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.

Optimizing the design of invasive placebo interventions in randomized controlled trials.

BACKGROUND: Placebo-controlled trials play an important role in the evaluation of healthcare interventions. However, they can be challenging to design and deliver for invasive interventions, including surgery. In-depth understanding of the component parts of the treatment intervention is needed to ascertain what should, and should not, be delivered as part of the placebo. Assessment of risk to patients and strategies to ensure that the placebo effectively mimics the treatment are also required. To date, no guidance exists for the design of invasive placebo interventions. This study aimed to develop a framework to optimize the design and delivery of invasive placebo interventions in RCTs. METHODS: A preliminary framework was developed using published literature to: expand the scope of an existing typology, which facilitates the deconstruction of invasive interventions; and identify placebo optimization strategies. The framework was refined after consultation with key stakeholders in surgical trials, consensus methodology and medical ethics. RESULTS: The resulting DITTO framework consists of five stages: deconstruct treatment intervention into constituent components and co-interventions; identify critical surgical element(s); take out the critical element(s); think risk, feasibility and role of placebo in the trial when considering remaining components; and optimize placebo to ensure effective blinding of patients and trial personnel. CONCLUSION: DITTO considers invasive placebo composition systematically, accounting for risk, feasibility and placebo optimization. Use of the framework can support the design of high-quality RCTs, which are needed to underpin delivery of healthcare interventions.

ANTECEDENTES: Los ensayos controlados con placebo juegan un papel importante en la evaluación de las intervenciones sanitarias. Sin embargo, pueden ser difíciles de diseñar e implementar en el caso de intervenciones invasivas, incluida la cirugía. Se necesita un conocimiento profundo de los componentes de la intervención terapéutica (para determinar qué se debe y qué no se debe administrar como parte del placebo). También se precisa de una evaluación del riesgo para los pacientes y de las estrategias para garantizar que el placebo imite el tratamiento de forma efectiva. Hasta la fecha no existen guías para el diseño de intervenciones invasivas con placebo. Este estudio tuvo como objetivo desarrollar un marco para optimizar el diseño y la práctica de intervenciones invasivas con placebo dentro en los ensayos clínicos aleatorizados (ECA). MÉTODOS: Utilizando la literatura publicada, se desarrolló un marco preliminar para i) ampliar el alcance de los modelos existentes para facilitar la deconstrucción de las actuaciones invasivas, y ii) identificar estrategias para optimizar el placebo. El marco se perfeccionó tras consultar con partes interesadas ​​en ensayos quirúrgicos, metodología de consenso y ética médica. RESULTADOS: El marco DITTO resultantes consiste en cinco etapas: Etapa 1: deconstrucción de la intervención de tratamiento en sus componentes esenciales y co-intervenciones; Etapa 2: identificar el(los) elemento(s) quirúrgico(s) básico(s); Etapa 3: eliminar el(los) elemento(s) básico(s); Etapa 4: considerar el riesgo, la viabilidad y el papel del placebo en el ensayo al tener en cuenta los demás componentes; y Etapa 5: optimizar el placebo para garantizar el cegamiento efectivo de los pacientes y del personal del ensayo. CONCLUSIÓN: DITTO considera de forma sistemática la naturaleza invasiva del placebo, teniendo en cuenta el riesgo, la viabilidad y la optimización del placebo. El uso de este marco de referencia puede ayudar al diseño de ECAs de alta calidad, necesarios para afianzar la implementación de intervenciones sanitarias.

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.

Randomized feasibility trial of replacing or discarding the nail plate after nail-bed repair in children.

BACKGROUND: Nail-bed injuries are the most common hand injury in children. Surgical dogma is to replace the nail plate after repairing the nail bed. Recent evidence suggests this might increase infection rates and returns to clinic. The aim of this feasibility trial was to inform the design and conduct of a definitive trial comparing replacing or discarding the nail plate after nail-bed repair. METHODS: This study recruited participants from four hand units in the UK between April and July 2015. Participants were children under the age of 16 years with a nail-bed injury requiring surgery. They were randomized to either having the nail plate replaced or discarded after nail-bed repair. The follow-up method was also allocated randomly (postal versus clinic). Information was collected on complications at 2 weeks and 30 days, and on nail-plate appearance at 4 months using the Zook classification. Two possible approaches to follow-up were also piloted and compared. RESULTS: During the recruitment phase, there were 156 potentially eligible children. Sixty were randomized in just over 3 months using remote web-based allocation. By 2 weeks, there were two infections, both in children with replaced nail plates. The nail-replaced group also experienced more complications. There was no evidence of a difference in return rates between postal and clinic follow-up. CONCLUSION: Recruitment was rapid and nail-bed repair appeared to have low complication and infection rates in this pilot trial. The findings have led to revision of the definitive trial protocol, including the mode and timing of follow-up, and modification of the Zook classification.

Standardizing and monitoring the delivery of surgical interventions in randomized clinical trials.

BACKGROUND: The complexity of surgical interventions has major implications for the design of RCTs. Trials need to consider how and whether to standardize interventions so that, if successful, they can be implemented in practice. Although guidance exists for standardizing non-pharmaceutical interventions in RCTs, their application to surgery is unclear. This study reports new methods for standardizing the delivery of surgical interventions in RCTs. METHODS: Descriptions of 160 surgical interventions in existing trial reports and protocols were identified. Initially, ten reports were scrutinized in detail using a modified framework approach for the analysis of qualitative data, which informed the development of a preliminary typology. The typology was amended with iterative sequential application to all interventions. Further testing was undertaken within ongoing multicentre RCTs. RESULTS: The typology has three parts. Initially, the overall technical purpose of the intervention is described (exploration, resection and/or reconstruction) in order to establish its constituent components and steps. This detailed description of the intervention is then used to establish whether and how each component and step should be standardized, and the standards documented within the trial protocol. Finally, the typology provides a framework for monitoring the agreed intervention standards during the RCT. Pilot testing within ongoing RCTs enabled standardization of the interventions to be agreed, and case report forms developed to capture deviations from these standards. CONCLUSION: The typology provides a framework for use during trial design to standardize the delivery of surgical interventions and document these details within protocols. Application of this typology to future RCTs may clarify details of the interventions under evaluation and help successful interventions to be implemented.

Systematic review of intervention design and delivery in pragmatic and explanatory surgical randomized clinical trials.

BACKGROUND: Surgical interventions are complex, with multiple components that require consideration in trial reporting. This review examines the reporting of details of surgical interventions in randomized clinical trials (RCTs) within the context of explanatory and pragmatic study designs. METHODS: Systematic searches identified RCTs of surgical interventions published in 2010 and 2011. Included studies were categorized as predominantly explanatory or pragmatic. The extent of intervention details in the reports were compared with the CONSORT statement for reporting trials of non-pharmacological treatments (CONSORT-NPT). CONSORT-NPT recommends reporting the descriptions of surgical interventions, whether they were standardized and adhered to (items 4a, 4b and 4c). Reporting of the context of intervention delivery (items 3 and 15) and operator expertise (item 15) were assessed. RESULTS: Of 4541 abstracts and 131 full-text articles, 80 were included (of which 39 were classified as predominantly pragmatic), reporting 160 interventions. Descriptions of 129 interventions (80.6 per cent) were provided. Standardization was mentioned for 47 (29.4 per cent) of the 160 interventions, and 22 articles (28 per cent) reported measurement of adherence to at least one aspect of the intervention. Seventy-one papers (89 per cent) provided some information about context. For one-third of interventions (55, 34.4 per cent), some data were provided regarding the expertise of personnel involved. Reporting standards were similar in trials classified as pragmatic or explanatory. CONCLUSION: The lack of detail in trial reports about surgical interventions creates difficulties in understanding which operations were actually evaluated. Methods for designing and reporting surgical interventions in RCTs, contributing to the quality of the overall study design, are required. This should allow better implementation of trial results into practice.

The rise of big clinical databases.

BACKGROUND: The routine collection of large amounts of clinical data, 'big data', is becoming more common, as are research studies that make use of these data source. The aim of this paper is to provide an overview of the uses of data from large multi-institution clinical databases for research. METHODS: This article considers the potential benefits, the types of data source, and the use to which the data is put. Additionally, the main challenges associated with using these data sources for research purposes are considered. RESULTS: Common uses of the data include: providing population characteristics; identifying risk factors and developing prediction (diagnostic or prognostic) models; observational studies comparing different interventions; exploring variation between healthcare providers; and as a supplementary source of data for another study. The main advantages of using such big data sources are their comprehensive nature, the relatively large number of patients they comprise, and the ability to compare healthcare providers. The main challenges are demonstrating data quality and confidently applying a causal interpretation to the study findings. CONCLUSION: Large clinical database research studies are becoming ubiquitous and offer a number of potential benefits. However, the limitations of such data sources must not be overlooked; each research study needs to be considered carefully in its own right, together with the justification for using the data for that specific purpose.

Randomized controlled trial comparing rubber band ligation with stapled haemorrhoidopexy for Grade II circumferential haemorrhoids: long-term results.

OBJECTIVE: An improved understanding of the pathophysiology of haemorrhoids has resulted in the introduction of new surgical techniques including stapled haemorrhoidopexy (SH). This randomized controlled trial compared the long-term effectiveness of SH with rubber band ligation (RBL) in the treatment of grade II circumferential symptomatic haemorrhoids. METHOD: A consecutive cohort of patients was randomly allocated to either SH or RBL. Data on haemorrhoidal symptoms, Cleveland continence scores, sphincter assessment, SF-36, EQ-5D, HAD score and prior treatment history were assessed at enrollment and reassessed by long-term postal questionnaire. The details were analysed using spss 12.0 from Microsoft Access. RESULTS: Sixty patients were allocated by computer block randomization. Both groups were balanced for age, sex and symptoms. Recurrence favoured SH [3 vs 11; OR 0.18, 95% CI (0.03 to 0.86), P = 0.028] at 1 year and, at a mean of 40.67 (31-47) months [4 vs 12; OR 0.23, 95% CI (0.05, 0.95); P = 0.039]. SH patients experienced prolonged pain [Median (IQR) = 7 (5,7) vs 3 (1,7), P = 0.008] and took a longer time to return to work [6 (3,7) vs 3 (1,6) days, P = 0.018]. This was no significant difference in quality of life. CONCLUSION: Stapled haemorrhoidopexy achieved better disease control at 1 year without any major complication. This was sustained in the long-term. Further studies with greater patient numbers are needed to confirm this study.

Clinical outcomes from a randomised comparison of Microwave Endometrial Ablation with Thermal Balloon endometrial ablation for the treatment of heavy menstrual bleeding.

OBJECTIVE: To compare the clinical outcomes of microwave endometrial ablation and thermal balloon ablation for the treatment of heavy menstrual bleeding. DESIGN: A double blind randomised controlled trial. SETTING: A UK teaching hospital. POPULATION: Three hundred and twenty women requesting endometrial ablation. METHODS: Operative data collection and patient completed postal questionnaires were used to ascertain women's satisfaction with outcome, acceptability of each procedure, changes in menstrual symptoms and health related quality of life and additional treatments received. MAIN OUTCOME MEASURES: Primary outcomes were satisfaction and menstrual scores 1 year. Secondary outcomes were operative differences, acceptability of treatment and changes in health related quality of life. RESULTS: Both technologies achieved high levels of satisfaction (-1%, 95% CI (-11, 9)). Menstrual scores were also similar (4%, 95% CI (-7, 19)) Microwave had a significantly shorter operating time, reduced usage of antiemetics and opiate analgesia, increased discharge by 6 hours and fewer device failures. CONCLUSIONS: Both treatments are acceptable to women, with high levels of satisfaction. Microwave is quicker to perform with faster hospital discharge.

64-Slice computed tomography angiography in the diagnosis and assessment of coronary artery disease: systematic review and meta-analysis.

CONTEXT: Coronary artery disease (CAD) is a major cause of mortality and ill health. OBJECTIVE: To assess whether 64-slice CT angiography might replace some coronary angiography (CA) for diagnosis and assessment of CAD. DATA SOURCES: Electronic databases, conference proceedings and reference lists of included studies. STUDY SELECTION: Eligible studies compared 64-slice CT with a reference standard of CA in adults with suspected/known CAD, reporting sensitivity and specificity or true and false positives and negatives. DATA EXTRACTION: Two reviewers independently extracted data from included studies. RESULTS: Forty studies were included; 28 provided sufficient data for inclusion in the meta-analyses, all using a cut off point of >/=50% stenosis to define significant CAD. In patient-based detection (n = 1286) 64-slice CT pooled sensitivity was 99% (95% credible interval (CrI) 97% to 99%), specificity 89% (95% CrI 83% to 94%), median positive predictive value (PPV) across studies 93% (range 64-100%) and negative predictive value (NPV) 100% (range 86-100%). In segment-based detection (n = 14 199) 64-slice CT pooled sensitivity was 90% (95% CrI 85% to 94%), specificity 97% (95% CrI 95% to 98%), median PPV across studies 76% (range 44-93%) and NPV 99% (range 95-100%). CONCLUSIONS: 64-Slice CT is highly sensitive for patient-based detection of CAD and has high NPV. An ability to rule out significant CAD means that it may have a role in the assessment of chest pain, particularly when the diagnosis remains uncertain despite clinical evaluation and simple non-invasive testing.

Systematic review of the safety of electrosurgery for tonsillectomy.

In the meta-analysis models, compared with cold steel dissection with ties/packs haemostasis (reference technique): * Bipolar diathermy dissection and haemostasis was associated with statistically significant lower odds of primary haemorrhage (OR 0.13, 95% CrI 0.03 to 0.51), including primary haemorrhage requiring return to theatre (OR 0.002, 95% CrI <0.001 to 0.26). * Coblation was associated with statistically significant higher odds of secondary haemorrhage requiring return to theatre (OR 33.82, 95% CrI 1.25 to 5676.00). * Monopolar and bipolar diathermy dissection and haemostasis (OR 4.12, 95% CrI 1.12 to 14.67; OR 2.86, 95% CrI 1.12 to 8.02, respectively), coblation (OR 3.75, 95% CrI 1.29 to 12.12), and cold steel dissection with monopolar or bipolar diathermy haemostasis (OR 4.83, 95% CrI 1.56 to 15.95; OR 9.18, 95% CrI 3.09 to 30.53, respectively) were all associated with statistically significant higher odds of secondary haemorrhage. * In deciding which technique to employ, factors to consider include patient characteristics, the underlying risk of primary or secondary haemorrhage, which is regarded as likely to be more serious, and the clinical significance of the observed differences in haemorrhage rates across techniques.

Tailored sinc pulses for uniform excitation and artifact-free radio frequency time-domain EPR imaging.

A method to generate shaped radiofrequency pulses for uniform excitation of electron spins in time-domain radio frequency (RF) electron paramagnetic resonance (EPR) imaging is presented. A commercial waveform generator was integrated with the transmit arm of the existing time-domain RF-EPR spectrometer to generate tailored excitation pulses with sub-nano second resolution for excitation with a 90 degrees flip-angle. A truncated sinc [sin(x)/x] pulse, tailored to compensate for the Q-profile (RF frequency response) of the resonator, was shown to yield images from phantom objects as well as in vivo images, with minimal distortion. These studies point to the advantages in using shaped sinc pulses to achieve improved uniform excitation over a relatively wide bandwidth region in time-domain RF-EPR imaging (RF-FT-EPRI).