Frailty and the Kidney Transplant Wait List: Protocol for a Multicenter Prospective Study

Background: Understanding how frailty affects patients listed for transplantation has been identified as a priority research need. Frailty may be associated with a high risk of death or wait-list withdrawal, but this has not been evaluated in a large multicenter cohort of Canadian wait-listed patients. Objective: The primary objective is to evaluate whether frailty is associated with death or permanent withdrawal from the transplant wait list. Secondary objectives include assessing whether frailty is associated with hospitalization, quality of life, and the probability of being accepted to the wait list. Design: Prospective cohort study. Setting: Seven sites with established renal transplant programs that evaluate patients for the kidney transplant wait list. Patients: Individuals who are being considered for the kidney transplant wait list. Measurements: We will assess frailty using the Fried Phenotype, a frailty index, the Short Physical Performance Battery, and the Clinical Frailty Scale at the time of listing for transplantation. We will also assess frailty at the time of referral to the wait list and annually after listing in a subgroup of patients. Methods: The primary outcome of the composite of time to death or permanent wait-list withdrawal will be compared between patients who are frail and those who are not frail and will account for the competing risks of deceased and live donor transplantation. Secondary outcomes will include number of hospitalizations and length of stay, and in a subset, changes in frailty severity over time, change in quality of life, and the probability of being listed. Recruitment of 1165 patients will provide >80% power to identify a relative hazard of ≥1.7 comparing patients who are frail to those who are not frail for the primary outcome (2-sided α = .05), whereas a more conservative recruitment target of 624 patients will provide >80% power to identify a relative hazard of ≥2.0. Results: Through December 2019, 665 assessments of frailty (inclusive of those for the primary outcome and all secondary outcomes including repeated measures) have been completed. Limitations: There may be variation across sites in the processes of referral and listing for transplantation that will require consideration in the analysis and results. Conclusions: This study will provide a detailed understanding of the association between frailty and outcomes for wait-listed patients. Understanding this association is necessary before routinely measuring frailty as part of the wait-list eligibility assessment and prior to ascertaining the need for interventions that may modify frailty. Trial Registration: Not applicable as this is a protocol for a prospective observational study.

Download Full-text

Maintaining musculoskeletal health using a behavioural therapy approach: a population-based randomised controlled trial (the MAmMOTH Study)

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-219091 ◽

2021 ◽

pp. annrheumdis-2020-219091 ◽

Cited By ~ 1

Author(s):

Gary J Macfarlane ◽

Marcus Beasley ◽

Neil Scott ◽

Huey Chong ◽

Paul McNamee ◽

...

Keyword(s):

Quality Of Life ◽

High Risk ◽

Primary Outcome ◽

Population Based ◽

Behavioural Therapy ◽

Short Course ◽

Life Years ◽

Secondary Outcomes ◽

Randomised Controlled

ObjectiveCognitive–behavioural therapy (CBT) has been shown to be effective in the management of chronic widespread pain (CWP); we now test whether it can prevent onset among adults at high risk.MethodsA population-based randomised controlled prevention trial, with recruitment through UK general practices. A mailed screening questionnaire identified adults at high risk of CWP. Participants received either usual care (UC) or a short course of telephone CBT (tCBT). The primary outcome was CWP onset at 12 months assessed by mailed questionnaire. There were seven secondary outcomes including quality of life (EuroQol Questionnaire-five dimensions-five levels/EQ-5D-5L) used as part of a health economic assessment.Results996 participants were randomised and included in the intention-to-treat analysis of which 825 provided primary outcome data. The median age of participants was 59 years; 59% were women. At 12 months there was no difference in the onset of CWP (tCBT: 18.0% vs UC: 17.5%; OR 1.05; 95% CI 0.75 to 1.48). Participants who received tCBT were more likely to report better quality of life (EQ-5D-5L utility score mean difference 0.024 (95% CI 0.009 to 0.040)); and had 0.023 (95% CI 0.007 to 0.039) more quality-adjusted life-years at an additional cost of £42.30 (95% CI −£451.19 to £597.90), yielding an incremental cost-effectiveness ratio of £1828. Most secondary outcomes showed significant benefit for the intervention.ConclusionsA short course of tCBT did not prevent onset of CWP in adults at high risk, but improved quality of life and was cost-effective. A low-cost, short-duration intervention benefits persons at risk of CWP.Trial registration numberClinicalTrials.gov Registry (NCT02668003).

Download Full-text

Restarting antiplatelet therapy after spontaneous intracerebral hemorrhage

Neurology ◽

10.1212/wnl.0000000000005742 ◽

2018 ◽

Vol 91 (1) ◽

pp. e26-e36 ◽

Cited By ~ 6

Author(s):

Ching-Jen Chen ◽

Dale Ding ◽

Thomas J. Buell ◽

Fernando D. Testai ◽

Sebastian Koch ◽

...

Keyword(s):

Quality Of Life ◽

Intracerebral Hemorrhage ◽

Functional Outcomes ◽

Primary Outcome ◽

Modified Rankin Scale ◽

Health Related Quality ◽

Related Quality ◽

Health Related ◽

Secondary Outcomes

ObjectiveTo compare the functional outcomes and health-related quality of life metrics of restarting vs not restarting antiplatelet therapy (APT) in patients presenting with intracerebral hemorrhage (ICH) in the ERICH (Ethnic/Racial Variations of Intracerebral Hemorrhage) study.MethodsAdult patients aged 18 years and older who were on APT before ICH and were alive at hospital discharge were included. Patients were dichotomized based on whether or not APT was restarted after hospital discharge. The primary outcome was a modified Rankin Scale score of 0–2 at 90 days. Secondary outcomes were excellent outcome (modified Rankin Scale score 0–1), mortality, Barthel Index, and health status (EuroQol–5 dimensions [EQ-5D] and EQ-5D visual analog scale scores) at 90 days.ResultsThe APT and no APT cohorts comprised 127 and 732 patients, respectively. Restarting APT was associated with lower rates of good functional outcome (36.5% vs 40.8%; p = 0.021) and lower Barthel Index scores at 90 days (p = 0.041). The 2 cohorts were then matched in a 1:1 ratio, and the matched cohorts each comprised 107 patients. No difference in primary outcome was observed between restarting vs not restarting APT (35.5% vs 43.9%; p = 0.105). There were also no differences between the secondary outcomes of the 2 cohorts.ConclusionRestarting APT in patients with ICH of mild to moderate severity after acute hospitalization is not associated with worse functional outcomes or health-related quality of life at 90 days. In patients with significant cardiovascular risk factors who experience an ICH, restarting APT remains the decision of the treating practitioner.

Download Full-text

A Randomized Assessor-Blinded Wait-List-Controlled Trial to Assess the Effectiveness of Acupuncture in the Management of Chemotherapy-Induced Peripheral Neuropathy

Integrative Cancer Therapies ◽

10.1177/1534735419836501 ◽

2019 ◽

Vol 18 ◽

pp. 153473541983650 ◽

Cited By ~ 10

Author(s):

Alexander Molassiotis ◽

Lorna K. P. Suen ◽

Hui Lin Cheng ◽

T. S. K. Mok ◽

Sara C. Y. Lee ◽

...

Keyword(s):

Quality Of Life ◽

Peripheral Neuropathy ◽

Standard Care ◽

Primary Outcome ◽

Controlled Trial ◽

Symptom Distress ◽

Gynecologic Oncology Group ◽

Wait List ◽

Wait List Control

Purpose: Chemotherapy-induced peripheral neuropathy is a complex side effect with few available treatment options. The aim of the study was to test the effectiveness of an 8-week course of acupuncture in the management of chemotherapy-induced peripheral neuropathy in cancer patients who were receiving or had received neurotoxic chemotherapy. Methods: Randomized assessor-blinded controlled trial with 2 arms; one arm received acupuncture twice weekly for 8 weeks, while the other arm was a wait-list control group receiving only standard care. Primary outcome was pain intensity and interference over the past week using the Brief Pain Inventory at the end of the intervention. Secondary outcomes included clinical assessment (CTCAE [Common Toxicity Criteria for Adverse Events] grading and Total Neuropathy Score–Clinical Version) and nerve conduction studies; and patient-reported outcome measures (Functional Assessment of Cancer Therapy–Gynecologic Oncology Group–Neurotoxicity Quality of Life scale and Symptom Distress Scale) assessed at baseline, end of treatment (8 weeks), week 14, and week 20 from the beginning of treatment. Results: Eighty-seven patients were randomized to the experimental arm (n = 44) and to the standard care wait-list control arm (n = 43). Significant changes at 8 weeks were detected in relation to primary outcome (pain), the clinical neurological assessment, quality of life domains, and symptom distress (all P < .05). Improvements in pain interference, neurotoxicity-related symptoms, and functional aspects of quality of life were sustained in the 14-week assessment ( P < .05), as were physical and functional well-being at the 20-week assessment ( P < .05). Conclusions: Acupuncture is an effective intervention for treating chemotherapy-induced peripheral neuropathy and improving patients’ quality of life and experience with neurotoxicity-related symptoms with longer term effects evident.

Download Full-text

Effect of acupuncture on lung cancer-related fatigue: study protocol for a multi-center randomized controlled trial

Trials ◽

10.1186/s13063-019-3701-0 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 2

Author(s):

Zhaoqin Wang ◽

Shanshan Li ◽

Luyi Wu ◽

Qin Qi ◽

Huirong Liu ◽

...

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Primary Outcome ◽

Acupuncture Treatment ◽

Acupuncture Group ◽

Randomized Controlled ◽

Link Type ◽

Cancer Related Fatigue ◽

Secondary Outcomes

Abstract Background Fatigue is one of the primary symptoms in lung cancer, with a prevalence of 88.0% in survivors of cancer, and an even higher prevalence post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue; however, randomized controlled trials (RCTs) of suitable sample size are limited. Method/design This is a multi-center, patient-blinded RCT. A total of 320 eligible patients will be recruited in four centers and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1 ratio. Treatment will be given twice per week for 12 sessions. Treatment will be given at acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of The Brief Fatigue Inventory. The secondary outcomes will be measured using The European Organization for Research and The Treatment of Cancer Quality of Life Questionnaire, and the Hamilton Rating Scale for Depression. The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week, and at follow up time points) and the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat analysis will be used in this RCT. Discussion This trial protocol provides an example of the clinical application acupuncture treatment in the management of lung cancer-related fatigue. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment. Trial registration Chinese Clinical Trial Registry, ChiCTR1900022831. Registered on 27 April 2019. URL: http://www.chictr.org.cn/showproj.aspx?proj=37823

Download Full-text

Therapist-Guided Internet-Based Treatments for Loneliness: A Randomized Controlled Three-Arm Trial Comparing Cognitive Behavioral Therapy and Interpersonal Psychotherapy

Psychotherapy and Psychosomatics ◽

10.1159/000516989 ◽

2021 ◽

pp. 1-8

Author(s):

Anton Käll ◽

Malin Bäck ◽

Camilla Welin ◽

Hanna Åman ◽

Rasmus Bjerkander ◽

...

Keyword(s):

Quality Of Life ◽

Cognitive Behavioral Therapy ◽

Primary Outcome ◽

Behavioral Therapy ◽

Interpersonal Psychotherapy ◽

Cognitive Behavioral ◽

Control Group ◽

Wait List

Introduction: Chronic loneliness has been linked to many adverse outcomes, including mental health problems. Psychological treatment of loneliness can be effective, but the evidence base is limited. Objective: To investigate the efficacy of 2 internet-based interventions based on cognitive behavioral therapy (ICBT) and interpersonal psychotherapy (IIPT) relative to a wait-list control group and each other. Methods: A total of 170 participants were recruited and randomized to either 9 weeks of ICBT (n = 68), IIPT (n = 68), or a wait-list condition (n = 34). The primary outcome was loneliness, measured using the UCLA Loneliness Scale before, during, and after treatment. Secondary measures of psychiatric disorders and quality of life were administered before and after treatment. Follow-up was conducted 4 months after the treatment had ended. Primary outcome data were analyzed using growth curve modeling. Secondary outcomes were analyzed using robust regression models. The trial was preregistered (ClinicalTrials.gov ID: NCT03807154). Results: The ICBT condition had a significantly greater impact on loneliness compared to the wait-list and IIPT conditions. Effect sizes were moderate to large (Cohen d = 0.71) compared to the wait-list and moderate (d = 0.53) compared to IIPT. The IIPT condition did not differ significantly from the wait-list. Both active treatments led to significant increases in quality of life. Only the ICBT group had significantly lower symptoms of depression and generalized anxiety compared to the wait-list group. Treatment gains were maintained but not improved at follow-up. Conclusions: ICBT can be an efficacious option for alleviating loneliness. The IIPT intervention was not as effective.

Download Full-text

Hippotherapy: benefits in children with cerebral palsy with application of the Rehabilitation Treatment Taxonomy / Equoterapia: benefícios em crianças com paralisia cerebral com a aplicação da taxonomia de tratamento em reabilitação

Brazilian Journal of Animal and Environmental Research ◽

10.34188/bjaerv4n2-078 ◽

2021 ◽

Vol 4 (2) ◽

pp. 2520-2540

Author(s):

Juliana M. P. Starling ◽

Ana Paula B. Gontijo ◽

Rosana Ferreira Sampaio ◽

Juliana Vaz de Melo Mambrini ◽

Sérgio Teixeira Da Fonseca ◽

...

Keyword(s):

Quality Of Life ◽

Cerebral Palsy ◽

Primary Outcome ◽

Age Groups ◽

Older Children ◽

Rehabilitation Treatment ◽

Longitudinal Measurements ◽

Children With Cerebral Palsy ◽

Secondary Outcomes

Purpose: To explore the effects of hippotherapy for children with cerebral palsy (CP) with different ages, topographies and severities. Method: Before-after study with three longitudinal measurements: (T1) initial, (T2) 3-months, (T3) 6-months after T1. CP children (n=31) stratified by age (4-7; 8-12 years), severity (mild, moderate, severe), topography (hemiplegia, diplegia, quadriplegia), previous hippotherapy time (3-6m, 6 months) undertook their individual weekly 30-minute hippotherapy sessions. Postural control and balance (PCB) was the primary outcome; gross-motor function (GMF) and quality of life (QL) were the secondary outcomes. Results: Changes in PCB associated with changes in GMF. Older children, with mild severity and diplegia had higher PCB and GMF scores between T1 and T3. Age groups’ initial differences in QL disappeared after 6 months. The Rehabilitation Treatment Taxonomy (RTT) guided interpretation of effects. Conclusion: The positive changes in motor and psychosocial outcomes depended on children’s age, time in rehabilitation and type of CP.

Download Full-text

Emollient bath additives for the treatment of childhood eczema (BATHE): multicentre pragmatic parallel group randomised controlled trial of clinical and cost effectiveness

BMJ ◽

10.1136/bmj.k1332 ◽

2018 ◽

pp. k1332 ◽

Cited By ~ 16

Author(s):

Miriam Santer ◽

Matthew J Ridd ◽

Nick A Francis ◽

Beth Stuart ◽

Kate Rumsby ◽

...

Keyword(s):

Quality Of Life ◽

Cost Effectiveness ◽

Topical Corticosteroid ◽

Primary Outcome ◽

Control Group ◽

Significant Difference ◽

The Mean ◽

Secondary Outcomes ◽

Bath Additives

AbstractObjectivesTo determine the clinical effectiveness and cost effectiveness of including emollient bath additives in the management of eczema in children.DesignPragmatic randomised open label superiority trial with two parallel groups.Setting96 general practices in Wales and western and southern England.Participants483 children aged 1 to 11 years, fulfilling UK diagnostic criteria for atopic dermatitis. Children with very mild eczema and children who bathed less than once weekly were excluded.InterventionsParticipants in the intervention group were prescribed emollient bath additives by their usual clinical team to be used regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management, including leave-on emollients, and caregivers were given standardised advice on how to wash participants.Main outcome measuresThe primary outcome was eczema control measured by the patient oriented eczema measure (POEM, scores 0-7 mild, 8-16 moderate, 17-28 severe) weekly for 16 weeks. Secondary outcomes were eczema severity over one year (monthly POEM score from baseline to 52 weeks), number of eczema exacerbations resulting in primary healthcare consultation, disease specific quality of life (dermatitis family impact), generic quality of life (child health utility-9D), utilisation of resources, and type and quantity of topical corticosteroid or topical calcineurin inhibitors prescribed.Results483 children were randomised and one child was withdrawn, leaving 482 children in the trial: 51% were girls (244/482), 84% were of white ethnicity (447/470), and the mean age was 5 years. 96% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 77% (370/482) completed questionnaires for more than 80% of the time points for the primary outcome (12/16 weekly questionnaires to 16 weeks). The mean baseline POEM score was 9.5 (SD 5.7) in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. The mean POEM score over the 16 week period was 7.5 (SD. 6.0) in the bath additives group and 8.4 (SD 6.0) in the no bath additives group. No statistically significant difference was found in weekly POEM scores between groups over 16 weeks. After controlling for baseline severity and confounders (ethnicity, topical corticosteroid use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additives group were 0.41 points higher than in the bath additives group (95% confidence interval −0.27 to 1.10), below the published minimal clinically important difference for POEM of 3 points. The groups did not differ in secondary outcomes, economic outcomes, or adverse effects.ConclusionsThis trial found no evidence of clinical benefit from including emollient bath additives in the standard management of eczema in children. Further research is needed into optimal regimens for leave-on emollient and soap substitutes.Trial registrationCurrent Controlled Trials ISRCTN84102309.

Download Full-text

Endoscope-assisted (with robotic guidance and using a hybrid technique) interhemispheric transcallosal hemispherotomy: a comparative study with open hemispherotomy to evaluate efficacy, complications, and outcome

Journal of Neurosurgery Pediatrics ◽

10.3171/2018.8.peds18131 ◽

2019 ◽

Vol 23 (2) ◽

pp. 187-197 ◽

Cited By ~ 4

Author(s):

P. Sarat Chandra ◽

Heri Subianto ◽

Jitin Bajaj ◽

Shabari Girishan ◽

Ramesh Doddamani ◽

...

Keyword(s):

Quality Of Life ◽

Blood Loss ◽

Hospital Stay ◽

Primary Outcome ◽

Operating Time ◽

First Episode ◽

Hybrid Technique ◽

The Mean ◽

Secondary Outcomes

OBJECTIVEEndoscope-assisted hemispherotomy (EH) has emerged as a good alternative option for hemispheric pathologies with drug-resistant epilepsy.METHODSThis was a prospective observational study. Parameters measured included primary outcome measures (frequency, severity of seizures) and secondary outcomes (cognition, behavior, and quality of life). Blood loss, operating time, complications, and hospital stay were also taken into account. A comparison was made between the open hemispherotomy (OH) and endoscopic techniques performed by the senior author.RESULTSOf 59 cases (42 males), 27 underwent OH (8 periinsular, the rest vertical) and 32 received EH. The mean age was 8.65 ± 5.41 years (EH: 8.6 ± 5.3 years; OH: 8.6 ± 5.7 years). Seizure frequency per day was 7 ± 5.9 (EH: 7.3 ± 4.6; OH: 15.0 ± 6.2). Duration of disease (years since first episode) was 3.92 ± 1.24 years (EH: 5.2 ± 4.3; OH: 5.8 ± 4.5 years). Number of antiepileptic drugs per patient was 3.9 ± 1.2 (EH: 4.2 ± 1.2; OH: 3.8 ± 0.98). Values for the foregoing variables are expressed as the mean ± SD. Pathologies included the following: postinfarct encephalomalacia in 19 (EH: 11); Rasmussen’s syndrome in 14 (EH: 7); hemimegalencephaly in 12 (EH: 7); hemispheric cortical dysplasia in 7 (EH: 4); postencephalitis sequelae in 6 (EH: 2); and Sturge-Weber syndrome in 1 (EH: 1). The mean follow-up was 40.16 ± 17.3 months. Thirty-nine of 49 (79.6%) had favorable outcomes (International League Against Epilepsy class I and II): in EH the total was 19/23 (82.6%) and in OH it was 20/26 (76.9%). There was no difference in the primary outcome between EH and OH (p = 0.15). Significant improvement was seen in the behavioral/quality of life performance, but not in IQ scores in both EH and OH (p < 0.01, no intergroup difference). Blood loss (p = 0.02) and hospital stay (p = 0.049) were less in EH.CONCLUSIONSEH was as effective as the open procedure in terms of primary and secondary outcomes. It also resulted in less blood loss and a shorter postoperative hospital stay.

Download Full-text

Quality of life after transoral CO2 laser posterior cordotomy with or without partial arytenoidectomy for bilateral adductor vocal cord paralysis

European Archives of Oto-Rhino-Laryngology ◽

10.1007/s00405-021-06971-7 ◽

2021 ◽

Author(s):

Marta Filauro ◽

Alberto Vallin ◽

Elisa Marcenaro ◽

Francesco Missale ◽

Marco Fragale ◽

...

Keyword(s):

Quality Of Life ◽

Vocal Cord ◽

Selection Criteria ◽

Primary Outcome ◽

Vocal Cord Paralysis ◽

Invasive Treatment ◽

Airway Patency ◽

Vocal Function ◽

Secondary Outcomes

Abstract Objectives Bilateral adductor vocal cord paralysis (BAVCP) is a rare and challenging condition whose main consequence is reduction of airway patency at the glottic level, often causing respiratory distress, while vocal function tends to remain almost normal. We investigated the effect of transoral glottal widening on quality of life and decannulation rates in patients affected by BAVCP. Methods We retrospectively evaluated patients affected by BAVCP and treated by transoral CO2 posterior cordotomy with or without medial partial arytenoidectomy (PC ± MPA) at two referral centers. The primary outcome was change in quality of life, evaluated pre- and post-operatively by the ADVS, VHI-30, and EAT-10 questionnaires. Secondary outcomes were the need for retreatments and, for patients with tracheotomy, the time to decannulation. Results Thirty-three patients met selection criteria. The etiology was post-surgical in 27 cases (81.8%), idiopathic in 4 (12.1%), a trauma-related in 1 (6.0%), and to other causes in 1 (3.0%). In 22 cases (66.7%), PC was combined with MPA. A significant improvement in responses for the ADVS (p < .0001) and EAT-10 (p < .0001) was observed, whereas the VHI-30 score did not change significantly post-operatively. All nine patients with a tracheostomy were successfully decannulated within 18 months after the surgical procedure. Conclusions For patients affected by BAVCP, PC ± MPA by transoral CO2 laser microsurgery is a safe, customizable and minimally invasive treatment that can guarantee an affordable balance between quality of life in terms of phonation and swallowing and acceptable airway patency.

Download Full-text

Effectiveness of a complex intervention on Prioritising Multimedication in Multimorbidity (PRIMUM) in primary care: results of a pragmatic cluster randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-017740 ◽

2018 ◽

Vol 8 (2) ◽

pp. e017740 ◽

Cited By ~ 17

Author(s):

Christiane Muth ◽

Lorenz Uhlmann ◽

Walter E Haefeli ◽

Justine Rochon ◽

Marjan van den Akker ◽

...

Keyword(s):

Quality Of Life ◽

General Practice ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Cluster Randomised ◽

Secondary Outcomes ◽

Randomised Controlled

ObjectivesInvestigate the effectiveness of a complex intervention aimed at improving the appropriateness of medication in older patients with multimorbidity in general practice.DesignPragmatic, cluster randomised controlled trial with general practice as unit of randomisation.Setting72 general practices in Hesse, Germany.Participants505 randomly sampled, cognitively intact patients (≥60 years, ≥3 chronic conditions under pharmacological treatment, ≥5 long-term drug prescriptions with systemic effects); 465 patients and 71 practices completed the study.InterventionsIntervention group (IG): The healthcare assistant conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision support system, the general practitioner optimised medication, discussed it with patients and adjusted it accordingly. The control group (CG) continued with usual care.Outcome measuresThe primary outcome was a modified Medication Appropriateness Index (MAI, excluding item 10 on cost-effectiveness), assessed in blinded medication reviews and calculated as the difference between baseline and after 6 months; secondary outcomes after 6 and 9 months’ follow-up: quality of life, functioning, medication adherence, and so on.ResultsAt baseline, a high proportion of patients had appropriate to mildly inappropriate prescriptions (MAI 0–5 points: n=350 patients). Randomisation revealed balanced groups (IG: 36 practices/252 patients; CG: 36/253). Intervention had no significant effect on primary outcome: mean MAI sum scores decreased by 0.3 points in IG and 0.8 points in CG, resulting in a non-significant adjusted mean difference of 0.7 (95% CI −0.2 to 1.6) points in favour of CG. Secondary outcomes showed non-significant changes (quality of life slightly improved in IG but continued to decline in CG) or remained stable (functioning, medication adherence).ConclusionsThe intervention had no significant effects. Many patients already received appropriate prescriptions and enjoyed good quality of life and functional status. We can therefore conclude that in our study, there was not enough scope for improvement.Trial registration numberISRCTN99526053. NCT01171339; Results.

Download Full-text