Comprehensive Geriatric Care to Improve Mobility after Hip Fracture: An RCT

Gerontology ◽  
2020 ◽  
Vol 66 (6) ◽  
pp. 542-548
Author(s):  
Wendy L. Cook ◽  
Penelope M.A. Brasher ◽  
Pierre Guy ◽  
Stirling Bryan ◽  
Meghan G. Donaldson ◽  
...  
Keyword(s):  
Hip Fracture ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Geriatric Care ◽  
Small Sample ◽  
Community Dwelling ◽  
Post Discharge ◽  
Mobility Performance ◽  
Discharge Care ◽  
Comprehensive Geriatric Care

<b><i>Background:</i></b> Comprehensive geriatric care (CGC) for older adults during hospitalization for hip fracture can improve mobility, but it is unclear whether CGC delivered after a return to community living improves mobility compared with usual post-discharge care. <b><i>Objective:</i></b> To determine if an outpatient clinic-based CGC regime in the first year after hip fracture improved mobility performance at 12 months. <b><i>Methods:</i></b> A two-arm, 1:1 parallel group, pragmatic, single-blind, single-center, randomized controlled trial at 3 hospitals in Vancouver, BC, Canada. Participants were community-dwelling adults, aged ≥65 years, with a hip fracture in the previous 3–12 months, who had no dementia and walked ≥10 m before the fracture occurred. Target enrollment was 130 participants. Clinic-based CGC was delivered by a geriatrician, physiotherapist, and occupational therapist. Primary outcome was the Short Physical Performance Battery (SPPB; 0–12) at 12 months. <b><i>Results:</i></b> We randomized 53/313 eligible participants with a mean (SD) age of 79.7 (7.9) years to intervention (<i>n</i> = 26) and usual care (UC, <i>n</i> = 27), and 49/53 (92%) completed the study. Mean 12-month (SD) SPPB scores in the intervention and UC groups were 9.08 (3.03) and 8.24 (2.44). The between-group difference was 0.9 (95% CI –0.3 to 2.0, <i>p</i> = 0.13). Adverse events were similar in the 2 groups. <b><i>Conclusion:</i></b> The small sample size of less than half our recruitment target precludes definitive conclusions about the effect of our intervention. However, our results are consistent with similar studies on this population and intervention.

scholarly journals 34 Discharge After Hip Fracture Surgery by Mobilisation Timing: Secondary Analysis of the UK National Hip Fracture Database

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i7-i11
Author(s):  
A Goubar ◽  
O Almilaji ◽  
F C Martin ◽  
C Potter ◽  
G D Jones ◽  
...  
Keyword(s):  
Hip Fracture ◽  
Average Rate ◽  
Small Sample Size ◽  
Small Sample ◽  
Competing Risk ◽  
Hospital Death ◽  
Early Mobilisation ◽  
Hip Fracture Surgery ◽  
Risk Of Death ◽  
Fracture Surgery

Abstract Background To maximise the benefits of hip fracture surgery the National Institute for Health and Care Excellence Clinical Guideline recommends mobilisation on the day after hip fracture surgery based a low to moderate quality trial with a small sample size. There is a need to generate additional evidence to support early mobilisation as a new UK Best Practice Tariff (BPT). Objective To determine whether mobilisation timing was associated with the cumulative incidence of hospital discharge by 30-days after hip fracture surgery, accounting for potential confounders and the competing risk of in-hospital death. Method We examined data for 135,105 patients 60 years or older who underwent surgery for nonpathological first hip fracture between January 2014 and December 2016 in any hospital in England or Wales. We tested whether the cumulative incidences of discharge differed between those mobilised early (within 36 hours of surgery) and those mobilised late accounting for potential confounders and the competing risk of in-hospital death. Results 106,722 (79%) of patients first mobilised early. The average rate of discharge was 60.1 (95% CI 59.8–60.5) per 1,000 patient days, varying from 65.2 (95% CI 64.8–65.6) among those who mobilised early to 44.5 (95% CI 43.9–45.1) among those who mobilised late, accounting for the competing risk of death. By 30-days postoperatively, the crude and adjusted odds ratios of discharge were 2.26 (95% CI 2.2–2.32) and 1.93 (95% CI 1.86–1.99) respectively among those who first mobilised early compared to those who mobilised late, accounting for the competing risk of death. Conclusion Early mobilisation led to a near two fold increase in the adjusted odds of discharge by 30-days postoperatively. We recommend inclusion of mobilisation within 36 hours of surgery as a new UK BPT to help reduce delays to mobilisation currently experienced by one-fifth of patients surgically treated for hip fracture.

scholarly journals DIAGNOSIS OF ENDOCRINE DISEASE: The diagnostic performance of adrenal biopsy: a systematic review and meta-analysis

2016 ◽  
Vol 175 (2) ◽  
pp. R65-R80 ◽  
Author(s):  
Irina Bancos ◽  
Shrikant Tamhane ◽  
Muhammad Shah ◽  
Danae A Delivanis ◽  
Fares Alahdab ◽  
...  
Keyword(s):  
Systematic Review ◽  
Diagnostic Performance ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Small Sample ◽  
Cochrane Central Register ◽  
Moderate Risk ◽  
Adrenal Biopsy ◽  
Adrenocortical Carcinomas

ObjectiveTo perform a systematic review of published literature on adrenal biopsy and to assess its performance in diagnosing adrenal malignancy.MethodsMedline In-Process and Other Non-Indexed Citations, MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trial were searched from inception to February 2016. Reviewers extracted data and assessed methodological quality in duplicate.ResultsWe included 32 observational studies reporting on 2174 patients (39.4% women, mean age 59.8 years) undergoing 2190 adrenal mass biopsy procedures. Pathology was described in 1621/2190 adrenal lesions (689 metastases, 68 adrenocortical carcinomas, 64 other malignancies, 464 adenomas, 226 other benign, 36 pheochromocytomas, and 74 others). The pooled non-diagnostic rate (30 studies, 2013 adrenal biopsies) was 8.7% (95%CI: 6–11%). The pooled complication rate (25 studies, 1339 biopsies) was 2.5% (95%CI: 1.5–3.4%). Studies were at a moderate risk for bias. Most limitations related to patient selection, assessment of outcome, and adequacy of follow-up. Only eight studies (240 patients) could be included in the diagnostic performance analysis with a sensitivity and specificity of 87 and 100% for malignancy, 70 and 98% for adrenocortical carcinoma, and 87 and 96% for metastasis respectively.ConclusionsEvidence based on small sample size and moderate risk of bias suggests that adrenal biopsy appears to be most useful in the diagnosis of adrenal metastasis in patients with a history of extra-adrenal malignancy. Adrenal biopsy should only be performed if the expected findings are likely to alter the management of the individual patient and after biochemical exclusion of catecholamine-producing tumors to help prevent potentially life-threatening complications.

Six Versus 12 Weeks of Outpatient Physical Therapy Including Progressive Resistance Training in Cognitively Intact Older Adults After Hip Fracture: A Multicenter Randomized Controlled Trial

2021 ◽  
Author(s):  
Jan A Overgaard ◽  
Thomas Kallemose ◽  
Kathleen K Mangione ◽  
Morten T Kristensen
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Hip Fracture ◽  
Physical Therapy ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Walking Distance ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Cognitively Intact

Abstract Background Recovery of function and regaining muscle strength are challenging after hip fracture. We compared the effectiveness of a 12- versus 6-week outpatient physical therapy program with progressive resistive training (PRT) to increase strength and physical performance. Methods This parallel, superiority, 2-group randomized controlled trial was conducted in 4 clinics that enrolled community-dwelling, cognitively intact older adults (+60 years) with a surgical repair of a hip fracture and no major medical conditions. Participants received 12 or 6 weeks of PRT and standardized physical therapy, twice weekly. Pain was monitored throughout. Primary outcome was the change in the 6-minute walk test (6MWT) from baseline to 12-week follow-up. Randomization via a computer-generated allocation sequence was implemented using sealed, sequentially numbered opaque envelopes and assessors were blinded to group assignment. Results Participants (81% women) with a mean (SD) age of 77 (8.1) years were enrolled at an average of 18 days after hip fracture surgery and randomized into a 12-week group (n = 50) or a 6-week group (n = 50). Mean (SD) change scores in the 6MWT were 143.8 (81.1) and 161.5 (84.1) m in the 12- and 6-week groups, respectively (both exceeding the minimal clinically important difference of 55 m). The mean between-group difference was −17.7 m (95% CI −50.1, 14.8). Pain during training did not exceed moderate levels nor increase as training intensity increased. Conclusion Twelve weeks of physical therapy with PRT was not superior to 6 weeks in improving walking distance. Hip fracture-related pain was relatively low and indicated strength testing and training was well tolerated. Clinical Trials Registration Number: NCT01174589

Abstract 3725: Simvastatin but Not Pravastatin Affects Sleep: Findings from the UCSD Statin Study

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Beatrice A Golomb ◽  
Edwin K Kwon ◽  
Michael H Criqui ◽  
Joel E Dimsdale
Keyword(s):  
Sleep Quality ◽  
Rating Scale ◽  
Sleep Problems ◽  
Small Sample Size ◽  
Case Reports ◽  
Controlled Trial ◽  
Small Sample ◽  
T Test ◽  
Secondary Outcome ◽  
Regression Analyses

Background : Case reports have suggested possible effects of lipophilic statins on sleep in some subjects. Most randomized studies evaluating the effect of statins on sleep have had small sample size and short duration (≤ 6 weeks). Whether statins affect sleep on average, favorably or adversely, has been unclear. Goal : To assess the effects of lipophilic and hydrophilic statins on sleep. Subjects : 1016 adult men and women without diabetes or heart disease, with LDL-cholesterol 115–190mg/dL. Design : Randomized double blind placebo-controlled trial of simvastatin 20mg, pravastatin 40mg or placebo for 6 months. Sleep was a prespecified secondary outcome. It was assessed by both an adaptation of the Leeds sleep scale (a visual analog scale of sleep quality); and a rating scale of sleep problems. Both items were measured at baseline and on-treatment. Analysis : Baseline comparability of randomization groups including sleep measures was affirmed. T-test of mean on-treatment sleep scores across randomization groups was performed. This complemented regression analyses, adjusted for baseline values of the respective sleep assessment. Results : Groups were comparable at baseline on variables including both sleep measures. Simvastatin use was associated with significantly worse sleep quality, and significantly greater reported sleep problems than either pravastatin or placebo, by t-test and regression analyses. Pravastatin did not differ significantly from placebo on any sleep outcome. Conclusion : Findings were compatible with the hypothesis that statins may impair sleep in some subjects, and that this impairment may arise selectively with lipophilic statins. Table 1. Effects of Statins on Sleep: Regression Analysis

The Cottage: providing medical respite care in a home-like environment for people experiencing homelessness

2018 ◽  
Vol 22 (1) ◽  
pp. 54-64
Author(s):  
Angela Gazey ◽  
Shannen Vallesi ◽  
Karen Martin ◽  
Craig Cumming ◽  
Lisa Wood
Keyword(s):  
Case Studies ◽  
Small Sample Size ◽  
Treatment Compliance ◽  
Small Sample ◽  
Health Conditions ◽  
Hospital Inpatient ◽  
City Hospital ◽  
Post Discharge ◽  
Content Type ◽  
The Usa

Purpose Co-existing health conditions and frequent hospital usage are pervasive in homeless populations. Without a home to be discharged to, appropriate discharge care and treatment compliance are difficult. The Medical Respite Centre (MRC) model has gained traction in the USA, but other international examples are scant. The purpose of this paper is to address this void, presenting findings from an evaluation of The Cottage, a small short-stay respite facility for people experiencing homelessness attached to an inner-city hospital in Melbourne, Australia. Design/methodology/approach This mixed methods study uses case studies, qualitative interview data and hospital administrative data for clients admitted to The Cottage in 2015. Hospital inpatient admissions and emergency department presentations were compared for the 12-month period pre- and post-The Cottage. Findings Clients had multiple health conditions, often compounded by social isolation and homelessness or precarious housing. Qualitative data and case studies illustrate how The Cottage couples medical care and support in a home-like environment. The average stay was 8.8 days. There was a 7 per cent reduction in the number of unplanned inpatient days in the 12-months post support. Research limitations/implications The paper has some limitations including small sample size, data from one hospital only and lack of information on other services accessed by clients (e.g. housing support) limit attribution of causality. Social implications MRCs provide a safe environment for individuals to recuperate at a much lower cost than inpatient admissions. Originality/value There is limited evidence on the MRC model of care outside of the USA, and the findings demonstrate the benefits of even shorter-term respite post-discharge for people who are homeless.

Three-year results of phase I retinal gene therapy trial for CNGA3-mutated achromatopsia: results of a non randomised controlled trial

2021 ◽  
pp. bjophthalmol-2021-319067
Author(s):  
Felix Friedrich Reichel ◽  
Stylianos Michalakis ◽  
Barbara Wilhelm ◽  
Ditta Zobor ◽  
Regine Muehlfriedel ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Primary Endpoint ◽  
Statistical Power ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Small Sample ◽  
Functional Improvement ◽  
Limiting Factor ◽  
Serious Adverse Events

AimsTo determine long-term safety and efficacy outcomes of a subretinal gene therapy for CNGA3-associated achromatopsia. We present data from an open-label, nonrandomised controlled trial (NCT02610582).MethodsDetails of the study design have been previously described. Briefly, nine patients were treated in three escalating dose groups with subretinal AAV8.CNGA3 gene therapy between November 2015 and October 2016. After the first year, patients were seen on a yearly basis. Safety assessment constituted the primary endpoint. On a secondary level, multiple functional tests were carried out to determine efficacy of the therapy.ResultsNo adverse or serious adverse events deemed related to the study drug occurred after year 1. Safety of the therapy, as the primary endpoint of this trial, can, therefore, be confirmed. The functional benefits that were noted in the treated eye at year 1 were persistent throughout the following visits at years 2 and 3. While functional improvement in the treated eye reached statistical significance for some secondary endpoints, for most endpoints, this was not the case when the treated eye was compared with the untreated fellow eye.ConclusionThe results demonstrate a very good safety profile of the therapy even at the highest dose administered. The small sample size limits the statistical power of efficacy analyses. However, trial results inform on the most promising design and endpoints for future clinical trials. Such trials have to determine whether treatment of younger patients results in greater functional gains by avoiding amblyopia as a potential limiting factor.

A comparative assessment of orthodontic treatment outcomes using the quantitative light-induced fluorescence (QLF) method between direct bonding and indirect bonding techniques in adolescents: a single-centre, single-blind randomized controlled trial

2019 ◽  
Vol 42 (4) ◽  
pp. 441-453
Author(s):  
Aykan Onur Atilla ◽  
Taner Ozturk ◽  
Mustafa Murat Eruz ◽  
Ahmet Yagci
Keyword(s):  
Orthodontic Treatment ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
White Spot Lesion ◽  
Indirect Bonding ◽  
Signed Rank ◽  
Group 12 ◽  
Registration Number ◽  
Bonding Technique

Summary Introduction The aim of this two-arm parallel trial was to evaluate enamel demineralization in fixed orthodontic treatment using an indirect bonding technique in comparison to a direct bonding technique by the quantitative light-induced fluorescence (QLF) method. Design, settings and participants Fifty-six patients who needed fixed orthodontic treatment were randomly separated into either the direct bonding group or the indirect bonding group. The presence and extent of lesions on the buccal surfaces of all teeth, except the molar teeth, were assessed. The percentage of fluorescence loss (ΔF and ΔFmax), the degree of demineralization (ΔQ) and lesion area (WS area) were determined using the system’s software. The data were analysed with the Wilcoxon signed-rank and Mann–Whitney U-tests (P &lt; 0.05). Interventions Treatment with a direct bonding or an indirect bonding technique. Results This study was completed with 25 patients in the indirect bonding group (12 females, 13 males; mean age: 15.42 ± 1.71 years) and 26 patients in the direct bonding group (12 females, 14 males; mean age: 14.73 ± 1.65 years). In the indirect bonding technique, a few teeth (especially mandibular left canine: 50.45 ± 93.48; 95% confidence interval: −12.35 and 113.26) were found to develop significant white spot lesion (WSL) formation (P &lt; 0.05). However, the number of teeth with demineralization was higher in the direct bonding group (P &lt; 0.05). Conclusion The bonding procedures used in the indirect bonding technique contribute to reducing the degree of WSL formation. Further, the use of flowable composite adhesives in this bonding process is more effective at reducing the appearance of WSLs than in cases where conventional composite adhesives are used. Limitations The limitation of our trial may be the small sample size and the short follow-up time for the patients. Harms No harms were detected during the study. Protocol The protocol was not published before trial commencement. Registration This trial was registered post hoc at ‘Clinical Trials’ (http://www.clinicaltrials.gov), registration number (ID): NCT03738839.

Lower rates of mortality, readmission and reoperation in patients receiving acupuncture after hip fracture: a population-based analysis

2020 ◽  
Vol 38 (5) ◽  
pp. 352-360
Author(s):  
Jeff Chien-Fu Lin ◽  
Tzu-Chieh Lin ◽  
Chi-Fung Cheng ◽  
Ying-Ju Lin ◽  
Sophia Liang ◽  
...  
Keyword(s):  
Hip Fracture ◽  
Lower Risk ◽  
Small Sample Size ◽  
Population Based ◽  
Small Sample ◽  
Acupuncture Group ◽  
Research Database ◽  
Complication Rates ◽  
Using Data ◽  
Reoperation Rates

Background: Studies on the effects of acupuncture on mortality and complication rates in hip fracture patients are limited by small sample size and short follow-up time. We aimed to assess the associations of acupuncture use with mortality, readmission and reoperation rates in hip fracture patients using a longitudinal population-based database. Methods: A retrospective matched cohort study was conducted using data for the years 1996–2012 from Taiwan’s National Health Insurance Research Database. Hip fracture patients were divided into an acupuncture group consisting of 292 subjects who received at least 6 acupuncture treatments within 183 days of hip fracture, and a propensity score matched “no acupuncture” group of 876 subjects who did not receive any acupuncture treatment and who functioned as controls. The two groups were compared using survival analysis and competing risk analysis. Results: Compared to non-treated subjects, subjects treated with acupuncture had a lower risk of overall death (hazard ratio (HR): 0.41, 95% confidence interval (CI): 0.24–0.73, p = 0.002), a lower risk of readmission due to medical complications (subdistribution HR (sHR): 0.64, 95% CI: 0.44–0.93, p = 0.019) and a lower risk of reoperation due to surgical complications (sHR: 0.62, 95% CI: 0.40–0.96, p = 0.034). Conclusion: This is the first study to suggest that postoperative acupuncture in hip fracture patients is associated with significantly lower mortality, readmission and reoperation rates compared with those of matched controls.

A Pilot Randomized Sham-Controlled Trial of MC5-A Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN)

2019 ◽  
Vol 35 (1) ◽  
pp. 53-58 ◽  
Author(s):  
Thomas J. Smith ◽  
A. Rab Razzak ◽  
Amanda L. Blackford ◽  
Jennifer Ensminger ◽  
Catherine Saiki ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Rating Scale ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Brief Pain Inventory ◽  
Small Sample ◽  
Sham Treatment ◽  
The Real ◽  
Average Pain ◽  
Scrambler Therapy

Background: Chemotherapy-induced peripheral neuropathy (CIPN) affects 30% to 40% of patients with cancer with long-lasting disability. Scrambler therapy (ST) appeared to benefit patients in uncontrolled trials, so we performed a randomized sham-controlled Phase II trial of ST. Methods: The primary end point was “average pain” after 28 days on the Numeric Rating Scale. Each received ten 30-minute sessions of ST on the dermatomes above the painful areas, or sham treatment on the back, typically at L3-5 where the nerve roots would enter the spinal cord. Outcomes included the Brief Pain Inventory (BPI)-CIPN and the EORTC CIPN-20 scale. Patients were evaluated before treatment (day 0), day 10, and days 28, 60, and 90. Results: Data regarding pain as a primary outcome were collected for 33 of the 35 patients. There were no significant differences between the sham and the “real” ST group at day 10, 28, 60, or 90, for average pain, the BPI, or EORTC CIPN-20. Individual responses were noted during the ST treatment on the real arm, but most dissipated by day 30. There was improvement in the sensory subscale of the CIPN-20 at 2 months in the “real” group ( P = .14). All “real” patients wanted to continue treatment if available. Discussion: We observed no difference between sham and real ST CIPN treatment. Potential reasons include at least the following: ST does not work; the sham treatment had some effect; small sample size with heterogeneous patients; misplaced electrodes on an area of nonpainful but damaged nerves; or a combination of these factors.

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