[Summary text]
Study design: Cluster randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT: YES
Baseline Characteristics
Systematisk opsporing (Intervention)
Ingen systematisk opsporing (control)
Included criteria: Included in the study were all patients 18 years of age who weredischarged with a diagnosis of acute ischemic stroke. The targetpopulation consists of all acute ischemic stroke patients under thecare of neurologists either as consulting or attending physicians.
Excluded criteria: The inclusion and exclusioncriteria for the dysphagia screening indicator are: number of patientsscreened for dysphagia before food and drink/number of patients,excluding in-hospital transfers. Optional data included in-hospitalcomplications such as pneumonia and stroke severity on admissionas measured by the NIHSS. Five sites did not collect data onin-hospital complications or stroke severity, and we excluded theirdata from the outcome assessment part of the project.
Intervention Characteristics
Systematisk opsporing (Intervention)
Ingen systematisk opsporing (control)
Nutritional status
Severity dysphagia
Quality of life
Mortality
Aspiration pneumonia
Length of stay (LOS)
Readmissions
Length of hospital stay
Sponsorship source: J.A.H. is supported by National Institutes of Health grantK23NS02163. This work was also partially supported by fundingfrom the American Academy of Neurology, the American StrokeAssociation, and Boehringer Ingelheim Pharmaceuticals, Inc.
Country: USA
Setting: 15 healthcare institutions with a variety of practice settings.
Comments: Comment to setting: Three hospitals had 200 acute beds, 6 have 200 to 400 acute beds, and 6 had 400 acute beds. Other site characteristics included 4 urban academic hospitals, 2 academic affiliated community hospitals, and 9 community hospitals. A dedicated stroke unit was present in 73% (11 of 15)of hospitals, 93% (14 of 15) had stroke teams, and 100% had stroke pathways.
Authors name: Hinchey et al, 2005
Institution: Department of Neurology (J.A.H.), Saint Elizabeth’s Medical Center, Boston,
Email: Jhinchey@tufts-nemc.org
Address: Tufts-New England Medical Center, Institute for Clinical Research and Health Policy Studies, 750Washington St, Box 63, Boston, MA 02111.
Identifications:
Participants:
Study design:
Nkr Dysfagi This study is limited in that the design was not specific fora randomized controlled trial of dysphagia screening protocolsversus no protocols and was done as a secondaryanalysi
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Nkr Dysfagi OBS LOS is reported in median. Variability measures are not given
Dichotomous outcomes:
Elisabeth Ginnerup-Nielsen Pneumoni er omtalt som pneumoni og ikke som aspirationspneumoni???
Nkr Dysfagi OBS LOS is reported as median
Adverse outcomes:
Study design: Cluster randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT: YES
Baseline Characteristics
Systematisk opsporing (Intervention)
Ingen systematisk opsporing (control)
Included criteria: Patients were eligible if they spoke English, were aged18 years or older, had a diagnosis of ischaemic stroke or intracerebral haemorrhage, and presented within 48 h. of onset of symptoms to a participating ASU.
Excluded criteria: Patients were excluded if they did not have a telephone or were admitted for palliative care.
Intervention Characteristics
Systematisk opsporing (Intervention)
Ingen systematisk opsporing (control)
Severity dysphagia
Quality of life
Mortality
Aspiration pneumonia
Length of stay (LOS)
Readmissions
Nutritional status
Quality of life_mental
Length of hospital stay
Sponsorship source: National Health & Medical Research Council ID 353803, St Vincent’s Clinic Foundation, the CurranFoundation, Australian Diabetes Society-Servier, the College of Nursing, and Australian Catholic University.
Country: Australia
Setting: Acute Stroke Units
Comments: No comments
Authors name: Middleton et al, 2011
Institution: Nursing Research Institute, St Vincent’s & Mater Health Sydney and School of Nursing (NSW & ACT), Australian Catholic University, NSW, Australia
Email: sandy.middleton@acu.edu.au
Address: Prof Sandy Middleton, NursingResearch Institute, St Vincent’sHospital, Darlinghurst,NSW 2010, Australia
Identifications:
Participants:
Study design:
Baseline characteristics:
Elisabeth Ginnerup-Nielsen Age: <65 control: 137/498 (28%) Intervention: 195/625 (31%)65–74 control: 130/498 (26%) Intervention: 150/625 (24%)75–84 control: 158/498 (32%) Intervention: 181/625 (29%)≥85 control 73/498 (15%) Intervention: 99/625 (16%)Los Angeles Motor scale: 0 (mild stroke) control: 203/493 (41%) 262/622 (42%)≥1 (more severe stroke) control: 290/493 (59%) 360/622 (58%)
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Elisabeth Ginnerup-Nielsen Follow-up done at 3 months
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Systematisk opsporing (Intervention)
Ingen systematisk opsporing (control)
Included criteria: Patients admitted to the facility for orthopedic surgery who required a stay of at least one night in the hospital; were undergoing either elective, subacute,or emergency orthopedic surgery; and were admitted to the orthopedic surgery ward from the postanesthesia care unit (PACU) postoperatively.
Excluded criteria: younger than 65 years old,• unable to give informed consent,• presented with documented preexisting swallowing conditions (eg, dysphagia), or• were unable to swallow due to the nature of specific intraoperative interventions or postoperative procedures or complications (eg, fractured jaw surgery).
Intervention Characteristics
Systematisk opsporing (Intervention)
Ingen systematisk opsporing (control)
Severity dysphagia
Quality of life
Mortality
Aspiration pneumonia
Length of stay (LOS)
Readmissions
Nutritional status
Quality of life_mental
Length of hospital stay
Sponsorship source: AORN, The Canberra Hospital Salaried Specialist Fund, The Canberra Hospital Auxiliary, and the ACT Nurses Registration Board.
Country: Australia
Setting: Orthopedic surgery hospital ward
Comments: Email contacts not reported in publication, but retrieved through the Queensland University
Authors name: Osborne S, Gardner G, Gardner A, Franklin S, Tuohy E, Fisher A
Institution: Queensland University of Technology,School of Nursing, Kelvin Grove,Brisbane,Queensland,
Email: s.osborne@qut.edu.au
Address: Kelvin Grove, Brisbane, Queensland, Australia,
Identifications:
Participants:
Study design:
Baseline characteristics:
Nkr Dysfagi SD or range for age mean not reported in the paper
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Dichotomous outcomes:
Elisabeth Ginnerup-Nielsen OBS Aspiration pneumonia in this study = pneumonia and pneumonitis
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Systematisk opsporing (Intervention)
Ingen systematisk opsporing (control)
Included criteria: Primary diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, treatment with curative intent, ability to complete questionnaires in Dutch and ability to participate in the intervention
Excluded criteria: Patients were excluded if they hada previous or concomitant malignancy and/or were being treatedfor depression, diagnosed according to Diagnostic and StatisticalManual of Mental Disorders criteria (American PsychiatricAssociation, 2000), as stated in their medical record
Intervention Characteristics
Systematisk opsporing (Intervention)
Ingen systematisk opsporing (control)
Mortality
Aspiration pneumonia
Length of stay (LOS)
Readmissions
Severity dysphagia_ EORTC-H&N35_Swallowing
Quality of life_EORTIC-H&N35_Social eating
Quality of life_Global
Sponsorship source: The research was funded through a grant from the Dutch CancerSociety.
Country: The Netherlands
Setting: Outpatient oral maxillofacial and the otorhinolaryngology clinics of a Dutch university hospital
Comments:
Authors name: van der Meulen IC, May AM, de Leeuw JR, Koole R, Oosterom M2, Hordijk GJ, Ros WJ
Institution: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Email: i.c.vandermeulen@umcutrecht.nl
Address: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Street 6.131, PO Box: 85500, 3508GAUtrecht, The Netherlands
Identifications:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Nkr Dysfagi obs. use qol-global for quality of life
Dichotomous outcomes:
Nkr Dysfagi No estimates for these outcomes. Mortality reported for 24 month follow-up and not at 18 month
Adverse outcomes:
Congress abstract
Wrong intervention
Wrong outcomes
Wrong outcomes
Wrong outcomes
Wrong outcomes
Wrong outcomes
Wrong outcomes
Wrong outcomes
Dublet
Wrong outcomes
Wrong intervention
Wrong intervention
Congress abstract
Wrong comparator
Wrong outcomes
Dublet
Congress abstract
Congress abstract
Wrong comparator
Wrong comparator
Wrong outcomes
Wrong intervention
Wrong outcomes
Wrong intervention
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Comment: Citat: This is part of a group-randomized, controlled, multicenter trial.Citat: This study is limited in that the design was not specific for a randomized controlled trial of dysphagia screening protocols versus no protocols and was done as a secondary analysis.
Comment: A block randornization process was used
Quote: "After informed consent and the completion of cancer treatment, participants were randomised to the intervention or control group, using a web-based computer programme with an open block procedure stratified for sex and tumour stage."
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Comment: Nothing desribed. As randomization is not done correctly this item also receives high risk
Comment: De-identifi ed stratifi cation detailswere provided to an independent statistician who usedrandom number generating software to randomise withinstrata with allocation concealed until provided to theProject Offi cer (SD) who assigned ASUs to their groups.
Comment: Consecutive numbers were randomly selected in blocks of 20 numbers and placed in consecutively numbered opaque envelopes.
Comment: It is unclear how the persons who allocated the participants were blinded (they used a open block procedure) - Participants were randomised to the intervention or control group, using a web-based computer programme with an open block procedure stratified for sex and tumour stage. All researchers were blinded to the block sizes.
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Comment: Is not reported explicitly. The study was conducted using in-hospital data that were prospectivelycollected between December 2001 and January 31, 2003, aspart of the Stroke Practice Improvement Network (SPIN) registry.This is part of a group-randomized, controlled, multicenter trialassessing the efficacy of a multimodal intervention aimed at increasingthe adherence rates of 4 primary, in-hospital ischemic strokeprocess of care indicators
Comment: Citat: Patients were masked to ASU group allocation but clinicians delivering our intervention were not. For the outcomes quality of life this is a problem. Less for length of stayPatients were masked to ASU group allocationbut clinicians delivering our intervention were not. Either participants or some key study personnel were not blinded, but outcome assessment was blinded and the non-blindingof others unlikely to introduce bias
Comment: Either participants or key study personnel were not blinded, but outcome assessment was blinded and the nonblinding of others unlikely to introduce bias.
Comment: It is unclear how the authors ensured this item - "For the duration of the study, participants were not informed which treatment they received". The patients must have read the information form before the written consent, and in here it must be explained what interventions are given. Therefore, the patients must have known what they got.
Detection bias due to knowledge of the allocated interventions by outcome assessors
Comment: Nothing described. I don't think outcome assessors are blinded. Outcome (pneumonia) is objective and difficult to "cheat with". citat; Thedefinition of pneumonia includes either the clinical finding of ralesor dullness to percussion and 1 of the following: purulent sputum, orisolation of the organism, or chest radiograph showing evidence ofan infiltrate/consolidation/cavitation or pleural effusion and 1 of thefollowing: purulent sputum or isolation of the agent or antibodyevidence of an agent
Comment: An independent organisation was contracted to conductcomputer assisted telephone interviews with patients.Research assistants who undertook the computer-assistedtele phone interviews and the medical record audits weremasked to trial aims, design, and group allocation; the trialstatistician was masked to group allocation. Blinded retrospective medical record audits wereundertaken using data documented prospectively.
Comment: For obejctive pneumonia outcome probably not relevant
Comment: All outcome data were collected by an independent researcher.
Attrition bias due to amount, nature or handling of incomplete outcome data
Comment: Dropouts not described
Comment: ITT but unclear how. Analysis has been done on 558/626 in the intervention group and 451/500 pt's in the control group117 (10%) patients were lost tofollow-up or withdrew. Equal both groups.We used intention-to-treat analysis for all outcomes.
Comment: 32 to 26 in control group. 27 to 22 in intervention group. No intention to treat.
Comment: Citat: Of the participants who completed the assessment at 12 months, 49% hadreceived >5 counselling sessions; at 18 months the proportion was91% and at 24 months 95%. Two patients, one at 18 and one at 24months, received an additional seventh counselling session. - Still unclear how many dropped out of the control group? Did many drop out before first follow-up meassurement?
Reporting bias due to selective outcome reporting
Comment: One or more reported primary outcomes were not pre-specified. Death, npo, los.
Comment: All outcomes from protocol seem reported
Comment: There were no positive postoperative sip tests or trials of fluid recorded on the data collection sheets and thus, no outcome measure of aspiration risk. Therefore the authors performed subgroup analysis that were not pre-specified. The primary outcome (aspiration pneumonia) of interest in the study are reported only as percentages - however, it is possible to enter in meta-analysis
Comment: the published reports include all expected outcomes, including those that were pre-specified. All relevant estimates are given
Bias due to problems not covered elsewhere in the table
Comment: Had extreme baseline imbalance for age and race.
Comment: The study appears to be free of other sources of bias
Comment: The study appears to be free of other sources of bias. Adequate power for the analysis