Vogelaar 2014.
| Methods | RCT, not blinded | |
| Participants | Inflammatory bowel disease, in remission (CDAI < 150 or CAI < 10) and CRP < 10) experiencing fatigue (CIS‐fatigue score of ≥ 35). Exclusion criteria: Pregnant or breastfeeding women; history of lymphoproliferative disease or cancer, other than skin basocellular carcinoma; other gastrointestinal disease than IBD; listeriosis; HIV infection; immunodeficiency syndrome; CNS demyelinating disease; chronic hepatitis B or C virus infection or untreated tuberculosis; poorly controlled medical conditions, including anaemia, low iron levels, diabetes mellitus, kidney disease, liver disease and unstable Ischaemic heart disease; a known pre‐existing condition that could interfere with the participant’s participation such as psychiatric conditions or CNS trauma or active seizure disorders; surgery in the past 12 weeks prior to the screening visit; history of clinically significant drug or alcohol abuse in the last 2 years A total of 98 participants were randomised to the intervention group (SFT: n =48 [1 participant declined further participation after randomisation]) or control group (CAU n = 49) Baseline characteristics for each treatment group were not presented. Loss to follow‐up: One participant declined further participation after randomisation. |
|
| Interventions | Solution‐focused therapy (psychotherapy/coping styles for fatigue) Mode of delivery: 6 face‐to‐face group sessions during 3 months and a final booster session at 6 months. Each group consisted of 7 participants. In the fifth session, a partner, family member or close relative participated. Duration: 7 sessions, 1.5 hours per session Setting: 2 centres in the Netherlands Comparision treatment: none (care‐as‐usual) Co‐interventions: Not reported |
|
| Outcomes | Fatigue was assessed using the CIS and the FSS‐9. Quality of life was assessed using the IBDQ, SF‐36 and EQ‐5D. Adverse events were not reported. Other outcomes assessed: faecal calprotectin; depression and anxiety; sleep quality; disease activity; medication use; side effect of medication and laboratory parameters (CRP, leucocytes and haemoglobin) Assessment time point: Baseline, month 3, month 6, month 9 |
|
| Notes | Baseline characteristics were reported to be similar between the two groups, however, the data were not presented. No additional information supplied by the author |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Patients were randomised to the treatment or control arm in blocks of 14 subjects using randomisation lists drawn from a computer generated series of random numbers". |
| Allocation concealment (selection bias) | Unclear risk | Randomisation was conducted by the second author. The randomisation lists were anonymised for the randomisation process. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were informed about the study and the design of the treatment. Due to the psychosocial nature of this intervention, participants and personnel could not be blinded to the intervention receiving/delivering. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Self‐reported outcomes and participants were informed about the study and the design of the treatment. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Only one participant was excluded from the analysis after randomisation due to participant declining further participation. |
| Selective reporting (reporting bias) | High risk | Non‐standard reporting of CIS, FSS‐9, IBDQ, SF‐36 and EQ‐5D scores. Only fixed mixed models and estimates and effect sizes presented |
| Other bias | Low risk | Baseline characteristics similar between the treatment groups, however, the data were not presented. No apparent sources of bias |
AE: Adverse events
ALT: Alanine transaminase
ASA: aminosalicylate
AST: Aspartate transaminase
BUN: Blood urea nitrogen
CAI: Clinical Activity Index
CAU: Care‐as‐usual
CBT: Cognitive behavioural therapy
CD; Crohn's disease
CDAI: Crohn's Disease Activity Index
CDEIS: Crohn's Disease Endoscopic Index of Severity
CIS: Checklist of Individual Strength
CNS: Central nervous system
CRP: C‐reactive protein
CT: Computed tomography
DB: Double‐blind
DHA: Docosahexaenoic acid
EAc: Electroacupuncture
EDTA: Ethylenediaminetetraacetic acid
eow: every other week
EPA: Eicosapentanoic acid
EQ‐5D: EuroQol 5 dimensions
FACIT‐F: Functional Assessment of Chronic Illness Therapy‐Fatigue
FACIT‐FS: Functional Assessment of Chronic Illness Therapy‐Fatigue Scale
FBC: Full blood count
FSS‐9: 9‐item Fatigue Severity Scale
g/dL: grams per decilitre
Hb: Haemogloblin
HBI: Harvey Bradshaw Index
Hgb: Haemoglobin
HIV: Human immunodeficiency viruses
IBD: Inflammatory bowel disease
IBD‐F: Inflammatory Bowel Disease Fatigue scale
IBDQ: Inflammatory Bowel Disease Questionnaire
IBDQ‐9: 9‐item Inflammatory Bowel Disease Questionnaire
IDA: Iron deficiency anaemia
IL: Illinois
IQOLA: International Quality of Life Assessment
IU/D: International unit of Vitamin D
IXRS: Interactive voice response system
kg: Kilogram
LFT: Liver Function Test
MCS: Mental component summary
MedDRA: Medical Dictionary for Regulatory Activities
MFI: Multidimensional Fatigue Inventory
mg: milligrams
mg/kg/day: milligrams per kilograms per day
ml/L: millilitres per Liters
MRI: Magnetic Resonance Imaging
OFP: Oral ferrous products
PAA: Physical Activity Advice
PCS: Physical component summary
RCT: Randomised controlled trial
SAS: Statistical Analysis System
sc: Subcutaneous
SCCAI : Simple Clinical Colitis Activity Index
SCCI: Simple Clinical Colitis Index
SCDAI: Short Crohn's Disease Activity Index
SD: Standard deviation
SF‐36: 36‐Item Short Form
SFT: Solution‐focused therapy
ShaEAc: Sham electroacupuncture
SPSS: Statistical Package for the Social Sciences
SSCAI: Simple Clinical Colitis Activity Index
TNF: Tumor necrosis factor
TPMT: Thioprurine methyltransferase
TSAT: Transferrin saturation
UC: Ulcerative colitis
UCHL: University College London Hospitals
UK: United Kingdom
UK IBDQ: British version of the Inflammatory Bowel Disease Questionnaire
USA: United States of America
WBC: White blood cells
WL: Waiting list
μg/g: microgram per gram
ųmol/L: micromole/litre
25OHD: 25‐hydroxycholecalciferol or 25‐hydroxyvitamin D