Development of the Knee Standardized Clinical Interview: a research tool for studying the primary care clinical epidemiology of knee problems in older adults

G. Peat, H. Lawton, E. Hay1, J. Greig2, E. Thomas and for the KNE-SCI Study Group

Primary Care Sciences Research Centre, Keele University, Staffordshire ST5 5BG,
1 Staffordshire Rheumatology Centre, Haywood Hospital, Stoke-on-Trent and
2 Moorlands Medical Practice, Leek, UK


    Abstract
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Appendix
 References
 
Objective. To develop a standardized clinical interview, incorporating the perspectives of general practitioners (GPs) and rheumatologists, for primary care clinical epidemiological studies of adults aged 50 yr and over with knee problems.

Methods. Two parallel, consensus development studies using a modified nominal group technique involving GPs (n=5) and consultant rheumatologists (n=4) from North Staffordshire with reference panels of GPs (n=28) and rheumatologists (n=11) from selected centres in Great Britain, respectively. A single standardized clinical interview was formed using the clinical history questions identified in the consensus development studies and its feasibility was tested in a small sample of patients.

Results. In the GP consensus development study, 115 clinical history questions were identified, of which 71 were of agreed importance following postal rating, face-to-face discussion and re-rating. In the rheumatologist study, 158 questions were identified, of which 47 were of agreed importance. There was considerable overlap in the clinical history questions independently developed by the two studies. A single standardized clinical interview containing 74 questions was formed. It contained questions on the history, onset and recent course of the complaint; nature, location and severity of current knee symptoms; impact of knee problem; past history of knee problems; family history; comorbidity; previous/current investigations and treatment; ideas, concerns and expectations. In preliminary testing it took 20–45 min to conduct and was comprehensible to patients.

Conclusions. A research tool—the Knee Standardized Clinical Interview (KNE-SCI)—has been formed from consensus development studies involving GPs and rheumatologists. In preliminary testing, it is comprehensible to patients, and forms a coherent clinical interview for research data collection. However, further evaluation is required to determine its accuracy and reliability and its usefulness for clinical epidemiological research.

KEY WORDS: Clinical history, Research tool, Primary care, Knee


    Introduction
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Appendix
 References
 
There is increasing recognition of the need to undertake large, simple studies of the clinical examination [1, 2]. This is especially true in primary care where the majority of patients with ill-health are assessed and managed, and the absence of such studies is part of a wider ‘evidence gap’ [3]. Musculoskeletal conditions present a particular challenge as gold standards for diagnosis are frequently unavailable.

The clinical history is a logical starting point for clinical epidemiological research in this field. A careful history is still regarded as one of the most powerful assessment tools available to clinicians [4, 5] not only for diagnosis but also for understanding the nature and severity of the complaint, estimating its likely clinical course, and guiding appropriate management. However, appropriate tools are needed to conduct research on the clinical history and bridging the gap between research tools and clinical history-taking in practice raises several important questions. Can the ‘richness' of clinical history-taking be adequately represented in a standardized format? Can a consensus be reached on what is important?

We decided to address these issues as part of a longer-term study of knee problems in primary care. Knee pain is reported by approximately 25% of the general population aged 50 yr or over in a given year and is associated with some degree of disability in half of these [68]. Precise estimates of the primary care consultation prevalence for knee problems are lacking. However, an estimated 400 people per 10 000 practice population consult their general practitioner (GP) each year with knee pain labelled as ‘osteoarthritis' [9, 10]—the most common diagnosis in this age group. Differential diagnoses include extra-articular and peri-articular syndromes and serious but less common ‘red flag’ conditions (e.g. inflammatory arthropathy, intra-articular pathology) [11]. There is little detailed information on the reliability of diagnostic labelling in this setting, or on the patterns of care provided and the outcome of that care. In this paper we relate our attempts to develop a standardized clinical interview for assessing knee problems in older adults, and the results of this work. Future work will report on prospective testing in large-scale studies.

The aims of this study were: (i) to develop a standardized clinical interview [Knee Standardized Clinical Interview (KNE-SCI)] for primary care clinical epidemiological studies of adults aged 50 yr and over with knee problems which incorporated the perspectives of GPs and rheumatologists, emphasizing psychosocial as well as physical factors; and (ii) to test the feasibility of the interview and develop response options in a small sample of patients.


    Methods
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Appendix
 References
 
The KNE-SCI was developed in two phases. In the first phase, consensus development studies were used to identify clinical interview questions regarded by GPs and rheumatologists as important in the assessment of older adults with knee problems. In the second phase, a single standardized clinical interview was formed from the clinical history questions identified in the first phase and its feasibility was tested.

Phase 1. Consensus development studies
We set up two parallel, independent consensus development studies—one with local GPs (n=5) and one with local rheumatologists (n=4). The same modified nominal group technique was used for each (adapted from Bernstein et al. [12]). This involves independent postal rating, followed by face-to-face group discussion and independent re-rating [13]. This method was chosen as it offered the advantages of private rating combined with group discussion in a topic where differences in structure, content and style of clinical history between clinicians were anticipated.

Potentially important clinical history questions were generated by initial brainstorming with local GPs and rheumatologists and supplemented from standard texts. Consensus on the importance of each of the clinical history questions was measured amongst local clinicians (the ‘internal panel’) by independent postal rating using pre-defined criteria.

External feedback into the consensus development process was provided by separate ‘reference panels' of GPs (n=28) and rheumatologists (n=15). These groups were assembled from selected general practices and rheumatology centres across Great Britain to represent a range of settings, and included those with a special interest in joint pain in older adults. They were invited to participate in the independent postal rating round as per the internal panel.

Clinical history questions were automatically taken forward to Phase 2 after the postal rating round if there was consensus amongst the internal panel that the question was important and this was endorsed by consensus amongst the reference panel. Questions regarded as unimportant by the same process were automatically rejected.

All questions where there was no clear agreement between the internal and reference panels were carried forward for face-to-face discussion at a meeting of the internal panel members. During this meeting the results of the postal round were fed back along with any other comments and additional questions raised by the members of the reference panel. Each question was discussed in turn before independent re-rating. Questions were taken forward to Phase 2 if there was consensus after re-rating that they were important.

Phase 2. Formation of the KNE-SCI and feasibility testing
In Phase 2 we had two tasks: (i) to develop the items identified in Phase 1 into a format which could both reflect important aspects of the process of clinical history-taking and be usable as a research tool, and (ii) to introduce a limited number of items from the research literature to measure certain components which did not emerge from Phase 1.

Questions emerging from the two consensus studies were arranged into the format and order of a clinical interview. Feasibility testing was conducted in a small sample of patients (n=9) aged 50 yr and over with knee problems identified by their GP in five local practices with computerized morbidity registers. The interviews were conducted by two clinical researchers under the observation of a GP who noted the interviewer's performance and patients' verbal and non-verbal responses to questioning. After the interview, patients were invited to comment on the clarity, order and comprehensiveness of the interview. A further discussion of the interview and interviewers' performance was held after the patient had left. Suggested revisions to the KNE-SCI were made after each session. The methods for Phase 2 were approved by the Local Research Ethics Committee.

The results of the interviews were presented for group discussion at a meeting with representatives of the general practice and rheumatology internal panels where further refinement of the structure, order and response options of the KNE-SCI were made. Following this group meeting, further feasibility interviews were undertaken with five patients, again with an observer present.


    Results
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Appendix
 References
 
Phase 1. Consensus development studies
The results of the consensus development studies are summarized in Fig. 1Go.



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FIG. 1. Results of the consensus studies. (a) General Practice Consensus Study. (b) Rheumatology Consensus Study.

 
In the General Practice Consensus Study, 115 potentially important clinical history questions were identified from the initial brainstorming and from selected primary care texts [11, 1419]. From postal rating, 27 clinical history questions were regarded as important by both the internal panel and reference panel, and were taken forward to Phase 2. Eighty-eight questions remained for face-to-face group discussion, along with 13 additional questions proposed by members of the reference panel during the postal round (total=101). After rephrasing, re-structuring, face-to-face group discussion and re-rating by the internal panel, there was consensus that a further 44 questions were important. Hence, the final result of the General Practice Consensus Study was a total list of 71 questions of agreed importance for assessing older adults with knee problems.

In the Rheumatology Consensus Study, 158 potentially important clinical history questions were identified from brainstorming and selected rheumatology texts [2025]. From postal rating only seven clinical history questions were regarded as important by both the internal panel and reference panel. This left 151 questions for face-to-face group discussion, along with five additional questions proposed by members of the reference panel during the postal round. This number was reduced to 100 by rephrasing and re-structuring the questions. After face-to-face group discussion and re-rating by the internal panel, there was consensus that a further 40 were important. Hence, the result of the Rheumatology Consensus Study was a total list of 47 questions of agreed importance for assessing older adults with knee problems.

Phase 2. Formation of the KNE-SCI and feasibility testing
There was considerable overlap in the clinical history questions independently developed by the General Practice and Rheumatology Consensus Studies, although differences in style were apparent and each panel had stronger consensus in certain areas than others (e.g. questions regarding patient treatment preferences from the General Practice Consensus Study).

The principal amendments made to the clinical history questions developed from Phase 1 during feasibility interviews were related to the difference in interview context (patient-initiated consultation vs researcher-initiated appointment; treating clinician as assessor vs impartial researcher as interviewer) and the need to establish consistent, quantifiable response options for the information provided by patients. Open-ended items on the history of the present complaint and previous episodes were put into a structured format.

Several existing sources of questions were used to introduce a clear form of phrasing [26, 27] or to cover areas previously regarded as under-represented in clinical assessment and not identified during Phase 1 [28, 29]. A simple measure of average pain intensity in the past week was introduced and scored by patients on an 11-point numerical rating scale [30]. Worst pain intensity in the past week was also scored on this scale. The World Health Organization's Functioning and Disablement Checklist for assessing mental health in primary care was adapted and used as a brief, quantitative, structured form of questioning for assessing knee-related disability [31].

Minor amendments included adding a specific time-scale for recall of symptoms, and modifying the phrasing of a small number of questions to reflect forms previously recommended (e.g. ideas, concerns and expectations were checked against existing recommendations for assessing psychosocial ‘yellow flags' in low-back pain [32, 33]). The amended version of the KNE-SCI was pre-piloted on a further five patients, resulting in minor modifications only.

The final KNE-SCI contains 74 questions. It includes questions on the history, onset and recent course of the complaint; nature, location and severity of current knee symptoms; impact of knee problem; past history of knee problems; family history; comorbidity; previous/current investigations and treatment; ideas, concerns and expectations (Appendix). It takes 20–45 min to conduct, and from preliminary testing, is comprehensible to patients, and forms a coherent clinical interview for research data collection.


    Discussion
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Appendix
 References
 
As a preliminary step to undertaking clinical epidemiological research of knee problems in older adults, we have developed a standardized clinical interview (KNE-SCI) from general practice and rheumatology perspectives. As our intention is not just to focus on diagnostic accuracy, the KNE-SCI also aimed to reflect information gathered in the clinical history in this setting that may be important for understanding the nature and severity of patients' complaints, estimating the likely clinical course, and guiding appropriate management.

The process of development by consensus, albeit amongst only a small sample of GPs and rheumatologists, was designed to provide a high degree of face validity. The considerable overlap between questions independently identified as important by GPs and by rheumatologists would suggest that this was achieved. In preliminary patient testing, the KNE-SCI was found to be feasible for research use. However, we acknowledge the limitations of our approach.

Translating the complex, flexible approach of clinical assessment practised by clinicians into the format of a standardized, quantitative research tool inevitably leads to simplification. The KNE-SCI cannot fully represent the interactive, often open-ended, nature of the clinical history as it is conducted in clinical practice. However, the potential validity and usefulness of a standardized, quantitative approach to the clinical history is evident from recent work undertaken in a secondary care setting. A newly developed computer-based, self-administered tool for gathering standardized clinical history information compared favourably with conventional history-taking by specialist orthopaedic surgeons [34]. Furthermore, selected clinical history variables were able to discriminate with a high degree of accuracy patients with intra-articular pathology requiring surgical evaluation from those with patellofemoral problems more suitable for physiotherapy [35].

Pilot studies are currently in progress to more thoroughly test the response options and feasibility of the KNE-SCI as well as formally investigating the inter- and intra-observer reliability and relationship to external data sources. The long-term aim of this work is to determine the relationship between such quantified clinical history information and the diagnosis, clinical course and provision of primary health care for older adults with knee problems, and to develop clinical assessment tools that are practicable in the routine clinical setting.


    Appendix
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Appendix
 References
 
The Knee Standardized Clinical Interview (KNE-SCI): developmental version
Do you get problems in one or both knees?

If both:

Which knee is worse?

Have you got any problems with other joints?*

Is this problem in your knee a new problem which has occurred for the first time in the last 12 months?

If no:

How long ago did you first start having problems with this knee?

Before this, had you ever had any other previous problems at all with this knee?

Had you had any previous injury to the knee that resulted in you having to visit your doctor or go to accident and emergency?

Did this problem start suddenly or did it come on gradually over time?

Did it start following an accident or injury?

If yes:

Did it swell less than 8 hours after injury?

Have you claimed for this?

If yes:

Is the claim settled?

In the last 6 months, has the problem been getting better, getting worse, or staying the same?

If worse:

Has it got worse suddenly or gradually over the last 6 months?

What makes the knee problem worse?

What makes the knee problem better?

Thinking about your current problem, is the knee painful now?

In the last month, on how many days has the knee been painful?

If currently in pain or >=1 pain day in last month:

Could you indicate on this diagram where your knee pain is?*

Where is the worst pain?

Does the pain go anywhere else?

How would you rate your pain at its worst in the last week? (0–10 NRS)*

How would you rate your pain on average in the last week? (0–10 NRS)1*

Do you get any sudden twinges or sharp pain that lasts just a few seconds?2

Does it hurt when you're resting?

Does it stop you getting off to sleep?

Does it wake you up at night?

Does it hurt when you use it?

Does it hurt when you go upstairs or downstairs?

If yes:

Which is worse?

Does your knee pain stop you getting out of the house?

Do you have difficulty moving the knee when you first get out of bed?3

If yes:

How long does it take to get it moving?

Do you have difficulty moving your knee after staying in one position too long?3

If yes:

How long does it take to get it moving?

Has your knee swollen at all in the last 6 months?

If yes:

Where is the swelling?

Is it always swollen or does it come and go?

If intermittent:

How often has it swollen in the last month?

Is it swollen now?

Does it ever swell up dramatically?

Does the knee feel as if it's going to give way?

If yes:

Has it actually given way in the last 6 months?

If yes:

How often has it given way in the last month?

Has the knee locked in the last 6 months?

Has the knee looked red in the last 6 months?

Thinking back over the past month, have you been limited in any of the following activities most of the time? (Looking after yourself—bathing, dressing, eating, looking after others, going to work, doing housework or household chores, social activities, doing things with the family, or hobbies)4*

Because of these problems during the past month, how many days were you unable to fully carry out your usual daily activities?4

Are there any things you've stopped doing altogether because of your knee problem?

Do you have difficulty getting up from a chair because of your knee?

Have you had any falls in the last month?

Do you use a stick or any other walking aid?

What job do you do?

If in work or recently retired:

What effect has the knee problem had on your work?*

Do (or did) your parents or brothers or sisters have any joint problems?

If yes:

What problems did they have?

What do you think has caused the problem with your knee?

I understand that you're not a doctor, but many people have their own idea about what the problem with their knee is. What do you think is the matter with your knee now?

Are you worried that the knee will cause problems in future with your work?

Do you think that your knee is going to get better, worse, or stay the same over the next 6 months?

Do you find yourself worrying in case your knee becomes progressively worse?5

When people have had pain for a long time they can get a bit downhearted. Are you demoralized or depressed about your knee problem?

Have you had any of the following tests or investigations for your knee? (Blood tests, X-rays of the knee, scans of the knee)*

If yes:

Were any of these done in the last year?

Have you seen a doctor at the hospital about your knee problem?

Have you ever had any operations to the knee?

Are you waiting for any appointments or treatments for this knee problem?

What are you trying at the moment?*

What have you tried in the past?*

Has anything worked well?*

Apart from your knee problem, are you feeling well generally?

What are your main health problems or other medical conditions at the moment?

What would you consider to be your two most important health problems at the moment?

Are you taking any other medications?

*Response card available as a prompt for interviewees.

1From Levinson et al. [28].

2From Farrell et al. [27].

3From Lineker et al. [26].

4From Memel et al. [29].

5From WHO Collaborating Centre for Research and Training for Mental Health [31].


    Acknowledgments
 
The KNE-SCI Study Group members are: Dr G. Carpenter, Moorlands Medical Centre; Dr V. Cooper, Waterhouses Surgery; Professor P. Croft, Primary Care Sciences Research Centre; Dr P. Dawes, Staffordshire Rheumatology Centre; Dr J. Greig, Moorlands Medical Centre; Dr A. Hassell, Staffordshire Rheumatology Centre; Dr E. Hay, Staffordshire Rheumatology Centre & Primary Care Sciences Research Centre; H. Lawton, Primary Care Sciences Research Centre; Dr J. Lee, Leek Health Centre; Dr G. Peat, Primary Care Sciences Research Centre; Dr M. Porcheret, John Kelso Practice & Primary Care Sciences Research Centre; Dr A. Rees, Stockwell Surgery; Dr M. Shadforth, Staffordshire Rheumatology Centre; Dr E. Thomas, Primary Care Sciences Research Centre.

The authors would like to express their thanks for the participation, comments and criticisms of Dr N. Arden, Dr J. Barnardo, Dr A. Bartlam, Dr T. Brammah, Dr A. Campbell, Dr S. Carruthers, Dr B. Cooper, Dr P. Creamer, Dr G. Davenport, Dr J. Davies, Dr M. Davis, Professor P. Dieppe, Professor M. Doherty, Dr D. Evans, Dr T. Frank, Dr R. Gadsby, Dr L. Goldman, Dr I. Griffiths, Dr J. Hickling, Dr J. Hill, Dr G. Hosie, Dr S. Humphery, Dr D. Lain, Dr F. McGregor Smith, Dr J. Marks, Dr H. Morrison, Dr J. Oxtoby, Dr A. Ralphs, Dr A. Rossall, Dr B. Scriven, Dr S. Somerville, Dr M. Stephenson, Dr D. Symmons, Dr P. Thompson, Dr P. Thorburn, Dr P. Turner. This research was supported by a Programme Grant from the Medical Research Council and NHS R&D funding to Staffordshire Moorlands Primary Care Research Consortium.


    Notes
 
Correspondence to: G. Peat, Primary Care Sciences Research Centre, Hornbeam Building, Keele University, Staffordshire ST5 5BG, UK. Back


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 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Appendix
 References
 

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Accepted 13 March 2002





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