title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Analysis | Descriptive statistics were used to describe participant characteristics. All quantitative data analyses were performed using SPSS Version 25 (IBM Corp., Armonk, NY, USA). All qualitative data were audio-recorded and transcribed verbatim by MvT. Using data from the first focus group, first three of nine patient and fir... | PMC9996840 | ||
Results | PMC9996840 | |||
Phase 1 - development of matched treatment options | Three focus groups were conducted with physiotherapists and physiotherapy experts. Focus group participant characteristics can be found in Table
Focus group participant characteristicsWork background, 5 (100)1 (20)0 (0)1 (20)0 (0)5 (100)1 (20)(0)1 (20)(0)7 (100)4 (57)1 (14)4 (57)2 (29)*Columns add to pe... | PMC9996840 | ||
Developed version of the stratified blended physiotherapy approach, including matched treatments | pain | A visual representation of the developed Stratified Blended Physiotherapy approach, including the matched treatments, is presented in Table
Overview of the Stratified Blended Physiotherapy approach, developed in phase 1 of this study
Is to be matched to the patient’s risk of persistent disabling pain (low, medium or h... | PMC9996840 | |
Phase 2 - findings of the feasibility study | Eight physiotherapists invited 23 eligible patients. Of these patients, 13 signed informed consent forms and were enrolled in the study and the rest declined to participate after reading the information letter. Eight physiotherapists and 13 patients completed the follow-up questionnaire. No patients were lost to follow... | PMC9996840 | ||
Phase 2 - quantitative results | ’ | Physiotherapists’ satisfaction with delivery of the new approach was scored as ‘a little satisfied’ (median = 3; IQR = 1; n = 8). Physiotherapists’ experienced usability of the physiotherapist web based dashboard of the app was 40 (median; IQR = 9.4; n = 8), which is considered as ‘OK’ usability [Patients’ rating of gl... | PMC9996840 | |
Phase 2 - qualitative results | All 8 physiotherapists and 9 of the 13 invited patients who completed the follow-up questionnaires were interviewed. Four patients did not want to participate in an interview. Results were structured according to the main themes. | PMC9996840 | ||
Discussion | e-Exercise LBP, MSK complaints, neck/shoulder pain, pain | In the first phase of this study, matched treatment options were developed for six subgroups as part of the Stratified Blended Physiotherapy approach for patients with neck and/or shoulder complaints. Recommendations about the content and intensity of physiotherapy treatment were matched to the patient’s risk of persis... | PMC9996840 | |
Conclusion | In conclusion, this study described the participative intervention development and feasibility testing of physiotherapy delivered matched treatment options as part of the Stratified Blended Physiotherapy approach for patients with neck and/or shoulder complaints. To serve a diverse group of patients, both app-based as ... | PMC9996840 | ||
Acknowledgements | Not applicable. | PMC9996840 | ||
Authors’ contributions | All authors (MLvT, CJJK, MFP, JBS, NEF, RWJGO and CV) made substantial contributions to the design of this study, have drafted the work or substantively revised it. Furthermore, all authors (MLvT, CJJK, MFP, JBS, NEF, RWJGO and CV) read and approved the final version of this manuscript. Finally, all authors (MLvT, CJJK... | PMC9996840 | ||
Funding | This work was supported by the Scientific College Physical Therapy (WCF) of the Royal Dutch Society for Physical Therapy (KNGF). | PMC9996840 | ||
Data availability | The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. | PMC9996840 | ||
Declarations | PMC9996840 | |||
Ethics approval and consent to participate | Because the interventions used in the treatment are the same as reported in physiotherapeutic guidelines, and only the treatment delivery differs, the Medical Ethical Committee of the HU University of Applied Sciences declared that this study was not covered by the Dutch Medical Research Involving Human Subject Act (WM... | PMC9996840 | ||
Consent for publication | Not applicable. | PMC9996840 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9996840 | ||
List of abbreviations | MusculoskeletalSubgroup targeted treatmentUnited KingdomGlobal Perceived Effect – Dutch VersionNet Promoter ScoreSystem Usability ScaleElectronic health recordLow back pain | PMC9996840 | ||
References | PMC9996840 | |||
Purpose | diabetic vitrectomy | EYE, LOW VISION | Edited by: Ravirajsinh Jadeja, Augusta University, United StatesReviewed by: Alexander E. Berezin, Zaporizhia State Medical University, Ukraine; Meirong Chen, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, China; Du Liping, Chongqing Eye Institute, China†These authors have contributed equal... | PMC10485701 |
Methods | low vision | REGRESSION, NONPROLIFERATIVE DIABETIC RETINOPATHY, LOW VISION | This retrospective study included 186 patients (250 eyes) that underwent primary vitrectomy for proliferative diabetic retinopathy with a minimum follow-up period of one year. Patients were assigned to the training cohort (200 eyes) or validation cohort (50 eyes) at a 4:1 ratio randomly. Based on a cutoff value of 0.3 ... | PMC10485701 |
Results | tractional retinal detachment, hypertension | REGRESSION, TRACTIONAL RETINAL DETACHMENT, HYPERTENSION | Four independent risk factors were selected by stepwise forward regression, including tractional retinal detachment (β=1.443, OR=4.235, P<0.001), symptom duration ≥6 months (β=0.954, OR=2.595, P=0.004), preoperative BCVA measurement (β=0.540, OR=1.716, P=0.033), and hypertension (β=0.645, OR=1.905, P=0.044). AUC values... | PMC10485701 |
Conclusion | diabetic vitrectomy | LOW VISION | The prognostic nomogram established in this study is useful for predicting long-term low vision after diabetic vitrectomy. | PMC10485701 |
Introduction | PDR, TRD, Diabetic retinopathy, blindness, tractional retinal detachment, postoperative vision, vitreous hemorrhage | TRACTIONAL RETINAL DETACHMENT, DIABETIC RETINOPATHY, BLINDNESS, VITREOUS HEMORRHAGE, COMPLICATIONS | Diabetic retinopathy (DR) has become the leading cause of blindness among working-age adults (20–79 years old) (The development of microincision vitrectomy surgery has greatly improved the precision, safety, and efficiency of intraocular surgery in recent years. Pars plana vitrectomy (PPV) has been widely used in the t... | PMC10485701 |
Methods | PMC10485701 | |||
Study design and participants | PDR | EYE | This is a single-center and retrospective study (registered at ClinicalTrials.gov: NCT05631054). It was approved by the Ethics Committee of Tianjin Medical University Eye Hospital (approval number: 2022KY-27) and was conducted in accordance with the Declaration of Helsinki. We included 186 PDR patients (250 eyes) who u... | PMC10485701 |
Surgical procedures | cataracts, tamponade | RETINA, ADHESION, LENS, PROLIFERATIVE, CATARACTS, CORTEX | Standard 23- or 25-gauge PPV was performed under retrobulbar anesthesia. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) drugs was performed 3–5 days prior to surgery in eyes with broad basement adhesion of the fibrovascular proliferative membrane to the retina. The anterior, posterior, and per... | PMC10485701 |
Data collection | TRD, tractional retinal detachment, diabetes | TRACTIONAL RETINAL DETACHMENT, CORONARY HEART DISEASE, HYPERTENSION, CEREBRAL INFARCTION, DIABETES | We collected data by reviewing the patients’ medical records. As systemic factors, we collected the information on sex, age, diabetes type, diabetes duration, hypertension, dialysis, coronary heart disease, cerebral infarction, and blood test (the details are listed in Baseline characteristics of the training cohort.a:... | PMC10485701 |
Statistical analysis | diabetic vitrectomy, Low vision | REGRESSION, LOW VISION, LOW VISION | Low vision was defined as a BCVA<0.3, according to the standard of the WHO 2015 (The multivariate binary logistic regression analysis considered variables with a P-value<0.1 from the univariate analysis, and stepwise forward regression was used to explore variables with a P-value<0.05 as potential independent predictor... | PMC10485701 |
Results | PMC10485701 | |||
Patient characteristics and ophthalmic outcomes | PDR, NVG, retinal detachment | EYE, RETINAL DETACHMENT, LOW VISION | A total of 491 patients underwent primary vitrectomy for PDR at Tianjin Medical University Eye Hospital from January 2016 to October 2021. Among them, 186 patients (250 eyes) who met the eligibility criteria were included in this study. The mean follow-up duration was 32 ± 21 months. For all eyes, the mean postoperativ... | PMC10485701 |
Predictive model and nomogram development | TRD, diabetic vitrectomy, tractional retinal detatchment, low vision | REGRESSION, LOW VISION | In the training cohort of 200 eyes, low vision occurred in 89 eyes (44.5%). Considering the practical clinical application, we stratified three continuous variables: age (≤55 years old, >55 years old), symptom duration (<6 months, ≥6 months), and eGFR (<60 mL/min/1.73 mStepwise multivariate logistic regression for long... | PMC10485701 |
Validation and evaluation of the nomogram | TRD, tractional retinal detachment | REGRESSION, CORONARY HEART DISEASE, TRACTIONAL RETINAL DETACHMENT | The ROC curves for the model and each predictor are depicted in ROC curves of multivate logistic regression model.Calibration curve of the risk prediction model.Comparison of baseline characteristics of training cohort and validation cohort.a:chi-squared test, b: Mann-Whitney test, c: t-test; HbA1c, glycosylated hemogl... | PMC10485701 |
Renal function-stratified analysis | non-low vision, NVG, renal insufficiency | REGRESSION, HYPERTENSION, RENAL INSUFFICIENCY | In the training cohort, eGFR differed significantly only in the univariate analysis between the low and non-low vision groups. We further analyzed the features and prognosis of all the patients with borderline/normal renal function (n=184), early renal insufficiency (n=43), and poor renal function (n=23). For baseline ... | PMC10485701 |
Discussion | PDR, TRD, death, CKD, postoperative recurrent detachment, diabetic vitrectomy, kidney failure, NVG, hypertension, diabetes | MICROINVASIVE, LOW VISION, KIDNEY FAILURE, HYPERTENSION, COMPLICATIONS, DIABETES | For serious PDR complications, vitrectomy may be the only approach to improve visual acuity. Microinvasive vitreous surgery and an optimized vitrectomy platform with fluid and pressure control have greatly reduced the complications of PPV; however, some patients cannot fully achieve their ideal visual function long-ter... | PMC10485701 |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC10485701 | ||
Ethics statement | EYE | The studies involving human participants were reviewed and approved by Ethics Committee of Tianjin Medical University Eye Hospital. The patients/participants provided their written informed consent to participate in this study. Written informed consent was obtained from the individual(s) for the publication of any pote... | PMC10485701 | |
Author contributions | WL | BH, HG, ZW, and XL designed the study. HG and ZW wrote the manuscript. Data collection was performed by HG, ZW, ZN, XZ, KW, ND, SB, and WL. HG and ZW completed all statistical analysis. All authors contributed to the article and approved the submitted version. | PMC10485701 | |
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10485701 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10485701 | ||
References | PMC10485701 | |||
2. Materials and Methods | PMC9967049 | |||
2.1. Study Design | adenoid hypertrophy, OME | TYMPANIC MEMBRANE RETRACTION, POLAND, ADVERSE EFFECTS, ADENOID HYPERTROPHY, MIDDLE EAR, ACUTE OTITIS MEDIA, NECK DISEASE | We conducted a pilot, single-arm trial. Our study population comprised 36 patients recruited from the Outpatient Clinic of the Department of Otorhinolaryngology, Head and Neck Diseases in Olsztyn, Poland. All patients provided written informed consent. Patients were included if they filled the following criteria:Otolog... | PMC9967049 |
2.2. Intervention | The study intervention consisted of 3 days of inhalation (2 inhalations at each visit) with an AMSA device (ATOMISORAn atomizer, with a capacity of 12 mL, is a hand-held device fitted with a binary nasal adapter. It produces from an aerosol fluid with a particle size of 2.2 µm, emitted at a flow rate of 0.20 mL per min... | PMC9967049 | ||
2.3. Tympanometry | OME | Tympanometry was performed before and on after the intervention (the third day of the inhalation). Tympanograms were obtained using the Interacoustics Titan Clinical device and Titan Suite Software (Interacoustics A/S, Middelfart, Denmark). We measured the following parameters: volume (normal range: <2.5 mL), complianc... | PMC9967049 | |
2.4. Statistical Analysis | We described patients’ baseline characteristics using a median and interquartile range for continuous and percentages for categorical variables. First, at the participant level, we described a proportion of patients achieving response to AMSA treatment stratified by completeness and laterality. Then, the tympanometry d... | PMC9967049 | ||
3. Results | ADVERSE EVENTS, MIDDLE EAR | The baseline characteristics of study participants is summarized in All patients completed the intervention and participated in the follow-up visit. No major adverse events were reported.At the patient level (We observed a significant difference in the distribution of tympanogram types following the intervention (Analy... | PMC9967049 | |
4. Discussion | OME | MIDDLE EAR, PATHOLOGY, PATHOGENESIS | To the best of our knowledge, this study is the first trial of inhaled mucolytics and steroids in adults with OME, in whom tympanometry was assessed at baseline and after treatment. We found high rates of improvement in tympanometry after three days of treatment. Following AMSA administration, we observed significant i... | PMC9967049 |
5. Conclusions | OME | MIDDLE EAR, REMISSION | A 3-day course of mucolytics and steroid administration with AMSA was reported to be relatively effective for symptom withdrawal in adults with OME. Partial and complete OME remission was noted in, respectively, 81% and 39% of patients. Moreover, an increase in volume and pressure in the middle ear were observed follow... | PMC9967049 |
Author Contributions | Conceptualization, K.Z.-S. and N.J.-A.; methodology, K.Z.-S. and N.J.-A.; software, B.K.; validation, K.Z.-S. and B.K.; formal analysis, K.Z.-S.; investigation, K.Z.-S., B.K. and N.J.-A.; resources, K.Z.-S.; data curation, B.K.; writing—original draft preparation, K.Z.-S.; writing—review and editing, K.Z.-S.; visualiza... | PMC9967049 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board (or Ethics Committee) of the University of Warmia and Mazury (reference number 16/2017, 25 April 2017). | PMC9967049 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9967049 | ||
Data Availability Statement | Data available on request due to restrictions, e.g., privacy or ethics. The data presented in this study are available on request from the corresponding author. The data are not publicly available due to the protection of personal data. | PMC9967049 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC9967049 | ||
Subject terms | gastric cancer | METASTASIS, SECONDARY, RECURRENCE, GASTRIC CANCER | Indocyanine green (ICG) fluorescence imaging-guided lymphadenectomy has been demonstrated to be effective in increasing the number of lymph nodes (LNs) retrieved in laparoscopic gastrectomy for gastric cancer (GC). Previously, we reported the primary outcomes and short-term secondary outcomes of a phase 3, open-label, ... | PMC10654517 |
Introduction | Gastric cancer, deaths | GASTRIC CANCER, RECURRENCE, COMPLICATIONS | Gastric cancer (GC) accounts for approximately 8% of cancer-related deaths worldwideNonetheless, lymphadenectomy is often merely performed based on the surgeon’s preference and experience. However, owing to the complex vascular anatomy and lymphatic drainage around the stomach, efficient and accurate dissection of LNs ... | PMC10654517 |
Results | PMC10654517 | |||
Overall survival | deaths | The deaths of 52 patients resulted in a 3-year actual OS rate of 86.0% (18 of 129) in the ICG group and 73.6% (34 of 129) in the non-ICG group. The OS in the ICG group was statistically significantly better than that in the non-ICG group (log-rank | PMC10654517 | |
Disease-free survival | DFS | The DFS in the ICG group was statistically significantly better than that in the non-ICG group (log-rank In the ITT analysis, the survival analysis revealed that the DFS of the ICG group was better than that of the non-ICG group (log-rank | PMC10654517 | |
Recurrence | death | RECURRENCE | Within the first three years of follow-up, recurrence was found in 23 (cumulative incidence, 17.8%) and 40 (cumulative incidence, 31.0%) patients in the ICG and non-ICG groups, respectively (Table Treating death as the competing risk, a significant difference in the cumulative recurrence incidence was found between the... | PMC10654517 |
Incremental harvested lymph nodes in ICG group improve survival | REGRESSION | For pN0 patients, there is no statistically significant difference in prognosis between ICG and non-ICG patients (OS: Further analysis of patients with ≥30 retrieved LNs revealed that the OS in the ICG group was significantly higher than that in the non-ICG group (log-rank Multivariable Cox regression analysis (Supplem... | PMC10654517 | |
ICG reduces the LN dissection noncompliance and locoregional recurrence, and improves DFS | The LN dissection noncompliance rate in the ICG group (41 of 129 patients [31.8%]) was lower than that in the non-ICG group (74 of 129 patients [57.4%]; The OS of pN0 patients with compliant and noncompliant lymphadenectomy were comparable (log-rank Further analysis (Supplementary Fig. Among the full cohort, there are ... | PMC10654517 | ||
Discussion | tumor | REGRESSION, TUMOR, RECURRENCE, REFLUX, PRIMARY TUMOR | This RCT aimed to evaluate the role of ICG in LN tracing during laparoscopic radical gastrectomy. Our study shows that laparoscopic ICG fluorescence imaging-guided lymphadenectomy can improve the long-term OS and DFS of patients with GC and reduce the cumulative recurrence rate compared with conventional lymphadenectom... | PMC10654517 |
Methods | PMC10654517 | |||
Study design | The current study was a phase 3, parallel, open-label RCT conducted at the Fujian Medical University Union Hospital (FMUUH), a tertiary referral teaching hospital in China. This clinical trial was registered at | PMC10654517 | ||
Participants | Cancer, AJCC, gastric adenocarcinoma | ONCOLOGY, CANCER, GASTRIC ADENOCARCINOMA | Patients were eligible to participate if they were aged 18 to 75 years, had an Eastern Cooperative Oncology Group (ECOG) score of 0 (asymptomatic) or 1 (symptomatic but completely ambulatory), and had histologically confirmed gastric adenocarcinoma diagnosed at the preoperative clinical stage of cT1 to cT4a, N0/ + , M0... | PMC10654517 |
Randomization and masking | tumor | TUMOR, RECRUITMENT, BLIND | Eligible patients were randomly assigned by a 1:1 ratio to either the ICG or non-ICG group. The data manager (M.L.), who was not involved in the eligibility assessment and recruitment of patients, performed randomization with a list of randomly ordered treatment identifiers generated by a permuted block design using SA... | PMC10654517 |
Procedures | tumor, Dehydration | TUMOR, DEHYDRATION, STERILE, BLIND, PRIMARY TUMOR, DEHYDRATION | In the ICG group, ICG was endoscopically injected around the tumor in patients one day before operation; 1.25 mg/mL ICG (Dandong Yichuang Pharmaceutical Co) was prepared in sterile water, and 0.5 mL of the solution was injected into the submucosal layer at four quadrants around the primary tumor, amounting to 2.5 mg of... | PMC10654517 |
Outcomes | death, desirableOS, upper gastrointestinal endoscopy, cancer, weight loss | RECURRENCE, CANCER, RECURRENCE | The primary original protocol endpoint (Supplementary Information The current AJCC Staging manual recommends that the removal of ≥30 regional LNs is desirableOS was defined as the time from surgery to death from any cause or the last follow-up, and DFS was defined as the time from surgery to recurrence or death from an... | PMC10654517 |
Sample size | The main evaluation index in this study was the total number of retrieved LNs. Based on previous studies | PMC10654517 | ||
Statistical analysis | death | REGRESSION, SECONDARY, RECURRENCE, EVENT | There are no deviations in the analysis plan compared with the preregistered protocol. The per-protocol analysis set population was used for all analyses. ITT analysis was conducted for the primary end point and secondary survival points only. Continuous variables are expressed as mean (standard deviation (SD)), and ca... | PMC10654517 |
Reporting summary | Further information on research design is available in the | PMC10654517 | ||
Supplementary information |
Supplementary InformationReporting SummaryPeer Review FileSupplementary Data 1Description of Additional Supplementary Files | PMC10654517 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41467-023-42712-6. | PMC10654517 | ||
Acknowledgements | We thank those who have devoted a lot to this study, including pathologists, further-study doctors, statisticians and nurses. Thanks for Dr. Zhi-Hong Huang, Public Technology Service Center, Fujian Medical University. Thank you to statisticians Liu Fengqiong and Chen Fa for their guidance in statistics. This study was ... | PMC10654517 | ||
Author contributions | C.Q.Y., Z.Q., H.C.M. and Z.C.H.: Concept and design. L.Z.Y., L.P., X.J.W., J.M.C., W.H.G. and L.G.T.: Acquisition, analysis, or interpretation of data. C.Q.Y., Z.Q., L.Z.Y., H.C.M. and Z.C.H.: Drafting of the manuscript. C.Q.Y., Z.Q., L.Z.Y., H.C.M. and Z.C.H.: Statistical analysis. Z.Q.L., W.J.B., L.J.X., L.J., C.L.L.... | PMC10654517 | ||
Peer review | PMC10654517 | |||
Data availability | CM | The data supporting the findings in this study are available under controlled access due to data privacy laws related to patient consent for data. All the original clinical data will be made available on request from the corresponding author (Huang CM) at any time in a de-identified manner for research purposes only. T... | PMC10654517 | |
Competing interests | The authors declare no competing interests. | PMC10654517 | ||
References | PMC10654517 | |||
Background | REGRESSION | Two characteristics of commonly used outcomes in medical research are zero inflation and non-negative integers; examples include the number of hospital admissions or emergency department visits, where the majority of patients will have zero counts. Zero-inflated regression models were devised to analyze this type of da... | PMC10523642 | |
Methods | REGRESSION | We conducted a simulation study to evaluate the performance of two generalized linear models, negative binomial and zero-inflated negative binomial, for analyzing zero-inflated count data. Simulation scenarios assumed a randomized controlled trial design and varied the true underlying distribution, sample size, and rat... | PMC10523642 | |
Results | We first found that, regardless of the rate of zero inflation, there was little difference between the conventional negative binomial and its zero-inflated counterpart in terms of bias of the marginal treatment group coefficient. Second, even when the outcome was simulated from a zero-inflated distribution, a negative ... | PMC10523642 | ||
Conclusions | NB | REGRESSION | We recommend that the rate of zero inflation and overdispersion in the outcome should not be the sole and main justification for choosing zero-inflated regression models. Investigators should also consider other data characteristics when choosing a model for count data. In addition, if the performance of the NB and ZIN... | PMC10523642 |
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07648-8. | PMC10523642 | ||
Keywords | PMC10523642 | |||
Introduction | NB | REGRESSION | Zero-inflated (ZI) non-negative count data frequently arise in medical studies, e.g., number of clinic visits, admissions, days in hospital, number of serious illnesses, and medical costs. This data has the following distinct characteristics: (1) the presence of a large proportion of zero values (i.e., zero inflation [... | PMC10523642 |
Methods | NB | REGRESSION | The overall scheme of this simulation study is depicted in Fig. Overall flow chart of the study. We first fitted DD NB and ZINB regression models to the Telemedicine Study dataset. Based on the coefficients from data-derived (DD) models, we generated 5000 synthetic datasets. Unique characteristics of synthetic outcomes... | PMC10523642 |
Motivating example | NB, illness | REGRESSION, SECONDARY | Telemedicine (TM) is an emerging platform for the delivery of health-related services and medical information via telecommunication technology such as computers and smartphones. The COVID-19 pandemic heightened the importance and value of these contactless healthcare services. Previuosly [In this current study, the pri... | PMC10523642 |
Summary of NB and ZINB distributions | REGRESSION | The ZINB distribution is a mixture distribution in which a mass of The expected count is In the ZINB regression model, the parameters Here, | PMC10523642 | |
Simulation of synthetic data | REGRESSION | To obtain the simulated outcomes, two components are required: (1) regression coefficients from the DD models and (2) synthetic predictors (i.e., a treatment group variable and covariates for adjustment). The amount of zero counts in the simulated outcomes reflects both the regression coefficients and the synthetic pre... | PMC10523642 | |
Sensitivity analysis: sample size | Additionally, we varied the sample size of the synthetic data (60, 80, 100, 200, 600, and 800) to assess whether the results behave differently depending on the sample size. We used the same model parameters and distributions to simulate the | PMC10523642 | ||
Analysis of synthetic data | NB | Each of the three outcomes in the synthetic datasets was analyzed with two different GLMs: NB and ZINB models. For each model, we calculated bias, mean squared error (MSE), and coverage for | PMC10523642 | |
Ridge logistic regression using unique data characteristics as predictors | NB | We constructed a new dichotomous outcome variable (either 0 or 1) indicating whether the ZINB model gave a better fit to the synthetic dataset based on the AIC from the Adjusted odds ratio for a preference for a ZINB model (over an NB model in terms of AIC) regardless of the type of the DD modelUnique characteristics o... | PMC10523642 | |
Results | PMC10523642 | |||
Simulation metrics | As shown in Table Bias, mean squared error (MSE), and coverage for treatment group coefficient, | PMC10523642 | ||
Important predictors of ZINB being preferred | NB | REGRESSION, SENSITIVITY | Regardless of the The results from the ridge logistic regression analysis indicated that the mean of the non-zero part of the outcome was the strongest positive predictor of a preference for a ZINB model, with OR of 1.71 (Fig. Sensitivity analysis: adjusted odds ratio for a preference for a ZINB model (over an NB model... | PMC10523642 |
Discussion | NB | REGRESSION | The aim of this study was to compare the performance of NB and ZINB regression models in terms of bias, MSE, and coverage and to determine which properties of zero-inflated count data are better described by a ZINB model. Our simulation results indicated that a ZINB regression model does not necessarily outperform an N... | PMC10523642 |
Acknowledgements | Not applicable | PMC10523642 | ||
Authors’ contributions | KL and CP designed the study. KL analyzed the data and performed the simulation studies. KL and CP drafted and revised the manuscript. RM, EA, and JT provided trial data in the required format. All authors agreed to be responsible for all aspects of the manuscript. All authors read and approved the final manuscript. | PMC10523642 |
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