Randomised controlled study of two counselling models at the Swedish alcohol helpline: Effectiveness and sustainability outcomes at 12-month follow-up

Aim: This two-arm parallel randomised controlled trial explored the effectiveness of a brief counselling model compared with the usual multi-session counselling at an alcohol telephone helpline. Methods: A total of 320 callers who contacted the Swedish Alcohol Helpline (SAH) because of hazardous or harmful alcohol use were randomised to either brief structured intervention (self-help booklet plus one proactive call) or usual care (multi-session telephone counselling). The primary outcome was a downward shift in risk level at 12-month follow-up compared with baseline, based on self-reports. Sustained risk level reduction throughout the whole follow-up was also assessed as secondary outcome. Results: Both interventions were significantly associated with a shift to a lower level of risky alcohol use (75% among participants in the brief structured intervention, and 70% in the usual care group) after 12 months. There was no difference between the two interventions in the proportions changing alcohol use or sustaining risk level reduction. Conclusion: In the context of telephone helplines, minimal and extended interventions appear to be equally effective in promoting long-term change in alcohol use.

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Improving Follow-Up Adherence in a Primary Eye Care Setting

American Journal of Medical Quality ◽

10.1177/1062860615616860 ◽

2016 ◽

Vol 32 (1) ◽

pp. 73-79 ◽

Cited By ~ 5

Author(s):

Catherine E. Callinan ◽

Brianna Kenney ◽

Lisa A. Hark ◽

Ann P. Murchison ◽

Yang Dai ◽

...

Keyword(s):

Usual Care ◽

Patient Adherence ◽

Intervention Group ◽

Appointment Scheduling ◽

Secondary Outcome ◽

Controlled Study ◽

Care Group ◽

Eye Care ◽

Primary Eye Care

Lack of patient adherence with eye appointments can decrease ocular outcomes. This prospective, randomized, single-blinded controlled study assessed the effectiveness of multiple interventions in improving follow-up adherence to recommended eye appointments. Patients due for follow-up appointments were randomly assigned to usual care, automated intervention, or personal intervention. Automated-intervention patients and personal-intervention patients received a call one month prior to the recommended follow-up date, and a mailed appointment reminder letter. The call was automated for automated-intervention patients and personalized for personal-intervention patients. The primary outcome was adherence to the follow-up appointment. The secondary outcome was rate of appointment scheduling. Patients in the personal-intervention group had greater adherence to follow-up recommendations (38%) than patients in the usual care group (28%) and the automated-intervention group (30%). Personal intervention significantly increased appointment scheduling (51%) over usual care (32%) and automated intervention (36%). These results support systems-level changes to improve patient follow-up adherence in urban primary eye care settings.

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Is reduction of routine radiograph use in patients with distal radius fractures cost effective? Analysis of data from the multicentre, randomised controlled WARRIOR trial

BMJ Open ◽

10.1136/bmjopen-2019-035370 ◽

2020 ◽

Vol 10 (7) ◽

pp. e035370 ◽

Cited By ~ 1

Author(s):

Pieter van Gerven ◽

Johanna M van Dongen ◽

Sidney M Rubinstein ◽

Marco F Termaat ◽

Mostafa El Moumni ◽

...

Keyword(s):

Usual Care ◽

Distal Radius ◽

Cost Effective ◽

Distal Radius Fractures ◽

Care Group ◽

Radius Fractures ◽

Imaging Strategy ◽

The Difference ◽

Randomised Controlled

ObjectiveTo assess the cost effectiveness of a reduced imaging follow-up protocol of distal radius fractures compared with usual care.DesignAn economical evaluation conducted alongside a multicentre randomised controlled trial (RCT).SettingFour level-one trauma centres in the Netherlands.Participants341 patients participated (usual care (n=172), reduced imaging (n=169)).InterventionsPatients were randomised to usual care (routine radiography at 1, 2, 6 and 12 weeks) or a reduced imaging strategy (radiographs at 6 and 12 weeks only for a clinical indication).Outcome measuresFunctional outcome was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and quality-adjusted life years (QALYs) using the EuroQol-5Dimensions-3 Levels (EQ-5D-3L). Costs were measured using self-reported questionnaires and medical records, and analysed from a societal perspective. Multiple imputation, seemingly unrelated regression analysis and bootstrapping were used to analyse the data.ResultsClinical overall outcomes of both groups were comparable. The difference in DASH was −2.03 (95% CI −4.83 to 0.77) and the difference in QALYs was 0.025 (95% CI −0.01 to 0.06). Patients in the reduced imaging group received on average 3.3 radiographs (SD: 1.9) compared with 4.2 (SD: 1.9) in the usual care group. Costs for radiographic imaging were significantly lower in the reduced imaging group than in the usual care group (€−48 per patient, 95% CI −68 to −27). There was no difference in total costs between groups (€−401 per patient, 95% CI −2453 to 1251). The incremental cost-effectiveness ratio (ICER) for QALYs was −15 872; the ICER for the DASH was 198. The probability of reduced imaging being cost effective compared with usual care ranged from 0.8 to 0.9 at a willingness to pay of €20 000/QALY to €80 000/QALY.ConclusionsImplementing a reduced imaging strategy in the follow-up of distal radius fractures has a high probability of being cost effective for QALYs, without decreasing functional outcome. We, therefore, recommend imaging only when clinically indicated.Trial registration numberThe Netherlands trial register (NL4477).

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Impact of a mobile telerehabilitation solution on metabolic health outcomes and rehabilitation adherence in obese patients: a randomised controlled trial (Preprint)

10.2196/preprints.28242 ◽

2021 ◽

Author(s):

François Bughin ◽

Gaspard Bui ◽

Bronia Ayoub ◽

Leo Blervaque ◽

Didier Saey ◽

...

Keyword(s):

Body Composition ◽

Health Outcomes ◽

Usual Care ◽

Metabolic Parameters ◽

Therapeutic Education ◽

Controlled Study ◽

Care Group ◽

Obese Patients ◽

Significant Group ◽

Randomised Controlled

BACKGROUND Obesity is a challenge for public health. Combining exercise training, nutrition and therapeutic education in a metabolic rehabilitation (MR) is recommended for obesity management. Yet, randomized controlled study-based evidences are lacking. In addition MR is associated with poor patient’s adherence. Mobile Health (mHealth) devices improve the access to the MR components. OBJECTIVE Thus, a telerehabilitation (TR) solution could deliver a feasible multidisciplinary MR in obese patients and improve fat mass (FM), metabolic parameters and quality of life versus usual care. METHODS This was a randomised, controlled, parallel-design study. Fifty obese (body mass index BMI > 30 kg/m²) patients were included in a telerehabilitation group (TRG) or a usual care group (UCG) for 12 weeks. Patients underwent biometric impedance analyses, metabolic exercise tests, actimetry, QOL and satisfaction questionnaires. The primary outcome was the changes in body composition. Secondary outcomes were BW, metabolic parameters, exercise capacity, QOL, patient’s adhesion and satisfaction. RESULTS Forty-nine patients completed the study. No significant group*time interaction was found for FM. Compared to UCG, TRG patients significantly improved waist to hip ratio and EQVOD’s physical impact. Significant time effects occurred for body composition, 6MWT distance, exercise metabolism, sedentary time and QOL (p<0,05). Adherence (95%) and satisfaction in the TRG were good. CONCLUSIONS In obese adults, TR was able to deliver a full multidisciplinary rehabilitation in obese patients and improved their health outcomes. Given the patient’s adherence and satisfaction, pragmatic programs should consider mHealth devices to improve the access to MR. Further studies are warranted to establish the additional TR benefits versus usual care. CLINICALTRIAL Mobile Tele-rehabilitation Solution for Obese Patients NCT03396666 https://clinicaltrials.gov/ct2/show/NCT03396666?term=03396666&draw=2&rank=1

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Custom insoles versus sham and GP-led usual care in patients with plantar heel pain: results of the STAP-study - a randomised controlled trial

British Journal of Sports Medicine ◽

10.1136/bjsports-2019-101409 ◽

2020 ◽

pp. bjsports-2019-101409

Author(s):

Nadine Rasenberg ◽

Sita M A Bierma-Zeinstra ◽

Lars Fuit ◽

Michael Skovdal Rathleff ◽

Amy Dieker ◽

...

Keyword(s):

Usual Care ◽

Rating Scale ◽

Numerical Rating Scale ◽

Heel Pain ◽

Secondary Outcome ◽

Care Group ◽

Plantar Heel Pain ◽

Information Booklet ◽

Custom Made

ObjectivesTo compare custom-made insoles to sham insoles and general practice (GP)-led usual care in terms of pain at rest and during activity at 12 weeks follow-up in individuals with plantar heel pain.MethodsIn this randomised clinical trial 185 patients aged 18 to 65 years, with a clinical diagnosis of plantar heel pain for at least 2 weeks, but no longer than 2 years were recruited. Patients were randomly allocated into three groups: (1) GP-led treatment, plus an information booklet with exercises (usual care; n=46), (2) referral to a podiatrist for treatment with a custom-made insole plus an information booklet with exercises (custom-made insole; n=70) and (3) referral to a podiatrist and treatment with a sham insole plus an information booklet with exercises (sham insole; n=69). As well as the primary outcome of pain severity (11-point Numerical Rating Scale) we used the Foot Function Index (0 to 100) as a secondary outcome.ResultsOf 185 randomised participants, 176 completed the 12-week follow-up. There was no difference in pain or function between the insole and the sham groups at 12 weeks. Participants in the GP-led usual care group reported less pain during activity at 12 weeks, (mean difference (MD) 0.94, 95% CI 0.23 to 1.65), less first step pain (MD 1.48, 95% CI 0.65 to 2.31), better function (MD 7.37, 95% CI 1.27 to 13.46) and higher recovery rates (RR 0.48, 95% CI 0.24 to 0.96) compared with participants in the custom insole group.ConclusionsReferral to a podiatrist for a custom-made insole does not lead to a better outcome compared to sham insoles or compared to GP-led usual care.Trial registration numberNTR5346.

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Does MRI add value in general practice for patients with traumatic knee complaints? A 1-year randomised controlled trial

British Journal of Sports Medicine ◽

10.1136/bjsports-2017-098932 ◽

2018 ◽

Vol 53 (20) ◽

pp. 1285-1292 ◽

Cited By ~ 1

Author(s):

Nynke M Swart ◽

Kim van Oudenaarde ◽

Sita MA Bierma-Zeinstra ◽

Hans JL Bloem ◽

Wilbert B van den Hout ◽

...

Keyword(s):

General Practice ◽

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Healthcare Providers ◽

Primary Outcome Measure ◽

Care Group ◽

Randomised Controlled ◽

Daily Function

ObjectiveTo determine whether referral to MRI by the general practitioner (GP) is non-inferior to usual care (no access to MRI by GPs) in patients with traumatic knee complaints regarding knee-related daily function.MethodsThis was a multicentre, non-inferiority randomised controlled trial with 1-year follow-up. GPs invited eligible patients during or after their consultation. Eligible patients (18–45 years) consulted a GP with knee complaints due to a trauma during the previous 6 months. Patients allocated to the MRI group received an MRI at (median) 7 (IQR 1–33) days after the baseline questionnaire. Patients in the usual care group received information on the course of knee complaints, and a referral to a physiotherapist or orthopaedic surgeon when indicated. The primary outcome measure was knee-related daily function measured with the Lysholm scale (0 to 100; 100=excellent function) over 1 year, with a non-inferiority margin of 6 points.ResultsA total of 356 patients were included and randomised to MRI (n=179) or usual care (n=177) from November 2012 to December 2015. MRI was non-inferior to usual care concerning knee-related daily function during 1-year follow-up, for the intention-to-treat (overall adjusted estimate: 0.33; 95% CI −1.73 to 2.39) and per-protocol (overall adjusted estimate: 0.06; 95% CI −2.08 to 2.19) analysis. There were no differences between both groups in the amount of patients visiting other healthcare providers.ConclusionMRI in general practice in patients with traumatic knee complaints was non-inferior to usual care regarding knee-related daily function during 1-year follow-up.Trial registration numberNTR3689.

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PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽

10.1136/bmjopen-2021-050582 ◽

2021 ◽

Vol 11 (6) ◽

pp. e050582

Author(s):

Annette Mollerup ◽

Sofus Christian Larsen ◽

Anita Selmer Bennetzen ◽

Marius Henriksen ◽

Mette Kildevaeld Simonsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Hospital Admission ◽

Usual Care ◽

Pulmonary Disease ◽

Controlled Trial ◽

Self Care ◽

Secondary Outcome ◽

Link Type ◽

Randomised Controlled ◽

At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

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Metformin and N-acetyl Cysteine in Polycystic Ovarian Syndrome–-A Comparative Study

Indian Journal of Clinical Medicine ◽

10.1177/117739361000100002 ◽

2010 ◽

Vol 1 ◽

pp. 117739361000100 ◽

Cited By ~ 5

Author(s):

Kar Gayatri ◽

Jena Saubhagya Kumar ◽

Behera Basanta Kumar

Keyword(s):

Outcome Measures ◽

Clinical Features ◽

Polycystic Ovarian Syndrome ◽

Secondary Outcome ◽

Controlled Study ◽

Chi Square ◽

Hormonal Profile ◽

Acetyl Cysteine ◽

Randomised Controlled ◽

Ovarian Syndrome

Objective To compare the effects of Metformin with N-acetyl cysteine in polycystic ovarian syndrome (PCOS). Methods A prospective, randomised controlled study was conducted in the Department of Obstetrics and Gynaecology in a Medical College and General Hospital. Total 115 cases of polycystic ovarian syndrome presenting with different complaints were selected for the study. Fifty nine cases were treated with Metformin (Group-M) and other 56 with N-acetyl cysteine (Group-N). Primary outcome measures are improvement in clinical features and biochemical profile, where as secondary outcome measures are improvement in hormonal profile and ultrasonographic findings. Statistical analysis was done by Z test and Chi square test. Results From each group, 50 patients were ultimately evaluated. There was significant improvement in some of the clinical features like weight gain, acne and hirsutism in group-N ( P < 0.05), but there was no significant change in other features like oligomenorrhea, amenorrhoea and infertility. The biochemical markers of insulin resistance like fasting insulin, fasting glucose/insulin ratio and HOMA-IR were significantly reduced in group-N. Hormone levels like serum LH, FSH, TT and LH/FSH ratio was significantly decreased in group-N, but FT, FT/TT ratio and SHBG were similar in both the groups. Ultrasonographic findings were similar in both the groups. Conclusion N-acetyl Cysteine had better improvement in clinical, biochemical and hormonal profile than Metformin in PCOS patients. It can be used as a substitute for insulin reducing medications in treatment of PCOS patients, considering its limited adverse effects.

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Long-term outcome of two forms of randomised benzodiazepine discontinuation

The British Journal of Psychiatry ◽

10.1192/bjp.bp.105.012039 ◽

2006 ◽

Vol 188 (2) ◽

pp. 188-189 ◽

Cited By ~ 19

Author(s):

R. C. Oude Voshaar ◽

W. J. M. J. Gorgels ◽

A. J. J. Mol ◽

A. J. L. M. Van Balkom ◽

J. Mulder ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Term Outcome ◽

Long Term Outcome ◽

Randomised Controlled

SummaryAbouttwo-thirds of long-term users of benzodiazepines in the population are able to discontinue this drug with the aid of supervised programmes for tapering off. Little is known about the long-term outcome of such programmes, and they have never been compared with usual care. After a 15-month follow-up of a randomised controlled trial comparing such a programme with and without psychotherapy with usual care, we found significantly higher longitudinal abstinence rates in long-term benzodiazepine users who received a benzodiazepine tapering-off programme without psychotherapy (25 out of 69, 36%) compared with those who received usual care (5 out of 33, 15%; P=0.03).

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Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study)

10.21203/rs.2.328/v1 ◽

2019 ◽

Author(s):

Jeanette Trøstrup ◽

Lone Ramer Mikkelsen ◽

Poul Frost ◽

Annett Dalbøge ◽

Mette Terp Høybye ◽

...

Keyword(s):

Usual Care ◽

Mixed Model ◽

Exercise Intervention ◽

Randomised Trial ◽

Self Report ◽

Controlled Study ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

First Choice ◽

Randomised Controlled

Abstract Background: In Denmark, exercise therapy in combination with work modifications is the first choice treatment for persons with shoulder complaints and high occupational shoulder exposures. To obtain this treatment they must visit several healthcare providers, which makes usual care fragmented and uncoordinated. Therefore, we developed a new intervention which unifies the expertise that is needed. The main hypotheses are that a group-based Shoulder-Café intervention will reduce (I) shoulder complaints and (II) occupational shoulder exposures more effectively than an individual-based Shoulder-Guidance intervention (active control – enhanced usual care). Methods: A cluster-randomised trial is conducted including 120 employees with high occupational shoulder exposures. Companies (clusters) are randomised to either Shoulder-Café or Shoulder-Guidance with a 1:1 allocation ratio. Participants are 18–65 years old and have an Oxford Shoulder Score (OSS) ≤ 40. Both interventions include a home-based shoulder exercise programme, assessment of shoulder exposures by technical measurements and self-report, and general information on how to reduce shoulder exposures. The Shoulder-Café course also includes three café meetings with physiotherapist-supervised exercises, clinical shoulder evaluation, education on shoulder anatomy, workplace-oriented counselling, and an opportunity for a workplace visit by a health and safety consultant. The primary outcomes are the OSS at 6 month follow-up (hypothesis I), and the mean number of minutes/day with the arm elevated > 60° shortly after end of intervention (hypothesis II). We will use mixed model analysis that allows for company clustering, and data will be analysed according to the intention-to-treat principle. Discussion: Persons with shoulder complaints and high occupational shoulder exposures are an obvious target group for secondary prevention efforts. We developed the Shoulder-Café to reduce shoulder complaints and shoulder exposures while unifying the expertise that is needed to evaluate and treat shoulder complaints. If the intervention is effective, it would warrant widespread implementation. Trial registration: The trial was registered at Clinicaltrials.gov on 18 May 2017 (ID: NCT03159910). Keywords: Exercise, Intervention, Mechanical exposure, Occupation, Randomised controlled trial, Shoulder, Training programme.

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The Natural History of Back Pain after a Randomised Controlled Trial of Acupuncture Vs Usual Care – Long Term Outcomes

Acupuncture in Medicine ◽

10.1136/aim.25.4.121 ◽

2007 ◽

Vol 25 (4) ◽

pp. 121-129 ◽

Cited By ~ 6

Author(s):

Stephanie L Prady ◽

Kate Thomas ◽

Lisa Esmonde ◽

Simon Crouch ◽

Hugh MacPherson

Keyword(s):

Back Pain ◽

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Bodily Pain ◽

Care Group ◽

Long Term Outcomes ◽

Short Term Treatment ◽

Randomised Controlled

Introduction There is growing evidence about the effectiveness of acupuncture in the short term treatment of chronic low back pain but little is known about long term outcomes. To address this question we followed up participants of a past randomised controlled trial of acupuncture to assess outcomes after 5.5 to 7 years. Methods A postal questionnaire assessing pain, quality of life, disability, experience with back pain and healthcare resource use was sent to all 239 participants of the York Acupuncture for Back Pain trial. Results Response to the survey was low at 43.9%. Pain measured by the SF-36 Bodily Pain dimension was maintained in the acupuncture group since the last follow up 3.5 to 5 years previously. The usual care group had improved over the intervening years and there was now no evidence of a difference between the groups (difference −0.4 points, 95% confidence interval −10.1 to 9.7). The results were unchanged on sensitivity analysis using multiple imputation. In both groups back pain had not completely resolved and worry about back health was moderate. Physiotherapy and acupuncture were used at similar rates for continuing treatment. Discussion We theorise that exposure to a short course of acupuncture speeds natural recovery from a back pain episode, but improvements plateau after two years. Acupuncture is often accessed privately for long term management of back pain but is rarely available within the health service. While our study methods were robust, the low response rate means that our findings should be interpreted with caution.

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