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1.
HIV Med ; 24(5): 616-619, 2023 05.
Article in English | MEDLINE | ID: mdl-36478347

ABSTRACT

BACKGROUND: The study analysed 1711 patients of the Hospital for Infectious Diseases in Warsaw diagnosed with HIV infection in 2008-2010 and 2016-2018. Research was conducted examining the changes in CD4 cell counts before starting antiretroviral (ARV) treatment in order to find people who were misclassified as late-diagnosed. METHODS: Patients with late diagnosis were distinguished on the basis of the consensus definition. The Mann-Whitney U-test was used to analyse the change in CD4 cell counts before starting ARV treatment. RESULTS: In the years 2008-2010, the CD4 count was remeasured before starting ARV treatment in 90 late-diagnosed patients. The median change in the CD4 count was 22 cells/µL. In 49 of these, the number of CD4 cells spontaneously increased before the start of treatment. We can suspect that these patients were misclassified as late-diagnosed. CONCLUSIONS: The consensus definition of late diagnosis often leads to overestimation of the number of late-diagnosed patients. The crucial problem is a transient decline in the CD4 lymphocyte count in the acute phase of HIV infection. A potential solution is to introduce serum HIV viral load measurement into the definition.


Subject(s)
HIV Infections , Humans , HIV Infections/diagnosis , HIV Infections/drug therapy , Delayed Diagnosis , CD4 Lymphocyte Count , CD4-Positive T-Lymphocytes , Anti-Retroviral Agents/therapeutic use , Viral Load
2.
Crit Care ; 26(1): 207, 2022 07 07.
Article in English | MEDLINE | ID: mdl-35799300

ABSTRACT

BACKGROUND: Substantial interstudy heterogeneity exists in defining acute kidney injury (AKI) and baseline serum creatinine (SCr). This study assessed AKI incidence and its association with pediatric intensive care unit (PICU) mortality under different AKI and baseline SCr definitions to determine the preferable approach for diagnosing pediatric AKI. METHODS: In this multicenter prospective observational cohort study, AKI was defined and staged according to the Kidney Disease: Improving Global Outcome (KDIGO), modified KDIGO, and pediatric reference change value optimized for AKI (pROCK) definitions. The baseline SCr was calculated based on the Schwartz formula or estimated as the upper normative value (NormsMax), admission SCr (AdmSCr) and modified AdmSCr. The impacts of different AKI definitions and baseline SCr estimation methods on AKI incidence, severity distribution and AKI outcome were evaluated. RESULTS: Different AKI definitions and baseline SCr estimates led to differences in AKI incidence, from 6.8 to 25.7%; patients with AKI across all definitions had higher PICU mortality ranged from 19.0 to 35.4%. A higher AKI incidence (25.7%) but lower mortality (19.0%) was observed based on the Schwartz according to the KDIGO definition, which however was overcome by modified KDIGO (AKI incidence: 16.3%, PICU mortality: 26.1%). Furthermore, for the modified KDIGO, the consistencies of AKI stages between different baseline SCr estimation methods were all strong with the concordance rates > 90.0% and weighted kappa values > 0.8, and PICU mortality increased pursuant to staging based on the Schwartz. When the NormsMax was used, the KDIGO and modified KDIGO led to an identical AKI incidence (13.6%), but PICU mortality did not differ among AKI stages. For the pROCK, PICU mortality did not increase pursuant to staging and AKI stage 3 was not associated with mortality after adjustment for confounders. CONCLUSIONS: The AKI incidence and staging vary depending on the definition and baseline SCr estimation method used. The modified KDIGO definition based on the Schwartz method leads AKI to be highly relevant to PICU mortality, suggesting that it may be the preferable approach for diagnosing AKI in critically ill children and provides promise for improving clinicians' ability to diagnose pediatric AKI.


Subject(s)
Acute Kidney Injury , Critical Illness , Acute Kidney Injury/diagnosis , Acute Kidney Injury/epidemiology , Child , Cohort Studies , Creatinine , Critical Illness/epidemiology , Humans , Prospective Studies , Retrospective Studies , Severity of Illness Index , Time Factors
3.
J Ultrasound Med ; 41(7): 1657-1666, 2022 Jul.
Article in English | MEDLINE | ID: mdl-34668582

ABSTRACT

OBJECTIVES: Per a recent expert definition, diagnosis of selective fetal growth restriction (sFGR) in monochorionic diamniotic twins is based on an estimated fetal weight (EFW) <3% as sole criterion and/or combinations of 4 contributory criteria (1 twin EFW <10%; 1 twin abdominal circumference <10%; EFW discordance ≥25%; and smaller twin umbilical artery [UA] pulsatility index >95th percentile). We assessed these criteria in sFGR Type III (intermittent absent or reversed end-diastolic flow of the UA [iAREDF]) patients to test whether meeting the more stringent parameters of the consensus definition had worse outcomes, that is, progression to sFGR Type II (persistent AREDF) or twin-twin transfusion syndrome; or secondarily, decreased dual survivorship. METHODS: This was a retrospective study of referred sFGR Type III patients (2006-2017). Patients were retrospectively categorized using consensus criteria for 2 comparisons: 1) EFW <3% versus remaining cohort; 2) EFW <3% or met all 4 contributory criteria versus remaining cohort. RESULTS: Forty-eight patients were studied. Comparison 1: EFW <3% patients (58.3%) were not more likely to demonstrate disease progression (46.4% versus 65.0%, P = .2489) or worse dual survivorship (78.6% versus 85.0%, P = .7161). Comparison 2: EFW <3% or met all 4 contributory criteria (75.0%) patients were not more likely than the others to demonstrate progression (44.4% versus 83.3%, P = .0235) or worse dual survivorship (80.6% versus 83.3%, P = 1.0000). CONCLUSIONS: In a referred cohort of sFGR Type III patients, there was no evidence that meeting more stringent parameters of the consensus definition was associated with disease progression or dual survivorship.


Subject(s)
Fetal Growth Retardation , Ultrasonography, Prenatal , Consensus , Disease Progression , Female , Fetal Growth Retardation/diagnostic imaging , Fetal Weight , Gestational Age , Humans , Pregnancy , Pregnancy, Twin , Retrospective Studies , Twins, Monozygotic , Umbilical Arteries/diagnostic imaging
4.
Clin Invest Med ; 44(2): E71-76, 2021 06 14.
Article in English | MEDLINE | ID: mdl-34152710

ABSTRACT

PURPOSE: To solve complex health issues, an innovative and multidisciplinary framework is necessary. The Clinical Public Health (CPH) Division was established at the University of Toronto (UofT), Canada to foster inte-gration of primary care, preventive medicine and public health in education, practice and research. To better understand how the construct of CPH might be applied, we surveyed clinicians, researchers and public health professionals affiliated with the CPH Division to assess their understanding of the CPH concept and its utility in fostering broad collaboration. METHODS: A two-wave anonymous survey of the active faculty of the CPH Division, UofT was conducted across Canada. Wave 1 participants (n = 187; 2016) were asked to define CPH, while Wave 2 participants (n = 192; 2017) were provided a synthesis of Wave 1 results and asked to rank each definition. Both waves were asked about the need for a common definition, and to comment on CPH. RESULTS: Response rates for the first and second waves were 25% and 22%, respectively. Of the six definitions of CPH from Wave 1, "the intersection of clinical practice and public health," was most highly ranked by Wave 2 participants. Positive perceptions of CPH included multidisciplinary collaboration, new fields and insights, forward thinking and innovation. Negative perceptions included CPH being a confusing term, too narrow in scope or too clinical. CONCLUSION: The concept of Clinical Public Health can foster multidisciplinary collaboration to address com-plex health issues because it provides a useful framework for bringing together key disciplines and diverse professional specialties.


Subject(s)
Public Health , Canada , Humans , Surveys and Questionnaires
5.
Colorectal Dis ; 22(3): 331-341, 2020 03.
Article in English | MEDLINE | ID: mdl-32037685

ABSTRACT

AIM: Low anterior resection syndrome (LARS) is pragmatically defined as disordered bowel function after rectal resection leading to a detriment in quality of life. This broad characterization does not allow for precise estimates of prevalence. The LARS score was designed as a simple tool for clinical evaluation of LARS. Although the LARS score has good clinical utility, it may not capture all important aspects that patients may experience. The aim of this collaboration was to develop an international consensus definition of LARS that encompasses all aspects of the condition and is informed by all stakeholders. METHOD: This international patient-provider initiative used an online Delphi survey, regional patient consultation meetings, and an international consensus meeting. Three expert groups participated: patients, surgeons and other health professionals from five regions (Australasia, Denmark, Spain, Great Britain and Ireland, and North America) and in three languages (English, Spanish, and Danish). The primary outcome measured was the priorities for the definition of LARS. RESULTS: Three hundred twenty-five participants (156 patients) registered. The response rates for successive rounds of the Delphi survey were 86%, 96% and 99%. Eighteen priorities emerged from the Delphi survey. Patient consultation and consensus meetings refined these priorities to eight symptoms and eight consequences that capture essential aspects of the syndrome. Sampling bias may have been present, in particular, in the patient panel because social media was used extensively in recruitment. There was also dominance of the surgical panel at the final consensus meeting despite attempts to mitigate this. CONCLUSION: This is the first definition of LARS developed with direct input from a large international patient panel. The involvement of patients in all phases has ensured that the definition presented encompasses the vital aspects of the patient experience of LARS. The novel separation of symptoms and consequences may enable greater sensitivity to detect changes in LARS over time and with intervention.


Subject(s)
Postoperative Complications , Rectal Neoplasms , Consensus , Humans , Quality of Life , Syndrome
6.
HIV Med ; 17(3): 231-4, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26222266

ABSTRACT

OBJECTIVES: In 2011, a consensus was reached defining "late presenters" (LPs) as individuals presenting for care with a CD4 count < 350 cells/µL or with an AIDS-defining event, regardless of CD4 count. However, a transient low CD4 count is not uncommon in recent infections. The objective of this study was to investigate how measurements of late presentation change if the clinical stage at the time of diagnosis is taken into account. METHODS: Case surveillance data for newly diagnosed patients in Belgium in 1998-2012 were analysed, including CD4 count at diagnosis, the presence of AIDS-defining events, and recent infections (< 6 months) as reported by clinicians in the case of acute illness or a recent negative test. First, proportions of LPs were calculated according to the consensus definition. Secondly, LPs were reclassified as "nonlate" if infections were reported as recent. RESULTS: A total of 7949 HIV diagnoses were included in the study. Recent infections were increasingly reported over time, accounting for 8.2% of new infections in 1998 and 37.5% in 2012. The consideration of clinical stage significantly modified the proportion of LPs: 18.2% of men who have sex with men (MSM) diagnosed in 2012 would be classified as LPs instead of 30.9% using the consensus definition (P < 0.001). The proportion of patients misclassified as LPs increased significantly over time: 5% in MSM in 1998 vs. 41% in 2012. CONCLUSIONS: This study suggests that low CD4 counts in recent infections may lead to overestimation of late presentation when applying the consensus definition. The impact of transient CD4 count on late presentation estimates should be assessed and, if relevant, the introduction of clinical stage in the definition of late presentation should be considered.


Subject(s)
HIV Infections/diagnosis , HIV Infections/epidemiology , Belgium/epidemiology , CD4 Lymphocyte Count , Consensus , Delayed Diagnosis/statistics & numerical data , HIV Infections/pathology , Homosexuality, Male/statistics & numerical data , Humans , Male , Risk Factors
7.
Am J Surg ; 228: 192-198, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38616968

ABSTRACT

Background: Despite the widespread use of ultra-massive transfusion (UMT) as an intervention for trauma patients in hemorrhagic shock, no standard definition exists. We performed a systematic review to determine a consensus definition for UMT. Methods: A search was performed from 1979-2022. The authors screened studies defining UMT and associated outcomes as defined by our prespecified PICO questions. The PRISMA guidelines were used. Results: 1662 articles met criteria for eligibility assessment, 17 for full-text review and eight for data extraction. Only two studies demonstrated a consensus definition of UMT, which used ≥20 units of red blood cell product within 24hrs. Parameters associated with increased mortality included lower blood pressure, lower pulse and lower Glasgow Coma Score at the time of presentation and a higher injury severity score and undergoing a resuscitative thoracotomy. Conclusions: The absence of a consensus definition for UMT raises challenges from clinical, research and ethical perspectives. Based on our findings, the authors advocate for the feasibility of standardizing the definition of UMT as ≥20 units of red blood cell product within 24hrs.


Subject(s)
Blood Transfusion , Hypotension , Humans , Consensus , Heart Rate , Injury Severity Score
8.
Res Social Adm Pharm ; 20(6): 52-64, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38423929

ABSTRACT

BACKGROUND: Medication review practices have evolved internationally in a direction in which not only physicians but also other healthcare professionals conduct medication reviews according to agreed practices. Collaborative practices have increasingly highlighted the need for electronic joint platforms where information on medication regimens and their implementation can be documented, kept updated, and shared. OBJECTIVE: The aim of this study was to harmonize the definition of medication reviews and create a unified conceptual basis for their collaborative implementation and documentation in electronic patient records (definition appellation: collaborative medication review). METHODS: The study was conducted using the Delphi consensus survey with three interprofessional expert panel rounds in September-December 2020. The consensus rate was set at 80%. Experts assessed the proposed definition of collaborative medication review based on an international and national inventory of medication review definitions. The expert panel (n = 41) involved 12 physicians, 13 pharmacists, 10 nurses, and six information management professionals. The range of response rates for the rounds was 63-88%. RESULTS: The experts commented on which of the pre-selected items (n = 75) characterizing medication reviews should be included in the definition of collaborative medication review. The items were divided into the following five themes and 51 of them reached consensus: 1) Actions included in the collaborative medication review (n = 24/24), 2) Settings where the review should be conducted (n = 5/5), 3) Situations where the review should be considered as needed and carried out (n = 10/11), 4) Prioritization of top five benefits to be achieved by the review and 5) Prioritization of top five patient groups to whom the review should be targeted. CONCLUSIONS: A strong interprofessional consensus was reached on the definition of collaborative medication review. The most challenging was to identify individual patient groups benefiting from the review.


Subject(s)
Consensus , Delphi Technique , Documentation , Electronic Health Records , Humans , Male , Female , Health Personnel , Cooperative Behavior , Pharmacists/organization & administration , Medication Reconciliation
9.
Injury ; 55(2): 111179, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37972489

ABSTRACT

INTRODUCTION: Fracture-related infections (FRIs) are a major cause of trauma-associated morbidity worldwide. In 2018, an expert group supported by the AO Foundation, European Bone and Joint Infection Society developed a consensus definition of FRI. Still, there is limited knowledge on the applicability of this definition in low- and middle-income countries (LMICs). Given the unique barriers that cause low follow-up rates for orthopaedic trauma patients in LMICs, this study aims to evaluate the diagnostic performance of a telephone questionnaire in identifying patients with FRIs after open tibia fracture fixation in Tanzania. MATERIALS AND METHODS: Patients from a randomized controlled trial investigating the infection prevention benefit of locally applied gentamycin for open tibial fractures were included. Patients completed FRI based telephone questionnaires 7-10 days prior to scheduled follow-ups at 6 weeks, 3 months, 6 months, 9 months, and 1 year. The questionnaire included two "confirmatory" criteria questions for FRI (i.e., open wound and purulent drainage) and three "suggestive" criteria questions (i.e., wound drainage, fever, and warmth). Contingency tests were performed to identify the sensitivity and specificity between answers and adjudicated FRI diagnoses at the corresponding in-person follow-up. Data was analysed using STATA version 15.0 and MedCalc's online diagnostic test calculator. RESULTS: There were a total of 234 complete questionnaires and 85 unique patients included. The sensitivity and specificity of having any positive answer in the questionnaire was highest at 6 months (100 % and 92.5 %, respectively). For all time-points pooled, sensitivity was 71.4 % and specificity was 93.0 %. Drainage had the highest sensitivity (71.4 %) while fever had the highest specificity (99.6 %). For confirmatory criteria, sensitivity was 14.3 % and specificity was 96.0 %. Contrastingly, the sensitivity for suggestive criteria was higher (71.4 %), with a similar specificity (93.8 %). CONCLUSION: Our study indicates that telephone questionnaires have adequate diagnostic performance when assessing FRIs. The presence of drainage identified the majority of patients with FRI, and specificities were high across confirmatory and suggestive criteria. Our study is one of the first to evaluate telephone questionnaires as a diagnostic tool for FRIs in patients with open tibia fractures in a LMIC hospital and validates the FRI consensus definition criteria.


Subject(s)
Fractures, Open , Tibial Fractures , Humans , Tibia , Tanzania/epidemiology , Fractures, Open/complications , Fractures, Open/diagnosis , Fractures, Open/surgery , Tibial Fractures/complications , Tibial Fractures/surgery , Surveys and Questionnaires , Retrospective Studies
10.
J Sex Med ; 10(10): 2506-17, 2013 Oct.
Article in English | MEDLINE | ID: mdl-23937679

ABSTRACT

AIM: To assess the efficacy and safety of the selective oxytocin receptor antagonist epelsiban in the treatment of premature ejaculation (PE). METHODS: Double-blind, randomized, parallel-group, placebo-controlled, stopwatch-monitored, phase 2, multicenter study (GSK557296; NCT01021553) conducted in men (N=77) 18-55 years of age, with PE defined as per International Society for Sexual Medicine consensus definition. Patients provided informed consent prior to a 4-week un-medicated run-in to determine baseline intravaginal ejaculatory latency times (IELT) recorded in an electronic diary. Patients needed to make a minimum of four intercourse attempts and have a mean IELT<65 seconds to be considered for randomization. Men with moderate-to-severe erectile dysfunction were excluded from the study. Eligible patients were randomized to placebo, epelsiban 50 mg, or 150 mg, taken 1 hour before sexual activity. Active treatment IELT times were recorded in an electronic diary, along with subjective measures of intercourse satisfaction, over an 8-week treatment period. The Modified Index of Premature Ejaculation and International Index of Erectile Function were completed at study visits. MAIN OUTCOME MEASURES: Stopwatch timed IELT recordings and a modified version of the patient-reported outcome questionnaire the IPE were used in this study to determine the effect of epelsiban when taken orally prior to intercourse in subjects diagnosed with PE. RESULTS: The baseline (mean) IELT for patients pretreatment was (0.52, 0.63, and 0.59 minutes) for placebo, epelsiban 50 mg and 150 mg, respectively. On-treatment, average geometric least squares means of the median IELT values (mean) were slightly higher in the 50 mg and 150 mg groups (0.72 and 0.69 minutes), respectively, vs. the placebo group (0.62 minutes). Headache was the most common adverse event, and rates were similar across all groups. CONCLUSIONS: Epelsiban 50 mg and 150 mg were well tolerated, but did not result in a clinically or statistically significant change in IELT in men with PE, compared with placebo.


Subject(s)
Diketopiperazines/therapeutic use , Ejaculation/drug effects , Hormone Antagonists/therapeutic use , Morpholines/therapeutic use , Premature Ejaculation/drug therapy , ATP Binding Cassette Transporter, Subfamily B , ATP Binding Cassette Transporter, Subfamily B, Member 1/genetics , ATP Binding Cassette Transporter, Subfamily B, Member 1/metabolism , Adult , Diketopiperazines/adverse effects , Diketopiperazines/pharmacokinetics , Double-Blind Method , Genotype , Hormone Antagonists/adverse effects , Hormone Antagonists/pharmacokinetics , Humans , Least-Squares Analysis , Male , Middle Aged , Morpholines/adverse effects , Morpholines/pharmacokinetics , Netherlands , Patient Satisfaction , Pharmacogenetics , Premature Ejaculation/diagnosis , Premature Ejaculation/metabolism , Premature Ejaculation/physiopathology , Premature Ejaculation/psychology , Reaction Time , Receptors, Oxytocin/antagonists & inhibitors , Receptors, Oxytocin/metabolism , Sexual Behavior/drug effects , Surveys and Questionnaires , Time Factors , Treatment Outcome , United States , Young Adult
11.
ESMO Open ; 8(6): 102067, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37988953

ABSTRACT

BACKGROUND: Small retrospective series suggest that local consolidative treatment (LCT) may improve survival in oligometastatic pancreatic ductal adenocarcinoma (PDAC). However, no uniform definition of oligometastatic disease (OMD) in PDAC exists; this impedes meaningful conclusions. PATIENTS AND METHODS: A systematic literature search using PubMed, Web of Science, and Cochrane CENTRAL registries for studies and protocols reporting on definitions and/or LCT of OMD in PDAC was performed. The primary endpoint was the definition of OMD. Levels of agreement were categorized as consensus (≥75% agreement between studies), fair agreement (50%-74%), and absent/poor agreement (<50%). RESULTS: After screening of 5374 abstracts, the full text of 218 studies was assessed, of which 76 were included in the qualitative synthesis. The majority of studies were retrospective (n = 66, 87%), two were prospective studies and eight were study protocols. Studies investigated mostly liver (n = 38, 51%) and lung metastases (n = 15, 20%). Across studies, less than one-half (n = 32, 42%) reported a definition of OMD, while 44 (58%) did not. Involvement was limited to a single organ (consensus). Additional criteria for defining OMD were the number of lesions (consensus), metastatic site (poor agreement), metastatic size (poor agreement), treatment possibilities (poor agreement), and biomarker response (poor agreement). Liver OMD could involve three or fewer lesions (consensus) and synchronous disease (fair agreement), while lung metastases could involve two or fewer lesions and metachronous disease (consensus). The large majority of studies were at a high risk of bias or did not include any control groups. CONCLUSION: Definitions of OMD were not used or varied widely between studies hampering across-study comparability and highlighting an unmet need for a consensus. The present study is part of a multistep process that aims to develop an interdisciplinary consensus on OMD in pancreatic cancer.


Subject(s)
Lung Neoplasms , Pancreatic Neoplasms , Humans , Retrospective Studies , Prospective Studies , Consensus , Lung Neoplasms/pathology , Pancreatic Neoplasms/therapy , Pancreatic Neoplasms/pathology
12.
Ann Med Surg (Lond) ; 73: 103224, 2022 Jan.
Article in English | MEDLINE | ID: mdl-35079364

ABSTRACT

INTRODUCTION: and background: Surgical options for Dupuytren's disease (DD) are multiple, and Dupuytren's palmar fasciectomy (PF) is a common surgical procedure performed for contractures that cause functional and cosmetic disability. The recurrence rate for PF has been reported to be very variable, ranging from 12 to 73%, according to various studies. One of the reasons for the varied range is the inconsistency in the method followed to define recurrence. Subsequently, a consensus-based definition was formulated in 2016, and we analysed the outcome in our series of patients treated with PF based on this standard definition. We also analysed the residual deformity associated in these cases. METHOD: ology: Our study is a retrospective analysis of 142 consecutive cases of primary Dupuytren's palmar fasciectomy by a single surgeon in three different centres. We followed the international consensus definition for analysing recurrence in these cases, and we also analysed residual cases as a separate entity. RESULTS: The mean age of the cases was 67.13 years and the mean follow-up period was 3.95 years. Alcoholism, smoking, diabetes and hypercholesterolemia were the commonest associated risk factors. The commonest affected finger and the finger with the maximum deformity were the little finger. The overall rate of recurrence of deformity was 3.5% and the rate of residual deformity was 30.3%. The overall complication rate was 11.9%. CONCLUSION: Recurrence and residual deformity can be considered as separate entities. The term 'residual deformity' can be used to denote patients with persisting deformity or those who incur deformity within one year of the primary surgery.

13.
Injury ; 53(6): 1867-1879, 2022 Jun.
Article in English | MEDLINE | ID: mdl-35331479

ABSTRACT

BACKGROUND: The recently developed fracture-related infection (FRI) consensus definition, which is based on specific diagnostic criteria, has not been fully validated in clinical studies. We aimed to determine the diagnostic performance of the criteria of the FRI consensus definition and evaluated the effect of the combination of certain suggestive and confirmatory criteria on the diagnostic performance. METHODS: A multicenter, multi-national, retrospective cohort study was performed. Patients were subdivided into an FRI or a control group, according to the treatment they received and the recommendations from a multidisciplinary team ('intention to treat'). Exclusion criteria were patients with an FRI diagnosed outside the study period, patients younger than 18 years of age, patients with pathological fractures or patients with fractures of the skull, cervical, thoracic and lumbar spine. Minimum follow up for all patients was 18 months. RESULTS: Overall, 637 patients underwent revision surgery for suspicion of FRI. Of these, 480 patients were diagnosed with FRI, treated accordingly, and included in the FRI group. The other 157 patients were included in the control group. The presence of at least one confirmatory sign was associated with a sensitivity of 97.5%, a specificity of 100% and a high discriminatory value (AUROC 0.99, p < 0.001). The presence of a clinical confirmatory criterion or, if not present, at least one positive culture was associated with the highest diagnostic performance (sensitivity: 98.6%, specificity: 100%, AUROC: 0.99 (p < 0.001)). In the subgroup of patients without clinical confirmatory signs at presentation, specificities of at least 95% were found for the clinical suggestive signs of fever, wound drainage, local warmth and redness. CONCLUSIONS: The presence of at least one confirmatory criterion identifies the vast majority of patients with an FRI and was associated with an excellent diagnostic discriminatory value. Therefore, our study validates the confirmatory criteria of the FRI consensus definition. Infection is highly likely in case of the presence of a single positive culture with a virulent pathogen. When certain clinical suggestive signs (e.g., wound drainage) are observed (individually or in combination and even without a confirmatory criterion), it is more likely than not, that an infection is present.


Subject(s)
Fractures, Bone , Fractures, Spontaneous , Consensus , Fractures, Bone/complications , Fractures, Bone/diagnosis , Fractures, Bone/surgery , Humans , Retrospective Studies , Surgical Wound Infection/diagnosis
14.
Clin Rheumatol ; 40(9): 3853-3858, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34169373

ABSTRACT

In the medical literature, there are only a few references on refractory fibromyalgia and there is no consensus definition available on this concept. Some definitions of refractory fibromyalgia have been proposed based on the lack of response to a number of medications, and perhaps the most appropriate term is treatment-refractory fibromyalgia. To achieve the definition of treatment-refractory fibromyalgia, it is necessary to consider several previous steps, such as making sure the diagnosis has been made properly and a differential diagnosis with entities that can mimic fibromyalgia symptoms (including complete physical examination and laboratory test) has been made. The possibility that another factor that alters the response to treatment should be investigated, and in particular review all prescribed medication and search for some non-medical reasons that could mask the response to treatment (e.g., legal compensation). The definition of refractory fibromyalgia is complex and probably should include a lack of response to a specified number of drugs or to combination therapy with at least two non-pharmacological measures. In this article, it is not our purpose to present a formal definition, but to raise the possible bases for this purpose. We believe that it is a subject that must be discussed extensively before reaching a consensus definition. Key Points • There is no appropriate definition to classify fibromyalgia patients who do not respond to the usual pharmacological and non-pharmacological measures according to the national or international guidelines. • A consensus definition is required to classify these patients, which could help standardize future management strategies. In this article, we propose the bases on which refractory fibromyalgia could be defined.


Subject(s)
Fibromyalgia , Combined Modality Therapy , Consensus , Fibromyalgia/diagnosis , Fibromyalgia/therapy , Humans
15.
OTA Int ; 3(1): e057, 2020 Mar.
Article in English | MEDLINE | ID: mdl-33937682

ABSTRACT

A precise definition of infection after fracture fixation is essential for the evaluation of published research data and for the future establishment of uniform treatment concepts. Recently, a multidisciplinary expert panel has developed a consensus definition that includes 4 confirmatory criteria for infection following fracture fixation. These criteria are: Fistula, sinus, or wound breakdown; purulent drainage or deep purulence at surgery; positive cultures from at least 2 separate deep tissue/implant specimens taken during an operative intervention; and microorganisms in deep tissue specimens confirmed by histopathological staining. The consensus panel also identified 6 categories of suggestive criteria which are features associated with infection that requires further investigation.

16.
ANZ J Surg ; 90(3): 300-307, 2020 03.
Article in English | MEDLINE | ID: mdl-32040983

ABSTRACT

BACKGROUND: Low anterior resection syndrome (LARS) is pragmatically defined as disordered bowel function after rectal resection leading to a detriment in quality of life. This broad characterization does not allow for precise estimates of prevalence. The LARS score was designed as a simple tool for clinical evaluation of LARS. Although the LARS score has good clinical utility, it may not capture all important aspects that patients may experience. The aim of this collaboration was to develop an international consensus definition of LARS that encompasses all aspects of the condition and is informed by all stakeholders. METHODS: This international patient-provider initiative used an online Delphi survey, regional patient consultation meetings and an international consensus meeting. Three expert groups participated: patients, surgeons and other health professionals from five regions (Australasia, Denmark, Spain, Great Britain and Ireland, and North America) and in three languages (English, Spanish and Danish). The primary outcome measured was the priorities for the definition of LARS. RESULTS: Three hundred and twenty-five participants (156 patients) registered. The response rates for successive rounds of the Delphi survey were 86%, 96% and 99%. Eighteen priorities emerged from the Delphi survey. Patient consultation and consensus meetings refined these priorities to eight symptoms and eight consequences that capture essential aspects of the syndrome. Sampling bias may have been present, in particular, in the patient panel because social media was used extensively in recruitment. There was also dominance of the surgical panel at the final consensus meeting despite attempts to mitigate this. CONCLUSIONS: This is the first definition of LARS developed with direct input from a large international patient panel. The involvement of patients in all phases has ensured that the definition presented encompasses the vital aspects of the patient experience of LARS. The novel separation of symptoms and consequences may enable greater sensitivity to detect changes in LARS over time and with intervention.


Subject(s)
Intestinal Diseases/diagnosis , Postoperative Complications/diagnosis , Rectal Neoplasms/surgery , Adult , Aged , Aged, 80 and over , Consensus , Female , Humans , International Cooperation , Male , Middle Aged , Syndrome
17.
J Am Geriatr Soc ; 68(7): 1410-1418, 2020 07.
Article in English | MEDLINE | ID: mdl-32150289

ABSTRACT

OBJECTIVES: To develop an evidence-based definition of sarcopenia that can facilitate identification of older adults at risk for clinically relevant outcomes (eg, self-reported mobility limitation, falls, fractures, and mortality), the Sarcopenia Definition and Outcomes Consortium (SDOC) crafted a set of position statements informed by a literature review and SDOC's analyses of eight epidemiologic studies, six randomized clinical trials, four cohort studies of special populations, and two nationally representative population-based studies. METHODS: Thirteen position statements related to the putative components of a sarcopenia definition, informed by the SDOC analyses and literature synthesis, were reviewed by an independent international expert panel (panel) iteratively and voted on by the panel during the Sarcopenia Position Statement Conference. Four position statements related to grip strength, three to lean mass derived from dual-energy x-ray absorptiometry (DXA), and four to gait speed; two were summary statements. RESULTS: The SDOC analyses identified grip strength, either absolute or scaled to measures of body size, as an important discriminator of slowness. Both low grip strength and low usual gait speed independently predicted falls, self-reported mobility limitation, hip fractures, and mortality in community-dwelling older adults. Lean mass measured by DXA was not associated with incident adverse health-related outcomes in community-dwelling older adults with or without adjustment for body size. CONCLUSION: The panel agreed that both weakness defined by low grip strength and slowness defined by low usual gait speed should be included in the definition of sarcopenia. These position statements offer a rational basis for an evidence-based definition of sarcopenia. The analyses that informed these position statements are summarized in this article and discussed in accompanying articles in this issue of the journal. J Am Geriatr Soc 68:1410-1418, 2020.


Subject(s)
Consensus , Hand Strength/physiology , Mobility Limitation , Sarcopenia/diagnosis , Walking Speed/physiology , Absorptiometry, Photon , Accidental Falls/statistics & numerical data , Aged , Aged, 80 and over , Female , Hip Fractures , Humans , Independent Living , Male , Mortality/trends , United States
18.
J Frailty Aging ; 8(2): 67-71, 2019.
Article in English | MEDLINE | ID: mdl-30997918

ABSTRACT

Multiple definitions of frailty are used. We sought to quantify the frequency that frailty is insufficiently defined in published abstracts. We conducted a systematic review of MEDLINE/PubMed for English abstracts of original research investigating frailty as an exposure or outcome in humans from 2015-2017. A complete definition of frailty included: 1) a named measure of frailty, including "frailty" alone, 2) details on variables included (e.g. grip strength), 3) number of variables included (e.g. 33-item frailty index), and 4) details on cutoffs or levels of frailty unless a definition was used continuously. Our search yielded 1,110 titles; 490 abstracts met review criteria, 348 abstracts had any definition of frailty and were included. Majority reported a single measure of frailty (n=313, 90%). The most commonly used measures were variations of Fried's phenotype (n=167, 48%) and Rockwood's cumulative deficit model (n=101, 29%). Only 56 abstracts had complete definitions (16%). In 123 abstracts (35%), a means of measuring frailty was named, but no additional details were given. When details of the frailty measure were described, they generally referred to cutoffs or levels rather than variables used in the measure. A minority of abstracts of original manuscripts related to frailty research had adequate definitions of frailty. We encourage scientists to adopt a standardized approach to defining the term for all abstracts related to frailty research to facilitate systematic reviews, meta-analysis, and accurate reporting of frailty science.


Subject(s)
Frailty , Research , Terminology as Topic , Humans , Research/standards
19.
J Thorac Oncol ; 14(12): 2109-2119, 2019 12.
Article in English | MEDLINE | ID: mdl-31398540

ABSTRACT

INTRODUCTION: Improved outcome has been shown in patients with synchronous oligometastatic (sOM) NSCLC when treated with radical intent. As a uniform definition of sOM NSCLC is lacking, we developed a definition and diagnostic criteria by a consensus process. METHODS: A pan-European multidisciplinary consensus group was established. Consensus questions were built on the basis of current controversies, and definitions were extracted from a survey, cases and a systematic review. This statement was formulated during a consensus meeting. RESULTS: It was determined that definition of sOM NSCLC is relevant when a radical treatment that may modify the disease course (leading to long-term disease control) is technically feasible for all tumor sites with acceptable toxicity. On the basis of the review, a maximum of five metastases and three organs was proposed. Mediastinal lymph node involvement was not counted as a metastatic site. Fludeoxyglucose F 18 positron emission tomography-computed tomography and brain imaging were considered mandatory. A dedicated liver magnetic resonance imaging scan was advised for a solitary liver metastasis, and thoracoscopy and biopsies of distant ipsilateral pleural sites were recommended for a solitary pleural metastasis. For mediastinal staging, fludeoxyglucose F 18 positron emission tomography-computed tomography was deemed the minimum requirement, with pathological confirmation recommended if this influences the treatment strategy. Biopsy of a solitary metastatic location was mandated unless the multidisciplinary team is of the opinion that the risks outweigh the benefits. CONCLUSION: A multidisciplinary consensus statement on the definition and staging of sOM NSCLC has been formulated. This statement will help to standardize inclusion criteria in future clinical trials.


Subject(s)
Carcinoma, Non-Small-Cell Lung/diagnosis , Lung Neoplasms/diagnosis , Carcinoma, Non-Small-Cell Lung/pathology , Consensus , Female , Humans , Lung Neoplasms/pathology , Male , Neoplasm Staging
20.
Injury ; 49(3): 505-510, 2018 Mar.
Article in English | MEDLINE | ID: mdl-28867644

ABSTRACT

Fracture-related infection (FRI) is a common and serious complication in trauma surgery. Accurately estimating the impact of this complication has been hampered by the lack of a clear definition. The absence of a working definition of FRI renders existing studies difficult to evaluate or compare. In order to address this issue, an expert group comprised of a number of scientific and medical organizations has been convened, with the support of the AO Foundation, in order to develop a consensus definition. The process that led to this proposed definition started with a systematic literature review, which revealed that the majority of randomized controlled trials in fracture care do not use a standardized definition of FRI. In response to this conclusion, an international survey on the need for and key components of a definition of FRI was distributed amongst all registered AOTrauma users. Approximately 90% of the more than 2000 surgeons who responded suggested that a definition of FRI is required. As a final step, a consensus meeting was held with an expert panel. The outcome of this process led to a consensus definition of FRI. Two levels of certainty around diagnostic features were defined. Criteria could be confirmatory (infection definitely present) or suggestive. Four confirmatory criteria were defined: Fistula, sinus or wound breakdown; Purulent drainage from the wound or presence of pus during surgery; Phenotypically indistinguishable pathogens identified by culture from at least two separate deep tissue/implant specimens; Presence of microorganisms in deep tissue taken during an operative intervention, as confirmed by histopathological examination. Furthermore, a list of suggestive criteria was defined. These require further investigations in order to look for confirmatory criteria. In the current paper, an overview is provided of the proposed definition and a rationale for each component and decision. The intention of establishing this definition of FRI was to offer clinicians the opportunity to standardize clinical reports and improve the quality of published literature. It is important to note that the proposed definition was not designed to guide treatment of FRI and should be validated by prospective data collection in the future.


Subject(s)
Consensus , Fractures, Bone/complications , Orthopedics , Osteomyelitis/classification , Surgical Wound Infection/classification , Checklist , Humans , Osteomyelitis/etiology , Terminology as Topic
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