[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control (Usual care)
Control ( Sham)
Included criteria: Included if participants presented with (1) HNC of the oropharyngeal regions, confirmed by the clinical history and examination findings, with positive crosssectionalimaging studies and histopathologic biopsy, excludingother pathologic factors; (2) external beam radiotherapy was planned; (3) and they had no history of nonoral feeding for cancerrelated illness and were able to undergo MRI procedures.
Excluded criteria: Patients with(2) external beam radiotherapy wasplanned; (3) and a history of non-oral feeding for cancer-related illness.
Intervention Characteristics
Intervention
Control (Usual care)
Control ( Sham)
Death
Hospital re-admissions
Aspiration pneumonia
Nutritional status
Quality of life
Severity of dysphagia
Length of stay
Sponsorship source: none (No conflicts of interest)
Country: US
Setting: A university hospital cancer center
Comments:
Authors name: Carnaby-Mann G, Crary MA, Schmalfuss I, Amdur R, 2012
Institution: University of Florida Department of Behavioral Science and Community Health, College of Public Health and Health Professions
Email: gmann@phhp.ufl.edu
Address: 1225 Center Drive, P.O. Box 100175 HSC, Gainesville FL 32610-0175
Nkr Dysfagi on 01/07/2015 15:24
Baseline Characteristics
Tumor size (T grade) Median (range)BMI reported as mean (SD)
Nkr Dysfagi on 01/07/2015 18:44
Continuous Outcomes
Follow-up is at 6 weeks
Nkr Dysfagi on 01/07/2015 18:47
Dichotomous Outcomes
Two outcomes not reported, therefore 99 is reported in current tabel
Elisabeth Ginnerup-Nielsen on 02/07/2015 20:55
Continuous Outcomes
OBS: Der er opgivet i median og IQR og ikke mean / CI
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control (Usual care)
Included criteria: Patients newly diagnosed HNC. Were required to have adequate mental and cognitive ability to follow multiple-step commands and understand how to answer specific questions on a questionnaire
Excluded criteria: Patients with a history of head and neck surgery, including tracheostomy, those who had previously undergone radiation treatment, and thosewith a history of neurological diseases that could affect swallowing function.
Intervention Characteristics
Intervention
Control (Usual care)
Severity of dysphagia
Qol_Eating in public
Nutritional status
Days to oral intake
Mortality
Aspiration pneumonia
Readmissions
Sponsorship source: None reported
Country: US
Setting: Department of Otolaryngology– Head and Neck Surgery at The Mount Sinai Medical Center in New York, New York.
Comments:
Authors name: Kotz T, Federman AD, Kao J, Milman L, Packer S, Lopez-Prieto C, Forsythe K, Genden EM
Institution: Department of Otolaryngology–Head and Neck Surgery, Mount Sinai Medical Center,
Email: tamar.kotz@mountsinai.org
Address: 5 E 98th St, New York, NY 10029
Nkr Dysfagi on 01/07/2015 19:30
Baseline Characteristics
Age in mean (SD)
Nkr Dysfagi on 01/07/2015 21:06
Continuous Outcomes
Estimates reported in median and range
Elisabeth Ginnerup-Nielsen on 13/07/2015 16:33
Continuous Outcomes
OBS der er tale om en median og range. ikke 95% CIThe FOIS is a 7-point scale of oral dietary tolerance. It ranges from complete PEG dependence (1) totolerance of an oral diet with no restrictions (7)The PSS-H&N is a brief, clinician-rated instrument con-sisting of 3 discrete subscales: Eating in Public, Understand-ability of Speech, and Normalcy of Diet. Each sub-scale ranges from 0 to 100, with the higher score indicating betterfunction.
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control (Usual care)
Included criteria: Patients with newly diagnosed AmericanJoint Committee on Cancer stage II to stage IV oral and oropharyngeal cancer who underwent radiotherapy chemotherapy. Patients with planned neck dissection post-radiotherapy were included in this study.Age 21–79 years and no prior head and neck cancer,preexisting swallowing disorder, or neurologic history that might adversely affect cognition, tongue function, or swallowing.
Excluded criteria: Patients with a history of cervical spine surgery or other neurosurgical procedures that might affect swallowingwere excluded.
Intervention Characteristics
Intervention
Control (Usual care)
Death
Hospital re-admissions
Aspiration pneumonia
Nutritional status
Qol_Eating
Qol_Social_disruption
Severity of dysphagia
Days to oral intake
Readmissions
Sponsorship source: Supported by NIH/NIDCD Grant 5 R03 DC007497-02.
Country: USA
Setting: Patients were recruited across multiple sites
Comments:
Authors name: Lazarus CL, Husaini H, Falciglia D, DeLacure M, Branski RC, Kraus D, Lee N, Ho M, Ganz C, Smith B, Sanfilippo N, 2014
Institution: Department of Otolaryngology – Head and Neck Surgery, Beth Israel Medical Center, NewYork, USA
Email: clazarus@chpnet.org
Address: Department of Otolaryngology – Head and Neck Surgery.Beth Israel Medical Center10 Union Square East Suite 5BNewYork,NY 10003. USA
Nkr Dysfagi on 01/07/2015 21:46
Baseline Characteristics
Age in mean and SD.No other demographics is given separately for the two groups.
Nkr Dysfagi on 01/07/2015 22:17
Continuous Outcomes
Dysphagia severity is expressed with the OPSE based on VFS. instrumentel evaluation
Nkr Dysfagi on 01/07/2015 22:21
Dichotomous Outcomes
No estimates for this study on those outcomes
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control (Usual care)
Included criteria: Radiation-induced dysphagia and trismus in nasopha-ryngeal carcinoma (NPC) patients after radiotherapy.All patients were diagnosed with NPC and received ra-diotherapy.
Excluded criteria: Patients with cancer relapse, metastases, othermalignances, neurovascular disease, demyelinating disease, infection of the nervous system, or any oral and temporomandibular joint diseases were excluded from the study. Patients presented dysphagia or trismus as the initial symptoms of NPC were also excluded..
Intervention Characteristics
Intervention
Control (Usual care)
Dysphagia severity
Mortality
Aspiration pnemonia
Nutritional status
Quality of life
Days to oral intake
Readmissions
Sponsorship source: Chinese government through the National Natural Science Foundation of China (NSFC No. 30600164and NSFC No. 81072242) and by Sun Yat-Sen Memorial Hospital of Sun Yat‑Sen University by a Yat‑Sen Young Scientist Scholarship
Country: China
Setting: inpatients and outpatients of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University and the Cancer Center of Sun Yat-sen University
Comments:
Authors name: Tang Y, Shen Q, Wang Y, Lu K, Wang Y, Peng Y, 2010
Institution: Department of Neurology Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Email: yameitang@hotmail.com
Address: No. 107, Yan Jiang Xi Road, Guangzhou Guangdong Province, China, 510120
Nkr Dysfagi on 01/07/2015 23:04
Baseline Characteristics
Baseline data is not presented separately for the two groups. Therefore no data entered below, besides swallowing function measured by the water swallow test.
Britta Tendal on 08/07/2015 21:46
Baseline Characteristics
Only reported for the total sample: 32 men/11 women, Mean age 49.3 SD 11 (Range 17 to 69). All received radiotherapy
Britta Tendal on 08/07/2015 21:58
Dichotomous Outcomes
Dysphagia severity = number classified as effective
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control (Usual care)
Included criteria: Patients with advanced stage (III and IV), functionally or anatomically inoperable squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, or nasopharynx with concomitant chemoradiation (CCRT). Written informed consent
Excluded criteria: Unable to comprehend the function and use of the rehabilitation exercises and device (e.g., Alzheimer’sdisease, Korsakov’s disease). Physically unfit to use a rehabilitation device (e.g., neurological deficit)
Intervention Characteristics
Intervention
Control (Usual care)
Nutritional status
Dysphagia severity
Quality of life
Days to oral intake
Aspiration pneumonia
Mortality
Readmissions
Sponsorship source: Part of the study was supported by an unrestricted researchgrant from Atos Medical, Hörby, Sweden
Country: The Netherlands
Setting: The Netherlands Cancer Institute
Comments: Some of the background data is obtained from van der Molen L et al, A randomized preventive rehabilitation trial in advanced head and neck cancer patients treated with chemoradiotherapy: feasibility, compliance, and short-term effects. Dysphagia. 2011 Jun;26(2):155-70.The reason is that some of the method part as well as patient demographic is not reported in full in the current included paper.
Authors name: van der Molen L, van Rossum MA, Rasch CR, Smeele LE, Hilgers FJ.
Institution: Department of Head and Neck Oncology and Surgery,
Email: l.vd.molen@nki.nl
Address: Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands
Nkr Dysfagi on 02/07/2015 17:48
Baseline Characteristics
Baseline is obtained from van der Molen L et al, A randomized preventive rehabilitation trial in advanced head and neck cancer patients treated with chemoradiotherapy: feasibility, compliance, and short-term effects. Dysphagia. 2011 Jun;26(2):155-70.
Nkr Dysfagi on 02/07/2015 18:39
Continuous Outcomes
Qol not reported as the measurement used is researcher developed and not described in details - not possible to state whether it is actually Qol or not that is measured. Nutritional status is in medians and IQR
Britta Tendal on 08/07/2015 22:34
Baseline Characteristics
Britta Tendal on 08/07/2015 23:13
Dichotomous Outcomes
Timing in the outcome table is not correct. We do not look at baseline but longest fu or end of treatment
Britta Tendal on 08/07/2015 23:15
Continuous Outcomes
time points need to corrected. No baseline, insert 'End of treatment' and Follouw up 1 year and 2 year
Study design: Cluster randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT: YES
Baseline Characteristics
Intervention
Control (Usual care)
Included criteria: cancer patients who had undergone tongue resection and rehabilitation were diagnosed with dysphagia :(1) those who had undergone tongue resection and rehabilitation; (2) complete wound healing after surgery, allowing for functional training; (3) receiving nutritionand hydration via oral intake; (4) MDADI score of 60 or lower; and (5) able to understand Mandarin or Chinese dialect.
Excluded criteria: Not reported
Intervention Characteristics
Intervention
Control (Usual care)
Death
Hospital re-admissions
Aspiration pneumonia
Quality of life_Global_Free flap
Quality of life_Global_Pedicled flap
Dysphagia severity
Days to oral intake
Nutritional status
Sponsorship source: The authors declare that there is no source of financial or othersupport or any financial or professional relationships that may pose a competing interest
Country: China
Setting: Inpatients - Department of Oral and Maxillofacial Surgery of the Second Af fi liated Hospital of Sun Yat-sen University
Comments: No estimates are entered in this template - se note under outcome
Authors name: Zhen Y, Wang JG, Tao D, Wang HJ, Chen WL, 2012
Institution: Department of Oral and Maxillofacial Surgery, Sun Yet-sen Memorial Hospital of Sun Yat-sen University
Email: drchen@vip.163.com
Address: 107 Yan-jiang Road, Guangzhou 510120, China
Nkr Dysfagi on 06/07/2015 20:15
Continuous Outcomes
It seems that there are some mess in the reporting - it is difficult to state which of the estimates belongs to which Groups. Theodore, the subgroup analysis form table 3 is used
Wrong intervention
Congress abstract
Congress abstract
Wrong patient population
Wrong intervention
Wrong intervention
Congress abstract
Wrong study design
Wrong study design
Congress abstract
Wrong comparator
Congress abstract
Congress abstract
Wrong study design
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Comment: Computer-generated blocked random numbers list.
Quote: "Patients were randomized to receive the intervention or con- trol treatments."
Comment: Insufficient/lacf of information about the sequence generation process
Comment: Randomization was performed using a computer-generated randomization table
Quote: "Patients were randomly divided into the rehabilita- tion group or the control group."
Comment: Patients were randomly divided into the rehabilita- tion group or the control group.
Comment: Insufficient information about the sequence generation process to permit judgement."To avoid confounding the effects of subjects in the experimental and control groups in the same ward, 2 floors of 8 wards each were assigned to the control and experimental groups based on a subject ratio of 1:1 (control:experimental). Thus, 25 subjects on the first floor (8 wards) were assigned to the control group, and 25 subjects on the second floor (8 wards) were assigned to the experimental group."No significant differences between groups.
Comment: Randomizationwas performed centrally by computer at our institute usingblocks of six, stratified by tumor site (oral cavity and oropharynx, nasopharynx, and larynx and hypopharynx) (ALEA software).
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Comment: The randomization schedule was held in thetrial office, remote from the study environment.
Comment: The method of concealment is not described.Nothing descri
Comment: The method of concealment is not described
Comment: The study did not address this outcome
Comment: Method of concealment is not described +After enrollment, the randomization status of the ward will b revealed
Quote: "Randomization was performed centrally by computer at our institute using blocks of six, stratified by tumor site (oral cavity and oropharynx, nasopharynx, and larynx and hypopharynx) (ALEA software). For"
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Comment: Only the treating speech pathologist and patients were aware ofthe intervention assignment. The study staff worked independentlyof the hospital service and did not share trial information. Thespeech pathologists in the hospital service continued to receivesporadic referrals from the radiation oncology staff. The attendingradiation oncologists were unaware of the randomization assignmentof their patients.
Comment: No blinding for the participants and key personal, The outcome or outcome measurement is likely to be influenced by lack of blinding.
Comment: No blinding , and the outcome (self-report) is likely to be influenced by lack of blinding
Comment: No details, but not possible to blind
Comment: Insufficient information. However, either participants or the key study personnel could be blinded because of the type of interventions.
Comment: Either participants or key study personnel were not blinded. It is not possible due the intervention.
Detection bias due to knowledge of the allocated interventions by outcome assessors
Comment: The outcome was assessed by 2 independent speech pathologists (M.C., G.C.), who were unaware of the treatment allocation.Only the treating speech pathologist and patients were aware ofthe intervention assignment. The study staff worked independentlyof the hospital service and did not share trial information. Thespeech pathologists in the hospital service continued to receivesporadic referrals from the radiation oncology staff. The attendingradiation oncologists were unaware of the randomization assignmentof their patients.
Comment: A clinician specifically trained in the use these scales and blinded to the intervention assignment assessed all study patientsprior to the initiation of CRT within 1 week after completion of CRT and at 3 months, 6 months, 9 months, and 12 months after CRT.
Comment: All swallows were analyzed by aspeech-language pathologist blinded to the experimental condition. However, the Qol measures are prone to bias, as it is self report by patients who are not blinded to the intervention
Comment: The study did not address this outcomeThe study did not address this outcome. But not possible to blind subjective QOL measures - a critical outcome in this PICO
Comment: Insufficient information. It is not clear who did the data collection.All data were collected at the beginning of the study and at the end of 2 weeks. However, to prevent any changes in behavior of the rehabilitation nurse at the time of the study, ward managers were not contacted.......Objective assessments of swallowing were performed pre- andpost-training. Postoperative studies were performed 2e3 weeks and 4e1 months following surgery. These timings allowed for the performance of postoperative assessments and training.Second author: Unclear if assessors were blinded but MDADI is selfadministered - patients are assessing
Comment: A multidimensional assessment protocol was used. It is unclear how the data collection was undertaken.
Attrition bias due to amount, nature or handling of incomplete outcome data
Comment: Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups. ITT was performed - but the imputation was not described.. > 20% of atritionCitat: "All randomized patients were included in the intent-to-treat analysis". The follow-up data to 6 months were complete for 31 (56%) of the55 survivors. The data from the 3 patients who died and the 24patients lost to follow-up (16 at 6 weeks and 8 at 6 months) werecensored for the time spent in the study and included in theanalysisBut high dropout in all 3 groups = unclear risk
Quote: "Sixty-nine percent of patients (9 of 13) assigned to the intervention were unable to perform the swallowing ex- ercises throughout the entire course of their CRT. Four patients discontinued the swallowing exercises after week 4 of their radiation treatment, and 5 additional patients discontinued the exercises after week 5 of their radia- tion treatment."
Comment: All patients completed 7 weeks of radiation treatment. Baseline scores on all assessments were the same formost patients in the intervention and control arms. All patients completed the 12 months of follow-up.
Comment: ‘As-treated’ analysis done with substantial departure of the intervention received from that assigned at randomization - < 33.3% attrition in the experimental group.
Quote: "Three patients were excluded from analysis because of poor compliance."
Comment: Attrition < 20%: Four subjects were lost because they left China, died, or withdrew from the study. Finally, a total of 46 (92%) subjects participated in the present study (23 subjects in each group). But ‘As-treated’ analysis done.
Comment: 20 out of 49 lost to follow up
Reporting bias due to selective outcome reporting
Comment: No trial protocol but all outcomes seem reported
Comment: The published reports include all expected outcomes, including those that were pre-specified.All outcomes seem reported. No trial protocol.
Comment: The published reports include all expected outcomes, including those that were pre-specified i method section.
Comment: One outcomes of interest (functional assessment of dysphagia) are reported incompletely so that they cannot be entered in a meta-analysis
Comment: Only estimates for one group is given. "The mean MDADI score in the experimental group after swallowing training was 60.84 4.61. The mean MDADI global score was 60.00 5.29, mean emotional score was 57.04 6.08, mean functional score was 64.74 5.34, and mean physical score was 61.57 5.41; all scores were significantly higher in the controls than in the experimental group (P Œ 0.018). The individual meanglobal, emotional, and physical subscale scores were also significantly higher in the experimental group after swallowing trainingthan at baseline (P Œ 0.017).In addition, analysis methods or subsets of the data (e.g. subscales) that were not pre-specified. In general no paragraph describing the statistical analysis is provided.
Comment: outcomes of interest are reported incompletely so that they cannot be entered in a meta-analysis; "For all functional outcome parameters, percentages of reported/measured disorders were calculated."there were11 deaths in the course of the trial, but no information on the distribution between the two groups.
Bias due to problems not covered elsewhere in the table
Comment: Had not extreme baseline imbalance
Comment: Due to the relatively small sample size it might be possible that a Type II error has occured
Comment: Insufficient information to assess whether an important risk of bias exists. Baseline balance can not be evaluated as not data is reported,
Comment: Insufficient information to assess whether an important risk of bias exists
Comment: With the above risk of bias, there may be a risk of bias, but there is Insufficient information. The authors reports "First, the sample size was small, and patientswere not randomized into the two groups." (Already high risk in sequence generation).
Comment: The study appears to be free of other sources of bias