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Adaptation of the Wound Healing Questionnaire universal-reporter outcome measure for use in global surgery trials (TALON-1 study): mixed-methods study and Rasch analysis

NIHR Global Health Research Unit on Global Surgery ; Glasbey, James ; Ademuyiwa, Adesoji ; [et al.]

Oxford University Press (OUP) ; 2023

In: British Journal of Surgery Vol. 110, No. 6 ( 2023-05-16), p. 685-700

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In: British Journal of Surgery, Oxford University Press (OUP), Vol. 110, No. 6 ( 2023-05-16), p. 685-700

Abstract: The Bluebelle Wound Healing Questionnaire (WHQ) is a universal-reporter outcome measure developed in the UK for remote detection of surgical-site infection after abdominal surgery. This study aimed to explore cross-cultural equivalence, acceptability, and content validity of the WHQ for use across low- and middle-income countries, and to make recommendations for its adaptation. Methods This was a mixed-methods study within a trial (SWAT) embedded in an international randomized trial, conducted according to best practice guidelines, and co-produced with community and patient partners (TALON-1). Structured interviews and focus groups were used to gather data regarding cross-cultural, cross-contextual equivalence of the individual items and scale, and conduct a translatability assessment. Translation was completed into five languages in accordance with Mapi recommendations. Next, data from a prospective cohort (SWAT) were interpreted using Rasch analysis to explore scaling and measurement properties of the WHQ. Finally, qualitative and quantitative data were triangulated using a modified, exploratory, instrumental design model. Results In the qualitative phase, 10 structured interviews and six focus groups took place with a total of 47 investigators across six countries. Themes related to comprehension, response mapping, retrieval, and judgement were identified with rich cross-cultural insights. In the quantitative phase, an exploratory Rasch model was fitted to data from 537 patients (369 excluding extremes). Owing to the number of extreme (floor) values, the overall level of power was low. The single WHQ scale satisfied tests of unidimensionality, indicating validity of the ordinal total WHQ score. There was significant overall model misfit of five items (5, 9, 14, 15, 16) and local dependency in 11 item pairs. The person separation index was estimated as 0.48 suggesting weak discrimination between classes, whereas Cronbach’s α was high at 0.86. Triangulation of qualitative data with the Rasch analysis supported recommendations for cross-cultural adaptation of the WHQ items 1 (redness), 3 (clear fluid), 7 (deep wound opening), 10 (pain), 11 (fever), 15 (antibiotics), 16 (debridement), 18 (drainage), and 19 (reoperation). Changes to three item response categories (1, not at all; 2, a little; 3, a lot) were adopted for symptom items 1 to 10, and two categories (0, no; 1, yes) for item 11 (fever). Conclusion This study made recommendations for cross-cultural adaptation of the WHQ for use in global surgical research and practice, using co-produced mixed-methods data from three continents. Translations are now available for implementation into remote wound assessment pathways.

Type of Medium: Online Resource

ISSN: 0007-1323 , 1365-2168

URL: Article

DOI: 10.1093/bjs/znad058

Language: English

Publisher: Oxford University Press (OUP)

Publication Date: 2023

detail.hit.zdb_id: 2006309-X

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Icosapent Ethyl Reduces Ischemic Events in Patients With a History of Previous Coronary Artery Bypass Grafting: REDUCE-IT CABG

Verma, Subodh ; Bhatt, Deepak L. ; Steg, Ph. Gabriel ; [et al.]

Ovid Technologies (Wolters Kluwer Health) ; 2021

In: Circulation Vol. 144, No. 23 ( 2021-12-07), p. 1845-1855

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In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 144, No. 23 ( 2021-12-07), p. 1845-1855

Abstract: Despite advances in surgery and pharmacotherapy, there remains significant residual ischemic risk after coronary artery bypass grafting surgery. Methods: In REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl–Intervention Trial), a multicenter, placebo-controlled, double-blind trial, statin-treated patients with controlled low-density lipoprotein cholesterol and mild to moderate hypertriglyceridemia were randomized to 4 g daily of icosapent ethyl or placebo. They experienced a 25% reduction in risk of a primary efficacy end point (composite of cardiovascular death, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina) and a 26% reduction in risk of a key secondary efficacy end point (composite of cardiovascular death, myocardial infarction, or stroke) when compared with placebo. The current analysis reports on the subgroup of patients from the trial with a history of coronary artery bypass grafting. Results: Of the 8179 patients randomized in REDUCE-IT, a total of 1837 (22.5%) had a history of coronary artery bypass grafting, with 897 patients randomized to icosapent ethyl and 940 to placebo. Baseline characteristics were similar between treatment groups. Randomization to icosapent ethyl was associated with a significant reduction in the primary end point (hazard ratio [HR], 0.76 [95% CI, 0.63–0.92] ; P =0.004), in the key secondary end point (HR, 0.69 [95% CI, 0.56–0.87]; P =0.001), and in total (first plus subsequent or recurrent) ischemic events (rate ratio, 0.64 [95% CI, 0.50–0.81]; P =0.0002) compared with placebo. This yielded an absolute risk reduction of 6.2% (95% CI, 2.3%–10.2%) in first events, with a number needed to treat of 16 (95% CI, 10–44) during a median follow-up time of 4.8 years. Safety findings were similar to the overall study: beyond an increased rate of atrial fibrillation/flutter requiring hospitalization for at least 24 hours (5.0% vs 3.1%; P =0.03) and a nonsignificant increase in bleeding, occurrences of adverse events were comparable between groups. Conclusions: In REDUCE-IT patients with a history of coronary artery bypass grafting, treatment with icosapent ethyl was associated with significant reductions in first and recurrent ischemic events. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01492361.

Type of Medium: Online Resource

ISSN: 0009-7322 , 1524-4539

URL: Article

DOI: 10.1161/CIRCULATIONAHA.121.056290

Language: English

Publisher: Ovid Technologies (Wolters Kluwer Health)

Publication Date: 2021

detail.hit.zdb_id: 1466401-X

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Clinical Outcomes and Response to Vericiguat According to Index Heart Failure Event : Insights From the VICTORIA Trial

Lam, Carolyn S. P. ; Giczewska, Anna ; Sliwa, Karen ; [et al.]

American Medical Association (AMA) ; 2021

In: JAMA Cardiology Vol. 6, No. 6 ( 2021-06-01), p. 706-

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In: JAMA Cardiology, American Medical Association (AMA), Vol. 6, No. 6 ( 2021-06-01), p. 706-

Type of Medium: Online Resource

ISSN: 2380-6583

URL: Article

DOI: 10.1001/jamacardio.2020.6455

Language: English

Publisher: American Medical Association (AMA)

Publication Date: 2021

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Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study

Labeau, Sonia O. ; Afonso, Elsa ; Benbenishty, Julie ; [et al.]

Springer Science and Business Media LLC ; 2021

In: Intensive Care Medicine Vol. 47, No. 2 ( 2021-02), p. 160-169

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In: Intensive Care Medicine, Springer Science and Business Media LLC, Vol. 47, No. 2 ( 2021-02), p. 160-169

Type of Medium: Online Resource

ISSN: 0342-4642 , 1432-1238

URL: Article

DOI: 10.1007/s00134-020-06234-9

RVK:

XA 10000

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2021

detail.hit.zdb_id: 1459201-0

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Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study

Holbrook, Janet T. ; Sugar, Elizabeth A. ; Burke, Alyce E. ; [et al.]

Elsevier BV ; 2016

In: American Journal of Ophthalmology Vol. 164 ( 2016-04), p. 29-36

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In: American Journal of Ophthalmology, Elsevier BV, Vol. 164 ( 2016-04), p. 29-36

Type of Medium: Online Resource

ISSN: 0002-9394

URL: Article

DOI: 10.1016/j.ajo.2015.12.028

RVK:

XA 19500

RVK:

XA 10000

Language: English

Publisher: Elsevier BV

Publication Date: 2016

detail.hit.zdb_id: 2019600-3

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Factors Predicting Visual Acuity Outcome in Intermediate, Posterior, and Panuveitis: The Multicenter Uveitis Steroid Treatment (MUST) Trial

Kempen, John H. ; Van Natta, Mark L. ; Altaweel, Michael M. ; [et al.]

Elsevier BV ; 2015

In: American Journal of Ophthalmology Vol. 160, No. 6 ( 2015-12), p. 1133-1141.e9

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In: American Journal of Ophthalmology, Elsevier BV, Vol. 160, No. 6 ( 2015-12), p. 1133-1141.e9

Type of Medium: Online Resource

ISSN: 0002-9394

URL: Article

DOI: 10.1016/j.ajo.2015.09.017

RVK:

XA 19500

RVK:

XA 10000

Language: English

Publisher: Elsevier BV

Publication Date: 2015

detail.hit.zdb_id: 2019600-3

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Four-Year Visual Outcomes in the Protocol W Randomized Trial of Intravitreous Aflibercept for Prevention of Vision-Threatening Complications of Diabetic Retinopathy

Maturi, Raj K. ; Glassman, Adam R. ; Josic, Kristin ; [et al.]

American Medical Association (AMA) ; 2023

In: JAMA Vol. 329, No. 5 ( 2023-02-07), p. 376-

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In: JAMA, American Medical Association (AMA), Vol. 329, No. 5 ( 2023-02-07), p. 376-

Abstract: Anti–vascular endothelial growth factor (VEGF) injections in eyes with nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) reduce development of vision-threatening complications from diabetes over at least 2 years, but whether this treatment has a longer-term benefit on visual acuity is unknown. Objective To compare the primary 4-year outcomes of visual acuity and rates of vision-threatening complications in eyes with moderate to severe NPDR treated with intravitreal aflibercept compared with sham. The primary 2-year analysis of this study has been reported. Design, Setting, and Participants Randomized clinical trial conducted at 64 clinical sites in the US and Canada from January 2016 to March 2018, enrolling 328 adults (399 eyes) with moderate to severe NPDR (Early Treatment Diabetic Retinopathy Study [ETDRS] severity level 43-53) without CI-DME. Interventions Eyes were randomly assigned to 2.0 mg aflibercept (n = 200) or sham (n = 199). Eight injections were administered at defined intervals through 2 years, continuing quarterly through 4 years unless the eye improved to mild NPDR or better. Aflibercept was given in both groups to treat development of high-risk proliferative diabetic retinopathy (PDR) or CI-DME with vision loss. Main Outcomes and Measures Development of PDR or CI-DME with vision loss (≥10 letters at 1 visit or ≥5 letters at 2 consecutive visits) and change in visual acuity (best corrected ETDRS letter score) from baseline to 4 years. Results Among participants (mean age 56 years; 42.4% female; 5% Asian, 15% Black, 32% Hispanic, 45% White), the 4-year cumulative probability of developing PDR or CI-DME with vision loss was 33.9% with aflibercept vs 56.9% with sham (adjusted hazard ratio, 0.40 [97.5% CI, 0.28 to 0.57] ; P & amp;lt; .001). The mean (SD) change in visual acuity from baseline to 4 years was −2.7 (6.5) letters with aflibercept and −2.4 (5.8) letters with sham (adjusted mean difference, −0.5 letters [97.5% CI, −2.3 to 1.3]; P = .52). Antiplatelet Trialists’ Collaboration cardiovascular/cerebrovascular event rates were 9.9% (7 of 71) in bilateral participants, 10.9% (14 of 129) in unilateral aflibercept participants, and 7.8% (10 of 128) in unilateral sham participants. Conclusions and Relevance Among patients with NPDR but without CI-DME, at 4 years treatment with aflibercept vs sham, initiating aflibercept treatment only if vision-threatening complications developed, resulted in statistically significant anatomic improvement but no improvement in visual acuity. Aflibercept as a preventive strategy, as used in this trial, may not be generally warranted for patients with NPDR without CI-DME. Trial Registration ClinicalTrials.gov Identifier: NCT02634333

Type of Medium: Online Resource

ISSN: 0098-7484

URL: Article

DOI: 10.1001/jama.2022.25029

RVK:

XA 10000

Language: English

Publisher: American Medical Association (AMA)

Publication Date: 2023

detail.hit.zdb_id: 2958-0

detail.hit.zdb_id: 2018410-4

SSG: 5,21

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Diagnostic accuracy of antigen detection in urine and molecular assays testing in different clinical samples for the diagnosis of progressive disseminated histoplasmosis in patients living with HIV/AIDS: A prospective multicenter study in Mexico

Martínez-Gamboa, Areli ; Niembro-Ortega, María Dolores ; Torres-González, Pedro ; [et al.]

Public Library of Science (PLoS) ; 2021

In: PLOS Neglected Tropical Diseases Vol. 15, No. 3 ( 2021-3-8), p. e0009215-

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In: PLOS Neglected Tropical Diseases, Public Library of Science (PLoS), Vol. 15, No. 3 ( 2021-3-8), p. e0009215-

Abstract: The progressive disseminated histoplasmosis (PDH) has been associated with severe disease and high risk of death among people living with HIV (PLWHIV). Therefore, the purpose of this multicenter, prospective, double-blinded study done in ten Mexican hospitals was to determine the diagnostic accuracy of detecting Histoplasma capsulatum antigen in urine using the IMMY ALPHA Histoplasma EIA kit (IAHE), clarus Histoplasma GM Enzyme Immunoassay (cHGEI IMMY) and MiraVista Histoplasma Urine Antigen LFA (MVHUALFA); as well as the Hcp100 and 1281-1283 220 SCAR nested PCRs in blood, bone-marrow, tissue biopsies and urine. Methodology/Principal findings We included 415 PLWHIV older than 18 years of age with suspicion of PDH. Using as diagnostic standard recovery of H . capsulatum in blood, bone marrow or tissue cultures, or histopathological exam compatible, detected 108 patients (26%, [95%CI, 21.78–30.22]) with proven-PDH. We analyzed 391 urine samples by the IAHE, cHGEI IMMY and MVHUALFA; the sensitivity/specificity values obtained were 67.3% (95% CI, 57.4–76.2) / 96.2% (95% CI, 93.2–98.0) for IAHE, 91.3% (95% CI, 84.2–96.0) / 90.9% (95% CI, 87.0–94.0) for cHGEI IMMY and 90.4% (95% CI, 83.0–95.3) / 92.3% (95% CI, 88.6–95.1) for MVHUALFA. The Hcp100 nested PCR was performed on 393, 343, 75 and 297, blood, bone marrow, tissue and urine samples respectively; the sensitivity/specificity values obtained were 62.9% (95%CI, 53.3–72.5)/ 89.5% (95%CI, 86.0–93.0), 65.9% (95%CI, 56.0–75.8)/ 89.0% (95%CI, 85.2–92.9), 62.1% (95%CI, 44.4–79.7)/ 82.6% (95%CI, 71.7–93.6) and 34.9% (95%CI, 24.8–46.2)/ 67.3% (95%CI, 60.6–73.5) respectively; and 1281-1283 220 SCAR nested PCR was performed on 392, 344, 75 and 291, respectively; the sensitivity/specificity values obtained were 65.3% (95% CI, 55.9–74.7)/ 58.8% (95%CI, 53.2–64.5), 70.8% (95%CI, 61.3–80.2)/ 52.9% (95%CI, 46.8–59.1), 71.4% (95%CI, 54.7–88.2)/ 40.4% (95%CI, 26.4–54.5) and 18.1% (95%CI, 10.5–28.1)/ 90.4% (95%CI, 85.5–94.0), respectively. Conclusions/Significance The cHGEI IMMY and MVHUALFA tests showed excellent performance for the diagnosis of PDH in PLWHIV. The integration of these tests in clinical laboratories will certainly impact on early diagnosis and treatment.

Type of Medium: Online Resource

ISSN: 1935-2735

URL: Article

DOI: 10.1371/journal.pntd.0009215

DOI: 10.1371/journal.pntd.0009215.g001

DOI: 10.1371/journal.pntd.0009215.g002

DOI: 10.1371/journal.pntd.0009215.g003

DOI: 10.1371/journal.pntd.0009215.g004

DOI: 10.1371/journal.pntd.0009215.g005

DOI: 10.1371/journal.pntd.0009215.t001

DOI: 10.1371/journal.pntd.0009215.t002

DOI: 10.1371/journal.pntd.0009215.t003

DOI: 10.1371/journal.pntd.0009215.t004

DOI: 10.1371/journal.pntd.0009215.t005

DOI: 10.1371/journal.pntd.0009215.s001

DOI: 10.1371/journal.pntd.0009215.s002

DOI: 10.1371/journal.pntd.0009215.s003

DOI: 10.1371/journal.pntd.0009215.r001

DOI: 10.1371/journal.pntd.0009215.r002

DOI: 10.1371/journal.pntd.0009215.r003

DOI: 10.1371/journal.pntd.0009215.r004

Language: English

Publisher: Public Library of Science (PLoS)

Publication Date: 2021

detail.hit.zdb_id: 2429704-5

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Reacciones adversas a las vacunas

Matos-Alviso, Luis Jorge ; Reyes-Gómez, Ulises ; Reyes-Hernández, Katy Lizeth ; [et al.]

GRAPHIMEDIC SA DE CV ; 2023

In: Salud Jalisco Vol. 10, No. 2 ( 2023), p. 119-122

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In: Salud Jalisco, GRAPHIMEDIC SA DE CV, Vol. 10, No. 2 ( 2023), p. 119-122

Type of Medium: Online Resource

ISSN: 2448-8747

URL: Article

DOI: 10.35366/112491

Language: Spanish

Publisher: GRAPHIMEDIC SA DE CV

Publication Date: 2023

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Effect of Convalescent Plasma on Organ Support–Free Days in Critically Ill Patients With COVID-19 : A Randomized Clinical Trial

Writing Committee for the REMAP-CAP Investigators ; Abdelhady, Hesham ; Abdelrazik, Marwa ; [et al.]

American Medical Association (AMA) ; 2021

In: JAMA Vol. 326, No. 17 ( 2021-11-02), p. 1690-

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In: JAMA, American Medical Association (AMA), Vol. 326, No. 17 ( 2021-11-02), p. 1690-

Type of Medium: Online Resource

ISSN: 0098-7484

URL: Article

DOI: 10.1001/jama.2021.18178

RVK:

XA 10000

Language: English

Publisher: American Medical Association (AMA)

Publication Date: 2021

detail.hit.zdb_id: 2958-0

detail.hit.zdb_id: 2018410-4

SSG: 5,21

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