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Procedures | stroke | STROKE, ATRIAL FIBRILLATION, PATHOPHYSIOLOGY | The original intervention was designed by J.G.K. and A.T. The development process is described elsewhere.The final intervention was a series of 4 videos: (1) “What is AF?” discussing cardiac anatomy, the ECG, and AF risk factors; (2) “Management of Atrial Fibrillation,” addressing the pathophysiology of AF, including t... | PMC10709770 |
Trial Procedures | RECRUITMENT | Participants underwent assessments at baseline (prior to the first clinic visit), 2 days after their clinic visit, and at 90 days after recruitment. At baseline, we collected demographic information, medication adherence, motivation to maintain medication adherence, and AF knowledge. Race and ethnicity were self-report... | PMC10709770 | |
Study Outcomes | nonadherence, Atrial Fibrillation | ATRIAL FIBRILLATION | The primary outcome was prospectively defined as the odds of correctly answering each Jessa Atrial Fibrillation Knowledge Questionnaire (JAFKQ) question in the intervention group compared with the control group at 90 days. The JAFKQ is a 16-item questionnaire that addresses general AF knowledge with anticoagulation-spe... | PMC10709770 |
Statistical Analysis | REGRESSION, SECONDARY, RECRUITMENT | The original intended sample size of 360 was revised to 200 due to recruitment limitations in the context of the COVID-19 pandemic. A sample size of 200 participants (100 participants per group) was calculated to have 90% power (2-sided, type 1 error 5) to detect a difference in 90-day JAFKQ score of 8.95%. This calcul... | PMC10709770 | |
Results | Between November 18, 2020, and July 18, 2022, 208 participants were recruited from 657 patients screened in cardiology outpatient clinics ( | PMC10709770 | ||
Participant Baseline Characteristics | Atrial Fibrillation | ATRIAL FIBRILLATION, ATRIAL FIBRILLATION | Abbreviations: AF, atrial fibrillation; JAFKQ, Jessa Atrial Fibrillation Knowledge Questionnaire; NA, not applicable.Percentages calculated from available responses.Includes Central and South American, Pacific Islander, Polynesian, and Sub-Saharan African.Medical history was collected by clinical investigators from the... | PMC10709770 |
Violin Plot of Knowledge Questionnaire Performance and Satisfaction With Individual Videos | The number of participants at each point in the y-axis is indicated by the width of the plot body. | PMC10709770 | ||
Binomial Logistic Regression of Jessa Atrial Fibrillation Knowledge Questionnaire Performance | atrial fibrillation, Atrial Fibrillation | ATRIAL FIBRILLATION, ATRIAL FIBRILLATION | Abbreviation: OR, odds ratio.Adjusted by baseline Jessa Atrial Fibrillation Knowledge Questionnaire performance, atrial fibrillation diagnosis, education level, age, and sex.High engagement indicates watching videos on at least 3 separate occasions.There were no statistically significant differences between interventio... | PMC10709770 |
Satisfaction and Adherence Motivation by Treatment Group | ATRIAL FIBRILLATION | Abbreviations: AF, atrial fibrillation; OR, odds ratio.High engagement indicates watching videos on at least 3 separate occasions. The high engagement intervention subgroup is compared with the overall control group.There was also no statistically significant difference between intervention and control groups in motiva... | PMC10709770 | |
Discussion | This randomized clinical trial found provision of clinician-developed, patient-targeted educational videos prior to and following clinic appointments increased patient-knowledge regarding AF at 3 months compared with usual care. Self-reported medication adherence in the selected population was too high to detect a clin... | PMC10709770 | ||
Limitations | RECRUITMENT | This study has several limitations. The originally intended sample size of 360 participants was not achieved due to recruitment limitations during the COVID-19 pandemic, and we revised the sample size to 200 in consultation with the Western Sydney Local Health District Human Research Ethics Committee. This reduced the ... | PMC10709770 | |
Conclusions | The findings of this randomized clinical trial suggest that clinician-created educational videos could present a low-cost approach to augment patient-centered cardiovascular care. In this study, short clinician-created, patient-targeted educational videos offered weekly via email improved AF knowledge at 3 months after... | PMC10709770 | ||
Abstract | EDWARDS | Michelle Edwards Former employee of Pfizer. | PMC10712701 | |
Introduction | Activating | PMC10712701 | ||
Methods | Phase Ib dose escalation started with binimetinib 45 mg twice daily plus panitumumab 6 mg/kg administered every 2 weeks. In the phase II study, patients with measurable mCRC were enrolled into 4 groups based on previous anti-EGFR monoclonal antibody therapy and | PMC10712701 | ||
Results | No patients in the phase Ib portion ( | PMC10712701 | ||
Conclusions | toxicity | MUTANT | The combination of binimetinib and panitumumab had substantial toxicity and limited clinical activity for patients with mutant or WT This article reports the results of a study that evaluated the combination of the MEK1/2 inhibitor binimetinib and the EGFR inhibitor panitumumab in patients with | PMC10712701 |
Implications for Practice | cancer, tumors | CANCER, METASTATIC COLORECTAL CANCER, TUMORS | Epidermal growth factor receptor (EGFR) protein and the MAPK pathway (including the proteins RAS, RAF, MEK1/2, and ERK) are involved in cell growth and survival; activation of any of these proteins can cause cells to divide more rapidly, allowing cancer to develop. People with metastatic colorectal cancer (mCRC) tumors... | PMC10712701 |
Introduction | tumors | METASTATIC COLORECTAL CANCER, TUMORS | Monoclonal antibodies targeting epidermal growth factor receptors (EGFRs) have led to significant improvements in survival for patients with metastatic colorectal cancer (mCRC).Studies of acquired resistance to EGFRi show that progressing tumors remain dependent on extracellular signal-regulated kinase (ERK) activation... | PMC10712701 |
Materials and Methods | PMC10712701 | |||
Study Design | This was a 2-part, open-label, multicenter study (NCT01927341) comprising a phase Ib dose escalation followed by a phase II clinical efficacy evaluation and safety assessment of the combination treatment binimetinib + panitumumab. For phase II, 4 patient populations were enrolled based on previous anti-EGFR monoclonal ... | PMC10712701 | ||
Study Population | Tumors | TUMORS, DISEASE, ONCOLOGY | Both phases of the study enrolled adult patients (aged ≥18 years) with histologically or cytologically confirmed mCRC, evidence of measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), Eastern Cooperative Oncology Group performance status of 0 to 2, and written documentation of e... | PMC10712701 |
Study Objectives and Endpoints | toxicities, DLTs, intercurrent illness | DISEASE PROGRESSION, ADVERSE EVENTS, DISEASE, SECONDARY, REGRESSION | The objective of phase Ib was to determine the maximum tolerated dose (MTD) of binimetinib + panitumumab. The MTD is defined as the highest combination drug dosage not causing medically unacceptable dose-limiting toxicities (DLTs) in more than 35% of treated patients in the first cycle of treatment, based on an adaptiv... | PMC10712701 |
Study Treatment and Procedures | loose stools, Tumor, diarrhea, toxicity, abdominal cramping, Toxicity, skin toxicity | DISEASE PROGRESSION, SKIN TOXICITY, ADVERSE EVENT, TUMOR | In phase Ib, patients received a starting dose of binimetinib 45 mg twice daily (BID) + panitumumab 6 mg/kg once every 2 weeks (Q2W), the US Food and Drug Administration approved doses of both agents at the time. Dose de-escalation was planned as needed until the MTD/recommended phase II dose (RP2D) was reached. In pha... | PMC10712701 |
Statistical Analyses | The MTD/RP2D of the combination treatment was estimated based on the anticipated probability of DLTs in cycle 1 for patients in the dose-determining set, which consisted of all phase Ib patients who met specified minimum exposure criteria and had sufficient safety evaluations during cycle 1 or who discontinued earlier ... | PMC10712701 | ||
Results | PMC10712701 | |||
Patient Demographics and Disease Characteristics | ONCOLOGY, METASTATIC COLORECTAL CANCER, ADVERSE EVENT | In total, 53 patients were enrolled between November 19, 2013 and January 25, 2016: 10 in phase Ib and 43 in phase II (database lock: August 11, 2016; Patient flow diagram. Abbreviations: AE: adverse event; EGFRi: epidermal growth factor receptor inhibitor; mCRC: metastatic colorectal cancer; MUT: mutation; Overall, th... | PMC10712701 | |
Maximum Tolerated Dose/Recommended Phase II Dose | DLTs | No DLTs were reported during phase Ib of the study. The MTD/RP2D was determined to be binimetinib 45 mg BID + panitumumab 6 mg/kg Q2W. | PMC10712701 | |
Efficacy | PD | DISEASE | In phase Ib, no patients had a response to combination therapy with binimetinib + panitumumab; 7 patients had stable disease for a DCR of 70% (95%CI, 34.8-93.3). In phase II, one patient in the Summary of confirmed response per local assessment.Abbreviations: CI: confidence interval; CR: complete response; DCR: disease... | PMC10712701 |
Safety | gastrointestinal events, nausea, fatigue, diarrhea, vomiting, dermatitis acneiform, rash, fatigue/asthenia | ADVERSE EVENT | The median duration of exposure to binimetinib + panitumumab combination therapy was 9.1 (range 5.3-40.0) weeks in phase Ib and 6.1 (range 1.0-48.0) weeks in phase II of the study (Across both study phases, all patients experienced ≥1 AE, regardless of study drug relationship; the most common AEs were diarrhea (71.7%),... | PMC10712701 |
Discussion | right-sided colon cancer, DLTs | PRIMARY TUMOR, DISEASE | This phase Ib/II study aimed to determine the MTD and/or RP2D of the MEKi binimetinib given in combination with the EGFRi panitumumab and to investigate the efficacy and safety of the combination treatment in patients with mCRC. While there were no DLTs at the full dose of both agents, the combination was difficult to ... | PMC10712701 |
Acknowledgments | Cancer | CANCER | We thank the patients and their families, as well as the participating study teams, for making this study possible. Medical writing and editorial assistance were provided by Namiko Abe of Caudex and funded by Pfizer. In addition, the work was supported in part by a National Institutes of Health Cancer Center Support Gr... | PMC10712701 |
Funding | Cancer | CANCER | This study was sponsored by Array Biopharma in collaboration with Novartis. Array Biopharma was acquired by Pfizer in July 2019. Medical writing and editorial assistance were provided by Namiko Abe of Caudex and were funded by Pfizer. Research was supported by the National Institutes of Health Cancer Center Core Grant ... | PMC10712701 |
Conflict of Interest | Pierre, Diaccurate, Cancer | ONCOLOGY, CANCER | E.V.C. reports consulting or advisory roles with Array, AstraZeneca, Bayer, Biocartis, Bristol Myers Squibb, Celgene, Eli Lilly, Ipsen, MSD, Merck KGaA, Novartis, Pierre Fabre, Roche, Servier, Sirtex, and Taiho, and research funding to his institution from Amgen, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Celge... | PMC10712701 |
Author Contributions | Conception/design: J.T., Z.A.W. Provision of study material or patients: E.V.C., J.P.D., J.T., M.D., S.S., E.E., T.Z., Z.A.W. Collection and/or assembly of data: R.Y., J.P.D., J.T., L.L.S., M.D., E.E., S.K., T.Z., N.S., Z.A.W. Data analysis and interpretation: E.V.C., J.P.D., J.T., M.D., S.S., T.Z., Z.A.W. Manuscript w... | PMC10712701 | ||
Data Availability | Upon request, and subject to review, Pfizer will provide the data supporting the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual deidentified participant data. See | PMC10712701 | ||
References | PMC10712701 | |||
Objectives | Maximising the impact of community-based programmes requires understanding how supply of, and demand for, the intervention interact at the point of delivery. | PMC10410802 | ||
Design | malaria | MALARIA | Post-hoc analysis from a large-scale community health worker (CHW) study designed to increase the uptake of malaria diagnostic testing. | PMC10410802 |
Setting | Respondents were identified during a household survey in western Kenya between July 2016 and April 2017. | PMC10410802 | ||
Participants | fever | Household members with fever in the last 4 weeks were interviewed at 12 and 18 months post-implementation. We collected monthly testing data from 244 participating CHWs and conducted semistructured interviews with a random sample of 70 CHWs. | PMC10410802 | |
Primary and secondary outcome measures | fever | SECONDARY | The primary outcome measure was diagnostic testing before treatment for a recent fever. The secondary outcomes were receiving a test from a CHW and tests done per month by each CHW. | PMC10410802 |
Results | malaria | MALARIA | 55% (n=948 of 1738) reported having a malaria diagnostic test for their recent illness, of which 38.4% were tested by a CHW. Being aware of a local CHW (adjusted OR=1.50, 95% CI: 1.10 to 2.04) and belonging to the wealthiest households (vs least wealthy) were associated with higher testing (adjusted OR=1.53, 95% CI: 1.... | PMC10410802 |
Conclusion | malaria | MALARIA | Scale-up of community-based malaria testing is feasible and effective in increasing uptake among the poorest households. To maximise impact, it is important to recognise factors that may restrict delivery and demand for such services. | PMC10410802 |
Trial registration number | PMC10410802 | |||
STRENGTHS AND LIMITATIONS OF THIS STUDY | malaria | MALARIA, SECONDARY | This analysis draws on a large multidimensional dataset describing uptake of community-based services (intervention recipients) and delivery of services (intervention providers) in the context of a cluster randomised implementation trial, thereby allowing us to examine the strengths and shortcomings of the intervention... | PMC10410802 |
Introduction | malaria, fever | MALARIA, SECONDARY | Despite decades of control efforts, malaria remains a major public health problem. In 2019, an estimated 229 million cases of malaria occurred worldwide, most of which were in the WHO African Region (215 million or 94%).Prompt malaria diagnosis either by microscopy or rapid diagnostic tests (mRDTs) is recommended by WH... | PMC10410802 |
Methods | PMC10410802 | |||
Description of the main trial | malaria, febrile | MALARIA, SHOP | This is a post-hoc analysis of data collected within intervention clusters during a large community-based cluster randomised trial. The main results of the trial have been reported elsewhere.In Kenya, CHWs work on a volunteer basis and there are no formal education requirements. The ability to read and write are criter... | PMC10410802 |
Community surveys | malaria, fevers, fever | MALARIA | A community-based survey was conducted to collect individual-level study outcomes based on a population-based survey sampling strategy. This was a repeated cross-sectional household survey at four time points: baseline (pre-intervention), 6 months, 12 months and 18 months post-baseline. The survey was conducted in all ... | PMC10410802 |
Midpoint CHW survey | malaria | MALARIA | As part of the process evaluation, at the midpoint of this study, interviews were conducted with a random sample of 70 CHWs (median of 4 per CU) who were trained to conduct mRDTs (intervention CUs). The primary objective of these interviews was to determine the CHWs’ satisfaction with their role in the malaria project ... | PMC10410802 |
Demand and supply | malaria | MALARIA | To investigate factors that might have influenced the success of the intervention, the analysis was divided into demand and supply factors. On the demand side, the analysis investigates factors that might influence the community member’s outcome of having a test, first from any source and then from the CHW. Only respon... | PMC10410802 |
Outcome measures | fevers | SECONDARY | The primary outcome is the uptake of testing in the intervention clusters, defined as the proportion of fevers in the previous 4 weeks that received a diagnostic test from any source. The second primary outcome is the uptake of testing from a CHW among those who received a diagnostic test from any source.The secondary ... | PMC10410802 |
Statistical analysis | malaria, fever | REGRESSION, SECONDARY, MALARIA | A mixed-effects logistic regression analysis was used to evaluate the primary outcome measures on the uptake of testing and investigate risk factors that might have contributed to the outcomes of the intervention reported previously.For the primary outcome measures to evaluate the uptake of testing overall and from a C... | PMC10410802 |
Patient and public involvement | None. | PMC10410802 | ||
Results | MAY | A total of 272 CHWs in 16 intervention CUs were trained to perform mRDTs and 36 retail shops were enrolled to redeem vouchers. The intervention was launched on 21 July, 17 August and 22 September 2015 in Bokoli, Kiminini and Ndivisi subcounties, western Kenya, respectively, and continued until 5 May 2017. | PMC10410802 | |
Demand-side factors for use of malaria diagnostic testing | malaria, fever, acute illness | MALARIA, FEBRILE ILLNESS | In total, 3719 households were approached, 1877 had an eligible fever in the last 4 weeks, 56 did not know if there was an eligible fever, 0 refused and 1738 completed the survey with no missing answers (92.6%). The community-based demand analysis relies on 1738 complete surveys from participants in randomly selected h... | PMC10410802 |
Diagnostic testing by CHWs | malaria | MALARIA | In total, 32 404 mRDTs were conducted by the CHWs over the intervention period, and 33.7% (n=10 870) were positive. Those with a positive test received a voucher for a discounted quality-assured AL. These vouchers were redeemed at a participating outlet by 93.9% of voucher recipients. There were no instances of stock o... | PMC10410802 |
Discussion | fever, malaria, malarial illness, febrile illness, generalised, febrile | MALARIA, REGRESSION, FEBRILE ILLNESS | This study adds to the evidence that it is feasible for CHWs to offer malaria testing using mRDTs in the community. With the use of CHWs, large-scale malaria testing intervention can reach the underserved population who cannot afford to visit the health facilities for care and those who seek care in the retail sector. ... | PMC10410802 |
Conclusion | In summary, scale-up of health interventions through CHWs is feasible and effective at reaching the poorest households. However, in order to maximise the impact of community-based interventions, it is important to recognise factors that may restrict both delivery and demand for such services. It is critical to not only... | PMC10410802 | ||
Supplementary Material | PMC10410802 | |||
Reviewer comments | PMC10410802 | |||
Data availability statement | Data are available upon reasonable request. Trial data are available at | PMC10410802 | ||
Ethics statements | PMC10410802 | |||
Patient consent for publication | Not required. | PMC10410802 | ||
Ethics approval | This study involves human participants and ethical approval was granted by Moi University Institutional Research and Ethics Committee (formal approval no. 0001403) and Duke University Institutional Review Board (Pro00063384). Participants gave informed consent to participate in the study before taking part. | PMC10410802 | ||
References | PMC10410802 | |||
Trial design: | CHRONIC LOW BACK PAIN | This study investigated the effect of adding abdominal bracing to spinal stability exercise in patients with chronic low back pain (CLBP). This prospective, randomized pilot study included 67 patients and was conducted at the sports medicine center of a single hospital. | PMC10578739 | |
Methods: | Oswestry disability | LORDOSIS | The abdominal bracing group (ABBG) underwent spinal stability exercise with abdominal bracing (N = 33), comprising 50 minutes training twice a week for 24 weeks. The control group performed only spinal stability exercise (N = 34) for 50 minutes twice a week for 24 weeks. The ABBG received abdominal bracing training at ... | PMC10578739 |
Results: | Pain | The LLA increased over time in both the groups but was not significantly different between the groups. Spine extensor strength was improved over time in both the groups, and an interactive effect was observed at a spinal flexion angle of 60° and 72°. Pain and function were also improved over time in both the groups, bu... | PMC10578739 | |
Conclusions: | pain | LORDOSIS | Although adding abdominal bracing to spinal stability exercise did not affect the changes in the LLA, abdominal bracing improved the spinal extensor strength, pain, and function in patients with CLBP. Therefore, it is recommended to add abdominal bracing to spinal stability exercise to maintain the lordosis angle and t... | PMC10578739 |
1. Introduction | muscle weakness, anxiety, pain, Low back pain, causes disability, depression, LBP | LORDOSIS, MUSCLE WEAKNESS | Low back pain (LBP) is prevalent in modern society; back pain not only causes disability in daily life but also degrades the quality of life and can result in psychological problems, including depression and anxiety.Although various causes of CLBP have been reported, muscle weakness and imbalance around the lumbar spin... | PMC10578739 |
2. Methods | In this prospective randomized pilot study, randomization was performed by a therapist who was not involved in the study at the time of the first participant interviews. After baseline measurements, randomization was conducted by distributing blank envelopes with 2 group numbers to the participants, categorized by sex,... | PMC10578739 | ||
2.1. Participants | arthritis, scoliosis, pain | ARTHRITIS, SCOLIOSIS | In this study, the sample size was obtained using G* power version 3.1 (University of Dusseldorf, Dusseldorf, Germany), with an effect size (ES) of 0.40, a power of 0.95, and a significance level of.05. Seventy participants were selected considering a drop rate of 30%. Participants diagnosed with CLBP at an orthopedic ... | PMC10578739 |
2.2. Intervention | CONTRACTION, CONTRACTION | Both the groups visited a sports medical center (Nanoori Sports Medical Center, Gangnam-gu, Seoul, Korea) and participated in an SSE program comprising exercise for 50 minutes twice a week for 24 weeks. In each session, the ABBG also underwent ABB, which comprised preparation, relaxation, and contraction phases, before... | PMC10578739 | |
2.3. Outcome measurement | Oswestry disability, Pain | LORDOSIS | In this study, the LLA was the primary outcome, and the lateral view was obtained through X-ray imaging (Accury-625R, Dk, Medical system, Seoul, Korea) that included the lumbar spine and pelvis, with the participant in a standing position. To visualize spine alignment, the participant was asked to raise both arms over ... | PMC10578739 |
2.4. Statistical analysis | SPSS program version 23.0 (IBM Corp., Armonk, NY) was used for data analysis. Data normality was verified using the Kolmogorov–Smirnov test and analyzed using the parametric statistical method. An independent | PMC10578739 | ||
3. Results | ± | In the ABBG, 2 participants dropped out, and 33 participants (10 male/23 female) were finally analyzed. In the CG, 1 participant dropped out, and 34 participants (10 male/24 female) were finally analyzed (Fig. Baseline characteristics of study participants (n = 67).ABBG = abdominal bracing group, BMI = body mass index,... | PMC10578739 | |
3.3. Pain and function | disability, pain | The pain and function results from baseline to week 24 are shown in Table In both the groups, function (disability index) decreased over time. In the post hoc analysis, the function of the ABBG improved over time (baseline vs 12 weeks and 12 vs 24 weeks, | PMC10578739 | |
4. Discussion | Oswestry disability, LBP, pain | LORDOSIS, CONTRACTIONS | According to the results of this pilot study, adding ABB to SSE for patients with nonspecific CLBP was more effective on lumbar extensor strength, pain, and function than SSE alone. However, we were unable to confirm any benefit that the addition of ABB could have on the LLA.Although it is debated whether or not the LL... | PMC10578739 |
Acknowledgments | We would like to thank Editage for helping with English proofreading. | PMC10578739 | ||
Abbreviations: | pain | LORDOSIS, CHRONIC LOW BACK PAIN | abdominal bracingabdominal bracing groupcontrol groupchronic low back paineffect sizeintra-abdominal pressureinternal obliquelow back painlumbar lordosis angleOswestry disability indexspine stabilization exercisetransverse abdominisHSP and SWP contributed equally to this work.All data generated or analyzed during this ... | PMC10578739 |
References | PMC10578739 | |||
Background | Binge-eating, eating disorder | PATHOLOGY | Loss of Control Eating (LOC) is the most prevalent form of eating disorder pathology in youth, but research on evidence-based treatment in this group remains scarce. We assessed for the first time the effects and acceptance of a blended treatment program for youth between 14 and 24 years with LOC (Binge-eating Adolesce... | PMC10683190 |
Methods | Twenty-four youths (mean age 19.1 years) participated in an active treatment of nine-weeks including three face-to-face workshops and six weekly email-guided self-help sessions, followed by four email guided follow-up sessions, one, three, six and 12 months after the active treatment. All patients completed a two-weeks... | PMC10683190 | ||
Results | The number of weekly LOC episodes substantially decreased during both the waiting-time (effect size | PMC10683190 | ||
Conclusions | depressive symptoms | This first blended treatment study BEAT might be well suited to decrease core symptoms of LOC, depressive symptoms and appearance-based rejection sensitivity. More research is needed to establish readily accessible interventions targeted more profoundly at age-salient maintaining factors such as appearance-based reject... | PMC10683190 | |
Trial registration | The trial was registered at the German Clinical Trials Register (ID: DRKS00014580; registration date: 21/06/2018). | PMC10683190 | ||
Keywords | PMC10683190 | |||
Methods | PMC10683190 | |||
Patients | Overall, 24 youths (23 females, one male) were included in the pilot study of whom 16 (all female) completed the posttreatment and 13 the post follow-up assessment of BEAT (see Fig. Patient flow diagram | PMC10683190 | ||
Measures | PMC10683190 | |||
Statistical analyses | illness, eating disorder, depressive symptoms, ill, Depression, DSM-5 | SECONDARY, PATHOLOGY, DISORDERS | At pretreatment assessment patients were asked to provide age, gender, nationality and occupational status.LOC and further mental disorders were assessed by the Mini-DIPS, a structured interview to assess mental disorders according to the DSM-5 [The following two online self-report questionnaires were assessed weekly d... | PMC10683190 |
Results | PMC10683190 | |||
Preliminary findings on primary and secondary outcomes | PMC10683190 | |||
BED diagnoses and the number of patients with LOC | BED diagnoses and the number of patients with LOC at each time point are reported in Table | PMC10683190 | ||
Weekly LOC episodes (WBQ) | The WBQ was assessed 17 times during the whole study, which allowed a detailed observation of the temporal course from pretreatment to post follow-up at week 59. Contrary to our hypotheses, the WBQ not only linearly decreased during the active treatment (slope Temporal course of the WBQ from assessment points pretreatm... | PMC10683190 | ||
Secondary outcomes | PMC10683190 | |||
Depressive symptoms (BDI-FS) | As for the WBQ, the BDI-FS was assessed 17 times during the whole study and thus allowed a detailed observation of the temporal course from pretreatment to post follow-up (see Fig. Temporal course of the BDI-FS from assessment points pretreatment (week 0) to post follow-up (week 59). See Fig. Contrary to our expectatio... | PMC10683190 | ||
General eating disorder pathology (EDE-Q global score) and BMI-SDS | As expected, the EDE-Q global score decreased between pretreatment and posttreatment (week 0 to week 11; including the waiting-time and active treatment) by In accordance with our hypothesis, mean BMI-SDS scores did not change between pretreatment, posttreatment, 6-month follow-up and post follow-up ( | PMC10683190 |
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