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Article ; Online: Pharmacological interventions for treating intrahepatic cholestasis of pregnancy.

Walker, Kate F / Chappell, Lucy C / Hague, William M / Middleton, Philippa / Thornton, Jim G

The Cochrane database of systematic reviews

2020 Volume 7, Page(s) CD000493

Abstract: Background: Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder that can develop in pregnancy. It occurs when there is a build-up of bile acids in the maternal blood. It has been linked to adverse maternal and fetal/neonatal outcomes. As the ...

Abstract	Background: Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder that can develop in pregnancy. It occurs when there is a build-up of bile acids in the maternal blood. It has been linked to adverse maternal and fetal/neonatal outcomes. As the pathophysiology is poorly understood, therapies have been largely empiric. As ICP is an uncommon condition (incidence less than 2% a year), many trials have been small. Synthesis, including recent larger trials, will provide more evidence to guide clinical practice. This review is an update of a review first published in 2001 and last updated in 2013. Objectives: To assess the effects of pharmacological interventions to treat women with intrahepatic cholestasis of pregnancy, on maternal, fetal and neonatal outcomes. Search methods: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (13 December 2019), and reference lists of retrieved studies. Selection criteria: Randomised or quasi-randomised controlled trials, including cluster-randomised trials and trials published in abstract form only, that compared any drug with placebo or no treatment, or two drug intervention strategies, for women with a clinical diagnosis of intrahepatic cholestasis of pregnancy. Data collection and analysis: The review authors independently assessed trials for eligibility and risks of bias. We independently extracted data and checked these for accuracy. We assessed the certainty of the evidence using the GRADE approach. Main results: We included 26 trials involving 2007 women. They were mostly at unclear to high risk of bias. They assessed nine different pharmacological interventions, resulting in 14 different comparisons. We judged two placebo-controlled trials of ursodeoxycholic acid (UDCA) in 715 women to be at low risk of bias. The ten different pharmacological interventions were: agents believed to detoxify bile acids (UCDA) and S-adenosylmethionine (SAMe); agents used to bind bile acids in the intestine (activated charcoal, guar gum, cholestyramine); Chinese herbal medicines (yinchenghao decoction (YCHD), salvia, Yiganling and Danxioling pill (DXLP)), and agents aimed to reduce bile acid production (dexamethasone) Compared with placebo, UDCA probably results in a small improvement in pruritus score measured on a 100 mm visual analogue scale (VAS) (mean difference (MD) -7.64 points, 95% confidence interval (CI) -9.69 to -5.60 points; 2 trials, 715 women; GRADE moderate certainty), where a score of zero indicates no itch and a score of 100 indicates severe itching. The evidence for fetal distress and stillbirth were uncertain, due to serious limitations in study design and imprecision (risk ratio (RR) 0.70, 95% CI 0.35 to 1.40; 6 trials, 944 women; RR 0.33, 95% CI 0.08 to 1.37; 6 trials, 955 women; GRADE very low certainty). We found very few differences for the other comparisons included in this review. There is insufficient evidence to indicate if SAMe, guar gum, activated charcoal, dexamethasone, cholestyramine, Salvia, Yinchenghao decoction, Danxioling and Yiganling, or Yiganling alone or in combination are effective in treating women with intrahepatic cholestasis of pregnancy. Authors' conclusions: When compared with placebo, UDCA administered to women with ICP probably shows a reduction in pruritus. However the size of the effect is small and for most pregnant women and clinicians, the reduction may fall below the minimum clinically worthwhile effect. The evidence was unclear for other adverse fetal outcomes, due to very low-certainty evidence. There is insufficient evidence to indicate that SAMe, guar gum, activated charcoal, dexamethasone, cholestyramine, YCHD, DXLP, Salvia, Yiganling alone or in combination are effective in treating women with cholestasis of pregnancy. There are no trials of the efficacy of topical emollients. Further high-quality trials of other interventions are needed in order to identify effective treatments for maternal itching and preventing adverse perinatal outcomes. It would also be helpful to identify those women who are mostly likely to respond to UDCA (for example, whether bile acid concentrations affect how women with ICP respond to treatment with UDCA).
MeSH term(s)	Charcoal/therapeutic use ; Cholagogues and Choleretics/therapeutic use ; Cholestasis/complications ; Cholestasis/therapy ; Cholestyramine Resin/therapeutic use ; Dexamethasone/therapeutic use ; Drugs, Chinese Herbal/therapeutic use ; Female ; Fetal Distress/epidemiology ; Galactans/therapeutic use ; Glucocorticoids/therapeutic use ; Humans ; Mannans/therapeutic use ; Plant Gums/therapeutic use ; Pregnancy ; Pregnancy Complications/therapy ; Pruritus/etiology ; Pruritus/therapy ; Randomized Controlled Trials as Topic ; S-Adenosylmethionine/therapeutic use ; Stillbirth/epidemiology ; Ursodeoxycholic Acid/therapeutic use
Chemical Substances	Cholagogues and Choleretics ; Drugs, Chinese Herbal ; Galactans ; Glucocorticoids ; Mannans ; Plant Gums ; Cholestyramine Resin (11041-12-6) ; Charcoal (16291-96-6) ; Ursodeoxycholic Acid (724L30Y2QR) ; S-Adenosylmethionine (7LP2MPO46S) ; Dexamethasone (7S5I7G3JQL) ; guar gum (E89I1637KE)
Language	English
Publishing date	2020-07-27
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't ; Systematic Review
ISSN	1469-493X
ISSN (online)	1469-493X
DOI	10.1002/14651858.CD000493.pub3
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Article ; Online: An initial investigation into endothelial CC chemokine expression in the human rheumatoid synovium.

Rump, Lisa / Mattey, Derek L / Kehoe, Oksana / Middleton, Jim

Cytokine

2017 Volume 97, Page(s) 133–140

Abstract: Rheumatoid arthritis (RA) is a destructive and chronic autoimmune inflammatory disease. Synovial inflammation is a major feature of RA and is associated with leukocyte recruitment. Leukocytes cross the endothelial cells (ECs) into the synovial tissue and ...

Abstract	Rheumatoid arthritis (RA) is a destructive and chronic autoimmune inflammatory disease. Synovial inflammation is a major feature of RA and is associated with leukocyte recruitment. Leukocytes cross the endothelial cells (ECs) into the synovial tissue and fluid and this migration is mediated via a range of chemokines and adhesion molecules on the ECs. As important mediators of leukocyte extravasation, a number of chemokines from each of the chemokine families have been established as expressed in the RA joint. However, as little information is available on which chemokines are expressed/presented by the ECs themselves, the purpose of the study was to ascertain which of the CC chemokines were localised in RA ECs. Immunofluoresence was used to assess the presence of the CC-family chemokines in RA synovial ECs using von-Willebrand factor (VWF) as a pan-endothelial marker and a range of human chemokine antibodies. The percentage of VWF positive vessels which were positive for the chemokines was determined. The presence of the four most highly expressed novel chemokines were further investigated in non-RA synovial ECs and the sera and synovial fluid (SF) from patients with RA and osteoarthritis (OA). Statistical analysis of immunofluorescence data was carried out by Student's t-test. For analysis of ELISA data, Kruskal-Wallis ANOVA followed by Dunn's multiple comparison test was utilised to analyse differences in sera and SF levels for each chemokine between RA and OA. Spearman rank correlations of sera and SF chemokine levels with a range of clinical variables were also performed. Chemokine detection varied, the least abundant being CCL27 which was present in 8.3% of RA blood vessels and the most abundant being CCL19 which was present in 80%. Of the 26 chemokines studied, 19 have not been previously observed in RA ECs. Four of these novel chemokines, namely CCL7, CCL14, CCL16 and CCL22 were present on ≥60% of vessels. CCL14 and CCL22 were shown to be increased in RA ECs compared to non-RA ECs, p=0.0041 and p=0.014 respectively. EC chemokines CCL7, CCL14, CCL16 and CCL22 also occurred in RA synovial fluid and sera as established by ELISA. CCL7 was shown to be significantly increased in sera and SF from RA patients compared to that from osteoarthritis (OA) patients (p<0.01), and to have a highly significant correlation with the level of anti-CCP (R=0.93, p=0.001). Less abundant chemokines shown to be present in RA ECs were CCL1-3, CCL5, CCL10-13, CCL15, CCL17, CCL18, CCL20, CCL21 and CCL23-28. In conclusion, this initial study is the first to show the presence of a number of CC chemokines in RA ECs. It provides evidence that further validation and investigation into the presence and functionality of these novel chemokines expressed at RA synovial ECs may be warranted.
Language	English
Publishing date	2017-09
Publishing country	England
Document type	Journal Article
ZDB-ID	1018055-2
ISSN	1096-0023 ; 1043-4666
ISSN (online)	1096-0023
ISSN	1043-4666
DOI	10.1016/j.cyto.2017.05.023
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Article ; Online: Gap in funding for specialist hospitals treating patients with traumatic spinal cord injury under an activity-based funding model in New South Wales, Australia.

Vaikuntam, Bharat Phani / Middleton, James W / McElduff, Patrick / Walsh, John / Pearse, Jim / Connelly, Luke / Sharwood, Lisa N

Australian health review : a publication of the Australian Hospital Association

2020 Volume 44, Issue 3, Page(s) 365–376

Abstract: Objective The aim of this study was to estimate the difference between treatment costs in acute care settings and the level of funding public hospitals would receive under the activity-based funding model. Methods Patients aged ≥16 years who had ... ...

Abstract	Objective The aim of this study was to estimate the difference between treatment costs in acute care settings and the level of funding public hospitals would receive under the activity-based funding model. Methods Patients aged ≥16 years who had sustained an incident traumatic spinal cord injury (TSCI) between June 2013 and June 2016 in New South Wales were included in the study. Patients were identified from record-linked health data. Costs were estimated using two approaches: (1) using District Network Return (DNR) data; and (2) based on national weighted activity units (NWAU) assigned to activity-based funding activity. The funding gap in acute care treatment costs for TSCI patients was determined as the difference in cost estimates between the two approaches. Results Over the study period, 534 patients sustained an acute incident TSCI, accounting for 811 acute care hospital separations within index episodes. The total acute care treatment cost was estimated at A$40.5 million and A$29.9 million using the DNR- and NWAU-based methods respectively. The funding gap in total costs was greatest for the specialist spinal cord injury unit (SCIU) colocated with a major trauma service (MTS), at A$4.4 million over the study period. Conclusions The findings of this study suggest a substantial gap in funding for resource-intensive patients with TSCI in specialist hospitals under current DRG-based funding methods. What is known about the topic? DRG-based funding methods underestimate the treatment costs at the hospital level for patients with complex resource-intensive needs. This underestimation of true direct costs can lead to under-resourcing of those hospitals providing specialist services. What does this paper add? This study provides evidence of a difference between true direct costs in acute care settings and the level of funding hospitals would receive if funded according to the National Efficient Price and NWAU for patients with TSCI. The findings provide evidence of a shortfall in the casemix funding to public hospitals under the activity-based funding for resource-intensive care, such as patients with TSCI. Specifically, depending on the classification system, the principal referral hospitals, the SCIU colocated with an MTS and stand-alone SCIU were underfunded, whereas other non-specialist hospitals were overfunded for the acute care treatment of patients with TSCI. What are the implications for practitioners? Although health care financing mechanisms may vary internationally, the results of this study are applicable to other hospital payment systems based on diagnosis-related groups that describe patients of similar clinical characteristics and resource use. Such evidence is believed to be useful in understanding the adequacy of hospital payments and informing payment reform efforts. These findings may have service redesign policy implications and provide evidence for additional loadings for specialist hospitals treating low-volume, resource-intensive patients.
MeSH term(s)	Adolescent ; Adult ; Aged ; Australia ; Cost of Illness ; Female ; Health Care Costs/statistics & numerical data ; Hospitals, Public/economics ; Hospitals, Special/economics ; Humans ; Male ; Middle Aged ; New South Wales ; Spinal Cord Injuries/economics ; Spinal Cord Injuries/therapy ; Young Adult
Language	English
Publishing date	2020-05-27
Publishing country	Australia
Document type	Comparative Study ; Journal Article
ZDB-ID	639155-2
ISSN	1449-8944 ; 0159-5709 ; 0156-5788
ISSN (online)	1449-8944
ISSN	0159-5709 ; 0156-5788
DOI	10.1071/AH19083
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Article ; Online: Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial.

Hodgetts Morton, Victoria / Toozs-Hobson, Philip / Moakes, Catherine A / Middleton, Lee / Daniels, Jane / Simpson, Nigel A B / Shennan, Andrew / Israfil-Bayli, Fidan / Ewer, Andrew K / Gray, Jim / Slack, Mark / Norman, Jane E / Lees, Christoph / Tryposkiadis, Konstantinos / Hughes, Max / Brocklehurst, Peter / Morris, R Katie

Lancet (London, England)

2022 Volume 400, Issue 10361, Page(s) 1426–1436

Abstract: Background: Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed to determine the effectiveness of a monofilament suture ... ...

Abstract	Background: Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed to determine the effectiveness of a monofilament suture thread compared with braided suture thread on pregnancy loss rates in women undergoing a cervical cerclage. Methods: C-STICH was a pragmatic, randomised, controlled, superiority trial done at 75 obstetric units in the UK. Women with a singleton pregnancy who received a vaginal cervical cerclage due to a history of pregnancy loss or premature birth, or if indicated by ultrasound, were centrally randomised (1:1) using minimisation to receive a monofilament suture or braided suture thread for their cervical cerclage. Women and outcome assessors were masked to allocation as far as possible. The primary outcome was pregnancy loss, defined as miscarriage, stillbirth, or neonatal death in the first week of life, analysed in the intention-to-treat population (ie, all women who were randomly assigned). Safety was also assessed in the intention-to-treat population. The trial was registered with ISRCTN, ISRCTN15373349. Findings: Between Aug 21, 2015, and Jan 28, 2021, 2049 women were randomly assigned to receive a monofilament suture (n=1025) or braided suture (n=1024). The primary outcome was ascertained in 1003 women in the monofilament suture group and 993 women in the braided suture group. Pregnancy loss occurred in 80 (8·0%) of 1003 women in the monofilament suture group and 75 (7·6%) of 993 women in the braided suture group (adjusted risk ratio 1·05 [95% CI 0·79 to 1·40]; adjusted risk difference 0·002 [95% CI -0·02 to 0·03]). Interpretation: Monofilament suture did not reduce rate of pregnancy loss when compared with a braided suture. Clinicians should use the results of this trial to facilitate discussions around the choice of suture thread to optimise outcomes. Funding: National Institute of Health Research Health Technology Assessment Programme.
MeSH term(s)	Infant, Newborn ; Pregnancy ; Female ; Humans ; Cerclage, Cervical/methods ; Pregnancy Outcome ; Premature Birth/epidemiology ; Premature Birth/prevention & control ; Abortion, Spontaneous/epidemiology ; Abortion, Spontaneous/prevention & control ; Sutures
Language	English
Publishing date	2022-09-01
Publishing country	England
Document type	Randomized Controlled Trial ; Clinical Trial, Phase III ; Journal Article
ZDB-ID	3306-6
ISSN	1474-547X ; 0023-7507 ; 0140-6736
ISSN (online)	1474-547X
ISSN	0023-7507 ; 0140-6736
DOI	10.1016/S0140-6736(22)01808-6
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Article ; Online: Identifying Predictors of Higher Acute Care Costs for Patients With Traumatic Spinal Cord Injury and Modeling Acute Care Pathway Redesign: A Record Linkage Study.

Vaikuntam, Bharat Phani / Middleton, James Walter / McElduff, Patrick / Connelly, Luke / Pearse, Jim / Stanford, Ralph / Walsh, John / Sharwood, Lisa Nicole

Spine

2019 Volume 44, Issue 16, Page(s) E974–E983

Abstract: Study design: Record linkage study using healthcare utilization and costs data.: Objective: To identify predictors of higher acute-care treatment costs and length of stay for patients with traumatic spinal cord injury (TSCI).: Summary of background ...

Abstract	Study design: Record linkage study using healthcare utilization and costs data. Objective: To identify predictors of higher acute-care treatment costs and length of stay for patients with traumatic spinal cord injury (TSCI). Summary of background data: There are few current or population-based estimates of acute hospitalization costs, length of stay, and other outcomes for people with TSCI, on which to base future planning for specialist SCI health care services. Methods: Record linkage study using healthcare utilization and costs data; all patients aged more than or equal to 16 years with incident TSCI in the Australian state of New South Wales (June 2013-June 2016). Generalized Linear Model regression to identify predictors of higher acute care treatment costs for patients with TSCI. Scenario analysis quantified the proportionate cost impacts of patient pathway modification. Results: Five hundred thirty-four incident cases of TSCI (74% male). Total cost of all acute index episodes approximately AUD$40.5 (95% confidence interval [CI] ±4.5) million; median cost per patient was AUD$45,473 (Interquartile Range: $15,535-$94,612). Patient pathways varied; acute care was less costly for patients admitted directly to a specialist spinal cord injury unit (SCIU) compared with indirect transfer within 24 hours. Over half (53%) of all patients experienced at least one complication during acute admission; their care was less costly if they had been admitted directly to SCIU. Scenario analysis demonstrated that a reduction of indirect transfers to SCIU by 10% yielded overall cost savings of AUD$3.1 million; an average per patient saving of AUD$5,861. Conclusion: Direct transfer to SCIU for patients with acute TSCI resulted in lower treatment costs, shorter length of stay, and less costly complications. Modeling showed that optimizing patient-care pathways can result in significant acute-care cost savings. Reducing potentially preventable complications would further reduce costs and improve longer-term patient outcomes. Level of evidence: 3.
MeSH term(s)	Adolescent ; Adult ; Aged ; Australia ; Cost Savings ; Female ; Health Care Costs ; Hospital Costs ; Hospitalization/economics ; Humans ; Male ; Middle Aged ; New South Wales ; Patient Acceptance of Health Care ; Spinal Cord Injuries/economics
Language	English
Publishing date	2019-03-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	752024-4
ISSN	1528-1159 ; 0362-2436
ISSN (online)	1528-1159
ISSN	0362-2436
DOI	10.1097/BRS.0000000000003021
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Article ; Online: Maximal Exercise Testing Using the Incremental Shuttle Walking Test Can Be Used to Risk-Stratify Patients with Pulmonary Arterial Hypertension.

Annals of the American Thoracic Society

2021 Volume 18, Issue 1, Page(s) 34–43

Abstract: Rationale: ...

Abstract	Rationale:
MeSH term(s)	Exercise Test ; Humans ; Pulmonary Arterial Hypertension ; Walk Test
Language	English
Publishing date	2021-03-05
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2717461-X
ISSN	2325-6621 ; 1943-5665 ; 2325-6621
ISSN (online)	2325-6621 ; 1943-5665
ISSN	2325-6621
DOI	10.1513/AnnalsATS.202005-423OC
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Article: Imaging and Risk Stratification in Pulmonary Arterial Hypertension: Time to Include Right Ventricular Assessment.

Frontiers in cardiovascular medicine

2022 Volume 9, Page(s) 797561

Abstract: Background: Current European Society of Cardiology and European Respiratory Society guidelines recommend regular risk stratification with an aim of treating patients with pulmonary arterial hypertension (PAH) to improve or maintain low-risk status (<5% ... ...

Abstract	Background: Current European Society of Cardiology and European Respiratory Society guidelines recommend regular risk stratification with an aim of treating patients with pulmonary arterial hypertension (PAH) to improve or maintain low-risk status (<5% 1-year mortality). Methods: Consecutive patients with PAH who underwent cardiac magnetic resonance imaging (cMRI) were identified from the Assessing the Spectrum of Pulmonary hypertension Identified at a Referral centre (ASPIRE) registry. Kaplan-Meier survival curves, locally weighted scatterplot smoothing regression and multi-variable logistic regression analysis were performed. Results: In 311 consecutive, treatment-naïve patients with PAH undergoing cMRI including 121 undergoing follow-up cMRI, measures of right ventricular (RV) function including right ventricular ejection fraction (RVEF) and RV end systolic volume and right atrial (RA) area had prognostic value. However, only RV metrics were able to identify a low-risk status. Age ( Conclusion: This study highlights the need for guidelines to include measures of RV function rather than RA area alone to aid the risk stratification of patients with PAH.
Language	English
Publishing date	2022-03-25
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2781496-8
ISSN	2297-055X
ISSN	2297-055X
DOI	10.3389/fcvm.2022.797561
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Article: Pulmonary Hypertension: Intensification and Personalization of Combination Rx (PHoenix): A phase IV randomized trial for the evaluation of dose-response and clinical efficacy of riociguat and selexipag using implanted technologies.

Varian, Frances / Dick, Jennifer / Battersby, Christian / Roman, Stefan / Ablott, Jenna / Watson, Lisa / Binmahfooz, Sarah / Zafar, Hamza / Colgan, Gerry / Cannon, John / Suntharalingam, Jay / Lordan, Jim / Howard, Luke / McCabe, Colm / Wort, John / Price, Laura / Church, Colin / Hamilton, Neil / Armstrong, Iain /

Hameed, Abdul / Hurdman, Judith / Elliot, Charlie / Condliffe, Robin / Wilkins, Martin / Webb, Alastair / Adlam, David / Benza, Ray L / Rahimi, Kazem / Shojaei-Shahrokhabadi, Mohadeseh / Lin, Nan X / Wason, James M S / McIntosh, Alasdair / McConnachie, Alex / Middleton, Jennifer T / Thompson, Roger / Kiely, David G / Toshner, Mark / Rothman, Alexander

Pulmonary circulation

2024 Volume 14, Issue 1, Page(s) e12337

Abstract: Approved therapies for the treatment of patients with pulmonary arterial hypertension (PAH) mediate pulmonary vascular vasodilatation by targeting distinct biological pathways. International guidelines recommend that patients with an inadequate response ... ...

Abstract	Approved therapies for the treatment of patients with pulmonary arterial hypertension (PAH) mediate pulmonary vascular vasodilatation by targeting distinct biological pathways. International guidelines recommend that patients with an inadequate response to dual therapy with a phosphodiesterase type-5 inhibitor (PDE5i) and endothelin receptor antagonist (ERA), are recommended to either intensify oral therapy by adding a selective prostacyclin receptor (IP) agonist (selexipag), or switching from PDE5i to a soluble guanylate-cyclase stimulator (sGCS; riociguat). The clinical equipoise between these therapeutic choices provides the opportunity for evaluation of individualized therapeutic effects. Traditionally, invasive/hospital-based investigations are required to comprehensively assess disease severity and demonstrate treatment benefits. Regulatory-approved, minimally invasive monitors enable equivalent measurements to be obtained while patients are at home. In this 2 × 2 randomized crossover trial, patients with PAH established on guideline-recommended dual therapy and implanted with CardioMEMS™ (a wireless pulmonary artery sensor) and ConfirmRx™ (an insertable cardiac rhythm monitor), will receive ERA + sGCS, or PDEi + ERA + IP agonist. The study will evaluate clinical efficacy via established clinical investigations and remote monitoring technologies, with remote data relayed through regulatory-approved online clinical portals. The primary aim will be the change in right ventricular systolic volume measured by magnetic resonance imaging (MRI) from baseline to maximal tolerated dose with each therapy. Using data from MRI and other outcomes, including hemodynamics, physical activity, physiological measurements, quality of life, and side effect reporting, we will determine whether remote technology facilitates early evaluation of clinical efficacy, and investigate intra-patient efficacy of the two treatment approaches.
Language	English
Publishing date	2024-03-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	2638089-4
ISSN	2045-8940 ; 2045-8932
ISSN (online)	2045-8940
ISSN	2045-8932
DOI	10.1002/pul2.12337
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Article ; Online: Assessing the impact of care pathways on potentially preventable complications and costs for spinal trauma patients: protocol for a data linkage study using cohort study and administrative data.

Vaikuntam, Bharat Phani / Middleton, James W / McElduff, Patrick / Pearse, Jim / Walsh, John / Cameron, Ian D / Sharwood, Lisa Nicole

BMJ open

2018 Volume 8, Issue 11, Page(s) e023785

Abstract: Introduction: Traumatic spinal cord injuries have significant consequences both for the injured individual and the healthcare system, usually resulting in lifelong disability. Evidence has shown that timely medical and surgical interventions can lead to ...

Abstract	Introduction: Traumatic spinal cord injuries have significant consequences both for the injured individual and the healthcare system, usually resulting in lifelong disability. Evidence has shown that timely medical and surgical interventions can lead to better patient outcomes with implicit cost savings. Potentially preventable secondary complications are therefore indicators of the effectiveness of acute care following traumatic injury. The extent to which policy and clinical variation within the healthcare service impact on outcomes and acute care costs for patients with traumatic spinal cord injury (TSCI) in Australia is not well described. Methods and analysis: A comprehensive data set will be formed using record linkage to combine patient health and administrative records from seven minimum data collections (including costs), with an existing data set of patients with acute TSCI (Access to Care Study), for the time period June 2013 to June 2016. This person-level data set will be analysed to estimate the acute care treatment costs of TSCI in New South Wales, extrapolated nationally. Subgroup analyses will describe the associated costs of secondary complications and regression analysis will identify drivers of higher treatment costs. Mapping patient care and health service pathways of these patients will enable measurement of deviations from best practice care standards and cost-effectiveness analyses of the different pathways. Ethics and dissemination: Ethics approval has been obtained from the New South Wales Population and Health Services Research Ethics Committee. Dissemination strategies include peer-reviewed publications in scientific journals and conference presentations to enable translation of study findings to clinical and policy audiences.
MeSH term(s)	Critical Pathways/standards ; Health Care Costs/statistics & numerical data ; Health Services Research/methods ; Humans ; Information Storage and Retrieval ; New South Wales ; Postoperative Complications/prevention & control ; Spinal Cord Injuries/complications ; Spinal Cord Injuries/economics
Language	English
Publishing date	2018-11-08
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2747269-3
ISSN	2044-6055 ; 2044-6055 ; 2053-3624
ISSN (online)	2044-6055
ISSN	2044-6055 ; 2053-3624
DOI	10.1136/bmjopen-2018-023785
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Article ; Online: C-STICH: Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes-a multicentre randomised controlled trial.

Israfil-Bayli, Fidan / Morton, Victoria Hodgetts / Hewitt, Catherine A / Ewer, Andrew K / Gray, Jim / Norman, Jane / Lees, Christoph / Simpson, Nigel A B / Shennan, Andrew / Tryposkiadis, Konstantinos / Hughes, Max / Daniels, Jane / Brocklehurst, Peter / Morris, Katie / Middleton, Lee / Toozs-Hobson, Philip

Trials

2021 Volume 22, Issue 1, Page(s) 664

Abstract: Background: Preterm birth is associated with significant mortality and morbidity for mothers and babies. Women are identified as high risk for preterm birth based on either previous medical/pregnancy history or on ultrasound assessment of the cervix. ... ...

Abstract	Background: Preterm birth is associated with significant mortality and morbidity for mothers and babies. Women are identified as high risk for preterm birth based on either previous medical/pregnancy history or on ultrasound assessment of the cervix. Women identified as high risk can be offered a cervical cerclage (a purse string stitch) around the cervix (neck of the womb) to reduce the risk of preterm birth. In women who have a cervical cerclage, the procedure can be performed using either a monofilament (single-stranded) or braided (woven) suture material. Both suture materials are routinely used for cervical cerclage and there is uncertainty as to which is superior. Methods: A multicentre, open, randomised controlled superiority trial of 2050 women presenting at obstetric units, deemed to be at risk of preterm birth and already scheduled to have a cervical cerclage as part of their standard care. Inclusion criteria include singleton pregnancies and an indication for cervical cerclage for either a history of three or more previous mid-trimester losses or premature births (≤ 28 weeks), insertion of cervical sutures in previous pregnancies, a history of mid trimester loss or premature birth with a (current) shortened (≤ 25 mm) cervix, or women whom clinicians deem to be at risk of preterm birth either by history or the results of an ultrasound scan. Exclusion criteria include women who have taken part in C-STICH previously, are aged less than 18 years old at the time of presentation, require a rescue cerclage, and are unwilling or unable to give informed consent and in whom a cerclage will be placed by any route other than vaginally (e.g. via an abdominal route). Following informed consent, women are randomised on a 1:1 basis to either monofilament or braided suture, by minimisation. The primary outcome is pregnancy loss (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life), and secondary outcomes include the core outcome set for preterm birth trials. Discussion: Optimising established interventions to prevent preterm birth is important in reducing perinatal mortality rates. Trial registration: ISRCTN 15373349 . Registered before recruitment on 03 December 2014 prior to first recruit.
MeSH term(s)	Adolescent ; Cerclage, Cervical ; Cervix Uteri/diagnostic imaging ; Cervix Uteri/surgery ; Female ; Humans ; Infant, Newborn ; Outcome Assessment, Health Care ; Pregnancy ; Premature Birth/etiology ; Premature Birth/prevention & control ; Sutures
Language	English
Publishing date	2021-09-28
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1468-6708
ISSN (online)	1745-6215 ; 1468-6694
ISSN	1468-6708
DOI	10.1186/s13063-021-05629-3
Database	MEDical Literature Analysis and Retrieval System OnLINE

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