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. 2020 Apr 16;2020(4):CD012005. doi: 10.1002/14651858.CD012005.pub2

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