scholarly journals The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years

2016 ◽  
Vol 20 (75) ◽  
pp. 1-158 ◽  
Author(s):  
David J Keene ◽  
Dipesh Mistry ◽  
Julian Nam ◽  
Elizabeth Tutton ◽  
Robert Handley ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Close Contact ◽  
Controlled Trial ◽  
Health Technology ◽  
Mean Difference ◽  
Ankle Fractures ◽  
Randomised Controlled ◽  
Ankle Function

BackgroundClose contact casting (CCC) may offer an alternative to open reduction and internal fixation (ORIF) surgery for unstable ankle fractures in older adults.ObjectivesWe aimed to (1) determine if CCC for unstable ankle fractures in adults aged over 60 years resulted in equivalent clinical outcome compared with ORIF, (2) estimate cost-effectiveness to the NHS and society and (3) explore participant experiences.DesignA pragmatic, multicentre, equivalence randomised controlled trial incorporating health economic evaluation and qualitative study.SettingTrauma and orthopaedic departments of 24 NHS hospitals.ParticipantsAdults aged over 60 years with unstable ankle fracture. Those with serious limb or concomitant disease or substantial cognitive impairment were excluded.InterventionsCCC was conducted under anaesthetic in theatre by surgeons who attended training. ORIF was as per local practice. Participants were randomised in 1 : 1 allocation via remote telephone randomisation. Sequence generation was by random block size, with stratification by centre and fracture pattern.Main outcome measuresFollow-up was conducted at 6 weeks and, by blinded outcome assessors, at 6 months after randomisation. The primary outcome was the Olerud–Molander Ankle Score (OMAS), a patient-reported assessment of ankle function, at 6 months. Secondary outcomes were quality of life (as measured by the European Quality of Life 5-Dimensions, Short Form questionnaire-12 items), pain, ankle range of motion and mobility (as measured by the timed up and go test), patient satisfaction and radiological measures. In accordance with equivalence trial US Food and Drug Administration guidance, primary analysis was per protocol.ResultsWe recruited 620 participants, 95 from the pilot and 525 from the multicentre phase, between June 2010 and November 2013. The majority of participants, 579 out of 620 (93%), received the allocated treatment; 52 out of 275 (19%) who received CCC later converted to ORIF because of loss of fracture reduction. CCC resulted in equivalent ankle function compared with ORIF at 6 months {OMAS 64.5 points [standard deviation (SD) 22.4 points] vs. OMAS 66.0 points (SD 21.1 points); mean difference –0.65 points, 95% confidence interval (CI) –3.98 to 2.68 points; standardised effect size –0.04, 95% CI –0.23 to 0.15}. There were no differences in quality of life, ankle motion, pain, mobility and patient satisfaction. Infection and/or wound problems were more common with ORIF [29/298 (10%) vs. 4/275 (1%)], as were additional operating theatre procedures [17/298 (6%) vs. 3/275 (1%)]. Malunion was more common with CCC [38/249 (15%) vs. 8/274 (3%);p < 0.001]. Malleolar non-union was lower in the ORIF group [lateral: 0/274 (0%) vs. 8/248 (3%);p = 0.002; medial: 3/274 (1%) vs. 18/248 (7%);p < 0.001]. During the trial, CCC showed modest mean cost savings [NHS mean difference –£644 (95% CI –£1390 to £76); society mean difference –£683 (95% CI –£1851 to £536)]. Estimates showed some imprecision. Incremental quality-adjusted life-years following CCC were no different from ORIF. Over common willingness-to-pay thresholds, the probability that CCC was cost-effective was very high (> 95% from NHS perspective and 85% from societal perspective). Experiences of treatments were similar; both groups endured the impact of fracture, uncertainty regarding future function and the need for further interventions.LimitationsAssessors at 6 weeks were necessarily not blinded. The learning-effect analysis was inconclusive because of limited CCC applications per surgeon.ConclusionsCCC provides a clinically equivalent outcome to ORIF at reduced cost to the NHS and to society at 6 months.Future workLonger-term follow-up of trial participants is under way to address concerns over potential later complications or additional procedures and their potential to impact on ankle function. Further study of the patient factors, radiological fracture patterns and outcomes, treatment responses and prognosis would also contribute to understanding the treatment pathway.Trial registrationCurrent Controlled Trials ISRCTN04180738.FundingThe National Institute for Health Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 75. See the NIHR Journals Library website for further project information. This report was developed in association with the National Institute for Health Research Oxford Biomedical Research Unit funding scheme. The pilot phase was funded by the AO Research Foundation.

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.

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 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 Mindful gratitude journaling: psychological distress, quality of life and suffering in advanced cancer: a randomised controlled trial

2021 ◽  
pp. bmjspcare-2021-003068
Author(s):  
Ting Ting Tan ◽  
Maw Pin Tan ◽  
Chee Loong Lam ◽  
Ee Chin Loh ◽  
David Paul Capelle ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psychological Distress ◽  
Randomised Controlled Trial ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Control Group ◽  
Randomised Controlled

ContextNumerous studies have shown that gratitude can reduce stress and improve quality of life.ObjectiveOur study aimed to examine the effect of mindful gratitude journaling on suffering, psychological distress and quality of life of patients with advanced cancer.MethodsWe conducted a parallel-group, blinded, randomised controlled trial at the University of Malaya Medical Centre, Malaysia. Ninety-two adult patients with advanced cancer, and an overall suffering score ≥4/10 based on the Suffering Pictogram were recruited and randomly assigned to either a mindful gratitude journaling group (N=49) or a routine journaling group (N=43).ResultsAfter 1 week, there were significant reductions in the overall suffering score from the baseline in both the intervention group (mean difference in overall suffering score=−2.0, 95% CI=−2.7 to −1.4, t=−6.125, p=0.000) and the control group (mean difference in overall suffering score=−1.6, 95% CI=−2.3 to −0.8, t=−4.106, p=0.037). There were also significant improvements in the total Hospital Anxiety and Depression Scale score (mean difference=−3.4, 95% CI=−5.3 to −1.5, t=−3.525, p=0.000) and the total Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being score (mean difference=7.3, 95% CI=1.5 to 13.1, t=2.460, p=0.014) in the intervention group after 7 days, but not in the control group.ConclusionThe results provide evidence that 7 days of mindful gratitude journaling could positively affect the state of suffering, psychological distress and quality of life of patients with advanced cancer.Trial registration numberThe trial was registered with the Australian and New Zealand Clinical Trials Registry (ACTRN1261800172191) and conducted in accordance with the Declaration of Helsinki.

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 A randomised controlled trial of Outpatient versus inpatient Polyp Treatment (OPT) for abnormal uterine bleeding

2015 ◽  
Vol 19 (61) ◽  
pp. 1-194 ◽  
Author(s):  
T Justin Clark ◽  
Lee J Middleton ◽  
Natalie AM Cooper ◽  
Lavanya Diwakar ◽  
Elaine Denny ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Inpatient Treatment ◽  
Controlled Trial ◽  
Abnormal Uterine Bleeding ◽  
Health Technology ◽  
Uterine Bleeding ◽  
Randomised Controlled ◽  
Uterine Polyps

BackgroundUterine polyps cause abnormal bleeding in women and conventional practice is to remove them in hospital under general anaesthetic. Advances in technology make it possible to perform polypectomy in an outpatient setting, yet evidence of effectiveness is limited.ObjectivesTo test the hypothesis that in women with abnormal uterine bleeding (AUB) associated with benign uterine polyp(s), outpatient polyp treatment achieved as good, or no more than 25% worse, alleviation of bleeding symptoms at 6 months compared with standard inpatient treatment. The hypothesis that response to uterine polyp treatment differed according to the pattern of AUB, menopausal status and longer-term follow-up was tested. The cost-effectiveness and acceptability of outpatient polypectomy was examined.DesignA multicentre, non-inferiority, randomised controlled trial, incorporating a cost-effectiveness analysis and supplemented by a parallel patient preference study. Patient acceptability was evaluated by interview in a qualitative study.SettingOutpatient hysteroscopy clinics and inpatient gynaecology departments within UK NHS hospitals.ParticipantsWomen with AUB – defined as heavy menstrual bleeding (formerly known as menorrhagia) (HMB), intermenstrual bleeding or postmenopausal bleeding – and hysteroscopically diagnosed uterine polyps.InterventionsWe randomly assigned 507 women, using a minimisation algorithm, to outpatient polypectomy compared with conventional inpatient polypectomy as a day case in hospital under general anaesthesia.Main outcome measuresThe primary outcome was successful treatment at 6 months, determined by the woman’s assessment of her bleeding. Secondary outcomes included quality of life, procedure feasibility, acceptability and cost per quality-adjusted life-year (QALY) gained.ResultsAt 6 months, 73% (166/228) of women who underwent outpatient polypectomy were successfully treated compared with 80% (168/211) following inpatient polypectomy [relative risk (RR) 0.91, 95% confidence interval (CI) 0.82 to 1.02]. The lower end of the CIs showed that outpatient polypectomy was at most 18% worse, in relative terms, than inpatient treatment, within the 25% margin of non-inferiority set at the outset of the study. By 1 and 2 years the corresponding proportions were similar producing RRs close to unity. There was no evidence that the treatment effect differed according to any of the predefined subgroups when treatments by variable interaction parameters were examined. Failure to completely remove polyps was higher (19% vs. 7%; RR 2.5, 95% CI 1.5 to 4.1) with outpatient polypectomy. Procedure acceptability was reduced with outpatient compared with inpatient polyp treatment (83% vs. 92%; RR 0.90, 95% CI 0.84 to 0.97). There were no significant differences in quality of life. The incremental cost-effectiveness ratios at 6 and 12 months for inpatient treatment were £1,099,167 and £668,800 per additional QALY, respectively.ConclusionsWhen treating women with AUB associated with uterine polyps, outpatient polypectomy was non-inferior to inpatient polypectomy at 6 and 12 months, and relatively cost-effective. However, patients need to be aware that failure to remove a polyp is more likely with outpatient polypectomy and procedure acceptability lower.Trial registrationCurrent Controlled Trials ISRCTN 65868569.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 61. See the NIHR Journals Library website for further project information.

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 Effectiveness of a peer-mediated educational intervention in improving general practitioner diagnostic assessment and management of dementia: a cluster randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e021125 ◽  
Author(s):  
Dimity Pond ◽  
Karen Mate ◽  
Nigel Stocks ◽  
Jane Gunn ◽  
Peter Disler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Outcome Measures ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Mean Difference ◽  
Secondary Outcome ◽  
General Practices ◽  
Randomised Controlled

ObjectiveTest effectiveness of an educational intervention for general practitioners (GPs) on quality of life and depression outcomes for patients.DesignDouble-blind, cluster randomised controlled trial.SettingGeneral practices in Australia between 2007 and 2010.ParticipantsGeneral practices were randomly allocated to the waitlist (n=37) or intervention (n=66) group, in a ratio of 1:2. A total of 2030 (1478 intervention; 552 waitlist) community-dwelling participants aged 75 years or older were recruited via 168 GPs (113 intervention; 55 waitlist).InterventionsA practice-based academic detailing intervention led by a peer educator that included: (1) training in use of the GP assessment of cognition dementia screening instrument; (2) training in diagnosis and management based on Royal Australian College of General Practitioners Dementia Guidelines; (3) addressing GPs’ barriers to dementia diagnosis; and (4) a business case outlining a cost-effective dementia assessment approach.Outcome measuresPrimary outcome measures were patient quality of life and depression; secondary outcome measures were: (1) sensitivity and specificity of GP identification of dementia; (2) referral to medical specialists and/or support services; (3) patient satisfaction with care; and (4) carer quality of life, depression and satisfaction with care.ResultsThe educational intervention had no significant effect on patient quality of life or depression scores after 12 months. There were however improvements in secondary outcome measures including sensitivity of GP judgement of dementia (p=0.002; OR 6.0, 95% CI 1.92 to 18.73), satisfaction with GP communication for all patients (p=0.024; mean difference 2.1, 95% CI 0.27 to 3.93) and for patients with dementia (p=0.007; mean difference 7.44, 95% CI 2.02 to 12.86) and enablement of carers (p=0.0185; mean difference 24.77, 95% CI 4.15 to 45.40).ConclusionPractice-based academic detailing did not improve patient quality of life or depression scores but did improve detection of dementia in primary care and patient satisfaction with GP communication.Trial registration numberACTRN12607000117415; Pre-results.

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