SAFE PACE 2: Syncope and Falls in the Elderly — Pacing and Carotid Sinus Evaluation

✓ There is still controversy over whether or not patients should be hyperventilated after traumatic brain injury, and a randomized trial has never been conducted. The theoretical advantages of hyperventilation are cerebral vasoconstriction for intracranial pressure (ICP) control and reversal of brain and cerebrospinal fluid (CSF) acidosis. Possible disadvantages include cerebral vasoconstriction to such an extent that cerebral ischemia ensues, and only a short-lived effect on CSF pH with a loss of HCO3− buffer from CSF. The latter disadvantage might be overcome by the addition of the buffer tromethamine (THAM), which has shown some promise in experimental and clinical use. Accordingly, a trial was performed with patients randomly assigned to receive normal ventilation (PaCO2 35 ± 2 mm Hg (mean ± standard deviation): control group), hyperventilation (PaCO2 25 ± 2 mm Hg: HV group), or hyperventilation plus THAM (PaCO2 25 ± 2 mm Hg: HV + THAM group). Stratification into subgroups of patients with motor scores of 1–3 and 4–5 took place. Outcome was assessed according to the Glasgow Outcome Scale at 3, 6, and 12 months. There were 41 patients in the control group, 36 in the HV group, and 36 in the HV + THAM group. The mean Glasgow Coma Scale score for each group was 5.7 ± 1.7, 5.6 ± 1.7, and 5.9 ± 1.7, respectively; this score and other indicators of severity of injury were not significantly different. A 100% follow-up review was obtained. At 3 and 6 months after injury the number of patients with a favorable outcome (good or moderately disabled) was significantly (p < 0.05) lower in the hyperventilated patients than in the control and HV + THAM groups. This occurred only in patients with a motor score of 4–5. At 12 months posttrauma this difference was not significant (p = 0.13). Biochemical data indicated that hyperventilation could not sustain alkalinization in the CSF, although THAM could. Accordingly, cerebral blood flow (CBF) was lower in the HV + THAM group than in the control and HV groups, but neither CBF nor arteriovenous difference of oxygen data indicated the occurrence of cerebral ischemia in any of the three groups. Although mean ICP could be kept well below 25 mm Hg in all three groups, the course of ICP was most stable in the HV + THAM group. It is concluded that prophylactic hyperventilation is deleterious in head-injured patients with motor scores of 4–5. When sustained hyperventilation becomes necessary for ICP control, its deleterious effect may be overcome by the addition of THAM.

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Telephone follow-up of the elderly after cataract surgery

British Journal of Visual Impairment ◽

10.1177/0264619619874825 ◽

2019 ◽

Vol 38 (2) ◽

pp. 184-195

Author(s):

Tallita Mello Delphino Machado ◽

Rosimere Ferreira Santana ◽

Raquel Dantas Vaqueiro ◽

Carla Targino Bruno dos Santos ◽

Priscilla Alfradique de Souza

Keyword(s):

Cataract Surgery ◽

Older Persons ◽

Controlled Trial ◽

Intervention Group ◽

The Elderly ◽

Control Group ◽

Telephone Intervention ◽

Nursing Diagnosis ◽

Surgical Recovery

Study’s purpose: To analyze the effectiveness of telephone intervention for the nursing diagnosis of delayed surgical recovery in older persons who have undergone cataract surgery. Design: Blinded, randomized, and controlled trial. A total of 95 patients of both sexes who were over 60 years old and had undergone cataract surgery were divided into an intervention group (48 patients) and a control group (47 patients), allocated using BioEstat 5.3 Software. Results: The intervention included postoperative follow-up recovery of cataracts and prevention of complications performed on the 1st, 4th, 10th, and 20th postoperative days. After the intervention, the intervention group had a decrease in the length of surgical recovery ( p = .000). The occurrence in the intervention group was 6.3%, while in the control group, it was 36.2% (odds ratio (OR) = 0.118; confidence interval (CI) = 1.02, 10.23). The number of nursing interventions nevertheless decreased during the telephone follow-up. Conclusion: For older persons, the telephone guidelines increase adherence to treatment, promote clinical improvement, promote surgical recovery over time, and improve independence and autonomy.

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Manganese and Lipoflavonoid Plus® to Treat Tinnitus: A Randomized Controlled Trial

Journal of the American Academy of Audiology ◽

10.3766/jaaa.15106 ◽

2016 ◽

Vol 27 (08) ◽

pp. 661-668 ◽

Cited By ~ 2

Author(s):

Eveling Rojas-Roncancio ◽

Richard Tyler ◽

Hyung-Jin Jun ◽

Tang-Chuan Wang ◽

Haihong Ji ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Data Collection And Analysis ◽

Loudness Match ◽

Minimal Masking Level ◽

Lost To Follow Up ◽

To Receive

Background: Several tinnitus sufferers suggest that manganese has been helpful with their tinnitus. Purpose: We tested this in a controlled experiment where participants were committed to taking manganese and Lipoflavonoid Plus® to treat their tinnitus. Research Design: Randomized controlled trial. Study Sample: 40 participants were randomized to receive both manganese and Lipoflavonoid Plus® for 6 months, or Lipoflavonoid Plus® only (as the control). Data Collection and Analysis: Pre- and postmeasures were obtained with the Tinnitus Handicap Questionnaire, Tinnitus Primary Functions Questionnaire, and tinnitus loudness and annoyance ratings. An audiologist performed the audiogram, the tinnitus loudness match, and minimal masking level. Results: Twelve participants were dropped out of the study because of the side effects or were lost to follow-up. In the manganese group, 1 participant (out of 12) showed a decrease in the questionnaires, and another showed a decrease in the loudness and annoyance ratings. No participants from the control group (total 16) showed a decrease in the questionnaires ratings. Two participants in the control group reported a loudness decrement and one reported an annoyance decrement. Conclusions: We were not able to conclude that either manganese or Lipoflavonoid Plus® is an effective treatment for tinnitus.

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Efficacy of Physiotherapy Including a Craniocervical Training Programme for Tension-Type Headache; A Randomized Clinical Trial

Cephalalgia ◽

10.1111/j.1468-2982.2006.01163.x ◽

2006 ◽

Vol 26 (8) ◽

pp. 983-991 ◽

Cited By ~ 73

Author(s):

H van Ettekoven ◽

C Lucas

Keyword(s):

Controlled Trial ◽

Training Group ◽

Training Programme ◽

Time Frame ◽

Primary Outcome Measure ◽

Tension Type Headache ◽

Control Group ◽

Headache Frequency ◽

Type Headache

We conducted a multicentre, randomized controlled trial with blinded outcome assessment. The treatment period was 6 weeks with follow-up assessment immediately thereafter and after 6 months. The objective was to determine the effectiveness of a craniocervical training programme combined with physiotherapy for tension-type headache. Eighty-one participants meeting the diagnostic criteria for tension-type headache were randomly assigned to an exercise group (physiotherapy and an additional craniocervical training programme) and a control group (physiotherapy alone). The primary outcome measure was headache frequency. Secondary outcomes included headache intensity and duration, Quality of Life (SF-36) and the Multidimensional Headache Locus of Control scale (MHLC). At 6 months' follow-up, the craniocervical training group showed significantly reduced headache frequency, intensity and duration ( P < 0.001 for all). Effect sizes were large and clinically relevant. Loss to follow-up amounted to 3.7±. Physiotherapy including craniocervical training reduces symptoms of tension-type headache significantly over a prolonged time frame.

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A Trial Protocol for the Effectiveness of Digital Interventions for Preventing Depression in Adolescents: The Future Proofing Study

10.21203/rs.2.14135/v1 ◽

2019 ◽

Author(s):

Aliza Werner-Seidler ◽

Kit Huckvale ◽

Mark E. Larsen ◽

Alison L. Calear ◽

Kate Maston ◽

...

Keyword(s):

Large Scale ◽

Controlled Trial ◽

Control Group ◽

School Students ◽

Mixed Effect ◽

School Based ◽

Cognitive Behaviour ◽

The Future ◽

To Receive

Abstract Background Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programs. However, barriers to implementing and accessing these programs remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programs. The Future Proofing Study is a large-scale school-based trial investigating whether Cognitive Behaviour Therapies (CBT) delivered by smartphone application can prevent depression.Methods A randomized controlled trial targeting up to 20,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomized at the cluster level to receive either the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level RCT (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur at post-intervention (both trial stages), and at 6, 12, 24, 36, 48- and 60-months post-baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed effect models.Discussion This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programs should be deployed in school-based settings in Australia and beyond.

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Effectiveness of Platelet Rich Plasma for the Management of Knee Osteoarthritis

10.53350/pjmhs211571553 ◽

2021 ◽

Vol 15 (7) ◽

pp. 1553-1556

Author(s):

Adnan Qamar ◽

Saima Naz Mohsin ◽

Uzma Nasim Siddiqui ◽

Sana Naz ◽

Sana Danish

Keyword(s):

Knee Osteoarthritis ◽

Normal Saline ◽

Platelet Rich Plasma ◽

Controlled Trial ◽

Saline Group ◽

Control Group ◽

Plasma Therapy ◽

Vas Score ◽

To Receive

Aim: To determine impact of platelet rich plasma therapy for the management of knee osteoarthritis. Study design: Prospective double-blinded, add –on randomized, placebo-controlled trial Place and duration of study: Department of Orthopedics, Shaikh Zayed Hospital Lahore from 1st January 2019 to 30th June 2019 Methodology: Fifty volunteer participants fulfilling inclusion criteria were enrolled. One hundred knees of patients were randomly allocated into two groups. Knees were assigned either of the two groups. Platelet rich plasma group which was assigned to receive 5ml of platelet rich plasma and normal saline (NS) group which was assigned to receive 5ml of NS labeled as control group. All patients given 3 successive intra-articular injections of 5 mL of autologous platelet rich plasma or 5ml of normal saline was given at weekly intervals. Patients were blinded and subjected to a standardized injection protocol and the intensity of pain was assessed on visual analog scale (VAS) for pain. Results: The VAS scores decreased from 50.9±14.7 at baseline assessment to 43.6±16.2 at 1-month follow-up after completion of therapy for PRP group (p<0.0203). The improvement was maintained from the end of the therapy to 3 and 6 months’ follow-up, as measure of VAS score as 30.54±11.8 and 20.2±8.6 respectively (p<0.0001). In normal saline group, there was very slight decrease in VAS score from baseline i.e. 49.8±19.5 to 48±22.7, 44±16.6, and 42±21.7 at 1, 3 and 6 months interval. Conclusion: Platelet rich plasma therapy can provide effective pain control up to 6 months post injection in knee osteoarthritis. Key words: Platelet rich plasma (PRP), Knee osteoarthritis (OA), Pain score

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Efficacy of Text Messaging and Personal Consultation by Pharmacy Students Among Adults With Hypertension: Randomized Controlled Trial (Preprint)

10.2196/preprints.16019 ◽

2019 ◽

Author(s):

Panpan Zhai ◽

Khezar Hayat ◽

Wenjing Ji ◽

Qian Li ◽

Li Shi ◽

...

Keyword(s):

Medication Adherence ◽

Text Messaging ◽

Controlled Trial ◽

Intervention Group ◽

Text Messages ◽

Chinese Patients ◽

Control Group ◽

To Receive ◽

Sms Text Messaging

BACKGROUND Hypertension is one of the leading risk factors for ischemic heart diseases, and high rates of hypertension prevalence have either remained the same or increased in developing countries in recent years. Unfortunately, about 20% to 50% of patients with chronic diseases have been nonadherent to their drug therapy. SMS text messaging and pharmacy student–led consultations have the potential to help patients manage their blood pressure (BP). OBJECTIVE The aim of this study was to assess the effectiveness, feasibility, and acceptability of SMS text messaging and consultation to manage the BP of Chinese patients with hypertension. METHODS We conducted a two-arm cluster randomized controlled trial among patients with hypertension in Xi’an City, Shaanxi Province, China, and recruited 384 patients from 8 community health care centers. Patients were randomized into an intervention group to receive SMS text messages and consultations or into a control group to receive usual care for 3 months. We sent SMS text messages at 3-day intervals and collected data at baseline (including demographics, clinical outcomes, medication complexity, side effects, patient behavior, knowledge about hypertension, BP, and medication adherence) and the 3-month follow-up (including BP, medication adherence, and knowledge about hypertension). RESULTS We assessed 445 patients with hypertension and excluded 61 patients who were not eligible or who had not filled out their questionnaires. The mean age of the patients was 68.5 (SD 7.9) years in the intervention group and 69.4 (SD 9.7) years in the control group, and the sample was primarily female (265/384, 69.0%). Patients in the intervention group showed significant improvements in systolic BP (SBP; mean 134.5 mm Hg, SD 15.5 mm Hg vs mean 140.7 mm Hg, SD 15.2 mm Hg; P=.001), medication adherence (mean 7.4, SD 1.2 vs mean 7.0, SD 1.3; P=.04), and knowledge about hypertension (mean 6.3, SD 0.9 vs mean 5.9, SD 1.2; P=.004) compared with those in the control group. In measures of diastolic BP (DBP), the two arms showed nonsignificant improvements (mean 78.2 mm Hg, SD 9.0 mm Hg vs mean 77.2 mm Hg, SD 10.3 mm Hg; P=.06). In total, 176 patients had controlled BP at the 3-month follow-up (98 patients in the intervention group vs 78 patients in the control group), but it was nonsignificant (P=.08). CONCLUSIONS The use of SMS text messaging and consultation to manage SBP and improve medication adherence is effective, feasible, and acceptable among Chinese patients with hypertension, although a significant difference was not observed with regard to DBP. It is important to maximize the potential of SMS text messaging and consultation by increasing the feasibility and acceptance of mobile interventions and conduct a cost-effectiveness analysis on this method. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR1900026862; http://www.chictr.org.cn/showproj.aspx?proj=42717.

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Early home-supported discharge for patients with stroke in Portugal: a randomised controlled trial

Clinical Rehabilitation ◽

10.1177/0269215515627282 ◽

2016 ◽

Vol 31 (2) ◽

pp. 197-206 ◽

Cited By ~ 9

Author(s):

Silvina Santana ◽

José Rente ◽

Conceição Neves ◽

Patrícia Redondo ◽

Nina Szczygiel ◽

...

Keyword(s):

Stroke Unit ◽

Controlled Trial ◽

Functional Independence Measure ◽

Functional Independence ◽

Primary Outcome Measure ◽

Control Group ◽

Stroke Patients ◽

Control Groups ◽

Open Label

Objective: To evaluate an early home-supported discharge service for stroke patients. Design: We carried out a prospective, randomised, open-label, blinded-endpoint trial (allocation ratio of 1:1) with patients assigned to either an early home-supported discharge service or usual care. Setting: The study was undertaken in Aveiro, Portugal, between April 2009 and April 2013. Subjects: We included stroke patients aged 25–85 years admitted to the stroke unit with an initial Functional Independence Measure of up to 100, who gave informed consent. Interventions: Patients in the early home-supported discharge group began their rehabilitation intervention in the stroke unit and the early home-supported discharge team worked with them at home for a maximum of one month. Patients in the control group received usual services. Main measures: The primary outcome measure was the Functional Independence Measure at six months after stroke. Results: We randomised 190 patients of whom 34 were lost to follow-up. There were no significant differences (p > 0.5) in the average scores of Functional Independence Measure between the early home-supported discharge (69 ±22; mean ±SD) and the control groups (71 ±17) measured at baseline; and between the early home-supported discharge (107 ±20) and the control groups (107 ±25) measured at six months. The number of individuals with a low Functional Independence Measure score (<60) in the early home-supported discharge group compared with the control group was higher at admission (34/95 vs. 26/95) and lower at follow-up (2/74 vs. 5/78). Conclusions: It was feasible to implement early home-supported discharge procedures in a Southern European setting, but we have not shown convincing differences in disability at six months.

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Efficacy Of Mobile Phone Use On Adherence To Nevirapine Prophylaxis And Retention In Care Among The HIV-Exposed Infants In Prevention Of Mother To Child Transmission Of HIV: A Randomized Controlled Trial

10.21203/rs.3.rs-47935/v1 ◽

2020 ◽

Author(s):

Lilian Maureen Nyatichi Kebaya ◽

Dalton Wamalwa ◽

Nyambura Kariuki ◽

Bashir Admani ◽

Philip Ayieko ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Retention In Care ◽

Control Group ◽

Hiv Exposed Infants ◽

Randomized Controlled ◽

Phone Calls ◽

Hiv Exposed ◽

To Receive

Abstract Background: HIV is a major contributor to infant mortality. A significant gap remains between the uptake of infant and maternal antiretroviral regimens and only a minority of HIV-exposed infants receives prophylaxis and safe infant feeding. Losses to follow-up of HIV-exposed infants are associated with shortcomings of facility-based PMTCT models with weak community support of linkages. Use of mobile phones offers an opportunity to improving care and promoting retention for the mother-baby pairs and achievement of an HIV-free generation.Objectives: To compare self-reported adherence to infant Nevirapine (NVP) prophylaxis and retention in care over 10 weeks in HIV exposed infants randomized to 2-weekly mobile phone calls (intervention) versus no phone calls (control).Design: Open label Randomized controlled trial Methods: One hundred and fifty HIV infected women drawn from 3 health facilities in Western Kenya and their infants were randomly assigned to receive either phone-based reminders on PMTCT messages or standard health care messages (no calls) within 24 hours of delivery. Women in the intervention arm continued to receive fortnightly phone calls. At 6- and 10-weeks following randomization we collected data on infant adherence to Nevirapine, mode of infant feeding, early HIV testing and retention in care in both study arms. All analyses were intention to treat.Results: At 6 weeks follow-up, 90.7% (n = 68) of participants receiving phone calls reported adherence to infant NVP prophylaxis, compared with 72% (n = 54) of participants in the control group (p = 0.005). Participants in the intervention arm were also significantly more likely to remain in care than participants in the control group [78.7% (n = 59) vs. 58.7% (n = 44), p = 0.009 at 6 weeks and 69.3% (n = 52) vs. 37.3% (n = 28), p < 0.001 at 10 weeks].Conclusions: These results suggest that phone calls are potentially an important tool to improve adherence to infant NVP prophylaxis and retention in care for HIV-exposed infants.Trial registration: PACTR202007654729602. Registered 6 June 2018 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3449

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A Trial Protocol for the Effectiveness of Digital Interventions for Preventing Depression in Adolescents: The Future Proofing Study

10.21203/rs.2.14135/v2 ◽

2019 ◽

Author(s):

Aliza Werner-Seidler ◽

Kit Huckvale ◽

Mark E. Larsen ◽

Alison L. Calear ◽

Kate Maston ◽

...

Keyword(s):

Large Scale ◽

Controlled Trial ◽

Control Group ◽

School Students ◽

Mixed Effect ◽

School Based ◽

Cognitive Behaviour ◽

The Future ◽

To Receive

Abstract Background Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programs. However, barriers to implementing and accessing these programs remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programs. The Future Proofing Study is a large-scale school-based trial investigating whether Cognitive Behaviour Therapies (CBT) delivered by smartphone application can prevent depression.Methods A randomized controlled trial targeting up to 20,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomized at the cluster level to receive either the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level RCT (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur at post-intervention (both trial stages), and at 6, 12, 24, 36, 48- and 60-months post-baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed effect models.Discussion This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programs should be deployed in school-based settings in Australia and beyond.

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