Form:RCT Study: Difference between revisions
Appearance
No edit summary |
No edit summary |
||
Line 93: | Line 93: | ||
{| class="formtable" | {| class="formtable" | ||
! Setting: {{#info: Refers to cancer therapy setting. | ! Setting: {{#info: Refers to cancer therapy setting. | ||
Neoadjuvant therapy: given before the primary treatment for cancer (usually surgery); | |||
Adjuvant therapy: given after the primary treatment for cancer (usually surgery); | Adjuvant therapy: given after the primary treatment for cancer (usually surgery); | ||
Palliative therapy: focuses on providing relief from symptoms and improving the quality of life for patients, without necessarily targeting the underlying disease; | Palliative therapy: focuses on providing relief from symptoms and improving the quality of life for patients, without necessarily targeting the underlying disease; | ||
Line 143: | Line 143: | ||
{{{field|Arm type|input type=checkboxes|default=?}}} | {{{field|Arm type|input type=checkboxes|default=?}}} | ||
'''Number of participants (arm):''' | '''Number of participants (arm):''' {{{field|Number of participants (arm)|input type=text|mandatory|default=-999}}} | ||
{{{field|Number of participants (arm)|input type=text|mandatory|default=-999}}} | |||
'''Drop-out:''' {{#info: Number of participants who left the study for any reason or did not provide information on every data collection date|note}} {{{field|Drop-out|input type=textarea|mandatory|default=?}}} | '''Drop-out:''' {{#info: Number of participants who left the study for any reason or did not provide information on every data collection date|note}} {{{field|Drop-out|input type=textarea|mandatory|default=?}}} | ||
Line 174: | Line 173: | ||
'''Outcome type:''' {{#info: As specificed by the authors| note}} {{{field|Outcome type|input type=radiobutton|mandatory|default=?|values=?,Primary,Secondary,Others,NI}}} | '''Outcome type:''' {{#info: As specificed by the authors| note}} {{{field|Outcome type|input type=radiobutton|mandatory|default=?|values=?,Primary,Secondary,Others,NI}}} | ||
'''Outcome name:''' {{{field|Outcome name|input type=text with autocomplete|mandatory|default=?|delimiter=,|values= | '''Outcome name:''' {{{field|Outcome name|input type=text with autocomplete|mandatory|default=?|delimiter=,|values=Anorexia/Cachexia,Antibodies, Anxiety,Appetite,Arterial inflow,BMD (Bone Mineral Density),Body composition,Carnitine level,Carotenoid concentration,Cerebral oedema,CINV (Chemotherapy-Induced Nausea and Vomiting),Cognitive functioning,Cognitive impairment,Depression,Dermatitis,DFS (Disease-Free Survival),Diarrhoe,Distress,Duration of fever,Dysgeusia,EFS (Event-Free Survival),Ejection fraction,Emesis,Erectile dysfunction,Erythema,Esophagitis,Fatigue,Fibrosis,Folic acid level,Frequency of rescue analgesics,Functional status,Functionality,Haematological indices,Haematological toxicity,Hand-foot syndrome,Hand grip strength,Hepatotoxicity,Hot flushes,Hormone level,Ileus (intestinal obstruction),Incidence of acute GVHD (Graft-Versus-Host Disease),Laboratory parameters,Length of hospital stay,LFS (Local-Free Survival),Lymphedema,Menopausal symptoms,Mental status/ function,MFS (Metastases-Free Survival),Mood/Affect,Mortality rate,MTD (Maximum Tolerated Dose),Mucositis,Musculoskeletal symptoms,Nausea,Nausea and Vomiting,Neurotoxicity,Neutropenia,Non-haematological indices,Nutrition status,Objective signs and subjective symptoms,Oral ulcus,OS (Overall Survival),Ototoxicity,Pain,PD (Pharmacodynamics),Performance Status,Peripheral neuropathy,PFS (Progression-Free Survival),Pharyngitis,Physical functioning,PK (Pharmacokinetics),Postoperative opiate consumption,PSADT (Prostate-Specific Antigen Doubling Time),PSA level (Prostate-Specific Antigen),Quality of life,Recurrence rate,Reduction of complication rates,Relaxation,Restoration of bowel function after surgery,RFS (Recurrence-Free Survival),Salivary gland function,Selenium level,Seroconversion,Shoulder mobility,Side effects of androgen deprivation/suppression,Skeletal morbidity-free survival,Sleep,Stress,Taste alteration,Tea polyphenol uptake,Thromboembolic event rates,Toxicity,Tumor progression,Tumor response,Vaginal atrophy,Vitamin A level,Vitamin B6 level,Vitamin B12 level,Vitamin B17 level,Vitamin C level,Vitamin D level,Vitamin E level,Vomiting,Weight,Well-being,Wound healing,Wound odour,Xerostomia,Zinc level,Unspecified effects,NI,?}}} | ||
'''Outcome specification:''' {{{field|Outcome specification|input type=textarea|default=?}}} | '''Outcome specification:''' {{{field|Outcome specification|input type=textarea|default=?}}} | ||
'''Type of measurement:''' {{{field|Type of measurement|input type=tokens|mandatory|default=?|delimiter=,|values=AQoL-8D (Assessment of Quality of Life),ASAT (Auditory Sustained Attention Test),Atomic absorption,Audiogram,AUSCAN (Australian/Canadian Osteoarthritis Hand Index),BCPT (Breast Cancer Prevention Symptom Scales),BFI (Brief Fatigue Inventory),BIA (Bioelectrical impedance analysis),Blood Test,BPI-SF (Brief Pain Inventory - Short Form),CES-D (Center for Epidemiologic Studies - Depression Scale),Chemiluminescent immunoassay | '''Type of measurement:''' {{{field|Type of measurement|input type=tokens|mandatory|default=?|delimiter=,|values=AQoL-8D (Assessment of Quality of Life),ASAT (Auditory Sustained Attention Test),Atomic absorption,Audiogram,AUSCAN (Australian/Canadian Osteoarthritis Hand Index),BCPT (Breast Cancer Prevention Symptom Scales),BFI (Brief Fatigue Inventory),BIA (Bioelectrical impedance analysis),Blood Test,BPI-SF (Brief Pain Inventory - Short Form),CES-D (Center for Epidemiologic Studies - Depression Scale),Chemiluminescent immunoassay,CTCAE (Common Terminology Criteria of Adverse Events),Cystoscopy,Diary questionnaire,DXA (Dual energy X-ray Absorptiometry),Dynamometer,Echo-color Doppler,ECOG Performance Status Scale (Eastern Cooperative Oncology Group),Electrophysiological evaluation,ELISA protocol (Enzyme-Linked Immunoabsorbent Assay),EORTC QLQ (European Organisation for Research and Treatment of Cancer Core/ Quality of Life questionnaire),ESAS (Edmonton Symptom Assessment Scale),FAACT (Functional Assessment of Anorexia-Cachexia Therapy),FACIT (Functional Assessment of Chronic Illness Therapy),FACT (Functional Assessment of Cancer Therapy),FGS (Hughes' Functional Grading Scale),FIQ (Fibromyalgia Impact Questionnaire),FLIE (Functional Living Index for Emesis),Genitourinary atrophy self-assessment tool,GFAAS (Graphite Furnace Atomic Absorption Spectrometry),Global Charter Fatigue Scale,HADS (Hospital Anxiety and Depression Scale),HAQ-DI (Health Assessment Questionnaire-Disability Index),HFRDIS (Hot Flash Related Daily Interference Scale),HFS (Hot Flush Score),HGST Maximum (Handgrip Strength Test),Histological examination,HNQR (Head and Neck Radiotherapy Questionnaire),HSCS (High Sensitivity Cognitive Screen),ICI Test (Intracavernosal Injection Test),IIEF (International Index of Erectile Function),Interview,KPS (Karnofsky Performance Status),LASA (Linear Analogue Self-Assessment),LENT SOMA Scale (Late Effects on Normal Tissues/ Subjective Objective Management Analysis),MADRS (Montgomery-Asberg Depression Rating Scale),MAT (Multinational Association of Supportive Care in Cancer-Antiemesis Tool),McDonald criteria,MENQOL (Menopause-Specific Quality of Life),MFI-20 (Multidimensional Fatigue Inventory-20),MMSE (Mini-Mental State Exam),MOS SF-12 (Medical Outcomes Study/ 12-Item Short Form Health Survey),MPQ-SF (McGill Pain Questionnaire - Short Form),MRI (Magnetic Resonance Imaging),NCI-CTC v.2 (National Cancer Institute-Common Toxic Criteria),NCI Grading Scale (National Cancer Institute),NDS (Neurological Disability Score),Neurologic examination,Neuropathy specific question,NRS (Numeric Rating Scale),NRS (Nutritional Risk Screening),NSS (Neurological Symptom Score),Observation,OMAS (Oral Mucositis Assessment Scale),Otoacoustic Emissions Testing,PHLF (Post Hepatectomy Liver Failure),PHS (Cognitive subscale of the Perceived Health Scale),pH-value,Physical functioning (grip strength;6 minute walk;leg extension),POMS (Profile of Mood States),Postoperative morbidity/complications (classification according to Clavien-Dindo),PROMIS (Patient-Reported Outcomes Measurement Information System),PSQI (Pittsburgh Sleep Quality Index),QoR-40 (Quality of Recovery-40 Questionnaire),RDS (Radiation Dermatitis Severity),RECIST 1.0 Criteria (Response Evaluation Criteria in Solid Tumors),Reidel-Seiffer tuning fork,RPSAS (Radiation Proctopathy System Assessment Scale),RTOG Acute Radiation Morbidity Scoring Criteria (Radiation Therapy Oncology Group),Scale,Scintigraphy,Self-developed measurement instrument,SF-36 (Short Form-36 Health Survey),SI (Symptom Inventory questionnaire),SOMA (Subjective Objective Medical management and Analytic evaluation of injury),SPECT (Single Photon Emission Computed Tomography),Spectrophotometry,SPPB (Short Physical Performance Battery),Symptom experience diary (NCCTG),Three-stimulus drop technique (by Henkin),TMT (Trail Making Test),TNS (Total Neuropathy Score),Ultrasonography,Urinalysis,VAS (Visual Analogue Scale),VMI (Vaginal Maturation Index),VNS (Verbal Numerical Scale),Western Ontario and McMaster Osteoarthritis Index,WHO-Scale (World Health Organisation),Wound volume,Others,NI,NA,?}}} | ||
'''Results during intervention:''' {{{field|Results during intervention|input type=textarea|mandatory|default=?}}} | '''Results during intervention:''' {{{field|Results during intervention|input type=textarea|mandatory|default=?}}} | ||
Line 186: | Line 185: | ||
{| class="formtable" | {| class="formtable" | ||
! Bias arising from the randomization process | ! Bias arising from the randomization process | ||
| {{{field|Bias arising from the randomization process|input type=radiobutton|mandatory|default=?}}} | | {{{field|Bias arising from the randomization process|input type=radiobutton|mandatory|default=?|values=?,low risk,some concerns,high risk}}} | ||
|- | |- | ||
! Bias due to deviation from intended intervention (assignment to intervention) | ! Bias due to deviation from intended intervention (assignment to intervention) | ||
| {{{field|Bias due to deviation from intended intervention (assignment to intervention)|input type=radiobutton|mandatory|default=?}}} | | {{{field|Bias due to deviation from intended intervention (assignment to intervention)|input type=radiobutton|mandatory|default=?|values=?,low risk,some concerns,high risk,NA}}} | ||
|- | |- | ||
! Bias due to deviation from intended intervention (adhering to intervention) | ! Bias due to deviation from intended intervention (adhering to intervention) | ||
| {{{field|Bias due to deviation from intended intervention (adhering to intervention)|input type=radiobutton|mandatory|default=NA}}} | | {{{field|Bias due to deviation from intended intervention (adhering to intervention)|input type=radiobutton|mandatory|default=NA|values=?,low risk,some concerns,high risk,NA}}} | ||
|- | |- | ||
! Bias due to missing outcome data | ! Bias due to missing outcome data | ||
| {{{field|Bias due to missing outcome data|input type=radiobutton|mandatory|default=?}}} | | {{{field|Bias due to missing outcome data|input type=radiobutton|mandatory|default=?|values=?,low risk,some concerns,high risk}}} | ||
|- | |- | ||
! Bias in measurement of the outcome | ! Bias in measurement of the outcome | ||
| {{{field|Bias in measurement of the outcome|input type=radiobutton|mandatory|default=?}}} | | {{{field|Bias in measurement of the outcome|input type=radiobutton|mandatory|default=?|values=?,low risk,some concerns,high risk}}} | ||
|- | |- | ||
! Bias in selection of the reported result | ! Bias in selection of the reported result | ||
| {{{field|Bias in selection of the reported result|input type=radiobutton|mandatory|default=?}}} | | {{{field|Bias in selection of the reported result|input type=radiobutton|mandatory|default=?|values=?,low risk,some concerns,high risk}}} | ||
|- | |- | ||
! Other sources of bias | ! Other sources of bias | ||
| {{{field|Other sources of bias|input type=radiobutton|mandatory|default=?}}} | | {{{field|Other sources of bias|input type=radiobutton|mandatory|default=?|values=?,low risk,some concerns,high risk,NA}}} | ||
|- | |- | ||
! Overall RoB judgment | ! Overall RoB judgment | ||
| {{{field|Overall RoB judgment|input type=radiobutton|mandatory|default=?}}} | | {{{field|Overall RoB judgment|input type=radiobutton|mandatory|default=?|values=?,low risk,some concerns,high risk}}} | ||
|} | |} | ||
Line 232: | Line 231: | ||
{{{for template|Further points for assessing the study}}} | {{{for template|Further points for assessing the study}}} | ||
== | ==Sample== | ||
{| class="formtable" | {| class="formtable" | ||
! Power analysis performed | ! Power analysis performed | ||
| {{{field|power analysis performed|input type=radiobutton|mandatory|default=?}}} | | {{{field|power analysis performed|input type=radiobutton|mandatory|default=?}}} | ||
|- | |- | ||
! Reasons | ! Sample size corresponds to power analysis | ||
| {{{field| | | {{{field|Sample size corresponds to power analysis|input type=radiobutton|mandatory|default=?}}} | ||
|- | |||
! Reasons for insufficient sample size based on power analysis | |||
| {{{field|Reasons given for samples being too small according to power analysis|input type=textarea|mandatory|default=?}}} | |||
|- | |||
! If no power analysis performed: at least moderate sample size (n >= 30 per arm) | |||
| {{{field|Samples sufficiently large|input type=radiobutton|mandatory|default=?}}} | |||
|- | |- | ||
! Ethnicity mentioned | ! Ethnicity mentioned | ||
| {{{field|Ethnicity mentioned|input type=radiobutton|mandatory|default=?}}} | | {{{field|Ethnicity mentioned|input type=radiobutton|mandatory|default=?}}} | ||
|} | |} | ||
== | ==Alternative Explanation== | ||
{| class="formtable" | {| class="formtable" | ||
! Other explanations for an effect besides the investigated intervention | |||
| {{{field|Other explanations for an effect besides the investigated intervention|input type=radiobutton|mandatory|default=?}}} | |||
|- | |||
! Possibility of attention effects {{#info: e.g. due to lack of a placebo arm|note}} | ! Possibility of attention effects {{#info: e.g. due to lack of a placebo arm|note}} | ||
| {{{field|Possibility of attention effects|input type= | | {{{field|Possibility of attention effects|input type=textarea|mandatory|default=?}}} | ||
|- | |- | ||
! Possibility of placebo effects | ! Possibility of placebo effects | ||
| {{{field|Possibility of placebo effects|input type= | | {{{field|Possibility of placebo effects|input type=textarea|mandatory|default=?}}} | ||
|- | |- | ||
! Other reasons | ! Other reasons | ||
Line 259: | Line 264: | ||
==Statistics== | ==Statistics== | ||
{| class="formtable" | {| class="formtable" | ||
! Correct use of parametric and non-parametric tests | |||
| {{{field|Correct use of parametric and non-parametric tests|input type=radiobutton|mandatory|default=?}}} | |||
! Correct | |||
| {{{field|Correct | |||
|- | |- | ||
! Correction for multiple testing | ! Correction for multiple testing | ||
| {{{field|Correction for multiple testing|input type=radiobutton|mandatory|default=?}}} | | {{{field|Correction for multiple testing|input type=radiobutton|mandatory|default=?}}} | ||
|- | |- | ||
! Measurement of compliance | ! Measurement of compliance | ||
| {{{field|Measurement of compliance|input type=radiobutton|mandatory|default=?}}} | | {{{field|Measurement of compliance|input type=radiobutton|mandatory|default=?}}} | ||
|- | |- | ||
Line 274: | Line 276: | ||
| {{{field|Blinding reliable|input type=radiobutton|mandatory|default=?}}} | | {{{field|Blinding reliable|input type=radiobutton|mandatory|default=?}}} | ||
|- | |- | ||
! Check whether blinding was successful | ! Check whether blinding (of participants) was successful | ||
| {{{field|Check whether blinding was successful|input type=radiobutton|mandatory|default=?}}} | | {{{field|Check whether blinding was successful|input type=radiobutton|mandatory|default=?}}} | ||
|- | |- | ||
Line 280: | Line 282: | ||
| {{{field|Consistent reporting in numbers|input type=radiobutton|mandatory|default=?}}} | | {{{field|Consistent reporting in numbers|input type=radiobutton|mandatory|default=?}}} | ||
|- | |- | ||
! | ! Comprehensive and coherent reporting | ||
| {{{field|Comprehensive and coherent reporting|input type=radiobutton|mandatory|default=?}}} | |||
|- | |||
! Cross-Over study | |||
| {{{field|Cross-over|input type=radiobutton|mandatory|default=?}}} | |||
|- | |||
! Sufficient washout period | |||
| {{{field|sufficient washout period|input type=radiobutton|mandatory|default=?}}} | | {{{field|sufficient washout period|input type=radiobutton|mandatory|default=?}}} | ||
|- | |- | ||
! | ! Tested for carry-over effects | ||
| {{{field|Tested for carry-over effects|input type=radiobutton|mandatory|default=?}}} | | {{{field|Tested for carry-over effects|input type=radiobutton|mandatory|default=?}}} | ||
|- | |- | ||
! | ! Tested for sequence effects | ||
| {{{field|Were sequence effects tested|input type=radiobutton|mandatory|default=?}}} | | {{{field|Were sequence effects tested|input type=radiobutton|mandatory|default=?}}} | ||
|} | |} | ||
==Interpretation of results== | ==Interpretation of results== | ||
Line 300: | Line 302: | ||
| {{{field|Effect sizes reported|input type=radiobutton|mandatory|default=?}}} | | {{{field|Effect sizes reported|input type=radiobutton|mandatory|default=?}}} | ||
|- | |- | ||
! Side effects | ! Side effects systematically recorded | ||
| {{{field|Were side effects systematically recorded|input type=radiobutton|mandatory|default=?}}} | |||
|- | |||
! Side effects considered in result interpretation | |||
| {{{field|Side effects taken into account in the interpretation of the results|input type=radiobutton|mandatory|default=?}}} | | {{{field|Side effects taken into account in the interpretation of the results|input type=radiobutton|mandatory|default=?}}} | ||
|- | |- | ||
! Ethics votum | |||
| {{{field|Ethics / CoI / Funding|input type=radiobutton|mandatory|default=?}}} | |||
! Ethics | |||
| {{{field|Ethics / CoI / Funding|input type= | |||
|} | |} | ||
{{{end template}}} | {{{end template}}} |
Revision as of 11:55, 21 August 2024
This is the "RCT Study" form. To create a page with this form, enter the page name below; if a page with that name already exists, you will be sent to a form to edit that page.