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1.
Paul Declerck Georgios Bakalos Elias Zintzaras Bettina Barton Thomas Schreitmüller 《Clinical therapeutics》2018,40(5):798-809.e2
Purpose
With the introduction of biosimilars of anticancer monoclonal antibodies (mAbs) in oncology, physicians are potentially confronted with the question whether it is clinically adequate to switch patients who are clinically stable on treatment with the reference product to a newly available biosimilar (or vice versa/from 1 biosimilar to another). For a proper impact assessment of switching, robust, product-specific, and clinically relevant evidence should be required, ideally including data from appropriately designed switching studies. In this article, we assess the current body of switching data available for approved or proposed biosimilars of anticancer mAbs.Methods
PubMed was systematically searched and ClinicalTrials.gov and abstract databases of selected congresses were hand-searched to identify all switching studies including biosimilars of anticancer mAbs.Findings
We identified 8 switching studies with biosimilars of rituximab (CT-P10, GP2013, PF-05280586, and BCD-020) and trastuzumab (ABP 980). Two were performed in oncology indications and the other 6 in rheumatoid arthritis (RA). Key elements of a well-designed switching study, such as randomization and blinding, were contained in several of the studies, but significant limitations were also present. The most frequent limitations were low statistical power because of small patient numbers, lack of an appropriate control arm, short follow-up, chosen outcome measures, and (for studies performed in RA) the concern whether switching data can be extrapolated to oncology indications. Accordingly, the data from these studies need to be interpreted with caution. Of note, all identified studies included a single switch only, whereas multiple switches may occur in the real-world setting. The scientific need to evaluate the impact of repeated switching has been recognized by the US Food and Drug Administration, who incorporated such a requirement in its draft guidance on interchangeability.Implications
From the scarce data available, the consequences of switching between reference product mAbs and their biosimilar(s) in the oncology setting are as yet unknown. Additional clinical evidence from well-designed switching studies is needed to guide switching decisions. 相似文献2.
Abstract
In addition to the general clinical benefit offered, biosimilars may not only generate savings for healthcare budgets but also improve patient access to biologic products. Since the first biosimilar was approved in Europe in 2006, a further 36 different biosimilar drugs have been approved for several indications. Despite the wealth of experience gained and the reported data supporting the use of biosimilars, both in naïve and biologic-experienced patients, some healthcare professionals continue to express doubt regarding the rigorous approval process for biosimilars and uncertainty with how to incorporate them into daily clinical practice. These opinions can be transferred to patients through poor or lack of communication, meaning that patients may lack confidence in treatment quality and, as a result, be susceptible to the nocebo effect. At the 2017 American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting, during a debate the question was asked as to whether the nocebo effect was in fact being used to describe “any result you don’t agree with”. Here, we detail that the nocebo effect has been demonstrated in a number of clinical trials, and that this effect may negatively affect acceptance in patients switching from an originator product to a biosimilar. Awareness of the potential for the nocebo effect and adoption of enhanced communication techniques may be useful in mitigating the nocebo effect. Effective healthcare professional–patient dialogue is key in transferring confidence to the patient, and has been shown to reduce nocebo effects in patients when switching from an originator to a biosimilar.Funding
Biogen International GmbH.3.
Tumor necrosis factor (TNF) inhibitors are widely used biologics for the treatment of several chronic inflammatory diseases. The launch of anti-TNF biosimilars has introduced the possibility of non-medical switching between originator biologics and their biosimilars. However, the potential clinical and patient-reported consequences of non-medical switching remain largely unknown, as much of the evidence comes from poorly or uncontrolled real-world evidence (RWE) studies that often have an element of bias and nonstandardized outcome measures. To appropriately evaluate the safety, efficacy, and immunogenicity of non-medical switching from an originator to its biosimilar, we propose that seven key study design elements should be considered when assessing the existing evidence: studies should be (1) randomized and double-blind, (2) adequately controlled, and (3) adequately powered; include (4) multiple switching, (5) an assessment of immunogenicity, and (6) adequate follow-up duration; and (7) report individual patient-level outcomes. This systematic review assessed the robustness and consistency of the current non-medical switching evidence, with a focus on TNF inhibitors. A comprehensive literature search (January 2012–February 2018) identified 98 publications corresponding to 91 studies (17 randomized controlled trials and 74 RWE studies) describing non-medical switching from a TNF inhibitor originator to its biosimilar. When assessing the totality of this evidence, none of the non-medical switching studies conducted to date were found to use all seven of the key design elements, and the absence of these elements dilutes the robustness of the data. Furthermore, discontinuation rates varied widely among studies (0–87%), suggesting heterogeneity and inconclusiveness of the current efficacy, safety, and immunogenicity evidence, particularly at an individual patient level. Therefore, patients should not be indiscriminately switched from an originator TNF inhibitor to its biosimilar for non-medical reasons. Switching decisions should remain between the treating physicians and their patients and be made on a case-by-case basis, relying upon robust scientific evidence.Funding: AbbVie.Plain Language Summary: Plain language summary available for this article. 相似文献
4.
Takanori Asakura Taku Nakagawa Shoji Suzuki Ho Namkoong Kozo Morimoto Makoto Ishii Atsuyuki Kurashima Tomoko Betsuyaku Kenji Ogawa Naoki Hasegawa 《Journal of infection and chemotherapy》2019,25(3):218-221
Background
The optimal duration of antimicrobial therapy for Mycobacterium avium complex lung disease (MAC-LD) is unknown, and recurrence rates are high after treatment discontinuation. Intermittent therapy is recommended for the initial treatment of non-cavitary nodular/bronchiectatic MAC-LD. We hypothesized that intermittent maintenance therapy (IMT) could effectively prevent recurrence after successful treatment of MAC-LD.Methods
Adult patients diagnosed with MAC-LD who received IMT after successful daily therapy (DT) between January 1, 2006 and December 31, 2016 were identified from clinical databases at three institutions in Japan. Treatment outcomes were evaluated for all patients.Results
Of 38 patients (median age, 66 years; 29 women; nodular/bronchiectatic form, 29 patients) who received IMT after successful treatment, one was excluded due to death from an unknown cause, 1 month after IMT initiation. Finally, treatment outcomes were evaluated for 37 patients. Twenty-eight (76%) patients had sustained negative culture results over a median follow-up duration of 2.7 (interquartile range [IQR], 1.9–6.0) years, while six (16%) required switching to DT because of clinical deterioration over a median follow-up duration of 2.7 (IQR, 1.6–4.1) years. Favorable clinical outcomes were achieved for all patients who exhibited clinical deterioration. All patients tolerated the antimicrobials without discontinuation, and follow-up drug susceptibility testing showed negative results for clarithromycin-resistant MAC in the patients who experienced clinical deterioration.Conclusions
IMT after successful treatment may be a feasible option for patients with MAC-LD. Further studies should determine the population that would benefit from this strategy. 相似文献5.
Bryan Spinelli Michael J. Kallan Xiaochen Zhang Andrea Cheville Andrea Troxel Joy Cohn Lorraine Dean Kathleen Sturgeon Margaret Evangelista Zi Zhang David Ebaugh Kathryn H. Schmitz 《Archives of physical medicine and rehabilitation》2019,100(2):315-326
Objective
The goal of this study was to develop and assess intra- and interrater reliability and validity of a clinical evaluation tool for breast cancer–related lymphedema, for use in the context of outcome evaluation in clinical trials.Design
Blinded repeated measures observational study.Setting
Outpatient research laboratory.Participants
Breast cancer survivors with and without lymphedema (N=71).Interventions
Not applicable.Main Outcome Measure
The assessment of intraclass correlation coefficients (ICCs) for the Breast Cancer–Related Lymphedema of the Upper Extremity (CLUE) standardized clinical evaluation tool.Results
Intrarater reliability for the CLUE tool was ICC: 0.88 (95% confidence interval [95% CI], 0.71-0.96). Interrater reliability for the CLUE tool was ICC: 0.90 (95% CI, 0.79-0.95). Concurrent validity of the CLUE score (Pearson r) was 0.79 with perometric interlimb difference and 0.53 with the Norman lymphedema overall score.Conclusions
The CLUE tool shows excellent inter- and intrarater reliability. The overall CLUE score for the upper extremity also shows moderately strong concurrent validity with objective and subjective measures. This newly developed clinical, physical assessment of upper extremity lymphedema provides standardization and a single score that accounts for multiple constructs. Next steps include evaluation of sensitivity to change, which would establish usefulness to evaluate intervention efficacy. 相似文献6.
Purpose
In light of recently published guidelines from the US Food and Drug Administration (FDA) on the communication of real-world data (RWD) and real-world evidence (RWE) to support regulatory decision making, it is important to understand how such data are developed, the limitations of these data, and how to best use RWD to improve patient care. Historically, the use of RWE has been approached with skepticism because of its often-retrospective nature compared with data from conventional randomized controlled trials (RCTs). This review discusses the role and function of RWE and RWD in clinical research. We summarize the types of RWE used in clinical research, outline the challenges and limitations involved with these data, and suggest how these types of analyses can supplement results from clinical trials to foster a more complete understanding of a drug or disease area of interest. In particular, we focus on the role of RWE in investigating chronic myeloid leukemia (CML) and tyrosine kinase inhibitor therapy for CML.Methods
We reviewed FDA guidance on the use of RWE and conducted a PubMed literature search to evaluate published data from real-world studies in CML.Findings
RWE includes analysis of RWD gathered from nonconventional sources, including patient registries, observational studies, and social media, among others. Importantly, although real-world studies do not adhere to the same degree of controlled conditions and predefined patient-management strategies as do conventional clinical trials, analyses resulting from these studies can be held to a high degree of validation and standardization, making them as meaningful as those from RCTs. In CML, RWE has informed early treatment milestones and has provided a window into patient perspectives regarding treatment. These types of analyses have already informed and can continue to inform disease management. These improvements in disease management, in turn, will help clinicians to better forecast treatment challenges and allow for the optimization of future treatment paradigms.Implications
Real-world studies are different from conventional RCTs and therefore provide insight into distinct aspects of treatment and patient outcomes. Together with results from clinical trials, RWE can help to illustrate a more complete picture of the tolerability, effectiveness, and impact of a drug. The recently published guidelines indicate that the FDA expects a growing role for RWE. 相似文献7.
Luisa Galli Elisabetta Venturini Andrea Bassi Guido Castelli Gattinara Elena Chiappini Claudio Defilippi Andrea Diociaiuti Susanna Esposito Silvia Garazzino Antonietta Giannattasio Andrzej Krzysztofiak Stefano Latorre Andrea Lo Vecchio Paola Marchisio Carlotta Montagnani Giangiacomo Nicolini Andrea Novelli Gian Maria Rossolini Iria Neri 《Clinical therapeutics》2019,41(3):532-551.e17
Purpose
The main objective of this article was to offer practical suggestions, given the existing evidence, for identifying and managing bacterial impetigo, abscess, and cellulitis in ambulatory and hospital settings.Methods
Five Italian pediatric societies appointed a core working group. In selected conditions, specially trained personnel evaluated quality assessment of treatment strategies according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology. Only randomized controlled trials (RCTs) and observational studies were included for quality assessment according to the GRADE methodology. MEDLINE, Ovid MEDLINE, EMBASE, and Cochrane Library databases were searched with a strategy combining MeSH and free text terms.Findings
The literature review included 364 articles focusing on impetigo, skin abscess, and cellulitis/orbital cellulitis. The articles included for quality assessment according to the GRADE methodology for impetigo comprised 5 RCTs and 1 observational study; for skin abscess, 10 RCTs and 3 observational studies were included; for cellulitis and erysipelas, 5 RCTs and 5 observational studies were included; and for orbital cellulitis, 8 observational studies were included. Recommendations were formulated according to 4 grades of strength for each specific topic (impetigo, skin abscesses, cellulitis, and orbital cellulitis). Where controversies arose and expert opinion was considered fundamental due to lack of evidence, agreement according to Delphi consensus recommendations was included.Implications
Based on a literature review and on local epidemiology, this article offers practical suggestions for use in both ambulatory and hospital settings for managing the most common bacterial SSTIs. 相似文献8.
Mercedes Gimeno-Gracia Fernando Gomollón 《Expert opinion on biological therapy》2019,19(10):1031-1043
ABSTRACTIntroduction: Biosimilars, as defined by the European Medicines Agency, have been used in Europe since 2006. The landscape was considerably expanded when the first biosimilar of a monoclonal was approved and introduced in the European market. CT-P13 was developed by Celltrion as an infliximab biosimilar in 2013, not without controversy. As these complex molecules cannot be completely identical, some experts, clinicians, and even patients were skeptical regarding the real bioequivalence of the drugs. Currently, several new infliximab and adalimumab biosimilars are available or will reach the market in a few months.Areas covered: Our goal is to review, mainly from a clinical perspective, the available evidence for bioequivalence of anti-TNF biosimilars. We aim to take into account not only preclinical studies, mostly done for regulatory issues, but also data from clinical studies.Expert opinion: We can conclude that bioequivalence with originator is well demonstrated in those drugs which have followed European Medicines Agency regulatory pathways. Switching from originator to biosimilar appears safe for all indications. However, there are few data available for switching from one biosimilar to another, or for complete interchangeability. Prospective studies and strict pharmacovigilance are recommended. 相似文献
9.
Marcia A. Clevesy Tricia K. Gatlin Callie Cheese Kord Strebel 《Nursing for Women's Health》2019,23(1):21-30
Objective
The purpose of this project was to improve health care providers’ postpartum depression (PPD) knowledge and screening practices with the implementation of a standardized screening tool.Design
The plan–do–study–act model was used as a framework to measure and implement a practice change aimed at universal screening for PPD.Setting/Local Problem
Health care providers’ screening practices for PPD were inconsistent and lacked use of a standardized screening tool at a southwestern U.S. community women’s health care clinic serving minority women of lower socioeconomic status.Participants
Health care providers at a community women’s health care clinic.Intervention/Measurements
A single educational in-service was presented to health care providers regarding preventive PPD screening practices and documentation recommendations. Measurements included pre- and post-education questionnaire results and electronic health record chart reviews.Results
PPD screening documentation rates increased from 56% to 92.7% (p < .5).Conclusion
PPD screening education for health care providers and the addition of EPDS criteria to the electronic health record were associated with increased screening rates for PPD at a community women’s health care clinic. 相似文献10.
Jennifer Turney Ann Lowther Jeanine Pyka Deene&#x; Mollon Willa Fields 《Nursing for Women's Health》2019,23(1):31-37
Objective
To develop an evidence-based practice project to evaluate the effect of delaying a newborn’s first bath on exclusive breastfeeding rates at discharge.Design
A pre- and post-implementation evaluation of the effect of delaying the first bath on exclusive breastfeeding rates at discharge.Setting
A postpartum unit in a southern California community hospital.Participants
Breastfeeding dyads of women and newborns (>37 weeks gestational age) who were admitted to the postpartum unit.Intervention/Measurements
Postpartum nurses involved in the unit practice council, in collaboration with unit leadership, changed the newborn’s first bath practice through development of a bathing guideline, nurse education, and mother education. Measurements of the practice change included time of the first bath and exclusive breastfeeding rates at discharge.Results
We observed an increased time for the newborn’s first bath from 6.88 hours to 13.71 hours (p ≤ .001). The number of times women chose not to bathe their newborns while in the hospital also increased by approximately seven times, from 0.16% to 1.1%. The rate of exclusive breastfeeding at discharge did not change significantly after implementation (p ≥ .05), regardless of when the first bath was given.Conclusion
Delaying a newborn’s first bath was not associated with an increase in exclusive breastfeeding rates. More research is needed to determine the effect of bath times. 相似文献11.
Josephine McMurray Heather McNeil Alicia Gordon Jacobi Elliott Paul Stolee 《Archives of physical medicine and rehabilitation》2019,100(1):39-44
Objective
To develop and test face and content validity, and user interface design of a rehabilitative care patient experience measure.Design
Mixed methods, cross-sectional validation study that included subject matter expert input. Cognitive interviewing tested user interface and design.Setting
Outpatient rehabilitative care settings.Participants
Subject matter experts (n=3), health care providers (n=137), and patients and caregivers (n=5) contributed to the question development. Convenience and snowball sampling were used to recruit rehabilitative care patients postdischarge (n=9) for cognitive interviews to optimize survey design and user interface (N=154).Interventions
Not applicable.Main Outcome Measure
This novel survey instrument measures 6 concepts previously identified as key to outpatient rehabilitative care patients’ experience: ecosystem issues, client and informal caregiver engagement, patient and health care provider relations, pain and functional status, group and individual identity, and open-ended feedback.Results
502 survey questions from psychometrically tested instruments, secondary data from a related ethnographic study, and consultations with health care providers, patients, caregivers, and subject matter experts, were analyzed to create a 10-item questionnaire representing 6 key constructs that influence patient experience quality. Cognitive interviewing with 9 patients (3 rounds of 3 participants each), produced 3 progressively edited versions of the survey instrument. A final version required no further modifications.Discussion
Rehabilitative care clients have characteristics that differentiate their experience from that of other sectors and patient groups, warranting a distinct experience measure. The survey instrument includes a parsimonious set of questions that address strategic issues in the ongoing improvement of care delivery and the patient experience in the rehabilitative care sector.Conclusion
The rehabilitative care patient experience survey instrument developed has an acceptable user interface, and content and face validity. Psychometric testing of the survey instrument is reported elsewhere. 相似文献12.
David B. Matchar Kirsten Eom Pamela W. Duncan Mina Lee Rita Sim Nirmali R. Sivapragasam Christopher T. Lien Marcus Eng Hock Ong 《Archives of physical medicine and rehabilitation》2019,100(1):1-8
Objective
To perform a cost-effectiveness analysis of a multifactorial, tailored intervention to reduce falls among a heterogeneous group of high-risk elderly people.Design
Randomized control trial.Settings
Communities.Participants
Adults aged at least 65 years (N=354) seen at the emergency department (ED) for a fall or fall-related injury and discharged home.Interventions
The intervention group received a tailored program of physical therapy focused on progressive training in strength, balance, and gait for a period of 3 months. They also received screening and referrals for low vision, polypharmacy, and environmental hazards. The Short Physical Performance Battery (SPPB) test was assessed at regular intervals to allocate participants into either a home-based or group center-based program. The control group received usual care prescribed by a physician and educational materials on falls prevention.Main Outcome Measures
The incremental cost-effectiveness ratio (ICER) over the 9-month study period based on intervention costs and utility in terms of quality-adjusted life years (QALYs) calculated from EuroQol-5D scores.Results
The ICER was 120,667 Singapore dollars (S$) per QALY gained (S$362/0.003 QALYs), above benchmark values (S$70,000). However, the intervention was more effective and cost-saving among those with SPPB scores of greater than 6 at baseline, higher cognitive function, better vision and no more than 1 fall in the preceding 6 months. The intervention was also cost-effective among those with 0-1 critical comorbidities (S$22,646/QALY).Conclusion
The intervention was, overall, not cost-effective, compared to usual care. However, the program was cost-effective among healthier subgroups, and even potentially cost-saving among individuals with sufficient reserve to benefit. 相似文献13.
Ghazala T. Saleem Jewel E. Crasta Beth S. Slomine Gabriela Lucila Cantarero Stacy J. Suskauer 《Archives of physical medicine and rehabilitation》2019,100(4):724-738
Objective
To systematically examine the safety and effectiveness of transcranial direct current stimulation (tDCS) interventions in pediatric motor disorders.Data Sources
PubMed, EMBASE, Cochrane, CINAHL, Web of Science, and ProQuest databases were searched from inception to August 2018.Study Selection
tDCS randomized controlled trials (RCTs), observational studies, conference proceedings, and dissertations in pediatric motor disorders were included. Two authors independently screened articles based on predefined inclusion criteria.Data Extraction
Data related to participant demographics, intervention, and outcomes were extracted by 2 authors. Quality assessment was independently performed by 2 authors.Data Synthesis
A total of 23 studies involving a total of 391 participants were included. There was no difference in dropout rates between active (1 of 144) and sham (1 of 144) tDCS groups, risk difference 0.0, 95% confidence interval (?.05 to .04). Across studies, the most common adverse effects in the active group were tingling (17.2%), discomfort (8.02%), itching (6.79%), and skin redness (4%). Across 3 studies in children with cerebral palsy, tDCS significantly improved gait velocity (MD=.23; 95% confidence interval [0.13-0.34]; P<.0005), stride length (MD=0.10; 95% confidence interval [0.05-0.15]; P<.0005), and cadence (MD=15.7; 95% confidence interval [9.72-21.68]; P<.0005). Mixed effects were found on balance, upper extremity function, and overflow movements in dystonia.Conclusion
Based on the studies reviewed, tDCS is a safe technique in pediatric motor disorders and may improve some gait measures and involuntary movements. Research to date in pediatric motor disorders shows limited effectiveness in improving balance and upper extremity function. tDCS may serve as a potential adjunct to pediatric rehabilitation; to better understand if tDCS is beneficial for pediatric motor disorders, more well-designed RCTs are needed. 相似文献14.
15.
Samantha Backhaus Dawn Neumann Devan Parrott Flora M. Hammond Claire Brownson James Malec 《Archives of physical medicine and rehabilitation》2019,100(2):195-204.e1
Objectives
This study aimed to (1) examine the efficacy of a treatment to enhance a couple’s relationship after brain injury particularly in relationship satisfaction and communication; and (2) determine couples’ satisfaction with this type of intervention.Design
Randomized waitlist-controlled trial.Setting
Midwestern outpatient brain injury rehabilitation center.Participants
Participants (N=44; 22 persons with brain injury and their intimate partners) were randomized by couples to the intervention or waitlist-controlled group, with 11 couples in each group.Interventions
The Couples Caring and Relating with Empathy intervention is a 16-week, 2-hour, manualized small group treatment utilizing psychoeducation, affect recognition, empathy training, cognitive-behavioral and dialectical-behavioral strategies, communication skills training, and Gottman’s theoretical framework for couples adjusted for individuals with brain injury.Main Outcome Measures
The Dyadic Adjustment Scale, Quality of Marriage Index (QMI), and the Four Horsemen of the Apocalypse communication questionnaire were implemented. Measures were completed by the person with brain injury and that person’s partner at 3 time points: baseline, immediate postintervention, 3-month follow-up.Results
The experimental group showed significant improvement at posttest and follow-up on the Dyadic Adjustment Scale and the Horsemen questionnaire compared to baseline and to the waitlist-controlled group which showed no significant changes on these measures. No significant effects were observed on the QMI for either group. Satisfaction scores were largely favorable.Conclusions
Results suggest this intervention can improve couples’ dyadic adjustment and communication after brain injury. High satisfaction ratings suggest this small group intervention is feasible with couples following brain injury. Future directions for this intervention are discussed. 相似文献16.
Carol Y. Scovil Jude J. Delparte Saagar Walia Heather M. Flett Stacey D. Guy Michelle Wallace Anthony S. Burns Dalton L. Wolfe 《Archives of physical medicine and rehabilitation》2019,100(2):327-335
Objective
To use the theoretical frameworks of implementation science to implement pressure injury (PI) prevention best practices in spinal cord injury (SCI) rehabilitation.Design
Quality improvement.Setting
Six Canadian SCI rehabilitation centers.Participants
Inpatients (N=2371) admitted from 2011 to 2015.Interventions
The SCI Knowledge Mobilization Network (SCI KMN) selected and implemented 2 PI prevention best practices at 6 Canadian SCI rehabilitation centers: (1) completing a comprehensive PI risk assessment comprised of a structured risk assessment instrument followed by an individualized, interprofessional risk factor determination and prevention plan; and (2) providing structured and individualized PI prevention patient education. Active Implementation Frameworks provided a systematic approach to best practice implementation.Main Outcome Measures
Implementation indicators (completion rates) and patient outcomes (PI incidence, patient education survey).Results
After implementation, risk assessment completion rates improved from 46% to 94% (P<.05). Between initial (2012-2013) and full (2014-2015) implementation stages, completion rates improved for both interprofessional risk factor determination (67% to 96%) and prevention plans (67% to 94%). Documentation of patient education also increased to 86% (vs. 71% preimplementation). At rehabilitation admission 22% of patients had PIs, with 14% of individuals developing new PIs during rehabilitation. The overall PI prevalence was 30%. Considering only PIs of stage 2 or greater, prevalence was 21% and incidence 7%. There were no statistically significant differences in PI incidence between pre- and postimplementation. Patient education surveys indicated that PI education improved patients’ knowledge of prevention strategies.Conclusions
Active Implementation Frameworks supported successful implementation of PI prevention best practices across the 6 participating SCI KMN sites. Achieving a reduction in PI incidence will require additional measures, and there is an ongoing need to strengthen the evidence base underpinning PI prevention guidelines. 相似文献17.
Ma José Ariza-Mateos Irene Cabrera-Martos Araceli Ortiz-Rubio Irene Torres-Sánchez Janet Rodríguez-Torres Marie Carmen Valenza 《Archives of physical medicine and rehabilitation》2019,100(1):9-16
Objective
To explore the effects of a 6-week patient-centered graded exposure intervention added to manual therapy in women with chronic pelvic pain (CPP) and fear of movement/(re)injury.Design
Prospective 3-armed randomized controlled trial.Setting
Faculty of Health Sciences.Participants
A total of 49 women with CPP and substantial fear of movement were randomly allocated to 1 of 3 groups: (1) patient-centered graded exposure intervention added to manual therapy; (2) manual therapy; (3) control group.Interventions
The 6-week intervention consisted of 12 sessions in the group receiving manual therapy and 6 additional sessions of graded exposure therapy in the group receiving both interventions.Main Outcome Measures
Primary outcomes were fear-avoidance behavior assessed using the Fear-Avoidance Beliefs Questionnaire and pain interference and severity evaluated with the Brief Pain Inventory. The secondary outcome was disability evaluated with the Oswestry Disability Index. All the variables were assessed in a blinded manner at baseline, after the treatment, and at 3-month follow-up.Results
Our results show interaction effects (P<.05) for all the outcomes. Graded exposure added to manual therapy is distinctly superior to manual therapy alone in maintaining improvements for long-term fear-avoidance behavior and physical functioning.Conclusions
Graded exposure added to manual therapy is a promising approach with long-term effects for women with CPP and fear of movement/(re)injury. 相似文献18.
Shu Cole Dubravka Svetina Gale Whiteneck 《Archives of physical medicine and rehabilitation》2019,100(1):52-59
Objective
To develop an environmental-barriers scale, Travel Restrictions Influencing Participation (TRIP), in the context of travel for people living with spinal cord injury (SCI).Design
A mixed-method approach where, in the qualitative phase, items were developed and written based on results of interviewers with different stakeholder groups and, in the quantitative phase, survey data were collected to examine the psychometric properties of the scale.Setting
Home, work, and community settings.Participants
People living with SCI, caregivers/family members, therapists, and travel professionals (N=333).Interventions
None.Main Outcome Measures
A 19-item TRIP scale that measures the travel barriers encountered by people with SCI.Results
Results from 83 semi-structured in-depth interviews with 4 stakeholder groups guided the writing of items in the TRIP scale. Seven cognitive interviews and an expert panel conducted reviews for content validity of the scale, and 19 items were included in the quantitative assessment of the scale. A total of 250 patients enrolled in the Rocky Mountain Regional Spinal Injury System was systematically selected to report their experience with each travel barrier. Item-response theory–based Rasch analysis revealed that TRIP has acceptable psychometric properties.Conclusions
The 19-item TRIP scale demonstrates promising psychometric properties for the scale to be used in clinical settings to quickly identify environmental barriers individuals with SCI encounter when traveling. It has the potential to assist with developing interventions that will improve the travel experience of individuals with SCI or to assist with strategies to overcome travel barriers. 相似文献19.
Ryan Nussbaum Christopher Kelly Eleanor Quinby Ami Mac Bambang Parmanto Brad E. Dicianno 《Archives of physical medicine and rehabilitation》2019,100(1):115-127
Objective
To conduct systematic review to better define how medical mobile applications (apps) have been used in environments relevant to physical medicine and rehabilitation.Data Sources
PUBMED, IEEE, ACM Digital Library, SCOPUS, INSPEC, and EMBASE.Study Selection
A 10-year date limit was used, spanning publication dates from June 1, 2006, to June 30, 2016. Terms related to physical medicine and rehabilitation as well as mobile apps were used in 10 individual search strategies.Data Extraction
Two investigators screened abstracts and applied inclusion and exclusion criteria. Full-length articles were retrieved. Duplicate articles were removed. If a study met all criteria, the article was reviewed in full.Data Synthesis
Specific variables of interest were extracted and added to summary tables. Summary tables were used to categorize studies according themes, and a list of app features was generated.Conclusions
The search yielded abstracts from 8116 studies, and 102 studies were included in the systematic review. Approximately one-third of the studies evaluated apps as interventions, and the remaining two-thirds of the studies assessed functioning of the app or participant interaction with the app. Some apps may have positive benefits when used to deliver exercise or gait training interventions, as self-management systems, or as measurement tools.Registration
The protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) network (no. CRD42016046672). 相似文献20.
Hsieh-Chun Hsieh 《Archives of physical medicine and rehabilitation》2019,100(4):591-597