Predicting pain and function outcomes in people consulting with shoulder pain: the PANDA-S clinical cohort and qualitative study protocol.

INTRODUCTION: People presenting with shoulder pain considered to be of musculoskeletal origin is common in primary care but diagnosing the cause of the pain is contentious, leading to uncertainty in management. To inform optimal primary care for patients with shoulder pain, the study aims to (1) to investigate the short-term and long-term outcomes (overall prognosis) of shoulder pain, (2) estimate costs of care, (3) develop a prognostic model for predicting individuals' level and risk of pain and disability at 6 months and (4) investigate experiences and opinions of patients and healthcare professionals regarding diagnosis, prognosis and management of shoulder pain. METHODS AND ANALYSIS: The Prognostic And Diagnostic Assessment of the Shoulder (PANDA-S) study is a longitudinal clinical cohort with linked qualitative study. At least 400 people presenting to general practice and physiotherapy services in the UK will be recruited. Participants will complete questionnaires at baseline, 3, 6, 12, 24 and 36 months. Short-term data will be collected weekly between baseline and 12 weeks via Short Message Serevice (SMS) text or software application. Participants will be offered clinical (physiotherapist) and ultrasound (sonographer) assessments at baseline. Qualitative interviews with ≈15 dyads of patients and their healthcare professional (general practitioner or physiotherapist).Short-term and long-term trajectories of Shoulder Pain and Disability Index (using SPADI) will be described, using latent class growth analysis. Health economic analysis will estimate direct costs of care and indirect costs related to work absence and productivity losses. Multivariable regression analysis will be used to develop a prognostic model predicting future levels of pain and disability at 6 months using penalisation methods to adjust for overfitting. The added predictive value of prespecified physical examination tests and ultrasound findings will be examined. For the qualitative interviews an inductive, exploratory framework will be adopted using thematic analysis to investigate decision making, perspectives of patients and clinicians on the importance of diagnostic and prognostic information when negotiating treatment and referral options. ETHICS AND DISSEMINATION: The PANDA-S study has ethical approval from Yorkshire and The Humber-Sheffield Research Ethics Committee, UK (18/YH/0346, IRAS Number: 242750). Results will be disseminated through peer-reviewed publications, social and mainstream media, professional conferences, and the patient and public involvement and engagement group supporting this study, and through newsletters, leaflets and posters in participating sites. TRIAL REGISTRATION NUMBER: ISRCTN46948079.

Use of implantable meshes for augmented rotator cuff repair: a systematic review and meta-analysis.

OBJECTIVE: To appraise studies reporting on clinical effectiveness and safety of surgical meshes used to augment rotator cuff repairs (RCRs). DESIGN: Systematic review and meta-analysis. DATA SOURCES: MEDLINE, Embase and Cochrane databases were searched between April 2006 and April 2020. ELIGIBILITY CRITERIA: All studies evaluating adults (≥18 years) undergoing RCR were considered. There were no language restrictions. DATA EXTRACTION AND SYNTHESIS: Screening, data extraction and quality appraisal were conducted by two independent reviewers. Meta-analysis was conducted using a random-effects models if ≥2 comparative studies reported the same outcome measure. Risk of bias assessment was undertaken for randomised (RoB2, Cochrane) and comparative studies (ROBINS-I, Cochrane). RESULTS: We included 60 studies, consisting of 7 randomised controlled trials, 13 observational comparative studies and 40 observational case series. All comparative studies reported on shoulder-specific functional outcome scores, 18 on the radiographic occurrence of re-tear and 14 on pain score metrics. All studies contained some risk of bias.Compared with non-augmented repair, a small improvement in shoulder-specific function or pain scores was observed for synthetic patches with a mean improvement of 6.7 points on the University of California Los Angles (UCLA) shoulder score (95% CI 0.1 to 13.4) and 0.46 point reduction on the Visual Analogue Scale (95% CI -0.74 to -0.17), respectively. A reduced likelihood of radiologically observed re-tear was observed for synthetic (risk ratio (RR) 0.41, 95% CI 0.27 to 0.61) and allograft (RR 0.34, 95% CI 0.18 to 0.65) patches. A total of 49 studies reported on the occurrence of complications. Slightly higher crude complication rates were observed following patch-augmented repair (2.1%) than standard repair (1.6%). CONCLUSIONS: While several studies suggest a decreased failure rate and small improvements in shoulder function and pain following augmented RCR, a paucity of rigorous clinical evaluation, for both effectiveness and safety, prevents firm recommendations. PROSPERO REGISTRATION NUMBER: CRD42017057908.

The use of a patch to augment rotator cuff surgery - A survey of UK shoulder and elbow surgeons.

BACKGROUND: Rotator cuff tears are a common cause of shoulder pain and can result in prolonged periods of pain, disability and absence from work. Rotator cuff repair surgery is increasingly used in an attempt to resolve symptoms but has failure rates of around 40%. There is a pressing need to improve the outcome of rotator cuff repairs. Patch augmentation increasingly being used within the NHS in an attempt to reduce repair failures. The aim of this survey was to determine current UK practice and opinion relating to the factors that influence choice of patch, current patient selection and willingness to assist with generation of improved evidence. METHODS: An online survey was sent to the surgeon members of the British Elbow and Shoulder Society (BESS). Questions covered respondent demographics, experience with patches, indications for patch augmentation and willingness to be involved in a randomised trial of patch augmented rotator cuff surgery. RESULTS: The response rate was 105/550 (19%). 58% of respondents had used a patch to augment rotator cuff surgery. 70% of patch users had undertaken an augmented repair within the last 6 months. A wide surgical experience in augmentation was reported (ranging 1 to 200 implants used). However, most surgeons reported low volume usage, with a median of 5 rotator cuff augmentation procedures performed. At least 10 different products had been used. Most of the patches used were constructed from human decellularised dermis tissue, although porcine derived and synthetic based patches had also been used. Only 3-5% stated they would undertake an augmented repair for small tears across ages, whereas 28-40% and 19-59% would do so for large or massive tears respectively. When assessing patient suitability, patient age seemed relevant only for those with large and massive tears. Half of the surgeons reported an interest in taking part in a randomised controlled trial (RCT) evaluating the role of patch augmentation for rotator cuff surgery, with a further 22% of respondent's undecided. CONCLUSIONS: A variety of patches have been used by surgeons to augment rotator cuff repair with a wide range of operator experience. There was substantial uncertainty about which patch to use and differing views on which patients were most suitable. There is a clear need for robust clinical evaluation and further research in this area.

Cost-effectiveness analysis of a placebo-controlled randomized trial evaluating the effectiveness of arthroscopic subacromial decompression in patients with subacromial shoulder pain.

AIMS: The aims of this study were to compare the use of resources, costs, and quality of life outcomes associated with subacromial decompression, arthroscopy only (placebo surgery), and no treatment for subacromial pain in the United Kingdom National Health Service (NHS), and to estimate their cost-effectiveness. PATIENTS AND METHODS: The use of resources, costs, and quality-adjusted life-years (QALYs) were assessed in the trial at six months and one year. Results were extrapolated to two years after randomization. Differences between treatment arms, based on the intention-to-treat principle, were adjusted for covariates and missing data were handled using multiple imputation. Incremental cost-effectiveness ratios were calculated, with uncertainty around the values estimated using bootstrapping. RESULTS: Cumulative mean QALYs/mean costs of health care service use and surgery per patient from baseline to 12 months were estimated as 0.640 (standard error (se) 0.024)/£3147 (se 166) in the decompression arm, 0.656 (se 0.020)/£2830 (se 183) in the arthroscopy only arm and 0.522 (se 0.029)/£1451 (se 151) in the no treatment arm. Statistically significant differences in cumulative QALYs and costs were found at six and 12 months for the decompression versus no treatment comparison only. The probabilities of decompression being cost-effective compared with no treatment at a willingness-to-pay threshold of £20 000 per QALY were close to 0% at six months and approximately 50% at one year, with this probability potentially increasing for the extrapolation to two years. DISCUSSION: The evidence for cost-effectiveness at 12 months was inconclusive. Decompression could be cost-effective in the longer-term, but results of this analysis are sensitive to the assumptions made about how costs and QALYs are extrapolated beyond the follow-up of the trial.

Surgical management of the elderly elbow.

The elbow has a major role in helping with the positioning of the hand in space. Any pathology of the joint can result in pain, loss of function and difficulties with activities of daily living. With an increasingly elderly population the degenerative conditions affecting the elbow are becoming more prevalent. Besides traumatic injury, the more commonly encountered problems are osteoarthritis, inflammatory arthritis, nerve compression and stiffness. An awareness of these conditions is important for those who provide care to this patient group. Whilst many of these conditions can be managed conservatively in primary care, some patients are referred to secondary care and elect for surgical treatments. This review considers the surgical treatments for the common elbow pathologies in the elderly population, including the potential complications associated with such treatments.

Evidence-based surgical training in orthopaedics: how many arthroscopies of the knee are needed to achieve consultant level performance?

Despite being one of the most common orthopaedic operations, it is still not known how many arthroscopies of the knee must be performed during training in order to develop the skills required to become a Consultant. A total of 54 subjects were divided into five groups according to clinical experience: Novices (n = 10), Junior trainees (n = 10), Registrars (n = 18), Fellows (n = 10) and Consultants (n = 6). After viewing an instructional presentation, each subject performed a simple diagnostic arthroscopy of the knee on a simulator with visualisation and probing of ten anatomical landmarks. Performance was assessed using a validated global rating scale (GRS). Comparisons were made against clinical experience measured by the number of arthroscopies which had been undertaken, and ROC curve analysis was used to determine the number of procedures needed to perform at the level of the Consultants. There were marked differences between the groups. There was significant improvement in performance with increasing experience (p < 0.05). ROC curve analysis identified that approximately 170 procedures were required to achieve the level of skills of a Consultant. We suggest that this approach to identify what represents the level of surgical skills of a Consultant should be used more widely so that standards of training are maintained through the development of an evidenced-based curriculum.

Skin cancer, and some limitations on how we innovate and practice medicine.

Successfully delivering medical care and acquiring and disseminating the new knowledge that underpins clinical advance requires dealing with a number of both theoretical and organizational issues that may impede progress. Firstly, we have to move beyond the idea that biology and medicine are synonymous, and realize that tropes such as 'bench to bedside' or 'translational' frequently do not capture the way medical advance occurs. Medicine is more engineering than science, and the constraints imposed by society and economics, as well as historical models of working, may all delay improvements in healthcare delivery. Secondly, the generation of new ideas is influenced by the social organization and financial underpinning of science. Comparisons with other areas of science and technology suggest that medical science is dysfunctional and lacking in genuine innovation, particularly when cost is factored in as a key denominator. There are reasons to believe that matters are getting worse, and that the climate for revolutionary discovery is less supportive in both academia and industry than it was in the mid-to-late twentieth century. Thirdly, healthcare delivery is subject to a number of factors that limit cheap and effective care. These include payment systems that encourage unnecessary care, self-interest by medical guilds and insurers, and regulators that seek to limit new ways of working. Finally, there is also a striking failure to study and understand medical competence, how we educate doctors and other clinicians, and how technology might help to reduce costs.

Protocol for the United Kingdom Rotator Cuff Study (UKUFF): a randomised controlled trial of open and arthroscopic rotator cuff repair.

This protocol describes a pragmatic multicentre randomised controlled trial (RCT) to assess the clinical and cost effectiveness of arthroscopic and open surgery in the management of rotator cuff tears. This trial began in 2007 and was modified in 2010, with the removal of a non-operative arm due to high rates of early crossover to surgery. Cite this article: Bone Joint Res 2014;3:155-60.

Frozen shoulder - A stiff problem that requires a flexible approach.

Frozen shoulder is a specific, painful and debilitating condition effecting patients mainly in middle age. While it has been recognised for over 100 years, it is still mis-diagnosed, with a natural history that is poorly understood and with limited evidence for the efficacy for various treatments. This review considers what is known about this common painful condition and the treatments available.

Learning and retaining simulated arthroscopic meniscal repair skills.

BACKGROUND: Previous studies of task-specific skills have suggested that a loss of technical performance occurs if the skill is not practiced for a six-month period. The aims of this study were to objectively demonstrate the learning curve for a complex arthroscopic task (meniscal repair) by means of motion analysis and to determine the impact of task repetition on the retention of this skill. METHODS: Nineteen orthopaedic residents with experience in routine knee arthroscopy but not in arthroscopic meniscal repair were recruited into a randomized study. During the initial learning phase, all subjects performed twelve meniscal repairs on a knee simulator over a three-week period. A validated motion analysis tracking system was used to objectively record the performance and learning of each subject; the outcomes were the time taken, distance traveled, and number of hand movements. The subjects were then randomized into three groups. Group A performed one meniscal repair each month, Group B performed one meniscal repair at three months, and Group C performed no repairs during this interim phase. All three groups then returned at the six-month point for the final assessment phase, during which they carried out an additional twelve meniscal repairs over three weeks. RESULTS: All subjects demonstrated a clear learning curve during the initial learning phase, with significant objective improvement in all motion analysis parameters over the initial twelve episodes (p < 0.0001). Although some residents had reached a learning plateau by twelve episodes, others continued to make further improvements for up to another nine episodes. Importantly, Group C did not display any loss of skill between the initial learning phase and final evaluation phase despite a six-month break in task repetition (p > 0.05). CONCLUSIONS: In contrast to previous studies, residents did not lose any skill over a six-month interruption in task performance, and other residents took longer to produce a more consistent performance.

Simple visual parameters for objective assessment of arthroscopic skill.

BACKGROUND: Restrictions placed on the working hours of doctors over the past decade have resulted in substantial changes to the training and assessment of orthopaedic surgical residents. Many who are responsible for training the surgeons of the future have become concerned that this reduced clinical exposure is having a detrimental impact on technical skill acquisition. Consequently, there is a need for surgical educators to develop more objective methods for assessing surgical skill. The primary aim of this study was to determine whether a novel set of visual parameters assessing visuospatial ability, fine motor dexterity, and gaze control could objectively discriminate among various levels of arthroscopic experience. The secondary aim was to evaluate the correlations between these new parameters and previously established technical skill assessment methods. METHODS: Twenty-seven subjects were divided into a novice group (n = 7), a resident group (n = 15), and an expert group (n = 5) on the basis of arthroscopic experience. All subjects performed a diagnostic knee arthroscopy task on a simulator. Their performance was assessed with use of novel simple visual parameters that included the prevalence of instrument loss, triangulation time, and prevalence of lookdowns. Performance was also evaluated with use of previously validated technical skill assessment methods (a global rating scale and motion analysis). RESULTS: A significant difference in performance among the groups was demonstrated with use of all three novel visual parameters, the global rating scale, and motion analysis (p < 0.05). There were strong and highly significant correlations (p < 0.0001) between each of the novel parameters and the previously validated skill assessment methods. CONCLUSIONS: This study demonstrates the construct validity of three novel visual parameters for objectively assessing arthroscopic performance. These parameters are simple, can be used easily in the operating room, and are strongly correlated with current validated methods of technical skill assessment.

Identifying orthopaedic surgeons of the future: the inability of some medical students to achieve competence in basic arthroscopic tasks despite training: a randomised study.

The aim of this study was to investigate the effect of training on the arthroscopic performance of a group of medical students and to determine whether all students could be trained to competence. Thirty-three medical students with no previous experience of arthroscopy were randomised to a 'Trained' or an 'Untrained' cohort. They were required to carry out 30 episodes of two simulated arthroscopic tasks (one shoulder and one knee). The primary outcome variable was task success at each episode. Individuals achieved competence when their learning curve stabilised. The secondary outcome was technical dexterity, assessed objectively using a validated motion analysis system. Six subjects in the 'Untrained' cohort failed to achieve competence in the shoulder task, compared with one in the 'Trained' cohort. During the knee task, two subjects in each cohort failed to achieve competence. Based on the objective motion analysis parameters, the 'Trained' cohort performed better on the shoulder task (p < 0.05) but there was no significant difference for the knee task (p > 0.05). Although specific training improved the arthroscopic performance of novices, there were individuals who could not achieve competence despite focused training.These findings may have an impact on the selection process for trainees and influence individual career choices.

The use of patient-reported outcome measures and patient satisfaction ratings to assess outcome in hemiarthroplasty of the shoulder.

We have compared the outcome of hemiarthroplasty of the shoulder in three distinct diagnostic groups, using survival analysis as used by the United Kingdom national joint registers, patient-reported outcome measures (PROMs) as recommended by Darzi in the 2008 NHS review, and transition and satisfaction questions. A total of 72 hemiarthroplasties, 19 for primary osteoarthritis (OA) with an intact rotator cuff, 22 for OA with a torn rotator cuff, and 31 for rheumatoid arthritis (RA), were followed up for between three and eight years. All the patients survived, with no revisions or dislocations and no significant radiological evidence of loosening. The mean new Oxford shoulder score (minimum/worst 0, maximum/best 48) improved significantly for all groups (p < 0.001), in the OA group with an intact rotator cuff from 21.4 to 38.8 (effect size 2.9), in the OA group with a torn rotator cuff from 13.3 to 27.2 (effect size 2.1) and in the RA group from 13.7 to 28.0 (effect size 3.1). By this assessment, and for the survival analysis, there was no significant difference between the groups. However, when ratings using the patient satisfaction questions were analysed, eight (29.6%) of the RA group were 'disappointed', compared with one (9.1%) of the OA group with cuff intact and one (7.7%) of the OA group with cuff torn. All patients in the OA group with cuff torn indicated that they would undergo the operation again, compared to ten (90.9%) in the OA group with cuff intact and 20 (76.9%) in the RA group. The use of revision rates alone does not fully represent outcome after hemiarthroplasty of the shoulder. Data from PROMs provides more information about change in pain and the ability to undertake activities and perform tasks. The additional use of satisfaction ratings shows that both the rates of revision surgery and PROMs need careful interpretation in the context of patient expectations.

Tendinopathy and tears of the rotator cuff are associated with hypoxia and apoptosis.

The aim of this study was to investigate the occurrence of tissue hypoxia and apoptosis at different stages of tendinopathy and tears of the rotator cuff. We studied tissue from 24 patients with eight graded stages of either impingement (mild, moderate and severe) or tears of the rotator cuff (partial, small, medium, large and massive) and three controls. Biopsies were analysed using three immunohistochemical techniques, namely antibodies against HIF-1alpha (a transcription factor produced in a hypoxic environment), BNip3 (a HIF-1alpha regulated pro-apoptotic protein) and TUNEL (detecting DNA fragmentation in apoptosis). The HIF-1alpha expression was greatest in mild impingement and in partial, small, medium and large tears. BNip3 expression increased significantly in partial, small, medium and large tears but was reduced in massive tears. Apoptosis was increased in small, medium, large and massive tears but not in partial tears. These findings reveal evidence of hypoxic damage throughout the spectrum of pathology of the rotator cuff which may contribute to loss of cells by apoptosis. This provides a novel insight into the causes of degeneration of the rotator cuff and highlights possible options for treatment.

Genetic influences in the progression of tears of the rotator cuff.

The aim of this study was to investigate genetic influences on the development and progression of tears of the rotator cuff. From a group of siblings of patients with a tear of the rotator cuff and of controls studied five years earlier, we determined the prevalence of tears of the rotator cuff with and without associated symptoms using ultrasound and the Oxford Shoulder Score. In the five years since the previous assessment, three of 62 (4.8%) of the sibling group and one of the 68 (1.5%) controls had undergone shoulder surgery. These subjects were excluded from the follow-up. Full-thickness tears were found in 39 of 62 (62.9%) siblings and in 15 of 68 (22.1%) controls (p = 0.0001). The relative risk of full-thickness tears in siblings as opposed to controls was 2.85 (95% confidence interval (CI) 1.75 to 4.64), compared to 2.42 (95% CI 1.77 to 3.31) five years earlier. Full-thickness tears associated with pain were found in 30 of 39 (76.9%) tears in the siblings and in eight of 15 (53.3%) tears in the controls (p = 0.045). The relative risk of pain associated with a full-thickness tear in the siblings as opposed to the controls was 1.44 (95% CI 2.04 to 8.28) (p = 0.045). In the siblings group ten of 62 (16.1%) had progressed in terms of tear size or development compared to one of 68 (1.5%) in the control group which had increased in size. Full-thickness rotator cuff tears in siblings are significantly more likely to progress over a period of five years than in a control population. This implies that genetic factors have a role, not only in the development but also in the progression of full-thickness tears of the rotator cuff.

Retention of arthroscopic shoulder skills learned with use of a simulator. Demonstration of a learning curve and loss of performance level after a time delay.

BACKGROUND: In orthopaedic surgery, arthroscopy is an irreplaceable diagnostic and interventional tool, and its breadth of use is increasing. The aim of this study was to investigate the surgeon's capacity for retention of an unfamiliar arthroscopic skill. METHODS: Six fellowship-trained lower-limb surgeons were given standardized instruction regarding the performance of an arthroscopic Bankart suture on a laboratory-based simulator. They performed three single Bankart sutures on each of four occasions, one to two weeks apart. Six months later, the same surgeons repeated the study. They received no further instruction or guidance. Their performance was objectively assessed with use of validated motion-analysis equipment to record the total path length of the surgeon's hands, number of hand movements, and time taken to perform the sutures. RESULTS: A learning curve showing significant and objective improvement in performance was demonstrated for all outcome parameters in both experiments (p < 0.005). The learning curve at six months was a repeated learning curve showing no significant difference from the initial learning curve. CONCLUSIONS: This study objectively demonstrated a loss of all of the initial improvement in the performance of an arthroscopic Bankart suture following a six-month interval in which the surgeons did not do the procedure.

The morphological and immunocytochemical features of impingement syndrome and partial-thickness rotator-cuff tear in relation to outcome after subacromial decompression.

We assessed the predictive value of the macroscopic and detailed microscopic appearance of the coracoacromial ligament, subacromial bursa and rotator-cuff tendon in 20 patients undergoing subacromial decompression for impingement in the absence of full-thickness tears of the rotator cuff. Histologically, all specimens had features of degenerative change and oedema in the extracellular matrix. Inflammatory cells were seen, but there was no evidence of chronic inflammation. However, the outcome was not related to cell counts. At three months the mean Oxford shoulder score had improved from 29.2 (20 to 40) to 39.4 (28 to 48) (p < 0.0001) and at six months to 45.5 (36 to 48) (p < 0.0001). At six months, although all patients had improved, the seven patients with a hooked acromion had done so to a less extent than those with a flat or curved acromion judged by their mean Oxford shoulder scores of 43.5 and 46.5 respectively (p = 0.046). All five patients with partial-thickness tears were within this group and demonstrated less improvement than the patients with no tear (mean Oxford shoulder scores 43.2 and 46.4, respectively, p = 0.04). These findings imply that in the presence of a partial-thickness tear subacromial decompression may require additional specific treatment to the rotator cuff if the outcome is to be improved further.

The pathogenesis and surgical treatment of tears of the rotator cuff.

This review discusses the pathogenesis and surgical treatment of tears of the rotator cuff.

Evidence and the industrialization of medicine.

Medicine is changing rapidly. In part, this is due to the accumulation of discoveries in biomedical science. However, this is not sufficient to explain the changes clinicians see. Whereas once medical advance concerned discoveries external to clinical practice (such as the identification of a causative microorganism or gene), medical practice itself is now a subject of study. What clinicians know, how they acquire knowledge, and how knowledge is distributed are all subjects of scrutiny. In short, medicine is being industrialized: we can see the twin changes of specialization, and the desire to codify practice such that those with different educational backgrounds can undertake a clinical role. Key to such change is the role played by evidence. Whereas once natural science was seen to determine clinical practice, this view is now known to be mistaken. How we can formally combine evidence from different traditions is, despite the claims of the evidence-based medicine movement, as yet unresolved.