BioMed CentralBMC Musculoskeletal Disorders ss Open AcceStudy protocol The Clinical Assessment Study of the Hand (CAS-HA): a prospective study of musculoskeletal hand problems in the general population Helen Myers*1, Elaine Nicholls1, June Handy1, George Peat1, Elaine Thomas1, Rachel Duncan1, Laurence Wood1, Michelle Marshall1, Catherine Tyson2, Elaine Hay1 and Krysia Dziedzic1 Address: 1Primary Care Musculoskeletal Research Centre, Keele University, Keele, Staffordshire, ST5 5BG, UK and 2North Staffordshire Combined Healthcare NHS Trust, Stoke-on-Trent, Staffordshire, ST2 8LD, UK Email: Helen Myers* - h.l.myers@cphc.keele.ac.uk; Elaine Nicholls - e.nicholls@cphc.keele.ac.uk; June Handy - j.e.handy@cphc.keele.ac.uk; George Peat - g.m.peat@cphc.keele.ac.uk; Elaine Thomas - e.thomas@cphc.keele.ac.uk; Rachel Duncan - r.c.duncan@cphc.keele.ac.uk; Laurence Wood - l.r.j.wood@cphc.keele.ac.uk; Michelle Marshall - m.marshall@cphc.keele.ac.uk; Catherine Tyson - CatherineA.Tyson@northstaffs.nhs.uk; Elaine Hay - e.m.hay@cphc.keele.ac.uk; Krysia Dziedzic - k.s.dziedzic@cphc.keele.ac.uk * Corresponding author Abstract Background: Pain in the hand affects an estimated 12–21% of the population, and at older ages the hand is one of the most common sites of pain and osteoarthritis. The association between symptomatic hand osteoarthritis and disability in everyday life has not been studied in detail, although there is evidence that older people with hand problems suffer significant pain and disability. Despite the high prevalence of hand problems and the limitations they cause in older adults, little attention has been paid to the hand by health planners and policy makers. We plan to conduct a prospective, population-based, observational cohort study designed in parallel with our previously reported cohort study of knee pain, to describe the course of musculoskeletal hand problems in older adults and investigate the relative merits of different approaches to classification and defining prognosis. Methods/Design: All adults aged 50 years and over registered with two general practices in North Staffordshire will be invited to take part in a two-stage postal survey. Respondents to the survey who indicate that they have experienced hand pain or problems within the previous 12 months will be invited to attend a research clinic for a detailed assessment. This will consist of clinical interview, hand assessment, screening test of lower limb function, digital photography, plain x-rays, anthropometric measurement and brief self-complete questionnaire. All consenting clinic attenders will be followed up by (i) general practice medical record review, (ii) repeat postal questionnaire at 18-months, and (iii) repeat postal questionnaire at 3 years. Discussion: This paper describes the protocol for the Clinical Assessment Study of the Hand (CAS-HA), a prospective, population-based, observational cohort study of community-dwelling older adults with hand pain and hand problems based in North Staffordshire. Published: 30 August 2007 BMC Musculoskeletal Disorders 2007, 8:85 doi:10.1186/1471-2474-8-85 Received: 25 July 2007 Accepted: 30 August 2007 This article is available from: http://www.biomedcentral.com/1471-2474/8/85 © 2007 Myers et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Page 1 of 9 (page number not for citation purposes) http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=17760988 http://www.biomedcentral.com/1471-2474/8/85 http://creativecommons.org/licenses/by/2.0 http://www.biomedcentral.com/ http://www.biomedcentral.com/info/about/charter/ BMC Musculoskeletal Disorders 2007, 8:85 http://www.biomedcentral.com/1471-2474/8/85 Background Musculoskeletal diseases have a major impact on the health of the population [1]. In adults aged 50 years and over osteoarthritis (OA) is the cause of the majority of musculoskeletal pain and disability [2]. Although the pro- jected increase in the proportion of older people in the population has propelled OA up the agenda of health planners and policy makers, the main focus of attention has been on lower limb OA. Less attention has been given to the hand, despite the fact that the prevalence of hand pain in the general population has been estimated between 12% and 21% [3-5] and at older ages the hand is one of the most common sites of pain and OA [6]. The relationship between symptomatic hand OA and disabil- ity in everyday life has not been studied in detail [7], and although there is some evidence that older people with hand problems suffer significant pain and disability [8] and psychological and emotional distress as a result of functional limitation [9], little is known about the specific ways in which these problems interfere with daily life, or how their impact varies with age, gender and pain sever- ity. Although older people with hand problems view OA as a serious condition, the majority do not consult their general practitioner with their hand problem over the course of a year, even when severely affected [8]. Defining hand OA for epidemiological research and in clinical practice is problematic. Clinical criteria [10] and radiographic grading [11] for the classification of hand OA have been developed to establish uniformity in the reporting of this disease. However, population studies have shown that symptoms are only present in a minority of those with radiographic changes [12], suggesting that the clinical syndrome and the structural disease of OA appear to be separate, albeit related, entities. Conse- quently, it is doubtful whether the "true" prevalence of symptomatic hand OA can be captured from clinical or radiographic studies alone [10]. In North Staffordshire a programme of research into oste- oarthritis in primary care is being undertaken. The pro- gramme comprises a series of linked studies designed to establish the optimal management of osteoarthritis in older adults in primary care. The clinical assessment stud- ies are part of this programme and are prospective cohort studies whose main objective is to provide population- based evidence that will indicate the most useful way of assessing older adults with hand pain and problems and knee pain in primary care. The studies will provide pri- mary care practitioners with a description of the popula- tion of older adults with hand pain and problems and knee pain in clinically meaningful terms i.e. using simple clinical history and examination techniques. Addition- ally, they should help to determine if clinical classification of musculoskeletal hand and knee conditions is useful at the population level and what simple questions and assessment tools identify important groups, both cross- sectionally and longitudinally. The aim of this paper is to outline the protocol for the Clinical Assessment Study of the Hand (CAS-HA). The protocol for the Clinical Assess- ment Study (Knee) (CAS(K)) has been reported previ- ously [13]. Cross sectional study The general aim of the cross sectional component of the CAS-HA is to provide population-based evidence that will indicate the most useful way of assessing older adults with hand pain or hand problems in primary care. Addition- ally, we aim to identify clinical, functional and radio- graphic sub-groups within the study population. Specifically our study will consider the following ques- tions: • What is the prevalence of clinical signs and symptoms? How does this relate to hand function? • What is the prevalence of 'red flags' indicative of possi- ble serious joint pathology? • In what respect do consulters and non-consulters differ at baseline? • Can simple signs and symptoms accurately identify older adults with radiographic hand OA? • What is the relationship between symptomatic hand OA and soft tissue syndromes e.g. carpal tunnel syndrome? Longitudinal study Accurate information on the likely course of hand pain and problems in this population will play an important role in deciding how best to manage these problems and may possibly help to inform preventative measures in the future. To address this we intend to establish a cohort at baseline that will be followed up at 18-month intervals (subject to further funding and ethical approval). The study is designed in accordance with previously published requirements for reporting longitudinal studies in rheu- matology [14,15]. The general aim of the longitudinal component of the CAS-HA is to determine the course of hand pain and problems over time. Specifically, our study will address the following questions: • How common is deterioration in terms of hand pain, hand problems and functional limitation? Can this be predicted? • Does radiographic OA predict change in severity and characteristics of symptomatic hand OA? Page 2 of 9 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:85 http://www.biomedcentral.com/1471-2474/8/85 • What proportion of this sample consult their general practitioner for hand pain or problems within the follow- up period? Can this be predicted by information collected at baseline? • What is the relative contribution of clinical history, hand assessment, digital imaging, x-rays and lower limb func- tion as prognostic markers? Methods/Design A population-based prospective observational cohort study of hand pain and problems in older people (50 years and over) has been designed in parallel to our previ- ously reported cohort study of knee pain in older people [13]. The hand cohort study will be conducted in 5 phases with a sample of people, aged 50 years and over, regis- tered with two local general practices (Figure 1). Ethical approval for CAS-HA baseline and 18-month follow up has been obtained from the North Staffordshire Local Research Ethics Committee. Ethical approval for 3-year follow up has been obtained from the Hereford and Worcester Local Research Ethics Committee. Phase 1: Baseline two-stage mailed survey Phase 2: Baseline clinical assessment study of the hand (CAS-HA) Phase 3: Eighteen month prospective review of general practice medical records Phase 4: Follow-up mailed survey at 18 months Phase 5: Follow-up mailed survey at 3 years Phase 1: Baseline two-stage mailed survey Full details of Phase 1 design and methods have been pre- viously reported [16]. Briefly, Phase 1 consists of a Health Survey questionnaire that will be mailed to all adults aged 50 years and over registered with the two participating practices. Respondents who provide written consent to further contact and who report pain or problems (e.g. stiffness or knobbly swellings) in the hands, or pain in the hips, knees or feet will be sent a second questionnaire (the Regional Pains Survey questionnaire). These two ques- tionnaires include measures of general health status, socio-demographic characteristics, psychological and life- style variables, and pain and disability (general and site specific). Hand specific questions are provided in Table 1. Non-responders to each questionnaire will be sent a reminder postcard at two weeks and, for those who do not respond to the postcard, a repeat questionnaire at 4 weeks. Phase 2: Baseline clinical assessment study of the hand (CAS-HA) Respondents to the Regional Pains Survey questionnaire who report experiencing hand pain or problems within the last 12 months and who provide written consent to further contact will be sent a letter of invitation to the CAS-HA research clinic and an information sheet outlin- ing the study. The process of recruiting participants and the practical organisation and running of the CAS-HA research clinic will follow the same procedures as those reported previously for CAS(K) [13]. Briefly, participants will be offered an appointment to attend the research clinic where they will be assessed by a trained research therapist after giving written, informed consent. Research clinics will be held at a local National Health Service Trust Hospital and will offer a maximum of 16 appointments per week. Participants will undertake the following standardised assessment: digital photography of the hands, clinical interview and hand assessment, lower extremity function test, brief self-complete questionnaire, plain radiography of the hands and knees, and simple anthropometric meas- urement. Digital photography of the hands Each participant will have four photographs taken of their hands by an assessor using a digital camera (Olympus Camedia C-4040 ZOOM: resolution 2272 × 1704 pixels) attached to a copy stand. The dorsal and palmar aspects of both hands, including the wrists, will be photographed. Photographs will be taken according to pre-defined writ- ten protocols that include standard positioning of partici- pants. Clinical interview and hand assessment Participants will be interviewed and examined by a trained assessor blinded to the findings from radiography and digital photography. The proposed content of the interview and assessment is provided in Table 2. Briefly, this procedure will comprise two components. Firstly, participants will be screened to identify possible red flags indicative of potentially serious pathology, namely recent trauma to the hands likely to have resulted in significant tissue damage, and acutely swollen, painful hands or knees. Secondly, a structured, standardised clinical inter- view and hand assessment developed and piloted for the study will be conducted [17,18]. For assessments requir- ing instrumented measures, equipment will be calibrated prior to the start of the study. Lower extremity function The Short Physical Performance Battery (SPPB) [19] will be conducted in all participants. This includes a standing balance test, a timed repeated chair stand test (5 repeti- Page 3 of 9 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:85 http://www.biomedcentral.com/1471-2474/8/85 Page 4 of 9 (page number not for citation purposes) Flowchart of study proceduresFigure 1 Flowchart of study procedures. Data collection points are in shaded boxes. BMC Musculoskeletal Disorders 2007, 8:85 http://www.biomedcentral.com/1471-2474/8/85 tions) and a 4-metre gait speed test. The conduct and scor- ing of the SPPB will be as recommended on the training CD-ROM (Guralnik, personal communication). Brief self-complete questionnaire During the clinic visit, participants will complete a brief self-complete questionnaire containing questions relating to their hand problem (Table 2). Questions relating to knee problems will also be asked – days of pain, aching or stiffness in previous month, days in pain in the previous 6 months [20], episode duration [21], the Chronic Pain Grade [22] and symptom satisfaction (adapted from [23]). Radiography and anthropometric measurement Radiography of both hands and knees will be obtained for all participants. Plain radiographs of each hand will be taken (1 hand per film). A posteroanterior (PA) view will be taken, where the palmar aspect of the hand will be placed on the film with the fingers extended, separated slightly and spaced evenly (Buckland-Wright, personal communication). Imaging of the tibiofemoral joint of the knee will be undertaken using weight-bearing semiflexed (MTP) posteroanterior (PA) view according to a defined protocol [24]. The patellofemoral joint of the knee will be imaged with the lateral and skyline view, both in a recum- bent position with the knee flexed to 45°. Weight (kgs) and height (cms) of each participant will be measured using digital scales (Seca Ltd., Birmingham, UK) and a wall mounted height meter (Holtain Ltd., Crymych, UK) respectively. Table 1: Hand specific data to be collected at baseline (Regional Pains Survey Questionnaire) Concept Measurement method Details Characteristic of complaint Hand dominance right, left, both Duration of hand problem years/months Hand problem in past 12 months*§ yes, no Hand pain in past 12 months*§ yes, no Side of pain in past 12 months*§ right, left, both Duration of pain in past 12 months*§ < 7 days, 1–4 weeks, 1–3 months, 3+months Most problematic hand*§ right, left, both Hand pain, symptoms and physical features AIMS 2*§ [30] pain sub-scale AUSCAN*§ [34] pain and stiffness sub-scales In past month, severity of stiffness, aching, tenderness, weakness, clumsiness, burning, tingling, numbness *§ severe, moderate, mild, very mild, none In past month, days of joint warmth, dropping objects, frustration *§ all, most, some, few, no Hand pain lasting ≥ 1 day in past month*§‡ yes, no Painful areas in last month: hand drawings [31]*§ shaded areas Nodes: hand drawings*§ [32] circled joints Aesthetics Michigan Hand Outcomes Questionnaire§ [33] appearance sub-scale Function AIMS 2*§‡ [30] hand and finger function sub-scale AIMS 2§ [30] arm function sub-scale AUSCAN*§ [34] physical function sub-scale Difficulty with usual activities: pick up coins, hold book, clench fist, self-care, open packets no, mild, moderate, severe, unable to do Illness perceptions Illness Perceptions Questionnaire Revised (IPQ- R) [35] 9 dimensions: illness coherence, treatment control, personal control, timeline (acute/ chronic), timeline (cyclical), consequences, emotional representation, identity, causes Health care related to hand problem AIMS 2*§ [30] medication sub-scale Hand injuries ... ever yes, no: right, left, both Hand operations ... ever yes, no: right, left, both Consulted GP in past 12 months§ yes, no NHS and private services used in past 12 months§ (adapted from [36]) yes, no to physiotherapy, occupational therapy, hospital specialist, acupuncture, osteopath/ chiropractor, drugs on prescription, hand operation, hand injection, other Occupational impact Excessive use of hands in occupation yes, no Pastimes and hobbies Excessive use of hands in pastimes and hobbies yes, no Impact of symptoms AIMS 2*§ [30] impact subscale *Also gathered at 18 months; § Also gathered at 3 years; ‡ Minimum data to be sought at 18 months and 3 years from non-responders Page 5 of 9 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:85 http://www.biomedcentral.com/1471-2474/8/85 Page 6 of 9 (page number not for citation purposes) Table 2: Hand specific data to be collected during clinical assessment (CAS-HA) Concept Measurement method Details Clinical Interview Questions: Characteristic of complaint Duration of hand problem < 12 months, 1-<5 years, 5-<10 years, 10 years + Onset: sudden, gradual yes, no, for right and left hands Onset: following accident or injury yes, no, for right and left hands Hand pain and hand symptoms Pain/tenderness in past month yes, no Hand pain descriptors from McGill Pain Questionnaire§ [37] 15 descriptors Pain location: hand drawing shading both hands front and back Pain present all the time yes, no Pain related to sleep disturbance yes, no Pain limits activity yes, no Hand stiffness in past month yes, no Side of stiffness right, left, both Hand stiffness on waking in past month yes, no Duration of morning stiffness ≤ 30 mins, 30+ mins Finger locking, triggering yes, no Release of locking yes, no Altered sensation (pins + needles, tingling, numbness) in past month yes, no Altered sensation location: hand drawing shading both hands front and back Altered sensation worse at night yes, no Occupational impact Stop work due to hand problem yes, no Absence from work due to hand problem yes, no Management/self-help Adaptation: gadgets, help, avoidance, change method, stop/reduce activity, take longer, other yes, no 17 treatments/self-help activities tried recently yes, no Any treatments effective yes, no Family history of joint problems Relatives with joint problems: father, mother, brother, sister yes, no Hand involvement yes, no Diagnostic and causal attributions Open-ended questions free text Health problems Open-ended question: 2 most important health problems free text Hand Assessment (right and left hands): Upper limb screen 9 movements (adapted from [38]) yes, no, unable to assess Observation/Palpation Swelling, nodes, bony enlargement, deformity at selected joints yes, no Thenar muscle wasting yes, no Dupuytren's yes, no Measurement Thumb opposition [39] yes, no, for 10 positions Thumb extension degrees Wrist extension degrees Wrist flexion degrees Tests Phalen's [40,41] positive, negative, unable to assess Grind [42,43] positive, negative, unable to assess Finklestein's [42,44] positive, negative, unable to assess Hand function Grip Ability Test [45] timed (seconds) Power grip (JAMAR dynomometer) [46] lbs Pinch grip (B&L pinch gauge) [46] lbs Brief self-complete questionnaire: Hand pain and hand symptoms Days of hand pain, ache or stiffness in past month*§ [10] all, most, some, few, no Severity of hand pain in past month*§ numerical rating scale (0–10) Thumb pain during activity in past month*§ yes, no Swelling in hands in past month yes, no Impact of symptoms Severity of overall hand problems in past month*§ none, very mild, mild, moderate, severe Bothersomeness of hand problem in past 2 weeks*§ (adapted from [47]) not at all, slightly, moderately, very much, extremely Symptom satisfaction*§ (adapted from [23]) 5-point Likert scale: very dissatisfied to very satisfied *Also gathered at 18 months; § Also gathered at 3 years; ‡ Minimum data to be sought at 18 months and 3 years from non-responders BMC Musculoskeletal Disorders 2007, 8:85 http://www.biomedcentral.com/1471-2474/8/85 Post-clinic procedure The practical organisation, administration and communi- cation post-clinic will be identical to that described by Peat et al [13], but with emphasis on the hand rather than the knee. A trained observer with a background in diag- nostic radiography will score the hand radiographs. Standardised coding of radiographic features using the Kellgren and Lawrence [11] grading system will be com- pleted for sixteen joints in each hand and wrist, the distal interphalangeal joints (DIP), the proximal interphalan- geal joints (PIP), the interphalangeal joint of the thumb (IP), the metacarpophalangeal joints (MCP), the thumb carpometacarpal joint (CMC) and the trapezioscaphoid joint (TS). Knee films will be scored for individual radio- graphic features, including osteophytes, joint space nar- rowing, sclerosis and subluxation. The Altman Atlas [25] and scoring system [26] are to be used for the PA and sky- line views and the Burnett Atlas [27] for the lateral view. Additionally, PA and skyline views will be assigned a Kel- lgren and Lawrence grade [11]. Quality assurance and quality control Quality assurance and control are important in longitudi- nal studies especially when using observers to gather data [28]. In the current study, the clinical interview, hand assessment, lower limb screen, and the taking and scoring of radiographs will be subject to a number of quality assurance and control procedures. The study protocol and inter- and intra-assessor reliability of the clinical interview and hand assessment have been formally tested in a pilot study [18]. Reliability studies investigating inter- and intra-observer reproducibility will be conducted for the scoring of radiographs. All assessors will receive training using the study protocols prior to the commencement of data collection. Assessors will practice interviews and assessments using the proto- cols with healthy volunteers and expert participants. All radiographers participating in the study will also receive training prior to the start of the research clinics. A detailed assessor manual containing study protocols will be pro- vided to all members of the CAS-HA team for reference during the study period. A programme of quality control measures previously reported [13] will be implemented throughout the course of the study. Phase 3: Prospective review of general practice medical records All participants in Phase 1 who give written consent for their GP records to be accessed will have their computer- ised medical records tagged by a member of the Centre's Table 3: Hand specific data to be collected only at 18 months and 3 years Concept Measurement method Details Perceived change in hand problem since baseline Transition index [48]‡ completely recovered, much better, better, no change, worse, much worse Health care related to hand problem since baseline Hand injury yes, no Hand operation yes, no Consulted GP in past 18 months† yes, no NHS and private services used in past 18 months† (adapted from [36]) yes, no to physiotherapy, occupational therapy, hospital specialist, acupuncture, osteopath/ chiropractor, drugs on prescription, hand operation, hand injection, other Occupational impact since baseline Time off work yes, no Stopped work yes, no Hand pain and hand symptoms Days of hand swelling in past month all, most, some, few, no Days of hand pain in past 6 months^ [22] no, 1–30, 31–89, 90+ days Hand pain severity in past 6 months^ numerical rating scale (1–10) Coping strategies for hand pain Single-item Coping Strategies Questionnaire (CSQ) [49] numerical rating scale (0–7) with verbal anchors (never do that, always do that) Illness perceptions Shortened version adapted from IPQ-R [35] 6 dimensions: illness coherence, personal control, timeline (acute/chronic), timeline (cyclical), consequences, emotional representation Management/self-help 7 treatments/self-help activities tried in past month: simple painkiller; anti-inflammatory tablets; creams, gels, or rubs; glucosamine or chondroitin sulphate; warmth, heat; cold; hand exercises yes, no Narrative account Open-ended question: course of hand pain and problems‡ free text ‡ Minimum data to be sought at 18 months and 3 years from non-responders; †Data only gathered at 18 months; ^Data only gathered at 3 years Page 7 of 9 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:85 http://www.biomedcentral.com/1471-2474/8/85 Health Informatics team. The protocol for this phase of the study has been previously reported [13]. Phase 4 and 5: Follow-up mailed survey at 18 months and 3 years A follow-up survey will be mailed to all Phase 2 partici- pants 18 months and 3 years after their baseline clinical assessment. The focus of follow-up will be on clinical change in symptoms and function and possible determi- nants of this. The proposed content of these surveys is pro- vided in Tables 1, 2, 3. Primary outcome data will be sought from non-respondents by telephone or post. Par- ticipants who have moved practice during the follow-up period will be traced using the NHS tracing service and their new general practitioner will be asked for permission to include them in the follow-up. Sample size The sample size for this study was determined by the esti- mated numbers of participants needed in Phase 2 to ensure sufficient power for both cross-sectional and longi- tudinal analyses. A target sample of 500 was set. We esti- mate that 90% of follow-up questionnaires will be returned and that approximately 70 participants (12%) will report clinically significant deterioration over the 18- month period [29]. With this number of participants, we will have 80% power to detect a risk ratio of 1.6 or greater with a minimum 64% exposure rate (e.g. presence of radi- ographic OA) in those who have deteriorated, and a 50% exposure rate in those who do not, at 95% level of confi- dence. Statistical analysis Linking data collected at the clinical assessment with that from the 18-month and 3-year follow-up questionnaires, we will be able to determine prospectively the factors that are related to clinical deterioration using risk ratios and associated 95% confidence intervals. Discussion The Clinical Assessment Study of the Hand (CAS-HA) is a prospective, population-based, observational cohort study based in North Staffordshire that intends to investi- gate issues surrounding the classification and course of hand pain, problems and hand osteoarthritis in commu- nity-dwelling adults aged 50 years and over. This study will complement our previous study on knee pain in older people [13]. Abbreviations AIMS2, Arthritis Impact Measurement Scale 2; AUSCAN, AUStralian CANadian Osteoarthritis Hand Index; CAS- HA, Clinical Assessment Study of the Hand; CAS(K), Clin- ical Assessment Study of the Knee; CMC, carpometacar- pal; CSQ, Coping Strategies Questionnaire; DIP, distal interphalangeal; GP, General Practitioner; IP, inter- phalangeal; IPQ-R, Illness Perceptions Questionnaire Revised; MCP, metacarpophalangeal; MTP, metatar- sophalangeal; OA, Osteoarthritis; PA, posteroanterior; PIP, proximal interphalangeal; SPPB, Short Physical Per- formance Battery; TS, trapezioscaphoid. Competing interests The author(s) declare that they have no competing inter- ests. Authors' contributions All authors participated in the design of the study and drafting the manuscript. All authors read and approved the final manuscript. Acknowledgements This study is supported financially by a Programme Grant awarded by the Medical Research Council, UK (Grant Code: G9900220) and by Support for Science funding secured by North Staffordshire Primary Care Research Consortium for NHS service support costs. KD was supported by a grant from the Arthritis Research Campaign. The authors would like to thank the administrative and health informatics staff at Keele University's Primary Care Musculoskeletal Research Centre, especially Charlotte Clements, staff of the participating general practices and Haywood Hospital, especially Dr Jackie Saklatvala, Carole Jackson and the Radiographers at the Department of Radiography, and Carol Graham and Nikki Edwards at the Department of Occupational Therapy. The authors would like to thank the following for permission to use published measures at baseline: Prof N Bellamy (AUSCAN), Dr K Chung (Michigan Hand Outcomes Questionnaire), Prof M Doherty (finger nodes drawings), Prof R Meenan (AIMS2), Prof D Symmons (hand pain drawings), and Prof J Weinman (IPQ-R). The authors gratefully acknowledge the advice and per- mission to use the SPPB training CD-ROM from Dr Jack Guralnik. We also gratefully acknowledge the assistance of Prof Chris Buckland-Wright for advice and training for the x-ray protocols. References 1. Woolf AD, Pfleger B: Burden of major musculoskeletal condi- tions. Bull World Health Organ 2003, 81:646-656. 2. Zhang Y, Niu J, Kelly-Hayes M, Chaisson CE, Aliabadi P, Felson DT: Prevalence of symptomatic hand osteoarthritis and its impact on functional status among the elderly: The Framing- ham Study. Am J Epidemiol 2002, 156:1021-1027. 3. 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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=7473483 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=7473483 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=6715829 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=6715829 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=16103861 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=16103861 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=16103861 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=9804720 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=9804720 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=9804720 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=12927618 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=12927618 http://www.biomedcentral.com/1471-2474/8/85/prepub Abstract Background Methods/Design Discussion Background Cross sectional study Longitudinal study Methods/Design Phase 1: Baseline two-stage mailed survey Phase 2: Baseline clinical assessment study of the hand (CAS-HA) Digital photography of the hands Clinical interview and hand assessment Lower extremity function Brief self-complete questionnaire Radiography and anthropometric measurement Post-clinic procedure Quality assurance and quality control Phase 3: Prospective review of general practice medical records Phase 4 and 5: Follow-up mailed survey at 18 months and 3 years Sample size Statistical analysis Discussion Abbreviations Competing interests Authors' contributions Acknowledgements References Pre-publication history