Abstract
Background Description of safety problems and harm in general practices has previously relied on information from health professionals, with scarce attention paid to experiences of patients.
Aim To examine patient-reported experiences and outcomes of patient safety in primary care.
Design and setting Cross-sectional study in 45 general practices across five regions in the north, centre, and south of England.
Method A version of the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire was sent to a random sample of 6736 patients. Main outcome measures included ‘practice activation’ (what a practice does to create a safe environment); ‘patient activation’ (how proactive are patients in ensuring safe healthcare delivery); ‘experiences of safety events’ (safety errors); ‘outcomes of safety’ (harm); and ‘overall perception of safety’ (how safe patients rate their practice).
Results Questionnaires were returned by 1244 patients (18.4%). Scores were high for ‘practice activation’ (mean [standard error] = 80.4 out of 100 [2.0]) and low for ‘patient activation’ (26.3 out of 100 [2.6]). Of the patients, 45% reported experiencing at least one safety problem in the previous 12 months, mostly related to appointments (33%), diagnosis (17%), patient provider communication (15%), and coordination between providers (14%). Twenty-three per cent of the responders reported some degree of harm in the previous 12 months. The overall assessment of level of safety of practices was generally high (86.0 out of 100 [16.8]).
Conclusion Priority areas for patient safety improvement in general practices in England include appointments, diagnosis, communication, coordination, and patient activation.
INTRODUCTION
The growing interest in primary care patient safety worldwide1,2 is perhaps best exemplified by the Safer Primary Care initiative established by the World Health Organization in 2012 for advancing understanding and knowledge about the risks to patients, the magnitude and nature of the preventable harm caused by unsafe practices, and safe mechanisms to protect patients.3,4 A recent systematic review including studies from 21 different countries estimated that two to three patient safety incidents occur per 100 primary care consultations.5 Available evidence suggests that between 45% and 76% of them can be prevented.6 Despite increasing awareness of its potential impact on population health, major gaps in understanding remain and there is scarce evidence on how safety might be improved in primary care.7
One of the barriers hindering progress in this area is that most research has relied on information supplied by healthcare providers, with limited attention paid to patients’ perspectives.8,9 As highlighted by the World Health Organization in a recent report,10 the person using healthcare services is the only consistent factor throughout the care pathway. They hold key information vital for process, systems, and policy improvement. Tapping into such a rich resource could contribute significantly to improving safety in primary care.10–13
Previous studies have used patient-reported information to evaluate the safety of health care.14–18 However, most followed a hospital-oriented approach to patient safety research, and were mostly focused on medication safety and technical aspects of health care. As observed by a number of recent qualitative studies,19–23 these issues do not fully account for patients’ priorities and perspectives of safety in primary care, for which issues around trust, patient– provider relationships, continuity, or access to health care play a more important role. In an attempt to close this gap, a patient-centred tool was developed recently to measure patient safety in general practices: the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC).24 This validated instrument enables comprehensive measurement of patient perceptions, experiences, and outcomes of patient safety in primary care.
How this fits in
Most research on patient safety has been conducted in the hospital setting, and less is known about safety in general practices. A validated questionnaire was used to examine patients’ perceptions and experiences of patient safety in English general practices. The study showed that patient-reported experiences of safety problems and harm are common but preventable. Special attention should be paid to areas related to appointments, diagnosis, communication and coordination between healthcare professionals, and settings.
The aim of this study was to use the PREOS-PC questionnaire to examine patients’ perceptions and experiences of safety problems and harm in general practices in England.
METHOD
Study design and participants
This was a cross-sectional study. In June 2014 the PREOS-PC questionnaire was sent to 6736 adult (aged ≥18 years) patients from 45 general practices distributed across five regions in the north, centre, and south of England. Practices were selected through purposefully sampling to ensure variation in terms of list size and deprivation.
Each practice sent the questionnaire with a covering letter and a pre-paid return envelope to a computer-generated random sample of 150 adult patients who had had at least one interaction with their primary healthcare providers in the previous 12 months. A reminder was sent after an interval of approximately 2 weeks to patients in 10 practices rather than to the whole sample of practices because of limited resources.
Conceptualisation and measurement of patient safety in primary care
Details of the conceptual framework used in this study and the development process, validation, and psychometric properties of the PREOS-PC survey are available elsewhere.24 In short, patient safety was conceptualised as a:
‘Property of healthcare systems and services associated with the occurrence, prevention and amelioration of patient safety events’.
An event was defined as:
‘Harm or potential harm to one or more patients due to an interaction with the healthcare system that fails to adhere to accepted standards of care, or due to the intrinsic risks of healthcare’.
The survey was used to measure patient-reported patient safety as conceptualised above. Responders reported on their perceptions, experiences, and outcomes in relation to the safety of the health care received from their GP practice over the previous 12 months. The version used in this study contained 71 items distributed in five main domains: practice activation (what a practice does to create a safe environment and to ensure safety); patient activation (how proactive patients are in ensuring safe healthcare delivery); experiences of patient safety events (safety errors); outcomes of patient safety (harm); and patients’ overall perception of safety (how safe patients rate their practice).
Statistical analyses
All analyses were conducted at the patient level and were based on individual items and on scales. Item-based analyses consisted of the calculation of the number and percentage of patients answering each of the response categories in each item. Scale scores were calculated as the percentage of the maximum score achievable on all items, with scores ranging from 0 to 100. For all the scales, higher scores suggested higher levels of patient safety. For multi-item scales, where responses were missing for more than 50% of the items, the whole scale was scored as missing; otherwise a score was derived using the available items without any imputation. Scale-based analyses were restricted to the scales showing the best psychometric properties in each of the five PREOS-PC domains (Appendix 1), consisting of the calculation of weighted scores’ mean and standard error (SE).
Inverse probability weights, related to likelihood of response, were applied in analysis to produce results more representative of the full practice populations, not just the patients who participated. For each participating practice, data were extracted on the sex and age distributions of the patients registered. Subsequently, separate sex and age probability weights were computed for each practice. For example, if data were received from 30 male patients from a practice with 3000 male registered patients, the weight was calculated as 3000/30 = 100 (so each male in the sample would represent 100 males at that practice). The sex and age weights were then multiplied and rescaled for the weighted samples to match the practice list sizes.
Tables report both unweighted and weighted (in square brackets) results for questionnaire items and scales; results in the main text are weighted. In general, weighted results did not substantially differ from unweighted results.
All data manipulation and analysis were carried out in Stata 12.1.
RESULTS
Description of participating practices
In comparison with the overall characteristics of all English practices, participating practices were larger on average (mean list size 8744 versus 7041) and had a slightly higher proportion of non-white patients (18.8% versus 15.9%), but were very similar with respect to sex balance, proportion of older patients, and deprivation (Table 1).
Response rate
The overall response rate was 18.4% (1244 out of 6736). Compared with the overall characteristics of all eligible patients registered in the 45 participating practices, responders were more likely to be female (59% versus 51%), aged ≥65 years (39% versus 20%) and of white ethnic group (91% versus 82%) (Table 2).
Practice activation
In general, patients perceived that their providers took adequate measures to ensure safe healthcare delivery, with more than two-thirds of the patients reporting the most positive options (always/often) for the 11 Likert-scale items measuring ‘practice activation’ (Table 3). The only exception was the response to the item ‘The general practitioner told you about what side effects of your treatments to watch for’, for which only 63% (after weighting) of the patients provided positive answers. Most (90%) of the patients agreed that delivering safe health care was a top priority for their providers. The mean (SE) score of the ‘practice activation’ scale was 80.4 out of 100 (2.0) points.
Patient activation
In general, patients reported low levels of activation: 62% reported that they ‘never’ or ‘rarely’ raised a concern when they thought something was wrong with their health care, and 71% reported that they ‘never’ or ‘rarely’ made a suggestion to their healthcare providers when they thought that something could be done to improve the services provided. The mean (SE) score of the ‘patient activation’ scale was 26.3 out of 100 (2.6) points.
Experiences of safety problems
A total of 479 patients (45%) reported at least one safety problem with the health care received in their practice in the last 12 months. The most commonly reported problem was not having access to appointments when needed (33%, n = 353) (Table 4). Other commonly reported problems were related to diagnosis (17%), patient–provider communication (15%), coordination between professionals in the practice (14%), and coordination between professionals from different settings (11%). Only 29 patients (4%) reported a medication-related safety problem. The mean (SE) score of the ‘experiences of safety problems’ scale was 90.2 out of 100 (3.0) points.
Out of the 479 patients that reported a safety problem, most (95%) perceived that the problem could have been prevented. In terms of responsibility for the safety problem, 76% perceived that professionals of their practices had at least some responsibility, whereas only 22% perceived that they themselves had some responsibility. Most (59%) did not take any action in response to the safety problem experienced (for example, reporting it to a healthcare professional, asking for an explanation about the problem, or asking for measures to prevent it occurring again). On reporting safety problems, 48% reported that the safety problem was acknowledged by the practice (although only 29% thought it had been taken seriously), and 38% rated the response of the practice to the safety problem as ‘poor’ or ‘fair’.
Experiences of harm
Reports of having experienced harm as a result of the health care provided by their practice during the previous 12 months were received from 221 patients (23%) (Table 5). The most common types of harm were related to mental health (including anxiety or stress) problems (18.5%, n = 147), limitations in social activities (14%), and pain (11%). Sixty-three patients reported that the harm experienced led to a permanent health problem (Appendix 2). The mean (SE) score of the ‘experiences of harm’ scale was 92.1 out of 100 (2.8) points.
Overall perception of patient safety
Overall, patients had a positive perception of the safety of the health care provided in their practice, with 91% (n = 1072) of them agreeing that their providers were trustworthy. The overall assessment of the level of safety of practices was positive, with a mean (SE) score of 84.6 out of 100 (1.8) points.
DISCUSSION
Summary
In this study, it was observed that patients had a positive perception of the levels of safety in their practices. Almost half of them, however, reported experiencing one or more safety problems and a quarter reported experiencing some degree of harm as a result of the health care received in the previous 12 months.
Strengths and limitations
This is the first large-scale quantitative study examining the safety of the health care provided in general practices in England as perceived by the patients. It included 45 practices from a large geographic area, urban and rural settings, and with different levels of deprivation. Patients’ perceptions and experiences were measured using a valid and reliable patient-centred instrument, which supports the validity of the findings.
A number of limitations must be acknowledged. The overall response rate in the study was modest (18.4%). Non-response may introduce bias if non- responders differ from responders on the key measures of interest. Patients who experienced safety problems or harm may have been more likely to complete the survey than those who did not; this would have resulted in an overestimation of the occurrence and severity of these problems. Only an English version of the questionnaire was used, which may also have increased response bias. Future work on this area should include development of additional language versions of the questionnaire. Although the magnitude of such bias in the sample cannot be estimated, previous meta-analyses suggest that its effect can be reduced by using rigorous probability sampling processes, as used in this study.25 In addition, response probability weights were applied in analysis to minimise bias from under-represented groups of patients (younger and male). Weighting was not applied for ethnic group as some practices had very few non-white responders resulting in unstable weight estimates; in addition, low percentages of non-white patients mean that any adjustment would have had only a very small effect on the results.
Comparison with existing literature
One of the main findings in this study is the substantial proportion of patients reporting experiences of safety problems, which is higher than in previous studies (15.6% reported by Kistler et al 26 and 5.5% by Solberg et al 27). The measures used in previous studies focused on clinical and technical aspects of safe health care, whereas in this study a patient-centred instrument was used that expanded the number of potential problems. The high rate of safety problems observed was mainly driven by access-related problems, which typically consisted of difficulties in obtaining appointments when needed. It is worth noting that this study was conducted during a period of economic austerity in England. The financial cuts imposed on healthcare provision may have affected access more severely than other areas of safety. This hypothesis is supported by data from the GP Patient Survey (a survey measuring patient experiences in general practices in England, mailed each year to 2.7 million patients),28 which revealed an increase over the previous 4 years in the percentage of patients who had to wait more than 1 week for an appointment (from 13% in 2012 to 18% in 2015).29 Although this is a valid patient safety issue from the patients’ perspective,19,23 it also raises a number of issues regarding appropriate access and potential direct and indirect harm caused by too much access.
The second most common problem was related to diagnosis (reported by 17% of the participants), which is similar to the 13% rate observed by Kistler et al in the US.26 Patients perceived a diagnostic safety problem when they experienced a delay in being diagnosed (which in some instances led to an exacerbation of their condition), or when they received a different diagnosis after seeking a second opinion. A considerable proportion of the research conducted so far on the area of patient safety in primary care has focused on medication-related safety problems.14–18 It was observed, however, that medication-related problems were relatively uncommon when compared with other issues examined. This finding resonates with previous research, which suggested that patients are more likely to identify safety problems related to access and relational issues rather than technical issues such as improper medical treatment.30
The proportion of patients reporting harm (23%) was higher than that reported in a previous study in the US.26 Patients were more likely to report being harmed psychologically and emotionally, suggesting that the current focus of patient safety efforts on adverse drug events and surgical mishaps could overlook other patient priorities. As pointed out in a recent systematic review,18 in contrast to the expansive literature regarding clinician distress associated with adverse events, the physical, financial, and psychological harms to patients are understudied.19,23 Notably, in this study, harm leading to permanent health deterioration was reported by 63 patients (23% of all patients reporting harm). This may be an overestimation caused by response bias. It could also be attributable to how patients conceptualise safety and harm.21 This figure is, however, consistent with results from a national telephone survey carried out in the US on behalf of the National Patient Safety Foundation, which showed that 32% of the patients reporting harm to physical health regarded it as permanent, as did the 22% that reported harm to emotional health.31 As they stand, the present results appear to challenge the traditional view of harm being a source of concern in hospital but not in primary care settings.32
Implications for practice
This is the first large-scale study evaluating patient-reported experiences and outcomes of the safety of general practices in England. A number of priority areas for improving patient safety in practices in England have emerged: appointments, diagnosis, communication, and coordination.
Moreover, low levels of patient activation were observed, with most of the patients showing reluctance to raise concerns when they perceived something was wrong with their care. Potential for patients to contribute to their safety by speaking up about their concerns depends heavily on the quality of patient–professional interactions and relationships,33 and therefore interventions focused on improving patient–provider interactions are worth exploring.
The present study showed that patient-reported safety problems are common and preventable, but less than half of them are acknowledged by practices. This may suggest that practices are not able to detect them, which could be caused partially by a significant mismatch between what practice staff and patients perceive as safety issues. Achieving safer primary care is crucial for practices to better understand patients’ experiences and perspectives about the safety of the health care they receive.23 For that purpose the routine use of standardised and validated patient-centred instruments, such as the PREOS-PC questionnaire, might prove a valuable resource.
Finally, the significant proportion of patients rating their practices’ reactions after noticing a safety event as ‘poor’ or ‘fair’ might suggest the need for practices to develop and follow standardised procedures to ensure safety events are adequately and satisfactorily tackled when identified.
Acknowledgments
The authors would like to thank all GP practices and all patients participating in this study.
Appendix 1. Main outcome measures
Practice activation (Cronbach’s α = 0.89)
Thinking about the health care you have received in your GP surgery in the last 12 months, in general how often did you feel that your GP(s) … (Always; Often; Sometimes; Rarely; Never; Not applicable)
Was (were) available when you needed to see or talk to them?
Gave you enough time to say what you wanted to say and to ask questions?
Encouraged you to talk about any concerns about your health care?
Explained your tests and treatments in a way you could understand?
Told you about what side effects of your treatments to watch for?
Took your concerns seriously?
Helped you to arrange/organise the right type of care (referrals, follow-up, etcetera)?
Had access to relevant information when needed (medical history, test results, etcetera)?
Seemed to be aware of the recommendations for care from other professionals treating you?
Seemed to work well together with the other professionals in the practice?
Thinking about the health care you have received in your GP surgery in the last 12 months, to what extent would you agree that delivering safe care was a top priority for your GPs, nurses, and other staff in your GP surgery? [Strongly agree; Agree; Neither agree nor disagree; Disagree; Strongly disagree; I don’t know]
Patient activation (Cronbach’s α = 0.80)
Thinking about the health care you have received in your GP surgery in the last 12 months, how often did you … (Always; Often; Sometimes; Rarely; Never; Not applicable)
Raise a concern to your GPs, nurses, or other staff in your GP surgery when you thought something was wrong with your health care?
Make a suggestion to your GPs, nurses, or other staff in your GP surgery when you thought something could be done to improve the service provided?
Experiences of safety problems (Cronbach’s α = 0.75)
Thinking about the health care you have received in your GP surgery in the last 12 months, do you believe you had any problem related to … (No; Only once; More than once)
Diagnosis of your problems (for example, wrong diagnosis)?
The medication prescribed or given to you at your GP surgery (for example, receiving a medication that was meant for a different patient)?
Other treatments prescribed or administered at your GP surgery (such as minor surgery or acupuncture)?
Vaccines prescribed or administered at your GP surgery (for example, receiving a vaccine that you already knew you were allergic to)?
Blood tests and other laboratory tests ordered or performed at your GP surgery (for example, the test results being misplaced)?
Diagnostic and monitoring procedures other than blood and laboratory tests (such as an ear examination, or biopsy, etc.) ordered or performed at your GP surgery (for example, not receiving a procedure when needed)?
Communication between you and the healthcare professionals in your GP surgery (for example, not receiving the information you needed about your health problems or health care)?
Communication and coordination between the healthcare professionals in your GP surgery (for example, important information about your healthcare not being passed between the healthcare professionals)?
Communication and coordination between professionals in your GP surgery and other professionals outside of the GP surgery (for example, a letter being missing from a hospital consultant)?
Your appointments (for example, not getting an appointment when you needed one)?
Your health records (for example, your health records not being available when needed)?
Experiences of harm (Cronbach’s α = 0.96)
Do you think you have experienced any of the following types of harm as a result of the health care provided in your GP surgery in the last 12 months? (Not at all; Hardly any; Yes, somewhat; Yes, a lot; Yes, extreme)
Pain
Harm to your physical health
Harm to your mental health
Increased limitations in doing your usual social activities
Increased healthcare needs
Increased personal care needs
Increased financial needs
Overall rating of patient safety
On a scale of 0–10, how safe do you think the health care you received in your GP surgery was in the last 12 months? Please do this by putting a mark on the line below like this:
Appendix 2. Time to recover from harm
Time to recover from: | n(%) [weighted ] | |||||
---|---|---|---|---|---|---|
<1 week | >1 week but <1 month | >1 month but I eventually recovered | I have a permanent problem | Total N | ||
Pain | 20 (21.7) [47.9] | 16 (17.4) [21.5] | 14 (15.2) [9.1] | 42 (45.7) [21.5] | 92 | |
Physical health | 9 (12.9) [5.9] | 9 (12.7) [47.7] | 19 (26.8) [22.0] | 34 (47.9) [24.4] | 71 | |
Mental health | 22 (29.0) [22.7] | 16 (21.1) [50.7] | 16 (21.1) [12.3] | 22 (29.0) [14.3] | 76 | |
Limitations doing usual activities | 8 (10.4) [7.6] | 10 (13.0) [44.5] | 17 (22.1) [21.0] | 42 (54.6) [26.9] | 77 | |
Overall harm | 45 (27.8) [20.2] | 23 (14.2) [46.3] | 31 (19.1) [10.6] | 63 (38.9) [22.9] | 162 | |
About the same | Slightly worse | Worse | Much worse | Total N | ||
How much worse was the overall health as a result of the harm experienced? | 91 (54.2) [38.1] | 39 (23.2) [46.2] | 25 (14.9) [8.5] | 13 (7.7) [7.2] | 168 |
Notes
Funding
This research is part-funded by the National Institute for Health Research School for Primary Care Research (NIHR SPCR). Jose M Valderas was supported by a National Institute of Health Research (NIHR) Clinician Scientist Award (NIHR/CS/010/024). The views expressed are those of the authors and not necessarily those of the NIHR, the NHS, or the Department of Health.
Ethical approval
Ethical approval was granted by Nottingham Research Ethics Committee (13/EM/0258).
Provenance
Freely submitted; externally peer reviewed.
Competing interests
The authors have declared no competing interests.
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- Received August 8, 2016.
- Revision requested September 22, 2016.
- Accepted November 8, 2016.
- © British Journal of General Practice 2017