conducted. A sample of 140 patients between 18 and 65 years of age with a diagnosis of subacromial impingement syndrome (SAIS) as assessed by physical therapists will be recruited. Eligible patients will be randomized to either the intervention group (usual care in combination with the particular tape technique) or the control group (usual care without this tape technique). In both groups, usual care will consist of individualized physical therapy care. The primary outcomes will be shoulder-specific function (the Simple Shoulder Test) and pain severity (11-point numerical rating scale). The economic evaluation will be performed using a societal perspective. All relevant costs will be registered using cost diaries. Utilities (Quality Adjusted Life Years) will be measured using the EuroQol. The data will be collected at baseline, and 4, 12, and 26 weeks follow-up. DISCUSSION: This pragmatic study will provide information about the effectiveness and cost-effectiveness of taping in patients presenting with clinical signs of SAIS. TRIAL REGISTRATION NUMBER: NTR2575.

Does arthroscopic acromioplasty provide any additional value in the treatment of shoulder impingement syndrome?: a two-year randomised controlled trial.

We report a randomised controlled trial to examine the effectiveness and cost-effectiveness of arthroscopic acromioplasty in the treatment of stage II shoulder impingement syndrome. A total of 140 patients were randomly divided into two treatment groups: supervised exercise programme (n = 70, exercise group) and arthroscopic acromioplasty followed by a similar exercise programme (n = 70, combined treatment group). The main outcome measure was self-reported pain on a visual analogue scale of 0 to 10 at 24 months, measured on the 134 patients (66 in the exercise group and 68 in the combined treatment group) for whom endpoint data were available. An intention-to-treat analysis disclosed an improvement in both groups but without statistically significant difference in outcome between the groups (p = 0.65). The combined treatment was considerably more costly. Arthroscopic acromioplasty provides no clinically important effects over a structured and supervised exercise programme alone in terms of subjective outcome or cost-effectiveness when measured at 24 months. Structured exercise treatment should be the basis for treatment of shoulder impingement syndrome, with operative treatment offered judiciously until its true merit is proven.

A comparison of work absence periods and the associated costs for two different modes of exercise therapies for patients with longstanding subacromial pain.

BACKGROUND: There are no studies on economic issues concerning rehabilitation exercises for shoulder pain. OBJECTIVE: The aim of the study was to investigate sick leave and the associated costs after a medical exercise therapy programme in patients with longstanding subacromial pain/impingement. METHODS: A randomised controlled trial in which 61 patients were randomly assigned either to a high-dosage medical exercise therapy group (HD) (n=31) or to a low dosage exercise therapy group (LD) (n=30). Both groups were given three treatments a week over 3 months. The differences between the groups were number of repetitions, number of sets and time performing global aerobic exercises. RESULTS: The outcome for the HD group was significantly (p<0.05) better compared to the LD group. The reduction in costs for sick leave for the HD group was 59.1%, whereas for the LD group, the reduction was only 42.3%, which is a significant difference. CONCLUSION: In patients with longstanding subacromial pain, HD medical exercise therapy might be an efficient treatment approach.