appendix d: sample abstraction forms · proportion of rn among nursing personnel yes no ......

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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

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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