Feedback from Outcome Measures and Treatment Effectiveness, Treatment Efficiency, and Collaborative Practice: A Systematic Review.
Ontology highlight
ABSTRACT:
SUBMITTER: Gondek D
PROVIDER: S-EPMC4831994 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BACKGROUND: Dupuytren's disease of the hand is a common condition affecting the palmar fascia, resulting in progressive flexion deformities of the digits and hence limitation of hand function. The optimal treatment remains unclear as outcomes studies have used a variety of measures for assessment. METHODS: A literature search was performed for all publications describing surgical treatment, percutaneous needle aponeurotomy or collagenase injection for primary or recurrent Dupuytren's disease where outcomes had been monitored using functional measures. RESULTS: Ninety-one studies met the inclusion criteria. Twenty-two studies reported outcomes using patient reported outcome measures (PROMs) ranging from validated questionnaires to self-reported measures for return to work and self-rated disability. The Disability of Arm, Shoulder and Hand (DASH) score was the most utilised patient-reported function measure (n=11). Patient satisfaction was reported by eighteen studies but no single method was used consistently. Range of movement was the most frequent physical measure and was reported in all 91 studies. However, the methods of measurement and reporting varied, with seventeen different techniques being used. Other physical measures included grip and pinch strength and sensibility, again with variations in measurement protocols. The mean follow-up time ranged from 2 weeks to 17 years. CONCLUSIONS: There is little consistency in the reporting of outcomes for interventions in patients with Dupuytren's disease, making it impossible to compare the efficacy of different treatment modalities. Although there are limitations to the existing generic patient reported outcomes measures, a combination of these together with a disease-specific questionnaire, and physical measures of active and passive individual joint Range of movement (ROM), grip and sensibility using standardised protocols should be used for future outcomes studies. As Dupuytren's disease tends to recur following treatment as well as extend to involve other areas of the hand, follow-up times should be standardised and designed to capture both short and long term outcomes.
| S-EPMC3637830 | biostudies-other
Project description:OBJECTIVE: To review and characterize existing health care efficiency measures in order to facilitate a common understanding about the adequacy of these methods. DATA SOURCES: Review of the MedLine and EconLit databases for articles published from 1990 to 2008, as well as search of the "gray" literature for additional measures developed by private organizations. STUDY DESIGN: We performed a systematic review for existing efficiency measures. We classified the efficiency measures by perspective, outputs, inputs, methods used, and reporting of scientific soundness. PRINCIPAL FINDINGS: We identified 265 measures in the peer-reviewed literature and eight measures in the gray literature, with little overlap between the two sets of measures. Almost all of the measures did not explicitly consider the quality of care. Thus, if quality varies substantially across groups, which is likely in some cases, the measures reflect only the costs of care, not efficiency. Evidence on the measures' scientific soundness was mostly lacking: evidence on reliability or validity was reported for six measures (2.3 percent) and sensitivity analyses were reported for 67 measures (25.3 percent). CONCLUSIONS: Efficiency measures have been subjected to few rigorous evaluations of reliability and validity, and methods of accounting for quality of care in efficiency measurement are not well developed at this time. Use of these measures without greater understanding of these issues is likely to engender resistance from providers and could lead to unintended consequences.
| S-EPMC2699907 | biostudies-other
Project description:BACKGROUND:Heterogeneity has been noted in the selection and reporting of disease-specific, pediatric outcomes in randomized controlled trials (RCTs). The consequence is invalid results or difficulty comparing results across trials. The primary objective of this systematic review was to assess primary outcome and outcome measure selection and reporting, in pediatric eosinophilic esophagitis (EoE) treatment trials. As secondary objectives, we compared trial disease definition to established concensus guidelines, and the efficacy of current EoE treatments. METHODS:We searched MEDLINE, EMBASE, The Cochrane Library, Cochrane Central Register of Controlled Trials (CENTRAL), and CINAHL since 2001. We also searched clinical trial registries (portal.nihr.ac.uk; clinicaltrials.gov; isrctn.com; and anzctr.org.au) and references of included studies. We included RCTs of EoE treatment in patients 0-18 years. Two authors independently assessed articles. RESULTS:Eleven studies met inclusion criteria. All identified primary outcomes, however, of 9 unique primary outcomes, only 2 were used in more than one study. In total, 25 unique primary and secondary outcome measures were employed for pediatric EoE treatment trials. Measurement properties and rationale for their selection was rarely provided. Uptake of consensus-based diagnostic criteria was 25 % in trials initiated after 2011. Due to the small number and heterogeneity of studies obtained, no meta-analysis of treatment efficacy could be undertaken. This SR was limited to exclusively pediatric RCTs. CONCLUSIONS:The results of this study confirm the need for a standardized set of core outcomes that are universally reported in pediatric EoE trials. Consistent disease definition and standardized outcome reporting will facilitate meta-analyses across similar trials and inform future clinical decision-making. Systematic review registration number CRD42013003798.
| S-EPMC5006498 | biostudies-literature
Project description:BackgroundIn this systematic review we sought to characterize practice effects on traditional in-clinic or digital performance outcome measures commonly used in one of four neurologic disease areas (multiple sclerosis; Huntington's disease; Parkinson's disease; and Alzheimer's disease, mild cognitive impairment and other forms of dementia), describe mitigation strategies to minimize their impact on data interpretation and identify gaps to be addressed in future work.MethodsFifty-eight original articles (49 from Embase and an additional 4 from PubMed and 5 from additional sources; cut-off date January 13, 2021) describing practice effects or their mitigation strategies were included.ResultsPractice effects observed in healthy volunteers do not always translate to patients living with neurologic disorders. Mitigation strategies include reliable changes indices that account for practice effects or a run-in period. While the former requires data from a reference sample showing similar practice effects, the latter requires a sufficient number of tests in the run-in period to reach steady-state performance. However, many studies only included 2 or 3 test administrations, which is insufficient to define the number of tests needed in a run-in period.DiscussionSeveral gaps have been identified. In particular the assessment of practice effects on an individual patient level as well as the temporal dynamics of practice effects are largely unaddressed. Here, digital tests, which allow much higher testing frequency over prolonged periods of time, can be used in future work to gain a deeper understanding of practice effects and to develop new metrics for assessing and accounting for practice effects in clinical research and clinical trials.
| S-EPMC9445299 | biostudies-literature
Project description:BackgroundThe World Health Organization claimed that measuring outcomes is necessary to understand the benefits of assistive technology (AT) and create evidence-based policies and systems to ensure universal access to it. In clinical practice, there is an increasing need for standardized methods to track AT interventions using outcome assessments.ObjectiveThis review provides an overview of the available outcome measures that can be used at the follow-up stage of any AT intervention and integrated into daily clinical or service practice.MethodsWe systematically searched for original manuscripts regarding available and used AT outcome measures by searching for titles and abstracts in the PubMed, Scopus, and Web of Science databases up to March 2023.ResultsWe analyzed 955 articles, of which 50 (5.2%) were included in the review. Within these, 53 instruments have been mentioned and used to provide an AT outcome assessment. The most widely used tool is the Quebec User Evaluation of Satisfaction with Assistive Technology, followed by the Psychosocial Impact of Assistive Technology Scale. Moreover, the identified measures addressed 8 AT outcome domains: functional efficacy, satisfaction, psychosocial impact, caregiver burden, quality of life, participation, confidence, and usability. The AT category Assistive products for activities and participation relating to personal mobility and transportation was the most involved in the reviewed articles.ConclusionsAmong the 53 cited instruments, only 17 (32%) scales were designed to evaluate specifically assistive devices. Moreover, 64% (34/53) of the instruments were only mentioned once to denote poor uniformity and concordance in the instruments to be used, limiting the possibility of comparing the results of studies. This work could represent a good guide for promoting the use of validated AT outcome measures in clinical practice that can be helpful to AT assessment teams in their everyday activities and the improvement of clinical practice.
| S-EPMC10687703 | biostudies-literature
Project description:Study questionWhich outcomes and outcome measures are reported in interventional trials evaluating the treatment of adenomyosis?Summary answerWe identified 38 studies, reporting on 203 outcomes using 133 outcome measures.What is known alreadyHeterogeneity in outcome evaluation and reporting has been demonstrated for several gynaecological conditions and in fertility studies. In adenomyosis, previous systematic reviews have failed to perform a quantitative analysis for central outcomes, due to variations in outcome reporting and measuring.Study design size durationA systematic search of Embase, Medline and Cochrane Register of Controlled Trials (CENTRAL) was performed with a timeframe from 1950 until February 2021, following the preferred reporting items for systematic reviews and meta-analysis (PRISMA).Participants/materials setting methodsStudies reporting on any uterus-sparing intervention to treat adenomyosis, both prospective and retrospective, were eligible for inclusion. Inclusion criteria were a clear definition of diagnostic criteria for adenomyosis and the modality used to make the diagnosis, a clear description of the intervention, a follow-up time of ≥6 months, a study population of n ≥ 20, a follow-up rate of at least 80%, and English language. The population included premenopausal women with adenomyosis. Risk of bias was assessed using the Evidence Project risk of bias tool.Main results and the role of chanceWe included 38 studies (6 randomized controlled trials and 32 cohort studies), including 5175 participants with adenomyosis. The studies described 10 interventions and reported on 203 outcomes, including 43 classified as harms, in 29 predefined domains. Dysmenorrhoea (reported in 82%), heavy menstrual bleeding (HMB) (in 79%) and uterine volume (in 71%) were the most common outcomes. Fourteen different outcome measures were used for dysmenorrhoea and 17 for HMB. Quality of life was reported in 9 (24%) studies, patient satisfaction with treatment in 1 (3%). A clear primary outcome was stated in only 18%.Limitations reasons for cautionThis review includes studies with a high risk of bias.Wider implications of the findingsShortcomings in the definition and choice of outcomes and outcome measures limit the value of the conducted research. The development and implementation of a core outcome set (COS) for interventional studies in adenomyosis could improve research quality. This review suggests a lack of patient-centred research in adenomyosis and people with adenomyosis should be involved in the development and implementation of the COS.Study funding/competing interestsNo funds specifically for this work were received. T.T. receives fees from General Electrics for lectures on ultrasound independently of this project.Trial registration numberThis review is registered with the International Prospective Register of Systematic Reviews (PROSPERO; registration number CRD42020177466) and the Core Outcome Measures in Effectiveness Trials (COMET) initiative (registration number 1649).
| S-EPMC8398753 | biostudies-literature
Project description:BackgroundRecently different subtypes of myasthenia gravis (MG) have been described. They differ for clinical features and pathogenesis but the prognosis and response to treatment is less clear. The aim of the study was to evaluate outcome and treatment effectiveness including side effects in late onset MG (LOMG) compared with early onset MG (EOMG).MethodsWe analysed retrospectively 208 MG patients. Clinical features were recorded as well as treatment and side effects. Outcome at the last follow-up was evaluated with MGSTI and MGPIS scales.ResultsThe 208 patients included were classified as follow: 36 ocular MG, 40 EOMG, 72 LOMG, 25 thymoma-associated, 14 anti-MuSK and 21 double seronegative. Similar positive outcome was achieved in either early and late onset subgroup. We found pharmacological remission and minimal manifestations at the MGFA-PIS in the 95% and 94,4% of EOMG and LOMG respectively but in LOMG a lower dose of immunosuppressors (MGSTI< 2) was required compared to EOMG (p = 0,048). Severe side effects were present in a small percentage of patients in both group but diabetes was more frequent in LOMG vs EOMG (2,2% vs 5%, p = 0.017).ConclusionsDespite LOMG has more comorbidities that might interfere with treatment and outcome, therapeutic management does not seem to differ between EOMG and LOMG. A similar positive outcome was seen in both subgroups but LOMG group seems to require lower doses of medication to control symptoms.
| S-EPMC7650071 | biostudies-literature
Project description:AimSix Phase III randomized trials have determined the effectiveness of chemoradiotherapy as primary treatment for anal squamous cell carcinoma (ASCC), but outcomes reported in these trials varied widely, hindering evidence synthesis. To improve reporting in all future trials, we aim to develop a core outcomes set (COS). As the first stage of COS development, we undertook a systematic review to summarize the outcomes reported in studies evaluating chemoradiotherapy for ASCC.MethodSystematic literature searches identified studies evaluating radiotherapy or chemoradiotherapy for ASCC. Outcomes and accompanying definitions were extracted verbatim and categorized into domains.ResultsFrom 5170 abstracts, we identified 95 eligible studies, reporting 1192 outcomes and 533 unique terms. We collapsed these terms into 86 standardized outcomes and five domains: survival; disease activity; life impact [including quality of life (QoL)]; delivery of care; and toxicity. The most commonly reported domains were survival and disease activity, reported in 74 (86%) and 54 (62%) studies, respectively. No outcome was reported in every publication. Over half (43/86) of the standardized outcome terms were reported in fewer than five studies, and 21 (25%) were reported in a single study only. There was wide variation in definitions of disease-free survival, colostomy-free survival and progression-free survival (PFS). Anal continence was reported in only 35 (41%) studies.ConclusionOutcomes reported in studies evaluating chemoradiotherapy for ASCC were heterogenous and definitions varied widely. Outcomes likely to be important to patients, such as ano-rectal function, toxicity and QoL, have been neglected. A COS for future trials will address these issues.
| S-EPMC5969105 | biostudies-literature
Project description:BackgroundAfter dermatitis, acne is the next skin disease to contribute most to the burden of skin diseases worldwide. Recently, seven core outcome domains have been identified, which together form an Acne Core Outcome Set (ACORN). One of these was satisfaction with acne treatment.ObjectivesTo identify studies that described the development of patient-reported outcome measures (PROMS), evaluated one or more measurement properties of a PROM, or evaluated the interpretability of a PROM in patients with acne regarding treatment satisfaction.MethodsThe COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) search strategy for identifying PROMS on acne treatment satisfaction was used. We searched PubMed, MEDLINE, Embase, LILACS, Web of Science, Cochrane Library, Emcare, PsycINFO and Academic Search premier (June 2020). Study selection, data extraction and assessment of methodological quality according to COSMIN guidance were carried out independently by two authors.ResultsOnly one study could be included, describing the development of a treatment satisfaction measure in patients with acne. The development was assessed as inadequate and data on measurement properties were lacking. Additionally, we found 188 studies reporting treatment satisfaction solely as an outcome, using a wide variety of methods, none of them standardized or validated.ConclusionsWe could not find a PROM on treatment satisfaction to recommend for a core outcome set in acne. There is an unmet need for a PROM on treatment satisfaction in acne that is robustly developed, designed and validated.
| S-EPMC8359297 | biostudies-literature
Project description:BackgroundFor the treatment of depressive disorders, the framework of collaborative care has been recommended, which showed improved outcomes in the primary care sector. Yet, an earlier literature review did not find sufficient evidence to draw robust conclusions on the cost-effectiveness of collaborative care.PurposeTo systematically review studies on the cost-effectiveness of collaborative care, compared with usual care for the treatment of patients with depressive disorders in primary care.MethodsA systematic literature search in major databases was conducted. Risk of bias was assessed using the Cochrane Collaboration's tool. Methodological quality of the articles was assessed using the Consensus on Health Economic Criteria (CHEC) list. To ensure comparability across studies, cost data were inflated to the year 2012 using country-specific gross domestic product inflation rates, and were adjusted to international dollars using purchasing power parities (PPP).ResultsIn total, 19 cost-effectiveness analyses were reviewed. The included studies had sample sizes between n = 65 to n = 1,801, and time horizons between six to 24 months. Between 42% and 89% of the CHEC quality criteria were fulfilled, and in only one study no risk of bias was identified. A societal perspective was used by five studies. Incremental costs per depression-free day ranged from dominance to US$PPP 64.89, and incremental costs per QALY from dominance to US$PPP 874,562.ConclusionDespite our review improved the comparability of study results, cost-effectiveness of collaborative care compared with usual care for the treatment of patients with depressive disorders in primary care is ambiguous depending on willingness to pay. A still considerable uncertainty, due to inconsistent methodological quality and results among included studies, suggests further cost-effectiveness analyses using QALYs as effect measures and a time horizon of at least 1 year.
| S-EPMC4437997 | biostudies-literature