Category: Nevin Manimala

Stat Med. 2022 Nov 25. doi: 10.1002/sim.9594. Online ahead of print.

ABSTRACT

There is a growing medical interest in combining several agents and optimizing their dosing schedules in a single trial in order to optimize the treatment for patients. Evaluating at doses of several drugs and their scheduling in a single Phase I trial simultaneously possess a number of statistical challenges, and specialized methods to tackle these have been proposed in the literature. However, the uptake of these methods is slow and implementation examples of such advanced methods are still sparse to date. In this work, we share our experience of proposing a model-based partial ordering continual reassessment method (POCRM) design for three-dimensional dose-finding in an oncology trial. In the trial, doses of two agents and the dosing schedule of one of them can be escalated/de-escalated. We provide a step-by-step summary on how the POCRM design was implemented and communicated to the trial team. We proposed an approach to specify toxicity orderings and their a-priori probabilities, and developed a number of visualization tools to communicate the statistical properties of the design. The design evaluation included both a comprehensive simulation study and considerations of the individual trial behavior. The study is now enrolling patients. We hope that sharing our experience of the successful implementation of an advanced design in practice that went through evaluations of several health authorities will facilitate a better uptake of more efficient methods in practice.

PMID:36428217 | DOI:10.1002/sim.9594

Br J Oral Maxillofac Surg. 2022 Oct 4:S0266-4356(22)00271-6. doi: 10.1016/j.bjoms.2022.09.008. Online ahead of print.

ABSTRACT

The aim of this study was to evaluate the prognostic significance of dysplasia in patients undergoing primary surgery with curative intent in the treatment of oral squamous cell carcinoma (OSCC). This study specifically aimed to demonstrate the effect of dysplasia on local recurrence, disease specific survival (DSS) and overall survival (OS). Data collection for 833 patients with OSCC undergoing treatment for curative intent was undertaken retrospectively for the period of February 2006 to May 2020. Analysis of any association between known clinicopathological prognostic categorical variables with respect to dysplasia was undertaken using the chi squared test. A Kaplan-Meier analysis was performed to demonstrate the impact of dysplasia on DSS and OS, and Cox’s proportional-hazards model deployed to obtain hazard ratios associated with dysplasia and the outcomes of interest. Dysplasia was statistically significant in predicting disease specific and overall survival in patients undergoing primary surgery for OSCC (DSS p<0.001, HR 0.577; 95%CI 0.428 to 0.777), OS p<0.001 HR 0.691; 95%CI 0.562 to 0.850) with the absence of dysplasia predicting poorer outcomes. The absence of dysplasia correlated with pathological higher T and N stage, increased categorised depth of tumour invasion, non-cohesive invasive front, lymphovascular invasion, perineural invasion, extranodal extension and increased modified Glasgow Prognostic Score. No significant prognostic relationship was attributable to the presence of dysplasia at a surgical margin. The absence of dysplasia appeared to be a significant independent prognostic indicator for patients with OSCC. The presence or absence of dysplasia may provide a heuristic means of stratifying OSCC primary lesions in terms of disease hostility.

PMID:36428155 | DOI:10.1016/j.bjoms.2022.09.008

Injury. 2022 Nov 1:S0020-1383(22)00802-6. doi: 10.1016/j.injury.2022.10.031. Online ahead of print.

ABSTRACT

INTRODUCTION: Concomitant patellar tendon (PT) tear with cruciate or multi-ligament knee injuries (MLKI) following high-velocity injury requires a systematic approach.

METHODS: The study is a retrospective case series of patients (2008-2019) with concomitant PT ligament injury with cruciate or collateral ligament injury (MLKI), including bony avulsion injuries. Isolated cruciate and MLKI without patellar tendon tears are excluded. N = 32 patients (1 female and 31 male) are divided into two groups, Group 1 (11 patients) with PT tear and ACL tear and group 2 (21 patients) with PT tear and MLKIs. Patients were taken up for a single stage in types 1,2,3 and staged repair with reconstruction for types 4,5 of our new classification. All the patients are followed up regularly, and IKDC and Lyshom’s score and objective radiological stress x-rays taken at each follow-up RESULTS: Incidence of PTT combined injuries among all knee ligament injuries is 0.57%. The mean age was 35.09+/-11.96 SD(group1) and 36.55+/-11.89 SD(group2). The average follow-up was 34.45 months +/- 12.86SD (group 1) and 35.3 months +/- 15.75 SD (group2). Mean post-operative Lysholm score and IKDC score of group 1 and group 2 improvement was statistically significant p-value <=0.01. The mean post-operative ROM of the two groups were 132.73 (SD 6.46) (Group 1) and 111.75 (15.75) (Group 2) and was a statistically significant p-value <0.01. Residual lag of 30^° seen in all patients improved by 3rd month in group 1 and 6th month in group 2. Knee stiffness is seen in 2 patients and superficial infection in 2 patients.

CONCLUSION: PTT combined injuries are rare and occurs due to direct impact injuries. Single-stage PT repair with ACL reconstruction gives adequate stability, and extensor lag is eminent and needs supervised rehabilitation. PT with MLKI is a challenging scenario that can be performed in single-stage/multiple stages, depending on the injuries, surgical expertise, and institutional facilities. Newer simplified classification aids surgeons in planning a treatment strategy.

PMID:36428146 | DOI:10.1016/j.injury.2022.10.031

Vascular. 2022 Nov 25:17085381221142219. doi: 10.1177/17085381221142219. Online ahead of print.

ABSTRACT

OBJECTIVE: Current guidelines recommend dual antiplatelet therapy (DAPT) in patients undergoing carotid artery stenting. The most common DAPT regimen is aspirin and clopidogrel, a P2Y12 receptor antagonist; however, the prevalence of clopidogrel resistance (CR) in patients undergoing percutaneous coronary interventions may exceed 60%. Few studies have investigated the prevalence and impact of CR in patients undergoing extracranial carotid artery stenting, particularly transcarotid artery revascularization (TCAR).

METHODS: Consecutive high-risk patients ≥ 18 years who underwent TCAR for high grade (≥70%) and/or symptomatic (≥50%) carotid stenosis with preoperative P2Y12 testing between August 2019 and December 2021 were identified across five institutions. Preoperative platelet reactivity was measured with the VerifyNow P2Y12 Reaction Unit (PRU) Test (Instrumentation Laboratory, Bedford, MA), with CR defined as PRU ≥ 194 and hyper-response as PRU <70. Patients without preoperative P2Y12 testing within 30 days prior to TCAR or those on a non-clopidogrel P2Y12 inhibitor preoperatively were excluded. The primary outcome of interest was prevalence of CR. Secondary outcomes of interest included the incidence of ischemic and hemorrhagic complications.

RESULTS: Of 92 patients identified, the majority were male (59%) and Caucasian (75%) with a mean age of 75 years (±8, range 56–92). Preoperatively, 93% of patients were on aspirin, 100% on clopidogrel, and 13% on therapeutic anticoagulation. At presentation, 36% were symptomatic. The mean preoperative P2Y12 was 156 PRU (±76, range 6–349). In total, 30 (33%) patients met criteria for CR (mean PRU 240 ± 37; range 197-349), and 15 (16%) met criteria for hyper-responder (mean PRU 38 ± 20; range 6-68). There was no significant difference by clopidogrel response phenotype in terms of sex (p = 0.246), race (p = 0.384), or symptomatic presentation (p = 0.956). Postoperatively, the cumulative incidence of stroke and MI was 2.1%, with no statistically significant difference in the incidence of in-hospital stroke (PRU 238, p = 0.489) or MI (PRU 168, p = 1) between clopidogrel phenotypes. Three (3.3%) patients, one CR (PRU 240) and two responders (PRU 119 and PRU 189), experienced postoperative access site hematomas that required no subsequent intervention. No other index hospitalization hemorrhagic complications occurred.

CONCLUSIONS: Using preoperative P2Y12 testing with a threshold PRU ≥ 194 to define CR, we identified a high prevalence of CR in patients undergoing TCAR similar to that in the pre-existing coronary literature. We found no significant differences in postoperative ischemic or hemorrhagic complications by clopidogrel response phenotype, although complication rates in the overall study cohort were low. CR may be a spectrum from responder to partial responder to complete non-responder, and this may account for the differences in our CR cohort compared to the ROADSTER 2 protocol deviation cohort. Further investigation is warranted to determine if a quantitative assessment of CR is sufficient to identify patients at risk of developing secondary cerebrovascular ischemic events in this patient population.

PMID:36428145 | DOI:10.1177/17085381221142219

J Pediatr Nurs. 2022 Nov 22:S0882-5963(22)00292-5. doi: 10.1016/j.pedn.2022.11.010. Online ahead of print.

ABSTRACT

PURPOSE: To describe pediatric nurses’ perception of readiness to care for parents of children with special healthcare needs.

DESIGN AND METHODS: This cross-sectional, exploratory study surveyed 56 pediatric nurses from a large tertiary care center in Appalachia. Participants completed an anonymous electronic survey aimed at evaluating perception of discharge preparation and readiness to care. Data analysis included descriptive statistics and Chi square comparisons.

RESULTS: The majority of participants (80%) reported spending 12 h or less preparing parents for discharge. The domains rated lowest on readiness to care included financial, psychological, and emotional. Participants anticipate parents spending an average of 13.9 h a day serving as the child’s primary caregiver in the home.

CONCLUSIONS: Subjective, ‘unseen’ domains of readiness are often under-assessed and evaluated. Parents are often discharged with limited preparation to assume around-the-clock care for a child with special healthcare needs, specifically related to their holistic health and wellbeing.

PRACTICE IMPLICATIONS: Standardization of discharge preparation and readiness evaluation should focus on overall parent preparedness, including financial, psychological, and emotional domains. Discharge preparation should begin at the time of admission to familiarize parents with care. Clear, frequent communication should be used to emphasize realistic expectations and assess unique needs. Provision of accessible community-based resources should be given early to better equip parents with supportive services once home.

PMID:36428130 | DOI:10.1016/j.pedn.2022.11.010

Occup Environ Med. 2022 Nov 25:oemed-2022-108637. doi: 10.1136/oemed-2022-108637. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate if adding motivational interviewing (MI) or a stratified vocational advice intervention (SVAI) to usual case management (UC), reduced sickness absence over 6 months for workers on sick leave due to musculoskeletal disorders.

METHODS: We conducted a three-arm parallel pragmatic randomised controlled trial including 514 employed workers (57% women, median age 49 (range 24-66)), on sick leave for at least 50% of their contracted work hours for ≥7 weeks. All participants received UC. In addition, those randomised to UC+MI were offered two MI sessions from social insurance caseworkers and those randomised to UC+SVAI were offered vocational advice from physiotherapists (participants with low/medium-risk for long-term sickness absence were offered one to two sessions, and those with high-risk were offered three to four sessions).

RESULTS: Median sickness absence was 62 days, (95% CI 52 to 71) in the UC arm (n=171), 56 days (95% CI 43 to 70) in the UC+MI arm (n=169) and 49 days (95% CI 38 to 60) in the UC+SVAI arm (n=169). After adjusting for predefined potential confounding factors, the results showed seven fewer days in the UC+MI arm (95% CI -15 to 2) and the UC+SVAI arm (95% CI -16 to 1), compared with the UC arm. The adjusted differences were not statistically significant.

CONCLUSIONS: The MI-NAV trial did not show effect on return to work of adding MI or SVAI to UC. The reduction in sickness absence over 6 months was smaller than anticipated, and uncertain due to wide CIs.

TRIAL REGISTRATION NUMBER: NCT03871712.

PMID:36428098 | DOI:10.1136/oemed-2022-108637

Eur J Oral Sci. 2022 Nov 25:e12901. doi: 10.1111/eos.12901. Online ahead of print.

ABSTRACT

The aim of this study was to compare the marginal and internal adaptation of three-unit fixed dental prostheses (FDPs) fabricated from different metal-free materials using CAD/CAM methods. A total of 100 three-unit FDPs were produced from a cubic zirconia, a fiber-reinforced resin composite, a polyetheretherketone (PEEK), a polyetherketoneketone (PEKK), and a polymer composite material by the CAD/CAM method (n = 20 per material). The zirconia group was considered the control/reference material. Marginal and internal gap values of the produced FDPs were measured using the silicone replica method at ×40 magnification under a stereomicroscope. The obtained data were analyzed using one-way ANOVA and Tukey’s HSD tests. The marginal and internal gap values for the cubic zirconia material were found to be statistically significantly lower than those seen for the PEEK, polymer composite, PEKK, and fiber-reinforced resin composite materials. While the marginal and internal adaptation of the cubic zirconia material was found to be better than the others, it should be noted that the marginal and internal gap values for all other materials tested were found to be within the clinically acceptable range.

PMID:36428097 | DOI:10.1111/eos.12901

Arch Psychiatr Nurs. 2022 Dec;41:87-95. doi: 10.1016/j.apnu.2022.07.004. Epub 2022 Jul 10.

ABSTRACT

This quasi-experimental study aimed to determine the effects of a nonviolent communication-based anger management program on self-esteem, anger expression, and aggression in 44 psychiatric inpatients (experimental group: n = 21; control group: n = 24). The program consisted of six sessions of 60 min each, using a non-equivalent control group pretest-posttest design, and thereafter analyzing the intervention effects. Results showed statistically significant differences between the experimental and control groups in anger expression and anger suppression. There were positive, though not statistically significant, changes in self-esteem and aggression. The findings indicated a decreasing effect of anger expression and anger suppression.

PMID:36428080 | DOI:10.1016/j.apnu.2022.07.004

Arch Psychiatr Nurs. 2022 Dec;41:312-316. doi: 10.1016/j.apnu.2022.09.010. Epub 2022 Sep 24.

ABSTRACT

AIM: In the present study, we aimed to evaluate the effectiveness of group reminiscence on death anxiety and adaptation of the elderly to old age.

METHODS: This is a clinical trial study. Using simple random sampling method, we divided 32 elderly people into the intervention (n = 16) and control (n = 16) groups. Reminiscence therapy was held in 12 sessions. The study instruments including demographic characteristics questionnaire, Mini Mental Status Examination, Templer Death Anxiety, and aging adjustment questionnaires were filled out by the samples in 3 steps before the intervention, after the last day of the intervention, and 30 days after the end of the interventional sessions.

RESULTS: In the intervention group, the mean score of death anxiety and adjustment to old age before the intervention showed a statistically significant difference with the post-intervention stages (P < 0.05); however, in the control group, the mean scores of death anxiety and adjustment to old age in the 3 steps were not statistically significant (P > 0.05). Also, no statistically significant difference was found between the intervention and control groups before the intervention (P > 0.05), but there was a statistically significant relationship in the steps immediately after the last day of the intervention and 30 days after the end of the interventional sessions (P < 0.05).

CONCLUSION: The findings of the present study indicate that reminiscence therapy is able to effectively reduce the anxiety of death in the elderly; also, reminiscence therapy can be used to improve the adaptation ability of the elderly to old age.

PMID:36428066 | DOI:10.1016/j.apnu.2022.09.010

Arch Psychiatr Nurs. 2022 Dec;41:271-276. doi: 10.1016/j.apnu.2022.09.006. Epub 2022 Sep 16.

ABSTRACT

BACKGROUND: Nursing students experienced mental symptoms when they switched to distance education due to the pandemic.

AIMS: This study was conducted to evaluate the effects of online laughter therapy sessions on depression, anxiety, stress, and loneliness levels in first-year nursing students.

METHODS: In this randomized controlled trial, 61 healthy nursing students were randomly assigned to intervention (n = 32) and control groups (n = 29). The intervention group received online laughter therapy twice weekly for four weeks. The control group received no intervention. The data were collected using a demographic questionnaire, the Depression Anxiety Stress Scale, and the De Jong Gierveld Loneliness Scale at the study initiation and week four in both groups.

RESULTS: There was no difference between the mean scores of the groups in the pre-test (p > 0.05). There was a statistically significant difference between groups in terms of depression after online laughter therapy sessions (p < 0.05), but there was no significant difference between anxiety, stress, and loneliness levels (p > 0.05).

CONCLUSIONS: Online laughter therapy sessions significantly reduced depression but had no effect on anxiety, stress, and loneliness. During the COVID-19 pandemic, online laughter therapy can be organized to reduce depression levels.

PMID:36428060 | DOI:10.1016/j.apnu.2022.09.006