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Research ArticleMethodology

Measuring Patient Safety in Primary Care: The Development and Validation of the “Patient Reported Experiences and Outcomes of Safety in Primary Care” (PREOS-PC)

Ignacio Ricci-Cabello, Anthony J. Avery, David Reeves, Umesh T. Kadam and Jose M. Valderas
The Annals of Family Medicine May 2016, 14 (3) 253-261; DOI: https://doi.org/10.1370/afm.1935
Ignacio Ricci-Cabello
1Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom
PhD
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Anthony J. Avery
2Division of Primary Care, School of Medicine, University of Nottingham Medical School, Queen’s Medical Centre, Nottingham, United Kingdom
PhD
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David Reeves
3Centre for Biostatistics, Institute of Population Health, University of Manchester, Manchester, United Kingdom
PhD
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Umesh T. Kadam
4Arthritis Primary Care Research Centre, Institute for Primary Care and Health Sciences, University of Keele, Keele, United Kingdom
5Health Services Research Unit, Institute for Science and Technology in Medicine, University of Keele, Keele, United Kingdom
PhD
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Jose M. Valderas
6Health Services & Policy Research Group, Patient Centred Care, University of Exeter Collaboration for Academic Primary Care (APEx), University of Exeter Medical School, University of Exeter, Exeter, United Kingdom
PhD
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  • For correspondence: J.M.Valderas@exeter.ac.uk
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    Figure 1

    Development process of the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC).

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    Table 1

    Structure of the Trial Version of the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC 0.2)

    DomainQuantitative Summary Open-Ended Questions
    ConstructsItems in Scalea
    Practice activationPractice activation111
    Patient activationPatient activation21
    Experiences of safety problemsTypes of patient safety problems experienced123
    Most recent experience: type of patient safety problem, location, people involved and degrees of responsibility (including patient), preventability[12]b
    Outcomes of patient safety (harm)Harm specific to health domain52
    Health care, personal care, and financial needs3
    Time to recover from harm (type specific)4
    Time to recover from harm (overall)1
    Amount of harm experienced (overall)1c
    Impact on overall health1
    General perceptions of patient safetyTrustworthiness10
    Overall rating of patient safety1c
    Total12 constructs11 scales (54 items)7
    • ↵a Items are based on Likert scales unless otherwise noted.

    • ↵b These 12 items are not part of any scale, since their purpose is descriptive rather than evaluative.

    • ↵c Visual analog scale.

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    Table 2

    Demographic Characteristics of the Participants

    CharacteristicN (%)
    Sexa
     Male497 (41.11)
     Female712 (58.89)
    Ageb
     18–34140 (12.03)
     35–64570 (48.97)
     ≥65454 (39.00)
    Ethnicityc
     White1,082 (91.15)
     Other ethnic group105 (8.85)
    Educational level
     Degree, degree equivalent, and above411 (35.16)
     Other qualifications532 (45.51)
     No qualifications226 (19.33)
    Health status
     Very good or good892 (73.54)
     Fair, bad, or very bad321 (26.46)
    Number of long-term conditions
     0330 (27.99)
     1329 (27.91)
     2–3366 (31.04)
     >3154 (13.06)
    Number of medications taken
     0344 (30.10)
     1–2311 (27.21)
     3–4222 (19.42)
     >4266 (23.27)
    • ↵a Mean (SD) proportion of females registered in the 45 practices that participated in the study: 0.51 (0.05).

    • ↵b Mean (SD) proportion of eligible patients aged >65 years registered in the 45 practices that participated in the study: 0.20 (0.01).

    • ↵c Mean (SD) proportion of patients from nonwhite ethnicity registered in the 45 practices that participated in the study: 0.18 (0.04).

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    Table 3

    Distribution of Scores and Reliability of the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) Scales

    DomainConstructNScore Respondents With Lowest Possible Score, %Respondents With Highest Possible Score, %Internal Consistency Test-Retest Reliabilitya ICCb (95% CI)Practice Mean Scores
    MinMaxMean (SD)
    Cronbach’s α, mean (min, max)Inter-Item Correlation, mean (max, min)Precision (standard error)Intra-Cluster Correlation Coefficient (95%CI)ReliabilityNumber of Responses Needed for 0.7 Reliability
    Practice activation1,1329.0910083.69 (18.01)020.560.89 (0.86; 0.90)0.41 (0.39; 0.43)0.72 (0.55–0.83)c3.440.07 (0.03–0.11)c0.6631
    Patient activation966010025.1 (30.8)47.05.580.800.670.55 (0.25–0.75)c6.570.022 (0.001–0.050)c0.33104
    Experiences of safety problems1,171072.724.8 (9.4)63.1900.75 (0.71; 0.76)0.22 (0.20; 0.24)0.57 (0.37–0.72)1.830.02 (0.00–0.05)0.36109
    Outcomes of patient safety (harm)Harm specific to the health domain1,05301004.7 (14.1)81.80.290.96 (0.95; 0.96)0.83 (0.82; 0.85)0.72 (0.55–0.83)c2.880.025 (0.001–0.053)c0.3890
    Health care, personal care, and financial needs1,043091.662.4 (10.8)92.600.88 (0.78; 0.89)0.72 (0.63; 0.80)−0.02 (−0.29 to 0.26)2.230.019 (0.001–0.046)c0.31118
    Time to recover from harm (type specific)15707524.7 (26.7)37.700.81 (0.71; 0.86)0.52 (0.45; 0.67)Not estimatedd13.590.057 (0.001–0.21)0.18309e
    Time to recover from harm (overall)162010056.4 (41.6)27.632.27N/AN/ANot estimatedd19.500.17 (0.001–0.34)c0.4585e
    Amount of harm experienced (overall)169010035.3 (26.3)3.00.60N/AN/ANot estimatedd13.570.000 (0.000–0.126)––
    Impact on overall health168010025.4 (32.5)54.27.74N/AN/ANot estimatedd15.550.11 (0.001–0.256)c0.32148e
    General perceptions of patient safetyTrustworthiness1,133010087.5 (16.1)0.356.78N/AN/A0.26 (−0.02 to 0.50)c3.160.032 (0.002–0.061)c0.4571
    Overall rating of patient safety1,139010086.0 (16.8)0.219.79N/AN/A0.24 (−0.03 to 0.48)c3.290.029 (0.001–0.058)c0.4378
    • N/A = not applicable (single item scales).

    • ↵a Based on data from 64 patients who completed the questionnaire again after 2 weeks.

    • ↵b One-way random effects intra-class correlation coefficients.

    • ↵c P <.05.

    • ↵d Not enough data to conduct the analyses (fewer than 10 of the respondents who completed the retest questionnaires reported harm experiences).

    • ↵e Responses needed to have sufficient cases reporting harm.

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    Table 4

    Known Group Analysis Based on Characteristics of Patients and Practices

    Practice ActivationaExperiences of Safety ProblemsbImpact on Health (Health Domain Specific)bImpact on Health Care, Personal Care, and Financial NeedsbOverall Rating of Patient Safetya
    Patient characteristics, β (95%CI)c
    Number of long-term conditions0.49 (0.53–0.93)1.58 (0.82–2.35)0.88 (0.36–1.40)0.11 (−0.42 to 0.64)
    Number of medications0.03 (−0.34 to 0.39)0.14 (−0.6 to 0.33)0.65 (0.13–1.16)0.49 (0.19–0.80)0.17 (−0.17 to 0.53)
    English as a second language
     Yes (n = 87)11111
     No (n = 1,118)5.71 (0.57–10.86)−4.37 (−8.30 to −0.44)−2.83 (−7.65 to 1.98)7.87 (2.95–12.80)−4.67(−10.36 to 1.02)
    Born in the UK
     Yes (n = 1,093)11111
     No (n = 112)−2.46 (−6.95 to 2.03)2.83 (−0.02 to 5.68)1.48 (−2.38 to 5.34)−5.13 (−8.64 to −1.63)3.13 (−0.19 to 6.47)
    Practice characteristics, r (95%CI)d
    Practice size0.24 (−0.06 to 0.50)−0.27 (−0.52 to 0.03)−0.11 (−0.40 to 0.19)−0.02 (−0.31 to 0.28)0.01 (−0.20 to 0.39)
    Proportion of patients aged >65 years0.06 (−0.25 to 0.35)−0.08 (−0.37 to 0.22)−0.07 (−0.36 to 0.24)−0.04 (−0.34 to 0.26)0.14 (−0.16 to 0.42)
    Deprivation scoree−0.32 (−0.56 to −0.02)0.30 (0.00–0.55)0.20 (−0.10 to 0.47)0.18 (−0.13 to 0.45)−0.36 (−0.60 to −0.07)
    Safety Climatef−0.09 (−0.45 to 0.29)0.06 (−0.32 to 0.42)0.10 (−0.28 to 0.46)0.15 (−0.50 to 0.25)0.07 (−0.31 to 0.43)
    • ↵a Higher scores indicate perception of safer practices.

    • ↵b Higher scores indicate more severe/frequent access problems or more severe harm.

    • ↵c Bivariate linear regression.

    • ↵d Correlation coefficient.

    • ↵e Deprivation measured using the Index of Multiple Deprivation; higher scores indicate higher deprivation levels.

    • ↵f Safety climate measured using the instrument “PC-SafeQuest” (information available only from 31 practices).

Additional Files

  • Figures
  • Tables
  • Supplemental Appendixes

    Supplemental Appendix 1. Characteristics of the participating practices; Supplemental Appendix 2. Comparison of patient characteristics and scale scores between respondents to the first invitation vs the respondents to the reminders; Supplemental appendix 3. Confirmatory Factor Analysis for the evaluation of construct validity; Supplemental Appendix 4. Correlation between scales; Supplemental appendix 5. Record of the modifications introduced during the development of PREOS-PC; Supplemental appendix 6. Patient reported experiences and outcomes of safety in primary care (PREOS-PC).

    Files in this Data Supplement:

    • Supplemental data: Appendixes - PDF file
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The Annals of Family Medicine: 14 (3)
The Annals of Family Medicine: 14 (3)
Vol. 14, Issue 3
May/June 2016
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Measuring Patient Safety in Primary Care: The Development and Validation of the “Patient Reported Experiences and Outcomes of Safety in Primary Care” (PREOS-PC)
Ignacio Ricci-Cabello, Anthony J. Avery, David Reeves, Umesh T. Kadam, Jose M. Valderas
The Annals of Family Medicine May 2016, 14 (3) 253-261; DOI: 10.1370/afm.1935

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Measuring Patient Safety in Primary Care: The Development and Validation of the “Patient Reported Experiences and Outcomes of Safety in Primary Care” (PREOS-PC)
Ignacio Ricci-Cabello, Anthony J. Avery, David Reeves, Umesh T. Kadam, Jose M. Valderas
The Annals of Family Medicine May 2016, 14 (3) 253-261; DOI: 10.1370/afm.1935
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