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Table 1 Study demographics and sample characteristics

From: Swallowing interventions for the treatment of dysphagia after head and neck cancer: a systematic review of behavioural strategies used to promote patient adherence to swallowing exercises

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

  1. Notes: (I) = intervention group; (C) = control group; T = total sample; RCT = randomised controlled trial; HNC = head and neck cancer; SPSS = swallowing performance status scale; PSS = performance status scale; OPSE = oro-pharyngeal swallow efficiency; FOIS = functional oral intake scale; MASA = Mann swallowing assessment; WST = water swallow test; IID = inter-incisor distance; * Later papers linked to this study include follow-up measures at 2-years, and 6 years