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P AT I E NT E XP E RI E NCE S OF P AT I E NT S AF E T Y I N
P RI MARY CAR E . A S YS T E MAT I C RE VI E W OF
QUAL I T AT I VE S T UDI E S .
- RE S E ARCH P ROT OCOL -

Research Team: Valderas JM (JMV), Ricci N (NR), Sarah C.(SC), Campbell S (SC).
Updated 13
th
December, 2012.
CONTENTS
Introduction .......................................................................................................................................................................... 2
Objective ............................................................................................................................................................................... 2
Method ................................................................................................................................................................................... 2
Search method for identification of studies ........................................................................................................... 2
1. Searching in databases. ............................................................................................................................... 2
2. Searching in the selected articles. .......................................................................................................... 2
Managing the references. ............................................................................................................................................ 3
Selection of studies. ...................................................................................................................................................... 3
Eligibility criteria .................................................................................................................................................... 3
Screening process ................................................................................................................................................... 3
Title and abstract screening. .............................................................................................................................. 4
Full text screening .................................................................................................................................................. 4
Data extraction and critical appraisal ...................................................................................................................... 6
1. Data extraction ............................................................................................................................................... 6
2. Critical appraisal ............................................................................................................................................ 6
Analysis of findings ...................................................................................................................................................... 9
Appendix 1. Search Strategy (executed on 09-01-2012) .............................................................................. 13
Appendix 2. Using EndNote to record and manage the information .............................................................. 15
Appendix 3. Agreement report .................................................................................................................................... 16
Appendix 4. Critical Appraisal Skills Programme (CASP). .............................................................................. 17
Figure 1 .............................................................................................................................................................................. 21
Figure 2 ............................................................................................................................................................................... 22

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INTRODUCTION
We aim to systematically review patients experiences in relation to Patient Safety in General Practice,
as part of a project for the construction of a toolkit for the measurement of safety in English Primary
Care practices (Developing, testing and implementing the NSPCR Patient Safety Toolkit in general
practices in England , NIHR School for Primary Care research, 2011-2013; 569,740.0). We will
identify emerging themes / domains elicited from patients in using qualitative methods, specifically
the key attributes of safe general practice. Moreover, this will inform on going work to develop an
operational definition of primary care patient safety, as part of a wider objective of the Patient Safety
Toolkit study. This information will be later used to inform the identification and development of
tools that have the greatest potential to assess these attributes.
OBJECTIVE
To identify domains and themes related to Patient Safety important to, and as experienced by Primary
Care patients in the United Kingdom.
METHOD
SEARCH METHOD FOR IDENTIFICATION OF STUDIES
The search methodology will involve two steps. First, we will perform a search in different databases
and will select the relevant articles. Subsequently, we will screen the citing and cited references of the
relevant articles previously identified.
1. SEARCHING IN DATABASES.
We developed the search strategy according to available guidance from the Cochrane
Collaboration (1), in general, and Cochrane Qualitative Methods Group (2), in particular. The
databases selected for the systematic review are: Medline (In-Process & Other Non-Indexed
Citations and Ovid MEDLINE(R), 1948 to Present), Embase (Embase 1974 to 2012 January 31),
both acceded via Ovid SP (3) and CINAHL (from 1981 to present), acceded via EBSCO (4).
Three different search strategies were designed according to the specific characteristics of each
database. They include four main blocks (Primary Care, Patient Safety, United Kingdom, and
Qualitative Methods). The final search strategy is available in Appendix 1. A complete report of
the development and results of the search strategies is available in a separate document.
2. SEARCHING IN THE SELECTED ARTICLES.
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We will review backward & forward citation for Web of Knowledge (5) for the publications
finally identified as relevant at the end of the screening process (i.e., those that are chosen to be
included in the review).
MANAGING THE REFERENCES.
After conducting the searches, the results of the searches will be exported to an independent database.
Subsequently, all the references will be merged in a unique database, and duplicates will be
automatically identified and removed. Each team member will receive a copy of this final database.
We will use the reference manager software EndNote X5.
Selection of studies.
ELIGIBILITY CRITERIA
We will include:
Types of studies: The review will include studies which use qualitative methods of data collection
and analysis, i.e., either a stand-alone study or a discrete part of a larger mixed-method study. We
also will include studies using attitudinal surveys.
Types of articles: original articles and review articles including systematic and narrative
reviews-.
Types of participant: Primary Care patients that have or have not suffered any adverse event. All
ages, conditions and types of intervention will be included.
Type of outcome measures:
a. Domains or themes that patient think are critical in relation with patient safety in Primary
Care.
b. Key attributes of safe General Practices from a patient perspective.
Geographical area: Studies conducted in United Kingdom
Date of publication: We will include articles published since and including 1990.

We will exclude:
Articles not published in English
Citations without an abstract
SCREENING PROCESS
The screening process will be conducted in three different stages: 1 screening titles; 2 abstracts; and 3
full texts (figure 1). Each stage will start with a pilot study, aimed at ensuring the homogeneity among
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reviewers in applying the eligibility criteria. The information regarding the eligibility of a reference -
relevant or not relevant- will be recorded in the EndNote database X5. This will allow us to
automatically monitor all the screening process. A detailed explanation of how we could use EndNote
to record the screening results is provided in the appendix 2.
TITLE AND ABSTRACT SCREENING.
1. Pilot study. All the research team members will independently review the same sample of
references. References will be categorized as relevant or not relevant according to the
eligibility criteria above described. The results of this stage will be sent back to the rest of the
team. NR will analyse the agreement and will send an agreement report to the rest of the team. A
summary of the information that will contain this report is available in the appendix 3. To
homogenize the criteria among reviewers, all discrepancies will be discussed during a
teleconference meeting. However, all discrepant references will be included in the next stage, as
only references excluded by the four team members will be excluded. At the title stage the pilot
will involve the screening of 50 randomly selected references, while at the abstract stage we will
screen a convenience sample of 30 references -selecting previously discrepant references-.
2. Screening. It will take place after the pilot study. Each of the four team members will read half
(3/6) of the total references (excluding those previously reviewed in the pilot study), so that all
references will be independently read by two reviewers. References will be distributed among the
reviewers trying to maximize the number of interactions between them (see table 1). The
agreement will be calculated, but in the title and abstract stages the discrepancies will not be
discussed until reach consensus: all the references selected as relevant by at least one reviewer
will be included in the next stage.

Table 1. Reference distribution among reviewers (maximizing the number of
interactions among them)
Reviewers References divided by sextils
1 2 3 4 5 6
JMV
SC
SaC
NR

FULL TEXT SCREENING
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1. Obtaining the full text. We will obtain the full text of all the references included after the
abstract screening. All the pdfs files will be incorporated to the bibliographic database, which
will be delivered to the rest of the team.
2. Pilot. A convenience sample of 10 full text articles -chosen among those discrepant in the
previous stage- will be screened by all the reviewers. At this stage we will apply the
maximum specificity criteria, i.e., disagreements will be discussed with the rest of the team
until consensus is reached and only references selected as relevant by all the team will be
included. As previously, the agreement will be analysed and a report will be sent to the rest of
the team. For all the excluded references, the exclusion reason will be recorded in an Excel
sheet.
3. Screening. Each reviewer will read the full text of half of the references previously selected
articles (except those included in the pilot), so that all the articles will be independently read
by two reviewers. The team will contact investigators for clarification where eligibility cannot
be determined from the published study. As previously, articles will be distributed among the
research team trying to maximize the number of interactions between them. Again,
disagreements will be discussed in a meeting with the rest of the team until reach consensus
and only references selected as relevant by all the team will be included.

Finally, we will review backward & forward citation for Web of Knowledge for the publications
finally identified as relevant after the screening process (i.e., references which are cited by and cite
our relevant articles). Moreover, we will include the list of references provided by the Linnaeus
Group. All these new references will be stored in a second bibliographic database. They will also be
screened by using the three stages above described (title, abstract and full text), but no further pilot
studies will be necessary, as we assume criteria will be very homogeneous at this point.

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DATA EXTRACTION AND CRITICAL APPRAISAL
Data extraction and critical appraisal will be conducted simultaneously. Both processes will be piloted
against a random sample of 10 studies.
1. DATA EXTRACTION
A data extraction form will be designed based on previous similar systematic reviews and according
to the specific characteristics of this one. The data extraction form will include the following items:
Bibliographic information.
Study characteristics -objective, research method, setting-.
Participant characteristics - age, ethnicity, type of experience with patient safety-.
Main findings
o describing the understandings of the participants (first-order constructs)
o interpretations or conclusions of the authors (second order constructs)
Results of the critical appraisal.
However, it is expected modifications in the data extraction form as a result of the pilot study.
All the reviewers will participate in the data extraction. The information of 50% of the articles finally
selected will be extracted by NR and reviewed by SC and vice versa. The other 50% will be extracted
by JMV and checked be SC and vice versa. Disagreement will be resolved by discussion until
consensus is reached. The completed extraction form for each study will be sent electronically to its
first author, with a request to check for accuracy and completeness of extraction. All the information
will be stored in an Access database.


2. CRITICAL APPRAISAL
Currently there is an important controversy in the literature regarding critical appraisal of qualitative
research. A research has been conducted to identify the most suitable tools to assess the
methodological quality of the studies which are going to be included in our Systematic Review. As a
result of this process, we suggest the use of the Critical Appraisal Skills Program (CASP) for
qualitative studies (6) (appendix 4). The main reasons for proposing CASP are:
This tool has been widely used in previous similar systematic reviews (7-16).
It contains only 10 items, allowing a rapid evaluation.
It is suitable to be applied for different types of qualitative designs.

Three categories will be established for each item: 1 clearly not met; 2 clearly met and 3 unclear. Each
paper will be independently appraised by two reviewers and discrepancies will be discussed with all
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the team members until consensus is reached. We will use the critical appraisal process not to exclude
papers prior to the synthesis; rather, it will be used to provide a context for the interpretation of the
synthesized findings.
Data extraction form
Extraction item Details
Citation
Aims or Research
question

Eligibility criteria of
the participants

Sample (participant)
characteristics

Recruitment context
(e.g. where people
were recruited from)

Sampling method
Theoretical
background

Qualitative method
Data collection
Data analysis
Themes
More information on
themes

Most relevant
findings

Recommendations

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Critical appraisal. CASP tool
1
YES NO COMMENTS
/NOTES
1 Was there a clear statement of the aims of the research?
Consider: what the goal of the research was, why it is important and its relevance (this
should be explicitly stated in the abstract or introduction).

2 Is a qualitative methodology appropriate?
Consider if the research seeks to interpret or illuminate the actions and/or subjective
experiences of research participants (because of the nature of the studies we are including, it
is very likely that the answer for this question will always YES. Only in case of clear doubts
we will answer NO)

3 Was the research design appropriate to address the aims of the research?
Consider: if the researcher has justified the research design (e.g. have they discussed how
they decided which methods to use?). We will answer YES only in the case we can find in
the text the justification of the research design.

4 Was the recruitment strategy appropriate to the aims of the research?
Answer YES only in the case the researchers provide information enough to conclude that
there is no selection bias. In case you identify a selection bias OR authors dont provide
information about the recruitment strategy, we will answer NO.

5 Were the data collected in a way that addressed the research issue?
3 aspects need to be reported in order to answer YES:
if the researcher has discussed saturation of data AND
if the researcher has made the methods explicit (e.g. for interview method, is there
an indication of how interviews were conducted, did they used a topic guide?) AND
if the form of data is clear (e.g. tape recordings, video material, notes etc).

6 Has the relationship between researcher and participants been adequately considered?
Consider whether it is clear: if the researcher critically examined their own role, potential
bias and influence during: formulation of research questions, data collection, including
sample recruitment, and choice of location.
In case information is reported by the authors either in the methodology section (how they
avoided this bias) or in the limitations (acknowledging the bias)we will answer YES.
Otherwise we will answer NO.

7 Have ethical issues been taken into consideration? Consider:if approval has been sought
from the ethics committee

8 Was the data analysis sufficiently rigorous?
4 criteria need to be addressed:
Sufficient data are presented to support the findings (i.e., authors include in the
paper the quotes) AND
Report the type of analysis used (thematic analysis, grounded theory)AND
There is an agreement between primary data and secondary data (the results of the
authors has to correspond with the information they extracted).
Report of triangulation (more than one analyst)

9 Is there a clear statement of findings? Consider:
2 criteria need to be addressed in order to answer YES:
Summary of the results presented at the beginning of the discussion.
Adequate discussion of the evidence both for and against the researchers arguments

10 How valuable is the research?
Answer YES only if they report the possible implications of their paper for
research OR for practice OR for policy.





1
Critical Appraisal Skills Programme (CASP). Making sense of evidence. 10 questions to help you make sense
of qualitative research. England: Public Health Resource Unit, 2006.
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ANALYSIS OF FINDINGS

Different approaches have been suggested in order to analyse the results of a Systematic Review of qualitative
studies (see table 1). According to the Cochrane Collaboration (1), the election of the most appropriate one
should be based on the purpose of each Systematic Review (see figure 1).
Keeping in mind that the objective of our Systematic Review is to To identify domains and themes related to
Patient Safety important to, and as experienced by Primary Care patients in the United Kingdom, it seems
reasonable to use the Thematic Anlaysis, which have been described as identification of prominent or
recurrent themes in the literature, and summarising the findings of different studies under thematic headings.
Figure 1. Decision flow chart (copied from (18)).
Meta-ethnography
Thematic analysis with theory
generation
Grounded theory
Decision to conduct a qualitative evidence
synthesis
To aggregate / summarise /
integrate qualitative data to
address specific questions
in relation to a Cochrane
intervention review
To interpret synthesised qualitative
evidence and develop explanatory
theory or models
Primarily to integrate and interpret
qualitative and quantitative evidence
within a single approach or
integrated model
Can be used to develop
explanatory theory
Purpose of the additional
qualitative synthesis
Thematic analysis without
theory generation
Meta-aggregation
Meta-summary
Realist review
EPPI approach
Narrative synthesis
Bayesian synthesis
Critical interpretive synthesis
Product
Explanatory theory, analytical or
conceptual framework or
interpretative framework/ mechanism
Product
Aggregated findings from
source papers

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Table 1 Summary of selected approaches to joint synthesis of qualitative and quantitative evidence. Adapted from Dixon-Woods (19) et al., and Cochrane Handbook of (2)
Method Outline of approach Sub-forms and developments Some problems Some strengths
Narrative
summary
Narrative description and ordering of primary
evidence (perhaps selected) with commentary
and interpretation
May be theory-led . May include
triangulation of different evidence types
Lack of transparency
Many variants and absence of
procedures/standards
May be dependent on skills/prejudices
of reviewer
Can cope with large evidence base, comprising
diverse evidence types
Flexibility
Could be used for theory-building
Thematic analysis Identification of major/recurrent themes in
literature; summary of findings of primary
studies under these thematic headings
May be theory- or data-driven
Lack of transparency regarding process
decisions
Largely descriptive basis to groupings,
not necessarily developing theory,
accounting for contradictions
Flexible procedures for reviewers
Copes well with diverse evidence types
Could be used for theory-building
Grounded theory Constant comparative method (CCM)
identifies patterns and interrelations in primary
data. Sampling responds to analysis, until
theoretical saturation reached.
Many researchers use only part of
approach, e.g. just CCM
Possible criticism of lack of
transparency
Variants are rife
Seeks generalised explanations/theories
Suggests means of sampling papers for
inclusion in review
Sampling to theoretical saturation limits
number of papers to review
Can potentially deal with diverse evidence
types
Meta-ethnography Reciprocal translational analysis identifies key
themes in each study, then seeks to translate
these into context of each other study. Themes
with best overall fit/explanatory power
adopted. Attempt made to explain
contradictions. Seeks general interpretative
(lines of argument) synthesis.
Sometimes restricted to primary studies
from a single paradigm
Does not guide sampling
Lack of transparency regarding
selection of primary studies
May be order-of-synthesis effects
Seeks higher order (generalised) theories
Can potentially deal with diverse evidence
types
Realist synthesis Theory-driven synthesis based on purposive
sampling of primary studies. Context data
retained. Basic theory is refined concerning
applicability in context
Subdivisions: meta-data synthesis,
drawing on meta-ethnographic
approach; metamethod synthesis,
comparing impact of methods on
findings; meta-theory synthesis,
exploring theoretical frameworks
Lacks transparency regarding choice of
evidence to synthesise
Can deal with very diverse evidence types
Explicit orientation towards testing of theory
Meta-study General framework for and guidance on
technique, including question formulation and
selection of primary studies

Currently proposed only for qualitative
research
Depends on the rigour of the
underlying methods
Can potentially deal with diverse evidence
types
Usefully draws attention to different purposes
and outcomes of synthesis
Explicitly oriented towards production of mid-
range theory
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Miles and
Huberman
Evidence from each primary study first
summarised and coded under broad thematic
headings. Evidence then aggregated and
summarised within theme across studies, with
brief citation of primary evidence.
Commonalities and differences between
studies noted.
No guidance on sampling of primary
studies
Highly systematic method
Potentially allows inclusion of diverse evidence
types
Could be used for theory-building
Content analysis Evidence from each primary study coded under
broad thematic headings, using extraction tool
designed to aid reproducibility. Occurrences of
each theme counted and tabulated
More recent forms of content analysis
encourage amore interpretive approach
Emphasis on frequency compared with
importance, context-specificity, and
interpretation of evidence
Term is often mis-used
Software available
Can incorporate diverse evidence types
Could be used for theory-building if not
confined to description
Case survey Each primary study treated as a case. Study
findings and attributes extracted using closed-
form questions, for reliability. Survey analysis
methods used on extracted data.

Applicable to outcomes, but less
adequate for process
Lacks sensitivity to interpretive aspects
of evidence
Can incorporate diverse evidence types
Can cope with large numbers of primary studies
Could be used for theory-building
Qualitative
comparative
analysis
Boolean analysis of necessary and sufficient
conditions for particular outcomes to be
observed, based on presence/absence of
independent variables and outcomes in each
primary study
Focused on causality determination, not
interpretive aspects of qualitative data
Transparent
Systematic
Can incorporate diverse forms of evidence
Allows competing explanations to be explored
and retained and permits theories about
causality
Does not require as many cases as case survey
method
Bayesian
metaanalysis
Quantified beliefs about effects of variables
from qualitative studies formally combined
(through Bayes paradigm) with evidence from
quantitative studies
Reversal of roles of qualitative and
quantitative
evidence possible in principle
Conceptually simple, but may be
technically
complex to implement (and thus lose
transparency)
Impact of analysts prior beliefs can be
explicitly explored
Can incorporate diverse forms of evidence
Could be used for theory-building


12

According to Dixon-Woods et al,.(19) thematic analysis involves the identification of prominent or recurrent
themes in the literature, and summarising the findings of different studies under thematic headings. Summary
tables, providing descriptions of the key points, can then be produced. Several recent attempts at providing
structured or systematic overviews of diverse areas of evidence have adopted this kind of approach. Garcia et al,
for example, report a thematic analysis of womens views of ultrasound in pregnancy, involving tabulation of
papers and counts of papers contributing data on each theme. (20)
Thematic analysis allows clear identification of prominent themes, and organised and structured ways of dealing
with the literature under these themes. It is flexible, allowing considerable latitude to reviewers and a means of
integrating qualitative and quantitative evidence. However, it suffers from several important problems. Thematic
analysis can be either data driven driven by the themes identified in the literature itself or theory driven
oriented to evaluation of particular themes through interrogation of the literature. The failure of much writing on
thematic analysis to distinguish adequately between these two approaches has resulted in a lack of transparency.
More generally, there is lack of clarity about exactly what thematic analysis involves and the processes by which
it can be achieved; for example, there is a lack of explicitness about procedures and aims, including the extent to
which thematic analyses should be descriptive or interpretive. It is unclear whether the structure of the analysis
should reflect the frequency with which particular themes are reported, or whether the analysis should be weighted
towards themes that appear to have a high level of explanatory value. If thematic analysis is limited to
summarising themes reported in primary studies, it offers little by way of theoretical structure within which to
develop higher order thematic categories beyond those identified from the literature.

Thematic analysis has been applied in similar Systematic Reviews. It allows an integration and interpretation of
the information. Some of the articles that have used this methodology are (12, 20-23)



13

APPENDIX 1. SEARCH STRATEGY (EXECUTED ON 09-01-2012)

Medline Embase CINAHL
Blocks N Terms HITS Terms HITS Terms HITS
PRIMARY
CARE
1
exp General Practice/ or exp Ambulatory Care/ or
exp primary health care/ or ((general or family or
primary or community or ambulatory) adj2 (care?
or health$ or service?)).tw.
254370
exp General Practice/ or exp Ambulatory Care/ or exp
primary health care/ or ((general or family or primary or
community or ambulatory) adj2 (care? or health$ or
service?)).tw.
274011 (MH "Family Practice") OR (MH "Ambulatory Care") OR (MH
"Primary Health Care") OR ( TI ((general or family or primary or
community or ambulatory) W2 (care* or health* or service*)) ) OR (
AB ((general or family or primary or community or ambulatory) W2
(care* or health* or service*)) )
80573
2
exp general practitioners/ or exp physicians,
family/ or exp physicians, primary care/ or GP?.tw.
or ((general or family or primary or community or
ambulatory) adj1 (practitioner? or physician? or
doctor? or nurse? or provider?)).tw.
111135 exp general practitioner/ or GP?.tw. or ((general or family or
primary or community or ambulatory) adj1 (practitioner? or
physician? or doctor? or nurse? or provider?)).tw.
150027 (MH "Physicians, Family") OR TI GP* OR TI ( ((general or family
or primary or community or ambulatory) W1 (practitioner* or
physician* or doctor* or nurse* or provider*)) ) OR AB GP* OR AB
( ((general or family or primary or community or ambulatory) W1
(practitioner* or physician* or doctor* or nurse* or provider*)) )
28555
3
exp community health centers/ or ((general or
family or primary or community or ambulatory)
adj1 (center? or centre? or practice?)).tw.
48405 exp health center/ or ((general or family or primary or
community or ambulatory) adj1 (center? or centre? or
practice?)).tw.
65023 (MH "Practitioner's Office") OR (MH "Community Health Centers")
OR TI ( ((general or family or primary or community or ambulatory)
W1 (center* or centre* or practice*)) ) OR AB ( ((general or family
or primary or community or ambulatory) W1 (center* or centre* or
practice*)) )
15737
4
(AMERICAN FAMILY PHYSICIAN or AM FAM
PHYSICIAN or "Am. Fam. Physician" or
ANNALS OF FAMILY MEDICINE or ANN FAM
MED or "Ann. Fam. Med" or Atencion Primaria or
ATEN PRIM or "Aten. Prim." or BMC Family
Practice or "BMC Fam. Pract." or BRITISH
JOURNAL OF GENERAL PRACTICE or "Br. J.
Gen. Pract." or BRIT J GEN PRACT or
CANADIAN FAMILY PHYSICIAN or "Can.
Fam. Phys." or CAN FAM PHYSICIAN or
FAMILY MEDICINE or "Fam. Med" or "FAM
MED." or FAMILY PRACTICE or "Fam. Pr." or
"FAM PRACT." or Journal of the American Board
of Family Medicine or "J. Am. Board Fam. Med."
or J AM BOARD FAM MED or JOURNAL OF
FAMILY PRACTICE or "J. Fam. Pract." or "J
FAM PRACTICE." or "PRIMARY CARE." or
SCANDINAVIAN JOURNAL OF PRIMARY
HEALTH CARE or "Scand. J. Prim. Health Care"
or PRIMARY CARE or Australian Family
Physician or "Aust. Fam. Physician" or AUST
FAM PHYSICIAN or Australian Journal of
Primary Health or "Aust. J. Prim. Health" or AUST
J PRIM HEALTH).jn.
55981 AMERICAN FAMILY PHYSICIAN.jn. or AM FAM
PHYSICIAN.ja. or "Am. Fam. Physician".ja. or (ANNALS
OF FAMILY MEDICINE.jn. or ANN FAM MED.ja. or
"Ann. Fam. Med.".ja.) or (Atencion Primaria.jn. or ATEN
PRIM.ja. or "Aten. Prim.".ja.) or (BMC Family Practice.jn.
or "BMC Fam. Pract.".ja. or BMC FAM PRACT.ja.) or
(BRITISH JOURNAL OF GENERAL PRACTICE.jn. or
"Br. J. Gen. Pract.".ja. or BRIT J GEN PRACT.ja.) or
(CANADIAN FAMILY PHYSICIAN.jn. or "Can. Fam.
Phys.".ja. or CAN FAM PHYSICIAN.ja.) or (FAMILY
MEDICINE.jn. or "Fam. Med.".ja. or FAM MED.ja.) or
(FAMILY PRACTICE.jn. or "Fam. Pr.".ja. or FAM
PRACT.ja.) or (Journal of the American Board of Family
Medicine.jn. or "J. Am. Board Fam. Med.".ja. or J AM
BOARD FAM MED.ja.) or (JOURNAL OF FAMILY
PRACTICE.jn. or "J. Fam. Pract.".ja. or J FAM
PRACTICE.ja.) or (PRIMARY CARE.jn. or Primary
Care.ja. or PRIMARY CARE.ja.) or (SCANDINAVIAN
JOURNAL OF PRIMARY HEALTH CARE.jn. or "Scand.
J. Prim. Health Care".ja. or SCAND J PRIM HEALTH.ja.)
or (Australian Family Physician.jn. or "Aust. Fam.
Physician".ja. or AUST FAM PHYSICIAN.ja.) or
(Australian Journal of Primary Health.jn. or "Aust. J. Prim.
Health.".ja. or AUST J PRIM HEALTH.ja.)
65410 (JN AMERICAN FAMILY PHYSICIAN OR JT AM FAM
PHYSICIAN OR JT Am. Fam. Physician) OR (JN Atencion
Primaria OR JT ATEN PRIM OR JT Aten. Prim) OR (JN BMC
Family Practice OR JT BMC Fam. Pract. OR JT BMC FAM
PRACT) OR (JN BRITISH JOURNAL OF GENERAL PRACTICE
OR JT Br. J. Gen. Pract. OR JT BRIT J GEN PRACT) OR (JN
CANADIAN FAMILY PHYSICIAN OR JT Can. Fam. Phys. OR JT
CAN FAM PHYSICIAN) OR (JN FAMILY MEDICINE OR JT
Fam. Med. OR JT FAM MED) OR (JN FAMILY PRACTICE OR JT
Fam. Pr. OR JT FAM PRACT) OR (JN Journal of the American
Board of Family Medicine OR JT J. Am. Board Fam. Med. OR JT J
AM BOARD FAM MED) OR (JN JOURNAL OF FAMILY
PRACTICE OR JT J. Fam. Pract. OR JT J FAM PRACTICE) OR
(JN PRIMARY CARE OR JT Primary Care OR JT PRIMARY
CARE) OR (JN SCANDINAVIAN JOURNAL OF PRIMARY
HEALTH CARE OR JT Scand. J. Prim. Health Care OR JT SCAND
J PRIM HEALTH) OR (JN Australian Family Physician OR JT
Aust. Fam. Physician OR JT AUST FAM PHYSICIAN) OR (JN
Australian Journal of Primary Health OR JT Aust. J. Prim. Health.
OR JT AUST J PRIM HEALTH) OR (JN ANNALS OF FAMILY
MEDICINE OR JT ANN FAM MED OR JT Ann. Fam. Med.)
14666
5
1 or 2 or 3 or 4 378413 1 or 2 or 3 or 4 443086 (S1 or S2 or S3 or S4) 108615
14

PATIENT
SAFETY
6
exp Safety Management/ or exp Patient Safety/ or
patient safety.tw. or safety culture.tw. or (safe$2
adj2 (practice? or management?)).tw. or (st.fs. and
(safe or safety).tw.)
44589 exp patient safety/ or patient safety.tw. or safety culture.tw.
or (safe$2 adj2 (practice? or management?)).tw. or (st.fs.
and (safe or safety).tw.)
43610 (MH "Patient Safety+") OR (MH "Hand Off (Patient Safety)") OR
(MH "Cultural Safety") OR TI (patient safety or safety culture or
(safe* W2 (practice* or management*))) OR AB (patient safety or
safety culture or (safe* W2 (practice* or management*)))
46231
7
((adverse? or preventable? or safet$3) adj1 (event?
or effect? or reaction? or outcome?)).tw.
163587 exp adverse outcome/ or exp adverse drug reaction/ or
((adverse? or preventable? or safet$3) adj1 (event? or
effect? or reaction? or outcome?)).tw.
497628 (MH "Adverse Health Care Event+") OR TI ( ((adverse* or
preventable* or safet*) W1 (event* or effect* or reaction* or
outcome*)) ) OR AB ( ((adverse* or preventable* or safet*) W1
(event* or effect* or reaction* or outcome*)) )
51186
8
harm$2.tw. 23113 harm$2.tw.
28397
TI harm* OR AB harm* 13872
9
exp Iatrogenic Disease/ or iatrogenic.tw. 24216 exp Iatrogenic Disease/ or iatrogenic.tw. 473645 (MH "Iatrogenic Disease") OR TI "Iatrogenic" OR AB "Iatrogenic"
2219
10
exp Medical Errors/ or ((medica$ or diagnostic? or
therapeutic$ or administration? or dispensing? or
prescri$) adj1 (error? or mistake? or fault?)).tw.
76322 exp medical error/ or ((medica$ or diagnostic? or
therapeutic$ or administration? or dispensing? or prescri$)
adj1 (error? or mistake? or fault?)).tw.
72338 (MH "Health Care Errors+") OR TI ( ((medica* or diagnostic* or
therapeutic* or administration* or dispensing* or prescri*) N1
(error* or mistake* or fault*)) ) OR AB ( ((medica* or diagnostic* or
therapeutic* or administration* or dispensing* or prescri*) N1
(error* or mistake* or fault*)) )
20880
11
exp Malpractice/ or malpractice?.tw. 29164 exp Malpractice/ or malpractice?.tw. 30241 (MH "Malpractice") OR TI Malpractice* OR AB Malpractice* 6857
12
(Quality & safety in health care or Qual Saf Health
Care or International Journal for Quality in Health
Care or IJQHC).jn. and safe$2.mp.
595 ((Quality & safety in health care or International Journal for
Quality in Health Care).jn. or (Qual Saf Health Care or
IJQHC).ja.) and safe$2.mp.
651 ((JN Quality & safety in health care OR JT Qual Saf Health Care)
OR (JN International Journal for Quality in Health Care OR JT
IJQHC) AND safe*)
948
13
6 or 7 or 8 or 9 or 10 or 11 or 12 343189 6 or 7 or 8 or 9 or 10 or 11 or 12 786990 (S6 or S7 or S8 or S9 or S10 or S11 or S12) 92303
UNITED
KINGDO
M
14
exp Great Britain/ 269034 exp United Kingdom/ 279276 (MH "United Kingdom+") 185291
15
(United Kingdom or UK or England or Great
Britain or British or Hebrides or Northern Ireland
or Scotland or Wales).in,tw.
879445 (United Kingdom or UK or England or Great Britain or
British or Hebrides or Northern Ireland or Scotland or
Wales).in,tw.
1772173 ((AF United Kingdom or UK or England or Great Britain or British
or Hebrides or Northern Ireland or Scotland or Wales) OR (TI United
Kingdom or UK or England or Great Britain or British or Hebrides or
Northern Ireland or Scotland or Wales) OR (AB United Kingdom or
UK or England or Great Britain or British or Hebrides or Northern
Ireland or Scotland or Wales))
94012
16
14 or 15 1045024 14 or 15 1913945 S14 or S15 217038
QUALITA
TIVE
STUDES
17
interview:.tw. or px.fs. or exp health services
administration/
2414128 (interview: or qualitative).tw. or exp health care
organization/
1183338 (MH "Study Design+") OR (MH "Attitude+") OR (MH
"Interviews+")
555615
18
exp qualitative research/ or exp Interviews as
Topic/ or ((qualitative adj2 (research or stud$3 or
analysis or method? or approach$2 or data)) or
focus group? or meta synthesis or interview? or
grounded theor$3 or ((content or conversation) adj1
analysis) or ethnograph$ or group discussion?).mp.
208590 exp qualitative research/ or exp content analysis/ or exp
interview/ or exp grounded theory/ or exp ethnography/ or
((qualitative adj2 (research or stud$3 or analysis or method?
or approach$2 or data)) or focus group? or meta synthesis or
interview? or grounded theor$3 or ((content or
conversation) adj1 analysis) or ethnograph$ or group
discussion?).mp.
262921 (MH "Qualitative Studies+") or (MH "Focus Groups") OR (MH
"Content Analysis") OR (MH "Grounded Theory") or (MH
"Ethnographic Research") or ((qualitative* N2 (research or stud* or
analysis or method* or approach* or data)) or focus group* or meta
synthesis or interview* or grounded theor* or ((content or
conversation) N1 analysis) or ethnograph* or group discussion*)
156672
19
17 or 18 2440965 17 or 18 1225391 S17 or S18 578790
20
5 and 13 and 16 and 19 1432 5 and 13 and 16 and 19 2094 S5 and S13 and S16 and S19 356
21
exp Animals/ not exp Humans/ 3644792 exp animal/ not exp human/ 1276287 (MH "Animals+") NOT (MH "Human") 21328
22
20 not 21 1432 20 not 21 2094 S20 NOT S21 356
23
limit 22 to last 22 years 1386 limit 22 to last 22 years 1963 Limiters - Published Date from: 19900101-20121231 354
15

APPENDIX 2. USING ENDNOTE TO RECORD AND MANAGE
THE INFORMATION

During the screening process, the information regarding the eligibility of a reference (relevant
or not relevant) will be recorded in the EndNote database. Each author will receive a
personalized database, containing only the reference which is going to screen. The screening
process will consist in eliminating the not relevant references from the database.
At the end of each stage (pilot and screening of titles, abstracts and full texts), the results of
the screening will be sent to the rest of the authors in a XML extension, reducing thus the size
of the file. We will export the references in a XML extension by selecting the references to
export, and subsequently by going to file/export/save as XML. Otherwise, to import the
references of the rest of reviewers, we will go to File/Import/file/ and select the import option
EndNote generated XML.
Finally, all databases will be merged, the agreement will calculated the followings databases
will be created for the next screening process (figure 2).
16

APPENDIX 3. AGREEMENT REPORT

RS
SC NR
A
a
N
b
K
e
A N K A N K
N N Ref ID list N N Ref ID list N N Ref ID list
JMV

NR

SC

a, Agreement; b, Not agreement; c, number of references; d, list of the references (only identification number); e Kappa statistic

17

APPENDIX 4. CRITICAL APPRAISAL SKILLS PROGRAMME
(CASP).



18



19


20


21

FIGURE 1

22

FIGURE 2

23

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