bluuebunny/crossref_metadata_2025_split huggingface dataset:
Large to massive rotator cuff tendon tears: a protocol for a systematic review investigating the effectiveness of exercise therapy on pain, disability and quality of life
Authors: Fahy Kathryn , Galvin Rose , Lewis Jeremy , McCreesh Karen 
Published: September 2021

Background: Chronic non-traumatic rotator cuff tendon tears are inextricably linked with the natural process of aging often resulting in severe disability, poor quality of life and an added burden to the health care system. The occurrence of rotator cuff tendon tears increases exponentially with every decade of life to approximately 60% in individuals over 80 years of age. Exercise is a commonly prescribed intervention although research on its efficacy is in its infancy and often conflicting. The purpose of this systematic review is to investigate the effectiveness of exercise interventions for people diagnosed with large to massive rotator cuff tendon tears. Methods: This systematic review will adhere to the PRISMA reporting guidelines. A comprehensive search of five databases will be conducted. Randomised clinical trials (RCT) or quasi-randomised control trials will be included if they evaluate exercise as the core intervention or as part of the intervention in the management of large to massive rotator cuff tears. To quantify response to treatment we will compare changes in pain, disability and quality of life (QoL). The Consensus on Exercise Reporting Template (CERT) will be used to characterise the different types of exercise intervention. The Cochrane Risk of Bias Tool will be used to assess study quality. A narrative synthesis with meta-analysis will be performed, and the certainty of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. Discussion: This review will synthesise the totality of GRADE A and B evidence on the effectiveness of exercise for large to massive rotator cuff tendon tears. It will provide clinically important information and guidance for immediate implementation by clinicians, health policymakers and may be used to guide future research. PROSPERO registration: 244502 (24/03/2021)
Early outcomes after robotic arm-assisted bi-unicompartmental knee arthroplasty compared with total knee arthroplasty: a prospective, randomized controlled trial
Authors: Blyth Mark J. G. , Banger Matthew S. , Doonan James , Jones Bryn G. , MacLean Angus D. , Rowe Philip J. 
Published: September 2021

AimsThe aim of this study was to compare the clinical outcomes of robotic arm-assisted bi-unicompartmental knee arthroplasty (bi-UKA) with conventional mechanically aligned total knee arthroplasty (TKA) during the first six weeks and at one year postoperatively.MethodsA per protocol analysis of 76 patients, 43 of whom underwent TKA and 34 of whom underwent bi-UKA, was performed from a prospective, single-centre, randomized controlled trial. Diaries kept by the patients recorded pain, function, and the use of analgesics daily throughout the first week and weekly between the second and sixth weeks. Patient-reported outcome measures (PROMs) were compared preoperatively, and at three months and one year postoperatively. Data were also compared longitudinally and a subgroup analysis was conducted, stratified by preoperative PROM status.ResultsBoth operations were shown to offer comparable outcomes, with no significant differences between the groups across all timepoints and outcome measures. Both groups also had similarly low rates of complications. Subgroup analysis for preoperative psychological state, activity levels, and BMI showed no difference in outcomes between the two groups.ConclusionRobotic arm-assisted, cruciate-sparing bi-UKA offered similar early clinical outcomes and rates of complications to a mechanically aligned TKA, both in the immediate postoperative period and up to one year following surgery. Further work is required to identify which patients with osteoarthritis of the knee will derive benefit from a cruciate-sparing bi-UKA. Cite this article: Bone Joint J 2021;103-B(10):1561–1570.
Clinical validation of the Oswestry-Bristol Classification as part of a decision algorithm for trochlear dysplasia surgery
Authors: Sharma Nikhil , Rehmatullah Nader , Kuiper Jan Herman , Gallacher Peter , Barnett Andrew J. 
Published: September 2021

AimsThe Oswestry-Bristol Classification (OBC) is an MRI-specific assessment tool to grade trochlear dysplasia. The aim of this study is to validate clinically the OBC by demonstrating its use in selecting treatments that are safe and effective.MethodsThe OBC and the patellotrochlear index were used as part of the Oswestry Patellotrochlear Algorithm (OPTA) to guide the surgical treatment of patients with patellar instability. Patients were assigned to one of four treatment groups: medial patellofemoral ligament reconstruction (MPFLr); MPFLr + tibial tubercle distalization (TTD); trochleoplasty; or trochleoplasty + TTD. A prospective analysis of a longitudinal patellofemoral database was performed. Between 2012 and 2018, 202 patients (233 knees) with a mean age of 24.2 years (SD 8.1), with recurrent patellar instability were treated by two fellowship-trained consultant sports/knee surgeons at The Robert Jones and Agnes Hunt Orthopaedic Hospital. Clinical efficacy of each treatment group was assessed by Kujala, International Knee Documentation Committee (IKDC), and EuroQol five-dimension questionnaire (EQ-5D) scores at baseline, and up to 60 months postoperatively. Their safety was assessed by complication rate and requirement for further surgery. The pattern of clinical outcome over time was analyzed using mixed regression modelling.ResultsIn all, 135 knees (mean age 24.9 years (SD 9.4)) were treated using a MPFLr. Ten knees (7.4%) required additional surgery. A total of 50 knees (mean age 24.4 years (SD 6.3)) were treated using MPFLr + TTD. Ten (20%) required additional surgery. A total of 20 knees (mean age 19.5 years (SD 3.0)) were treated using trochleoplasty + TTD. Three patients (15%) required additional surgery. In each treatment group, there was a significant improvement in Kujala, IKDC, and EQ-5D at one year postoperatively (p < 0.001) with a recognized level of overall complication rate.ConclusionThe OBC is a valid assessment tool to grade patients with trochlear dysplasia and, when used as part of the OPTA, helps to determine treatments that are safe and effective. This fulfils the requirements for its application in mainstream clinical practice. Cite this article: Bone Joint J 2021;103-B(10):1586–1594.
Oral tranexamic acid for an additional 24 hours postoperatively versus a single preoperative intravenous dose for reducing blood loss in total knee arthroplasty: results of a randomized controlled trial (TRAC-24)
Authors: Magill Paul , Hill Janet C. , Bryce Leeann , Martin Una , Dorman Al , Hogg Rosemary , Campbell Christina , Gardner Evie , McFarland Margaret , Bell Jennifer , Benson Gary , Beverland David 
Published: September 2021

Aims In total knee arthroplasty (TKA), blood loss continues internally after surgery is complete. Typically, the total loss over 48 postoperative hours can be around 1,300 ml, with most occurring within the first 24 hours. We hypothesize that the full potential of tranexamic acid (TXA) to decrease TKA blood loss has not yet been harnessed because it is rarely used beyond the intraoperative period, and is usually withheld from ‘high-risk’ patients with a history of thromboembolic, cardiovascular, or cerebrovascular disease, a patient group who would benefit greatly from a reduced blood loss. Methods TRAC-24 was a prospective, phase IV, single-centre, open label, parallel group, randomized controlled trial on patients undergoing TKA, including those labelled as high-risk. The primary outcome was indirect calculated blood loss (IBL) at 48 hours. Group 1 received 1 g intravenous (IV) TXA at the time of surgery and an additional 24-hour postoperative oral regime of four 1 g doses, while Group 2 only received the intraoperative dose and Group 3 did not receive any TXA. Results Between July 2016 and July 2018, 552 patients were randomized to either Group 1 (n = 241), Group 2 (n = 243), or Group 3 (n = 68), and 551 were included in the final analysis. The blood loss did differ significantly between the two intervention groups (733.5 ml (SD 384.0) for Group 1 and 859.2 ml (SD 363.6 ml) for Group 2; mean difference -125.8 ml (95% confidence interval -194.0 to -57.5; p < 0.001). No differences in mortality or thromboembolic events were observed in any group. Conclusion These data support the hypothesis that in TKA, a TXA regime consisting of IV 1 g perioperatively and four oral 1 g doses over 24 hours postoperatively significantly reduces blood loss beyond that achieved with a single IV 1 g perioperative dose alone. TXA appears safe in patients with history of thromboembolic, cardiovascular, and cerebrovascular disease. Cite this article: Bone Joint J 2021;103-B(10):1595–1603.
Implant brand portfolios, the potential for camouflage of data, and the role of the Orthopaedic Data Evaluation Panel in total knee arthroplasty
Authors: Phillips Jonathan Robert Anthony , Tucker Keith 
Published: September 2021

Aims Knee arthroplasty surgery is a highly effective treatment for arthritis and disorders of the knee. There are a wide variety of implant brands and types of knee arthroplasty available to surgeons. As a result of a number of highly publicized failures, arthroplasty surgery is highly regulated in the UK and many other countries through national registries, introduced to monitor implant performance, surgeons, and hospitals. With time, the options available within many brand portfolios have grown, with alternative tibial or femoral components, tibial insert materials, or shapes and patella resurfacings. In this study we have investigated the effect of the expansion of implant brand portfolios and where there may be a lack of transparency around a brand name. We also aimed to establish the potential numbers of compatible implant construct combinations. Methods Hypothetical implant brand portfolios were proposed, and the number of compatible implant construct combinations was calculated. Results A simple knee portfolio with cemented cruciate-retaining (CR) and posterior-stabilized (PS) components, with and without a patella, has four combinations. If there are two options available for each component, the numbers double for each option, resulting in 32 combinations. The effect of adding a third option multiplies the number by 1.3. Introducing compatible uncemented options, with the effect of hybrids, multiplies the number by 4. An implant portfolio with two femoral components (both in CR and PS), with two insert options and a patella, all in cemented and uncemented versions leads to 192 possible compatible implant construct combinations. There are implant brands available to surgeons with many more than two options. Conclusion This study demonstrates that the addition of multiple variants within a knee brand portfolio leads to a large number (many hundreds) of compatible implant construct combinations. Revision rates of implant combinations are not currently reviewed at this level of granularity, leading to the risk of camouflage of true outcomes. Cite this article: Bone Joint J 2021;103-B(10):1555–1560.
The influence of hospital-level variables on hip fracture outcomes
Authors: Farrow Luke , Hall Andrew J. , Ablett Andrew D. , Johansen Antony , Myint Phyo K. 
Published: September 2021

Aims The aim of this study was to determine the impact of hospital-level service characteristics on hip fracture outcomes and quality of care processes measures. Methods This was a retrospective analysis of publicly available audit data obtained from the National Hip Fracture Database (NHFD) 2018 benchmark summary and Facilities Survey. Data extraction was performed using a dedicated proforma to identify relevant hospital-level care process and outcome variables for inclusion. The primary outcome measure was adjusted 30-day mortality rate. A random forest-based multivariate imputation by chained equation (MICE) algorithm was used for missing value imputation. Univariable analysis for each hospital level factor was performed using a combination of Tobit regression, Siegal non-parametric linear regression, and Mann-Whitney U test analyses, dependent on the data type. In all analyses, a p-value < 0.05 denoted statistical significance. Results Analyses included 176 hospitals, with a median of 366 hip fracture cases per year (interquartile range (IQR) 280 to 457). Aggregated data from 66,578 patients were included. The only identified hospital-level variable associated with the primary outcome of 30-day mortality was hip fracture trial involvement (no trial involvement: median 6.3%; trial involvement: median 5.7%; p = 0.039). Significant key associations were also identified between prompt surgery and presence of dedicated hip fracture sessions; reduced acute length of stay and both a higher number of hip fracture cases per year and more dedicated hip fracture operating lists; Best Practice Tariff attainment and greater number of hip fracture cases per year, more dedicated hip fracture operating lists, presence of a dedicated hip fracture ward, and hip fracture trial involvement. Conclusion Exploratory analyses have identified that improved outcomes in hip fracture may be associated with hospital-level service characteristics, such as hip fracture research trial involvement, larger hip fracture volumes, and the use of theatre lists dedicated to hip fracture surgery. Further research using patient level data is warranted to corroborate these findings. Cite this article: Bone Joint J 2021;103-B(10):1627–1632.
Laboratory evaluation of twelve portable devices for medicine quality screening
Authors: Zambrzycki Stephen C. , Caillet Celine , Vickers Serena , Bouza Marcos , Donndelinger David V. , Geben Laura C. , Bernier Matthew C. , Newton Paul N. , Fernández Facundo M. 
Published: September 2021

BackgroundPost-market surveillance is a key regulatory function to prevent substandard and falsified (SF) medicines from being consumed by patients. Field deployable technologies offer the potential for rapid objective screening for SF medicines.Methods and findingsWe evaluated twelve devices: three near infrared spectrometers (MicroPHAZIR RX, NIR-S-G1, Neospectra 2.5), two Raman spectrometers (Progeny, TruScan RM), one mid-infrared spectrometer (4500a), one disposable colorimetric assay (Paper Analytical Devices, PAD), one disposable immunoassay (Rapid Diagnostic Test, RDT), one portable liquid chromatograph (C-Vue), one microfluidic system (PharmaChk), one mass spectrometer (QDa), and one thin layer chromatography kit (GPHF-Minilab). Each device was tested with a series of field collected medicines (FCM) along with simulated medicines (SIM) formulated in a laboratory. The FCM and SIM ranged from samples with good quality active pharmaceutical ingredient (API) concentrations, reduced concentrations of API (80% and 50% of the API), no API, and the wrong API. All the devices had high sensitivities (91.5 to 100.0%) detecting medicines with no API or the wrong API. However, the sensitivities of each device towards samples with 50% and 80% API varied greatly, from 0% to 100%. The infrared and Raman spectrometers had variable sensitivities for detecting samples with 50% and 80% API (from 5.6% to 50.0%). The devices with the ability to quantitate API (C-Vue, PharmaChk, QDa) had sensitivities ranging from 91.7% to 100% to detect all poor quality samples. The specificity was lower for the quantitative C-Vue, PharmaChk, & QDa (50.0% to 91.7%) than for all the other devices in this study (95.5% to 100%).ConclusionsThe twelve devices evaluated could detect medicines with the wrong or none of the APIs, consistent with falsified medicines, with high accuracy. However, API quantitation to detect formulations similar to those commonly found in substandards proved more difficult, requiring further technological innovation.
Wastewater based environmental surveillance of toxigenic Vibrio cholerae in Pakistan
Authors: Zohra Tanzeel , Ikram Aamer , Salman Muhammad , Amir Afreenish , Saeed Asim , Ashraf Zurva , Ahad Abdul 
Published: September 2021

Background
Pakistan has been experiencing intervals of sporadic cases and localized outbreaks in the last two decades. No proper study has been carried out in order to find out the environmental burden of toxigenic V. cholerae as well as how temporal and environmental factors associated in driving cholera across the country.

Methods
We tested waste water samples from designated national environment surveillance sites in Pakistan with RT-PCR assay. Multistage sampling technique were utilized for samples collection and for effective sample processing Bag-Mediated Filtration system, were employed. Results were analysed by district and month wise to understand the geographic distribution and identify the seasonal pattern of V. cholera detection in Pakistan.

Results
Between May 2019, and February 2020, we obtained and screened 160 samples in 12 districts across Pakistan. Out of 16 sentinel environmental surveillance sites, 15 sites showed positive results against cholera toxigenic gene with mostly lower CT value (mean, 34±2) and have significant difference (p < 0.05). The highest number of positive samples were collected from Sindh in month of November, then in June it is circulating in different districts of Pakistan including four Provinces respectively.

Conclusion
V. cholera detection do not follow a clear seasonal pattern. However, the poor sanitation problems or temperature and rainfall may potentially influence the frequency and duration of cholera across the country. Occurrence of toxigenic V. cholerae in the environment samples showed that cholera is endemic, which is an alarming for a potential future cholera outbreaks in the country.
Left ventricular longitudinal strain variations assessed by speckle-tracking echocardiography after a passive leg raising maneuver in patients with acute circulatory failure to predict fluid responsiveness: A prospective, observational study
Authors: Roy Clemence , Duclos Gary , Nafati Cyril , Gardette Mickael , Lopez Alexandre , Pastene Bruno , Gaudray Eliott , Boussuges Alain , Antonini François , Leone Marc , Zieleskiewicz Laurent 
Published: September 2021

Background
An association was reported between the left ventricular longitudinal strain (LV-LS) and preload. LV-LS reflects the left cardiac function curve as it is the ratio of shortening over diastolic dimension. The aim of this study was to determine the sensitivity and specificity of LV-LS variations after a passive leg raising (PLR) maneuver to predict fluid responsiveness in intensive care unit (ICU) patients with acute circulatory failure (ACF).

Methods
Patients with ACF were prospectively included. Preload-dependency was defined as a velocity time integral (VTI) variation greater than 10% between baseline (T0) and PLR (T1), distinguishing the preload-dependent (PLD+) group and the preload-independent (PLD-) group. A 7-cycles, 4-chamber echocardiography loop was registered at T0 and T1, and strain analysis was performed off-line by a blind clinician. A general linear model for repeated measures was used to compare the LV-LS variation (T0 to T1) between the two groups.

Results
From June 2018 to August 2019, 60 patients (PLD+ = 33, PLD- = 27) were consecutively enrolled. The VTI variations after PLR were +21% (±8) in the PLD+ group and -1% (±7) in the PLD- group (p<0.01). Mean baseline LV-LS was -11.3% (±4.2) in the PLD+ group and -13.0% (±4.2) in the PLD- group (p = 0.12). LV-LS increased in the whole population after PLR +16.0% (±4.0) (p = 0.04). The LV-LS variations after PLR were +19.0% (±31) (p = 0.05) in the PLD+ group and +11.0% (±38) (p = 0.25) in the PLD- group, with no significant difference between the two groups (p = 0.08). The area under the curve for the LV-LS variations between T0 and T1 was 0.63 [0.48–0.77].

Conclusion
Our study confirms that LV-LS is load-dependent; however, the variations in LV-LS after PLR is not a discriminating criterion to predict fluid responsiveness of ICU patients with ACF in this cohort.
Magnitude and correlates of alcohol use disorder in south Gondar zone, northwest Ethiopia: A community based cross-sectional study
Authors: Legas Getasew , Asnakew Sintayehu , Belete Amsalu , Beyene Getnet Mihretie , Wubet Gashaw Mehiret , Bayih Wubet Alebachew , Chanie Ermias Sisay , Tigabu Agimasie , Dessie Tigabu 
Published: September 2021

Background
Alcohol use disorder is the major public health problem in low- and middle-income countries that account for up to 70% of alcohol related premature mortality in the region. Therefore, the aim of this study was to assess the magnitude of alcohol use disorder and its associated factors among adult residents in south Gondar zone, Northwest Ethiopia.

Methods
A community-based cross-sectional study was conducted among 848 adult residents of the south Gondar zone from January 13 to February 13, 2020. A multistage sampling technique was used to recruit study participants. We assessed alcohol use disorder (AUD) using the alcohol use disorder identification test (AUDIT). A binary logistic regression model was employed to identify factors associated with AUD.

Results
The prevalence of alcohol use disorder over the last 12-months was found to be 23.7% (95% CI: 20.9, 26.7). Being male (AOR = 4.34, 95 CI; 2.800, 6.743), poor social support (AOR = 1.95, 95 CI: 1.098, 3.495), social phobia (AOR = 1.69, 95 CI; 1.117, 2.582), perceived high level of stress (AOR = 2.85, 95 CI; 1.829, 34.469), current cigarette smoking (AOR = 3.06, 95 CI; 1.764, 5.307) and comorbid depression (AOR = 1.81, 95 CI; 1.184, 2.778) were significantly associated with alcohol use disorder.

Conclusion
The prevalence of alcohol use disorder is high among adult residents of the south Gondar zone and associated with many factors. So, it needs public health attention to decrease the magnitude of alcohol use disorder in Ethiopia.