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Genicular Nerve Block for Pain Management in Patients With Knee Osteoarthritis: A Randomized Placebo-Controlled Trial

Arthritis Rheumatol. 2022 Nov 11. doi: 10.1002/art.42384. Online ahead of print.

ABSTRACT

OBJECTIVE: This study was undertaken to determine the efficacy of ultrasound-guided genicular nerve block (GNB) for the management of knee pain in patients with knee osteoarthritis.

METHODS: We performed a 12-week parallel-group, placebo-controlled randomized trial of GNB. Within 2 weeks of randomization, patients with knee osteoarthritis in the active arm received 3 injections of 5.7 mg celestone chronodose (1 ml) and 0.5% bupivacaine (3 ml) to the inferomedial, superomedial, and superolateral genicular nerves; patients with knee osteoarthritis in the placebo arm received injections of normal saline. At baseline and at weeks 2, 4, 8, and 12, patients recorded their pain and disability on a 100-mm visual analog scale (VAS) (the primary outcome measure), the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), and the Intermittent and Constant Osteoarthritis Pain scale. Statistical significance was set at a 2-sided Type I error of α = 0.0125 for comparisons at each of the 4 time points. We used a global perceived effect scale to measure patient satisfaction.

RESULTS: The 59 patients (36 female, 23 male) who completed the trial had a mean ± SD age of 68.2 ± 8.6 years. Patients in the active group reported improvements in pain scores at 2, 4, 8, and 12 weeks with a diminution of the effect over time. VAS scores at baseline and at weeks 2, 4, 8, and 12 in the active group (n = 31) versus placebo group (n = 28) were 6.2 versus 5.3 (P = 0.294), 2.7 versus 4.7 (P < 0.001), 3.2 versus 5.1 (P < 0.001), 3.9 versus 4.9 (P < 0.001), and 4.6 versus 5.1 (P = 0.055), respectively. Total WOMAC scores at baseline and at weeks 2, 4, 6, 8, and 12 in the active group versus the placebo group were 54.5 versus 48.1 (P = 0.177), 32.9 versus 44.4 (P < 0.001), 33.7 versus 45.8 (P < 0.001), 39.2 versus 44.8 (P = 0.001), and 42.65 versus 45.1 (P = 0.012), respectively.

CONCLUSION: GNB offers short-term pain relief for knee osteoarthritis.

PMID:36369781 | DOI:10.1002/art.42384

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Management of post-stroke fatigue: an Australian health professional survey

Disabil Rehabil. 2022 Nov 11:1-7. doi: 10.1080/09638288.2022.2143578. Online ahead of print.

ABSTRACT

PURPOSE: Evidence for post-stroke fatigue management is limited. We aimed to explore how Australian health professionals assess and assist fatigue management. Our objectives were to identify fatigue assessment tools and interventions used, explore clinician’s confidence managing fatigue and explore whether management of post-stroke fatigue differs from management of fatigue related to other conditions.

MATERIALS AND METHODS: An online cross-sectional survey was completed by Australian health professionals (n = 60) providing services to people with fatigue. Analysis of open-ended questions identified common interventions and descriptive statistics were calculated for closed and dichotomized questions.

RESULTS: Routine use of formal fatigue assessment tools was low (17%, n = 10). Most respondents reporting use of the Fatigue Impact Scale, Fatigue Assessment Scale and Fatigue Severity Scale. To address fatigue, respondents reported providing energy optimization strategies, education, and exercise interventions in clinical practice. Less frequently reported interventions were strategies to adapt tasks, sleep hygiene, psychology, nutrition, and pharmacology interventions. Respondents were “moderately” confident managing post-stroke fatigue. Respondents did not report differences between how they manage post-stroke fatigue and fatigue present in other conditions.

CONCLUSIONS: Few Australian health professionals formally assess post-stroke fatigue. Management is multidisciplinary and based on evidence from fatigue management in other conditions.Implications for rehabilitationMost health professionals are not routinely using formal assessment tools for fatigue, possibly due to a lack of consensus on best practice in research.Common strategies recommended by health professionals include energy optimisation strategies, education and exercise.Comprehensive guidelines for post-stroke fatigue management are yet to be established.Health professionals should assess post-stroke fatigue using a validated tool to ensure an individualised approach to management based on the current available clinical guidelines.

PMID:36369739 | DOI:10.1080/09638288.2022.2143578

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Evaluation of a comprehensive maternal newborn health intervention in rural Tanzania: single-arm pre-post coverage survey results

Glob Health Action. 2022 Dec 31;15(1):2137281. doi: 10.1080/16549716.2022.2137281.

ABSTRACT

BACKGROUND: In Tanzania, maternal and newborn deaths can be prevented via quality facility-based antenatal care (ANC), delivery, and postnatal care (PNC). Scalable, integrated, and comprehensive interventions addressing demand and service-side care-seeking barriers are needed.

OBJECTIVE: Assess coverage survey indicators before and after a comprehensive maternal newborn health (MNH) intervention in Misungwi District, Tanzania.

METHODS: A prospective, single-arm, pre- (2016) and post-(2019) coverage survey (ClinicalTrials.gov #NCT02506413) was used to assess key maternal and newborn health (MNH) outcomes. The Mama na Mtoto intervention included district activities (planning, leadership training, supportive supervision), health facility activities (training, equipment, infrastructure upgrades), and plus community health worker mobilization. Implementation change strategies, a process model, and a motivational framework incorporated best practices from a similar Ugandan intervention. Cluster sampling randomized hamlets then used ‘wedge sampling’ protocol as an alternative to full household enumeration. Key outcomes included: four or more ANC visits (ANC4+); skilled birth attendant (SBA); PNC for mother within 48 hours (PNC-woman); health facility delivery (HFD); and PNC for newborn within 48 hours (PNC-baby). Trained interviewers administered the ‘Real Accountability: Data Analysis for Results Coverage Survey to women 15-49 years old. Descriptive statistics incorporated design effect; the Lives Saved Tool estimated deaths averted based on ANC4+/HFD.

RESULTS: Between baseline (n = 2,431) and endline (n = 2,070), surveys revealed significant absolute percentage increases for ANC4+ (+11.6, 95% CI [5.4, 17.7], p < 0.001), SBA (+16.6, 95% CI [11.1, 22.0], p < 0.001), PNC-woman (+9.2, 95% CI [3.2, 15.2], p = 0.002), and HFD (+17.2%, 95% CI [11.3, 23.1], p < 0.001). A PNC-baby increase (+6.1%, 95% CI [-0.5, 12.8], p = 0.07) was not statistically significant. An estimated 121 neonatal and 20 maternal lives were saved between 2016 and 2019.

CONCLUSIONS: Full-district scale-up of a comprehensive MNH package embedded government health system was successfully implemented over a short time and associated with significant maternal care-seeking improvements and potential for lives saved.

PMID:36369729 | DOI:10.1080/16549716.2022.2137281

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Validation of case definition algorithms for the ascertainment of congenital anomalies

Birth Defects Res. 2022 Nov 11. doi: 10.1002/bdr2.2112. Online ahead of print.

ABSTRACT

BACKGROUND: Congenital anomalies (CA) are one of the leading causes of infant mortality and long-term disability. Many jurisdictions rely on health administrative data to monitor these conditions. Case definition algorithms can be used to monitor CA; however, validation of these algorithms is needed to understand the strengths and limitations of the data. This study aimed to validate case definition algorithms used in a CA surveillance system in British Columbia (BC), Canada.

METHODS: A cohort of births between March 2000 and April 2002 in BC was linked to the Health Status Registry (HSR) and the BC Congenital Anomalies Surveillance System (BCCASS) to identify cases and non-cases of specific anomalies within each surveillance system. Measures of algorithm performance were calculated for each CA using the HSR as the reference standard. Agreement between both databases was calculated using kappa coefficient. The modified Standards for Reporting Diagnostic Accuracy guidelines were used to enhance the quality of the study.

RESULTS: Measures of algorithm performance varied by condition. Positive predictive value (PPV) ranged between approximately 73%-100%. Sensitivity was lower than PPV for most conditions. Internal congenital anomalies or conditions not easily identifiable at birth had the lowest sensitivity. Specificity and negative predictive value exceeded 99% for all algorithms.

CONCLUSION: Case definition algorithms may be used to monitor CA at the population level. Accuracy of algorithms is higher for conditions that are easily identified at birth. Jurisdictions with similar administrative data may benefit from using validated case definitions for CA surveillance as this facilitates cross-jurisdictional comparison.

PMID:36369700 | DOI:10.1002/bdr2.2112

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Later onset of Childhood Disintegrative Disorder (CDD): a case report

Neurocase. 2022 Aug;28(4):369-374. doi: 10.1080/13554794.2022.2130804. Epub 2022 Oct 23.

ABSTRACT

Childhood Disintegrative Disorder (CDD) is a rare condition characterized by regression of developmental and behavioral functioning after a period of apparently normal development, with an age of onset around 4 years. CDD is not included within the latest edition of the Diagnostic and Statistical Manual of Mental Disorders. We present a case report of an 11-year-old male who achieved normal development for up to 7 years followed by a deterioration of previously acquired linguistic, intellectual, and social skills. Following treatment with lithium carbonate combined with risperidone, the patient experienced a reduction in irritability and aggression. CDD is a rare condition; therefore, the data presented may be useful to investigate its characteristics of the onset, to improve the understanding of the aspects of differentiation from the Autism Spectrum Disorder and finally to propose the possibility of treatment.

PMID:36369699 | DOI:10.1080/13554794.2022.2130804

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Biopsy strategies for intermediate and high suspicion thyroid nodules with macrocalcifications

Curr Med Res Opin. 2022 Nov 11:1-20. doi: 10.1080/03007995.2022.2146404. Online ahead of print.

ABSTRACT

OBJECTIVE: 1) To find strategies to improve diagnostic performance of ultrasound-guided biopsy of intermediate and high suspicion thyroid nodules with macrocalcifications, 2) To find malignancy rates of nodules with macrocalcification.

MATERIALS AND METHODS: From 2018 to 2022, fine-needle aspiration biopsy (FNAB) and core needle biopsy (CNB) were retrospectively evaluated. Macrocalcifications were categorized into three types: intra-nodular, rim, and entirely calcified. Diagnostic performance was compared between biopsy modes (FNAB vs. CNB) and FNAB techniques (to-and-fro vs. whirling). Multivariate logistic regression was performed to determine features associated with performance of FNAB. Malignancy rates were calculated according to macrocalcification types.

RESULTS: Total of 114 procedures (87 FNAB and 27 CNB) in 89 nodules per 86 patients (mean age, 64 years; 76 women) were performed. Overall, CNB performed better than FNAB (unsatisfactory rate: 3.7% vs. 33.3%, p = 0.005). For macrocalcification thicker than 2 mm, whirling FNAB technique demonstrated comparable unsatisfactory rate with statistical trends toward significance (to-and-fro: 69.2% vs. whirling: 27.8%, p = 0.055). Entirely calcified nodule was associated with poor performance of FNAB (adjusted odds ratio 4.46 [95%CI: 1.19 – 16.67], p = 0.027). Overall malignancy was 22.5%, and higher in intra-nodular macrocalcification than rim and entirely calcified type (68.4% vs. 21.1% vs. 10.5%, p = 0.025).

CONCLUSION: For entirely calcified type, CNB should be considered first to improve diagnosis. For other types, FNAB can be performed, and whirling technique may be an alternative technique in thicker macrocalcification. Malignancy in intermediate and high suspicion nodules with macrocalcification have non-negligible rates.

PMID:36369696 | DOI:10.1080/03007995.2022.2146404

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Extended physiotherapy after Intensive Care Unit (ICU) stay: A prospective pilot study with a before and after design

Physiother Theory Pract. 2022 Nov 11:1-9. doi: 10.1080/09593985.2022.2143251. Online ahead of print.

ABSTRACT

OBJECTIVE: To examine whether extended compared to standard level of physiotherapy is feasible and has beneficial effects on physical function in ICU survivors.

METHODS: This prospective pilot study with a before and after design included patients discharged from ICU to a surgical ward. The comparison group were recruited between January and April 2019 and received standard level of physiotherapy. The intervention group were recruited between May and December 2019 and received extended physiotherapy, corresponding to 50% additional physiotherapist, working 4 hours per weekday. The intervention participants received an individual rehabilitation plan developed in collaboration with a ward-based physiotherapist, and an extended number of sessions provided by the extra resource included practicing individualized exercises, for example walking and stair climbing. Physical function was measured with the Chelsea Critical Care Physical Assessment tool (CPAx) at ICU discharge, during hospital stay and discharge. Group differences were analyzed using the Mann-Whitney U-test and Chi2 test.

RESULTS: Out of 46 eligible patients, 39 (85%) fulfilled the study (comparison n = 12, intervention n = 27) and were included in the final analyses. No adverse events occurred, and the attendance rate was high (98.5%). There were no statistically significant differences between the groups regarding physical function, hospital stay, and readmissions, but there were tendencies to better outcomes in all these parameters in favor of the intervention group. Additionally, patients in the intervention group had statistically significantly higher scores in the CPAx items “transferring from bed to chair” (median 5 vs 4, p = .039) and “stepping” (median 5 vs 4, p = .005) at hospital discharge.

CONCLUSION: This pilot study indicates that extended physiotherapy after ICU discharge is feasible and does not entail patient safety risks. However, determining the potential beneficial effects for the patients remains to be evaluated in a larger trial.

PMID:36369693 | DOI:10.1080/09593985.2022.2143251

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Drilling- and withdrawing-related thermal effects of implant site preparation for ceramic and stainless steel twist drills in standardized bovine bone

Clin Implant Dent Relat Res. 2022 Nov 11. doi: 10.1111/cid.13151. Online ahead of print.

ABSTRACT

INTRODUCTION: Excessive surgical trauma is believed to be among the most important causes for early implant losses. As thermal injury to the bone is not only dependent on the amount of generated heat but also on the tissue exposure time, and the greatest temperature increase was found within the withdrawing period, the entire osteotomy procedure with the parameters contributing to thermal damage is of particular clinical relevance. The aim of this study was to investigate the thermal performance of metal-based and ceramic implant drills regarding the temperature exposure time during the whole osteotomy process.

MATERIALS AND METHODS: This investigation consisted of 240 individual preparations in total, comprising two different drilling depths (10 and 16 mm), two irrigation methods (external and without irrigation), two implant drill materials (stainless steel and zirconia), and three consecutive drill diameters per material (2.0/2.2, 2.8, and 3.5 mm) with 10 identical repetitions. Real-time multichannel temperature measurement was conducted during automated drilling procedures in standardized bovine bone specimens.

RESULTS: The maximum temperature changes were highly associated with the time period of passive drill withdrawing (p ≤ 0.05), irrespective of drill material, drilling depth, or drill diameter. Statistically significant differences in temperature generation between stainless steel and ceramic drills were observed in irrigated testing sites at both drilling depths with smaller drill diameters (2.0/2.2 and 2.8 mm, p ≤ 0.05).

CONCLUSION: Results of this in vitro study could demonstrate a strong association between the highest temperature increase and the passive withdrawing time period in both investigated drill materials. Considering these findings and the resulting thermal bone damage due to the whole surgical procedure, high overall temperatures in combination with a prolonged heat exposure time may impact the future osseointegration process.

PMID:36369670 | DOI:10.1111/cid.13151

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Randomised clinical trial: efficacy and safety of the live biotherapeutic product MRx1234 in patients with irritable bowel syndrome

Aliment Pharmacol Ther. 2022 Nov 11. doi: 10.1111/apt.17310. Online ahead of print.

ABSTRACT

BACKGROUND: MRx1234 is a live biotherapeutic product that contains a strain of Blautia hydrogenotrophica. It is in development for the treatment of irritable bowel syndrome (IBS).

AIMS: To assess the efficacy and safety of MRx1234 in patients with IBS with predominant constipation (IBS-C) or diarrhoea (IBS-D) METHODS: We conducted a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Patients aged 18-70 years in two parallel cohorts (IBS-C; IBS-D) were randomised (1:1) to MRx1234 or placebo for 8 weeks. The primary efficacy endpoint was overall responder rate-a composite of improved bowel habit (IBS-C: stool frequency; IBS-D: stool consistency) and abdominal pain intensity-for ≥50% of the treatment period in each cohort. Statistical testing was at a one-sided 0.10 significance level.

RESULTS: Of 366 randomised patients (164 IBS-C; 202 IBS-D), 365 received any study medication (177 MRx1234, 188 placebo). Numerically, although not statistically significantly different, more patients who received MRx1234 than placebo were overall responders in the IBS-C (25.0% vs. 17.1%) and IBS-D (23.4% vs. 17.8%) cohorts. Similar results were observed in the additional combined cohort analysis (24.1% vs. 17.5%; p = 0.063). For the components of the primary endpoint, significantly more patients on MRx1234 than placebo reported improvement in bowel habit in the IBS-C, IBS-D and combined cohorts, while improvements in abdominal pain were observed in each cohort. The safety profile of MRx1234 was similar to placebo.

CONCLUSIONS: MRx1234 has the potential to become a novel, safe treatment option for patients with IBS-C or IBS-D, and for those who have mixed symptoms or transition between subtypes.

CLINICALTRIALS: gov #NCT03721107.

PMID:36369645 | DOI:10.1111/apt.17310

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The Basic VRS-Effect Study: Clinical Trial Outcomes and Cost-Effectiveness of Low Vision Rehabilitation in Portugal

Ophthalmol Ther. 2022 Nov 11. doi: 10.1007/s40123-022-00600-0. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim of this study was twofold: (1) to investigate the clinical impact of vision rehabilitation in patients with vision impairment and (2) to investigate the cost-effectiveness of a basic vision rehabilitation service in Portugal.

METHODS: The trial recruited patients diagnosed with age-related macular degeneration or diabetic retinopathy (DR) and visual acuity in the range 0.4-1.0logMAR in the better-seeing eye. Participants were randomised to one of the study arms consisting of immediate intervention and delayed intervention. The intervention included: new refractive correction, optical reading aids, in-office training and advice about modifications at home. Visual ability, health-related quality of life and costs were measured. Economic analysis was performed to evaluate whether the intervention was cost-effective. The trial compared the outcomes 12 weeks after the start in both arms.

RESULTS: Of the 46 participants, 34 (74%) were diagnosed with DR, 25 (54%) were female, and mean age was 70.08 years (SD = 8.74). In the immediate intervention arm visual ability increased a mean of 0.523 logits (SE = 0.11) (p < 0.001). Changes in the delayed intervention arm were not statistically significant (p = 0.95). Acuity in the better-seeing eye, near acuity and critical print size also improved during the study. The mean cost of the intervention was €118.79 (SD = 24.37). The incremental cost-effectiveness ratio using the EQ-5D-5L was 30,421€/QALY and 1186€/QALY when using near acuity.

CONCLUSION: The current study gives evidence of positive clinical impact of a basic vision rehabilitation intervention and shows that a basic vision rehabilitation service is cost-effective. These findings are important to clinical and rehabilitation practices and for planning vision rehabilitation services.

TRIAL REGISTRATION: Retrospectively registered, 21/01/2019. ISRCTN10894889, https://www.isrctn.com/ISRCTN10894889.

PMID:36369618 | DOI:10.1007/s40123-022-00600-0