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Socio-demographic characteristics by site of participants screened for SiVET studies in Kenya and Uganda (2014–2017). | SECONDARY | Entebbe had the biggest proportion of participants aged ≥30 years (49.9%, n = 501) and those with secondary education or higher (49.9%, n = 692). Informal high-risk jobs were reported by 76.4% of participants and Entebbe was the only site with participants having formal jobs (7.9%) as their main occupation. Details in | PMC10351693 | |
Hepatitis B status of participants screened for the SiVET studies in Kenya and Uganda by baseline characteristics. | acute infection, chronic infection, HBV infection | ACUTE INFECTION, CHRONIC INFECTION, NAIROBI | *HR = High Risk; LR = Low RiskThe prevalence of HBV infection was 3.9% among males and 2.8% among females while prevalence by site was: Entebbe (4.9%); Kampala (4.1%) and Nairobi (0.3%). The highest HBV prevalence was found among participants aged 25-29-years (5.2%), those with primary level education (4.5%), and those... | PMC10351693 |
Characteristics associated with having no prior Hepatitis B virus infection among participants screened for the SiVET studies in Kenya and Uganda (2014–2017) | HBV infection | REGRESSION, NAIROBI | We present the results of the logistic regression analyses of having no prior HBV infection among participants who had complete data on HBsAg and HBcAb-Total (n = 1265).In the unadjusted analysis, participants from Kampala (AOR 2.19; 95% CI 1.64–2.94) and Nairobi (AOR 2.79; 95% CI 2.06–3.81) had significantly higher od... | PMC10351693 |
Characteristics associated with having no prior Hepatitis B infection among participants screened for SiVET studies in Kenya and Uganda (n = 1265). | * N not equal to 1,265 because of missing data; OR = Odds ratio; CI = Confidence Interval; Ref = reference group | PMC10351693 | ||
Secondary analysis of characteristics associated with Hepatitis B infection among participants screened for the SiVET studies in Kenya and Uganda (2014–2017) | HBV infection | SECONDARY, NAIROBI | We performed a secondary analysis among 1,340 (98.1%) screened participants, with a test result for HBsAg. The analysis of HBsAg positivity showed that age group and sex were associated with living with HBV after adjustment for other demographic variables. Participants aged 25–29 years were more likely to be infected t... | PMC10351693 |
Discussion | acute infection, deaths, hepatitis, HBV infection | ACUTE INFECTION, NAIROBI, HIV INFECTION, RECRUITMENT, HEPATITIS B, HEPATITIS | Overall, we found that HBV prevalence and immunity due to Hepatitis B vaccination were low among participants who were screened for SiVET studies in Uganda and Kenya with two thirds of participants having test results suggesting no prior HBV infection. We did observe significant heterogeneity among study populations, w... | PMC10351693 |
Limitations | HBV co-infections | REGRESSION, RECRUITMENT | The results of this work are comprised of participants undergoing screening from three SiVETs, each of which had their own enrollment criteria and target populations. Because screening efforts encouraged persons without HIV to enroll, and HIV/ HBV co-infections are not uncommon, our estimates of HBV are likely underest... | PMC10351693 |
Conclusions and recommendations | Hepatitis B, HBV infection | HEPATITIS B | HBV prevalence and immunity due to vaccination are low among potential HIV vaccine trial participants and a high proportion have no prior exposure to HBV. Younger individuals and those recruited from existing cohorts/ clinics are more likely not to have prior HBV infection. HBV screening should continue for HIV vaccine... | PMC10351693 |
Supporting information | PMC10351693 | |||
Characteristics associated with Hepatitis B surface antigen positivity among participants screened for SiVET studies in Kenya and Uganda (n = 1340). | (PDF)Click here for additional data file.(XLSX)Click here for additional data file.We also wish to acknowledge the study staff and participants. | PMC10351693 | ||
References | PMC10351693 | |||
Subject terms | nausea, neutropenia, fatigue, anemia, MIBC, muscle-invasive bladder cancer | ADVERSE EVENTS, NEUTROPENIA, ANEMIA | Cystectomy is a standard treatment for muscle-invasive bladder cancer (MIBC), but it is life-altering. We initiated a phase 2 study in which patients with MIBC received four cycles of gemcitabine, cisplatin, plus nivolumab followed by clinical restaging. Patients achieving a clinical complete response (cCR) could proce... | PMC10667093 |
Main | MIBC, DDR, muscle-invasive bladder cancer | DNA DAMAGE, RECURRENCE | Radical cystectomy is a standard treatment for muscle-invasive bladder cancer (MIBC). However, radical cystectomy is a life-changing operation due to the need for urinary diversion and is associated with a 90-d mortality risk of up to 6–8% (ref. Given the potential to achieve a pCR with TURBT followed by neoadjuvant ch... | PMC10667093 |
Results | PMC10667093 | |||
Patient characteristics and treatment | Cisplatin-eligible patients with cT2–T4aN0M0 MIBC received treatment with four cycles of gemcitabine and cisplatin plus nivolumab (Extended Data Fig. Between 8 August 2018 and 24 November 2020, 76 patients were enrolled with baseline characteristics as detailed in Table Baseline patient characteristics ( | PMC10667093 | ||
Coprimary endpoint analysis | SECONDARY | The co-primary endpoint of cCR was achieved in 33 of 76 patients (43%, 95% confidence interval (CI): 32%, 55%; Fig. The median metastasis-free and overall survival for the entire study cohort was not reached at the time of the data lock (secondary endpoints). To further contextualize the prognostic impact of achieving ... | PMC10667093 | |
Clinical outcomes according to cCR status | The median follow-up for patients achieving a cCR was 30 months (range, 18–42 months) at the data lock and the clinical outcomes of this group are detailed in Fig. | PMC10667093 | ||
Clinical outcomes of patients enrolled on HCRN GU16-257 achieving a cCR. | cancer | CANCER, RECURRENCE | * Patient underwent cystectomy for radiographic changes concerning for local recurrence without evidence of cancer on biopsy or final cystectomy specimen. † Patient opted for immediate cystectomy.Thirty-nine patients did not achieve a cCR, and 34 of 39 underwent cystectomy (four received off protocol radiation and one ... | PMC10667093 |
Safety | treatment-emergent adverse | The treatment-emergent adverse events are detailed in Extended Data Table | PMC10667093 | |
Genomic features associated with clinical outcomes | SECONDARY | In an effort to refine future selection of patients for this risk-adapted treatment approach, a secondary objective of the study was to assess whether the presence of a set of genomic alterations in baseline TURBT tissue would enhance the positive predictive value of cCR. Tumor-only targeted DNA sequencing of pre-treat... | PMC10667093 | |
Radiographic features associated with clinical outcomes | bladder tumors | BLADDER TUMORS, RESIDUAL TUMOR | Conventional radiographic assessments are largely qualitative, and bladder tumors are particularly difficult to assess given the anatomy of the bladder and challenges distinguishing post-treatment bladder wall thickening from residual tumor | PMC10667093 |
Immunological features associated with clinical outcomes | To determine whether baseline and/or on-treatment immune parameters were associated with achieving a cCR or with metastasis-free survival or overall survival, additional exploratory analyses were pursued. PD-L1 immunohistochemical staining (22C3 antibody clone) of baseline TURBT specimens was completed in a central lab... | PMC10667093 | ||
Discussion | MIBC, tumor necrosis | RECURRENCES, TUMOR NECROSIS, METASTATIC BLADDER CANCER | To our knowledge, this is among the first prospective trials to test TURBT plus cisplatin-based chemotherapy as definitive bladder-sparing treatment for MIBC; the first to define the performance characteristics of uniformly assessed and defined cCR as a tool for patient selection for this strategy; and the first to int... | PMC10667093 |
Methods | PMC10667093 | |||
Study design | MIBC | HCRN GU 16–257 is phase 2, investigator-initiated, multicenter clinical trial. Cisplatin-eligible patients with MIBC enrolled at seven medical centers received treatment with gemcitabine, cisplatin, plus nivolumab (Fig. | PMC10667093 | |
Patients | vitiligo, pneumonitis, cancers, neuropathy, malignancy, interstitial lung disease, psoriasis, infection, hypothyroidism, Cancer | DISORDER, VITILIGO, CANCERS, ADVERSE EVENT, HEPATITIS B, VIRUS, PNEUMONITIS, NEUROPATHY, INTERSTITIAL LUNG DISEASE, PSORIASIS, INFECTION, HEPATITIS C, TYPE I DIABETES MELLITUS, ONCOLOGY, HYPOTHYROIDISM, AUTOIMMUNE DISEASE, CANCER | Inclusion criteria:Written informed consent and HIPAA authorization for release of personal health information before registrationAge ≥18 years at the time of consentEastern Cooperative Oncology Group (ECOG) performance status of ≤1 within 28 d before registrationHistological evidence of clinically localized muscle-inv... | PMC10667093 |
Treatment | toxicity | EVENTS, ADVERSE EVENT | Cycles 1–4 of treatment included gemcitabine 1,000 mg mAdverse events were graded according to the NCI CTCAE version 4.03. Adverse events were managed according to algorithms based on the specific toxicity as defined in the protocol. | PMC10667093 |
Clinical restaging and cCR definition | malignancy, tumor, tumors | RESIDUAL, TUMOR, TUMORS, METASTATIC DISEASE | After cycle 4 of gemcitabine, cisplatin, plus nivolumab, patients underwent clinical restaging including MRI of the abdomen and pelvis or CT if MRI was contraindicated and CT of the chest, rigid cystoscopy with biopsies and urine cytology. Transurethral resection of any visible tumor and/or the prior tumor site was per... | PMC10667093 |
PD-L1 immunohistochemistry on baseline TURBT specimens | tumor | CPS, TUMOR, INFILTRATING | Immunohistochemistry for PD-L1 was performed in the Department of Pathology at the Mount Sinai Hospital using the 22C3 antibody clone. PD-L1 expression was quantified by a single genitourinary pathologist (G.K.H.) blinded to clinical outcome data using the combined positive score (CPS), defined as the percentage of PD-... | PMC10667093 |
DNA sequencing of baseline TURBT specimens | Archival baseline TURBT tissue underwent tumor-only targeted DNA sequencing using the Illumina NextSeq platform (Caris Life Sciences). An Agilent custom-designed SureSelect XT assay (Caris MI TumorSeek 592-Gene NGS Panel) was used to enrich 591 whole-gene targets. Sequencing and gene variant calling were carried out as... | PMC10667093 | ||
Mass cytometry (CyTOF) | Mass cytometry (CyTOF) was performed on PBMCs obtained on cycle 1, day 1 and cycle 3, day 1 of treatment. PBMCs were stained with the CyTOF antibody panel detailed in Supplementary Table Astrolabe was employed for automated computational annotation (Astrolabe Diagnostics). CyTOF analysis was performed using Astrolabe a... | PMC10667093 | ||
Multiplex protein immunoassay | tumor | TUMOR | Plasma (cycle 1, day 1 and cycle 3, day 1) and urine (at time of restaging) were analyzed using the Olink Immuno-Oncology panel, which measures 92 proteins involved in immune response and tumor biology, using the Olink multiplex assay (Olink Bioscience) according to the manufacturer’s instructions. The Olink panel uses... | PMC10667093 |
Statistical analysis | REGRESSION | The co-primary objectives of the study were to (1) estimate the cCR rate with gemcitabine, cisplatin, plus nivolumab and (2) assess the positive predictive value of cCR for a composite outcome measure of (1) 2-year metastasis-free survival in patients achieving a cCR and opting to not undergo immediate cystectomy or (2... | PMC10667093 | |
Reporting summary | Further information on research design is available in the | PMC10667093 | ||
Online content | Any methods, additional references, Nature Portfolio reporting summaries, source data, extended data, supplementary information, acknowledgements, peer review information; details of author contributions and competing interests; and statements of data and code availability are available at 10.1038/s41591-023-02568-1. | PMC10667093 | ||
Supplementary information |
Supplementary Tables 1–5.Reporting SummaryClinical Trial Protocol. | PMC10667093 | ||
Extended data | PMC10667093 | |||
Schematic representation of the design of HCRN GU16-257. | MFS, muscle-invasive urothelial cancer of the bladder | BLADDER TUMOR | Patients with muscle-invasive urothelial cancer of the bladder diagnosed based on standard of care TURBT (transurethral resection of bladder tumor) received four cycles of gemcitabine, cisplatin, plus nivolumab followed by clinical restaging consisting of cystoscopy with biopsies, urine cytology, and imaging including ... | PMC10667093 |
Vesical Imaging-Reporting And Data System (VI-RADS) scoring of bladder magnetic resonance imaging (MRI) post-treatment with gemcitabine, cisplatin, plus nivolumab and association with clinical outcomes. | (
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Relationship between PD-L1 immunohistochemical staining of pre-treatment transurethral resection of bladder tumor specimens (n = 59) and clinical outcomes. | (
| PMC10667093 | ||
Peripheral blood mass cytometry (CyTOF) and association with response and overall survival. | (
| PMC10667093 | ||
Peripheral blood protein analytes and association with response and overall survival. | (
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Extended data | is available for this paper at 10.1038/s41591-023-02568-1. | PMC10667093 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41591-023-02568-1. | PMC10667093 | ||
Acknowledgements | Cancer | CANCER | This trial was funded by Bristol Myers Squibb, and translational analyses were supported by the V Foundation for Cancer Research T2019-011 (M.D.G. and J.Z.). Scientific and financial support for the CIMAC-CIDC Network is provided through NCI Cooperative Agreements U24CA224319 (to the Icahn School of Medicine at Mount S... | PMC10667093 |
Author contributions | T.J., G.K., | Conception and design: M.D.G. Financial support: M.D.G. Administrative support: M.D.G. and S.I. Provision of study materials: M.D.G., S.D., K.G.C., T.B.D., J.P.C., B.O., A.D., R.M., C.K., R.B., H.X., K.N., Y.K., E.E., R.M., S.G., J.S. and S.K.P. Collection and assembly of data: M.D.G., S.D., S.I., E.G., K.G.C., S.L., B... | PMC10667093 | |
Peer review | PMC10667093 | |||
Data availability | SECONDARY | In accordance with NIH’s Genomic Data Sharing Policy, the DNA sequencing data used to support the findings of this study have been deposited under controlled access in the database of Genotypes and Phenotypes (dbGaP) under accession number phs0003372. Genomic, clinical, mass cytometry and protein analyte data from this... | PMC10667093 | |
Competing interests | HTG, A.H., Genotwin, T.J. | ONCOLOGY, EMD | M.D.G. has received research funding from Bristol Myers Squibb, Novartis, Dendreon, AstraZeneca, Merck and Genentech. He has served as a consultant to Bristol Myers Squibb, Merck, Genentech, AstraZeneca, Pfizer, EMD Serono, SeaGen, Janssen, Numab, Dragonfly, GlaxoSmithKline, Basilea, UroGen, Rappta Therapeutics, Alliga... | PMC10667093 |
References | PMC10667093 | |||
Key Points | PMC10251208 | |||
Question | Does receipt of peer comparison (also known as social norm or relative performance) feedback on antibiotic prescribing have a significant negative impact on job satisfaction among primary care clinicians in Boston, Massachusetts, and Los Angeles, California? | PMC10251208 | ||
Findings | SECONDARY | In this secondary analysis of a randomized clinical trial conducted from November 1, 2011, to April 1, 2014, the intervention, which delivered a comparison of individual clinician performance with that of top-performing peers in monthly emails, did not reduce mean job satisfaction beyond the noninferiority margin of cl... | PMC10251208 | |
Meaning | SECONDARY | These findings suggest that behavioral interventions aimed at improving performance can be designed in a way that may protect clinician job satisfaction.This secondary analysis of a randomized clinical trial examines whether a national randomized trial using peer comparison feedback to change antibiotic-prescribing beh... | PMC10251208 | |
Importance | Interventions that improve clinician performance through feedback should not contribute to job dissatisfaction or staff turnover. Measurement of job satisfaction may help identify interventions that lead to this undesirable consequence. | PMC10251208 | ||
Objective | To evaluate whether mean job satisfaction was less than the margin of clinical significance among clinicians who received social norm feedback (peer comparison) compared with clinicians who did not. | PMC10251208 | ||
Design, Setting, and Participants | SECONDARY | This secondary, preregistered, noninferiority analysis of a cluster randomized trial compared 3 interventions to reduce inappropriate antibiotic prescribing in a 2 × 2 × 2 factorial design from November 1, 2011, to April 1, 2014. A total of 248 clinicians were enrolled from 47 clinics. The sample size for this analysis... | PMC10251208 | |
Interventions | Feedback comparing individual clinician performance to top-performing peers, delivered in monthly emails (peer comparison). | PMC10251208 | ||
Main Outcomes and Measures | The primary outcome was a response to the following statement: “Overall, I am satisfied with my current job.” Responses ranged from 1 (strongly disagree) to 5 (strongly agree). | PMC10251208 | ||
Results | A total of 201 clinicians (response rate, 81%) from 43 of the 47 clinics (91%) provided a survey response about job satisfaction. Clinicians were primarily female (n = 129 [64%]) and board certified in internal medicine (n = 126 [63%]), with a mean (SD) age of 48 (10) years. The clinic-clustered difference in mean job ... | PMC10251208 | ||
Conclusions and Relevance | ’ | SECONDARY | In this secondary analysis of a randomized clinical trial, peer comparison did not lead to lower job satisfaction. Features that may have protected against dissatisfaction include clinicians’ agency over the performance measure, privacy of individual performance, and allowing all clinicians to achieve top performance. | PMC10251208 |
Trial Registration | ClinicalTrials.gov Identifiers: | PMC10251208 | ||
Introduction | Many performance improvement interventions that exert social influence have shown early signs of success, | PMC10251208 | ||
Methods | This report follows the Consolidated Standards of Reporting Trials ( | PMC10251208 | ||
Study Design and Participants | Respiratory Infections | RESPIRATORY INFECTIONS | The Use of Behavioral Economics and Social Psychology to Improve Treatment of Acute Respiratory Infections Trial was a multisite, cluster randomized trial with practice as the unit of randomization.A total of 248 participants (practicing attending clinicians or advanced practice nurses) were enrolled from 47 participat... | PMC10251208 |
Intervention | respiratory tract infections | Peer comparison feedback was delivered in monthly email messages from practice leadership during the 18-month intervention period. We assessed clinicians’ inappropriate prescribing rates within each geographic region using electronic health record data. Clinicians ranked in the lowest decile of inappropriate prescribin... | PMC10251208 | |
Measurement | Exit surveys, which included a question about job satisfaction, were launched 1 to 12 weeks (varying by institution) following the 18-month intervention. Thereafter, clinicians received up to 3 reminders to complete their survey by the end of 8 weeks; completion times were the same between clinicians who did and did no... | PMC10251208 | ||
Hypothesis Testing | We preregistered a noninferiority hypothesis test (Our null hypothesis is that the peer comparison intervention | PMC10251208 | ||
Sample Size | SECONDARY | This study is a prespecified secondary analysis using data from a randomized clinical trial conducted from November 1, 2011, to April 1, 2014. A total of 248 clinicians were enrolled from 47 clinics. The sample size for this analysis was determined by the number of nonmissing job satisfaction scores from the original e... | PMC10251208 | |
Statistical Analysis | SECONDARY | Data analysis was performed from October 12 to April 13, 2022. Analyses were completed using R, version 3.6.0 (R Project for Statistical Computing), Stata, version 16 (StataCorp LLC), and SAS, version 9.4 (SAS Institute Inc). We used the regress command in Stata to test the difference in mean job satisfaction. We also ... | PMC10251208 | |
Results | The participant response rate was 81% (201 of 248), and the clinic participation rate was 91% (43 of 47) ( | PMC10251208 | ||
Practice and Clinician Characteristics | PCP | Abbreviations: FTE, full-time equivalent; PCP, primary care practice.Mean (SD) job satisfaction was 3.73 (0.88). Prescribers randomized to peer comparison had 0.11 (95% CI, −0.19 to 0.42; | PMC10251208 | |
Discussion | Performance feedback using peer comparison is a widely used approach in health and public policy to change behavior. We rejected the hypothesis that there were negative effects on job satisfaction after a peer comparison intervention. We note that a previous study | PMC10251208 | ||
Limitations | SECONDARY | This study has some limitations. The primary limitation is that it is a secondary analysis of a randomized clinical trial. Additionally, participant enrollment and nonresponse to the survey may have introduced selection effects, although study enrollment (70%) and the survey response rate (81%) were relatively high. Su... | PMC10251208 | |
Conclusions | The conflicting findings between the 2 studies suggest that the details of how peer comparison is implemented may be crucial for its success and impact on clinician well-being. | PMC10251208 | ||
Objective: | migraine | MIGRAINE | Design a feasible study to assess the efficacy and safety of Craniosacral therapy (CST) in the treatment of migraine, using a rigorous and innovative randomized controlled study design involving complementary light-touch sham treatments (CLST) as an attention control intervention. | PMC10637508 |
Methods: | migraine, Headache, Anxiety, headache | MIGRAINE, SECONDARY, ADVERSE EVENTS | This was a single-center, randomized, cross-over placebo-controlled experimental design. A total of 87 participants who suffered migraine attacks from 4 to 9 per month were randomly assigned into either 2 weekly units of CST or CLST for 4 weeks. And then the 2 groups were crossed and continued treatment for 4 weeks plu... | PMC10637508 |
Results: | headache | All 87 individuals had been screened for eligibility, of which 60 were licensed for the study. The difference of HIT-6 and headache frequency between the 2 groups was not significant at the baseline. But the headache frequency and HIT-6 of 2 groups were all declined respectively after the CST at week 4 (group A) and we... | PMC10637508 | |
Conclusion: | migraine, headache-related disability | MIGRAINE | The results indicated that standardized CST was both effective and safe in alleviating the migraine intensity and frequency as well as the headache-related disability. Further larger research is needed. | PMC10637508 |
1. Introduction | migraine, treat).Migraine, Headache, Migraine | MIGRAINE, CHRONIC DAILY HEADACHE, MIGRAINE, HEADACHE DISORDERS | Migraine is a common disabling condition that spans the globe.According to the definition of International Headache Society, migraine is a recurrent headache disorder manifesting in attacks lasting 4 to 72 hours (when untreated or unsuccessfully treat).Migraine affects people quality of life and work ability and social... | PMC10637508 |
2. Materials and methods | PMC10637508 | |||
2.1. Design | migraine | MIGRAINE | This was a single-center, randomized, cross-over, placebo-controlled trial design, completed by neurologists and trained professional rehabilitation therapist. We design a feasibility study to assess the efficacy and safety of CST in the treatment of migraine, using a rigorous and innovative randomized controlled study... | PMC10637508 |
2.2. Participants | Headache | HEADACHE DISORDERS, HEADACHE DISORDERS | The neurologist used guidelines from the international classification of headache disorders third edition to select patients from hospital where he works and invited them to participate in the study.Eligibility of subjects for clinical effectiveness trial of Craniosacral therapy.International Classification of Headache... | PMC10637508 |
2.3. Criteria for inclusion and exclusion | Criteria for inclusion (Table | PMC10637508 | ||
2.4. Randomization and blinding | First, after signed the concealed allocation protocol, the subjects were randomly divided into 2 groups to receive different non-pharmacological treatments. We adopted simple randomization and used the number table grouping method for grouping: group A for CST and group B for CLST. Instead, they were told that 2 differ... | PMC10637508 | ||
2.5. Intervention | headache | GROUP B | We chose 3 rehabilitation therapists who had received unified craniosacral treatment training for craniosacral treatment and 3 other rehabilitation therapists who also had received unified other treatment training for sham treatment. This research design period lasted 12 weeks, and every 4 week was 1 round of treatment... | PMC10637508 |
2.5.1. Craniosacral therapy. | cranial muscle fascia | Since the brain, spinal cord, cranial muscle fascia and all related structures are the content of the craniosacral system, its restrictions or imbalance will directly affect any or all aspects of the performance of the central nervous system. | PMC10637508 | |
2.5.2. Complementary light-touch sham treatments. | CLST was applied on standardized anatomic areas, equal to those treated with CST. The CLST was also completed by 3 therapists who had received unified training. The CLST protocol was designed to mimic the length of the CST protocol in the treatment session, the sequence of interactions with the therapist, and the terms... | PMC10637508 | ||
2.6. Outcome measures and study instruments | PMC10637508 | |||
2.6.1. Primary outcome: HIT-6 and Headache frequency. | migraine, headache | MIGRAINE | The HIT-6, which has been translated 27 different languages so far,The 6-item headache impact test.According to the Delphi study by Luedtke, HIT-6 and headache frequency are the most useful and meaningful outcome for research on the effectiveness of non-pharmacological intervention for headache and migraine. | PMC10637508 |
2.6.2. Secondary outcome: The scores of HDI and the HAMA; the safety and feasibility. | PMC10637508 | |||
The Henry Ford Headache Disability Inventory (HDI): | Headache, headaches, headache | HDI can be used to periodically evaluate a patient with headache and can be used to determine the effectiveness of a management strategy over time. It is a 40-item self-assessment scale designed to facilitate the clinician assessment of the patient perception of the functional and emotional aspects of their headaches (... | PMC10637508 | |
Hamilton Anxiety Scale (HAMA): | migraine, anxiety | MIGRAINE | Studies have found that anxiety, especially general anxiety, is very common in migraine patients. | PMC10637508 |
The safety and feasibility: | ADVERSE EVENTS, SIDE EFFECT | Safety assessment was obtained by direct contact with research staff or by asking patients about the frequency and the severity of side effect before and after each treatment round. Besides, patients were also required to record side effects and simultaneous treatment and medicine use in daily records. No serious adver... | PMC10637508 | |
2.7. Statistical analyses | The SPSS 17.0 for Windows was used to perform statistical analyses. All values were expressed as the mean ± standard deviation. The data of 2 groups were analyzed using the repeated measurement analysis of variance. Differences are considered statistically significant when | PMC10637508 | ||
3. Results | All 87 individuals had been screened for eligibility, of which 60 were licensed for the study. Evenly divided into group A and group B. Figure Our rehabilitation center and professional therapist. | PMC10637508 | ||
3.1. Baseline data | migraine, SD | MIGRAINE | The age of the subjects ranged from 20 to 50 years old and the average age of group A was 40.7 ± 9.6 years. 12 cases were male; The average age of group B was 38 ± 10.3 years. 11 cases were male. The commonly related factors of migraine were also shown in Table Baseline characteristics.Date is presented as mean ± stand... | PMC10637508 |
3.2. Primary outcome: HIT-6 and Headache frequency | PMC10637508 | |||
3.2.1. HIT-6. | The HIT-6 are presented in Table HIT-6 of the 2 groups of patients before and after treatment.Table 3 presents the mean and standard deviation of the total score for the HIT-6 for every group at each time point. There was no difference in HIT-6 between the 2 groups at baseline. Compare with the CLST, the HIT-6 of the g... | PMC10637508 | ||
3.2.2. Headache frequency. | Headache, headache | According to the criteria for inclusion, the headache frequency of subject was from 5 to 9 per month. The frequency and trend of headache are shown in Table Headache frequency changes.Table 4 present the Mean and standard deviation of headache frequency at baseline, after the first round of treatment (week 4) and the s... | PMC10637508 |
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