Does length of time spent on the waiting list for TURP influence the outcome?

With an ever increasing demand for operative procedures within the NHS but little increase in capacity, waiting lists are lengthening, particularly for benign procedures. We sought to determine whether increasing time on a waiting list influences the outcome from a transurethral resection of prostate (TURP), with a primary outcome measure of success at inpatient trial without catheter (TWOC) and pre-operative, peri-operative and post-operative secondary outcome measures. Data was collected from four separate retrospective TURP audits performed between 2009-2015. A total of 379 TURP procedures were included with the time on the waiting list ranging from 8 to 384 days. In patients who were not catheterised pre-operatively success at in patient TWOC by 30 day intervals (in 30 day intervals from 1-30 days to over 151 days) was 79%, 83%, 88%, 87%, 100% and 83%; in those with a catheter, success was 46%, 71%, 75%, 100%, 50% and 86%. In conclusion waiting longer for a TURP does not adversely affect the outcome of inpatient TWOC. Level of evidence: Not applicable – this is a single centre audit over multiple time points.

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A phase III trial of intramuscular recombinant interferon beta as treatment for exacerbating-remitting multiple sclerosis: design and conduct of study and baseline characteristics of patients

Multiple Sclerosis Journal ◽

10.1177/135245859500100210 ◽

1995 ◽

Vol 1 (2) ◽

pp. 118-135 ◽

Cited By ~ 64

Author(s):

LD Jacobs ◽

DL Cookfair ◽

RA Rudick ◽

RM Herndon ◽

J R Richert ◽

...

Keyword(s):

Primary Outcome ◽

Interferon Beta ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Phase Iii ◽

Secondary Outcome ◽

Recombinant Interferon ◽

Study Population ◽

The Mean ◽

Baseline Characteristics

The design and conduct of a randomized, double-blinded, placebo-controlled, multicenter, phase III study of recombinant interferon beta-1a (IFN-β-1a) as treatment for exacerbating-remitting MS are described, as are baseline characteristics of the study population. The purpose of the study was to determine if 6.0 × 106 IU (30 μg) of IFN-β-1a, administered by weekly intramuscular (i.m.) injections, was effective in delaying the onset of sustained disability. The primary outcome measure was time to onset of treatment failure, defined as a worsening on the Kurtzke Expanded Disability Status Scale (EDSS) of greater than or equal to 1.0 point compared with baseline, persisting for at least 6 months. An intent-to-treat design was used. The primary outcome measure was analyzed using the Mantel-Cox log-rank statistic and Kaplan-Meier survival curves. Secondary outcomes included quantitative measures of upper and lower extremity function, neuropsychological test performance, functional and quality of life assessments and several measures derived from annual brain MRI studies. Entry criteria included prestudy exacerbation rates of at least 0.67 per year and EDSS scores of 1.0–3.5. A total of 301 MS patients were randomly assigned to receive weekly i.m. injections of IFN-β-1a or placebo. The average age of the study population at entry was 37 years; 92% were Caucasian and 73% were women. The mean prestudy disease duration was 6.5 years, mean prestudy exacerbation rate was 1.2 per year and the mean EDSS score was 2.3. The randomization yielded well-balanced treatment arms. Various aspects of the study are discussed, including: (1) the decision to focus study design on sustained disability; (2) the rationale for the treatment regimen; (3) measures taken to assure the reliability of the primary outcome measure; and (4) a description of the secondary outcome measures.

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Association between workarounds and medication administration errors in bar-code-assisted medication administration in hospitals

Journal of the American Medical Informatics Association ◽

10.1093/jamia/ocx077 ◽

2017 ◽

Vol 25 (4) ◽

pp. 385-392 ◽

Cited By ~ 15

Author(s):

Willem van der Veen ◽

Patricia MLA van den Bemt ◽

Hans Wouters ◽

David W Bates ◽

Jos WR Twisk ◽

...

Keyword(s):

Prospective Observational Study ◽

Primary Outcome ◽

Outcome Measure ◽

Medication Administration ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Bar Code ◽

Implementation Evaluation ◽

Medication Administration Errors ◽

Large Numbers

Abstract Objective To study the association of workarounds with medication administration errors using barcode-assisted medication administration (BCMA), and to determine the frequency and types of workarounds and medication administration errors. Materials and Methods A prospective observational study in Dutch hospitals using BCMA to administer medication. Direct observation was used to collect data. Primary outcome measure was the proportion of medication administrations with one or more medication administration errors. Secondary outcome was the frequency and types of workarounds and medication administration errors. Univariate and multivariate multilevel logistic regression analysis were used to assess the association between workarounds and medication administration errors. Descriptive statistics were used for the secondary outcomes. Results We included 5793 medication administrations for 1230 inpatients. Workarounds were associated with medication administration errors (adjusted odds ratio 3.06 [95% CI: 2.49-3.78]). Most commonly, procedural workarounds were observed, such as not scanning at all (36%), not scanning patients because they did not wear a wristband (28%), incorrect medication scanning, multiple medication scanning, and ignoring alert signals (11%). Common types of medication administration errors were omissions (78%), administration of non-ordered drugs (8.0%), and wrong doses given (6.0%). Discussion Workarounds are associated with medication administration errors in hospitals using BCMA. These data suggest that BCMA needs more post-implementation evaluation if it is to achieve the intended benefits for medication safety. Conclusion In hospitals using barcode-assisted medication administration, workarounds occurred in 66% of medication administrations and were associated with large numbers of medication administration errors.

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A Sternum-Disk Distance Method to Identify the Skin Level for Approaching a Surgical Segment without Fluoroscopy Guidance during Anterior Cervical Discectomy And Fusion

Asian Spine Journal ◽

10.4184/asj.2017.11.1.50 ◽

2017 ◽

Vol 11 (1) ◽

pp. 50-56

Author(s):

Gun Woo Lee ◽

Myun-Whan Ahn ◽

Ji-Hoon Shin ◽

Jae Woo Park ◽

Jae-Hyung Uh ◽

...

Keyword(s):

Primary Outcome ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Kappa Coefficient ◽

Anterior Cervical Discectomy ◽

Secondary Outcome ◽

Distance Method ◽

Cervical Discectomy ◽

Observer Reliability ◽

The Mean

<sec><title>Study Design</title>A retrospective review of prospectively collected data.</sec><sec><title>Purpose</title>To introduce the sternum-disk distance (SDD) method for approaching the exact surgical level without C-arm guidance during anterior cervical discectomy and fusion (ACDF) surgery and to evaluate its accuracy and reliability.</sec><sec><title>Overview of Literature</title>Although spine surgeons have tried to optimize methods for identifying the skin level for accessing the operative disk level without C-arm guidance during ACDF, success has rarely been reported.</sec><sec><title>Methods</title>In total, 103 patients who underwent single-level ACDF surgery with the SDD method were enrolled. The primary outcome measure was the accuracy of the SDD method. The secondary outcome measures were the mean SDD value at each cervical level from the cranial margin of the sternum in the neutral and extension positions of the cervical spine and the inter- and intra-observer reliability of the SDD outcome determined using repeated measurements by three orthopedic spine surgeons.</sec><sec><title>Results</title>The SDD accuracy (primary outcome measure) was indicated in 99% of the patients (102/103). The mean SDD values in the neutral-position magnetic resonance imaging (MRI) were 108.8 mm at C3–C4, 85.3 mm at C4–C5, 64.4 mm at C5–C6, 44.3 mm at C6–C7, and 24.1 mm at C7–T1; and those in the extension-position MRI were 112.9 mm at C3–C4, 88.7 mm at C4–C5, 67.3 mm at C5–C6, 46.5 mm at C6–C7, and 24.3 mm at C7–T1. The Cohen kappa coefficient value for intra-observer reliability was 0.88 (excellent reliability), and the Fleiss kappa coefficient value for inter-observer reliability as reported by three surgeons was 0.89 (excellent reliability).</sec><sec><title>Conclusions</title>Based on the results of the present study, we recommend performing ACDF surgery using the SDD method to determine the skin level for approaching the surgical cervical segment without fluoroscopic guidance.</sec>

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Combining Lovastatin and Minocycline for the Treatment of Fragile X Syndrome: Results From the LovaMiX Clinical Trial

Frontiers in Psychiatry ◽

10.3389/fpsyt.2021.762967 ◽

2022 ◽

Vol 12 ◽

Author(s):

Camille Champigny ◽

Florence Morin-Parent ◽

Laurence Bellehumeur-Lefebvre ◽

Artuela Çaku ◽

Jean-François Lepage ◽

...

Keyword(s):

Clinical Trial ◽

Fragile X Syndrome ◽

Outcome Measures ◽

Primary Outcome ◽

Outcome Measure ◽

Fragile X ◽

Combined Therapy ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Global Score

Background: Limited success of previous clinical trials for Fragile X syndrome (FXS) has led researchers to consider combining different drugs to correct the pleiotropic consequences caused by the absence of the Fragile X mental retardation protein (FMRP). Here, we report the results of the LovaMiX clinical trial, the first trial for FXS combining two disease-modifying drugs, lovastatin, and minocycline, which have both shown positive effects when used independently.Aim: The main goals of the study were to assess the safety and efficacy of a treatment combining lovastatin and minocycline for patients with FXS.Design: Pilot Phase II open-label clinical trial. Patients with a molecular diagnostic of FXS were first randomized to receive, in two-step titration either lovastatin or minocycline for 8 weeks, followed by dual treatment with lovastatin 40 mg and minocycline 100 mg for 2 weeks. Clinical assessments were performed at the beginning, after 8 weeks of monotherapy, and at week 20 (12 weeks of combined therapy).Outcome Measures: The primary outcome measure was the Aberrant Behavior Checklist-Community (ABC-C) global score. Secondary outcome measures included subscales of the FXS specific ABC-C (ABC-CFX), the Anxiety, Depression, and Mood Scale (ADAMS), the Social Responsiveness Scale (SRS), the Behavior Rating Inventory of Executive Functions (BRIEF), and the Vineland Adaptive Behavior Scale second edition (VABS-II).Results: Twenty-one individuals out of 22 completed the trial. There were no serious adverse events related to the use of either drugs alone or in combination, suggesting good tolerability and safety profile of the combined therapy. Significant improvement was noted on the primary outcome measure with a 40% decrease on ABC-C global score with the combined therapy. Several outcome measures also showed significance.Conclusion: The combination of lovastatin and minocycline is safe in patients for FXS individuals and appears to improve several elements of the behavior. These results set the stage for a larger, placebo-controlled double-blind clinical trial to confirm the beneficial effects of the combined therapy.

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Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.2018.2 ◽

2018 ◽

Vol 213 (1) ◽

pp. 404-411 ◽

Cited By ~ 12

Author(s):

Ulrika Karlsson Stigsdotter ◽

Sus Sola Corazon ◽

Ulrik Sidenius ◽

Patrik Karlsson Nyed ◽

Helmer Bøving Larsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Well Being ◽

Behavioural Therapy ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Significant Difference ◽

Increasing Demand ◽

Randomised Controlled

BackgroundStress-related illnesses are a major threat to public health, and there is increasing demand for validated treatments.AimsTo test the efficacy of nature-based therapy (NBT) for patients with stress-related illnesses.MethodRandomised controlled trial (ClinicalTrials.gov ID NCT01849718) comparing Nacadia® NBT (NNBT) with the cognitive–behavioural therapy known as Specialised Treatment for Severe Bodily Distress Syndromes (STreSS). In total, 84 participants were randomly allocated to one of the two treatments. The primary outcome measure was the mean aggregate score on the Psychological General Well-Being Index (PGWBI).ResultsBoth treatments resulted in a significant increase in the PGWBI (primary outcome) and a decrease in burnout (the Shirom–Melamed Burnout Questionnaire, secondary outcome), which were both sustained 12 months later. No significant difference in efficacy was found between NNBT and STreSS for primary outcome and secondary outcomes.ConclusionsThe study showed no statistical evidence of a difference between NNBT and STreSS for treating patients with stress-related illnesses.Declaration of interestNone.

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188 The Use of a Group Based Upper Limb Programme in Improving Outcome in Acute Stroke Rehabilitation

Age and Ageing ◽

10.1093/ageing/afz103.111 ◽

2019 ◽

Vol 48 (Supplement_3) ◽

pp. iii17-iii65

Author(s):

Kerri Donnelly ◽

Enya Mulcahy ◽

Catherine Merrick ◽

Orla Fitzgerald

Keyword(s):

Acute Stroke ◽

Grip Strength ◽

Outcome Measures ◽

Upper Limb ◽

Primary Outcome ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Dominant Hand ◽

Nine Hole Peg Test

Abstract Background After a stroke 85% of patients experience altered arm function. Current research demonstrates that increasing upper limb rehabilitation results in improved outcomes (Ward et al., 2019). The Graded Repetitive Arm Supplementary Programme (GRASP) group is an established adjunctive therapy in the stroke service. The group provides additional therapy for suitable patients with upper extremity deficits. The group is run jointly by a physiotherapist and an occupational therapist. Patients attend twice weekly for a one hour period in addition to their regular therapy. The GRASP group consists of 3 levels of varying abilities and patients are categorised by their Fugl-Meyer score. Methods A prospective audit was completed in 2019 and data was collected using a word document and excel spread sheet. Standardised outcome measures were completed on admission and discharge to establish upper limb ability. The primary outcome measure was the Fugl-Meyer and the secondary outcome measures were the nine hole peg test and grip strength using the Dynamometer. Results 12 patients attended the GRASP group over this period. 75% were males. The average age was 76 years with the age range from 48-95 years. 58% of patients experienced upper limb weakness in their non-dominant hand. Post intervention data was not obtained for 5 patients due to unforeseeable discharge from the acute setting. Preliminary data to date shows that our primary outcome measure improved in 86% of patients with increases ranging from 2-11 points on the Fugl-Meyer score (Minimally Clinical Important Difference =5points). Our secondary outcome measures demonstrated patients had no change (28%) or an improvement (72%) in grip strength and 100% of patients improved on the time taken to complete the nine hole peg test. Conclusion The GRASP group was found to be effective in improving upper limb outcome measures in an acute stroke inpatient hospital setting.

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Prognostic value of reduction in left atrial size during a follow-up of heart failure: an observational study

BMJ Open ◽

10.1136/bmjopen-2020-044409 ◽

2021 ◽

Vol 11 (2) ◽

pp. e044409

Author(s):

Masayuki Shiba ◽

Takao Kato ◽

Takeshi Morimoto ◽

Hidenori Yaku ◽

Yasutaka Inuzuka ◽

...

Keyword(s):

Heart Failure ◽

Lower Risk ◽

Left Atrial ◽

Primary Outcome ◽

Outcome Measure ◽

No Reduction ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Group Change

ObjectiveThe association between sequential changes in left atrial diameter (LAD) and prognosis in heart failure (HF) remains to be elucidated. The present study aimed to investigate the link between reduction in LAD and clinical outcomes in patients with HF.DesignA multicentre prospective cohort study.SettingThis study was nested from the Kyoto Congestive Heart Failure registry including consecutive patients admitted for acute decompensated heart failure (ADHF) in 19 hospitals throughout Japan.ParticipantsThe current study population included 673 patients with HF who underwent both baseline and 6-month follow-up echocardiography with available paired LAD data. We divided them into two groups: the reduction in the LAD group (change <0 mm) (n=398) and the no-reduction in the LAD group (change ≥0 mm) (n=275).Primary and secondary outcomesThe primary outcome measure was a composite of all-cause death or hospitalisation for HF during 180 days after 6-month follow-up echocardiography. The secondary outcome measures were defined as the individual components of the primary composite outcome measure and a composite of cardiovascular death or hospitalisation for HF.ResultsThe cumulative 180-day incidence of the primary outcome measure was significantly lower in the reduction in the LAD group than in the no-reduction in the LAD group (13.3% vs 22.2%, p=0.002). Even after adjusting 15 confounders, the lower risk of reduction in LAD relative to no-reduction in LAD for the primary outcome measure remained significant (HR 0.59, 95% CI 0.36 to 0.97 p=0.04).ConclusionPatients with reduction in LAD during follow-up after ADHF hospitalisation had a lower risk for a composite endpoint of all-cause death or HF hospitalisation, suggesting that the change of LAD might be a simple and useful echocardiographic marker during follow-up.

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Hypokalemia Measurement and Management in Patients With Status Asthmaticus on Continuous Albuterol

Hospital Pediatrics ◽

10.1542/hpeds.2021-006265 ◽

2022 ◽

Author(s):

Courtney Cox ◽

Krishna Patel ◽

Rebecca Cantu ◽

Chary Akmyradov ◽

Katherine Irby

Keyword(s):

Potassium Level ◽

Primary Outcome ◽

Pediatric Patients ◽

Status Asthmaticus ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Secondary Outcome Measure ◽

Treatment Frequency ◽

Care Costs

OBJECTIVE: Status asthmaticus is commonly treated in pediatric patients by using continuous albuterol, which can cause hypokalemia. The primary aim of this study was to determine if serial potassium monitoring is necessary by examining treatment frequency of hypokalemia. METHODS: This retrospective analysis was performed in 185 pediatric patients admitted with status asthmaticus requiring continuous albuterol between 2017 and 2019. All patients were placed on intravenous fluids containing potassium. The primary outcome measure was the treatment of hypokalemia in relation to the number of laboratory draws for potassium levels. The secondary outcome measure was hypokalemia frequency and relation to the duration and initial dose of continuous albuterol. RESULTS: Included were 156 patients with 420 laboratory draws (average, 2.7 per patient) for potassium levels. The median lowest potassium level was 3.40 mmol/L (interquartile range, 3.2–3.7). No correlation was found between initial albuterol dose and lowest potassium level (P = .52). Patients with hypokalemia had a mean albuterol time of 12.32 (SD, 15.76) hours, whereas patients without hypokalemia had a mean albuterol time of 11.50 (SD, 12.53) hours (P = .29). Potassium levels were treated 13 separate times. CONCLUSIONS: The number of laboratory draws for potassium levels was high in our cohort, with few patients receiving treatment for hypokalemia beyond the potassium routinely added to maintenance fluids. Length of time on albuterol and dose of albuterol were not shown to increase the risk of hypokalemia. Serial laboratory measurements may be decreased to potentially reduce health care costs, pain, and anxiety surrounding needlesticks.

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Effectiveness of Unguided Internet-based Cognitive Behavioral Therapy and the Three Good Things Exercise for Insomnia: A Three-arm Randomized Controlled Trial (Preprint)

10.2196/preprints.28747 ◽

2021 ◽

Author(s):

Daisuke Sato ◽

Yoichi Sekizawa ◽

Chihiro Sutoh ◽

Yoshiyuki Hirano ◽

Sho Okawa ◽

...

Keyword(s):

Cognitive Behavioral Therapy ◽

Primary Outcome ◽

Outcome Measure ◽

Behavioral Therapy ◽

Primary Outcome Measure ◽

Cognitive Behavioral ◽

Secondary Outcome ◽

Economic Losses ◽

Sleep Questionnaire ◽

Insomnia Symptoms

BACKGROUND The treatment of insomnia with sleep medication causes problems such as long-term use, dependence, and significant economic losses, including medical expenses. Evidence-based lifestyle guidance is required to improve insomnia symptoms, not only in person but also in easy-to-use online formats. OBJECTIVE This study aimed to clarify whether unguided internet cognitive behavioral therapy (ICBT) or the three good things (TGT) exercise, both administered as self-help internet interventions without e-mail support, could improve insomnia symptoms compared to a waiting list control (WLC) group. METHODS A four week program was implemented, and participants were randomly allocated to one of the three groups. The primary outcome measure was Pittsburgh Sleep Questionnaire (PSQI) score at four weeks compared to baseline. RESULTS Of the 21,394 individuals who were invited to participate, 312 met the eligibility criteria and were randomly assigned to one of the three groups. Of these, 270 subjects (ICBT; n = 79, TGT; n = 88, WLC; n = 103) completed a post-intervention survey at four and eight weeks. The adjusted mean changes of the primary outcome measure (the Pittsburgh Sleep Questionnaire; PSQI) in the ICBT (-1.56, 95% CI: -2.52, -0.59; p <0.001) and TGT (-1.15, 95% CI: -2.08, -0.23; p = 0.0018) groups at four weeks from baseline showed a significant improvement compared to the WLC. The adjusted mean changes of the secondary outcome measures in sleep onset latency, total sleep time (TST), Athens Insomnia Scale (AIS) score, and Patient Health Questionnaire-9 (PHQ-9) score at four weeks from baseline, as well as in the PSQI at eight weeks from baseline, showed significant improvement in the ICBT. Moreover, TST, AIS and PHQ-9 scores at four weeks from baseline showed a significant improvement in the TGT group compared to the WLC. CONCLUSIONS Four weeks of unguided ICBT and the TGT exercises improved insomnia. CLINICALTRIAL The trial is registered with the UMIN Clinical Trial Registry (UMIN000034927)

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Allogenic simple limbal epithelial transplantation (alloSLET) from cadaveric donor eyes in patients with persistent corneal epithelial defects

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2019-315176 ◽

2020 ◽

pp. bjophthalmol-2019-315176

Author(s):

Jana Catharina Riedl ◽

Aytan Musayeva ◽

Joanna Wasielica-Poslednik ◽

Norbert Pfeiffer ◽

Adrian Gericke

Keyword(s):

Medical Records ◽

Primary Outcome ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Effective Treatment Option ◽

Corneal Surface ◽

Corneal Epithelial ◽

Cadaveric Donor ◽

Corrected Visual Acuity

Background/aimTo describe the clinical outcome of allogenic simple limbal epithelial transplantation (alloSLET) utilising tissue from cadaveric donor eyes after failed re-epithelialisation of the corneal surface.MethodsMedical records of 14 eyes from 14 patients treated for persistent corneal epithelial defects with alloSLET were reviewed. The primary outcome measure was complete epithelialisation of the corneal surface. Secondary outcome measures were best corrected visual acuity (BCVA) and postoperative side effects due to surgery or medical therapy.ResultsOf the 14 eyes, 7 received alloSLET only and 7 alloSLET together with penetrating keratoplasty (PK). Thirteen (92.9%) of 14 eyes had an epithelialised corneal surface 3 and 6 months after surgery and 10 (71.4%) of 14 eyes displayed an epithelialised corneal surface 12 months after surgery. In both subgroups, alloSLET only and alloSLET with PK, respectively, 5 (71.4%) of 7 eyes had a stable corneal epithelium 12 months after surgery, respectively. Postoperatively, BCVA improved markedly in the whole patient collective. However, the increase was not significant when looking at the two individual subgroups. One patient lost his bandage contact lens several times within the first postoperative month and had a partial detachment of the amniotic membrane. The ocular surface of this patient failed to epithelialise. In three patients, limbal donor pieces translocated to the centre of the cornea, which possibly prolonged the improvement of BCVA.ConclusionAlloSLET appears to be an effective treatment option in eyes with non-healing corneal epithelial defects when autologous limbal tissue is not available.

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