Background
Methods
Eligibility Criteria
Identification of studies
Data extraction
Study quality
Study characteristics
Intervention Characteristics
Analysis
Results
Synthesis of study and intervention characteristics
Study selection
Study characteristics
Sample characteristics
Author/year Country of Origin. | Setting | Type of study | Type of intervention (I) Control (C) | Oncology Treatment, sample characteristics | Sample size T = total I = new treatment, C = control | Gender (M:F) | Sample age for (I) and (C) groups. (mean and SD/range) | Baseline Swallowing status | Length of Follow-up |
---|---|---|---|---|---|---|---|---|---|
Mortensen 2015 [33] Denmark | University hospital | RCT (pre-treat) | (I) Individualised dietary advice, exercise protocol of standard exercises – 10reps/3× daily (C) = usual care, individual dietary advice. VFS and advice as needed. (active control) | Cancer of larynx, pharynx, oral cavity (T2-T4), unknown primary. Planned for radiotherapy with/without chemo. No previous oncology treatment. | T = 39 I = 19 C = 20 NB: 5 patients excluded at start. | 34:5 | I = 58 (39–77) C = 59 (40–74) | (I) SPSS =1.44 (C) SPSS = 1.38 | 11 months |
Van Den Berg 2014 [34] Netherlands | University medical centre | RCT (pre-treat) | (I) = combined diet counseling and individualized swallow therapy. (C) = weekly individual diet counseling for better nutrition. (active control) | Patients with stage II-IV HNC treated with postoperative radiation with/without chemotherapy. | T = 120 I = 60 C = 60 | 89:31 | I = 63 (33–83) C = 60 (40–86) | (I) PSS mean =78 (SD =26) (C) PSS mean =75 (SD = 25) | 30 weeks |
Ohba 2014 [40] Japan | University hospital | Retro-spective case–control design (peri-treatment) | (I) = shaker exercise during CRT. (C) = Mendelsohn manoeuvre only when dysphagia developed (delayed active) | Advanced HNC, laryngeal, oropharyngeal, hypopharyngeal cancers. | T = 51 I = 21 C = 30 | 46:5 | I = 65 (53–80) C = 63 (49–89) | Not reported | 2-4 weeks |
Lazarus 2014 [35] USA | Medical centre | RCT (post-treat) | (I) = isometric tongue exercises with traditional exercises. (C) = traditional exercises including ROM. (active control) | Patients with stage II-IV oral and oro-pharyngeal cancer, who previously underwent radiotherapy with/without chemo. | T = 23 I = 12 C = 11 | 22:1 | I = 62.3 (SD, 8.06) C = 61.7 (SD, 7.27) | (I) OPSE mean = 44.63 (dysphagia if less than 39) Tongue strength = 44.63 (C) OPSE =59.6 tongue strength = 49.3 | 10 weeks |
Virani 2013 [41] USA | Cancer centre | Non randomised trial – matched groups. (pre-treat) | (I) = behavioural swallow exercises (C) = repetitive swallowing tasks (active control) | Newly diagnosed HNC of the oral cavity, oropharynx, nasopharynx, larynx or unknown primary due to undergo radiotherapy with/without chemo. | T = 50 I = 26 C = 24 | 40:10 | I = 64 (24–90) C = 60 (43–85) | (I) FOIS =6.5 (C) FOIS =6.6 | 3 months |
Kotz 2012 [35] USA | Academic medical centre | RCT (pre-treat) | (I) = behavioural swallow exercises (5sets) (C) = no active treatment | Patients with HNC receiving CRT, excluding any surgery or previous radiation or previous history of dysphagia. | T = 26 I = 13 C = 13 | 20:6 | I = 57 (SD,10) C = 62 (SD,11) | I) FOIS =7 PSS =100 (C) FOIS =7 PSS =100 | 12 months |
Carnaby-Mann 2012 [37] USA | University Hospital Cancer Centre | RCT 3-arms (pre/peri) | (I) = pharyngocize and diet modification. (C) = usual care consisting of supervision for safe swallowing. Sham therapy – buccal extension manoeuvre –daily schedule. Active control – sham, and no treatment group | Newly diagnosed with oropharyngeal cancer and planned for external beam radiotherapy with/without chemo. TNM stage 1-4 | T = 58 I = 20 C = 20 Sham =18 | 44:14 | I =59 (SD,10.4) C = 54 (SD, 11.3) sham = 60 (SD, 12.2) | (I) MASA = 195.1 SD = 5.9 (C) MASA =195.5 SD = 4 sham = 194.7 SD = 3.5 scores >178 suggest no dysphagia. | 6 months |
Zhen 2012 [42] China | University Hospital | Quasi-experiment- Parallel cluster study (post-treat) | (I) = 30 min swallow training daily for 2 weeks (C) = no active treatment | All patients were post tongue surgery. MDADI score of 60 or lower on screening. | T = 46 I = 23 C = 23 | 29:17 | I =60.52 (SD,5.5) C = 57.5 (SD, 5.72) | Not reported | 1 month |
Ahlberg 2011 [43] Sweden | University Hospital | Non randomized parallel groups (pre-treat) | (I) = pre-treatment swallowing exercises. (C) = no active pretreatment intervention | Patients diagnosed with HNC due to receive curative radiotherapy | T = 374 I = 190 C = 184 | 253:121 | I =63.6 (SD, 13.1) C = 64.1 (SD, 12) | Not reported | 6 month outcomes, 2 year F/U. |
Tang 2011 [38] China | University Hospital | RCT (post-treat) | (I) = exercises and jaw stretch (C) = no active exercise intervention | Previously diagnosed with nasopharyngeal cancer and received radiotherapy – long term post-treatment. | T = 46 I = 25 C = 21 3 pts excluded | 32:11 (gender of patients excluded not reported) | T =49.3 (not indicated separately for groups) | (I) WST =3.6 IID = 1.89 (C) = WST =3.8 IID =1.8 | 3 months |
Van Der Molen [22] 2011 Netherlands | Cancer Centre | RCT (pre-treat) | (I) device based rehab protocol using therabite (C) standard treatment of best evidence- based exercises (active control) | Stage III-IV HNC (oral cavity, oropharynx, hypopharynx, larynx, nasopharynx) planned for curative chemo-radiation treatment. | T = 55 I = 27 C = 28 | 39:10 (gender of patients excluded not reported) | I = 56 (37–78) C = 57 (32–75) | Baseline function of each group not reported. Overall mean at pre-treatment: FOIS =7 |
*10 weeks 2 years, 6 years FU in later papers. |
Logemann 2009 [39] USA | 7 settings university hospitals cancer centres | RCT (post-treat) | (I) shaker exercise (C) traditional swallow therapy (active control) | Patients with prolonged oro-pharyngeal dysphagia of at least 3-month duration | T = 19 I = 8 C = 11 | 16:3 | Not provided | All had aspiration | 6 weeks |
Carroll 2007 [44] USA | University hospital | 2-arm Retrospective Case control Study (pre-treat) | (I) pre-treatment swallowing exercise protocol. C) usual care -swallow rehab as problems arose post treatment. (no active pre-treat exercises) | Patients with advanced squamous cell cancer of the oropharynx, hypopharynx and larynx treated with chemo-radiation. | T = 18 I = 9 C = 9 | 12:6 | I = 57.5 C = 60.7 | Not reported | 12 months |
Kulbersh 2006 [45] USA | University Hospital | 2-arm Prospective cohort study (pre-treat) | I) pre-treatment swallowing exercise protocol (C) exercises given at first visit after treatment. (delayed intervention) | All patients diagnosed with HNC with/without nodal disease but without metastatic disease | T = 37 I = 25 C = 12 | 28:9 | I =55.1 (SD, 9.6) C = 66.3 (SD, 10) | Not reported | 12 months |
Denk 1997 [46] Austria | ENT department | Non-randomised, 2-arm parallel group study (post-treat) | (I) therapy with video-endoscopic biofeedback. (C) conventional swallow therapy. (active control) | Patients with prolonged post-operative aspiration following resection of malignant tumours of the oropharyngeal swallowing structures. | T = 33 I = 19 C = 14 | 25:8 | I = 54 (37–68) C = 53 (37–79) | Prolonged post-op aspiration, with tube feeding | Variable, based on time to establish oral intake |
Quality assessment
Mortensen | Van Den Berg | Ohba | Lazarus | Virani | Kotz | Carnaby Mann | Zhen | Ahlberg | Tang | Van Der Molen | Logemann | Caroll | Kulbersh | Denk | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
✓ = yes | |||||||||||||||
?= | |||||||||||||||
✗ = no | |||||||||||||||
Quality criteria | |||||||||||||||
Randomisation detailed | ✓ | ✓ | n/a | ✓ | n/a | ? | ✓ | n/a | n/a | ? | ✓ | ✗ | n/a | n/a | n/a |
Allocation concealed | ? | ✗ | n/a | ? | n/a | ✗ | ✓ | n/a | n/a | ✗ | ? | ✗ | n/a | n/a | n/a |
Similar groups at baseline | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✗ | ✓ |
Subject blind | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ |
Therapist blind | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ |
Assessor blind | ? | ✗ | ✗ | ✓ | ✓ | ✓ | ✓ | ✗ | ✗ | ✗ | ✗ | ✓ | ✓ | ✗ | ✗ |
Co-intervention controlled | ? | ✗ | ✗ | ? | ✗ | ? | ✓ | ✗ | ✗ | ✗ | ? | ? | ? | ✗ | ? |
Acceptable compliance | ✗ | ? | ? | ✗ | ✗ | ✗ | ✗ | ✓ | ? | ✓ | ? | ? | ? | ? | ? |
Acceptable withdrawal rate | ✗ | ✓ | ✓ | ✗ | ✓ | ✗ | ✗ | ✓ | ✗ | ✓ | ✓ | ✗ | ✓ | ? | ✓ |
Timing of outcome | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✗ | ✓ | ✓ | ✓ | ✓ | ✓ | ✗ | ✗ |
Intention to treat | ✓ | ✓ | ✗ | ? | ✓ | ✓ | ✓ | ✗ | ✗ | ✗ | ✓ | ✓ | ✗ | ✗ | ✗ |
TOTAL | 4 | 5 | 3 | 4 | 5 | 4 | 7 | 3 | 2 | 4 | 5 | 4 | 4 | 0 | 2 |
Intervention characteristics
Actual check ticks (✔) = BCT present | Mortensen | V.D. Berg | Ohba | Lazarus | Virani | Kotz | Carnaby | Zhen | Ahlberg | Tang | V.D. Molen | Logemann | Carroll | Kulbersh | Denk | % studies |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Goals and Planning | ||||||||||||||||
Goal setting (behaviour) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 93 | |
Problem solving | ✓ | 7 | ||||||||||||||
Action planning | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 87 | ||
Review behaviour goals | ✓ | ✓ | 13 | |||||||||||||
Review outcome goals | ✓ | 7 | ||||||||||||||
Feedback and Monitoring | ||||||||||||||||
Monitoring of behaviour by others without feedback | ✓ | ✓ | ✓ | 20 | ||||||||||||
Feedback on behaviour | ✓ | ✓ | 13 | |||||||||||||
Self monitoring of behaviour | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 40 | |||||||||
Monitoring outcome of behaviour without feedback | ✓ | 7 | ||||||||||||||
biofeedback | ✓ | 7 | ||||||||||||||
Social Support | ||||||||||||||||
Social support (unspecified) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 47 | ||||||||
Social support (practical) | ✓ | ✓ | ✓ | ✓ | ✓ | 33 | ||||||||||
Shaping Knowledge | ||||||||||||||||
Instruction on how to perform the behaviour | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 100 |
Comparison of behaviour | ||||||||||||||||
Demonstration of the behaviour | ✓ | 7 | ||||||||||||||
Associations | ||||||||||||||||
Prompts and cues | ✓ | 7 | ||||||||||||||
Repetition and Substitution | ||||||||||||||||
Behavioural practice/rehearsal | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 80 | |||
Habit formation | ✓ | ✓ | 13 | |||||||||||||
Generalization of target behaviour | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 53 | |||||||
Comparison of outcomes | ||||||||||||||||
Credible source | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 60 | ||||||
Antecedents | ||||||||||||||||
Adding objects to the environment | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 40 | |||||||||
Total Number of BCTs | 8 | 8 | 4 | 8 | 6 | 10 | 10 | 4 | 8 | 10 | 7 | 8 | 7 | 6 | 6 |