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D-1
Appendix D: Sample Abstraction Forms
Nurse Staffing in North American Hospitals Staffing Ratios/Patient Outcomes Abstraction Form
(Complete for each study)
Number of the study First author Year of the publication Journal of the publication Database to identify the study Person to score the study Publication type (check one)
Published article Administrative report Dissertation Abstract/Presentation Book/book chapter
Purpose/aim of study Design of the study (check one)
prospective cohort retrospective cohort cross-sectional descriptive study case-control case-series randomized controlled clinical trial not randomized clinical interventions ecologic
Nurse staffing variables (independent variables) 1. Mark Yes/No by assessment in the study. 2. Provide the definition of each variable used in the article. Data source for nurse staffing variables (define) Nurse to patient ratios: Registered nurse/patient ratio
Yes No
If Yes, define
Licensed nurse practitioner/patient ratio
Yes No
If Yes, define
Aid/patient ratio, number of patients/aid
Yes No
If Yes, define
D-2
Proportion of RN among nursing personnel Yes No
If Yes, define
Licensed nurses/patient ratio
Yes No
If Yes, define
Proportion of licensed nurses among nursing personnel
Yes No
If Yes, define
Measures of nurse work hours Total hours of care/patient day
Yes No
If Yes, define
Registered nurse hours/patient day
Yes No
If Yes, define
Licensed nurse hours/patient day
Yes No
If Yes, define
Aid hours /patient day
Yes No
If Yes, define
Patient outcomes variables 1. Mark Yes/No by assessment in the study. 2. Provide the definition of the variable used in the article.
Mortality
Yes No
If Yes, define
Data source to measure mortality : Time of follow up from the day of surgery to death, in days____________ Time of follow up from hospitalization to death , in days_______________
D-3
Mortality rate in groups with different staffing levels
Yes No
If yes, how reported (mark all applicable):
Number of events
Proportion in %
Relative risk
Adverse drug events 1. Mark Yes/No by assessment in the study. 2. Provide the definition of each variable used in the article. 3. Provide the data source to measure the outcome. 4. Mark how the outcome was reported
Variable Assessment in the study Definition
Source to
measure
Reporting number of
events Proportion
in % Relative
risk
Yes No
Adverse events
Other
Length of stay.
Length of stay in the unit, days Yes No
Length of stay in the hospital, days
Yes No
Data source to measure LOS
Data extraction table: Complete cells with values of LOS reported in the article
Categories of independent staffing
variable LOS
Exposure variable Mean STD Median RR Lower 95%CL
Upper 95%CL
LOS in hospital in days LOS in units in days
D-4
Nurse quality outcomes
1. Mark Yes/No by assessment in the study. 2. Provide the definition of each variable used in the article. 3. Provide the data source to measure the outcome. 4. Mark how the outcome was reported
Variable Assessment in the study Definition
Source to
measure
Reporting number
of events Proportion
in % Relative
risk
Yes No
Falls
Injury
Pressure ulcers
Failure to rescue
Patient satisfaction. 1. Mark Yes/No by assessment in the study. 2. Mark how the outcome was reported
Variable Assessment in
the study Reporting
scores % of favorable
responses Relative
risk
Yes No
Satisfaction with nurse care
Satisfaction with education
Satisfaction with pain management
Time from the hospitalization to the measurement of the patient satisfaction, in days __________ days
Patient satisfaction scale (define)______________________________
D-5
Quality Measures: Patient related: 1. Mark Yes/No by assessment in the study. 2. Provide the definition of each variable used in the article. 3. Provide the data source to measure the outcome. 4. Mark how the outcome was reported
Variable Assessment in the study Definition
Source to
measure
Reporting number of
events Proportion
in % Relative
risk
Yes No
Urinary tract infection
Postoperative complications
Gastrointestinal bleeding
Hospital-acquired pneumonia
Shock
Atelectasis or pulmonal failure
Accidental extubation
Nosocomial infection
Surgical wound infection
Post surgical thrombosis
Cardio-pulmonary arrest
Any complication
Any Medical complication
Any surgical complication
Sepsis
Post surgical bleeding Other
D-6
Nurses related: 1. Mark Yes/No by assessment in the study. 2. Provide the definition of each variable used in the article. 3. Provide the data source to measure the outcome. 4. Mark how the outcome was reported
Variable Assessment in the study Definition
Source to
measure
Reporting number of
events Proportion
in % Relative
risk
Yes No
Turnover rate
Burnout
Vacancy
Nurse self-reported. 1. Mark Yes/No by assessment in the study. 2. Provide the definition of each variable used in the article. 3. Provide scale to measure the outcome. 4. Mark how the outcome was reported
Variable Assessment in the study Definition
Scale to measure
Reporting scores
% favorable responses
Relative risk
Yes No
Satisfaction with job Perception of adequacy of staffing
Perception of quality care
Autonomy of nurses
Nurses Governance
Stress
D-7
Patient characteristics.
Patient Eligibility criteria Complete the table with definitions used in the article: Inclusion criteria Exclusion criteria Age Sex Race Insurance Residency Hospitalization Availability of records Diagnosis (ICD code) Comorbidities Severity Acuity Other
Patients
Medical % of the sample Surgical % of the sample Adults % of the sample Pediatric % of the sample combined
Sample characteristics: Complete with values reported in the article and with page number in the article where the data was extracted:
Page in
the article Exposure categories
Exposure : # Subjects Mean age Sex % of males Not reported Race (%) White Black Asian Other Not reported Ethnicity(%) Hispanic Not Hispanic Other
D-8
Not reported Socioeconomic status (Scores) Not reported Primary diagnosis % ICD codes Co morbidities (case-mix index) Severity Acuity DRG Nurse characteristics. Nurse eligibility criteria Complete the table with definitions used in the article:
Inclusion criteria Exclusion criteria
Age
License
Experience
Gender
Working status
Self-selection Other
Nurses sample characteristics: Complete with values reported in the article and with page number in the article where the data was extracted:
Page in the
article
Exposure categories
Exposure : Mean age Gender % of males Not reported Race (%) White Black Asian Other Not reported
D-9
Ethnicity (%) Hispanic Not Hispanic Other Not reported Foreign graduates % Not reported
Other nurse characteristics which may impact patients outcomes: 1. Mark Yes/No by assessment in the study. 2. Provide the data source to measure the outcome.
Nurse education Yes No
Data Source
Nurse degree Yes No
Data Source
Nursing degree Non nursing degree
Associated degree
Diploma
BSN
MS
Doctorate
Nurse experience in years (in nursing)
Yes No
Data Source
Proportion of nurses with temporary positions (pool nurses)
Yes No
Data Source
Nursing unions
Yes No
Data Source
D-10
Organization characteristics which may impact patient outcomes. Hospital eligibility criteria Complete the table with definitions used in the article:
Inclusion criteria Exclusion criteria
Data source
Location
Size
Care
Teaching status Ownership Availability of information Self-selection Other
Status of selected hospital(s)
Number of eligible hospitals Number of enrolled hospitals Number of analyzed hospitals
if more than 1:
Teaching, % of the sample Not teaching, % of the sample Combined sample
Location Size (number of beds) Ownership
profit, % of the sample non profit, % of the sample public, % of the sample private, % of the sample
Technology index not reported
Computerization of communication and records not reported
Central hospital support adequacy not reported
HMO penetrating not reported
Clinical units Intensive care unit Labor and delivery Pre-natal Post-natal Nursery Emergency Trauma Critical care Visits Hospital general Medical Surgical Operating room Pediatric
D-11
Post-anesthesia Psychiatry Specialty Step down units Telemetry Combined Unknown
Data extraction tables.
/*Complete with values reported in the article with the page number in the articles the data was extracted for a quality control*/ /*Add as many lines for categories as necessary*/ /*Median is calculated when ranges only reported assuming normal distribution*/ /*Increment is analyzed when regression coefficients only reported*/ Staffing variables:
Variable
Categories defined by
authors Mean STD 95%CL Median Page
number
Ratios Registered nurse/patient ratio Licensed nurse/patient ratio Aid/patient ratio, number of patients/aid Number of Patients/Licensed nurses Proportion of RN among total nursing personnel in % Proportion of licensed nurses /total nursing staff in %
Hours Total hours of care/patient day Registered nurse hours/patient day Licensed nurse hours/patient day Aid hours /patient day
D-12
Patient outcomes.
/*Add lines for interactions Exposure*Interaction factor*/
Outcomes
Exposure categories (treatment
groups) Rate in %
Rate in % Events Subjects Page
Mean STD 95%CL Median Mortality Nurse quality outcomes Urinary tract infection Falls Injury Pressure ulcers Any complication Any Medical complication Any surgical complication Nosocomial infections Sepsis Surgical wound infection Postoperative complications Gastrointestinal bleeding Post surgical bleeding Hospital-acquired pneumonia Atelectasis or pulmonal failure Accidental extubation Post surgical Thrombosis Cardio-pulmonary arrest Failure to rescue Shock
Continuation of the previous table:
Outcomes Exposure categories
Relative Risk (RR)
Lower 95%CL of RR Upper 95%CL of RR Page
Mortality Nurse quality outcomes Falls Injury Pressure ulcers Urinary tract infection Any complication Any Medical complication Any surgical complication
D-13
Nosocomial infections Sepsis Surgical wound infection Postoperative complications Gastrointestinal bleeding Post surgical bleeding Hospital-acquired pneumonia Atelectasis or pulmonal failure Accidental extubation Post surgical Thrombosis Cardio-pulmonary arrest Failure to rescue Shock
Patient Satisfaction
Outcomes Exposure
Exposure categories (treatment
groups) Mean STD 95%CL Median Page Satisfaction with nurse care
Continuation of the previous table:
Outcomes Exposure categories
Relative Risk (RR)
Lower 95%CL of RR
Upper 95%CL of RR Page
Satisfaction with nurse care Satisfaction with pain management
Nurse characteristics:
Variable
Categories defined by
authors Mean STD 95%CL Median Page Nurses characteristics Nurse experience in years Nurses education (%) Associate degree BSN MS PhD Proportion of nurses with temporary positions (pool nurses) in % Organization characteristics Duration of shift in hours Proportion of nurses working full time
D-14
Variable
Categories defined by
authors Mean STD 95%CL Median Page Turnover rate Burnout, % Vacancy, % Nurses self-reported variables Satisfaction with job, % satisfied Perception of adequacy of staffing, % perceived as adequate Perception of quality care, % of satisfied Autonomy of nurses, % perceived as adequate Nurses Governance, % perceived as adequate Stress, % of perceived as significant
D-15
ASSESSMENT OF STUDY QUALITY OBSERVATIONAL STUDIES (based on “Systems to Rate the Strength Of Scientific Evidence, AHRQ Publication No. 02-E016, April 2002) Score each domain on a scale of 0 (poor, not defined) to 5 (excellent, clearly defined)
Observational Studies Quality Domains/Elements Score
Study question clearly focused and appropriate Notes:
Sampling of Study Population Random Convenient Self-selected Notes:
Clear definition of exposure Notes:
Primary/secondary outcomes defined Notes:
Statistical Analysis: Assessment of confounding attempted Did the analysis adjust for or examine the effects of various factors Patient characteristics Hospital characteristics Cluster of patients and hospitals Notes:
Statistical methods used to take into account the effect of more than one variable on the outcome such as multiple regression, multivariate analysis, regression modeling -see methods in paper Notes:
Measure of effect for outcomes and appropriate measure of precision (SE, 95%CL) Notes:
Conclusions supported by results with possible bias and limitations taken into consideration Notes:
Single versus Multi-site study (note one of the other) Notes:
Co morbidities mentioned Notes:
Co morbidities incorporated in the analyses Notes:
Total score
D-16
INTERVENTIONAL STUDIES. Intervention Studies Quality Domains/Elements Score
Study question clearly focused and appropriate Notes:
Sampling of Study Population Random Convenient Self-selected Notes:
Clear definition of exposure Notes:
Randomization used to allocate patients (units) into treatment groups Notes:
Randomization allocation concealment method Clearly adequate: Centralized randomization by telephone, randomization scheme controlled by pharmacy, numbered or coded identical containers administered sequentially, on site computer system which can only be accessed after entering the characteristics of an enrolled participant, sequentially numbered sealed opaque envelopes. Clearly Inadequate: Alternation (consequent, odd-even, etc.), date of birth, date of week
Sample size Justification of the sample size for each tested hypothesis
Statistical Analysis: Assessment of adequacy of randomization - distribution of confounding factors at baseline in treatment groups: Patient characteristics Hospital characteristics Cluster of patients and hospitals Notes:
Intention to treat analysis. All eligible patients (units) included into analysis. Notes:
For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (SE, 95% confidence interval). Notes:
Conclusions supported by results with clinical significance of effect size Notes:
Single versus Multi-site study (note one of the other) Notes:
Total score
D-17
Study design characteristics
Adequacy of the sampling (random selection or not) (check one) random sampling convenience sampling non-random sampling single hospital study self-selected not specified all sampled subjects were analyzed sampled subjects were excluded from the analysis___________%
95% CL as reported estimates of the association between exposure and outcomes
Yes No
P value as reported estimates of the association between exposure and outcomes
Yes No
Correlation coefficient reported between exposure and outcomes
Yes No
Propensity scores used for nonrandom unequal distribution of confounding factors among treatment groups
Yes No
Adjustment for confounding factors: Adjustment for age of the patients
Yes No
Adjustment for race of the patients
Yes No
Adjustment for patient sex
Yes No
Adjustment for patient Diagnoses/comorbidities
Yes No
Adjustment for socioeconomic status of the patients
Yes No
Adjustment for hospital (provider) characteristics
Yes No
Country
Canada State or province abbreviation Combined
D-18
Sampling units (can be more than one) patients hospitals hospital units nurses other (define)_______________
Analytic unit (can be more than one)
patients hospitals - hospital units - nurses
Level of evidence of the individual study (check one) Interventions:
I – Well-designed randomized controlled trial II-1A - Well-designed controlled trial with pseudo-randomization I-1B - Well-designed controlled trial without randomization
Observational studies
I-2A - Well-designed cohort (prospective) study with concurrent controls I-2B - Well-designed cohort (prospective) study with historical controls II-2C - Well-designed cohort (retrospective) study with concurrent controls II-3 – Well-designed case-controlled (retrospective) study III – Large differences from comparisons between times and/or places IY – Opinion of respected authorities based in clinical experience
D-19
Nurse Staffing in North American Hospitals Nursing Staffing Strategies /Patient Outcomes Abstraction Form
(Complete for each study)
Number of the study First author Year of the publication Journal of the publication Database to identify the study Person to score the study Publication type (check one)
Published article Administrative report Dissertation Abstract/Presentation Book/book chapter
Purpose/aim of study
Design of the study (check one) prospective cohort retrospective cohort cross-sectional descriptive study case-control case-series randomized controlled clinical trial not randomized clinical interventions ecologic
Nurse staffing strategies (independent variables). 1. Mark Yes/No by assessment in the study. 2. Provide the definition of each variable used in the article. Data source for variables (define) Use of temporary nursing agencies
Yes No
If Yes, define
Use of part time nurses Yes No
If Yes, define
Proportion of registered nurses
Yes No
If Yes, define
Experience mix of the nursing staffs
Yes No
If Yes, define
D-20
Continuing nurse education
Yes No
If Yes, define
Nurse staffing models 1. Mark Yes/No by assessment in the study. 2. Provide the definition of staffing strategies (changes in staffing) used in the article Patient Focused Care
Yes No
If Yes, define
Primary or Total Nursing Care
Yes No
If Yes, define
Team or Functional Nursing Care
Yes No
If Yes, define
Magnet Hospital Environment/Shared governance
Yes No
If Yes, define
Evidence Based Clinical Pathway
Yes No
If Yes, define
Staff scheduling strategies:
Shift Yes No
If Yes, define
Duration of shift in hours
Yes No
If Yes, define
Over time work
Yes No
If Yes, define
Decentralized scheduling – nurse manager
Yes No
If Yes, define
D-21
Patient outcomes variables 1. Mark Yes/No by assessment in the study. 2. Provide the definition of the variable used in the article.
Mortality
Yes No
If Yes, define
Data source to measure mortality :___________ Time of follow up from the day of surgery to death, in days____________ Time of follow up from hospitalization to death , in days_______________ Mortality rate in groups with different staffing levels
Yes No
If yes, how reported (mark all applicable):
Number of events
Proportion in %
Relative risk
Adverse Drug Events. 1. Mark Yes/No by assessment in the study. 2. Provide the definition of each variable used in the article. 3. Provide the data source to measure the outcome. 4. Mark how the outcome was reported
Variable Assessment in the study Definition
Source to
measure
Reporting number of
events Proportion
in % Relative
risk
Yes No
Adverse events
Other
Length of stay.
Length of stay in the unit, days Yes No
Length of stay in the hospital, days
Yes No
Data source to measure LOS
D-22
Data extraction table: Complete cells with values of LOS reported in the article
Categories of independent staffing
variable LOS
Exposure variable Mean STD Median RR Lower 95%CL
Upper 95%CL
LOS in hospital in days LOS in units in days
Nurse quality outcomes
1. Mark Yes/No by assessment in the study. 2. Provide the definition of each variable used in the article. 3. Provide the data source to measure the outcome. 4. Mark how the outcome was reported
Variable Assessment in the study Definition
Source to
measure
Reporting number
of events Proportion
in % Relative
risk
Yes No
Falls
Injury
Pressure ulcers
Failure to rescue
D-23
Patient satisfaction. 1. Mark Yes/No by assessment in the study. 2. Mark how the outcome was reported
Variable Assessment in
the study Reporting
scores % of favorable
responses Relative
risk
Yes No
Satisfaction with nurse care
Satisfaction with education
Satisfaction with pain management
Time from the hospitalization to the measurement of the patient satisfaction, in days __________ days
Patient satisfaction scale (define)______________________________
Other Quality Measures: Patient related: 1. Mark Yes/No by assessment in the study. 2. Provide the definition of each variable used in the article. 3. Provide the data source to measure the outcome. 4. Mark how the outcome was reported
Variable Assessment in the study Definition
Source to
measure
Reporting number of
events Proportion
in % Relative
risk
Yes No
Urinary tract infection
Postoperative complications
Gastrointestinal bleeding
Hospital-acquired pneumonia
Shock
Atelectasis or pulmonal failure
Accidental extubation
Nosocomial infection
D-24
Surgical wound infection
Post surgical thrombosis
Cardio-pulmonary arrest
Any complication
Any Medical complication
Any surgical complication
Sepsis
Post surgical bleeding Other
Nurses related: 1. Mark Yes/No by assessment in the study. 2. Provide the definition of each variable used in the article. 3. Provide the data source to measure the outcome. 4. Mark how the outcome was reported
Variable Assessment in the study Definition
Source to
measure
Reporting number of
events Proportion
in % Relative
risk
Yes No
Turnover rate
Burnout
Vacancy
D-25
Nurse self-reported. 1. Mark Yes/No by assessment in the study. 2. Provide the definition of each variable used in the article. 3. Provide scale to measure the outcome. 4. Mark how the outcome was reported
Variable Assessment in the study Definition
Scale to measure
Reporting scores
% favorable responses
Relative risk
Yes No
Satisfaction with job Perception of adequacy of staffing
Perception of quality care Patient characteristics.
Patient Eligibility criteria Complete the table with definitions used in the article: Inclusion criteria Exclusion criteria Age Sex Race Insurance Residency Hospitalization Availability of records Diagnosis (ICD code) Comorbidities Severity Acuity Other
Patients
Medical % of the sample Surgical % of the sample Adults % of the sample Pediatric % of the sample combined
D-26
Sample characteristics: Complete with values reported in the article and with page number in the article where the data was extracted:
Page in
the article Exposure categories
Exposure : # Subjects Mean age Sex % of males Not reported Race (%) White Black Asian Other Not reported Ethnicity(%) Hispanic Not Hispanic Other Not reported Socioeconomic status (Scores) Not reported Primary diagnosis % ICD codes Co morbidities (case-mix index) Severity Acuity DRG
D-27
Nurse characteristics. Nurse eligibility criteria Complete the table with definitions used in the article:
Inclusion criteria Exclusion criteria
Age
License
Experience
Gender
Working status
Self-selection Other
Nurses sample characteristics: Complete with values reported in the article and with page number in the article where the data was extracted:
Page in the
article
Exposure categories
Exposure : Mean age Gender % of males Not reported Race (%) White Black Asian Other Not reported Ethnicity (%) Hispanic Not Hispanic Other Not reported Foreign graduates % Not reported
D-28
Organization characteristics which may impact patient outcomes. Hospital eligibility criteria Complete the table with definitions used in the article:
Inclusion criteria Exclusion criteria
Data source
Location
Size
Care
Teaching status Ownership Availability of information Self-selection Other
Status of selected hospital(s)
Number of eligible hospitals Number of enrolled hospitals Number of analyzed hospitals
if more than 1:
Teaching, % of the sample Not teaching, % of the sample Combined sample
Location Size (number of beds) Ownership
profit, % of the sample non profit, % of the sample public, % of the sample private, % of the sample
Technology index not reported
Computerization of communication and records not reported
Central hospital support adequacy not reported
HMO penetrating not reported
Clinical units Intensive care unit Labor and delivery Pre-natal Post-natal Nursery Emergency Trauma Critical care Visits Hospital general Medical Surgical Operating room Pediatric
D-29
Post-anesthesia Psychiatry Specialty Step down units Telemetry Combined Unknown
Data extraction tables.
/*Complete with values reported in the article with the page number in the articles the data was extracted for a quality control*/ /*Add as many lines for categories as necessary*/ /*Median is calculated when ranges only reported assuming normal distribution*/ /* Increment is analyzed when regression coefficients only reported*/ Staffing variables:
Variable
Categories defined by
authors Mean STD 95%CL Median Page
number Proportion of part time nurses, in% Proportion of registered nurses, in % Proportion of nurses with BS, in % Proportion of nurses with MS, in % Duration of shift in hours
Patient outcomes.
/*Add lines for interactions Exposure*Interaction factor*/
Outcomes
Exposure categories (treatment
groups) Rate in %
Rate in % Events Subjects Page
Mean STD 95%CL Median Mortality Adverse events Adverse events Nurse quality outcomes Urinary tract infection Falls Injury Pressure ulcers Any complication Any Medical complication
D-30
Any surgical complication Nosocomial infections Sepsis Surgical wound infection Postoperative complications Gastrointestinal bleeding Post surgical bleeding Hospital-acquired pneumonia Atelectasis or pulmonal failure Accidental extubation Post surgical Thrombosis Cardio-pulmonary arrest Failure to rescue Shock
Outcomes Exposure categories
Relative Risk (RR)
Lower 95%CL of RR Upper 95%CL of RR Page
Mortality Adverse events Nurse quality outcomes Falls Injury Pressure ulcers Urinary tract infection Any complication Any Medical complication Any surgical complication Nosocomial infections Sepsis Surgical wound infection Postoperative complications Gastrointestinal bleeding Post surgical bleeding Hospital-acquired pneumonia Atelectasis or pulmonal failure Accidental extubation Post surgical Thrombosis Cardio-pulmonary arrest Failure to rescue Shock
D-31
Patient Satisfaction
Outcomes Exposure
Exposure categories (treatment
groups) Mean STD 95%CL Median Page Satisfaction with nurse care Satisfaction with pain management
D-32
ASSESSMENT OF STUDY QUALITY OBSERVATIONAL STUDIES (based on “Systems to Rate the Strength of Scientific Evidence, AHRQ Publication No. 02-E016, April 2002) Score each domain on a scale of 0 (poor, not defined) to 5 (excellent, clearly defined)
Observational Studies Quality Domains/Elements Score
Study question clearly focused and appropriate Notes:
Sampling of Study Population Random Convenient Self-selected Notes:
Clear definition of exposure Notes:
Primary/secondary outcomes defined Notes:
Statistical Analysis: Assessment of confounding attempted Did the analysis adjust for or examine the effects of various factors Patient characteristics Hospital characteristics Cluster of patients and hospitals Notes:
Statistical methods used to take into account the effect of more than one variable on the outcome such as multiple regression, multivariate analysis, regression modeling -see methods in paper Notes:
Measure of effect for outcomes and appropriate measure of precision (SE, 95%CL) Notes:
Conclusions supported by results with possible bias and limitations taken into consideration Notes:
Single versus Multi-site study (note one of the other) Notes:
Co morbidities mentioned Notes:
Co morbidities incorporated in the analyses Notes:
Total score
D-33
INTERVENTIONAL STUDIES. Intervention Studies Quality Domains/Elements Score
Study question clearly focused and appropriate Notes:
Sampling of Study Population Random Convenient Self-selected Notes:
Clear definition of exposure Notes:
Randomization used to allocate patients (units) into treatment groups Notes:
Randomization allocation concealment method Clearly adequate: Centralized randomization by telephone, randomization scheme controlled by pharmacy, numbered or coded identical containers administered sequentially, on site computer system which can only be accessed after entering the characteristics of an enrolled participant, sequentially numbered sealed opaque envelopes. Clearly Inadequate: Alternation (consequent, odd-even, etc.), date of birth, date of week
Sample size Justification of the sample size for each tested hypothesis
Statistical Analysis: Assessment of adequacy of randomization - distribution of confounding factors at baseline in treatment groups: Patient characteristics Hospital characteristics Cluster of patients and hospitals Notes:
Intention to treat analysis. All eligible patients (units) included into analysis. Notes:
For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (SE, 95% confidence interval). Notes:
Conclusions supported by results with clinical significance of effect size Notes:
Single versus Multi-site study (note one of the other) Notes:
Total score
D-34
Study design characteristics
Adequacy of the sampling (random selection or not) (check one) random sampling convenience sampling non-random sampling single hospital study self-selected not specified all sampled subjects were analyzed sampled subjects were excluded from the analysis___________%
95% CL as reported estimates of the association between exposure and outcomes
Yes No
P value as reported estimates of the association between exposure and outcomes
Yes No
Correlation coefficient reported between exposure and outcomes
Yes No
Propensity scores used for nonrandom unequal distribution of confounding factors among treatment groups
Yes No
Adjustment for confounding factors: Adjustment for age of the patients
Yes No
Adjustment for race of the patients
Yes No
Adjustment for patient sex
Yes No
Adjustment for patient Diagnoses/comorbidities
Yes No
Adjustment for socioeconomic status of the patients
Yes No
Adjustment for hospital (provider) characteristics
Yes No
Country
Canada State or province abbreviation Combined
D-35
Sampling units (can be more than one) patients hospitals hospital units nurses other (define)_______________
Analytic unit (can be more than one)
patients hospitals - hospital units - nurses
Level of evidence of the individual study (check one) Interventions:
I – Well-designed randomized controlled trial II-1A - Well-designed controlled trial with pseudo-randomization I-1B - Well-designed controlled trial without randomization
Observational studies
I-2A - Well-designed cohort (prospective) study with concurrent controls I-2B - Well-designed cohort (prospective) study with historical controls II-2C - Well-designed cohort (retrospective) study with concurrent controls II-3 – Well-designed case-controlled (retrospective) study III – Large differences from comparisons between times and/or places IY – Opinion of respected authorities based in clinical experience
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