scholarly journals P001 IS PROPHYLACTIC MESH IS ROUTINELY REQUIRED FOR STOMA CONSTRUCTION? IDENTIFICATION OF THE ‘TARGET GROUP’

2021 ◽  
Vol 108 (Supplement_8) ◽  
Author(s):  
Ahmed Hassan ◽  
Wei Toh ◽  
James Ayathamattam ◽  
Zachary Thomas ◽  
Ondrej Ryska
Keyword(s):  
Controlled Trial ◽  
Cost Benefit ◽  
Prophylactic Mesh ◽  
Nice Guidelines ◽  
Prophylactic Measures ◽  
Increased Risk ◽  
End Colostomy ◽  
Randomised Controlled

Abstract Background Evidence to support routine prophylactic mesh insertion during stoma construction is conflicting. The PREVENT randomised controlled trial (RCT) suggested lower incidence of parastomal hernia (PSH) with prophylactic mesh but with no quality of life or cost benefit. Another two RCTs has shown no prophylactic benefit (STOMAMESH & STOMA-const). Although European Hernia guidelines recommends routine prophylactic mesh in end-colostomy, NICE guidelines suggest mesh on individual basis not routinely. Aim To identify the group with higher risk to develop a symptomatic PSH when prophylactic mesh should be considered Material and Methods A single center retrospective review of all stoma formed. Younger patient than 18 years and patients who had less than 6 months’ follow-up were excluded. Development of PSH was confirmed by radiological evidence or direct intra-operative visualization Results 194 patients between January 2015 till December 2019 were included with mean follow-up of 15.7±13.5 months where 91 patients developed PSH. On multivariate analysis, older age (>65) (OR 2.3, 95% CI 1.08 – 4.99, p 0.03) and Obesity (OR 5.8, 95% CI 2.53 – 13.57, p 0.00) were risk factors of developing PSH. Among the PSH group, 28 were symptomatic (31%). Symptomatic subgroup had higher ASA (ASA >2) than asymptomatic subgroup (50% Vs 27%, p 0.05) Conclusions Obese patients older than 65 years are at increased risk of PSH. IF their ASA >2 this PSH is likely to become symptomatic. This is the group who should benefit the most from prophylactic measures including mesh insertion and should be targeted for future trials

The Nature stroke study; NASTRU - A randomised controlled trial of nature-based post-stroke fatigue rehabilitation

2019 ◽  
Author(s):  
Anna María Pálsdóttir ◽  
Kjerstin Stigmar ◽  
Bo Norrving ◽  
Patrik Grahn ◽  
Ingemar F Petersson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Perceived Value ◽  
Control Group ◽  
Post Stroke ◽  
Randomised Controlled

Abstract Fatigue is common after stroke and contributes to disability and impaired quality of life. Currently, there is insufficient evidence on the efficacy of any intervention for post-stroke fatigue. The aim of the study was to examine whether 10 weeks Nature-based rehabilitation (NRB) as add-on to standard care may improve post-stroke fatigue, perceived value of everyday occupations, function, activity and participation compared to standard care only (Clinical Trial.gov Identifier: NCT02435043, 2012/352, 05-06-2015). The study was carried out as a single blinded two-armed randomised controlled trial. Stroke survivors identified through routine 3-month follow-up visit (sub-acute) or medical records (chronic stroke > 1 year earlier) were randomised to Standard care + NBR or Standard care only. Blinded evaluations were conducted at follow-up 8 and 14 months after randomisation. The primary outcomes were post-stroke fatigue (Mental Fatigue Scale, total score) and perceived value of everyday occupations (Oval-pd) 8 months after randomisation. About a quarter of the screened patients were eligible; half accepted to participate and 101 were randomised, mean age 67 years, 60% female. The patients with sub-acute stroke were highly compliant with the intervention. Fatigue decreased to a value below the suggested cut-off for mental fatigue (<10.5) in the intervention group but not in the control group; no statistically significant differences were found though between the groups. Conclusion: NASTRU is the first randomised study on NBR for patients with post stroke fatigue. NBR was feasible and well tolerated. The study was underpowered due to difficulties in recruiting participants. No significant differences were detected between intervention and control group. A larger RCT is warranted. Keywords: clinical trial, enriched environment, everyday occupations, horticulture therapy, quality of life.

scholarly journals Evaluation of a positive psychotherapy group intervention for people with psychosis: pilot randomised controlled trial

2015 ◽  
Vol 25 (3) ◽  
pp. 235-246 ◽  
Author(s):  
Beate Schrank ◽  
Tamsin Brownell ◽  
Zivile Jakaite ◽  
Charley Larkin ◽  
Francesca Pesola ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Group Intervention ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Self Esteem ◽  
Positive Psychotherapy ◽  
Main Effect ◽  
Randomised Controlled

Aims.Third-wave psychological interventions have gained relevance in mental health service provision but their application to people with psychosis is in its infancy and interventions targeting wellbeing in psychosis are scarce. This study tested the feasibility and preliminary effectiveness of positive psychotherapy adapted for people with psychosis (WELLFOCUS PPT) to improve wellbeing.Methods.WELLFOCUS PPT was tested as an 11-week group intervention in a convenience sample of people with psychosis in a single centre randomised controlled trial (ISRCTN04199273) involving 94 people with psychosis. Patients were individually randomised in blocks to receive either WELLFOCUS PPT in addition to treatment as usual (TAU), or TAU only. Assessments took place before randomisation and after the therapy. The primary outcome was wellbeing (Warwick-Edinburgh Mental Well-Being Scale, WEMWBS). Secondary outcomes included symptoms (Brief Psychiatric Rating Scale), depression (Short Depression-Happiness Scale), self-esteem, empowerment, hope, sense of coherence, savouring beliefs and functioning, as well as two alternative measures of wellbeing (the Positive Psychotherapy Inventory and Quality of Life). Intention-to-treat analysis was performed. This involved calculating crude changes and paired-sample t-tests for all variables, as well as ANCOVA and Complier Average Causal Effect (CACE) Analysis to estimate the main effect of group on all outcomes.Results.The intervention and trial procedures proved feasible and well accepted. Crude changes between baseline and follow-up showed a significant improvement in the intervention group for wellbeing according to all three concepts assessed (i.e., WEMWBS, Positive Psychotherapy Inventory and Quality of Life), as well as for symptoms, depression, hope, self-esteem and sense of coherence. No significant changes were observed in the control group. ANCOVA showed no main effect on wellbeing according to the primary outcome scale (WEMWBS) but significant effects on symptoms (p = 0.006, ES = 0.42), depression (p = 0.03, ES = 0.38) and wellbeing according to the Positive Psychotherapy Inventory (p = 0.02, ES = 0.30). Secondary analysis adapting for therapy group further improved the results for symptom reduction (p = 0.004, ES = 0.43) and depression (p = 0.03, ES = 0.41) but did not lead to any more outcomes falling below the p = 0.05 significance level. CACE analysis showed a non-significant positive association between the intervention and WEMWBS scores at follow-up (b = 0.21, z = 0.9, p = 0.4).Conclusions.This study provides initial evidence on the feasibility of WELLFOCUS PPT in people with psychosis, positively affecting symptoms and depression. However, more work is needed to optimise its effectiveness. Future research might evaluate positive psychotherapy as a treatment for comorbid depression in psychosis, and consider alternative measurements of wellbeing.

scholarly journals Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial

Thorax ◽  
2020 ◽  
Vol 75 (5) ◽  
pp. 413-421 ◽  
Author(s):  
Henrik Hansen ◽  
Theresa Bieler ◽  
Nina Beyer ◽  
Thomas Kallemose ◽  
Jon Torgny Wilcke ◽  
...  
Keyword(s):  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Drop Out ◽  
Group Differences ◽  
Primary Analysis ◽  
Intention To Treat ◽  
Registration Number ◽  
Randomised Controlled

RationalePulmonary rehabilitation (PR) is an effective, key standard treatment for people with COPD. Nevertheless, low participant uptake, insufficient attendance and high drop-out rates are reported. Investigation is warranted of the benefits achieved through alternative approaches, such as pulmonary tele-rehabilitation (PTR).ObjectiveTo investigate whether PTR is superior to conventional PR on 6 min walk distance (6MWD) and secondarily on respiratory symptoms, quality of life, physical activity and lower limb muscle function in patients with COPD and FEV1 <50% eligible for routine hospital-based, outpatient PR.MethodsIn this single-blinded, multicentre, superiority randomised controlled trial, patients were assigned 1:1 to 10 weeks of groups-based PTR (60 min, three times weekly) or conventional PR (90 min, two times weekly). Assessments were performed by blinded assessors at baseline, end of intervention and at 22 weeks’ follow-up from baseline. The primary analysis was based on the intention-to-treat principle.Measurements and main resultsThe primary outcome was change in 6MWD from baseline to 10 weeks; 134 participants (74 females, mean±SD age 68±9 years, FEV1 33%±9% predicted, 6MWD 327±103 metres) were included and randomised. The analysis showed no between-group differences for changes in 6MWD after intervention (9.2 metres (95% CI: −6.6 to 24.9)) or at 22 weeks’ follow-up (−5.3 metres (95% CI: −28.9 to 18.3)). More participants completed the PTR intervention (n=57) than conventional PR (n=43) (χ2 test p<0.01).ConclusionPTR was not superior to conventional PR on the 6MWD and we found no differences between groups. As more participants completed PTR, supervised PTR would be relevant to compare with conventional PR in a non-inferiority design.Trial registration numberClinicalTrials.gov (NCT02667171), 28 January 2016.

scholarly journals Randomised controlled feasibility trial of real versus sham repetitive transcranial magnetic stimulation treatment in adults with severe and enduring anorexia nervosa: the TIARA study

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021531 ◽  
Author(s):  
Bethan Dalton ◽  
Savani Bartholdy ◽  
Jessica McClelland ◽  
Maria Kekic ◽  
Samantha J Rennalls ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Anorexia Nervosa ◽  
Eating Disorder ◽  
Magnetic Stimulation ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Controlled Trial ◽  
Eating Disorder Symptoms ◽  
Randomised Controlled

ObjectiveTreatment options for severe, enduring anorexia nervosa (SE-AN) are limited. Non-invasive neuromodulation is a promising emerging intervention. Our study is a feasibility randomised controlled trial of repetitive transcranial magnetic stimulation (rTMS) in individuals with SE-AN, which aims to inform the design of a future large-scale trial.DesignDouble-blind, parallel group, two-arm, sham-controlled trial.SettingSpecialist eating disorders centre.ParticipantsCommunity-dwelling people with anorexia nervosa, an illness duration of ≥3 years and at least one previous completed treatment.InterventionsParticipants received 20 sessions (administered over 4 weeks) of MRI-guided real or sham high-frequency rTMS to the left dorsolateral prefrontal cortex in addition to treatment-as-usual.OutcomesPrimary outcomes were recruitment, attendance and retention rates. Secondary outcomes included body mass index (BMI), eating disorder symptoms, mood, quality of life and rTMS safety and tolerability. Assessments were conducted at baseline, post-treatment and follow-up (ie, at 0 month, 1 month and 4 months post-randomisation).ResultsThirty-four participants (17 per group) were randomly allocated to real or sham rTMS. One participant per group was withdrawn prior to the intervention due to safety concerns. Two participants (both receiving sham) did not complete the treatment. rTMS was safe and well tolerated. Between-group effect sizes of change scores (baseline to follow-up) were small for BMI (d=0.2, 95% CI −0.49 to 0.90) and eating disorder symptoms (d=0.1, 95% CI −0.60 to 0.79), medium for quality of life and moderate to large (d=0.61 to 1.0) for mood outcomes, all favouring rTMS over sham.ConclusionsThe treatment protocol is feasible and acceptable to participants. Outcomes provide preliminary evidence for the therapeutic potential of rTMS in SE-AN. Largest effects were observed on variables assessing mood. This study supports the need for a larger confirmatory trial to evaluate the effectiveness of multi-session rTMS in SE-AN. Future studies should include a longer follow-up period and an assessment of cost-effectiveness.Trial registration numberISRCTN14329415; Pre-results.

scholarly journals The Effect of Non-Supervised Physical Activity Before and After Breast Cancer Surgery on Quality of Life; Follow-Up Results From a Randomised Controlled Trial (Physsurg-b)

2021 ◽  
Author(s):  
Jenny Eva Maria Heiman ◽  
Aron Onerup ◽  
David Bock ◽  
Eva Haglind ◽  
Roger Olofsson Bagge
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Physical Activity ◽  
Adjuvant Chemotherapy ◽  
Controlled Trial ◽  
Breast Cancer Surgery ◽  
Before And After ◽  
Randomised Controlled

Abstract PurposeWe conducted a randomised controlled trial (PhysSURG-B) to assess the short- and long-term effects of a non-supervised physical activity intervention at the time of breast cancer surgery. Here we report a secondary outcome, quality of life (QoL).MethodsFemale patients planned for surgery were randomly assigned to either an intervention of 30 minutes of self-administered physical aerobic activity daily 2 weeks before and 4 weeks after surgery, or control. QoL was assessed with questionnaires at baseline, 4 weeks and 12 months postop using the instruments FACT-B, RAND-36 and EQ-VAS.ResultsOut of 354 included participants at 12 months follow-up after surgery, 287 were available for QoL analysis. Comparing intervention to control, the results for the FACT- B score at 4 weeks showed an odds ratio (OR) of 0.975 (95% CI 0.636-1.495) and at 12 months an OR of 0.883 (95% CI 0.581-1.342). The subgroup of patients receiving adjuvant chemotherapy had significantly lower FACT-B at 12 months compared to no chemotherapy (OR 0.475, 95% CI 0.300-0.735). EQ-VAS showed OR 1.163 (95% CI 0.760-1.779) and 0.817 (95% CI 0.536-1.244) at 4 weeks and 12 months, respectively. RAND-36 domains “role limitations due to physical health” and “pain” showed a decrease at 4 weeks in both groups, returning towards baseline at 12 months follow-up.ConclusionAn intervention of non-supervised physical activity before and after surgery for breast cancer had no effect on QoL. Patients receiving adjuvant chemotherapy had significantly lower QoL, regardless of study group.Trial registrationClinicalTrials.gov registration number: NCT 02560662. Registered 25 September, 2015.

scholarly journals Adherence therapy for people with schizophrenia

2006 ◽  
Vol 189 (6) ◽  
pp. 508-514 ◽  
Author(s):  
Richard Gray ◽  
Morven Leese ◽  
Jonathan Bindman ◽  
Thomas Becker ◽  
Lorenzo Burti ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Education ◽  
Controlled Trial ◽  
Clinical Settings ◽  
Clinical Instability ◽  
Randomised Controlled ◽  
To Receive ◽  
Adherence Therapy

BackgroundThere is equivocal evidence of the effectiveness of adherence therapy in improving treatment adherence and clinical outcomes for people with schizophrenia.AimsTo evaluate the effectiveness of adherence therapy in improving quality of life for people with schizophrenia.MethodA 52-week, single-blind, multicentre randomised controlled trial of the effectiveness of adherence therapy. Participants were individually randomised to receive eight sessions of adherence therapy or health education. Assessments were undertaken at baseline and at 52-week follow-up.ResultsAdherence therapy was no more effective than health education in improving quality of life.ConclusionsThis effectiveness trial provides evidence for the lack of effect of adherence therapy in people with schizophrenia with recent clinical instability, treated in ordinary clinical settings.

scholarly journals TELEmedicine for EPIlepsy Care (TELE-EPIC): protocol of a randomised, open controlled non-inferiority clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053980
Author(s):  
Laura Licchetta ◽  
Marina Trivisano ◽  
Elisa Baldin ◽  
Susan Mohamed ◽  
Emanuel Raschi ◽  
...  
Keyword(s):  
Seizure Control ◽  
Controlled Trial ◽  
Complete Information ◽  
Video Consultation ◽  
Registration Number ◽  
Health Institutions ◽  
Potential Impact ◽  
Randomised Controlled

IntroductionEpilepsy is a chronic condition requiring consistent follow-up aimed at seizure control, and monitoring of anti-seizure medication (ASM) levels and side effects. Telemedicine (TM) offers invaluable support to patient follow-up, guaranteeing the prompt availability of a team of experts for persons with epilepsy (PWE) widely distributed across the country. Although many health institutions have endorsed the use of TM, robust data on effectiveness, safety and costs of TM applied to epilepsy are lacking. TELEmedicine for EPIlepsy Care (TELE-EPIC) will evaluate the effectiveness of video consultation (VC) via TM compared with usual care (UC) for the monitoring of PWE (TELE-EPIC_RCT). Moreover, TELE-EPIC will apply an innovative Volumetric Absorptive Microsampling (VAMS) device for quantitation of ASM through finger prick blood sampling as an alternative to venipuncture sampling (TELE-EPIC_VAMS).Methods and analysisTELE-EPIC_RCT is a multicentre, open, pragmatic two-arm randomised controlled trial prospectively including adult and paediatric outpatients with established diagnosis of epilepsy consecutively attending the Epilepsy Centres of Bologna and Rome, respectively. The primary outcome is the non-inferiority of VC on seizure control compared with UC after an 18-month follow-up. Secondary outcomes are adherence to treatment, ASM-related adverse events, quality of life, mood disorders, patient and caregiver satisfaction, safety and costs. TELE-EPIC_VAMS is a cross-validation study for blood ASM quantitation through a novel, VAMS-based device, comparing (1) VAMS versus plasma samples (reference standard method); and (2) nurse-collected versus self-collected blood by VAMS device.Ethics and disseminationThe study has been approved by the local ethics committee (349-2019-SPER-AUSLBO). Complete information about the state of project, relevant events and results will be regularly updated on the project’s webpage on ClinicalTrials.gov. The project’s results and data on the potential impact of TM in epilepsy will be disseminated on social media. A closeout meeting will be convened for the communication and dissemination of the project, highlighting its main achievements and impacts.Trial registration numberNCT04496310

scholarly journals Self-Management education for adults with poorly controlled epILEpsy [SMILE (UK)]: a randomised controlled trial

2018 ◽  
Vol 22 (21) ◽  
pp. 1-142 ◽  
Author(s):  
Leone Ridsdale ◽  
Alison McKinlay ◽  
Gabriella Wojewodka ◽  
Emily J Robinson ◽  
Iris Mosweu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Management Education ◽  
Controlled Trial ◽  
Health Technology ◽  
Self Management ◽  
Depression Symptoms ◽  
Randomised Controlled

BackgroundEpilepsy is a common neurological condition resulting in recurrent seizures. Research evidence in long-term conditions suggests that patients benefit from self-management education and that this may improve quality of life (QoL). Epilepsy self-management education has yet to be tested in a UK setting.ObjectivesTo determine the effectiveness and cost-effectiveness of Self-Management education for people with poorly controlled epILEpsy [SMILE (UK)].DesignA parallel pragmatic randomised controlled trial.SettingParticipants were recruited from eight hospitals in London and south-east England.ParticipantsAdults aged ≥ 16 years with epilepsy and two or more epileptic seizures in the past year, who were currently being prescribed antiepileptic drugs.InterventionA 2-day group self-management course alongside treatment as usual (TAU). The control group received TAU.Main outcome measuresThe primary outcome is QoL in people with epilepsy at 12-month follow-up using the Quality Of Life In Epilepsy 31-P (QOLIE-31-P) scale. Other outcomes were seizure control, impact of epilepsy, medication adverse effects, psychological distress, perceived stigma, self-mastery and medication adherence. Cost-effectiveness analyses and a process evaluation were undertaken.RandomisationA 1 : 1 ratio between trial arms using fixed block sizes of two.BlindingParticipants were not blinded to their group allocation because of the nature of the study. Researchers involved in data collection and analysis remained blinded throughout.ResultsThe trial completed successfully. A total of 404 participants were enrolled in the study [SMILE (UK),n = 205; TAU,n = 199] with 331 completing the final follow-up at 12 months [SMILE (UK),n = 163; TAU,n = 168]. In the intervention group, 61.5% completed all sessions of the course. No adverse events were found to be related to the intervention. At baseline, participants had a mean age of 41.7 years [standard deviation (SD) 14.1 years], and had epilepsy for a median of 18 years. The mean QOLIE-31-P score for the whole group at baseline was 66.0 out of 100.0 (SD 14.2). Clinically relevant levels of anxiety symptoms were reported in 53.6% of the group and depression symptoms in 28.0%. The results following an intention-to-treat analysis showed no change in any measures at the 12-month follow-up [QOLIE-31-P: SMILE (UK) mean: 67.4, SD 13.5; TAU mean: 69.5, SD 14.8]. The cost-effectiveness study showed that SMILE (UK) was possibly cost-effective but was also associated with lower QoL. The process evaluation with 20 participants revealed that a group course increased confidence by sharing with others and improved self-management behaviours.ConclusionsFor people with epilepsy and persistent seizures, a 2-day self-management education course is cost-saving, but does not improve QoL after 12-months or reduce anxiety or depression symptoms. A psychological intervention may help with anxiety and depression. Interviewed participants reported attending a group course increased their confidence and helped them improve their self-management.Future workMore research is needed on self-management courses, with psychological components and integration with routine monitoring.Trial registrationCurrent Controlled Trials ISRCTN57937389.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 21. See the NIHR Journals Library website for further project information.

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