Tag: statistics

Am J Ther. 2023 Jan-Feb 01;30(1):e36-e55. doi: 10.1097/MJT.0000000000001584. Epub 2022 Dec 20.

ABSTRACT

BACKGROUND: We present a systematic review and network meta-analysis (NMA) that is the precursor underpinning the Bayesian analyses that adjust for publication bias, presented in the same edition in AJT. The review assesses optimal cytoreduction for women undergoing primary advanced epithelial ovarian cancer (EOC) surgery.

AREAS OF UNCERTAINTY: To assess the impact of residual disease (RD) after primary debulking surgery in women with advanced EOC. This review explores the impact of leaving varying levels of primary debulking surgery.

DATA SOURCES: We conducted a systematic review and random-effects NMA for overall survival (OS) to incorporate direct and indirect estimates of RD thresholds, including concurrent comparative, retrospective studies of ≥100 adult women (18+ years) with surgically staged advanced EOC (FIGO stage III/IV) who had confirmed histological diagnoses of ovarian cancer. Pairwise meta-analyses of all directly compared RD thresholds was previously performed before conducting this NMA, and the statistical heterogeneity of studies within each comparison was evaluated using recommended methods.

THERAPEUTIC ADVANCES: Twenty-five studies (n = 20,927) were included. Analyses demonstrated the prognostic importance of complete cytoreduction to no macroscopic residual disease (NMRD), with a hazard ratio for OS of 2.0 (95% confidence interval, 1.8-2.2) for <1 cm RD threshold versus NMRD. NMRD was associated with prolonged survival across all RD thresholds. Leaving NMRD was predicted to provide longest survival (probability of being best = 99%). The results were robust to sensitivity analysis including only those studies that adjusted for extent of disease at primary surgery (hazard ratio 2.3, 95% confidence interval, 1.9-2.6). The overall certainty of evidence was moderate and statistical adjustment of effect estimates in included studies minimized bias.

CONCLUSIONS: The results confirm a strong association between complete cytoreduction to NMRD and improved OS. The NMA approach forms part of the methods guidance underpinning policy making in many jurisdictions. Our analyses present an extension to the previous work in this area.

PMID:36608071 | DOI:10.1097/MJT.0000000000001584

Am J Ther. 2023 Jan-Feb 01;30(1):e1-e9. doi: 10.1097/MJT.0000000000001573. Epub 2022 Nov 11.

ABSTRACT

BACKGROUND: Emerging evidence suggests low-dose buprenorphine (LDB) induction can expand opportunities for buprenorphine induction in patients who are taking taking methadone, short-acting opioid agonists, or who have anxiety about opioid withdrawal.

STUDY QUESTION: How is a rapid LDB protocol using transdermal buprenorphine tolerated in the hospital?

STUDY DESIGN: A prospective study of 20 patient encounters (n = 20 patients) with traditional buprenorphine induction before implementation of study protocol (control group) and 37 patient encounters (n = 34 patients) with LDB induction protocol (pilot group). Summary statistics were used to describe demographics, clinical opioid withdrawal scale and pain scores within 24 hours preprotocol and within 24 hours postprotocol initiation, hospital length of stay after protocol initiation, receipt of a buprenorphine prescription at discharge, and prescription activity at 30 days. T test and chi-square tests were used to analyze comparisons. A subset of pilot group patients completed a survey about their experience.

RESULTS: There were no statistically significant differences in pain and clinical opioid withdrawal scale scores between the pilot and control groups. There were 5 instances of precipitated withdrawal in the pilot group. There was no statistically significant difference in mean discharge time after protocol initiation between the pilot and control groups (P = 0.60). Most patients surveyed described a positive experience with LDB induction.

CONCLUSION: Hospitalization is a critical time to initiate buprenorphine for patients with opioid use disorder. Our data adds to the growing evidence that LDB induction is feasible for patients taking methadone and short-acting opioid agonists, and that a more rapid induction protocol is generally well-tolerated by patients although precipitated withdrawal is a risk. Finally, our rapid induction protocol did not seem to increase hospital length of stay compared with traditional induction.

PMID:36608069 | DOI:10.1097/MJT.0000000000001573

Am J Ther. 2022 Nov-Dec 01;29(6):e616-e624. doi: 10.1097/MJT.0000000000001558. Epub 2022 Aug 23.

ABSTRACT

BACKGROUND: Progressive chronic diseases presume a complex treatment plan that depends on the number of symptoms, their severity, and comorbidities. Drug management is an essential responsibility of the family caregiver of a palliative care patient, but has received limited attention in field research.

STUDY QUESTIONS: The aim of this study is to identify the complexity of the therapeutic plan followed at home by cancer or noncancer patients needing palliative care, and to assess its impact on the burden of the family caregivers.

STUDY DESIGN: This observational study was conducted at patient’s admission in a palliative care department. The study involved cancer and noncancer patients and their primary family caregivers. To measure the care burden, the Burden Scale for Family Caregiver was used and for the complexity of the therapeutic plan, the Medication Regime Complexity Index.

MEASURES AND OUTCOMES: To measure the care burden, the Burden Scale for Family Caregiver was used and for the complexity of the therapeutic plan, the Medication Regime Complexity Index.

RESULTS: One hundred and forty patients were enrolled with their family caregivers: patients with nononcological pathologies (n = 63) and patients with cancer (n = 77). Caregiver’s burden score is statistically significantly correlated with the complexity of the medical plan in both groups (P = 0.32 and P = 0.012 respectively). The average family caregiver’s burden was significantly higher in the nononcological group (45 ± 14.45 vs. 36.52 ± 15.05; P = 0.001). The number of medications that family caregivers administer daily for patients without cancer is higher than in the other subset (8.25 ± 4.94 vs. 5.89 ± 4.93; P = 0.004). Opioids were more frequently used for pain control in cancer patients (5 vs. 72; P = 0.0001).

CONCLUSIONS: The caregiver’s burden is high for nononcological patients. The complexity of the treatment plan (number of drugs and frequency of administration) is significantly correlated with the care burden. Further studies are needed to understand which interventions targeted on family caregivers will minimize the burden of care.

PMID:36608062 | DOI:10.1097/MJT.0000000000001558

PLoS One. 2023 Jan 6;18(1):e0280057. doi: 10.1371/journal.pone.0280057. eCollection 2023.

ABSTRACT

Scientific literature is giving greater importance to dynamic balance in fall prevention. Recently, the validity and reliability of the most employed functional tests for dynamic balance assessment has been investigated. Although these functional tests are practical and require minimal equipment, they are inherently subjective, as most do not use instrumented measurement data in the scoring process. Therefore, this study aimed to assess the validity and reliability of an instrumented unstable board for dynamic balance objective assessment in young adults through double-leg standing trials. A test-retest design was outlined with the unstable board positioned over a force platform to collect objective Center of Pressure (CoP) related and kinematic parameters. Fifteen young adults participated in two evaluation sessions (7-day apart) that comprised ten trials per two dynamic conditions (anterior-posterior and medio-lateral oscillations) aiming to maintain the board parallel to the ground. Pearson’s correlation coefficient (r) was employed to assess the validity of the kinematic parameters with those derived from the CoP. The test-retest reliability was investigated through Intraclass Correlation Coefficient (ICC), Standard Error of the measurement, Minimal Detectable Change, and Bland-Altman plots. Statistically significant correlations between the CoP and kinematic parameters were found, with r values ranging from 0.66 to 0.95. Good to excellent intrasession (0.89≤ICCs≤0.95) and intersession (0.66≤ICCs≤0.95) ICCs were found for the kinematics parameters. The Bland-Altman plots showed no significant systematic bias. The kinematics parameters derived from the unstable board resulted valid and reliable. The small size of the board makes it a suitable tool for the on-site dynamic balance assessment and a complement of computerized dynamic posturography.

PMID:36608060 | DOI:10.1371/journal.pone.0280057

JMIR Res Protoc. 2023 Jan 6;12:e40496. doi: 10.2196/40496.

ABSTRACT

BACKGROUND: Veterans Affairs Farming and Recovery Mental Health Services (VA FARMS) is an innovative pilot program to provide supportive resources for veterans with interests in agricultural vocations. Implemented at 10 pilot sites, VA FARMS will provide mental health services and resources for veterans while supporting training in gardening and agriculture. As each pilot site project has unique goals, outreach strategies, and implementation efforts based on the local environment and veteran population, evaluating the pilot program provides a unique challenge for evaluators. This paper describes the protocol to evaluate VA FARMS, which was specifically designed to enable site variation by providing both site-specific and cross-site understanding of site implementation processes and outcomes.

OBJECTIVE: The objectives of this paper are to (1) describe the protocol used for evaluating VA FARMS, as an innovative Department of Veterans Affairs (VA) agriculturally based, mental health, and employment pilot program serving veterans at 10 pilot sites across the Veterans Health Administration enterprise; and (2) provide guidance to other evaluators assessing innovative programs.

METHODS: This evaluation uses the context, inputs, process, product (CIPP) model, which evaluates a program’s content and implementation to identify strengths and areas for improvement. Data collection will use a concurrent mixed methods approach. Quantitative data collection will involve quarterly program surveys, as well as three individual veteran participant surveys administered upon the veteran’s entrance and exit of the pilot program and 3 months postexit. Quantitative data will include baseline descriptive statistics and follow-up statistics on veteran health care utilization, health care status, and agriculture employment status. Qualitative data collection will include participant observation at each pilot site, and interviews with participants, staff, and community stakeholders. Qualitative data will provide insights about pilot program implementation processes, veterans’ experiences, and short-term participation outcomes.

RESULTS: Evaluation efforts began in December 2018 and are ongoing. Between October 2018 and September 2020, 494 veterans had enrolled in VA FARMS and 1326 veterans were reached through program activities such as demonstrations, informational presentations, and town-hall discussions. A total of 1623 community members and 655 VA employees were similarly reached by VA FARMS programming during that time. Data were collected between October 2018 and September 2020 in the form of 336 veteran surveys, 30 veteran interviews, 27 staff interviews, and 11 community partner interviews. Data analysis is expected to be completed by October 2022.

CONCLUSIONS: This evaluation protocol will provide guidance to other evaluators assessing innovative programs. In its application to the VA FARMS pilot, the evaluation aims to add to existing literature on nature-based therapies and the rehabilitation outcomes of agricultural training programs for veterans. Results will provide programmatic insights on the implementation of pilot programs, along with needed improvements and modifications for the future expansion of VA FARMS and other veteran-focused agricultural programs.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40496.

PMID:36607716 | DOI:10.2196/40496

J Med Internet Res. 2023 Jan 6;25:e41669. doi: 10.2196/41669.

ABSTRACT

BACKGROUND: While e-cigarettes usually contain nicotine, their addictive potential is not yet fully understood. We hypothesized that if e-cigarettes are addictive, users will experience typical symptoms of addiction.

OBJECTIVE: The aim of our study was to investigate whether and how e-cigarette users report signs of addiction.

METHODS: We identified 3 large German-language e-cigarette online forums via a systematic Google search. Based on a netnographic approach, we used deductive content analysis to investigate relevant posts in these forums. Netnography has the advantage of limiting the social desirability bias that prevails in face-to-face research, such as focus groups. The data were coded according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for tobacco use disorder, adapted for e-cigarettes. The DSM-5 criteria were used to portray a broad spectrum of possible experiences of addiction.

RESULTS: Overall, 5337 threads in 3 forums were screened, and 451 threads containing relevant information were included in the analysis. Users reported experiences consistent with the DSM-5 criteria, such as craving e-cigarettes, excessive time spent vaping, and health issues related to e-cigarette use. However, our analysis also showed that users reported the absence of typical tobacco use disorder criteria, such as successful attempts to reduce the nicotine dosage. For most themes, reports of their absence were more frequent than of their presence. The absence of perceived addiction was mostly reported in contrast to prior tobacco smoking.

CONCLUSIONS: This is the first study to use a netnographic approach to explore unfiltered self-reports of experiences of e-cigarette addiction by users in online forums. As hypothesized, some but not all users reported subjective experiences that corresponded to the criteria of tobacco use disorder as defined by the DSM-5. Nevertheless, subjective reports also indicated that many e-cigarette users felt in control of their behavior, especially in contrast to their prior use of tobacco cigarettes. The finding that some e-cigarette users subjectively experience addiction highlights the need for effective cessation programs to support users who experience their e-cigarette use as burdensome. This research can guide the refinement of instruments to assess e-cigarette addiction and guide cessation programs.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s40359-021-00682-8.

PMID:36607713 | DOI:10.2196/41669

JAMA Netw Open. 2023 Jan 3;6(1):e2249785. doi: 10.1001/jamanetworkopen.2022.49785.

ABSTRACT

IMPORTANCE: Although incarcerated older adults experience higher rates of chronic disease and geriatric syndromes, it is unknown whether community-dwelling older adults with a history of incarceration are also at risk for worse health outcomes.

OBJECTIVE: To evaluate the association between a history of incarceration and health outcomes, including chronic health conditions and geriatric syndromes, in older age.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study using population-based data from the nationally representative Health and Retirement Study included US community-dwelling adults aged 50 years or older who completed the 2012 or 2014 survey waves assessing self-reported history of incarceration. Statistical analysis was completed from December 2021 to July 2022.

EXPOSURES: Self-reported history of incarceration.

MAIN OUTCOMES AND MEASURES: Geriatric health outcomes included cognitive impairment, mobility impairment, vision impairment, hearing impairment, urinary incontinence, and impairment of activities of daily living (ADLs). Chronic health outcomes included high blood pressure, diabetes, chronic lung disease, heart disease, stroke, mental health conditions, heavy alcohol use, and self-reported health. Survey weights were applied to adjust for the survey design.

RESULTS: Among 13 462 participants, 946 (7.6%) had experienced incarceration (mean [SD] age, 62.4 [7.8] years); compared with 12 516 people with no prior incarceration (mean [SD] age, 66.7 [10.0] years), previously incarcerated adults were more likely to be male (83.0% vs 42.8%; P < .001) and in the lowest quartile of wealth (44.1% vs 21.4%; overall P < .001). After adjusting for age, sex, race and ethnicity, wealth, educational attainment, and uninsured status, a history of incarceration was associated with a 20% to 80% increased risk of all geriatric syndromes evaluated, including impairment of ADLs (relative risk [RR], 1.62; 95% CI, 1.40-1.88) and hearing impairment (RR, 1.22; 95% CI, 1.04-1.44). Incarceration was also associated with increased risk of some chronic diseases, including chronic lung disease (RR, 1.56; 95% CI, 1.27-1.91), mental health conditions (RR, 1.80; 95% CI, 1.55-2.08), and heavy alcohol use (RR, 2.13; 95% CI, 1.59-2.84). Prior incarceration was not associated with diabetes or cardiovascular conditions.

CONCLUSIONS AND RELEVANCE: In this study, at least 1 in 15 older US adults reported a history of incarceration in their lifetime. Past incarceration was associated with many chronic diseases and geriatric syndromes even after accounting for socioeconomic status. These findings suggest that attention to incarceration history may be an important consideration in understanding and mitigating health risks in older age.

PMID:36607638 | DOI:10.1001/jamanetworkopen.2022.49785

J Cardiovasc Pharmacol. 2022 Nov 18. doi: 10.1097/FJC.0000000000001382. Online ahead of print.

ABSTRACT

Dual pathway inhibition (DPI) with low dose rivaroxaban and aspirin in patients with coronary artery (CAD) and/or peripheral artery disease (PAD) reduces the occurrence of cardiovascular (CV) events; however, the underlying mechanisms explaining these latter CV benefits are not clearly understood. Our explorative observational study aimed to evaluate the effect of DPI on plasma inflammation and coagulation markers among real-world patients with CAD and/or PAD. We prospectively included all consecutive patients with an established diagnosis of CAD and/or PAD treated with aspirin (ASA) 100 mg once daily (OD) and rivaroxaban 2.5 mg twice daily (TD). Clinical evaluation and laboratory analyses, including haemoglobin, renal function (creatinine, urea, cystatin-C); coagulation markers (INR, aPTT); inflammation markers (IL-6, CRP, lipoprotein-associated phospholipase A2, copeptin), growth differentiation factor-15 (GDF-15), were carried-out at baseline, before starting treatment, and at 4 and 24 weeks after study drugs administration. 54 consecutive patients (mean age 66 ± 7 years; male 83%) who completed the six-months follow-up were included. At 24 weeks follow-up, a statistically significant reduction in IL-6 serum levels (4.6 [3.5- 6.5] vs 3.4 [2.4- 4.3] pg/ml; p=0.0001) and fibrinogen (336 [290- 390] vs 310 [275- 364] mg/dl; P=0.04) was shown; moreover, a significant increase in GDF-15 serum level (1309 [974- 1961] vs 1538 [1286- 2913] pg/ml; p=0.002) was observed. Haemoglobin, renal function and cardiovascular homeostasis biomarkers remain stable over the time. The anti-Xa activity at both (0.005 [0-0.02] vs 0.2 [0.1-0.34]; p<0.0001) significantly increased. The dual pathway inhibitions with low-dose rivaroxaban and aspirin in patients with CAD and/or PAD were associated with the reduction of inflammation biomarkers.

PMID:36607629 | DOI:10.1097/FJC.0000000000001382

Spine (Phila Pa 1976). 2023 Feb 1;48(3):164-171. doi: 10.1097/BRS.0000000000004510. Epub 2022 Oct 13.

ABSTRACT

STUDY DESIGN: Multicenter retrospective analysis of routinely collected data.

OBJECTIVE: The underlying aim of this study was to identify potential treatment-related risk factors for odontoid fracture nonunion while accounting for known patient- and injury-related risk factors.

SUMMARY OF BACKGROUND DATA: Type II and III odontoid fractures represent the most common cervical spine fracture in elderly patients and are associated with a relatively high nonunion rate. The management of odontoid fractures is controversial and treatment strategies range from conservative treatment to extensive surgical stabilization and fusion.

METHODS: A total of 415 individuals who sustained odontoid fracture and were treated in either of four tertiary referral centers in Austria and Germany were included in the study. We included the following potential contributing factors for fracture nonunion in cross-validated extreme gradient boosted (XGBoost) and binary logistic regression models: age, gender, fracture displacement, mechanism of injury (high vs. low energy), fracture classification (Anderson II vs. III), presence of comorbidities (Charlson comorbidity index), and treatment (conservative, anterior screw fixation with one or two screws, posterior C1/C2 spondylodesis, cervico-occipital C0-C4 fusion).

RESULTS: In our cohort, 187 (45%) had radiologically confirmed odontoid nonunion six months postinjury. The odds for nonunion increase significantly with age, and are lower in type III compared to type II fractures. Also, odds for nonunion are significantly lower in posterior C1/C2 spondylodesis, and C0-C4 fusion compared to conservative treatment. Importantly, odds are not statistically significantly lower in the group treated with anterior screw fixation compared to conservative treatment. The factors gender, fracture displacement, mechanism of injury, and the presence of comorbidities did not produce significant odds.

CONCLUSION: Higher age, type II fractures, and conservative treatment are the main risk factors for odontoid nonunion. Anterior screw fixation did not differ significantly from conservative treatment in terms of fracture union.

LEVEL OF EVIDENCE: 3.

PMID:36607627 | DOI:10.1097/BRS.0000000000004510

Transl Vis Sci Technol. 2023 Jan 3;12(1):11. doi: 10.1167/tvst.12.1.11.

ABSTRACT

OBJECTIVE: This study aims to compare a new prototype for a portable anterior eye segment imaging system with the standard method for ophthalmology examination.

METHODS: The new imaging system consisted of two IMX219 Arducam autofocus sensors (Arducam, China, Nanjing) for Raspberry Pi V2 camera module connected to a Raspberry Pi Zero W (Raspberry Pi Foundation, UK, Cambridge) that clips to a wearable headset. The 2D videos of the anterior eye segment were recorded with the new system and a 720p FaceTime HD camera (Apple, Cupertino, CA). Afterward, ophthalmologists evaluated the videos using a standard clinical eye examination form. These evaluations were compared with the standard slit-lamp clinical assessment performed during the patient’s visit.

RESULTS: Thirty-five eyes were evaluated. The sensitivity and specificity percentages were statistically significant between the two imaging modalities (P ≤ 0.001). The evaluations performed from videos obtained with the new imaging system had better sensitivity and specificity percentages overall. However, statistically significant differences were only observed in cornea, anterior chamber, iris, and lens.

CONCLUSIONS: Specificity percentages were higher than sensitivity percentages in both imaging modalities, indicating that video evaluations are less accurate for pathological screening. Nevertheless, the new system evaluations were significantly better than the webcam evaluations.

TRANSLATIONAL RELEVANCE: This study presented an alternative system to assess eye conditions for telemedicine, one that provides more details than the current standard and uses new wearable headsets technologies.

PMID:36607624 | DOI:10.1167/tvst.12.1.11