The feasibility of determining the effectiveness and cost-effectiveness of medication organisation devices compared with usual care for older people in a community setting: systematic review, stakeholder focus groups and feasibility randomised controlled trial

BackgroundMedication organisation devices (MODs) provide compartments for a patient’s medication to be organised into the days of the week and the recommended times the medication should be taken.AimTo define the optimal trial design for testing the clinical effectiveness and cost-effectiveness of MODs.DesignThe feasibility study comprised a systematic review and focus groups to inform a randomised controlled trial (RCT) design. The resulting features were tested on a small scale, using a 2 × 2 factorial design to compare MODs with usual packaging and to compare weekly with monthly supply. The study design was then evaluated.SettingPotential participants were identified by medical practices.ParticipantsAged over 75 years, prescribed at least three solid oral dosage form medications, unintentionally non-adherent and self-medicating. Participants were excluded if deemed by their health-care team to be unsuitable.InterventionsOne of three MODs widely used in routine clinical practice supplied either weekly or monthly.ObjectivesTo identify the most effective method of participant recruitment, to estimate the prevalence of intentional and unintentional non-adherence in an older population, to provide a point estimate of the effect size of MODs relative to usual care and to determine the feasibility and acceptability of trial participation.MethodsThe systematic review included MOD studies of any design reporting medication adherence, health and social outcomes, resource utilisation or dispensing or administration errors. Focus groups with patients, carers and health-care professionals supplemented the systematic review to inform the RCT design. The resulting design was implemented and then evaluated through questionnaires and group discussions with participants and health-care professionals involved in trial delivery.ResultsStudies on MODs are largely of poor quality. The relationship between adherence and health outcomes is unclear. Of the limited studies reporting health outcomes, some reported a positive relationship while some reported increased hospitalisations associated with MODs. The pre-trial focus groups endorsed the planned study design, but suggested a minimum recruitment age of 50–60 years. A total of 35.4% of patients completing the baseline questionnaire were excluded because they already used a MOD. Active recruitment yielded a higher consent rate, but passive recruitment was more cost-effective. The prevalence of intentional non-adherence was 24.7% [n = 71, 95% confidence interval (CI) 19.7% to 29.6%] of participants. Of the remaining 76 participants, 46.1% (95% CI 34.8% to 57.3%) were unintentionally non-adherent. There was no indication of a difference in adherence between the study arms. Participants reported a high level of satisfaction with the design. Five adverse/serious adverse events were identified in the MOD study arms and none was identified in the control arms. There was no discernible difference in health economic outcomes between the four study arms; the mean intervention cost was £20 per month greater for MOD monthly relative to usual supply monthly.ConclusionsMOD provision to unintentionally non-adherent older people may cause medication-related adverse events. The primary outcome for a definitive MOD trial should be health outcomes. Such a trial should recruit patients by postal invitation and recruit younger patients.Future workA study examining the association between MOD initiation and adverse effects is necessary and a strategy to safely introduce MODs should be explored. A definitive study testing the clinical effectiveness and cost-effectiveness of MODs is also required.Study registrationCurrent Controlled Trials ISRCTN 30626972 and UKCRN 12739.FundingThis project was funded by National Institute for Health Research (NIHR) Health Technology Assessment Programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 50. See the NIHR Journals Library website for further project information.

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TRAPEZE: a randomised controlled trial of the clinical effectiveness and cost-effectiveness of chemotherapy with zoledronic acid, strontium-89, or both, in men with bony metastatic castration-refractory prostate cancer

Health Technology Assessment ◽

10.3310/hta20530 ◽

2016 ◽

Vol 20 (53) ◽

pp. 1-288 ◽

Cited By ~ 16

Author(s):

Nicholas James ◽

Sarah Pirrie ◽

Ann Pope ◽

Darren Barton ◽

Lazaros Andronis ◽

...

Keyword(s):

Prostate Cancer ◽

Cost Effectiveness ◽

Zoledronic Acid ◽

Randomised Controlled Trial ◽

Technology Assessment ◽

Cox Regression ◽

Controlled Trial ◽

Clinical Effectiveness ◽

Health Technology ◽

Randomised Controlled

BackgroundBony metastatic castration-refractory prostate cancer is associated with a poor prognosis and high morbidity. TRAPEZE was a two-by-two factorial randomised controlled trial of zoledronic acid (ZA) and strontium-89 (Sr-89), each combined with docetaxel. All have palliative benefits, are used to control bone symptoms and are used with docetaxel to prolong survival. ZA, approved on the basis of reducing skeletal-related events (SREs), is commonly combined with docetaxel in practice, although evidence of efficacy and cost-effectiveness is lacking. Sr-89, approved for controlling metastatic pain and reducing need for subsequent bone treatments, is generally palliatively used in patients unfit for chemotherapy. Phase II analysis confirmed the safety and feasibility of combining these agents. TRAPEZE aimed to determine the clinical effectiveness and cost-effectiveness of each agent.MethodsPatients were randomised to receive six cycles of docetaxel plus prednisolone: alone, with ZA, with a single Sr-89 dose after cycle 6, or with both. Primary outcomes were clinical progression-free survival (CPFS: time to pain progression, SRE or death) and cost-effectiveness. Secondary outcomes were SRE-free interval (SREFI), total SREs, overall survival (OS) and quality of life (QoL). Log-rank test and Cox regression modelling were used to determine clinical effectiveness. Cost-effectiveness was assessed from the NHS perspective and expressed as cost per additional quality-adjusted life-year (QALY). An additional analysis was carried out for ZA to reflect the availability of generic ZA.ResultsPatients: 757 randomised (median age 68.7 years; Eastern Cooperative Oncology Group scale score 0, 40%; 1, 52%; 2, 8%; prior radiotherapy, 45%); median prostate-specific antigen 143.78 ng/ml (interquartile range 50.8–353.9 ng/ml). Stratified log-rank analysis of CPFS was statistically non-significant for either agent (Sr-89,p = 0.11; ZA,p = 0.45). Cox regression analysis adjusted for stratification variables showed CPFS benefit for Sr-89 [hazard ratio (HR) 0.845, 95% confidence interval (CI) 0.72 to 0.99;p = 0.036] and confirmed no effect of ZA (p = 0.46). ZA showed a significant SREFI effect (HR 0.76; 95% CI 0.63 to 0.93;p = 0.008). Neither agent affected OS (Sr-89,p = 0.74; ZA,p = 0.91), but both increased total cost (vs. no ZA and no Sr-89, respectively); decreased post-trial therapies partly offset costs [net difference: Sr-89 £1341; proprietary ZA (Zometa®, East Hanover, NJ, USA) £1319; generic ZA £251]. QoL was maintained in all trial arms; Sr-89 (0.08 additional QALYs) and ZA (0.03 additional QALYs) showed slight improvements. The resulting incremental cost-effectiveness ratio (ICER) for Sr-89 was £16,590, with £42,047 per QALY for Zometa and £8005 per QALY for generic ZA.ConclusionStrontium-89 improved CPFS, but not OS. ZA did not improve CPFS or OS but significantly improved SREFI, mostly post progression, suggesting a role as post-chemotherapy maintenance therapy. QoL was well maintained in all treatment arms, with differing patterns of care resulting from the effects of Sr-89 on time to progression and ZA on SREFI and total SREs. The addition of Sr-89 resulted in additional cost and a small positive increase in QALYs, with an ICER below the £20,000 ceiling per QALY. The additional costs and small positive QALY changes in favour of ZA resulted in ICERs of £42,047 (Zometa) and £8005 for the generic alternative; thus, generic ZA represents a cost-effective option. Additional analyses on the basis of data from the Hospital Episode Statistics data set would allow corroborating the findings of this study. Further research into the use of ZA (and other bone-targeting therapies) with newer prostate cancer therapies would be desirable.Study registrationCurrent Controlled Trials ISRCTN12808747.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 53. See the NIHR Journals Library website for further project information.

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Clinical effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia: a multicentre randomised controlled trial

Health Technology Assessment ◽

10.3310/hta20110 ◽

2016 ◽

Vol 20 (11) ◽

pp. 1-100 ◽

Cited By ~ 7

Author(s):

Stefan Priebe ◽

Mark Savill ◽

Til Wykes ◽

Richard Bentall ◽

Christoph Lauber ◽

...

Keyword(s):

Cost Effectiveness ◽

Negative Symptoms ◽

Controlled Trial ◽

Clinical Effectiveness ◽

Health Technology ◽

Body Psychotherapy ◽

End Of Treatment ◽

Secondary Outcomes ◽

Randomised Controlled

BackgroundThe negative symptoms of schizophrenia significantly impact on quality of life and social functioning, and current treatment options are limited. In this study the clinical effectiveness and cost-effectiveness of group body psychotherapy as a treatment for negative symptoms were compared with an active control.DesignA parallel-arm, multisite randomised controlled trial. Randomisation was conducted independently of the research team, using a 1 : 1 computer-generated sequence. Assessors and statisticians were blinded to treatment allocation. Analysis was conducted following the intention-to-treat principle. In the cost-effectiveness analysis, a health and social care perspective was adopted.ParticipantsEligibility criteria: age 18–65 years; diagnosis of schizophrenia with symptoms present at > 6 months; score of ≥ 18 on Positive and Negative Syndrome Scale (PANSS) negative symptoms subscale; no change in medication type in past 6 weeks; willingness to participate; ability to give informed consent; and community outpatient. Exclusion criteria: inability to participate in the groups and insufficient command of English.SettingsParticipants were recruited from NHS mental health community services in five different Trusts. All groups took place in local community spaces.InterventionsControl intervention: a 10-week, 90-minute, 20-session group beginners’ Pilates class, run by a qualified Pilates instructor. Treatment intervention: a 10-week, 90-minute, 20-session manualised group body psychotherapy group, run by a qualified dance movement psychotherapist.OutcomesThe primary outcome was the PANSS negative symptoms subscale score at end of treatment. Secondary outcomes included measures of psychopathology, functional, social, service use and treatment satisfaction outcomes, both at treatment end and at 6-month follow-up.ResultsA total of 275 participants were randomised (140 body psychotherapy group, 135 Pilates group). At the end of treatment, 264 participants were assessed (137 body psychotherapy group, 127 Pilates group). The adjusted difference in means of the PANSS negative subscale at the end of treatment was 0.03 [95% confidence interval (CI) –1.11 to 1.17], showing no advantage of the intervention. In the secondary outcomes, the mean difference in the Clinical Assessment Interview for negative symptoms expression subscale at the end of treatment was 0.62 (95% CI –1.23 to 0.00), and in extrapyramidal movement disorder symptoms –0.65 (95% CI –1.13 to –0.16) at the end of treatment and –0.58 (95% CI –1.07 to –0.09) at 6 months’ follow-up, showing a small significant advantage of body psychotherapy. No serious adverse events related to the interventions were reported. The total costs of the intervention were comparable with the control, with no clear evidence of cost-effectiveness for either condition.LimitationsOwing to the absence of a treatment-as-usual arm, it is difficult to determine whether or not both arms are an improvement over routine care.ConclusionsIn comparison with an active control, group body psychotherapy does not have a clinically relevant beneficial effect in the treatment of patients with negative symptoms of schizophrenia. These findings conflict with the review that led to the current National Institute for Health and Care Excellence guidelines suggesting that arts therapies may be an effective treatment for negative symptoms.Future workDetermining whether or not this lack of effectiveness extends to all types of art therapies would be informative.Trial registrationCurrent Controlled Trials ISRCTN842165587.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. 20, No. 11. See the NIHR Journals Library website for further project information.

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CATheter Infections in CHildren (CATCH): a randomised controlled trial and economic evaluation comparing impregnated and standard central venous catheters in children

Health Technology Assessment ◽

10.3310/hta20180 ◽

2016 ◽

Vol 20 (18) ◽

pp. 1-220 ◽

Cited By ~ 13

Author(s):

Katie Harron ◽

Quen Mok ◽

Kerry Dwan ◽

Colin H Ridyard ◽

Tracy Moitt ◽

...

Keyword(s):

Health Care ◽

Intensive Care ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Health Technology ◽

Central Venous Catheters ◽

Central Venous ◽

Cost Impact ◽

Randomised Controlled

BackgroundImpregnated central venous catheters (CVCs) are recommended for adults to reduce bloodstream infection (BSI) but not for children.ObjectiveTo determine the effectiveness of impregnated compared with standard CVCs for reducing BSI in children admitted for intensive care.DesignMulticentre randomised controlled trial, cost-effectiveness analysis from a NHS perspective and a generalisability analysis and cost impact analysis.Setting14 English paediatric intensive care units (PICUs) in England.ParticipantsChildren aged < 16 years admitted to a PICU and expected to require a CVC for ≥ 3 days.InterventionsHeparin-bonded, antibiotic-impregnated (rifampicin and minocycline) or standard polyurethane CVCs, allocated randomly (1 : 1 : 1). The intervention was blinded to all but inserting clinicians.Main outcome measureTime to first BSI sampled between 48 hours after randomisation and 48 hours after CVC removal. The following data were used in the trial: trial case report forms; hospital administrative data for 6 months pre and post randomisation; and national-linked PICU audit and laboratory data.ResultsIn total, 1859 children were randomised, of whom 501 were randomised prospectively and 1358 were randomised as an emergency; of these, 984 subsequently provided deferred consent for follow-up. Clinical effectiveness – BSIs occurred in 3.59% (18/502) of children randomised to standard CVCs, 1.44% (7/486) of children randomised to antibiotic CVCs and 3.42% (17/497) of children randomised to heparin CVCs. Primary analyses comparing impregnated (antibiotic and heparin CVCs) with standard CVCs showed no effect of impregnated CVCs [hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.37 to 1.34]. Secondary analyses showed that antibiotic CVCs were superior to standard CVCs (HR 0.43, 95% CI 0.20 to 0.96) but heparin CVCs were not (HR 1.04, 95% CI 0.53 to 2.03). Time to thrombosis, mortality by 30 days and minocycline/rifampicin resistance did not differ by CVC. Cost-effectiveness – heparin CVCs were not clinically effective and therefore were not cost-effective. The incremental cost of antibiotic CVCs compared with standard CVCs over a 6-month time horizon was £1160 (95% CI –£4743 to £6962), with an incremental cost-effectiveness ratio of £54,057 per BSI avoided. There was considerable uncertainty in costs: antibiotic CVCs had a probability of 0.35 of being dominant. Based on index hospital stay costs only, antibiotic CVCs were associated with a saving of £97,543 per BSI averted. The estimated value of health-care resources associated with each BSI was £10,975 (95% CI –£2801 to £24,751). Generalisability and cost-impact – the baseline risk of BSI in 2012 for PICUs in England was 4.58 (95% CI 4.42 to 4.74) per 1000 bed-days. An estimated 232 BSIs could have been averted in 2012 using antibiotic CVCs. The additional cost of purchasing antibiotic CVCs for all children who require them (£36 per CVC) would be less than the value of resources associated with managing BSIs in PICUs with standard BSI rates of > 1.2 per 1000 CVC-days.ConclusionsThe primary outcome did not differ between impregnated and standard CVCs. However, antibiotic-impregnated CVCs significantly reduced the risk of BSI compared with standard and heparin CVCs. Adoption of antibiotic-impregnated CVCs could be beneficial even for PICUs with low BSI rates, although uncertainty remains whether or not they represent value for money to the NHS. Limitations – inserting clinicians were not blinded to allocation and a lower than expected event rate meant that there was limited power for head-to-head comparisons of each type of impregnation. Future work – adoption of impregnated CVCs in PICUs should be considered and could be monitored through linkage of electronic health-care data and clinical data on CVC use with laboratory surveillance data on BSI.Trial registrationClinicalTrials.gov NCT01029717.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 18. See the NIHR Journals Library website for further project information.

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Effect of emotional content on online video sharing among health care professionals and researchers (DIFFUSION): results and lessons learnt from a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-019419 ◽

2018 ◽

Vol 8 (4) ◽

pp. e019419

Author(s):

Junko Kiriya ◽

Phil Edwards ◽

Ian Roberts

Keyword(s):

Health Care ◽

Randomised Controlled Trial ◽

Health Care Professionals ◽

Controlled Trial ◽

Emotional Content ◽

Online Video ◽

Video Sharing ◽

Lessons Learnt ◽

Randomised Controlled

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Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial)

Health Technology Assessment ◽

10.3310/hta21240 ◽

2017 ◽

Vol 21 (24) ◽

pp. 1-198 ◽

Cited By ~ 9

Author(s):

Sarah Cockayne ◽

Sara Rodgers ◽

Lorraine Green ◽

Caroline Fairhurst ◽

Joy Adamson ◽

...

Keyword(s):

Cost Effectiveness ◽

Usual Care ◽

Incidence Rate ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Clinical Effectiveness ◽

Cost Effective ◽

Falls Prevention ◽

Randomised Controlled

BackgroundFalls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care.DesignA pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study.SettingNine NHS trusts in the UK and one site in Ireland.ParticipantsIn total, 1010 participants aged ≥ 65 years were randomised (intervention,n = 493; usual care,n = 517) via a secure, remote service. Blinding was not possible.InterventionsAll participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises.Main outcome measuresThe primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness.ResultsThe primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05;p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00;p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI –£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI –0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants.LimitationsOwing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care.ConclusionsThe intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective.Future workFurther research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients.Trial registrationCurrent Controlled Trials ISRCTN68240461.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. 21, No. 24. See the NIHR Journals Library website for further project information.

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Cost-effectiveness analysis of acupuncture compared with usual care for acute non-specific low back pain: secondary analysis of a randomised controlled trial

Acupuncture in Medicine ◽

10.1177/09645284211055747 ◽

2021 ◽

pp. 096452842110557

Author(s):

Trygve Skonnord ◽

Arne Fetveit ◽

Holgeir Skjeie ◽

Mette Brekke ◽

Margreth Grotle ◽

...

Keyword(s):

Health Care ◽

Cost Effectiveness ◽

Usual Care ◽

Controlled Trial ◽

Secondary Analysis ◽

Cost Effective ◽

Cost Effectiveness Analysis ◽

Effectiveness Analysis ◽

Randomised Controlled ◽

Care Costs

Objective: To assess the cost-effectiveness of a single treatment session of acupuncture, when applied in addition to usual care for acute low back pain (ALBP). Methods: Secondary analysis of a multicentre randomised controlled trial in Norwegian general practice. In total, 171 participants with ALBP ⩽14 days were randomised to a control group (CG) receiving usual care or to an acupuncture group (AG) receiving one additional session of Western medical acupuncture alongside usual care. Primary outcome measures for this cost-effectiveness analysis were quality-adjusted life years (QALYs), health care costs and societal costs at days 28 and 365, the incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB). The NMB was calculated on the basis of the Norwegian cost-effectiveness threshold of NOK 275,000 (USD 35,628) per QALY gained. Missing data were replaced by multiple chained imputation. Results: Eighty-six participants in the CG and 81 in the AG were included in the analysis. We found no QALY gain at day 28. At day 365, the incremental QALY of 0.035 was statistically significant. The differences in health care costs and societal costs were not statistically significant. Three out of four calculations led to negative ICERs (cost saving) and positive NMBs. For the health care perspective at day 365, the ICER was USD –568 per QALY and the NMB was USD 1265, with 95.9% probability of acupuncture being cost-effective. Conclusion: To our knowledge, this is the first cost-effectiveness analysis of acupuncture for ALBP. The findings indicate that acupuncture may be cost-effective from a 1-year perspective, but more studies are needed. Trial registration number: NCT01439412 (ClinicalTrials.gov).

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