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Medicine Apr 2016This systematic review was performed to investigate the ethical justification, methodological quality, validity and safety of placebo controls in randomized... (Meta-Analysis)
Meta-Analysis Review
This systematic review was performed to investigate the ethical justification, methodological quality, validity and safety of placebo controls in randomized placebo-controlled surgical trials.Central, MEDLINE, and EMBASE were systematically searched to identify randomized controlled trials comparing a surgical procedure to a placebo. "Surgical procedure" was defined as a medical procedure involving an incision with instruments. Placebo was defined as a blinded sham operation involving no change to the structural anatomy and without an expectable physiological response in the target body compartment.Ten randomized placebo-controlled controlled surgical trials were included, all of them published in high-ranking medical journals (mean impact factor: 20.1). Eight of 10 failed to show statistical superiority of the experimental intervention. Serious adverse events did not differ between the groups (rate ratio [RR] 1.38, 95% confidence interval [CI]: 0.92-2.06, P = 0.46). None of the trials had a high risk of bias in any domain. The ethical justification for the use of a placebo control remained unclear in 2 trials.Placebo-controlled surgical trials are feasible and provide high-quality data on efficacy of surgical treatments. The surgical placebo entails a considerable risk for study participants. Consequently, a placebo should be used only if justified by the clinical question and by methodological necessity. Based on the current evidence, a pragmatic proposal for the use of placebo controls in future randomized controlled surgical trials is made.
Topics: Patient Safety; Placebo Effect; Randomized Controlled Trials as Topic; Surgical Procedures, Operative
PubMed: 27124060
DOI: 10.1097/MD.0000000000003516 -
JMIR MHealth and UHealth Nov 2020Coronary heart disease (CHD) is a leading cause of disability and deaths worldwide. Secondary prevention, including cardiac rehabilitation (CR), is crucial to improve... (Review)
Review
BACKGROUND
Coronary heart disease (CHD) is a leading cause of disability and deaths worldwide. Secondary prevention, including cardiac rehabilitation (CR), is crucial to improve risk factors and to reduce disease burden and disability. Accessibility barriers contribute to underutilization of traditional center-based CR programs; therefore, alternative delivery models, including cardiac telerehabilitation (ie, delivery via mobile, smartphone, and/or web-based apps), have been tested. Experimental studies have shown cardiac telerehabilitation to be effective and cost-effective, but there is inadequate evidence about how to translate this research into routine clinical practice.
OBJECTIVE
This systematic review aimed to synthesize research evaluating the effectiveness of implementing cardiac telerehabilitation interventions at scale in routine clinical practice, including factors underlying successful implementation processes, and experimental research evaluating implementation-related outcomes.
METHODS
MEDLINE, Embase, PsycINFO, and Global Health databases were searched from 1990 through November 9, 2018, for studies evaluating the implementation of telerehabilitation for the self-management of CHD. Reference lists of included studies and relevant systematic reviews were hand searched to identify additional studies. Implementation outcomes of interest included acceptability, appropriateness, adoption, feasibility, fidelity, implementation cost, penetration, and sustainability. A narrative synthesis of results was carried out.
RESULTS
No included studies evaluated the implementation of cardiac telerehabilitation in routine clinical practice. A total of 10 studies of 2250 participants evaluated implementation outcomes, including acceptability (8/10, 80%), appropriateness (9/10, 90%), adoption (6/10, 60%), feasibility (6/10, 60%), fidelity (7/10, 70%), and implementation cost (4/10, 40%), predominantly from the participant perspective. Cardiac telerehabilitation interventions had high acceptance among the majority of participants, but technical challenges such as reliable broadband internet connectivity can impact acceptability and feasibility. Many participants considered telerehabilitation to be an appropriate alternative CR delivery model, as it was convenient, flexible, and easy to access. Participants valued interactive intervention components, such as real-time exercise monitoring and feedback as well as individualized support. The penetration and sustainability of cardiac telerehabilitation, as well as the perspectives of CR practitioners and health care organizations, have received little attention in existing cardiac telerehabilitation research.
CONCLUSIONS
Experimental trials suggest that participants perceive cardiac telerehabilitation to be an acceptable and appropriate approach to improve the reach and utilization of CR, but pragmatic implementation studies are needed to understand how interventions can be sustainably translated from research into clinical practice. Addressing this gap could help realize the potential impact of telerehabilitation on CR accessibility and participation as well as person-centered, health, and economic outcomes.
TRIAL REGISTRATION
International Prospective Register of Systematic Reviews (PROSPERO) CRD42019124254; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=124254.
Topics: Cardiovascular Diseases; Exercise; Humans; Secondary Prevention; Self-Management; Telerehabilitation
PubMed: 33245286
DOI: 10.2196/17957 -
Aripiprazole (intramuscular) for psychosis-induced aggression or agitation (rapid tranquillisation).The Cochrane Database of Systematic... Jan 2018People experiencing psychosis may become aggressive. Antipsychotics, such as aripiprazole in intramuscular form, can be used in such situations. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
People experiencing psychosis may become aggressive. Antipsychotics, such as aripiprazole in intramuscular form, can be used in such situations.
OBJECTIVES
To evaluate the effects of intramuscular aripiprazole in the treatment of psychosis-induced aggression or agitation (rapid tranquillisation).
SEARCH METHODS
On 11 December 2014 and 11 April 2017, we searched the Cochrane Schizophrenia Group's Study-based Register of Trials which is based on regular searches of CINAHL, BIOSIS, AMED, Embase, PubMed, MEDLINE, PsycINFO, and registries of clinical trials.
SELECTION CRITERIA
All randomised controlled trials (RCTs) that randomised people with psychosis-induced aggression or agitation to receive either intramuscular aripiprazole or another intramuscular intervention.
DATA COLLECTION AND ANALYSIS
We independently inspected citations and, where possible, abstracts, ordered papers and re-inspected and quality assessed these. We included studies that met our selection criteria. At least two review authors independently extracted data from the included studies. We chose a fixed-effect model. We analysed dichotomous data using risk ratio (RR) and the 95% confidence intervals (CI). We analysed continuous data using mean differences (MD) and their CIs. We assessed risk of bias for included studies and used GRADE to create 'Summary of findings' tables.
MAIN RESULTS
Searching found 63 records referring to 21 possible trials. We could only include three studies, all completed over the last decade, with 885 participants, of which 707 were included for quantitative analyses in this systematic review. Due to limited comparisons, small size of trials and a paucity of investigated and reported 'pragmatic' outcomes, evidence was mostly graded as low or very low quality. No trials reported useful data for one of our primary outcomes of tranquil or asleep by 30 minutes. Economic outcomes were also not reported in the trials.When compared with placebo, fewer people in the aripiprazole group needed additional injections compared to the placebo group (2 RCTs, n = 382, RR 0.69, 95% CI 0.56 to 0.85, very low-quality evidence). Clinically important improvement in agitation at two hours favoured the aripiprazole group (2 RCTs, n = 382, RR 1.50, 95% CI 1.17 to 1.92, very low-quality evidence). The numbers of non-responders after the first injection also favoured aripiprazole (1 RCT, n = 263, RR 0.49, 95% CI 0.34 to 0.71, low-quality evidence). Although no effect was found, more people in the aripiprazole compared to the placebo group experienced adverse effects (1 RCT, n = 117, RR 1.51, 95% CI 0.93 to 2.46, very low-quality evidence).Aripiprazole required more injections compared to haloperidol (2 RCTs, n = 477, RR 1.28, 95% CI 1.00 to 1.63, very low-quality evidence), with no significant difference in agitation (2 RCTs, n = 477, RR 0.94, 95% CI 0.80 to 1.11, very low-quality evidence), and similar non-responders after first injection (1 RCT, n = 360, RR 1.18, 95% CI 0.78 to 1.79, low-quality evidence). Aripiprazole and haloperidol did not differ when taking into account the overall number of people that experienced at least one adverse effect (1 RCT, n = 113, RR 0.91, 95% CI 0.61 to 1.35, very low-quality evidence).Compared to aripiprazole, olanzapine was better at reducing agitation (1 RCT, n = 80, RR 0.77, 95% CI 0.60 to 0.99, low-quality evidence) and had a more favourable effect on global state change scores (1 RCT, n = 80, MD 0.58, 95% CI 0.01 to 1.15, low-quality evidence), both at two hours. No differences were found in terms of experiencing at least one adverse effect during the 24 hours after treatment (1 RCT, n = 80, RR 0.75, 95% CI 0.45 to 1.24, very low-quality evidence). However, participants allocated to aripiprazole experienced less somnolence (1 RCT, n = 80, RR 0.25, 95% CI 0.08 to 0.82, low-quality evidence).
AUTHORS' CONCLUSIONS
The available evidence is of poor quality but there is some evidence aripiprazole is effective compared to placebo and haloperidol, but not when compared to olanzapine. However, considering that evidence comes from only three studies, caution is required in generalising these results to real-world practice. This review firmly highlights the need for more high-quality trials on intramuscular aripiprazole in the management of people with acute aggression or agitation.
Topics: Aggression; Antipsychotic Agents; Aripiprazole; Benzodiazepines; Haloperidol; Humans; Injections, Intramuscular; Olanzapine; Psychomotor Agitation; Randomized Controlled Trials as Topic; Tranquilizing Agents
PubMed: 29308601
DOI: 10.1002/14651858.CD008074.pub2 -
Hand Therapy Mar 2016Trapeziometacarpal osteoarthritis is associated with more pain and restrictions than other hand osteoarthritis due to the functional importance of the thumb. While the... (Review)
Review
Effectiveness of physical and occupational therapy on pain, function and quality of life in patients with trapeziometacarpal osteoarthritis - A systematic review and meta-analysis.
INTRODUCTION
Trapeziometacarpal osteoarthritis is associated with more pain and restrictions than other hand osteoarthritis due to the functional importance of the thumb. While the effectiveness of surgical and pharmacological interventions has been widely examined, there is a lack of specific evidence about conservative non-pharmacological trapeziometacarpal osteoarthritis therapies. The objective of this systematic review was to provide evidence-based knowledge on the effectiveness of physiotherapy and occupational therapy on pain, function and quality of life.
METHODS
A literature search of Medline, CINAHL, PEDro, OTseeker, EMB Dare Cochrane Database of Systematic Reviews and Cochrane CENTRAL was performed. Randomized and quasi-randomized controlled trials and corresponding systematic reviews, observational studies, pragmatic studies and case-control studies were included. The risk of bias was assessed.
RESULTS
Out of 218 studies, 27 were retained. A narrative summary and a series of meta-analyses were performed. Concerning pain reduction, the meta-analysis showed parity of pre-fabricated neoprene and custom-made thermoplastic splints: standardized mean difference (SMD) -0.01 (95%CI -0.43, 0.40) (p=0.95). Multimodal interventions are more effective on pain compared to single interventions: standardized mean difference -3.16 (95%CI -5.56, -0.75) ( = 0.01).
DISCUSSION
Physical and occupational therapy-related interventions, especially multimodal interventions, seem to be effective to treat pain in patients with trapeziometacarpal osteoarthritis. Pre-fabricated neoprene splints and custom-made thermoplastic splints may reduce pain equally. Single interventions seem not to be effective. Significant evidence for effectiveness on function and quality of life could not be found.
PubMed: 27110291
DOI: 10.1177/1758998315614037 -
The Patient Nov 2022Patient support programs aim to provide solutions beyond the medication itself, by enhancing treatment adherence, improving clinical outcomes, elevating patient...
BACKGROUND AND OBJECTIVE
Patient support programs aim to provide solutions beyond the medication itself, by enhancing treatment adherence, improving clinical outcomes, elevating patient experience, and/or increasing quality of life. As patient support programs increasingly play an important role in assisting patients, numerous observational studies and pragmatic trials designed to evaluate their impact on healthcare have been conducted in recent years. This review aims to characterize these studies.
METHODS
A systematic literature review, supplemented by a broad search of gray literature, was conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane recommendations. Observational studies and pragmatic trials conducted in Europe to evaluate the impact of patient support programs, published in English or Spanish between 17/03/2010 and 17/03/2020, were reviewed. Two patient support program definitions were applied starting with Ganguli et al.'s broad approach, followed by the European Medicines Agency definition, narrowed to Marketing Authorization Holders organized systems and their medicines. The quality of publications was assessed using the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement 22-item checklist.
RESULTS
Of the 49 identified studies following the Ganguli et al. definition, 20 studies met the European Medicines Agency definition and were reviewed. Patient support program impact was evaluated based on a wide range of methodologies: 70% assessed patient support program-related patient-reported outcomes, 55% reported clinical outcomes, and 25% reported economic impacts on health resources. Only 45% conducted a comparative analysis. Overall, 75% of the studies achieved their proposed objectives.
CONCLUSIONS
The heterogeneity of the observational studies reviewed reflects the complexity of patient support programs that are built ad hoc for specific diseases, treatments, and patients. Results suggest that patient support programs play a key role in promoting treatment effectiveness, clinical outcomes, and satisfaction. However, there is a need for standardizing the definition of patient support programs and the methods to evaluate their impact.
Topics: Humans; Quality of Life; Checklist; Treatment Outcome; Europe
PubMed: 35725866
DOI: 10.1007/s40271-022-00582-y -
Nutrients Sep 2022The education sector is recognised as an ideal platform to promote good nutrition and decision making around food and eating. Examining adolescents in this setting is... (Meta-Analysis)
Meta-Analysis Review
The Impact of Modifying Food Service Practices in Secondary Schools Providing a Routine Meal Service on Student's Food Behaviours, Health and Dining Experience: A Systematic Review and Meta-Analysis.
The education sector is recognised as an ideal platform to promote good nutrition and decision making around food and eating. Examining adolescents in this setting is important because of the unique features of adolescence compared to younger childhood. This systematic review and meta-analysis examine interventions in secondary schools that provide a routine meal service and the impact on adolescents’ food behaviours, health and dining experience in this setting. The review was guided by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Checklist and Cochrane Handbook recommendations. Studies published in English searched in four databases and a hand search yielded 42 interventions in 35 studies. Risk of bias was assessed independently by two reviewers. Interventions were classified using the NOURISHING framework, and their impact analysed using meta-analysis, vote-counting synthesis or narrative summary. The meta-analysis showed an improvement in students selecting vegetables (odds ratio (OR): 1.39; 1.12 to 1.23; p = 0.002), fruit serves selected (mean difference (MD): 0.09; 0.09 to 0.09; p < 0.001) and consumed (MD: 0.10; 0.04 to 0.15; p < 0.001), and vegetable serves consumed (MD: 0.06; 0.01 to 0.10; p = 0.024). Vote-counting showed a positive impact for most interventions that measured selection (15 of 25; 41% to 77%; p = 0.002) and consumption (14 of 24; 39% to 76%; p = 0.013) of a meal component. Interventions that integrate improving menu quality, assess palatability, accessibility of healthier options, and student engagement can enhance success. These results should be interpreted with caution as most studies were not methodologically strong and at higher risk of bias. There is a need for higher quality pragmatic trials, strategies to build and measure sustained change, and evaluation of end-user attitudes and perceptions towards intervention components and implementation for greater insight into intervention success and future directions (PROSPERO registration: CRD42020167133).
Topics: Adolescent; Child; Food Services; Health Behavior; Humans; Schools; Students; Vegetables
PubMed: 36079897
DOI: 10.3390/nu14173640 -
The Cochrane Database of Systematic... Jul 2016Inhalation of the enzyme dornase alfa reduces sputum viscosity and improves clinical outcomes of people with cystic fibrosis. This is an update of a previously published... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Inhalation of the enzyme dornase alfa reduces sputum viscosity and improves clinical outcomes of people with cystic fibrosis. This is an update of a previously published Cochrane review.
OBJECTIVES
To determine the effect of timing of dornase alfa inhalation on measures of clinical efficacy in people with cystic fibrosis (in relation to airway clearance techniques or time of day).
SEARCH METHODS
Relevant randomised and quasi-randomised controlled trials were identified from the Cochrane Cystic Fibrosis Trials Register, Physiotherapy Evidence Database (PEDro), and international cystic fibrosis conference proceedings.Date of the most recent search: 25 April 2016.
SELECTION CRITERIA
Any trial of dornase alfa in people with cystic fibrosis where timing of inhalation was the randomised element in the study with either: inhalation before compared to after airway clearance techniques; or morning compared to evening inhalation.
DATA COLLECTION AND ANALYSIS
Both authors independently selected trials, assessed risk of bias and extracted data with disagreements resolved by discussion. Relevant data were extracted and, where possible, meta-analysed.
MAIN RESULTS
We identified 115 trial reports representing 55 studies, of which five studies (providing data on 122 participants) met our inclusion criteria. All five studies used a cross-over design. Intervention periods ranged from two to eight weeks. Four trials compared dornase alfa inhalation before versus after airway clearance techniques. Inhalation after instead of before airway clearance did not significantly change forced expiratory volume at one second. Similarly, forced vital capacity and quality of life were not significantly affected; forced expiratory flow at 25% was significantly worse with dornase alfa inhalation after airway clearance, mean difference -0.17 litres (95% confidence interval -0.28 to -0.05), based on the pooled data from two small studies in children (seven to 19 years) with well-preserved lung function. All other secondary outcomes were statistically non-significant.In one trial, morning versus evening inhalation had no impact on lung function or symptoms.
AUTHORS' CONCLUSIONS
The current evidence derived from a small number of participants does not indicate that inhalation of dornase alfa after airway clearance techniques is more or less effective than the traditional recommendation to inhale nebulised dornase alfa 30 minutes prior to airway clearance techniques, for most outcomes. For children with well-preserved lung function, inhalation before airway clearance may be more beneficial for small airway function than inhalation after. However, this result relied on a measure with high variability and studies with variable follow up. In the absence of strong evidence to indicate that one timing regimen is better than another, the timing of dornase alpha inhalation can be largely based on pragmatic reasons or individual preference with respect to the time of airway clearance and time of day. Further research is warranted.
Topics: Administration, Inhalation; Adolescent; Child; Combined Modality Therapy; Cystic Fibrosis; Deoxyribonuclease I; Drug Administration Schedule; Humans; Quality of Life; Randomized Controlled Trials as Topic; Recombinant Proteins; Respiratory Therapy; Time Factors; Young Adult
PubMed: 27457496
DOI: 10.1002/14651858.CD007923.pub4 -
The Cochrane Database of Systematic... Oct 2017Lengthy duration of use may be a risk factor for umbilical venous catheter-associated bloodstream infection in newborn infants. Early planned removal of umbilical venous... (Review)
Review
BACKGROUND
Lengthy duration of use may be a risk factor for umbilical venous catheter-associated bloodstream infection in newborn infants. Early planned removal of umbilical venous catheters (UVCs) is recommended to reduce the incidence of infection and associated morbidity and mortality.
OBJECTIVES
To compare the effectiveness of early planned removal of UVCs (up to two weeks after insertion) versus an expectant approach or a longer fixed duration in preventing bloodstream infection and other complications in newborn infants.To perform subgroup analyses by gestational age at birth and prespecified planned duration of UVC placement (see "Subgroup analysis and investigation of heterogeneity").
SEARCH METHODS
We used the standard Cochrane Neonatal search strategy including electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 4), Ovid MEDLINE, Embase, and the Maternity & Infant Care Database (until May 2017), as well as conference proceedings and previous reviews.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials that compared effects of early planned removal of UVCs (up to two weeks after insertion) versus an expectant approach or a longer fixed duration in preventing bloodstream infection and other complications in newborn infants.
DATA COLLECTION AND ANALYSIS
Two review authors assessed trial eligibility and risk of bias and independently undertook data extraction. We analysed treatment effects and reported risk ratio (RR) and risk difference (RD) for dichotomous data, and mean difference (MD) for continuous data, with respective 95% confidence intervals (CIs). We planned to use a fixed-effect model in meta-analyses and to explore potential causes of heterogeneity in sensitivity analyses. We assessed the quality of evidence for the main comparison at the outcome level using GRADE methods.
MAIN RESULTS
We found one eligible trial. Participants were 210 newborn infants with birth weight less than 1251 grams. The trial was unblinded but otherwise of good methodological quality. This trial compared removal of an umbilical venous catheter within 10 days after insertion (and replacement with a peripheral cannula or a percutaneously inserted central catheter as required) versus expectant management (UVC in place up to 28 days). More infants in the early planned removal group than in the expectant management group (83 vs 33) required percutaneous insertion of a central catheter (PICC). Trial results showed no difference in the incidence of catheter-related bloodstream infection (RR 0.65, 95% CI 0.35 to 1.22), in hospital mortality (RR 1.12, 95% CI 0.42 to 2.98), in catheter-associated thrombus necessitating removal (RR 0.33, 95% confidence interval 0.01 to 7.94), or in other morbidity. GRADE assessment indicated that the quality of evidence was "low" at outcome level principally as the result of imprecision and risk of surveillance bias due to lack of blinding in the included trial.
AUTHORS' CONCLUSIONS
Currently available trial data are insufficient to show whether early planned removal of umbilical venous catheters reduces risk of infection, mortality, or other morbidity in newborn infants. A large, simple, and pragmatic randomised controlled trial is needed to resolve this ongoing uncertainty.
Topics: Catheter-Related Infections; Catheterization, Peripheral; Catheters; Cause of Death; Central Venous Catheters; Device Removal; Humans; Infant, Newborn; Infant, Very Low Birth Weight; Thrombosis; Time Factors; Umbilical Veins
PubMed: 29017005
DOI: 10.1002/14651858.CD012142.pub2 -
Frontiers in Medicine 2021Pragmatic trials inform clinical decision with better generalizability and can bridge different streams of medicine. This study collated the expectations regarding...
Pragmatic trials inform clinical decision with better generalizability and can bridge different streams of medicine. This study collated the expectations regarding pragmatic trial design of integrative medicine (IM) for diabetes and kidney diseases among patients and physicians. Dissonance between users' perspective and existing pragmatic trial design was identified. The association between risk of bias and pragmatism of study design was assessed. A 10-group semi-structured focus group interview series [21 patients, 14 conventional medicine (ConM) and 15 Chinese medicine (CM) physicians] were purposively sampled from private and public clinics in Hong Kong. Perspectives were qualitatively analyzed by constant comparative method. A systematic search of four databases was performed to identify existing IM pragmatic clinical trials in diabetes or kidney disease. Primary outcomes were the pragmatism, risk of bias, and rationale of the study design. Risk of bias and pragmatism were assessed based on Cochrane risk-of-bias tool and PRECIS-2, respectively. The correlation between risk of bias and pragmatism was assessed by regression models with sensitivity analyses. The subtheme on the motivation to seek IM service was analyzed, covering the perceived limitation of ConM effect, perceived benefits of IM service, and assessment of IM effectiveness. Patients expected IM service to retard disease progression, stabilize concomitant drug dosage, and reduce potential side effects associated with ConM. In the systematic review, 25 studies from six countries were included covering CM, Korean medicine, Ayurvedic medicine, and western herbal medicine. Existing study designs did not include a detailed assessment of concomitant drug change and adverse events. Majority of studies either recruited a non-representative proportion of patients as traditional, complementary, and integrative medicine (TCIM) diagnosis was used as inclusion criteria, or not reflecting the real-world practice of TCIM by completely dropping TCIM diagnosis in the trial design. Consultation follow-up frequency is the least pragmatic domain. Increase in pragmatism did not associate with a higher risk of bias. Existing IM pragmatic trial design does not match the patients' expectation in the analysis of incident concomitant drug change and adverse events. A two-layer design incorporating TCIM diagnosis as a stratification factor maximizes the generalizability of evidence and real-world translation of both ConM and TCIM.
PubMed: 34513860
DOI: 10.3389/fmed.2021.668913 -
Respiratory Medicine 2019Evidence to support the implementation of telehealth (TH) interventions in the management of chronic obstructive pulmonary disease (COPD) varies throughout Europe.... (Review)
Review
BACKGROUND
Evidence to support the implementation of telehealth (TH) interventions in the management of chronic obstructive pulmonary disease (COPD) varies throughout Europe. Despite more than ten years of TH research in COPD management, it is still not possible to define which TH interventions are beneficial to which patient group. Therefore, informing policymakers on TH implementation is complicated. We aimed to examine the provision and efficacy of TH for COPD management to guide future decision-making.
METHODS
A mapping study of twelve systematic reviews of TH interventions for COPD management was conducted. This was followed by an in-depth review of fourteen clinical trials performed in Europe extracted from the systematic reviews. Efficacy outcomes for COPD management were synthesized.
RESULTS
The mapping study revealed that systematic reviews with a meta-analysis often report positive clinical outcomes. Despite this, we identified a lack of pragmatic trial design affecting the synthesis of reported outcomes. The in-depth review visualized outcomes for three TH categories, which revealed a plethora of heterogeneous outcomes. Suggestions for reporting within these three outcomes are synthesized as targets for future empirical research reporting.
CONCLUSION
The present study indicates the need for more standardized and updated systematic reviews. Policymakers should advocate for improved TH trial designs, focusing on the entire intervention's adoption process evaluation. One of the policymakers' priorities should be the harmonization of the outcome sets, which would be considered suitable for deciding about subsequent reimbursement. We propose possible outcome sets in three TH categories which could be used for discussion with stakeholders.
Topics: Delivery of Health Care, Integrated; Europe; Humans; Pulmonary Disease, Chronic Obstructive; Telemedicine
PubMed: 31614305
DOI: 10.1016/j.rmed.2019.09.005