bluuebunny/crossref_metadata_2025_split huggingface dataset:
Does Patient Preference for Mode of Intervention Delivery Impact Intervention Efficacy and Attrition?
Authors: Plotnikoff Ronald C. , Stacey Fiona G. , Jansson Anna K. , Ewald Benjamin , Johnson Natalie A. , Brown Wendy J. , Holliday Elizabeth G. , Barker Daniel , James Erica L. 
Published: August 2019

Purpose: To explore whether there was a difference in objectively measured physical activity and study participation between people who received their preferred study group allocation (matched) and those who did not receive their preferred study group (mismatched). Design: Secondary data from the NewCOACH randomized controlled trial. Setting: Insufficiently active patients in the primary care settings in Sydney and Newcastle, Australia. Participants: One hundred seventy-two adults aged 20 to 81 years. Intervention: Participants indicated their intervention preference at baseline for (1) five face-to-face visits with an exercise specialist, (2) one face-to-face visit and 4 telephone follow-ups with an exercise specialist, (3) written material, or (4) slight-to-no preference. Participants were then allocated to an intervention group and categorized as either “matched” or “mismatched” based on their indications. Participants who reported a slight-to-no preference was categorized as “matched.” Measures: Daily step count as measured by pedometers and study participation. Analysis: Mean differences between groups in daily step count at 3 and 12 months (multiple linear regression models) and study participation at baseline, 3 months, and 12 months (χ2 tests). Results: Preference for an intervention group prior to randomization did not significantly (all P’s > .05 using 95% confidence interval) impact step counts (differences of <600 steps/day between groups) or study participation. Conclusion: Future research should continue to address whether the strength of preferences influence study outcome and participation and whether the study preferences change over time.
Anti-IFNAR treatment does not reverse neuropsychiatric disease in MRL/lpr lupus mice
Authors: Huang M W , Stock A D , Mike E V , Herlitz L , Kolbeck R , Putterman C 
Published: August 2019

Objective Many systemic lupus erythematosus patients display a type I interferon (IFN) signature, and IFNα levels positively correlate with disease severity. Previous studies blocking the type I IFN pathway systemically in lupus models showed some beneficial effects. However, its effects on neuropsychiatric manifestations have yet to be carefully assessed, even though IFNα has been associated with induction of depression. Our aim was to investigate whether disrupting the type I IFN pathway would attenuate the development of murine neuropsychiatric lupus. Methods Female MRL/ lpr mice were administered an antitype I IFN receptor (IFNAR) antibody or a control antibody intraperitoneally three times weekly for 12 weeks starting at age 4–5 weeks. Behavior was assessed during and at the end of the treatment schedule. Results No significant differences were seen between the anti-IFNAR– and control-treated mice when assessing for depression-like behavior or cognitive dysfunction, although anti-IFNAR antibody–treated mice displayed significant decreases in levels of IFN-stimulated genes. Anti-IFNAR treatment also did not significantly improve brain histology, cellular infiltration, or blood-brain barrier integrity. Conclusions Surprisingly, our results showed no improvement in neuropsychiatric disease and suggest that the role of IFNAR signaling in the pathogenesis of neuropsychiatric lupus continues to need to be carefully assessed.
Immune-mediated adverse events following influenza vaccine in cancer patients receiving immune checkpoint inhibitors
Authors: Gwynn Morgan E , DeRemer David L , Saunders Katherine M , Parikh Jigarkumar , Bollag Roni J , Clemmons Amber B 
Published: August 2019

Objectives The emergence of immune checkpoint inhibitors has transformed treatment paradigms for various malignancies. Patients with cancer are at increased risk of complications and hospitalizations from influenza; therefore, it is recommended that they receive inactivated influenza vaccination. However, efficacy and safety of inactivated influenza vaccination in patients receiving immune checkpoint inhibitors is uncertain. The objective of this prospective case series was to evaluate the incidence of immune-mediated adverse events (imAEs) following inactivated influenza vaccination in patients receiving immune checkpoint inhibitors. Changes in cytokine and chemokine levels were also evaluated. Methods Patients receiving immune checkpoint inhibitors during the 2017–2018 influenza season were eligible for study participation. Peripheral blood samples were collected prior to administration of inactivated influenza vaccine and two post-vaccination time points. Evaluation of new or worsening imAEs occurred via patient questionnaire and review of medical records for 60 days following inactivated influenza vaccination. Baseline imAEs were evaluated from review of medical records for 60 days prior to inactivated influenza vaccination. Serum cytokines and chemokines were measured using a multiplex Luminex assay. Results Twenty-four patients were enrolled in this study. Seven patients experienced any grade imAE (one patient having 2) within 60 days following inactivated influenza vaccination. The majority were Grades 1–2, including rash ( n = 3), hypothyroidism, myalgia, and colitis ( n = 1 each). Two patients experienced severe imAEs (grade 3 nephritis and grade 4 diabetes). No significant changes ( p > 0.05) in serum cytokine or chemokine concentrations were observed. Conclusions Although small, our study suggests that inactivated influenza vaccine may be safely administered to patients receiving immune checkpoint inhibitors. The majority of imAEs following inactivated influenza vaccination were Grades 1-2 and did not require changes in immune checkpoint inhibitor therapy.
Pharmacovigilance Assessment of Drug-Induced Acute Pancreatitis Using a Spontaneous Reporting Database
Authors: Niinomi Iku , Hosohata Keiko , Oyama Saki , Inada Ayaka , Wakabayashi Tomohito , Iwanaga Kazunori 
Published: August 2019

Background: Acute pancreatitis (AP) is associated with risks of morbidity and mortality. The incidence of AP recently increased compared to that traditionally reported in the literature. Objective: The purpose of this study was to evaluate the possible association between AP and drugs using the Japanese Adverse Drug Event Report (JADER) database, which is a spontaneous reporting database of adverse drug events. Methods: Adverse event reports submitted to the JADER database between 2004 and 2017 were analyzed. Disproportionality analysis was performed by calculating the reporting odds ratio (ROR) with 95% confidence intervals for signal detection. Results: A total of 3,443 reports (0.17% of all adverse events) were identified as drug-induced AP, in which 431 different drugs were involved. Acute pancreatitis was frequently reported in men (58.5%) in their 60s (19.1%); 40.6% developed AP within 4 weeks after the treatment. Among the most frequently reported drugs, signals were detected for prednisolone, ribavirin, sitagliptin, mesalazine, tacrolimus, and l-asparaginase, which are well-known causes of AP. Telaprevir, donepezil, and ustekinumab also generated signals. As for drugs with high RORs, l-asparaginase and alogliptin were noteworthy. Conclusion: Most of the identified drugs were already known to induce AP, but the likelihood of the reporting of AP varied among the drugs. Our results should raise physicians’ awareness of drugs associated with AP, but further investigation of these medications is warranted.
Endovascular versus medical therapy for large-vessel anterior occlusive stroke presenting with mild symptoms
Authors: Wolman Dylan N , Marcellus David G , Lansberg Maarten G , Albers Gregory , Guenego Adrien , Marks Michael P , Dodd Robert L , Do Huy M , Wintermark Max , Martin Blake W , Heit Jeremy J 
Published: August 2019

Background Acute ischemic stroke patients with a large-vessel occlusion but mild symptoms (NIHSS ≤ 6) pose a treatment dilemma between medical management and endovascular thrombectomy. Aims To evaluate the differences in clinical outcomes of endovascular thrombectomy-eligible patients with target-mismatch perfusion profiles who undergo either medical management or endovascular thrombectomy. Methods Forty-seven patients with acute ischemic stroke due to large-vessel occlusion, NIHSS ≤ 6, and a target-mismatch perfusion imaging profile were included. Patients underwent medical management or endovascular thrombectomy following treating neurointerventionalist and neurologist consensus. The primary outcome measure was NIHSS shift. Secondary outcome measures were symptomatic intracranial hemorrhage, in-hospital mortality, and 90-day mRS scores. The primary intention-to-treat and as-treated analyses were compared to determine the impact of crossover patient allocation on study outcome measures. Results Forty-seven patients were included. Thirty underwent medical management (64%) and 17 underwent endovascular thrombectomy (36%). Three medical management patients underwent endovascular thrombectomy due to early clinical deterioration. Presentation NIHSS ( P = 0.82), NIHSS shift ( P = 0.62), and 90-day functional independence (mRS 0–2; P = 0.25) were similar between groups. Endovascular thrombectomy patients demonstrated an increased overall rate of intracranial hemorrhage (35.3% vs. 10.0%; P = 0.04), but symptomatic intracranial hemorrhage was similar between groups ( P = 0.25). In-hospital mortality was similar between groups ( P = 0.46), though all two deaths in the medical management group occurred among crossover patients. Endovascular thrombectomy patients demonstrated a longer length of stay (7.6 ± 7.2 vs. 4.3 ± 3.9 days; P = 0.04) and a higher frequency of unfavorable discharge to a skilled-nursing facility ( P = 0.03) rather than home ( P = 0.05). Conclusions Endovascular thrombectomy may pose an unfavorable risk-benefit profile over medical management for endovascular thrombectomy-eligible acute ischemic stroke patients with mild symptoms, which warrants a randomized trial in this subpopulation.
Feasibility Studies of an Insulin-Only Bionic Pancreas in a Home-Use Setting
Authors: Ekhlaspour Laya , Nally Laura M. , El-Khatib Firas H. , Ly Trang T. , Clinton Paula , Frank Eliana , Tanenbaum Molly L. , Hanes Sarah J. , Selagamsetty Rajendranath R. , Hood Korey , Damiano Edward R. , Buckingham Bruce A. 
Published: August 2019

Background: We tested the safety and performance of the “insulin-only” configuration of the bionic pancreas (BP) closed-loop blood-glucose control system in a home-use setting to assess glycemic outcomes using different static and dynamic glucose set-points. Method: This is an open-label non-randomized study with three consecutive intervention periods. Participants had consecutive weeks of usual care followed by the insulin-only BP with (1) an individualized static set-point of 115 or 130 mg/dL and (2) a dynamic set-point that automatically varied within 110 to 130 mg/dL, depending on hypoglycemic risk. Human factors (HF) testing was conducted using validated surveys. The last five days of each study arm were used for data analysis. Results: Thirteen participants were enrolled with a mean age of 28 years, mean A1c of 7.2%, and mean daily insulin dose of 0.6 U/kg (0.4-1.0 U/kg). The usual care arm had an average glucose of 145 ± 20 mg/dL, which increased in the static set-point arm (159 ± 8 mg/dL, P = .004) but not in the dynamic set-point arm (154 ± 10 mg/dL, P = ns). There was no significant difference in time spent in range (70-180 mg/dL) among the three study arms. There was less time <70 mg/dL with both the static (1.8% ± 1.4%, P = .009) and dynamic set-point (2.7±1.5, P = .051) arms compared to the usual-care arm (5.5% ± 4.2%). HF testing demonstrated preliminary user satisfaction and no increased risk of diabetes burden or distress. Conclusions: The insulin-only configuration of the BP using either static or dynamic set-points and initialized only with body weight performed similarly to other published insulin-only systems.
Developing content to promote desistance in men who have committed intimate partner violence in same-sex relationships
Authors: Morris Jason , Gibbs Charlotte A , Jonah Omolara T , Bloomfield Sinead , Weatherstone Paul H , Ireland Jane L 
Published: August 2019

This article provides an overview of service development processes used to design a therapeutic approach that promotes desistance amongst men who have committed acts of Intimate Partner Violence (IPV) against their male partner or ex-partner. The article aims to explore how inclusive therapeutic service provision can be developed using the best available evidence, stakeholder consultation, co-production and technology. It does so by presenting a two-part study that draws upon a review of inclusive IPV theory alongside responses to a consultation designed to canvas stakeholder opinions (n = 14) of a proposed IPV service. It also provides a case study (n = 1) of the co-production of digital media with someone from the target group for that service. Implications for future service design for marginalised groups in the Criminal Justice System and provisions for people who have committed IPV are discussed. This article represents the views of the authors’ and not those of Her Majesty’s Prison and Probation Service (HMPPS).
Tibial bowing and tibial component placement in primary total knee arthroplasty in valgus knees: Are we overlooking?
Authors: Palanisami Dhanasekararaja , George Melvin J , Hussain Arif Mohammed , MD Chunchesh , Natesan Rajkumar , Shanmuganathan Rajasekaran 
Published: August 2019

Purpose: Tibial bowing in valgus knees with arthritis can lead to component malplacement during total knee arthroplasty (TKA). Incidence of valgus knees with medial tibial bowing, its effect on tibial component placement during primary TKA and methods to improve accuracy of the component placement were studied. Methods: Full-length weight-bearing alignment radiograph was taken in 117 patients (149 knees) with valgus deformity undergoing TKA. In these cases, the proximal tibial reference for extramedullary jig placement was planned preoperatively with reference to the tibial spines and classified as four zones. Results: The mean preoperative hip–knee–ankle (HKA) angle was 192.9° (180.3–234.5°). Bowing >3° was considered significant ( p < 0.001) and at this level of bowing, the proximal tibial reference was shifted from centre to medial. Tibial bowing <3° was considered straight and >3° as tibia valga. Tibia was bowed in 70 knees (46.97%). Severity of valgus deformity had strong positive correlation with the tibia valga ( p < 0.001). The post-operative medial proximal tibial angle (MPTA) and HKA angle were 91.63° (87.9–95.7°) and 182.6° (178.1–189.7°), respectively. The mean MPTA and post-operative HKA angle in bowed and straight tibiae were 90.35° versus 89.78° ( p = 0.547) and 181.5° versus 180.7° ( p = 0.5716), respectively, and the difference was not statistically significant. Conclusion: Medial tibial bowing is very common in valgus knees. Tibia valga has a strong positive correlation with the severity of valgus deformity. Accurate tibial component placement can be achieved with a medialized reference point for extramedullary tibial cutting jig in knees with significant tibia valga. The study has been registered in clinical trials registry – India (CTRI/2018/03/012283).
Comparison of the long-term outcome of cemented Charnley low-friction arthroplasty with hybrid arthroplasty in patients with congenital hip disease
Authors: Lampropoulou-Adamidou Kalliopi , Hartofilakidis George 
Published: August 2019

AimsTo our knowledge, no study has compared the long-term results of cemented and hybrid total hip arthroplasty (THA) in patients with osteoarthritis (OA) secondary to congenital hip disease (CHD). This is a demanding procedure that may require special techniques and implants. Our aim was to compare the long-term outcome of cemented low-friction arthroplasty (LFA) and hybrid THA performed by one surgeon.Patients and MethodsBetween January 1989 and December 1997, 58 hips (44 patients; one man, 43 woman; mean age 56.6 years (25 to 77)) with OA secondary to CHD were treated with a cemented Charnley LFA (group A), and 55 hips (39 patients; two men, 37 women; mean age 49.1 years (27 to 70)) were treated with a hybrid THA (group B), by the senior author (GH). The clinical outcome and survivorship were compared.ResultsAt all timepoints, group A hips had slightly better survivorship than those in group B without a statistically significant difference, except for the 24-year survival of acetabular components with revision for aseptic loosening as the endpoint, which was slightly worse. The survivorship was only significantly better in group A compared with group B when considering reoperation for any indication as the endpoint, 15 years postoperatively (74% vs 52%, p = 0.018).ConclusionWe concluded that there was not a substantial difference at almost any time in the outcome of cemented Charnley LFAs compared with hybrid THAs when treating patients with OA of the hip secondary to CHD. We believe, however, that after improvements in the design of components used in hybrid THA, this could be the method of choice, as it is technically easier with a shorter operating time. Cite this article: Bone Joint J 2019;101-B:1050–1057.
Femoral lengthening using the Precice intramedullary limb-lengthening system
Authors: Calder Peter R. , McKay Joseph E. , Timms Anna J. , Roskrow Tracy , Fugazzotto Sharon , Edel Penina , Goodier W. D. 
Published: August 2019

AimsThe Precice intramedullary limb-lengthening system has demonstrated significant benefits over external fixation lengthening methods, leading to a paradigm shift in limb lengthening. This study compares outcomes following antegrade and retrograde femoral lengthening in both adolescent and adult patients.Patients and MethodsA retrospective review of prospectively collected data was undertaken of a consecutive series of 107 femoral lengthening operations in 92 patients. In total, 73 antegrade nails and 34 retrograde nails were inserted. Outcome was assessed by the regenerate healing index (HI), hip and knee range of movement (ROM), and the presence of any complications.ResultsThe mean lengthening was 4.65 cm (1.5 to 8) in the antegrade group and 4.64 cm (1.6 to 8) in the retrograde group. Of the 107 lengthenings, 100 had sufficient datapoints to calculate the mean HI. This was 31.6 days/cm (15 to 108). There was a trend toward a lower (better) HI with an antegrade nail and better outcomes in adolescent patients, but these were not statistically significant. Hip and knee ROM was maintained and/or improved following commencement of femoral lengthening in 44 patients (60%) of antegrade nails and 13 patients (38%) of retrograde nails. In female patients, loss of movement occurred both earlier and following less total length achieved. Minor implant complications included locking bolt migration and in one patient deformity of the nail, but no implant failed to lengthen and there were no deep infections. Three patients had delayed union, five patients required surgical intervention for joint contracture.ConclusionThis study confirms excellent results in femoral lengthening with antegrade and retrograde Precice nails. There is a trend for better healing and less restriction in hip and knee movement following antegrade nails. There are clinical scenarios, that mandate the use of a retrograde nail. However, when these are not present, we recommend the use of antegrade nailing. Cite this article: Bone Joint J 2019;101-B:1168–1176
A precise method for determining acetabular component anteversion after total hip arthroplasty
Authors: Murphy Michael P. , Killen Cameron J. , Ralles Steven J. , Brown Nicholas M. , Hopkinson William J. , Wu Karen 
Published: August 2019

Aims Several radiological methods of measuring anteversion of the acetabular component after total hip arthroplasty (THA) have been described. These are limited by low reproducibility, are less accurate than CT 3D reconstruction, and are cumbersome to use. These methods also partly rely on the identification of obscured radiological borders of the component. We propose two novel methods, the Area and Orthogonal methods, which have been designed to maximize use of readily identifiable points while maintaining the same trigonometric principles. Patients and Methods A retrospective study of plain radiographs was conducted on 160 hips of 141 patients who had undergone primary THA. We compared the reliability and accuracy of the Area and Orthogonal methods with two of the current leading methods: those of Widmer and Lewinnek, respectively. Results The 160 anteroposterior pelvis films revealed that the proposed Area method was statistically different from those described by Widmer and Lewinnek (p < 0.001 and p = 0.004, respectively). They gave the highest inter- and intraobserver reliability (0.992 and 0.998, respectively), and took less time (27.50 seconds (sd 3.19); p < 0.001) to complete. In addition, 21 available CT 3D reconstructions revealed the Area method achieved the highest Pearson’s correlation coefficient (r = 0.956; p < 0.001) and least statistical difference (p = 0.704) from CT with a mean within 1° of CT-3D reconstruction between ranges of 1° to 30° of measured radiological anteversion. Conclusion Our results support the proposed Area method to be the most reliable, accurate, and speedy. They did not support any statistical superiority of the proposed Orthogonal method to that of the Widmer or Lewinnek method. Cite this article: Bone Joint J 2019;101-B:1042–1049.
Does time from fracture to surgery affect mortality and intraoperative medical complications for hip fracture patients?
Authors: Leer-Salvesen Sunniva , Engesæter Lars B. , Dybvik Eva , Furnes Ove , Kristensen Torbjørn B. , Gjertsen Jan-Erik 
Published: August 2019

Aims The aim of this study was to investigate mortality and risk of intraoperative medical complications depending on delay to hip fracture surgery by using data from the Norwegian Hip Fracture Register (NHFR) and the Norwegian Patient Registry (NPR). Patients and Methods A total of 83 727 hip fractures were reported to the NHFR between 2008 and 2017. Pathological fractures, unspecified type of fractures or treatment, patients less than 50 years of age, unknown delay to surgery, and delays to surgery of greater than four days were excluded. We studied total delay (fracture to surgery, n = 38 754) and hospital delay (admission to surgery, n = 73 557). Cox regression analyses were performed to calculate relative risks (RRs) adjusted for sex, age, American Society of Anesthesiologists (ASA) classification, type of surgery, and type of fracture. Odds ratio (OR) was calculated for intraoperative medical complications. We compared delays of 12 hours or less, 13 to 24 hours, 25 to 36 hours, 37 to 48 hours, and more than 48 hours. Results Mortality remained unchanged when total delay was less than 48 hours. Total delay exceeding 48 hours was associated with increased three-day mortality (RR 1.69, 95% confidence interval (CI) 1.23 to 2.34; p = 0.001) and one-year mortality (RR 1.06, 95% CI 1.04 to 1.22; p = 0.003). More intraoperative medical complications were reported when hospital delay exceeded 24 hours. Conclusion Hospitals should operate on patients within 48 hours after fracture to reduce mortality and intraoperative complications. Cite this article: Bone Joint J 2019;101-B:1129–1137.