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Form:RCT Study: Difference between revisions

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! Countries of data collection:  
! Countries of data collection:  
| {{{field|Countries of data collection|input type=text with autocomplete|delimiter=,|values=Afghanistan,Albania,Algeria,Andorra,Angola,Antigua & Deps,Argentina,Armenia,Australia,Austria,Azerbaijan,Bahamas,Bahrain,Bangladesh,Barbados,Belarus,Belgium,Belize,Benin,Bhutan,Bolivia,Bosnia Herzegovina,Botswana,Brazil,Brunei,Bulgaria,Burkina,Burundi,Cambodia,Cameroon,Canada,Cape Verde,Central African Rep,Chad,Chile,China,Colombia,Comoros,Congo,Congo {Democratic Rep},Costa Rica,Croatia,Cuba,Cyprus,Czech Republic,Denmark,Djibouti,Dominica,Dominican Republic,East Timor,Ecuador,Egypt,El Salvador,Equatorial Guinea,Eritrea,Estonia,Ethiopia,Europe,Fiji,Finland,France,Gabon,Gambia,Georgia,Germany,Ghana,Greece,Grenada,Guatemala,Guinea,Guinea-Bissau,Guyana,Haiti,Honduras,Hungary,Iceland,India,Indonesia,Iran,Iraq,Ireland {Republic},Israel,Italy,Ivory Coast,Jamaica,Japan,Jordan,Kazakhstan,Kenya,Kiribati,Korea North,Korea South,Kosovo,Kuwait,Kyrgyzstan,Laos,Latvia,Lebanon,Lesotho,Liberia,Libya,Liechtenstein,Lithuania,Luxembourg,Macedonia,Madagascar,Malawi,Malaysia,Maldives,Mali,Malta,Marshall Islands,Mauritania,Mauritius,Mexico,Micronesia,Moldova,Monaco,Mongolia,Montenegro,Morocco,Mozambique,Myanmar,{Burma},Namibia,Nauru,Nepal,Netherlands,New Zealand,Nicaragua,Niger,Nigeria,Norway,Oman,Pakistan,Palau,Panama,Papua New Guinea,Paraguay,Peru,Philippines,Poland,Portugal,Qatar,Romania,Russian Federation,Rwanda,St Kitts & Nevis,St Lucia,Saint Vincent & the Grenadines,Samoa,San Marino,Sao Tome & Principe,Saudi Arabia,Senegal,Serbia,Seychelles,Sierra Leone,Singapore,Slovakia,Slovenia,Solomon Islands,Somalia,South Africa,South Sudan,Spain,Sri Lanka,Sudan,Suriname,Swaziland,Sweden,Switzerland,Syria,Taiwan,Tajikistan,Tanzania,Thailand,Togo,Tonga,Trinidad & Tobago,Tunisia,Turkey,Turkmenistan,Tuvalu,Uganda,Ukraine,United Arab Emirates,United Kingdom,United Kingdom - Great Britain,United States,United States - New York,United States - Texas,Uruguay,Uzbekistan,Vanuatu,Vatican City,Venezuela,Vietnam,Yemen,Zambia,Zimbabwe,NI,?|default=?}}}
| {{{field|Countries of data collection|input type=text with autocomplete|delimiter=,|values=Afghanistan,Albania,Algeria,Andorra,Angola,Antigua & Deps,Argentina,Armenia,Australia,Austria,Azerbaijan,Bahamas,Bahrain,Bangladesh,Barbados,Belarus,Belgium,Belize,Benin,Bhutan,Bolivia,Bosnia Herzegovina,Botswana,Brazil,Brunei,Bulgaria,Burkina,Burundi,Cambodia,Cameroon,Canada,Cape Verde,Central African Rep,Chad,Chile,China,Colombia,Comoros,Congo,Congo {Democratic Rep},Costa Rica,Croatia,Cuba,Cyprus,Czech Republic,Denmark,Djibouti,Dominica,Dominican Republic,East Timor,Ecuador,Egypt,El Salvador,Equatorial Guinea,Eritrea,Estonia,Ethiopia,Europe,Fiji,Finland,France,Gabon,Gambia,Georgia,Germany,Ghana,Greece,Grenada,Guatemala,Guinea,Guinea-Bissau,Guyana,Haiti,Honduras,Hungary,Iceland,India,Indonesia,Iran,Iraq,Ireland {Republic},Israel,Italy,Ivory Coast,Jamaica,Japan,Jordan,Kazakhstan,Kenya,Kiribati,Korea North,Korea South,Kosovo,Kuwait,Kyrgyzstan,Laos,Latin America,Latvia,Lebanon,Lesotho,Liberia,Libya,Liechtenstein,Lithuania,Luxembourg,Macedonia,Madagascar,Malawi,Malaysia,Maldives,Mali,Malta,Marshall Islands,Mauritania,Mauritius,Mexico,Micronesia,Moldova,Monaco,Mongolia,Montenegro,Morocco,Mozambique,Myanmar,{Burma},Namibia,Nauru,Nepal,Netherlands,New Zealand,Nicaragua,Niger,Nigeria,North America,Norway,Oman,Pakistan,Palau,Panama,Papua New Guinea,Paraguay,Peru,Philippines,Poland,Portugal,Qatar,Romania,Russian Federation,Rwanda,St Kitts & Nevis,St Lucia,Saint Vincent & the Grenadines,Samoa,San Marino,Sao Tome & Principe,Saudi Arabia,Senegal,Serbia,Seychelles,Sierra Leone,Singapore,Slovakia,Slovenia,Solomon Islands,Somalia,South Africa,South Sudan,Spain,Sri Lanka,Sudan,Suriname,Swaziland,Sweden,Switzerland,Syria,Taiwan,Tajikistan,Tanzania,Thailand,Togo,Tonga,Trinidad & Tobago,Tunisia,Turkey,Turkmenistan,Tuvalu,Uganda,Ukraine,United Arab Emirates,United Kingdom,United Kingdom - Great Britain,United States,United States - New York,United States - Texas,Uruguay,Uzbekistan,Vanuatu,Vatican City,Venezuela,Vietnam,Yemen,Zambia,Zimbabwe,NI,?|default=?}}}
|-
|-
! LoE: {{#info: Level of evidence|note}}
! LoE: {{#info: Level of evidence|note}}
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{| 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);
- Curative therapy: aims to completely eradicate a disease and achieve a full recovery;
Adjuvant therapy: given after the primary treatment for cancer (usually surgery);
- Neo-adjuvant therapy: form of curative therapy, given before 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;
- Adjuvant therapy: form of curative therapy, given after the primary treatment for cancer (usually surgery);  
No therapy setting: includes patients who completed cancer therapy, patients who are currently not in cancer treatment and cancer survivors|note}}
- Palliative therapy: focuses on providing relief from symptoms and improving the quality of life for patients, without necessarily targeting the underlying disease;  
- Active surveillance: involves close monitoring of disease progression without any intervention (typically used for prostate cancer);
- No therapy setting: Patients who completed therapy/are currently not in cancer treatment, cancer survivors.|note}}
| {{{field|Setting|input type=checkboxes|delimiter=,|default=?|mandatory|values=?, Curative, Neo-adjuvant, Adjuvant, Palliative, Active surveillance, No therapy setting, NI}}}
| {{{field|Setting|input type=checkboxes|delimiter=,|default=?|mandatory|values=?, Curative, Neo-adjuvant, Adjuvant, Palliative, Active surveillance, No therapy setting, NI}}}
|-
|-
! Types of cancer: {{#info: "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included|note}}
! Types of cancer: {{#info: "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included|note}}
| {{{field|Types of cancer|input type=text with autocomplete|mandatory|default=?|delimiter=,|values=Adrenal Cancer,Anal Cancer,Bile Duct Cancer,Bone and Soft Tissue Cancers, Bone and Soft Tissue Cancers - Osteosarcoma,Bone and Soft Tissue Cancers - Ewing Sarcoma,Bone and Soft Tissue Cancers - Chondrosarcoma,Bone and Soft Tissue Cancers - Rhabdomyosarcoma,Bone and Soft Tissue Cancers – Liposarcoma,Brain and Central Nervous System (CNS) Cancers,Brain and Central Nervous System (CNS) Cancers - Astrocytoma,Brain and Central Nervous System (CNS) Cancers - Glioblastoma,Brain and Central Nervous System (CNS) Cancers - High-Grade Glioma,Brain and Central Nervous System (CNS) Cancers - Meningioma,Breast Cancer,Breast Cancer - Ductal Carcinoma,Breast Cancer - Lobular Carcinoma,Breast Cancer - Inflammatory Breast Cancer,Breast Cancer - Triple-Negative Breast Cancer,Carcinosarcoma,Colorectal Cancer,Colorectal Cancer - Colon Cancer,Colorectal Cancer - Rectal Cancer,Gastrointestinal Cancers,Gastrointestinal Cancers - Gastric (Stomach) Cancer,Gastrointestinal Cancers - Esophageal Cancer,Gastrointestinal Cancers - Pancreatic Cancer,Gastrointestinal Cancers - Liver Cancer,Genitourinary Cancers,Genitourinary Cancers - Bladder Cancer,Genitourinary Cancers - Kidney (Renal) Cancer,Genitourinary Cancers - Testicular Cancer,Genitourinary Cancers - Urethral Cancer,Gynecologic Cancers,Gynecologic Cancers - Ovarian Cancer,Gynecologic Cancers - Cervical Cancer,Gynecologic Cancers - Uterine Cancer,Gynecologic Cancers - Endometrial Cancer,Gynecologic Cancers - Vulvar Cancer,Head and Neck Cancers, Head and Neck Cancers - Oral Cancer,Head and Neck Cancers - Oropharyngeal Cancer,Head and Neck Cancers - Laryngeal Cancer,Head and Neck Cancers - Nasopharyngeal Cancer,Head and Neck Cancers - Tongue Cancer,Head and Neck Cancers - Thyroid Cancer,Head and Neck Cancers - Ethmoid Sinus Cancer,Hematologic Cancers, Hematologic Cancers - Leukemia (Acute Lymphocytic/Acute Myeloid/Chronic Lymphocytic/Chronic Myeloid), Hematologic Cancers - Lymphoma (Hodgkin and Non-Hodgkin),Hematologic Cancers - Multiple Myeloma,Lung Cancer,Lung Cancer - Small Cell Lung Cancer,Lung Cancer - Non-Small Cell Lung Cancer,Mesothelioma,Neuroblastoma,Prostate Cancer,Retinoblastoma,Skin Cancer,Skin Cancer - Basal Cell Carcinoma,Skin Cancer - Squamous Cell Carcinoma,Skin Cancer – Melanoma,Stomach Cancer,Solid Malignancies,Thymoma and Thymic Carcinoma,Unspecified Sarcoma,Other Cancers,NI,?}}}
| {{{field|Types of cancer|input type=text with autocomplete|mandatory|default=?|delimiter=,|values=Adrenal Cancer,Anal Cancer,Bile Duct Cancer,Bone and Soft Tissue Cancers, Bone and Soft Tissue Cancers - Osteosarcoma,Bone and Soft Tissue Cancers - Ewing Sarcoma,Bone and Soft Tissue Cancers - Chondrosarcoma,Bone and Soft Tissue Cancers - Rhabdomyosarcoma,Bone and Soft Tissue Cancers – Liposarcoma,Brain and Central Nervous System (CNS) Cancers,Brain and Central Nervous System (CNS) Cancers - Astrocytoma,Brain and Central Nervous System (CNS) Cancers - Glioblastoma,Brain and Central Nervous System (CNS) Cancers - High-Grade Glioma,Brain and Central Nervous System (CNS) Cancers - Meningioma,Breast Cancer,Breast Cancer - Ductal Carcinoma,Breast Cancer - Lobular Carcinoma,Breast Cancer - Inflammatory Breast Cancer,Breast Cancer - Triple-Negative Breast Cancer,Carcinosarcoma,Chest Cancer,Colorectal Cancer,Colorectal Cancer - Colon Cancer,Colorectal Cancer - Rectal Cancer,Eye Cancer,Eye Cancer - Retinoblastoma,Gastrointestinal Cancers,Gastrointestinal Cancers - Gallbladder Cancer,Gastrointestinal Cancers - Gastric (Stomach) Cancer,Gastrointestinal Cancers - Esophageal Cancer,Gastrointestinal Cancers - Pancreatic Cancer,Gastrointestinal Cancers - Liver Cancer,Genitourinary Cancers,Genitourinary Cancers - Bladder Cancer,Genitourinary Cancers - Kidney (Renal) Cancer,Genitourinary Cancers - Testicular Cancer,Genitourinary Cancers - Urethral Cancer,Gynecologic Cancers,Gynecologic Cancers - Ovarian Cancer,Gynecologic Cancers - Cervical Cancer,Gynecologic Cancers - Uterine Cancer,Gynecologic Cancers - Endometrial Cancer,Gynecologic Cancers - Vulvar Cancer,Head and Neck Cancers, Head and Neck Cancers - Oral Cancer,Head and Neck Cancers - Oropharyngeal Cancer,Head and Neck Cancers - Laryngeal Cancer,Head and Neck Cancers - Nasopharyngeal Cancer,Head and Neck Cancers - Tongue Cancer,Head and Neck Cancers - Thyroid Cancer,Head and Neck Cancers - Ethmoid Sinus Cancer,Hematologic Cancers, Hematologic Cancers - Leukemia (Acute Lymphocytic/Acute Myeloid/Chronic Lymphocytic/Chronic Myeloid), Hematologic Cancers - Lymphoma (Hodgkin and Non-Hodgkin),Hematologic Cancers - Multiple Myeloma,Lung Cancer,Lung Cancer - Small Cell Lung Cancer,Lung Cancer - Non-Small Cell Lung Cancer,Mesothelioma,Neuroblastoma,Prostate Cancer,Skin Cancer,Skin Cancer - Basal Cell Carcinoma,Skin Cancer - Squamous Cell Carcinoma,Skin Cancer – Melanoma,Stomach Cancer,Solid Malignancies,Thymoma and Thymic Carcinoma,Unspecified Sarcoma,Other Cancers,NI,?}}}
|-
|-
! Cancer stage: {{#info: Early Stage: generally refers to cancer that is localized to the area where it started, mostly stages I and II;
! Cancer stage: {{#info: Early Stage: generally refers to cancer that is localized to the area where it started, mostly stages I and II;
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'''One-time application:''' {{{field|One-time application|input type=checkbox|mandatory|default=No}}}
'''One-time application:''' {{{field|One-time application|input type=checkbox|mandatory|default=No}}}


'''Duration in days:''' {{#info: For long-term interventions, the number of days is an estimation.
'''Duration in days:''' {{#info: For long-term interventions, the number of days is an estimate.
A value of -999 indicates that the exact duration cannot be extracted from the study due to incomplete information. See ‘’Outcome timeline’’ or ‘’Dosage and regime’’ for further information.|note}}
A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See ''Outcome timeline'' or ''Dosage and regime'' for further information. |note}}
{{{field|Duration in days|input type=regexp|mandatory|default=?}}}
{{{field|Duration in days|input type=regexp|mandatory|default=?}}}


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'''Order number:''' {{{field|Order number|input type=text|mandatory|default=1}}}
'''Order number:''' {{{field|Order number|input type=text|mandatory|default=1}}}
'''Arm topic:''' {{{field|Arm topic|input type=tokens|mandatory|delimiter=,|values=Aloe vera,Boswellia serrata,Cannabinoids,Carnitine,Curcumin,Electroacupuncture,Enzymes (bromelain papain),Folic acid,Ginger,Ginkgo,Green tea (EGCG),Guarana,Low-carbohydrate or ketogenic diet,Lycopene,Reflexology,Resveratrol,Selenium,Vitamin A (beta-carotene),Vitamin B1,Vitamin B12,Vitamin B6,Vitamin C,Vitamin D,Vitamin E,Zeolites,Zinc,NI,?}}}


{{{end template}}}
{{{end template}}}
Line 173: Line 177:
'''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=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 name:''' {{{field|Outcome name|input type=text with autocomplete|mandatory|default=?|delimiter=,|values=Additional medication,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,Dysgeusia,Ejection fraction,Erectile dysfunction,Erythema,Esophagitis,Fatigue,Fever,Fibrosis,Folic acid level,Functionality,Haematological indices,Haematological toxicity,Hand-foot syndrome,Hand grip strength,Hormone level,Ileus (intestinal obstruction),Incidence of acute GVHD (Graft-Versus-Host Disease),Infection,Interaction with cancer treatment,Laboratory parameters,Length of hospital stay,Lymphedema,Menopausal symptoms,Mental status/ function,Mood/Affect,Mortality rate,Mucositis,Musculoskeletal symptoms,Nausea,Nausea and Vomiting,Nerve conduction velocity,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 morbidity/ complications,PSA level (Prostate-Specific Antigen),Quality of life,Recurrence rate,REE (Resting Energy Expenditure),Relaxation,RFS (Recurrence-Free Survival),Salivary gland function,Selenium level,Seroconversion,Sleep,Stomatitis,Stress,Symptom load,Taste alteration,Tea polyphenol uptake,Thromboembolic event rates,Toxicity,Treatment interruption,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,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,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,?}}}
'''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),BDI (Beck Depression Inventory),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,CNPI (Checklist of Non-Verbal Pain Indicators),CSSP (Catterall Skin Scoring Profile),CT (Computed Tomography),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),Electronic monitoring device,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,MDASI (M. D. Anderson Symptom Inventory),Measuring tape,MENQOL (Menopause-Specific Quality of Life),MFI-20 (Multidimensional Fatigue Inventory-20),MMSE (Mini-Mental State Exam),Morbidity rating scale (by Dische),MOS SF-12 (Medical Outcomes Study/ 12-Item Short Form Health Survey),MPQ-SF (McGill Pain Questionnaire - Short Form),MRI (Magnetic Resonance Imaging),MRS (Mood Rating Scale),MYCaW (Measure Yourself Concerns and Wellbeing),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,PAC-QoL (Patient Assessment of Constipation - Quality of Life),PGIC (Physician Global Impression of Change),PG-SGA (Patient-Generated Subjective Global Assessment),PHLF (Post Hepatectomy Liver Failure),PHS (Cognitive subscale of the Perceived Health Scale),pH-value,Physical examination,Physical functioning (grip strength;6 minute walk;leg extension),POMS (Profile of Mood States),PoSSe (Postoperative Symptom Severity Scale),Postoperative morbidity/complications (classification according to Clavien-Dindo),PROMIS (Patient-Reported Outcomes Measurement Information System),PSQ (Patient Satisfaction Questionnaire),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,Rhodes Inventory of Nausea,RPSAS (Radiation Proctopathy System Assessment Scale),RTOG Acute Radiation Morbidity Scoring Criteria (Radiation Therapy Oncology Group),Scale,SCID (Structured Clinical Interview for DSM IV),Scintigraphy,Self-developed measurement instrument,SF-36 (Short Form-36 Health Survey),SF-MPQ (Short-Form McGill Pain Questionnaire),SGIC (Subject Global Impression of Change),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),STAI (State-Trait-Anxiety-Inventory),Symptom experience diary (NCCTG),Thermometer,Three-stimulus drop technique (by Henkin),Tissue testing,TMT (Trail Making Test),TNS (Total Neuropathy Score),Ultrasonography,Unspecified questionnaire,Urinalysis,VAS (Visual Analogue Scale),VMI (Vaginal Maturation Index),VNS (Verbal Numerical Scale),Volometer,Western Ontario and McMaster Osteoarthritis Index,WHO-Scale (World Health Organisation),Wound volume,NI,NA,?}}}


'''Results during intervention:''' {{{field|Results during intervention|input type=textarea|mandatory|default=?}}}
'''Results during intervention:''' {{#info: ''Results during intervention'' means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.|note}}
'''Results after intervention:''' {{#info: If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under ''Results after intervention'' under the headline "Overall".|note}}
{{{field|Results during intervention|input type=textarea|mandatory|default=?}}}
'''Results after intervention:''' {{#info: ''Results after intervention'' means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.
If a categorization in ''Results during vs. after intervention'' is not possible (e.g. survival data), the results are summarized under ''Results after intervention'' under the headline "Overall".|note}}
{{{field|Results after intervention|input type=textarea|mandatory|default=?}}}
{{{field|Results after intervention|input type=textarea|mandatory|default=?}}}
==Risk of Bias Assessment: Cochrane RoB tool 2.0==
==Risk of Bias Assessment: Cochrane RoB tool 2.0==
{| 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,NA}}}
|-
|-
! 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, NA}}}
|-
|-
! 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, NA}}}
|-
|-
! 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,NA}}}
|-
|-
! 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,NA}}}
|}
|}


'''Order number:''' {{{field|Order number|input type=text|mandatory|default=1}}}
'''Order number:''' {{{field|Order number|input type=text|mandatory|default=1}}}
'''Outcome topic:''' {{{field|Outcome topic|input type=tokens|mandatory|delimiter=,|values=Aloe vera,Boswellia serrata,Cannabinoids,Carnitine,Curcumin,Electroacupuncture,Enzymes (bromelain papain),Folic acid,Ginger,Ginkgo,Green tea (EGCG),Guarana,Low-carbohydrate or ketogenic diet,Lycopene,Reflexology,Resveratrol,Selenium,Vitamin A (beta-carotene),Vitamin B1,Vitamin B12,Vitamin B6,Vitamin C,Vitamin D,Vitamin E,Zeolites,Zinc,NI,?}}}
{{{end template}}}
{{{end template}}}
{{{for template|Outcome Overview}}}
{{{for template|Outcome Overview}}}
Line 231: Line 239:


{{{for template|Further points for assessing the study}}}
{{{for template|Further points for assessing the study}}}
==Samples==
==Sample==
{| class="formtable"
{| class="formtable"
! Samples sufficiently large {{#info: e.g. n>30 per arm|note}}
| {{{field|Samples sufficiently large|input type=radiobutton|mandatory|default=?}}}
|-
! 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 given for samples being too small according to power analysis
! style="text-indent:3em;" | - Sample size corresponds to power analysis
| {{{field|reasons given for samples being too small according to power analysis|input type=textarea|mandatory|default=?}}}
| {{{field|Sample size corresponds to power analysis|input type=radiobutton|mandatory|default=?}}}
|-
! style="text-indent:3em;" | - 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=?}}}
|}
|}
==Are there other explanations for an effect besides the investigated intervention?==
==Alternative Explanation==
{| class="formtable"
{| class="formtable"
! Possibility of attention effects {{#info: e.g. due to lack of a placebo arm|note}}
! Other explanations for an effect besides the investigated intervention
| {{{field|Possibility of attention effects|input type=radiobutton|mandatory|default=?}}}
| {{{field|Other explanations for an effect besides the investigated intervention|input type=radiobutton|mandatory|default=?}}}
|-
|-
! Possibility of placebo effects
! style="text-indent:3em;" | - Possibility of attention effects {{#info: e.g. due to lack of a placebo arm|note}}
| {{{field|Possibility of placebo effects|input type=radiobutton|mandatory|default=?}}}
| {{{field|Possibility of attention effects|input type=textarea|mandatory|default=?}}}
|-
|-
! Other reasons
! style="text-indent:3em;" | - Possibility of placebo effects
| {{{field|Possibility of placebo effects|input type=textarea|mandatory|default=?}}}
|-
! style="text-indent:3em;" | - Other reasons
| {{{field|Other reasons|input type=textarea|mandatory|default=?}}}
| {{{field|Other reasons|input type=textarea|mandatory|default=?}}}
|}
|}
==Statistics==
==Statistics==
{| class="formtable"
{| class="formtable"
! Testing for normal distribution
! Correct use of parametric and non-parametric tests {{#info: Testing for normal distribution only necessary if parametric tests are used, NI: use of parametric tests without report of normal distribution testing|note}}  
| {{{field|Testing for normal distribution|input type=radiobutton|mandatory|default=?}}}
| {{{field|Correct use of parametric and non-parametric tests|input type=radiobutton|mandatory|default=?}}}
|-
! Correct application of statistical tests
| {{{field|Correct application of statistical tests|input type=radiobutton|mandatory|default=?}}}
|-
|-
! 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 (e.g. pill counting)
! Measurement of compliance
| {{{field|Measurement of compliance|input type=radiobutton|mandatory|default=?}}}
| {{{field|Measurement of compliance|input type=radiobutton|mandatory|default=?}}}
|-
|-
! Blinding reliable
! Consistent reporting in numbers (figures, flowchart, abstract, results)
| {{{field|Blinding reliable|input type=radiobutton|mandatory|default=?}}}
| {{{field|Consistent reporting in numbers|input type=radiobutton|mandatory|default=?}}}
|-
|-
! Check whether blinding was successful
! Comprehensive and coherent reporting
| {{{field|Check whether blinding was successful|input type=radiobutton|mandatory|default=?}}}
| {{{field|Comprehensive and coherent reporting|input type=radiobutton|mandatory|default=?}}}
|-
|-
! Consistent reporting in numbers (figures, flowchart, abstract, results)
! Cross-Over study
| {{{field|Consistent reporting in numbers|input type=radiobutton|mandatory|default=?}}}
| {{{field|Cross-over|input type=radiobutton|mandatory|default=?}}}
|-
|-
! Only for crossover studies: sufficient washout period (if intervention has a long half-life)
! style="text-indent:3em;" | - Sufficient washout period
| {{{field|sufficient washout period|input type=radiobutton|mandatory|default=?}}}
| {{{field|sufficient washout period|input type=radiobutton|mandatory|default=?}}}
|-
|-
! Only for crossover studies: Tested for carry-over effects
! style="text-indent:3em;" | - 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=?}}}
|-
|-
! Only for crossover studies: Were sequence effects tested
! style="text-indent:3em;" | - Tested for sequence effects
| {{{field|Were sequence effects tested|input type=radiobutton|mandatory|default=?}}}
| {{{field|Were sequence effects tested|input type=radiobutton|mandatory|default=?}}}
|-
! Comprehensive and coherent reporting
| {{{field|Comprehensive and coherent reporting|input type=radiobutton|mandatory|default=?}}}
|-
! Were side effects systematically recorded
| {{{field|Were side effects systematically recorded|input type=radiobutton|mandatory|default=?}}}
|}
|}
==Interpretation of results==
==Interpretation of results==
Line 299: Line 304:
| {{{field|Effect sizes reported|input type=radiobutton|mandatory|default=?}}}
| {{{field|Effect sizes reported|input type=radiobutton|mandatory|default=?}}}
|-
|-
! Side effects taken into account in the interpretation of the results
! 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=?}}}
|-
|-
! Mono- or multicentric (Transferability of results)
! Ethics votum
| {{{field|mono- or multicentric|input type=radiobutton|mandatory|default=?}}}
| {{{field|Ethics / CoI / Funding|input type=radiobutton|mandatory|default=?}}}
|-
! Ethics / CoI / Funding
| {{{field|Ethics / CoI / Funding|input type=textarea|mandatory|default=?}}}
|}
|}
{{{end template}}}
{{{end template}}}

Latest revision as of 09:17, 3 December 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.


Retrieved from "https://camih.med.uni-jena.de/camih/index.php?title=Form:RCT_Study&oldid=7512"