Nevin Manimala

BMJ Open. 2023 Oct 29;13(10):e073128. doi: 10.1136/bmjopen-2023-073128.

ABSTRACT

INTRODUCTION: Self-criticism is a key feature in people diagnosed with depression, resulting in significant psychological distress. Despite the fact that cognitive-behavioural treatments are readily available, a significant number of patients report experiencing cognitive, but not emotional, change following therapy, resulting in the maintenance of psychological symptoms. Additionally, interventions targeting emotional experiencing, such as chairwork, are generally implemented within large-scale therapeutic treatments. Therefore, within the present study, we aim to evaluate the efficacy and safety of a short intervention using emotion-focused chairwork to target self-criticism in patients diagnosed with depression.

METHODS AND ANALYSIS: The study is designed as a randomised controlled trial with two parallel arms. 62 patients diagnosed with depression will be randomised to the intervention group or the waiting-list control group receiving treatment as usual. The intervention comprises of three treatment sessions using the chairwork technique over the course of 3 weeks. Outcome assessments will take place 1 week before the first treatment session, as well as 1 week and 3 months after the last treatment session. The primary outcomes are self-criticism and self-compassion. Secondary outcomes assess depressive symptoms, emotion regulation and overall self-esteem. Statistical analysis will be performed using intention-to-treat analysis, as well as per-protocol analysis implementing linear-mixed models.

ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of the State Chamber of Physicians in Baden-Wuerttemberg, Germany (approval number: F-2023-12). Scientific findings shall be published in peer-reviewed journals to inform prospective clinical studies focusing on the implementation of chairwork within clinical practice.

TRIAL REGISTRATION NUMBER: German Clinical Trials Register (DRKS00031307; https://drks.de/search/de/trial/DRKS00031307).

PMID:37899154 | DOI:10.1136/bmjopen-2023-073128

BMJ Open. 2023 Oct 29;13(10):e070234. doi: 10.1136/bmjopen-2022-070234.

ABSTRACT

OBJECTIVES: The objective was to assess the prevalence of perinatal depressive symptoms and determine the trajectories of marital adjustment and depressive symptoms and their reciprocal relationships among Chinese perinatal women.

DESIGN: This was a prospective, longitudinal cross-lagged study.

SETTING: The study was conducted at the outpatient department of the largest women’s and children’s hospital in China, which is located in Chengdu, Sichuan Province.

PARTICIPANTS: Four hundred and sixty-three mothers were conveniently sampled.

MAIN OUTCOME MEASURES: The Dyadic Adjustment Scale and the Chinese version of the Edinburgh Postnatal Depression Scale were used to evaluate marital adjustment and depressive symptoms, respectively, at three time points: the first trimester of pregnancy (T1), the third trimester of pregnancy (T2) and 6 weeks after childbirth (T3). Descriptive statistics were used to assess the prevalence of perinatal depressive symptoms, and repeated-measures analysis of variance (ANOVA) was used to determine the trajectories of marital adjustment and depressive symptoms among the participants. A cross-lagged model was used to explore the reciprocal relationship between marital adjustment and depressive symptoms.

RESULTS: The prevalence of perinatal depressive symptoms among our participants ranged from 21.2% to 24.0%. Repeated-measures ANOVA showed that during the perinatal period there was a significant tendency towards worse marital adjustment (F=33.031, p=0.000) and a slight but not significant reduction in depressive symptoms (F=1.883, p=0.153) among the participants. The cross-lagged model showed that maternal marital adjustment at T1 significantly and negatively predicted depressive symptoms at T2 (β=-0.165, p<0.001), and that depressive symptoms at T2 significantly and negatively predicted marital adjustment at T3 (β=-0.135, p<0.001). However, the predictive effects of depressive symptoms at T1 on marital adjustment at T2 and that of marital adjustment at T2 on depressive symptoms at T3 were not significant.

CONCLUSION: The prevalence of perinatal depressive symptoms ranged from 21.2% to 24.0% among the participants. During the perinatal period, the marital adjustment of women tended to be worse; however, there was no significant change in depressive symptoms. This study showed that better marital adjustment at T1 was a protective factor against maternal depressive symptoms at T2, and a higher level of depressive symptoms at T2 was a risk factor for worse marital adjustment at T3.

PMID:37899151 | DOI:10.1136/bmjopen-2022-070234

BMJ Open. 2023 Oct 29;13(10):e076163. doi: 10.1136/bmjopen-2023-076163.

ABSTRACT

OBJECTIVE: Burnout and mental illness are frequent among healthcare professionals, leading to increased sick leave. Simulation-based team training has been shown to improve job satisfaction and mental health among healthcare professionals. This study seeks to investigate the relationship between simulation-based team training and sick leave.

DESIGN: Cohort study.

SETTING AND INTERVENTION: Five Danish hospitals.

PARTICIPANTS: A total of 15 751 individuals were screened for eligibility. To meet the eligibility criteria, individuals had to be employed in the same group (intervention or control) for the whole study period. A total of 14 872 individuals were eligible for analysis in the study.

INTERVENTION: From 2017 to 2019, a simulation-based team training intervention was implemented at two hospital sites. Three hospital sites served as the control group.

OUTCOME MEASURES: Data on sick leave from 2015 to 2020 covered five hospital sites. Using a difference-in-difference analysis, the rate of sick leave was compared across hospital sites (intervention vs control) and time periods (before vs after intervention).

RESULTS: Significant alterations in sick leave were evident when comparing the intervention and control groups. When comparing groups over time, the increase in sick leave was -0.3% (95% CI -0.6% to -0.0%) lower in the intervention group than in the control group. The difference-in-difference for the complete case analysis showed that this trend remained consistent, with analysis indicating a comparable lower increase in sick leave by -0.7% (95% CI -1.3% to -0.1%) in the intervention group.

CONCLUSION: The increase in sick leave rate was statistically significantly lower in the intervention group, implying that simulation-based team training could serve as a protective factor against sick leave. However, when investigating this simulation intervention over 5 years, other potential factors may have influenced sick leave, so caution is required when interpreting the results.

PMID:37899150 | DOI:10.1136/bmjopen-2023-076163

BMJ Open. 2023 Oct 29;13(10):e073363. doi: 10.1136/bmjopen-2023-073363.

ABSTRACT

OBJECTIVE: This study aims to examine the effects of the individually tailored complex intervention Participation Enabling Care in Nursing (PECAN) on activities and participation of residents with joint contractures.

DESIGN: Multicentre pragmatic cluster-randomised controlled trial.

SETTING: 35 nursing homes in Germany (August 2018-February 2020).

PARTICIPANTS: 562 nursing home residents aged ≥65 years with ≥1 major joint contracture (303 intervention group, 259 control group).

INTERVENTIONS: Nursing homes were randomised to PECAN (18 clusters) or optimised standard care (17 clusters) with researcher-concealed cluster allocation by facsimile. The intervention targeted impairments in activities and participation. Implementation included training and support for selected staff. Control group clusters received brief information.

PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint PaArticular Scales combined residents’ activities and participation at 12 months. The secondary outcome comprised quality of life. Safety measures were falls, fall-related consequences and physical restraints. Residents, staff and researchers were unblinded. Data collection, data entry and statistical analysis were blinded. Primary analyses were intention-to-treat at cluster level and individual level using a generalised mixed-effect regression model and imputation of missing data.

RESULTS: Primary outcome analyses included 301 intervention group residents and 259 control group residents. The mean change on the Activities Scale was -1.47 points (SD 12.2) in the intervention group and 0.196 points (SD 12.5) in the control group and -3.87 points (SD 19.7) vs -3.18 points (SD 20.8) on the Participation Scale. The mean differences of changes between the groups were not statistically significant: Activities Scale: -1.72 (97.5% CI -6.05 to 2.61); Participation Scale: -1.24 (97.5% CI -7.02 to 4.45). We found no significant difference in the secondary outcome and no effects on safety measures.

CONCLUSION: The complex intervention did not improve the activities and participation of nursing home residents on the PaArticular Scales at 12 months. Current nursing conditions in Germany may hamper implementation.

TRIAL REGISTRATION NUMBER: DRKS00015185.

PMID:37899149 | DOI:10.1136/bmjopen-2023-073363

Lupus Sci Med. 2023 Oct;10(2):e001018. doi: 10.1136/lupus-2023-001018.

ABSTRACT

OBJECTIVE: Antiphospholipid syndrome (APS) is a systemic autoimmune disorder characterised by venous thrombosis (VT) or arterial thrombosis (AT) and/or pregnancy morbidity and the presence of antiphospholipid antibodies. Direct oral anticoagulants (DOACs) hold several advantages to vitamin K antagonists (VKAs) for prevention of thrombosis and we wish to evaluate DOACs compared with VKAs in secondary prevention of thromboembolic events in patients with APS.

METHODS: We conducted searches of the published literature using relevant data sources (MEDLINE, Embase and Cochrane CENTRAL), and of trial registers for unpublished data and ongoing trials. We included randomised trials examining individuals >18 years with APS classified according to the criteria valid when the trial was carried out. Randomised controlled trials had to examine any DOAC agent compared with any comparable drug. We tabulated all occurrences of events from all eligible randomised trials. Due to few events, ORs and 95% CIs were calculated using the Peto method.

RESULTS: 5 randomised trials comprising 624 patients met the predefined eligibility criteria. The primary outcome measure was new thrombotic events, a composite endpoint of any VT or AT, during the VKA-controlled phase of treatment. According to the I² inconsistency index, there was evidence of statistical heterogeneity across the studies (I²=60%). Across trials, 29 and 10 thrombotic events were observed in 305 and 319 patients with APS treated with DOAC and VKA, respectively, corresponding to a combined Peto OR of 3.01 (95% CI 1.56 to 5.78, p=0.001). There was a significantly increased risk of AT while treated with DOACs compared with VKA (OR 5.5 (2.5, 12.1) p<0.0001), but no difference in the risk of VT (p=0.87). We found no significant difference in risk of bleeding.

CONCLUSIONS: DOACs were associated with a significant increase in the risk of a new thrombotic event, especially AT, favouring standard prophylaxis with warfarin.

PROSPERO REGISTRATION NUMBER: CRD42019126720.

PMID:37899090 | DOI:10.1136/lupus-2023-001018

BMJ Ment Health. 2023 Oct;26(1):e300694. doi: 10.1136/bmjment-2023-300694.

ABSTRACT

OBJECTIVE: There is no standard tool for assessing risk of bias (RoB) in prevalence studies. For the purposes of a living systematic review during the COVID-19 pandemic, we developed a tool to evaluate RoB in studies measuring the prevalence of mental health disorders (RoB-PrevMH) and tested inter-rater reliability.

METHODS: We decided on items and signalling questions to include in RoB-PrevMH through iterative discussions. We tested the reliability of assessments by different users with two sets of prevalence studies. The first set included a random sample of 50 studies from our living systematic review. The second set included 33 studies from a systematic review of the prevalence of post-traumatic stress disorders, major depression and generalised anxiety disorder. We assessed the inter-rater agreement by calculating the proportion of agreement and Kappa statistic for each item.

RESULTS: RoB-PrevMH consists of three items that address selection bias and information bias. Introductory and signalling questions guide the application of the tool to the review question. The inter-rater agreement for the three items was 83%, 90% and 93%. The weighted kappa scores were 0.63 (95% CI 0.54 to 0.73), 0.71 (95% CI 0.67 to 0.85) and 0.32 (95% CI -0.04 to 0.63), respectively.

CONCLUSIONS: RoB-PrevMH is a brief, user-friendly and adaptable tool for assessing RoB in studies on prevalence of mental health disorders. Initial results for inter-rater agreement were fair to substantial. The tool’s validity, reliability and applicability should be assessed in future projects.

PMID:37899074 | DOI:10.1136/bmjment-2023-300694

Technol Health Care. 2023 Oct 19. doi: 10.3233/THC-230877. Online ahead of print.

ABSTRACT

BACKGROUND: Day surgery is a new surgical model in which patients complete the admission, surgery, and discharge on the same day.

OBJECTIVE: The present study aimed to explore the effect of pre-admission “quasi-collective” health education for patients with ophthalmic day surgery.

METHODS: For this study, a total of 200 patients undergoing ophthalmic day surgery from February 2019 to December 2019 were enrolled as the research subjects. The patients were divided randomly into the observation group and the control group, with 100 cases in each group. For the control group, conventional health education was conducted after admission. On the day of admission, the admission education and peri-operative health education were performed. For the observation group, pre-admission health education was provided to the patients, and detailed education on the admission instructions, pre-operative precautions, and simulation of the intra-operative process were given by the medical staff. On the day of admission, the understanding of the education was evaluated, and any weaknesses in the health education were addressed. The anxiety status, method of handwashing, method of administering the drug to the eye, preoperative preparations, intra-operative training, preoperative medication, diet guidance, and postoperative care were compared between the two groups of patients.

RESULTS: Before discharge, there were significant differences in the anxiety scores, impact, and satisfaction of health education between the two groups of patients, all of which were statistically significant (P< 0.05).

CONCLUSION: The pre-admission “quasi-collective” health education for patients undergoing day surgery in ophthalmology was better than conventional health education.

PMID:37899068 | DOI:10.3233/THC-230877

Technol Health Care. 2023 Oct 19. doi: 10.3233/THC-220686. Online ahead of print.

ABSTRACT

BACKGROUND: The nursing model of establishing a chemotherapy safety management supervisory group has guaranteed the safety and effectiveness of intravenous chemotherapy while reducing the adverse effects of chemotherapy and improving patient satisfaction and quality of life.

OBJECTIVE: To explore the impact of establishing a nursing supervision group on improving the safety management of patients receiving chemotherapy in the oncology department.

METHODS: We selected a total of 60 patients who underwent chemotherapy at the oncology department between January and June 2021 and assigned them to the control group. They received conventional chemotherapy safety management nursing care. We selected another 60 patients undergoing chemotherapy in the oncology department between July and December 2021 and assigned them to the observation group. They received a nursing intervention model facilitated by the chemotherapy safety supervision team. We compared the intervention effects in the two groups.

RESULTS: Patient satisfaction was significantly higher in the observation group than in the control group (P< 0.05); the incidence of post-chemotherapy nausea and vomiting was significantly lower in the observation group than in the control group (P< 0.05); and the self-rating depression scale (SDS) and self-rating anxiety scale (SAS) scores of patients in the observation group were reduced (P< 0.05) and significantly lower than in the control group (P< 0.05). We used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core 30 (EORTC-QLQ-C30) and found a statistically significant difference in the quality of life of patients before the nursing intervention and on the day of discharge (P< 0.05).

CONCLUSION: The establishment of a chemotherapy safety management supervisory group was effective in reducing the incidence of post-chemotherapy nausea and vomiting as well as the patient’s psychological burden; it could also improve the quality of life of patients and their satisfaction with nursing care.

PMID:37899067 | DOI:10.3233/THC-220686

NeuroRehabilitation. 2023 Oct 26. doi: 10.3233/NRE-230153. Online ahead of print.

ABSTRACT

BACKGROUND: Long-term survival after spinal cord injury (SCI) has been extensively studied in the US and UK.

OBJECTIVE: To compare SCI epidemiology and survival results between the US and UK for the same time period and patient groups.

METHODS: We restricted attention to persons injured at ages 18 and older who had survived at least 2 years post injury and were not ventilator dependent. We performed survival analysis using logistic regression on person-year data with time-dependent covariates. The resulting mortality rates were used to construct life tables in order to obtain life expectancies.

RESULTS: The average age at injury, percentage male, and level/grade of injury were rather similar between the two countries. After adjustment for risk factors, UK mortality was 85% of that in the US (95% c.i. 80%, to 91%, p < 0.0001). Mortality increased by 0.3% per year over the 1980 to 2012 study period (HR = 1.003); this was not statistically significant (p = 0.44). The US and UK life expectancies are nearly the same percentage of their respective general population values, differing by at most 2% .

CONCLUSION: Long-term mortality after SCI in the UK is roughly 15% lower than that in the US. The general population mortality in the UK is also approximately 15% lower, however, and thus the percentages of normal life expectancy in the two countries prove to be strikingly similar.

PMID:37899064 | DOI:10.3233/NRE-230153

J Back Musculoskelet Rehabil. 2023 Oct 16. doi: 10.3233/BMR-230127. Online ahead of print.

ABSTRACT

BACKGROUND: Elastic taping that applies shear force affects joint movement. However, it remains uncertain whether elastic taping or stretching is more effective in improving flexibility.

OBJECTIVE: We investigated whether elastic taping for flexibility improvement is comparable to traditional stretching.

METHODS: In this randomized controlled trial, 64 university students were randomly allocated to two groups: elastic taping on the sole or 30 s of static stretching. The primary outcome measures were the straight leg raising angle, tested with an equivalence margin (± 9.61∘ on changes), and the fingertip-to-floor distance. Secondary outcomes were the hip flexor and knee extensor strength, two-step distance, adverse events, and pain intensity during the intervention, which were compared using conventional statistical methods.

RESULTS: The mean differences in straight leg raising between the two groups after the interventions were not greater than the equivalence margin (mean [95% CI]: 1.4 [-6.9, 9.5]; equivalence margin, -9.61∘ to 9.61∘). There were no consistent differences between groups in terms of secondary outcomes except for pain intensity during the intervention (p> 0.05). Elastic taping did not induce pain.

CONCLUSION: Elastic taping augments the flexibility-improving effect comparable to static stretching, based on an equivalence margin. Elastic taping of the sole appears to be an alternative method of improving flexibility.

PMID:37899054 | DOI:10.3233/BMR-230127