Tag: statistics

BMJ Open. 2022 Sep 8;12(9):e065154. doi: 10.1136/bmjopen-2022-065154.

ABSTRACT

OBJECTIVE: To identify evidence on the reporting quality of consensus methodology and to select potential checklist items for the ACcurate COnsensus Reporting Document (ACCORD) project to develop a consensus reporting guideline.

DESIGN: Systematic review.

DATA SOURCES: Embase, MEDLINE, Web of Science, PubMed, Cochrane Library, Emcare, Academic Search Premier and PsycINFO from inception until 7 January 2022.

ELIGIBILITY CRITERIA: Studies, reviews and published guidance addressing the reporting quality of consensus methodology for improvement of health outcomes in biomedicine or clinical practice. Reports of studies using or describing consensus methods but not commenting on their reporting quality were excluded. No language restrictions were applied.

DATA EXTRACTION AND SYNTHESIS: Screening and data extraction of eligible studies were carried out independently by two authors. Reporting quality items addressed by the studies were synthesised narratively.

RESULTS: Eighteen studies were included: five systematic reviews, four narrative reviews, three research papers, three conference abstracts, two research guidance papers and one protocol. The majority of studies indicated that the quality of reporting of consensus methodology could be improved. Commonly addressed items were: consensus panel composition; definition of consensus and the threshold for achieving consensus. Items least addressed were: public patient involvement (PPI); the role of the steering committee, chair, cochair; conflict of interest of panellists and funding. Data extracted from included studies revealed additional items that were not captured in the data extraction form such as justification of deviation from the protocol or incentives to encourage panellist response.

CONCLUSION: The results of this systematic review confirmed the need for a reporting checklist for consensus methodology and provided a range of potential checklist items to report. The next step in the ACCORD project builds on this systematic review and focuses on reaching consensus on these items to develop the reporting guideline.

PROTOCOL REGISTRATION: https://osf.io/2rzm9.

PMID:36201247 | DOI:10.1136/bmjopen-2022-065154

JAMA Netw Open. 2022 Oct 3;5(10):e2235089. doi: 10.1001/jamanetworkopen.2022.35089.

ABSTRACT

IMPORTANCE: A new International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code (U09.9 Post COVID-19 condition, unspecified) was introduced by the Centers for Disease Control and Prevention on October 1, 2021.

OBJECTIVE: To examine the use of the U09.9 code and describe concurrently diagnosed conditions to understand physician use of this code in clinical practice.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study of US patients with an ICD-10-CM code for post-COVID-19 condition used deidentified patient-level claims data aggregated by HealthVerity. Children and adolescents (aged 0-17 years) and adults (aged 18-64 and ≥65 years) with a post-COVID-19 condition code were identified between October 1, 2021, and January 31, 2022. To identify a prior COVID-19 diagnosis, 3 months of continuous enrollment (CE) before the post-COVID-19 diagnosis date was required.

MAIN OUTCOMES AND MEASURES: Presence of the ICD-10-CM U09.9 code.

RESULTS: There were 56 143 patients (7723 female patients [61.2%]; mean [SD] age, 47.6 [19.2] years) with a post-COVID-19 diagnosis code, with cases increasing in mid-December 2021 following the trajectory of the Omicron case wave by 3 to 4 weeks. The analysis cohort included 12 622 patients after the 3-month preindex CE criteria was applied. Among this cohort, the median (IQR) age was 49 (35-61) years; however, 1080 (8.6%) were pediatric patients. The U09.9 code was used most often in the outpatient setting, although 305 older adults (14.0%) were inpatients. Only 698 patients (5.5%) had at least 1 of the 5 codes listed as possible concurrent conditions in the coding guidance. Only 8879 patients (70.4%) had a documented acute COVID-19 diagnosis code (569 [52.7%] among children), and the median (IQR) time between acute COVID-19 and post-COVID-19 diagnosis codes was 56 (21-200) days. The most common concurrently coded conditions varied by age; children experienced COVID-19-like symptoms (eg, 207 [19.2%] had cough and 115 [10.6%] had breathing abnormalities), while 459 older adults aged 65 years or older (21.1%) experienced respiratory failure and 189 (8.7%) experienced viral pneumonia.

CONCLUSIONS AND RELEVANCE: This retrospective cohort study found patients with a post-COVID-19 ICD-10-CM diagnosis code following the acute phase of COVID-19 disease among patients of all ages in clinical practice in the US. The use of the U09.9 code encompassed a wide range of conditions. It will be important to monitor how the use of this code changes as the pandemic continues to evolve.

PMID:36201207 | DOI:10.1001/jamanetworkopen.2022.35089

JAMA Otolaryngol Head Neck Surg. 2022 Oct 6. doi: 10.1001/jamaoto.2022.2551. Online ahead of print.

ABSTRACT

IMPORTANCE: Venous thromboembolism (VTE) is a severe complication after free tissue transfer to the head and neck (H&N). Enoxaparin 30 mg twice daily (BID) is a common regimen for chemoprophylaxis. However, differences in enoxaparin metabolism based on body weight may influence its efficacy and safety profile.

OBJECTIVE: To assess the association between BMI and postoperative VTE and hematoma rates in patients treated with prophylactic enoxaparin 30 mg BID.

DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective review of a prospectively collected cohort from 2012 to 2022. Postoperative VTE, hematoma, and free flap pedicle thrombosis were recorded within 30 days of index surgery. The setting was a tertiary academic referral center. Participants included patients undergoing H&N reconstruction with free flaps that received fixed-dose subcutaneous enoxaparin 30 mg BID postoperatively. Statistical analysis was conducted from April to May 2022.

MAIN OUTCOMES AND MEASURES: Outcomes include incidence of VTE, hematoma, and flap pedicle thrombosis events within 30 days of the surgery. Univariate and multivariable regression models were used to evaluate associations between BMI and other patient factors with these outcomes.

RESULTS: Among the 765 patients included, 262 (34.24%) were female; mean (SD) age was 60.85 (12.64) years; and mean (SD) BMI was 26.36 (6.29). The rates of VTE and hematoma in the cohort were 3.92% (30 patients) and 5.09% (39 patients), respectively. After adjusting for patient factors, BMI was the only factor associated with VTE (OR, 1.07; 95% CI, 1.015-1.129). Obesity (BMI >30) was associated with increased odds of VTE (OR, 2.782; 95% CI, 1.197-6.564). Hematoma was not associated with BMI (OR, 0.988; 95% CI, 0.937-1.041). Caprini score of at least 9 was not associated with VTE (OR, 1.259; 95% CI, 0.428-3.701).

CONCLUSIONS AND RELEVANCE: This cohort study found that obesity was associated with an increased risk of VTE in patients after microvascular H&N reconstruction and while on standard postoperative chemoprophylaxis regimens. This association may suggest insufficient VTE prophylaxis in this group and a potential indication for weight-based dosing.

PMID:36201206 | DOI:10.1001/jamaoto.2022.2551

JAMA Ophthalmol. 2022 Oct 6:1-10. doi: 10.1001/jamaophthalmol.2022.3788. Online ahead of print.

ABSTRACT

IMPORTANCE: Anti-vascular endothelial growth factor (VEGF) therapy for retinopathy of prematurity (ROP) has potential ocular and systemic advantages compared with laser, but we believe the systemic risks of anti-VEGF therapy in preterm infants are poorly quantified.

OBJECTIVE: To determine whether there was an association with increased risk of pulmonary hypertension (PH) in preterm infants with ROP following treatment with anti-VEGF therapy as compared with laser treatment.

DESIGN, SETTING, AND PARTICIPANTS: This multicenter retrospective cohort study took place at neonatal intensive care units of 48 children’s hospitals in the US in the Pediatric Health Information System database from 2010 to 2020. Participants included preterm infants with gestational age at birth 22 0/7 to 31 6/7 weeks who had ROP treated with anti-VEGF therapy or laser photocoagulation.

EXPOSURES: Anti-VEGF therapy vs laser photocoagulation.

MAIN OUTCOMES AND MEASURES: New receipt of pulmonary vasodilators at least 7 days after ROP therapy was compared between exposure groups, matched using propensity scores generated from preexposure variables, and adjusted for birth year and hospital. The odds of receiving an echocardiogram after 30 days of age was also included to adjust for secular trends and interhospital variation in PH screening.

RESULTS: Among 1577 patients (55.9% male) meeting inclusion criteria, 689 received laser photocoagulation and 888 received anti-VEGF treatment (95% bevacizumab, 5% ranibizumab). Patients were first treated for ROP at median 36.4 weeks’ postmenstrual age (IQR, 34.6-38.7). A total of 982 patients (491 in each group) were propensity score matched. Good covariate balance was achieved, as indicated by a model variance ratio of 1.15. More infants who received anti-VEGF therapy were treated for PH, but when adjusted for hospital and year, this was no longer statistically significant (6.7%; 95% CI, 2.6-6.9 vs 4.3% 95% CI, 4.4-10.2; adjusted odds ratio, 1.62; 95% CI, 0.90-2.89; P = .10).

CONCLUSIONS AND RELEVANCE: Anti-VEGF therapy was not associated with greater use of pulmonary vasodilators after adjustment for hospital and year. Our findings suggest exposure to anti-VEGF may be associated with PH, although we cannot exclude the possibility of residual confounding based on systemic comorbidities or hospital variation in practice. Future studies investigating this possible adverse effect seem warranted.

PMID:36201183 | DOI:10.1001/jamaophthalmol.2022.3788

JAMA Oncol. 2022 Oct 6. doi: 10.1001/jamaoncol.2022.3755. Online ahead of print.

ABSTRACT

IMPORTANCE: The pathologic complete response (pCR) is supported by regulatory agencies as a surrogate end point for long-term patients’ clinical outcomes in the accelerated approval process of new drugs tested in neoadjuvant randomized clinical trials (RCTs) for early breast cancer (BC). However, a meaningful association between pCR and patients’ survival has been proven only at the patient level (ie, significantly better survival of patients who achieved pCR compared with those who did not), but not at trial level (ie, poor association between degree of improvement in pCR rate and survival reported across trials).

OBSERVATIONS: We critically discuss the potential reasons of such discrepancy between pCR surrogacy value at the patient and trial level, as well as the relevant implications for both clinical research and drug regulatory policy. We also describe alternative surrogate end points, including combined end points that jointly analyzed pathological response and event-free survival data, or the assessment of circulating tumor DNA (ctDNA). Such proposed surrogate end points could overcome limits of pCR and provide a reasonable trade-off between the 2 conflicting needs to have access to effective therapies rapidly, and to reliably assess patients’ clinical benefit.

CONCLUSIONS AND RELEVANCE: Using surrogate end points to grant drug approvals is justified only when they can provide accurate prediction of a drug’s effect on the long-term patient outcomes. Evidence currently available does not support pCR used alone as a reliable surrogate end point in regulatory neoadjuvant RCTs for BC. The surrogacy value at trial level of potentially more robust surrogate end points needs to be urgently tested.

PMID:36201176 | DOI:10.1001/jamaoncol.2022.3755

Swiss Med Wkly. 2022 Sep 15;152:w30223. doi: 10.4414/smw.2022.w30223. eCollection 2022 Sep 12.

ABSTRACT

BACKGROUND AND PURPOSE: Culturally diverse countries such as Switzerland face the challenge of providing cross-cultural competent care. Cross-cultural competent care needs an understanding of a patient’s cultural context in order to provide safe and effective care. Therefore, we sought to examine cross-cultural competence of Swiss paediatric oncology care providers, and to explore their perceptions of barriers to and facilitators of cross-culturally competent care.

DESIGN AND SAMPLE: We conducted a cross-sectional study. The data collection period was three weeks. Providers were recruited through collaborators at the participating paediatric oncology centres. All occupational groups who are in direct contact with patients and involved in their care were eligible (e.g., physicians, nurses, social workers, occupational therapists and physiotherapists). Surveying providers online, we captured five subscales of their cross-cultural competence and their perceptions as to how to facilitate cross-culturally competent paediatric oncology care. We employed the Cross-Cultural Competence of Healthcare Professionals (CCCHP) questionnaire. Besides descriptive and inferential statistics, we performed content analysis.

FINDINGS: The response rate was 73.2% (n = 183/250). Analyses revealed differences in cross-cultural competence between occupational groups of paediatric oncology providers. Overall, social workers’ cross-cultural competence was higher than nurses’ or occupational therapists’ and physiotherapists’ cross-cultural competence. Physicians’ cross-cultural competence was higher than nurses (with no statistically significant difference identified between physicians, occupational therapists and physiotherapists). Furthermore, our results suggest noteworthy differences among the four main occupational groups on the five CCCHP subscales. Physicians and social workers declared more positive attitudes than nurses; occupational therapists and physiotherapists reported lower skills than the other three groups; social workers scored higher on the emotions and empathy subscale than the other three groups; physicians were more knowledgeable and aware than nurses. Most frequently mentioned barriers were: language barriers (68.5%), different culture and values (19.2%), different illness understanding (9.2%). Most frequently mentioned facilitators were: professional translators (47.2%), continuous training (20.8%), professional cultural mediators (8.8%).

CONCLUSIONS/IMPLICATIONS: Trainings and interventions are widely considered a principal strategy to advance providers’ cross-cultural competence. Our findings of differences in cross-cultural competence among occupational groups further underpin the need to adapt training programmes and interventions to the respective occupational group and the respective dimension(s) of cross-cultural competence. In addition, professional translators and cultural mediators should be used. Lastly, reciprocal supervision and the promotion of multidisciplinary teams is crucial to enable oncology care providers to learn from each other and this exchange could also help to reduce some of the differences between the various occupational groups.

PMID:36201172 | DOI:10.4414/smw.2022.w30223

Am J Speech Lang Pathol. 2022 Oct 6:1-12. doi: 10.1044/2022_AJSLP-21-00357. Online ahead of print.

ABSTRACT

PURPOSE: Although traumatic brain injury (TBI) has a disproportionate impact on older adults, there has been limited inclusion of these individuals in post-TBI cognitive-communication research. This study was undertaken to compare demographic and injury characteristics, speech-language pathology input, and broad outcomes for younger and older adults admitted to inpatient rehabilitation following TBI.

METHOD: A retrospective audit of first occasion adult TBI admissions in 2019 to inpatient rehabilitation in an Australian metropolitan subacute hospital was conducted via medical record data. Admissions were located using International Statistical Classification of Diseases, Tenth Revision, Australian Modification (ICD-10-AM) coding that aligned with TBI. Comparisons were made for younger (18-54 years) and older (≥ 55 years) adults.

RESULTS: A total of 114 admissions (51.75% older adults) were included. Patient age ranged between 18 and 90 years. Falls caused TBI in the majority of older adults, whereas transport-related accidents were the most common cause for younger adults. Age-based trends for intracranial injury were observed. Cognitive-communication difficulties were the most common speech-language pathology diagnosis with no significant difference in prevalence between younger and older adults. Age group was not significantly associated with length of stay or discharge home.

CONCLUSIONS: The implications of injury-related trends for older adults on post-TBI cognitive-communication are poorly understood. This lack of information is problematic given the frequency of cognitive-communication difficulties in this population. Research into cognitive-communication following new onset TBI in older adults is crucial to support rehabilitation service provision and improve outcomes for older adults.

PMID:36201170 | DOI:10.1044/2022_AJSLP-21-00357

Forensic Sci Med Pathol. 2022 Oct 6. doi: 10.1007/s12024-022-00520-2. Online ahead of print.

ABSTRACT

This systematic review aims to determine whether linear or morphometric analysis of paranasal sinuses can be used for accurate determination of gender and to appraise which sinus can be evaluated for accurate gender determination.A comprehensive search of the specialized databases (PubMed/MEDLINE, Science Direct, Clinical Key, ProQuest, Google Scholar, Epistomonikos, LILACS, OpenGrey) and other institutional repositories was performed for including the studies which assessed paranasal sinuses for gender determination. Quality assessment was carried out with the AQUA tool. The meta-analysis was performed with the eligible study data at 95% CI and p ≤ 0.05 in the random-effects model.Forty-six studies evaluating frontal sinus (13), maxillary sinus (26), frontal and maxillary sinus (5), or three paranasal sinuses (2) were included. All the included studies assessed height, length, width, and volume, respectively, and other additional parameters (area, perimeter) if wherever applicable. Frontal sinus had significantly higher values for males compared to females except for left height (LH) and left volume (LV). Maxillary sinus measurements were significantly higher in males contrasted to females except for LH. Sub-group analyses revealed that analyses involving the population had statistically significant results for all the measured parameters for both the sinuses (p < 0.05 and p = 0.00, respectively).Measurements obtained from assessing sinuses reveal that there are variations in size, among populations in different geographic regions. Hence, more studies with improved sample sizes and standardized measurement protocols should be carried out on different populations to see the diversity and their reliability.

PMID:36201147 | DOI:10.1007/s12024-022-00520-2

Breast Cancer Res Treat. 2022 Oct 6. doi: 10.1007/s10549-022-06738-6. Online ahead of print.

ABSTRACT

PURPOSE: Using real-world data, interstitial lung disease (ILD) prevalence before and after HER2-directed therapy was estimated. Potential ILD risk factors in patients receiving HER2-directed therapy for metastatic breast cancer (mBC) were evaluated.

METHODS: Adults with HER2-directed therapy for mBC initiated between September 25, 1998, and February 22, 2020 were, included. ILD was defined broadly as one or more of 64 lung conditions. Patients were followed until incident ILD, death, last contact, or study end.

RESULTS: In total, 533 patients were identified with median age at mBC of 57, 51% had de novo mBC, 43% were ever smokers, 30% had lung metastases, 9% had thoracic radiation, 6% had chronic obstructive pulmonary disease, and 16% had prevalent ILD. ILD cumulative incidence at one year was 9% (95% CI 6%, 12%), with a median follow-up of 23 months. Smoking (HR 2.2, 95% CI 1.1, 4.8) and Black/African-American race (HR 3.4, 95% CI 1.6, 7.5) were significantly associated with ILD; HRs for preexisting lung conditions (HR 1.8, 95% CI 0.9, 3.8) and thoracic radiation (HR 2.3, 95% CI 0.8, 7.1) were not statistically significant. Prevalent ILD was associated with 13-fold greater occurrence of incident ILD. 85% of patients with prevalent or incident ILD were symptomatic.

CONCLUSIONS: This real-world population of patients with mBC had a high prevalence of ILD prior to HER2-directed therapy, reflecting the multifactorial causation of interstitial lung changes. The cumulative incidence of ILD in patients receiving HER2-directed therapy for mBC augments prior reports. Symptomatic presentation suggests an opportunity for early intervention.

PMID:36201127 | DOI:10.1007/s10549-022-06738-6

Clin Rheumatol. 2022 Oct 6. doi: 10.1007/s10067-022-06394-7. Online ahead of print.

ABSTRACT

OBJECTIVE: Kidney biopsy is essential for the diagnosis and classification of lupus nephritis. Percutaneous biopsy has a risk of bleeding-related complications; however, data on the risk of percutaneous kidney biopsy in patients with systemic lupus erythematosus (SLE) are scarce. In this study, we aimed to investigate the rate of bleeding-related complications and to examine the risk factors for complications of kidney biopsy in patients with systemic lupus erythematosus (SLE). METHODS: We retrospectively reviewed the medical records of patients with SLE who underwent ultrasound-guided percutaneous kidney biopsy between 2002 and 2020 at a tertiary referral center. Minor complications were defined as hematoma and passing hematuria not requiring an intervention. Major complications included bleeding events that required interventions after the biopsy. Statistical analysis with a multivariate logistic regression model was performed.

RESULTS: In a total of 277 patients with SLE, the rate of overall bleeding-related complications after kidney biopsy was 19.9% (minor 13.0%; major 6.9%). Among patients with major complications, 84.2% needed blood transfusion alone without embolization or surgery, whereas the remaining three patients needed embolization for bleeding control. Multivariate analysis revealed that thrombocytopenia (odds ratio [OR] 7.186, 95% confidence interval [CI] 2.315-22.300), and low eGFR (OR 3.478, 95% CI 1.094-11.056) were significantly associated with the risk of major bleeding-related complications after kidney biopsy.

CONCLUSION: Percutaneous kidney biopsy is accompanied by the risk of bleeding-related complications; however, most events in our study did not require vascular intervention for bleeding control. Low platelet count and low estimated glomerular filtration rate (eGFR) significantly increase the risk of complications after kidney biopsy in patients with SLE. Key Points • The rate of overall bleeding-related complications after kidney biopsy was about 20% of patients with SLE. • The most commonly observed events were gross hematuria followed by blood transfusion. • Thrombocytopenia and poor kidney function areis an important risk of bleeding-related complications after kidney biopsy.

PMID:36201125 | DOI:10.1007/s10067-022-06394-7