Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial

Collaborative model of care between Orthopaedics and allied healthcare professionals in knee... Background: Knee Osteoarthritis (OA) is a leading cause of global disability. The Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT) Model of Care (MoC) was developed by optimizing evidence-based non-surgical treatments to deliver value-based care for people with knee OA. The primary aim of this study is to determine the clinical effectiveness of the CONNACT MoC (3 months) compared to usual care. The secondary aims are: a) To determine the cost-effectiveness and b) To develop an evaluation and implementation framework to inform large scale implementation for this MoC. Methodology: Type 1 Effectiveness-Implementation Hybrid Trial using an explanatory sequential mixed-method approach. The study consists of 3 components. The first component is the pragmatic, parallel-arm, single-blinded randomized control trial. Inclusion criteria are patients with knee OA based on the National Institute of Health and Care Excellence (NICE) criteria with radiographic severity of greater than Kellgren-Lawrence 1, and Knee Injury and OA Outcome Score (KOOS ) of equal or less than 75. Exclusion criteria include other forms of arthritis, history of previous knee arthroplasty or wheelchair-bound patient. KOOS is the primary outcome measure at 3 months, 6 months and 1 year. Secondary outcomes include KOOS individual subscales, quality of life scoring, functional performance, global, diet and psychological related outcomes. The second component is an economic evaluation of the cost-effectiveness of the CONNACT MoC using a societal perspective. The third component is an implementation and evaluation framework using process evaluation under the RE-AIM framework using a mixed- (Continued on next page) * Correspondence: btanyj@hotmail.com Department of Orthopaedic Surgery, Woodlands Health Campus, National Healthcare Group, Singapore, Singapore Singapore General Hospital, Singapore City, Singapore Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 2 of 13 (Continued from previous page) method approach. Sample size of 100 patients has been calculated. Discussion: CONNACT MoC is a complex intervention. In line with the MRC guidance for developing and evaluating complex interventions, a pilot feasibility study was completed and a comprehensive approach including an RCT, economic evaluation and process evaluation is described in this study protocol. Results from this study will help clinicians, healthcare administrators and policymakers guide the sustainable and effective implementation of the CONNACT MoC for knee OA and serve as a basis for similar multidisciplinary MoC for chronic degenerative musculoskeletal conditions to be developed. Trial registration: Clinicaltrials.gov Identifier: NCT03809975. Registered January 182,019. Keywords: Study protocol, Effectiveness-implementation hybrid, Mixed methods, Knee osteoarthritis, Model of care, Randomized control trial Background programs, the Collaborative Model of Care between The world is experiencing a rapidly aging population, Orthopaedics and Allied Healthcare Professionals and with it an age-related increase in chronic musculo- (CONNACT) Model of Care (MoC) of knee OA was de- skeletal (MSK) disorders. Based on the 2010 Global Bur- veloped. CONNACT is a community-based, multidiscip- den of Disease Study, MSK disorders account for the linary 12-week program that uniquely uses an largest cause of disability around the world and in par- individualized approach based on a triaging criterion to ticular, osteoarthritis (OA) was ranked the 11th highest tailor the treatment to each patient in line with the global cause [1]. International guidelines are consistent “right care, delivered at the right time, by the right team, in their treatment recommendations for knee OA with in the right place, with the right resources” philosophy individualized lifestyle changes, especially exercise and coupled with a strong emphasis on patient activation weight loss programs, highlighted as first-line manage- and self-management strategies to promote long term ment [2, 3]. A stepwise approach is recommended where sustainable behavioural change. surgery is considered when non-surgical treatment fails. The Medical Research Council (MRC) Guidance on Despite all this, studies report that more than half of the developing and evaluation such complex interventions patients from established healthcare systems around the was utilized in the CONNACT development, evaluation world such as Australia and Canada are not receiving and eventual planned implementation [12]. A feasibility optimal non-surgical treatment [4–6]. study using a pilot randomized trial design was con- Surgery is often a result not from a failure of non- ducted to determine the feasibility of a full randomized surgical treatment but the failure of the healthcare sys- controlled trial (RCT) evaluating the CONNACT MoC tem to provide adequate and effective non-surgical treat- as the first step [13]. Results from the feasibility study ment. With knee arthroplasty rates expected to rise were instrumental in the design of this study protocol. rapidly [7], the literature suggests that at least a quarter of knee arthroplasties could have been avoided through Aim optimal non-surgical treatments [8]. While knee arthro- The primary aim of the study is to evaluate the clinical plasty surgery is an effective option for knee OA, it effectiveness (pain, function, quality of life) of the CON- should be applied only when all non-surgical treatment NACT MoC as compared with usual care in patients options have been exhausted as it is costly and not with- with knee OA. out risks and complications [9]. The secondary aims are to: There is an urgent need for new models of care (MoC) for knee OA developed by optimizing evidence-based 1. Evaluate the cost-effectiveness of the CONNACT non-surgical treatments to deliver value-based care. MoC for patients with knee OA There has been a paradigm shift globally, moving from 2. Develop an implementation and evaluation an acute episodic type treatment that was generally asso- framework to inform large scale implementation of ciated with OA to a chronic disease MoC [10]. Over the CONNACT MoC past decade, several models of care from around the world have been developed including the Good Life with We hypothesize that patients with knee OA who OA in Denmark (GLA:D) program and the OA Chronic undergo the CONNACT program will have better pain, Care Program (OACCP) program from Australia [11]. function and quality of life scores 12 months after Building from the well-established principles of these Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 3 of 13 initiating the program compared to patients who Participants undergo usual care. We will recruit patients based on the inclusion and ex- clusion criteria outlined in Table 1. Methodology Components of the CONNACT study Design The study is an Effectiveness-Implementation Hybrid 1. Randomized Controlled Trial Trial which combines both an effectiveness and imple- 2. Economic evaluation mentation component [14, 15]. It has been increasingly 3. Implementation and Evaluation Framework recognized that implementation is the main challenge in many models of care. An implementation gap, also COMPONENT 1: randomized controlled trial known as the “valley of death” exists between what Trial procedure current literature recommendation and translation to ac- The overall flow for the RCT is outlined in Fig. 1 based tual clinical practice [16]. Knee OA is a clear situation on the CONSORT guidelines. Patients who are referred where this “valley of death” has happened. As a result, by a primary healthcare or emergency medicine doctor there has been a greater emphasis on incorporation of to the Outpatient clinic at the Department of Ortho- an implementation element in studies to enhance dis- paedic Surgery at Tan Tock Seng Hospital, a tertiary re- semination with hybrid trials increasingly being con- ferral centre in Singapore with a suspected diagnosis of ducted [17]. knee OA will be screened based on the inclusion and ex- This will be a type 1 hybrid trial where the emphasis clusion criteria presented in Table 1. All referral letters and primary aim is to evaluate effectiveness through a are screened based on electronic medical records. pragmatic randomized trial under real-world conditions Patients who are eligible based on initial screening are and its secondary aim is to understand the context of invited to attend a recruitment clinic where they will be implementation through a mixed-method, process orien- assessed by the study team and invited to participate in tated approach. The pragmatic nature of the study was the study if they meet all the inclusion and exclusion cri- guided by the Pragmatic Explanatory Continuum Indica- teria. Informed written consent will be obtained. Patients tor Summary (PRECIS-2) tool [18]. will be randomized into the intervention or usual care The study will be conducted as a single centre prag- arm after collection of baseline data. Recruitment clinics matic, parallel-arm, single-blinded RCT using a mixed- will be carried out at the Tan Tock Seng Hospital Spe- method approach comparing the CONNACT multidis- cialist Outpatient Clinic. ciplinary personalized community-based MoC and the current MoC. The Standard Protocol Items: Recommen- Randomization and concealment of allocation dations for Interventional Trials (SPIRIT) [19] model Patients who consent to participate will be randomized (Additional file 5) and the OA Research Society Inter- (1:1 allocation ratio) between the intervention and usual national (OARSI) clinical trial recommendation on the care using a stratified permuted block randomization design and conduct of clinical trials for knee OA [20] method using block sizes of 4,6 and 8. Stratification is guided the development and reporting of the trial proto- based on gender to ensure equal distribution in both col. The findings of the trial will be reported according groups. The allocation sequence is generated by an inde- to the Consolidated Standards of Reporting Trials pendent statistician a priori and will be kept concealed (CONSORT) 2010 [21] guidelines for reporting parallel from the study team. Randomization will be done using group randomized trials. The study will utilize an ex- the REDCap randomization module based on the alloca- planatory sequential mixed methods design where the tion sequence and allocation will be locked once qualitative data through the use of surveys and inter- assigned. Randomization and intervention allocation will views will be used to interpret and provide context for only be performed by the study team after the patient is the quantitative results. counselled fully about the study and provides informed consent. Ethics approval Intervention – CONNACT model of care Ethics approval has been obtained from the Institution The development and core principles of the CONNACT Review Board (IRB) prior to the conduct of the study MoC has been described as part of the pilot study [25]. (NHG DSRB Ref: 2018/00408). Any protocol modifica- Grounded from a throughout literature search on the tion will be communicated to IRB in a timely manner. best practices in knee OA care [3, 26], a review of suc- Random audits will be performed by the IRB. cessful programs [11], international collaborations and the process evaluation patient interviews from the pilot Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 4 of 13 Table 1 Inclusion and Exclusion Criteria Inclusion Criteria (all 4 must be present) Exclusion Criteria National Institute of Health and Care Excellence (NICE) clinical criteria for knee Alternative diagnosis to knee OA e.g. referred pain from the spine OA [22] Age ≥ 45 years old and Has activity related knee pain and Has either or hip no morning knee-related stiffness or morning stiffness than last no longer than 30 min Radiographic severity of knee OA, Kellgren-Lawrence Score [23] > 1 Other forms of arthritis e.g. inflammatory, post-traumatic Knee Injury and OA Outcome Score [24] (KOOS )* ≤ 75 Inability to comply with study protocol e.g. cognitive impairment Community ambulator with or without walking aid Previous knee arthroplasty Wheelchair-bound patients Medical conditions that will medically interfere with study involvement e.g. decompensated heart failure, stroke, end-stage renal failure * KOOS is a composite score of the mean of four of the five subscale scores from the Knee Injury and OA Outcome Score (symptoms, pain, function from daily living and quality of life) Fig. 1 Randomized Control Trial Structure Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 5 of 13 study has allowed the CONNACT MoC to be further re- not interfere) to ‘10’ (completely interferes) scale. fined and contextualized. Provisional benchmarks have been set to identify clinic- The CONNACT MoC consists of a 12-week commu- ally meaningful improvements that can help differentiate nity based, individualized, multidisciplinary intervention between treatment “responders” and “non-responders” for knee OA. In summary, the core principles are firstly at the start of a clinical trial [41] Suggestions that symp- a chronic disease multidisciplinary model emphasizing tom reduction of 30% or more indicating moderately im- self-management and long term sustainable behavioural portant improvements and symptom reduction of 50% change, secondly, care stratification using a triage criter- or more considered “substantial improvements”. Taking ion and thirdly, implemented through a grounded reference from these guidelines, a cut-off score of “5” in- community-based setting. dicating moderate symptoms for pain, physical function- Table 2 outlines the intervention summary, including ing was used to decide for psychological intervention. each component, triaging criterion, intervention princi- The Patient Health Questionnaire-4 (PHQ-4) [35]isa ples and delivery. A full description of the intervention brief 4-item screening assessment of depression and in accordance with TIDieR [27] and CERT [28] report- anxiety symptoms. With anxiety known to exert an inde- ing guidelines is available in the Additional file 1. Fur- pendent effect on functioning separate from depression, ther rationale and details for the triaging criterion and screening for both depression and anxiety has been the self-management philosophy underpinning the thought to be necessary [42]. The first 2 items from the CONNACT MoC are elaborated below. PHQ-4 are taken from the original 9 item Patient Health Questionnaire (PHQ-9) and the next 2 items taken from Triaging criteria development the first 2-items on the General Anxiety Disorder The 3 measures that were chosen for psychological (GAD-7) questionnaire. The PHQ-4, therefore, forming intervention triaging criteria were Patient Health a composite score of depression and anxiety. Responses Questionnaire-4 (PHQ-4) [35], and Pain Intensity, En- on all 4 items are scored as “0” (not at all), “1” (several joyment of life and General Activity (PEG) [36] and Pa- day”, “2″ (more than half the days) and “3″ (nearly every tient Activated Measure (PAM) [37]. day). A score of more than 5 indicates at least a moder- PHQ-4 and PEG were chosen in light of the significant ate psychological distress from depression and/or anxiety impact of psychological conditions (anxiety, depression) and thus was used as cut off for psychological and pain intensity and interference in predicting out- intervention. comes in OA patients [38, 39]. The Pain Intensity, En- Patient activation is defined as an individual’s propen- joyment of life and General Activity (PEG) [36]isa sity to engage in adaptive health behaviour that may lead brief, 3-item assessment of pain intensity (1item) and to improved outcomes. Activation levels are measured pain interference (2 items) derived from the Brief Pain by the Patient Activated Measure (PAM) [37], a vali- Inventory (BPI) [40]. The PEG measures pain intensity dated questionnaire that looks at knowledge, skills and on a numerical rating scale of ‘0’ (no pain) to ‘10’ (pain confidence in managing health. Through the PAM score, as bad as you can imagine) and pain interference with patients can subsequently put into 4 groups, level 1 general activity and enjoyment of life also on a ‘0’ (does (poorly activated) to level 4 (highly activated). There has Table 2 Intervention Summary Intervention Criteria to receive Healthcare Professional Treatment Principles Delivery Format Component intervention Exercise Therapy All patients Physiotherapist American College of Sports Medicine Group sessions × 8 (ACSM) [29] and Neuromuscular Exercise (NEMEX) [30] guidelines Clinical Assessment All patients Orthopaedic Surgeon Clinical and Radiological Assessment Group Education and Education Psychologist Social Pharmacological Intervention “Expert” sessions × 2 Support Worker Patients Group session x 1 Dietetics and Nutrition BMI > 23.5 Dietician Dietary intervention to increase Group sessions × 3 dietary-related nutrition knowledge and self-efficacy for effective weight loss [31] Psychological support PHQ-4 > 5 or PEG Psychologist Social Acceptance and Commitment Group sessions × 3 > 4 on all scales Worker Therapy (ACT) principles [32, 33] or PAM < 3 Patient Activation [34] Pain Management Coping Strategies and improving compliance to behavioural modifications Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 6 of 13 been increasing evidence in the literature that PAM as a role model for patients. “Expert patients” been suc- scores are modifiable through targeted intervention and cessfully incorporated in other knee OA programs be- that high PAM scores have been associated with more fore [30]. satisfaction with healthcare services, better self- management behaviour and improved health outcome Usual care [43, 44]. As such, PAM levels of 1 and 2 were chosen as Usual care constitutes a referral to the outpatient a triaging criterion for targeted psychological interven- physiotherapist at the tertiary hospital where patients tion in an effort to boost activation levels. are usually seen 1–2 weeks post referral. The physiother- Body Mass Index will be used as a triaging criterion apist would conduct an assessment and recommend a for dietetic intervention. A lower cut off of BMI 23.5 has variety of lifestyle modifications and exercise therapy. been recommended for Asians [45] and will be used as a The type of exercises and number of physiotherapy ses- cut-off. sions were at the discretion of the patient and the physiotherapist. Self-management philosophy Self-management is a key foundation for the CON- NACT MoC. This will be achieved through several Outcome assessment and blinding methods. Firstly, through the program content. The edu- Outcome measures will be measured by blinded out- cation and psychology classes grounded in the principles come assessors. The outcome assessors will be either and psychological model of Acceptance and Commit- physiotherapy interns or research assistants. All outcome ment Therapy (ACT) [32, 33] and Patient Activation assessors will receive training prior to study initiation to [34] strategies which have been shown to the effective. ensure good inter- and intra-observer reliability, particu- In particular, there has already been evidence to show larly for the functional performance testing. Patients will the effectiveness of ACT in the local chronic pain popu- be instructed not to reveal their allocation to the out- lation in Singapore [46]. come assessors. Outcome assessment will be conducted Secondly, through the program delivery format. The either at the community rehabilitation facility or tertiary program’s duration of 12 weeks is based on current evi- hospital setting. Choice of outcome assessment location dence of the time taken for a habit to form [47]. The will be carefully monitored to ensure that outcomes as- program is structured as a weekly class with a gap of 3 sessors were not able to deduce the treatment arm. weeks between week 8 and week 12 factored in to allow patients the opportunity to incorporate these behav- Outcomes ioural modifications as part of their daily routine before The choice of outcome measures is based on the OARSI returning for the final session on week 12. In addition, guidelines for lifestyle diet and exercise clinical trials in after each session, patients will be given “homework” OA [50]. The recommended core outcomes are pain, and exercises to perform at home and are reviewed at physical function, global patient assessment and mobil- the next class. This combination of class-based and ity. Additional outcomes include health-related quality home-based individual treatment has been shown to be of life and global physician assessment. The outcome effective in knee OA [48]. In addition, group or class- measures will be collected at baseline, 3, 6 and 12 based interventions have also been shown to be more ef- months. Table 3 summarizes all the outcome measures fective compared to pure individual interventions in pro- and Additional file 4 outlines the different data collec- moting physical activity through cohesion and peer tion steps based on the SPIRIT guidelines. support [49]. A flexible post-intervention program will be available for patients who would like to continue to exercise together in a group and social network plat- Baseline measures forms e.g. Whatsapp group chats or Facebook groups The following baseline measures will be collected. will also be utilized to facilitate patient group interaction throughout and post-intervention. In addition, a support 1. Demographic – age, gender, race group session 3 months after program completion will 2. Socioeconomic status – education level, housing be arranged for reinforcement for key concepts and con- status, employment details tinued promotion of group interaction. 3. Co-morbidities and functional status – Charlson Thirdly, through the use of “expert patients”. These comorbidity index [58], Barthel Index for Activities “expert patients” are patients who have previously com- of Daily Living [59], Parker Mobility Score [60] pleted and benefitted from the CONNACT program. 4. Knee symptoms and duration They will be invited to volunteer and share their experi- 5. Radiographic severity of knee OA based on the ences and advice as part of the education class to serve Kellgren Lawrence Scale [23] Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 7 of 13 Table 3 Outcome Measures Overview Effectiveness Measures Compliance and Adherence Measures Physical Function Dietetics Psychology General KOOS Body Mass Index (BMI) Patient Health Questionnaire Quality of Life EQ-5D [51] Appointment default rate 4 (PHQ-4) [35] KOOS individual subscales Semi-Quantitative Food Patient Activation Measure Global Perceived Effect Exercise Adherence Frequency Questionnaire (PAM) [37] (GPE) [53] Questionnaire (FFQ) [52] Functional Performance Pain, Enjoyment, General Patient Acceptable Sports Injury Rehabilitation 1. Timed up-and-go Activity Scale (PEG) [36] Symptom Score (PASS) [54] Adherence Scale (SIRAS) [55] 2. 4 × 10 m face paced walk test 3. 4-stair climb test 4. 30s chair stand UCLA activity score [56] Analgesia Consumption [57] Adverse events Primary outcome in dietary habits. Modification to the original Food Fre- The primary outcome measure will be the mean of four quency Questionnaire (FFQ) was performed to reduce of the five subscale scores from the Knee Injury and OA the length and thereby responder burden and adapt it Outcome Score (KOOS ). KOOS contains 5 domains of based on local dietary practices. Scoring was developed questions, namely symptoms, pain, function (daily liv- by weighting fat/sugar/fibre content of the particular ing), function (sports, recreational activities) and quality food item based on the energy and nutrient composition of life [24]. Consistent with other studies with a similar reported by the Singapore Health Promotion Board population of elderly patients with knee OA, the func- (http://focus.hpb.gov.sg/eservices/ENCF/). Modified FFQ tion (sports, recreational activities) subscale were will only be done for patients who have a BMI > 23.5. deemed to be less relevant for this population and the remaining 4 domains were combined to form a compos- Psychological outcomes ite score [61]. The KOOS score has previously been vali- The Pain Interference Scale (Pain intensity (P), interfer- dated in Singapore [62]. ence with enjoyment of life (E), interference with general activity (G))(PEG) [36] is a 3 item scale developed and Secondary outcomes validated from the Brief Pain Inventory(BPI) for chronic The secondary outcomes have been classified into effect- pain measurement, particularly in chronic musculoskel- iveness and compliance outcomes. The effectiveness etal patients. The Patient Health Questionnaire-4 (PHQ- measures have been further subdivided based which as- 4) [35] is a validated questionnaire that allows measure- pect of the treatment it is likely to have the greatest im- ment of both anxiety and depression, both common psy- pact on. chological conditions associated with poorer quality of life in OA patients [38]. Patient activation is defined as Physical function outcomes an individual’s propensity to engage in adaptive health Secondary physical function outcome outcomes included behaviour that may lead to improved outcomes [43, 44]. KOOS individual subscales, functional performance and Activation levels are measured by the Patient Activated ULCA activity score. The choice of functional performance Measure (PAM) [37], a validated questionnaire that tests was based on the recommended OARSI performance looks at knowledge, skills and confidence in managing test for functional testing in OA [63]. A 4 × 10 m fast-paced health. walk test, timed up-and-go, 4-stair climb test and 30-s chair stand were chosen to encompass the key domains of func- tional activities from sit-to-stand, walking short distances, General outcomes stair negotiation and ambulatory transitions. The ULCA ac- Quality of Life will be measured using the EQ-5D, both tivity score is a validated score that is recommended for use the descriptive index and EQ-VAS [51]. The EQ-5D in patients with hip or knee OA [64]. value set that has been validated for the Singapore popu- lation using a time trade-off method and was used to Dietetics outcomes calculate utility values [65]. It will also be used in the In addition to Body Mass Index, Food Frequency Ques- computation for Quality of Life Years (QALYs) and tionnaire (FFQ) will be collected to monitor for change eventual cost-effectiveness. Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 8 of 13 Analgesia consumption will be measured using the Cu- questionnaire will be done at 3, 6 and 12 months. These mulative Analgesia Consumption Scale (CACS) which mea- adherence measures will only be performed in the inter- sures both the quantity and potency of the analgesia based vention arm patients due to the variability of treatment on WHO analgesia ladder over a 1 week period [57]. delivery in the usual care arm. Non-compliance will be Global perceived effect (GPE) [53] will be assessed defined as less than 75% attendance of the prescribed with the question: With respect to your knee, how treatment in the intervention arm. For usual care, the would you describe yourself now compared to before the number of physiotherapy sessions will be at the discre- treatment?? Answered on a seven-point Likert scale ran- tion of the patient; thus, no non-compliance cut off limit ging from ‘Improved, an important improvement’ to will be set. ‘Worse, an important worsening’. Satisfaction with current knee function will be assessed by the Patient Ac- Sample size calculation ceptable Symptom State (PASS) [54] using the question: The sample size needed to detect a 10-point difference “When you think of your knee function, will you con- between the intervention arm and usual care arm in sider your current condition as satisfying? Answered by KOOS was 41 patients in each arm based on a power of ‘yes’ or ‘no’. Participants not satisfied with current knee 90%, p-value of 0.05 (two-sided) and a standard devi- function will be asked to complete a second single-item ation of 14. The anticipated population KOOS and question, relating to treatment failure (TF) at the 12- standard deviations were based on the initial pilot study month follow-up: ‘Would you consider your current [25] done and the minimally clinically important differ- state as being so unsatisfactory that you think the treat- ence on 10-points (MCID) for KOOS [24]. In order to ment has failed?’. Answered by ‘yes’ or ‘no’. account for a missing data rate of 20%, 100 patients will Any adverse events (AE) and serious adverse events be recruited for the study. (SAE) will be collected during all follow-up visits using open-probe questioning to ensure all AE are recorded. Analysis plan SAE will be defined as any AE that results in The primary endpoint in this study is KOOS at 12- hospitalization or is life-threatening. Participation in the month follow-up. Results will be analysed by intention- trial for the subject will cease if a SAE occurs. Undergo- to-treat (ITT) principle. However, data will also be ana- ing an indicated surgical procedure such as a knee lysed by per-protocol (PP) approach to account for arthroplasty for knee OA due to failure of non-surgical protocol violations such as patients who were deemed treatment will not be considered an AE. In the event of not compliant to treatment or patients who underwent a more than 3 SAE, decision to stop the trial will be con- surgical procedure of the knee due to treatment failure sidered however the final decision will be made by the during the course of the study. Principal Investigator (PI) in conjunction with the ethics Descriptive frequency analysis will be used for baseline and clinical board. Provision for post-trial care and com- characteristics. For continuous variables, the mean and pensation will be made for subjects who suffer harm standard deviation will be reported and for categorical during the course of the trial. variables, the frequencies and percentages will be re- ported. Between-group comparisons of change from Compliance and adherence baseline to 1-year follow-up in the primary and second- Compliance and adherence are key aspects in any ary continuous outcomes will be analysed using a gener- exercises-based intervention for MSK conditions and alized linear mixed model (GLMM). Testing for having compliance measures allows for a more accurate normality of distributions of outcomes will be based interpretation of the results and form a significant part both on the Shapiro-Wilks test and a visual analysis of of the process evaluation [66]. Unfortunately, there is no the histogram plot. Categorical secondary outcomes will specific measure for exercise adherence that has been be analysed using the ordinal logistic regression function proven to be high quality, relevant and acceptable [67]. under GLMM. A two-sided p-value less than 0.05 will In order to give a holistic picture to adherence, the be considered as statistical significance. An analysis will Sports Injury Rehabilitation Adherence Scale (SIRAS) be done on the nature of the missing data to determine [55] will provide the healthcare providers perspective if the data was missing at random or a systemic bias was while a self-administered questionnaire for patients has present resulting the missing data. been designed to obtain patient’s input (Additional file 2). SIRAS is a 3-item instrument that assesses patient’s in- Data management tensity to exercise, the extent to which instructions were All data will be monitored by the PI or the study team, followed and receptiveness to change during each re- independent on the study sponsor. Data quality mea- habilitation session. SIRAS will be done after each sures include queries to identify outliers and missing physiotherapy session and the exercise adherence data. A unique identifier will be assigned to each subject Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 9 of 13 after enrolment to ensure patient confidentiality. Data outlines the definition and proposed data collection will be collected and stored on the Research Electronic based on the RE-AIM criteria. Data Capture (REDCAP) system which is a widely used A process evaluation will be embedded in the study. and secure web application for clinical data management The process evaluation is key in understanding the why in research. The REDCAP system is password protected and the how of any intervention by examining its imple- and will only be accessible by the study team. mentation, mechanisms of impact and contextual fac- tors. The MRC has developed a set of guidelines for the COMPONENT 2: economic evaluation conduct of process evaluations [74]. MRC recommends Aim and study design a basic framework for process evaluation with a different The aim of the economic evaluation is to evaluate the emphasis at each stage of the study. In the pilot phase, cost-effectiveness of a personalized, community based the key would be understanding the feasibility and inter- 12-week multidisciplinary program for patients with vention design optimization. In the main trial phase, the knee OA. The Panel on Cost-Effectiveness in Health and focus is on the fidelity of actual delivery, context and Medicine recommends the use of a societal perspective mechanism of impact. Context includes anything exter- to ensure that potentially important indirect costs such nal to the intervention that may act as a barrier or facili- as productivity and caregiver cost would not be omitted tator to its implementation. The mechanism of impact [68]. The study will be conducted from a societal per- seeks to identify the potential causal pathways that re- spective to determine the cost-effectiveness of the inter- sulted in the changes seen. vention [68]. Results from the economic evaluation will In addition, the Global Alliance for Musculoskeletal be reported based on the Consolidated Health Economic Health (GMUSC) have proposed a framework to help in- Evaluation Reporting Standards (CHEERS) Statement dividuals and organization with the planning, implemen- [69]. tation and evaluation of models of care (MoC) in MSK health [75]. The implementation and evaluation frame- Cost estimation and outcome measurement work in this study will utilize all 3 frameworks by using Cost data will be collected via hospital administrative da- RE-AIM framework to guide the focus areas, the MRC tabases and patient-reported questionnaires to estimate process evaluation to understand the underlying mecha- direct medical, direct non-medical and indirect costs. In- nisms and the GMUSC framework to ensure system- direct costs include health-related productivity loss due level relevance for scalability. Results from the study will to knee OA [70] from absenteeism and presenteeism, be reported according to the Standards for Reporting measured with the Work Productivity and Activity Im- Implementation Studies (StaRI) [76]. pairment Questionnaire (WPAI) [71]. The scope of the cost data collection was based on the validated OA Cost Qualitative study methodology and Consequences Questionnaire (OCC-Q) [72] and A combination of deductive and iterative approaches will adapted to the Singapore context to ensure that all rele- be used. A literature review will be conducted to gener- vant sources of cost were collected. The cost question- ate themes for the study topic guide. A combination of naire used can be found in Additional file 3. Cost data questionnaires and semi-structured interviews will be will be collected at 3 monthly intervals till 1-year follow- conducted based on the topic guide. Purposeful sam- up. pling with both healthcare professionals and patients in- The primary measure of health benefit will be Quality volved in the study will be used to identify appropriate of Life Years (QALYs) measured using the EQ-5D [51]. participants for interviews. The incremental cost-effectiveness ratio (ICER) over the Interviews will be conducted by an independent asses- trial period of this multidisciplinary non-surgical sor with previous experience in qualitative research not community-based program for knee OA compared to directly involved in the care of the patients. Any inter- usual care will be determined. viewer pre-existing bias will be identified and recorded. Transcripts and audio recordings will be stored digitally COMPONENT 3: implementation and evaluation and analysed using a qualitative analysis program to framework code data, link concepts, examine similarities and differ- RE-AIM framework ences and review patterns and themes. Coding will be The RE-AIM framework has been proposed as an appro- done iteratively. priate model to strengthen the case for policy change Themes emanating from transcripts will be identified and implementation for knee OA [11]. A recent study in through a framework method approach done by 2 inde- Canada in 2018 used the RE-AIM model to evaluate the pendent researchers supervised by a senior researcher cross-cultural adaption and implementation of the GLA: with significant experience in qualitative research to en- D program [30] for hip and knee OA [73]. Table 4 sure inter-observer reliability. Using the framework Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 10 of 13 Table 4 RE-AIM framework and Data Collection Dimension Definition Data Collection Reach The absolute number, proportion, and representativeness CONSORT flow Eligibility Log and reasons for of individuals who are willing to participate in a given non-participation Reasons for withdrawals initiative, intervention, or program. Qualitative methods Effectiveness The impact of an intervention on important outcomes, Primary and secondary outcomes Adverse including potential negative effects, quality of life, and outcomes Economic Evaluation economic outcomes. Adoption The absolute number, proportion, and representativeness Qualitative Methods with Healthcare of settings and intervention agents (people who deliver Professionals the program) who are willing to initiate a program. Implementation At the setting level, implementation refers to the Compliance (attendance logs, SIRAS, exercise intervention agents’ fidelity to the various elements adherence questionnaire) Process evaluation of an intervention’s protocol, including consistency of through Qualitative methods delivery as intended and the time and cost of the intervention. At the individual level, implementation refers to clients’ use of the intervention strategies. Maintenance The extent to which a program or policy becomes 12-month outcome measures Process evaluation institutionalized or part of the routine organizational through Qualitative methods practices and policies. Within the RE-AIM framework, maintenance also applies at the individual level. At the individual level, maintenance has been defined as the long-term effects of a program on outcomes after 6 or more months after the most recent intervention contact. method, the data is reduced through a matrix comparing outcomes to the degree of flexibility of intervention per- categories of data [77]. The framework method has been mitted. With rapidly evolving healthcare systems, com- shown to be an appropriate method for the evaluation of plex interventions are being developed in the common multidisciplinary complex intervention. Data will be drive to provide cost effective, sustainable care for pa- sampled till saturation. Results will be reported accord- tients. However due its inherent nature, there are issues ing to the Consolidated criteria for reporting qualitative in describing, developing, documenting and implement- research (COREQ) guideline [78]. ing complex intervention [80]. CONNACT MoC is a complex intervention that aims to promote long term sustainable behavioural change for pa- Discussion and conclusion tients with knee OA. In line with the MRC guidance for de- A rapidly aging global population has resulted in an OA veloping and evaluating complex interventions, building epidemic that is currently being poorly managed on a glo- from a pilot feasibility study, this study protocol describes a bal scale. CONNACT is a community-based, multidiscip- comprehensive approach including an RCT, economic linary 12-week program that uniquely uses an evaluation and process evaluation using a mixed method individualized approach based on a triaging criterion to approach. The primary aim of this study is to determine tailor the treatment to each patient coupled with a strong the clinical effectiveness of the CONNACT MoC compared emphasis on patient activation and self-management. to usual care. The secondary aims are: a) To determine the Traditional MoC for knee OA utilize a step-wise approach cost-effectiveness and b) To develop an evaluation and im- where all patients get baseline education, exercise and plementation framework to inform large scale implementa- weight loss advice before gradually moving up the treat- tion for this MoC. The study will utilize an explanatory ment ladder if treatment is unsuccessful [79]. In line with sequential mixed methods design where the qualitative data the “right care, delivered at the right time,bythe right will be critical in providing context for the quantitative re- team,inthe right place,with the right resources” philoso- sults allowing for a clearer interpretation. phy, CONNACT proposes the use of an individualized ap- Results from this study will help clinicians and health- proach through the use of a triaging criterion. care administrators work side by side to avoid the “valley A complex intervention is defined by the MRC as an of death”, bridge the gap between research and clinical intervention that contains several interacting compo- practice, guiding the sustainable and effective large-scale nents [12]. There are several dimensions of complexity implementation of the CONNACT MoC for knee OA. that can exist including the interaction between compo- In addition, CONNACT can serve as a basis for similar nents of the control and intervention arms, difficulty of multidisciplinary complex MoC for chronic degenerative behaviours change required to deliver or receive the musculoskeletal conditions to be developed in line with intervention, number of groups targeted, variability of the MRC guidelines. Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 11 of 13 Supplementary information Received: 7 July 2020 Accepted: 1 October 2020 The online version contains supplementary material available at https://doi. org/10.1186/s12891-020-03695-3. References Additional file 1. Appendix 1 – Intervention Description. (DOCX 26 kb) 1. Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, et al. The global burden of hip and knee osteoarthritis: estimates from the global burden of Additional file 2. Appendi× 2 – Patient Reported Exercise Compliance disease 2010 study. Ann Rheum Dis. 2014;73(7):1323–30. Questionnaire. (PDF 265 kb) 2. McGrory B, Weber K, Lynott JA, Richmond JC, Davis CM 3rd, Yates A Jr, et al. Additional file 3. Appendi× 3 – Cost Questionnaire. (DOCX 43 kb) The American Academy of Orthopaedic surgeons evidence-based clinical Additional file 4. Appendix 4 – SPIRIT diagram. (DOC 74 kb) practice guideline on surgical Management of Osteoarthritis of the knee. J Bone Joint Surg Am. 2016;98(8):688–92. Additional file 5. Appendix 5 – SPIRIT checklist. (DOC 124 kb) 3. McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma- Zeinstra SM, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthr Cartil. 2014;22(3):363–88. Abbreviations 4. Australian Institute for Health and Welfare (2010). Use of health services for CONNACT: Collaborative Model of Care between Orthopaedics and Allied arthritis and osteoporosis, in Arthritis Series no. 14. Cat. no. PHE 130. AIHW: Health Professionals Trial; MSK: Musculoskeletal; OA: Osteoarthritis; Canberra. MoC: Model of Care; RCT: Randomized Controlled Trial; NICE: National 5. Basedow M, Esterman A. Assessing appropriateness of osteoarthritis care Institute of Health and Care Excellence; ACSM: American College of Sports using quality indicators: a systematic review. J Eval Clin Pract. 2015;21(5): Medicine; NEMEX: Neuromuscular Exercise; OARSI: OA Research Society 782–9. International; KOOS: Knee Injury and OA Outcome Score; EQ-5D-5L: EuroQol 6. Hagen KB, Smedslund G, Osteras N, Jamtvedt G. Quality of community- 5 dimensions 5 level; BMI: Body Mass Index; PHQ-4: Patient Health based osteoarthritis care: a systematic review and meta-analysis. Arthritis Questionnaire 4; PEG: Pain, Enjoyment, General Activity Scale; Care Res (Hoboken). 2016;68(10):1443–52. ACT: Acceptance and Commitment Therapy; FFQ: Food Frequency 7. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and Questionnaire; ITT: Intention-to-treat; PAM: Patient Activation Measure; revision hip and knee arthroplasty in the United States from 2005 to 2030. J GPE: Global Perceived Effect; PASS: Patient Acceptable Symptom State; SIRA Bone Joint Surg Am. 2007;89(4):780–5. S: Sports Injury Rehabilitation Adherence Scale; PI: Principal Investigator; 8. Coggon D, Reading I, Croft P, McLaren M, Barrett D, Cooper C. Knee SD: Standard Deviation; GLMM: Generalized Linear Mixed Model osteoarthritis and obesity. Int J Obes Relat Metab Dis. 2001;25(5):622–7. 9. Mulcahy H, Chew FS. Current concepts in knee replacement: complications. Acknowledgements AJR Am J Roentgenol. 2014;202(1):W76–86. NA 10. Grover A, Joshi A. An overview of chronic disease models: a systematic literature review. Global J Health Sci. 2014;7(2):210–27. Authors’ contributions 11. Allen KD, Choong PF, Davis AM, Dowsey MM, Dziedzic KS, Emery C, et al. BYT was the lead investigator. All the authors (BYT, MJP, YSY, DJH, STS, JT, JC) Osteoarthritis: models for appropriate care across the disease continuum. were involved in the study methodology design and the preparation of the Best Pract Res Clin Rheumatol. 2016;30(3):503–35. manuscript and have approved the final manuscript. 12. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ (Clin Res ed). 2008;337:a1655. Funding 13. Tan BY, Ding BTK, Pereira MJ, Skou ST, Thumboo J, Car J. Collaborative Ng Teng Fong Health Innovation Program Grant $200,000. The funding body Model of Care between Orthopaedics and Allied Healthcare Professionals was not involved in the study design. Trial (CONNACT) – A Feasibility Study in patients with knee osteoarthritis using a mixed method approach. PREPRINT (Version 1) available at Research Availability of data and materials Square. 2020. Not applicable. 14. Peters D, Tran N, Adam T, Alliance for Health Policy and Systems Research, World Health Organization. Implementation research in health: a practical guide. 2013. Ethics approval and consent to participate 15. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness- Ethics approval was obtained through the Institution Review Board prior to implementation hybrid designs: combining elements of clinical the conduct of the study (National Healthcare Group Domain Specific effectiveness and implementation research to enhance public health Review Board Ref: 2018/00408). Written consent will be obtained from the impact. Med Care. 2012;50(3):217–26. study participants. 16. Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011;104(12): Consent for publication 510–20. NA 17. Klesges LM, Estabrooks PA, Dzewaltowski DA, Bull SS, Glasgow RE. Beginning with the application in mind: designing and planning health Competing interests behavior change interventions to enhance dissemination. Ann Behav Med. The authors declare that they have no competing interest. 2005;29(2):66–75. 18. Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The Author details PRECIS-2 tool: designing trials that are fit for purpose. BMJ (Clin Res ed). Department of Orthopaedic Surgery, Woodlands Health Campus, National 2015;350:h2147. Healthcare Group, Singapore, Singapore. Singapore General Hospital, 19. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Singapore City, Singapore. Health Services Outcome Research, National et al. SPIRIT 2013 statement: defining standard protocol items for clinical Healthcare Group, Singapore City, Singapore. Tan Tock Seng Hospital, trials. Ann Intern Med. 2013;158(3):200–7. Singapore City, Singapore. Institute of Bone and Joint Research, Kolling 20. McAlindon TE, Driban JB, Henrotin Y, Hunter DJ, Jiang GL, Skou ST, et al. Institute, University of Sydney and Rheumatology Department, Royal North OARSI clinical trials recommendations: design, conduct, and reporting of Shore Hospital, Sydney, Australia. Department of Sports Science and Clinical clinical trials for knee osteoarthritis. Osteoarthr Cartil. 2015;23(5):747–60. Biomechanics, Research Unit for Musculoskeletal Function and Physiotherapy, 21. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, University of Southern Denmark, Odense M, Denmark. Department of et al. CONSORT 2010 explanation and elaboration: updated guidelines for Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted reporting parallel group randomised trials. BMJ (Clin Res ed). 2010;340:c869. Hospitals, Slagelse, Denmark. Lee Kong Chian School of Medicine, Nanyang 22. National Institute for Health and Care Excellence (NICE) Guideline 2014. Technological University, Singapore City, Singapore. Osteoarthritis: care and management. Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 12 of 13 23. Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann knee osteoarthritis. Effectiveness of Supplementing a Home Exercise Rheum Dis. 1957;16(4):494–502. Programme With a Class Based Exercise Programme in the Treatment of 24. Roos EM, Lohmander LS. The knee injury and osteoarthritis outcome score Knee Osteoarthritis. 2001:1-. (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003; 49. Burke S, Carron A, Eys M, Ntoumanis N, Estabrooks P. Group versus 1:64. individual approach? A meta-analysis of the effectiveness of interventions to 25. Tan BY, Ding BTK, Pereira MJ, Skou ST, Thumboo J, Car J. Collaborative promote physical activity. Sport Exer Psychol Rev. 2005;2. model of care between Orthopaedics and allied healthcare professionals 50. Messier SP, Callahan LF, Golightly YM, Keefe FJ. OARSI clinical trials trial (CONNACT) - a feasibility study in patients with knee osteoarthritis recommendations: design and conduct of clinical trials of lifestyle diet and using a mixed method approach. BMC Musculoskelet Disord. 2020;21(1):592. exercise interventions for osteoarthritis. Osteoarthr Cartil. 2015;23(5):787–97. 26. Sanders JO, Murray J, Gross L. Non-arthroplasty treatment of osteoarthritis of 51. EuroQol--a new facility for the measurement of health-related quality of life. the knee. J Am Acad Orthop Surg. 2014;22(4):256–60. Health policy (Amsterdam, Netherlands). 1990;16(3):199–208. 27. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. 52. Neelakantan N, Whitton C, Seah S, Koh H, Rebello SA, Lim JY, et al. Better reporting of interventions: template for intervention description and Development of a Semi-Quantitative Food Frequency Questionnaire to replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. Assess the Dietary Intake of a Multi-Ethnic Urban Asian Population. 28. Slade S, Dionne C, Underwood M, Buchbinder R, Beck B, Bennell K, et al. Nutrients. 2016;8(9). Consensus on exercise reporting template (CERT): modified Delphi study. 53. Scott W, McCracken LM. Patients' impression of change following treatment Phys Ther. 2016;96. for chronic pain: global, specific, a single dimension, or many? J Pain. 2015; 29. American College of Sport Medicine (ACSM) Guidelines for Exercise Testing 16(6):518–26. and Prescription. 54. Dougados M, Moore A, Yu S, Gitton X. Evaluation of the patient acceptable 30. Skou ST, Roos EM. Good life with osteoArthritis in Denmark (GLA:D): symptom state in a pooled analysis of two multicentre, randomised, evidence-based education and supervised neuromuscular exercise delivered double-blind, placebo-controlled studies evaluating lumiracoxib and by certified physiotherapists nationwide. BMC Musculoskelet Disord. 2017; celecoxib in patients with osteoarthritis. Arthritis Res Ther. 2007;9:R11. 18(1):72. 55. Kolt GS, Brewer BW, Pizzari T, Schoo AMM, Garrett N. The sport injury 31. National Institute for Health and Care Excellence (NICE) Guideline 2014. rehabilitation adherence scale: a reliable scale for use in clinical Weight management: lifestyle services for overweight or obese adults. . physiotherapy. Physiotherapy. 2007;93(1):17–22. 32. Hayes SC SK, Wilson KG. Acceptance and commitment therapy (an 56. Naal FD, Impellizzeri FM, Leunig M. Which is the best activity rating scale for experiential approach to behavior change): New York: a division of patients undergoing total joint arthroplasty? Clin Orthop Relat Res. 2009; Guildford publications Inc; 1999. 467(4):958–65. 33. Yang S-Y, McCracken L. Acceptance and commitment therapy for chronic 57. Schoenthaler M, Miernik A, Offner K, Karcz WK, Hauschke D, Sevcenco S, pain. J Clin Outcomes Manag. 2014;21:134–44. et al. The cumulative analgesic consumption score (CACS): evaluation of a 34. Ngooi B. What are the crucial components of patient activation new score to describe postsurgical analgesic consumption as a surrogate interventions? Biomedical Journal of Scientific & Technical Research. 2017;1. parameter for postoperative pain and invasiveness of surgical procedures. 35. Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for Int Braz J Urol. 2014;40(3):330–6. anxiety and depression: the PHQ-4. Psychosomatics. 2009;50(6):613–21. 58. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying 36. Krebs EE, Lorenz KA, Bair MJ, Damush TM, Wu J, Sutherland JM, et al. prognostic comorbidity in longitudinal studies: development and validation. Development and initial validation of the PEG, a three-item scale assessing J Chronic Dis. 1987;40(5):373–83. pain intensity and interference. J Gen Intern Med. 2009;24(6):733–8. 59. Mahoney FI, Barthel DW. FUNCTIONAL EVALUATION: The BARTHEL index. 37. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of Maryland State Med J. 1965;14:61–5. a short form of the patient activation measure. Health Serv Res. 2005;40(6 Pt 60. Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip 1):1918–30. fracture. J Bone Joint Surg Br Volume. 1993;75(5):797–8. 38. Sharma A, Kudesia P, Shi Q, Gandhi R. Anxiety and depression in patients 61. Skou ST, Rasmussen S, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen with osteoarthritis: impact and management challenges. Open Access O, et al. The efficacy of 12 weeks non-surgical treatment for patients not Rheumatol. 2016;8:103–13. eligible for total knee replacement: a randomized controlled trial with 1- 39. Sharma L, Cahue S, Song J, Hayes K, Pai Y-C, Dunlop D. Physical functioning year follow-up. Osteoarthr Cartil. 2015;23(9):1465–75. over three years in knee osteoarthritis: role of psychosocial, local mechanical, 62. Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, et al. Cross-cultural and neuromuscular factors. Arthritis Rheum. 2003;48(12):3359–70. adaptation and validation of Singapore English and Chinese versions of the 40. Cleeland CS, Ryan KM. Pain assessment: global use of the brief pain knee injury and osteoarthritis outcome score (KOOS) in Asians with knee inventory. Ann Acad Med Singap. 1994;23(2):129–38. osteoarthritis in Singapore. Osteoarthr Cartil. 2006;14(11):1098–103. 41. Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. 63. Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, et al. Interpreting the clinical importance of treatment outcomes in chronic pain OARSI recommended performance-based tests to assess physical function clinical trials: IMMPACT recommendations. J Pain. 2008;9(2):105–21. in people diagnosed with hip or knee osteoarthritis. Osteoarthr Cartil. 2013; 21(8):1042–52. 42. Wise BL, Niu J, Zhang Y, Wang N, Jordan JM, Choy E, et al. Psychological factors and their relation to osteoarthritis pain. Osteoarthr Cartil. 2010;18(7): 64. Terwee CB, Bouwmeester W, van Elsland SL, de Vet HC, Dekker J. 883–7. Instruments to assess physical activity in patients with osteoarthritis of the 43. Hibbard JH, Greene J. What the evidence shows about patient activation: hip or knee: a systematic review of measurement properties. Osteoarthr better health outcomes and care experiences; fewer data on costs. Health Cartil. 2011;19(6):620–33. affairs (Project Hope). 2013;32(2):207–14. 65. Luo N, Wang P, Thumboo J, Lim YW, Vrijhoef HJ. Valuation of EQ-5D-3L 44. Hibbard JH, Greene J, Tusler M. Improving the outcomes of disease health states in Singapore: modeling of time trade-off values for 80 management by tailoring care to the patient's level of activation. Am J empirically observed health states. PharmacoEconomics. 2014;32(5):495–507. Manag Care. 2009;15(6):353–60. 66. Roddy E, Zhang W, Doherty M, Arden NK, Barlow J, Birrell F, et al. Evidence- 45. Hsu WC, Araneta MRG, Kanaya AM, Chiang JL, Fujimoto W. BMI cut points based recommendations for the role of exercise in the management of to identify at-risk Asian Americans for type 2 diabetes screening. Diabetes osteoarthritis of the hip or knee--the MOVE consensus. Rheumatology Care. 2015;38(1):150. (Oxford, England). 2005;44(1):67–73. 46. Yang S-Y, McCracken LM, Moss-Morris R. Psychological treatment needs for 67. McLean S, Holden MA, Potia T, Gee M, Mallett R, Bhanbhro S, et al. Quality chronic pain in Singapore and the relevance of the psychological flexibility and acceptability of measures of exercise adherence in musculoskeletal model. Pain Med. 2016;18(9):1679–94. settings: a systematic review. Rheumatology (Oxford, England). 2017;56(3): 47. Lally P, van Jaarsveld CHM, Potts HWW, Wardle J. How are habits formed: 426–38. Modelling habit formation in the real world. Eur J Soc Psychol. 2010;40(6): 68. Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, et al. 998–1009. Recommendations for conduct, methodological practices, and reporting of 48. McCarthy CJ. The effectiveness of supplementing a home exercise cost-effectiveness analyses: second panel on cost-effectiveness in health programme with a class based exercise programme in the treatment of and medicine. Jama. 2016;316(10):1093–103. Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 13 of 13 69. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEE RS) statement. BMJ (Clin Res ed). 2013;346:f1049. 70. Rice DP. Estimating the cost of illness. Am J Public Health Nation’s Health. 1967;57(3):424–40. 71. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. PharmacoEconomics. 1993; 4(5):353–65. 72. Pinto D, Robertson MC, Hansen P, Abbott JH. Good agreement between questionnaire and administrative databases for health care use and costs in patients with osteoarthritis. BMC Med Res Methodol. 2011;11:45. 73. Davis AM, Kennedy D, Wong R, Robarts S, Skou ST, McGlasson R, et al. Cross-cultural adaptation and implementation of good life with osteoarthritis in Denmark (GLA:D): group education and exercise for hip and knee osteoarthritis is feasible in Canada. Osteoarthr Cartil. 2018;26(2):211–9. 74. Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ (Clin Res ed). 2015;350:h1258. 75. Briggs AM, Jordan JE, Jennings M, Speerin R, Bragge P, Chua J, et al. Supporting the evaluation and implementation of musculoskeletal models of care: a globally informed framework for judging readiness and success. Arthritis Care Res (Hoboken). 2017;69(4):567–77. 76. Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, et al. Standards for Reporting Implementation Studies (StaRI) Statement. BMJ (Clin Res Ed). 2017;356:i6795. 77. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:117. 78. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349–57. 79. Roos EM, Juhl CB, Roos EM, Juhl CB. Osteoarthritis 2012 year in review: rehabilitation and outcomes. Osteoarthritis Cartilage. 2012;20(12):1477–83. 80. Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, et al. Designing and evaluating complex interventions to improve health care. BMJ (Clin Res Ed). 2007;334(7591):455–9. Publisher’sNote Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png BMC Musculoskeletal Disorders Springer Journals

Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial

Download PDF
13 pages

Loading next page...
 
/lp/springer-journals/collaborative-model-of-care-between-orthopaedics-and-allied-healthcare-SPO0019NNN

References (107)

Publisher
Springer Journals
Copyright
Copyright © The Author(s) 2020
eISSN
1471-2474
DOI
10.1186/s12891-020-03695-3
Publisher site
See Article on Publisher Site

Abstract

Background: Knee Osteoarthritis (OA) is a leading cause of global disability. The Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT) Model of Care (MoC) was developed by optimizing evidence-based non-surgical treatments to deliver value-based care for people with knee OA. The primary aim of this study is to determine the clinical effectiveness of the CONNACT MoC (3 months) compared to usual care. The secondary aims are: a) To determine the cost-effectiveness and b) To develop an evaluation and implementation framework to inform large scale implementation for this MoC. Methodology: Type 1 Effectiveness-Implementation Hybrid Trial using an explanatory sequential mixed-method approach. The study consists of 3 components. The first component is the pragmatic, parallel-arm, single-blinded randomized control trial. Inclusion criteria are patients with knee OA based on the National Institute of Health and Care Excellence (NICE) criteria with radiographic severity of greater than Kellgren-Lawrence 1, and Knee Injury and OA Outcome Score (KOOS ) of equal or less than 75. Exclusion criteria include other forms of arthritis, history of previous knee arthroplasty or wheelchair-bound patient. KOOS is the primary outcome measure at 3 months, 6 months and 1 year. Secondary outcomes include KOOS individual subscales, quality of life scoring, functional performance, global, diet and psychological related outcomes. The second component is an economic evaluation of the cost-effectiveness of the CONNACT MoC using a societal perspective. The third component is an implementation and evaluation framework using process evaluation under the RE-AIM framework using a mixed- (Continued on next page) * Correspondence: btanyj@hotmail.com Department of Orthopaedic Surgery, Woodlands Health Campus, National Healthcare Group, Singapore, Singapore Singapore General Hospital, Singapore City, Singapore Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 2 of 13 (Continued from previous page) method approach. Sample size of 100 patients has been calculated. Discussion: CONNACT MoC is a complex intervention. In line with the MRC guidance for developing and evaluating complex interventions, a pilot feasibility study was completed and a comprehensive approach including an RCT, economic evaluation and process evaluation is described in this study protocol. Results from this study will help clinicians, healthcare administrators and policymakers guide the sustainable and effective implementation of the CONNACT MoC for knee OA and serve as a basis for similar multidisciplinary MoC for chronic degenerative musculoskeletal conditions to be developed. Trial registration: Clinicaltrials.gov Identifier: NCT03809975. Registered January 182,019. Keywords: Study protocol, Effectiveness-implementation hybrid, Mixed methods, Knee osteoarthritis, Model of care, Randomized control trial Background programs, the Collaborative Model of Care between The world is experiencing a rapidly aging population, Orthopaedics and Allied Healthcare Professionals and with it an age-related increase in chronic musculo- (CONNACT) Model of Care (MoC) of knee OA was de- skeletal (MSK) disorders. Based on the 2010 Global Bur- veloped. CONNACT is a community-based, multidiscip- den of Disease Study, MSK disorders account for the linary 12-week program that uniquely uses an largest cause of disability around the world and in par- individualized approach based on a triaging criterion to ticular, osteoarthritis (OA) was ranked the 11th highest tailor the treatment to each patient in line with the global cause [1]. International guidelines are consistent “right care, delivered at the right time, by the right team, in their treatment recommendations for knee OA with in the right place, with the right resources” philosophy individualized lifestyle changes, especially exercise and coupled with a strong emphasis on patient activation weight loss programs, highlighted as first-line manage- and self-management strategies to promote long term ment [2, 3]. A stepwise approach is recommended where sustainable behavioural change. surgery is considered when non-surgical treatment fails. The Medical Research Council (MRC) Guidance on Despite all this, studies report that more than half of the developing and evaluation such complex interventions patients from established healthcare systems around the was utilized in the CONNACT development, evaluation world such as Australia and Canada are not receiving and eventual planned implementation [12]. A feasibility optimal non-surgical treatment [4–6]. study using a pilot randomized trial design was con- Surgery is often a result not from a failure of non- ducted to determine the feasibility of a full randomized surgical treatment but the failure of the healthcare sys- controlled trial (RCT) evaluating the CONNACT MoC tem to provide adequate and effective non-surgical treat- as the first step [13]. Results from the feasibility study ment. With knee arthroplasty rates expected to rise were instrumental in the design of this study protocol. rapidly [7], the literature suggests that at least a quarter of knee arthroplasties could have been avoided through Aim optimal non-surgical treatments [8]. While knee arthro- The primary aim of the study is to evaluate the clinical plasty surgery is an effective option for knee OA, it effectiveness (pain, function, quality of life) of the CON- should be applied only when all non-surgical treatment NACT MoC as compared with usual care in patients options have been exhausted as it is costly and not with- with knee OA. out risks and complications [9]. The secondary aims are to: There is an urgent need for new models of care (MoC) for knee OA developed by optimizing evidence-based 1. Evaluate the cost-effectiveness of the CONNACT non-surgical treatments to deliver value-based care. MoC for patients with knee OA There has been a paradigm shift globally, moving from 2. Develop an implementation and evaluation an acute episodic type treatment that was generally asso- framework to inform large scale implementation of ciated with OA to a chronic disease MoC [10]. Over the CONNACT MoC past decade, several models of care from around the world have been developed including the Good Life with We hypothesize that patients with knee OA who OA in Denmark (GLA:D) program and the OA Chronic undergo the CONNACT program will have better pain, Care Program (OACCP) program from Australia [11]. function and quality of life scores 12 months after Building from the well-established principles of these Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 3 of 13 initiating the program compared to patients who Participants undergo usual care. We will recruit patients based on the inclusion and ex- clusion criteria outlined in Table 1. Methodology Components of the CONNACT study Design The study is an Effectiveness-Implementation Hybrid 1. Randomized Controlled Trial Trial which combines both an effectiveness and imple- 2. Economic evaluation mentation component [14, 15]. It has been increasingly 3. Implementation and Evaluation Framework recognized that implementation is the main challenge in many models of care. An implementation gap, also COMPONENT 1: randomized controlled trial known as the “valley of death” exists between what Trial procedure current literature recommendation and translation to ac- The overall flow for the RCT is outlined in Fig. 1 based tual clinical practice [16]. Knee OA is a clear situation on the CONSORT guidelines. Patients who are referred where this “valley of death” has happened. As a result, by a primary healthcare or emergency medicine doctor there has been a greater emphasis on incorporation of to the Outpatient clinic at the Department of Ortho- an implementation element in studies to enhance dis- paedic Surgery at Tan Tock Seng Hospital, a tertiary re- semination with hybrid trials increasingly being con- ferral centre in Singapore with a suspected diagnosis of ducted [17]. knee OA will be screened based on the inclusion and ex- This will be a type 1 hybrid trial where the emphasis clusion criteria presented in Table 1. All referral letters and primary aim is to evaluate effectiveness through a are screened based on electronic medical records. pragmatic randomized trial under real-world conditions Patients who are eligible based on initial screening are and its secondary aim is to understand the context of invited to attend a recruitment clinic where they will be implementation through a mixed-method, process orien- assessed by the study team and invited to participate in tated approach. The pragmatic nature of the study was the study if they meet all the inclusion and exclusion cri- guided by the Pragmatic Explanatory Continuum Indica- teria. Informed written consent will be obtained. Patients tor Summary (PRECIS-2) tool [18]. will be randomized into the intervention or usual care The study will be conducted as a single centre prag- arm after collection of baseline data. Recruitment clinics matic, parallel-arm, single-blinded RCT using a mixed- will be carried out at the Tan Tock Seng Hospital Spe- method approach comparing the CONNACT multidis- cialist Outpatient Clinic. ciplinary personalized community-based MoC and the current MoC. The Standard Protocol Items: Recommen- Randomization and concealment of allocation dations for Interventional Trials (SPIRIT) [19] model Patients who consent to participate will be randomized (Additional file 5) and the OA Research Society Inter- (1:1 allocation ratio) between the intervention and usual national (OARSI) clinical trial recommendation on the care using a stratified permuted block randomization design and conduct of clinical trials for knee OA [20] method using block sizes of 4,6 and 8. Stratification is guided the development and reporting of the trial proto- based on gender to ensure equal distribution in both col. The findings of the trial will be reported according groups. The allocation sequence is generated by an inde- to the Consolidated Standards of Reporting Trials pendent statistician a priori and will be kept concealed (CONSORT) 2010 [21] guidelines for reporting parallel from the study team. Randomization will be done using group randomized trials. The study will utilize an ex- the REDCap randomization module based on the alloca- planatory sequential mixed methods design where the tion sequence and allocation will be locked once qualitative data through the use of surveys and inter- assigned. Randomization and intervention allocation will views will be used to interpret and provide context for only be performed by the study team after the patient is the quantitative results. counselled fully about the study and provides informed consent. Ethics approval Intervention – CONNACT model of care Ethics approval has been obtained from the Institution The development and core principles of the CONNACT Review Board (IRB) prior to the conduct of the study MoC has been described as part of the pilot study [25]. (NHG DSRB Ref: 2018/00408). Any protocol modifica- Grounded from a throughout literature search on the tion will be communicated to IRB in a timely manner. best practices in knee OA care [3, 26], a review of suc- Random audits will be performed by the IRB. cessful programs [11], international collaborations and the process evaluation patient interviews from the pilot Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 4 of 13 Table 1 Inclusion and Exclusion Criteria Inclusion Criteria (all 4 must be present) Exclusion Criteria National Institute of Health and Care Excellence (NICE) clinical criteria for knee Alternative diagnosis to knee OA e.g. referred pain from the spine OA [22] Age ≥ 45 years old and Has activity related knee pain and Has either or hip no morning knee-related stiffness or morning stiffness than last no longer than 30 min Radiographic severity of knee OA, Kellgren-Lawrence Score [23] > 1 Other forms of arthritis e.g. inflammatory, post-traumatic Knee Injury and OA Outcome Score [24] (KOOS )* ≤ 75 Inability to comply with study protocol e.g. cognitive impairment Community ambulator with or without walking aid Previous knee arthroplasty Wheelchair-bound patients Medical conditions that will medically interfere with study involvement e.g. decompensated heart failure, stroke, end-stage renal failure * KOOS is a composite score of the mean of four of the five subscale scores from the Knee Injury and OA Outcome Score (symptoms, pain, function from daily living and quality of life) Fig. 1 Randomized Control Trial Structure Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 5 of 13 study has allowed the CONNACT MoC to be further re- not interfere) to ‘10’ (completely interferes) scale. fined and contextualized. Provisional benchmarks have been set to identify clinic- The CONNACT MoC consists of a 12-week commu- ally meaningful improvements that can help differentiate nity based, individualized, multidisciplinary intervention between treatment “responders” and “non-responders” for knee OA. In summary, the core principles are firstly at the start of a clinical trial [41] Suggestions that symp- a chronic disease multidisciplinary model emphasizing tom reduction of 30% or more indicating moderately im- self-management and long term sustainable behavioural portant improvements and symptom reduction of 50% change, secondly, care stratification using a triage criter- or more considered “substantial improvements”. Taking ion and thirdly, implemented through a grounded reference from these guidelines, a cut-off score of “5” in- community-based setting. dicating moderate symptoms for pain, physical function- Table 2 outlines the intervention summary, including ing was used to decide for psychological intervention. each component, triaging criterion, intervention princi- The Patient Health Questionnaire-4 (PHQ-4) [35]isa ples and delivery. A full description of the intervention brief 4-item screening assessment of depression and in accordance with TIDieR [27] and CERT [28] report- anxiety symptoms. With anxiety known to exert an inde- ing guidelines is available in the Additional file 1. Fur- pendent effect on functioning separate from depression, ther rationale and details for the triaging criterion and screening for both depression and anxiety has been the self-management philosophy underpinning the thought to be necessary [42]. The first 2 items from the CONNACT MoC are elaborated below. PHQ-4 are taken from the original 9 item Patient Health Questionnaire (PHQ-9) and the next 2 items taken from Triaging criteria development the first 2-items on the General Anxiety Disorder The 3 measures that were chosen for psychological (GAD-7) questionnaire. The PHQ-4, therefore, forming intervention triaging criteria were Patient Health a composite score of depression and anxiety. Responses Questionnaire-4 (PHQ-4) [35], and Pain Intensity, En- on all 4 items are scored as “0” (not at all), “1” (several joyment of life and General Activity (PEG) [36] and Pa- day”, “2″ (more than half the days) and “3″ (nearly every tient Activated Measure (PAM) [37]. day). A score of more than 5 indicates at least a moder- PHQ-4 and PEG were chosen in light of the significant ate psychological distress from depression and/or anxiety impact of psychological conditions (anxiety, depression) and thus was used as cut off for psychological and pain intensity and interference in predicting out- intervention. comes in OA patients [38, 39]. The Pain Intensity, En- Patient activation is defined as an individual’s propen- joyment of life and General Activity (PEG) [36]isa sity to engage in adaptive health behaviour that may lead brief, 3-item assessment of pain intensity (1item) and to improved outcomes. Activation levels are measured pain interference (2 items) derived from the Brief Pain by the Patient Activated Measure (PAM) [37], a vali- Inventory (BPI) [40]. The PEG measures pain intensity dated questionnaire that looks at knowledge, skills and on a numerical rating scale of ‘0’ (no pain) to ‘10’ (pain confidence in managing health. Through the PAM score, as bad as you can imagine) and pain interference with patients can subsequently put into 4 groups, level 1 general activity and enjoyment of life also on a ‘0’ (does (poorly activated) to level 4 (highly activated). There has Table 2 Intervention Summary Intervention Criteria to receive Healthcare Professional Treatment Principles Delivery Format Component intervention Exercise Therapy All patients Physiotherapist American College of Sports Medicine Group sessions × 8 (ACSM) [29] and Neuromuscular Exercise (NEMEX) [30] guidelines Clinical Assessment All patients Orthopaedic Surgeon Clinical and Radiological Assessment Group Education and Education Psychologist Social Pharmacological Intervention “Expert” sessions × 2 Support Worker Patients Group session x 1 Dietetics and Nutrition BMI > 23.5 Dietician Dietary intervention to increase Group sessions × 3 dietary-related nutrition knowledge and self-efficacy for effective weight loss [31] Psychological support PHQ-4 > 5 or PEG Psychologist Social Acceptance and Commitment Group sessions × 3 > 4 on all scales Worker Therapy (ACT) principles [32, 33] or PAM < 3 Patient Activation [34] Pain Management Coping Strategies and improving compliance to behavioural modifications Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 6 of 13 been increasing evidence in the literature that PAM as a role model for patients. “Expert patients” been suc- scores are modifiable through targeted intervention and cessfully incorporated in other knee OA programs be- that high PAM scores have been associated with more fore [30]. satisfaction with healthcare services, better self- management behaviour and improved health outcome Usual care [43, 44]. As such, PAM levels of 1 and 2 were chosen as Usual care constitutes a referral to the outpatient a triaging criterion for targeted psychological interven- physiotherapist at the tertiary hospital where patients tion in an effort to boost activation levels. are usually seen 1–2 weeks post referral. The physiother- Body Mass Index will be used as a triaging criterion apist would conduct an assessment and recommend a for dietetic intervention. A lower cut off of BMI 23.5 has variety of lifestyle modifications and exercise therapy. been recommended for Asians [45] and will be used as a The type of exercises and number of physiotherapy ses- cut-off. sions were at the discretion of the patient and the physiotherapist. Self-management philosophy Self-management is a key foundation for the CON- NACT MoC. This will be achieved through several Outcome assessment and blinding methods. Firstly, through the program content. The edu- Outcome measures will be measured by blinded out- cation and psychology classes grounded in the principles come assessors. The outcome assessors will be either and psychological model of Acceptance and Commit- physiotherapy interns or research assistants. All outcome ment Therapy (ACT) [32, 33] and Patient Activation assessors will receive training prior to study initiation to [34] strategies which have been shown to the effective. ensure good inter- and intra-observer reliability, particu- In particular, there has already been evidence to show larly for the functional performance testing. Patients will the effectiveness of ACT in the local chronic pain popu- be instructed not to reveal their allocation to the out- lation in Singapore [46]. come assessors. Outcome assessment will be conducted Secondly, through the program delivery format. The either at the community rehabilitation facility or tertiary program’s duration of 12 weeks is based on current evi- hospital setting. Choice of outcome assessment location dence of the time taken for a habit to form [47]. The will be carefully monitored to ensure that outcomes as- program is structured as a weekly class with a gap of 3 sessors were not able to deduce the treatment arm. weeks between week 8 and week 12 factored in to allow patients the opportunity to incorporate these behav- Outcomes ioural modifications as part of their daily routine before The choice of outcome measures is based on the OARSI returning for the final session on week 12. In addition, guidelines for lifestyle diet and exercise clinical trials in after each session, patients will be given “homework” OA [50]. The recommended core outcomes are pain, and exercises to perform at home and are reviewed at physical function, global patient assessment and mobil- the next class. This combination of class-based and ity. Additional outcomes include health-related quality home-based individual treatment has been shown to be of life and global physician assessment. The outcome effective in knee OA [48]. In addition, group or class- measures will be collected at baseline, 3, 6 and 12 based interventions have also been shown to be more ef- months. Table 3 summarizes all the outcome measures fective compared to pure individual interventions in pro- and Additional file 4 outlines the different data collec- moting physical activity through cohesion and peer tion steps based on the SPIRIT guidelines. support [49]. A flexible post-intervention program will be available for patients who would like to continue to exercise together in a group and social network plat- Baseline measures forms e.g. Whatsapp group chats or Facebook groups The following baseline measures will be collected. will also be utilized to facilitate patient group interaction throughout and post-intervention. In addition, a support 1. Demographic – age, gender, race group session 3 months after program completion will 2. Socioeconomic status – education level, housing be arranged for reinforcement for key concepts and con- status, employment details tinued promotion of group interaction. 3. Co-morbidities and functional status – Charlson Thirdly, through the use of “expert patients”. These comorbidity index [58], Barthel Index for Activities “expert patients” are patients who have previously com- of Daily Living [59], Parker Mobility Score [60] pleted and benefitted from the CONNACT program. 4. Knee symptoms and duration They will be invited to volunteer and share their experi- 5. Radiographic severity of knee OA based on the ences and advice as part of the education class to serve Kellgren Lawrence Scale [23] Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 7 of 13 Table 3 Outcome Measures Overview Effectiveness Measures Compliance and Adherence Measures Physical Function Dietetics Psychology General KOOS Body Mass Index (BMI) Patient Health Questionnaire Quality of Life EQ-5D [51] Appointment default rate 4 (PHQ-4) [35] KOOS individual subscales Semi-Quantitative Food Patient Activation Measure Global Perceived Effect Exercise Adherence Frequency Questionnaire (PAM) [37] (GPE) [53] Questionnaire (FFQ) [52] Functional Performance Pain, Enjoyment, General Patient Acceptable Sports Injury Rehabilitation 1. Timed up-and-go Activity Scale (PEG) [36] Symptom Score (PASS) [54] Adherence Scale (SIRAS) [55] 2. 4 × 10 m face paced walk test 3. 4-stair climb test 4. 30s chair stand UCLA activity score [56] Analgesia Consumption [57] Adverse events Primary outcome in dietary habits. Modification to the original Food Fre- The primary outcome measure will be the mean of four quency Questionnaire (FFQ) was performed to reduce of the five subscale scores from the Knee Injury and OA the length and thereby responder burden and adapt it Outcome Score (KOOS ). KOOS contains 5 domains of based on local dietary practices. Scoring was developed questions, namely symptoms, pain, function (daily liv- by weighting fat/sugar/fibre content of the particular ing), function (sports, recreational activities) and quality food item based on the energy and nutrient composition of life [24]. Consistent with other studies with a similar reported by the Singapore Health Promotion Board population of elderly patients with knee OA, the func- (http://focus.hpb.gov.sg/eservices/ENCF/). Modified FFQ tion (sports, recreational activities) subscale were will only be done for patients who have a BMI > 23.5. deemed to be less relevant for this population and the remaining 4 domains were combined to form a compos- Psychological outcomes ite score [61]. The KOOS score has previously been vali- The Pain Interference Scale (Pain intensity (P), interfer- dated in Singapore [62]. ence with enjoyment of life (E), interference with general activity (G))(PEG) [36] is a 3 item scale developed and Secondary outcomes validated from the Brief Pain Inventory(BPI) for chronic The secondary outcomes have been classified into effect- pain measurement, particularly in chronic musculoskel- iveness and compliance outcomes. The effectiveness etal patients. The Patient Health Questionnaire-4 (PHQ- measures have been further subdivided based which as- 4) [35] is a validated questionnaire that allows measure- pect of the treatment it is likely to have the greatest im- ment of both anxiety and depression, both common psy- pact on. chological conditions associated with poorer quality of life in OA patients [38]. Patient activation is defined as Physical function outcomes an individual’s propensity to engage in adaptive health Secondary physical function outcome outcomes included behaviour that may lead to improved outcomes [43, 44]. KOOS individual subscales, functional performance and Activation levels are measured by the Patient Activated ULCA activity score. The choice of functional performance Measure (PAM) [37], a validated questionnaire that tests was based on the recommended OARSI performance looks at knowledge, skills and confidence in managing test for functional testing in OA [63]. A 4 × 10 m fast-paced health. walk test, timed up-and-go, 4-stair climb test and 30-s chair stand were chosen to encompass the key domains of func- tional activities from sit-to-stand, walking short distances, General outcomes stair negotiation and ambulatory transitions. The ULCA ac- Quality of Life will be measured using the EQ-5D, both tivity score is a validated score that is recommended for use the descriptive index and EQ-VAS [51]. The EQ-5D in patients with hip or knee OA [64]. value set that has been validated for the Singapore popu- lation using a time trade-off method and was used to Dietetics outcomes calculate utility values [65]. It will also be used in the In addition to Body Mass Index, Food Frequency Ques- computation for Quality of Life Years (QALYs) and tionnaire (FFQ) will be collected to monitor for change eventual cost-effectiveness. Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 8 of 13 Analgesia consumption will be measured using the Cu- questionnaire will be done at 3, 6 and 12 months. These mulative Analgesia Consumption Scale (CACS) which mea- adherence measures will only be performed in the inter- sures both the quantity and potency of the analgesia based vention arm patients due to the variability of treatment on WHO analgesia ladder over a 1 week period [57]. delivery in the usual care arm. Non-compliance will be Global perceived effect (GPE) [53] will be assessed defined as less than 75% attendance of the prescribed with the question: With respect to your knee, how treatment in the intervention arm. For usual care, the would you describe yourself now compared to before the number of physiotherapy sessions will be at the discre- treatment?? Answered on a seven-point Likert scale ran- tion of the patient; thus, no non-compliance cut off limit ging from ‘Improved, an important improvement’ to will be set. ‘Worse, an important worsening’. Satisfaction with current knee function will be assessed by the Patient Ac- Sample size calculation ceptable Symptom State (PASS) [54] using the question: The sample size needed to detect a 10-point difference “When you think of your knee function, will you con- between the intervention arm and usual care arm in sider your current condition as satisfying? Answered by KOOS was 41 patients in each arm based on a power of ‘yes’ or ‘no’. Participants not satisfied with current knee 90%, p-value of 0.05 (two-sided) and a standard devi- function will be asked to complete a second single-item ation of 14. The anticipated population KOOS and question, relating to treatment failure (TF) at the 12- standard deviations were based on the initial pilot study month follow-up: ‘Would you consider your current [25] done and the minimally clinically important differ- state as being so unsatisfactory that you think the treat- ence on 10-points (MCID) for KOOS [24]. In order to ment has failed?’. Answered by ‘yes’ or ‘no’. account for a missing data rate of 20%, 100 patients will Any adverse events (AE) and serious adverse events be recruited for the study. (SAE) will be collected during all follow-up visits using open-probe questioning to ensure all AE are recorded. Analysis plan SAE will be defined as any AE that results in The primary endpoint in this study is KOOS at 12- hospitalization or is life-threatening. Participation in the month follow-up. Results will be analysed by intention- trial for the subject will cease if a SAE occurs. Undergo- to-treat (ITT) principle. However, data will also be ana- ing an indicated surgical procedure such as a knee lysed by per-protocol (PP) approach to account for arthroplasty for knee OA due to failure of non-surgical protocol violations such as patients who were deemed treatment will not be considered an AE. In the event of not compliant to treatment or patients who underwent a more than 3 SAE, decision to stop the trial will be con- surgical procedure of the knee due to treatment failure sidered however the final decision will be made by the during the course of the study. Principal Investigator (PI) in conjunction with the ethics Descriptive frequency analysis will be used for baseline and clinical board. Provision for post-trial care and com- characteristics. For continuous variables, the mean and pensation will be made for subjects who suffer harm standard deviation will be reported and for categorical during the course of the trial. variables, the frequencies and percentages will be re- ported. Between-group comparisons of change from Compliance and adherence baseline to 1-year follow-up in the primary and second- Compliance and adherence are key aspects in any ary continuous outcomes will be analysed using a gener- exercises-based intervention for MSK conditions and alized linear mixed model (GLMM). Testing for having compliance measures allows for a more accurate normality of distributions of outcomes will be based interpretation of the results and form a significant part both on the Shapiro-Wilks test and a visual analysis of of the process evaluation [66]. Unfortunately, there is no the histogram plot. Categorical secondary outcomes will specific measure for exercise adherence that has been be analysed using the ordinal logistic regression function proven to be high quality, relevant and acceptable [67]. under GLMM. A two-sided p-value less than 0.05 will In order to give a holistic picture to adherence, the be considered as statistical significance. An analysis will Sports Injury Rehabilitation Adherence Scale (SIRAS) be done on the nature of the missing data to determine [55] will provide the healthcare providers perspective if the data was missing at random or a systemic bias was while a self-administered questionnaire for patients has present resulting the missing data. been designed to obtain patient’s input (Additional file 2). SIRAS is a 3-item instrument that assesses patient’s in- Data management tensity to exercise, the extent to which instructions were All data will be monitored by the PI or the study team, followed and receptiveness to change during each re- independent on the study sponsor. Data quality mea- habilitation session. SIRAS will be done after each sures include queries to identify outliers and missing physiotherapy session and the exercise adherence data. A unique identifier will be assigned to each subject Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 9 of 13 after enrolment to ensure patient confidentiality. Data outlines the definition and proposed data collection will be collected and stored on the Research Electronic based on the RE-AIM criteria. Data Capture (REDCAP) system which is a widely used A process evaluation will be embedded in the study. and secure web application for clinical data management The process evaluation is key in understanding the why in research. The REDCAP system is password protected and the how of any intervention by examining its imple- and will only be accessible by the study team. mentation, mechanisms of impact and contextual fac- tors. The MRC has developed a set of guidelines for the COMPONENT 2: economic evaluation conduct of process evaluations [74]. MRC recommends Aim and study design a basic framework for process evaluation with a different The aim of the economic evaluation is to evaluate the emphasis at each stage of the study. In the pilot phase, cost-effectiveness of a personalized, community based the key would be understanding the feasibility and inter- 12-week multidisciplinary program for patients with vention design optimization. In the main trial phase, the knee OA. The Panel on Cost-Effectiveness in Health and focus is on the fidelity of actual delivery, context and Medicine recommends the use of a societal perspective mechanism of impact. Context includes anything exter- to ensure that potentially important indirect costs such nal to the intervention that may act as a barrier or facili- as productivity and caregiver cost would not be omitted tator to its implementation. The mechanism of impact [68]. The study will be conducted from a societal per- seeks to identify the potential causal pathways that re- spective to determine the cost-effectiveness of the inter- sulted in the changes seen. vention [68]. Results from the economic evaluation will In addition, the Global Alliance for Musculoskeletal be reported based on the Consolidated Health Economic Health (GMUSC) have proposed a framework to help in- Evaluation Reporting Standards (CHEERS) Statement dividuals and organization with the planning, implemen- [69]. tation and evaluation of models of care (MoC) in MSK health [75]. The implementation and evaluation frame- Cost estimation and outcome measurement work in this study will utilize all 3 frameworks by using Cost data will be collected via hospital administrative da- RE-AIM framework to guide the focus areas, the MRC tabases and patient-reported questionnaires to estimate process evaluation to understand the underlying mecha- direct medical, direct non-medical and indirect costs. In- nisms and the GMUSC framework to ensure system- direct costs include health-related productivity loss due level relevance for scalability. Results from the study will to knee OA [70] from absenteeism and presenteeism, be reported according to the Standards for Reporting measured with the Work Productivity and Activity Im- Implementation Studies (StaRI) [76]. pairment Questionnaire (WPAI) [71]. The scope of the cost data collection was based on the validated OA Cost Qualitative study methodology and Consequences Questionnaire (OCC-Q) [72] and A combination of deductive and iterative approaches will adapted to the Singapore context to ensure that all rele- be used. A literature review will be conducted to gener- vant sources of cost were collected. The cost question- ate themes for the study topic guide. A combination of naire used can be found in Additional file 3. Cost data questionnaires and semi-structured interviews will be will be collected at 3 monthly intervals till 1-year follow- conducted based on the topic guide. Purposeful sam- up. pling with both healthcare professionals and patients in- The primary measure of health benefit will be Quality volved in the study will be used to identify appropriate of Life Years (QALYs) measured using the EQ-5D [51]. participants for interviews. The incremental cost-effectiveness ratio (ICER) over the Interviews will be conducted by an independent asses- trial period of this multidisciplinary non-surgical sor with previous experience in qualitative research not community-based program for knee OA compared to directly involved in the care of the patients. Any inter- usual care will be determined. viewer pre-existing bias will be identified and recorded. Transcripts and audio recordings will be stored digitally COMPONENT 3: implementation and evaluation and analysed using a qualitative analysis program to framework code data, link concepts, examine similarities and differ- RE-AIM framework ences and review patterns and themes. Coding will be The RE-AIM framework has been proposed as an appro- done iteratively. priate model to strengthen the case for policy change Themes emanating from transcripts will be identified and implementation for knee OA [11]. A recent study in through a framework method approach done by 2 inde- Canada in 2018 used the RE-AIM model to evaluate the pendent researchers supervised by a senior researcher cross-cultural adaption and implementation of the GLA: with significant experience in qualitative research to en- D program [30] for hip and knee OA [73]. Table 4 sure inter-observer reliability. Using the framework Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 10 of 13 Table 4 RE-AIM framework and Data Collection Dimension Definition Data Collection Reach The absolute number, proportion, and representativeness CONSORT flow Eligibility Log and reasons for of individuals who are willing to participate in a given non-participation Reasons for withdrawals initiative, intervention, or program. Qualitative methods Effectiveness The impact of an intervention on important outcomes, Primary and secondary outcomes Adverse including potential negative effects, quality of life, and outcomes Economic Evaluation economic outcomes. Adoption The absolute number, proportion, and representativeness Qualitative Methods with Healthcare of settings and intervention agents (people who deliver Professionals the program) who are willing to initiate a program. Implementation At the setting level, implementation refers to the Compliance (attendance logs, SIRAS, exercise intervention agents’ fidelity to the various elements adherence questionnaire) Process evaluation of an intervention’s protocol, including consistency of through Qualitative methods delivery as intended and the time and cost of the intervention. At the individual level, implementation refers to clients’ use of the intervention strategies. Maintenance The extent to which a program or policy becomes 12-month outcome measures Process evaluation institutionalized or part of the routine organizational through Qualitative methods practices and policies. Within the RE-AIM framework, maintenance also applies at the individual level. At the individual level, maintenance has been defined as the long-term effects of a program on outcomes after 6 or more months after the most recent intervention contact. method, the data is reduced through a matrix comparing outcomes to the degree of flexibility of intervention per- categories of data [77]. The framework method has been mitted. With rapidly evolving healthcare systems, com- shown to be an appropriate method for the evaluation of plex interventions are being developed in the common multidisciplinary complex intervention. Data will be drive to provide cost effective, sustainable care for pa- sampled till saturation. Results will be reported accord- tients. However due its inherent nature, there are issues ing to the Consolidated criteria for reporting qualitative in describing, developing, documenting and implement- research (COREQ) guideline [78]. ing complex intervention [80]. CONNACT MoC is a complex intervention that aims to promote long term sustainable behavioural change for pa- Discussion and conclusion tients with knee OA. In line with the MRC guidance for de- A rapidly aging global population has resulted in an OA veloping and evaluating complex interventions, building epidemic that is currently being poorly managed on a glo- from a pilot feasibility study, this study protocol describes a bal scale. CONNACT is a community-based, multidiscip- comprehensive approach including an RCT, economic linary 12-week program that uniquely uses an evaluation and process evaluation using a mixed method individualized approach based on a triaging criterion to approach. The primary aim of this study is to determine tailor the treatment to each patient coupled with a strong the clinical effectiveness of the CONNACT MoC compared emphasis on patient activation and self-management. to usual care. The secondary aims are: a) To determine the Traditional MoC for knee OA utilize a step-wise approach cost-effectiveness and b) To develop an evaluation and im- where all patients get baseline education, exercise and plementation framework to inform large scale implementa- weight loss advice before gradually moving up the treat- tion for this MoC. The study will utilize an explanatory ment ladder if treatment is unsuccessful [79]. In line with sequential mixed methods design where the qualitative data the “right care, delivered at the right time,bythe right will be critical in providing context for the quantitative re- team,inthe right place,with the right resources” philoso- sults allowing for a clearer interpretation. phy, CONNACT proposes the use of an individualized ap- Results from this study will help clinicians and health- proach through the use of a triaging criterion. care administrators work side by side to avoid the “valley A complex intervention is defined by the MRC as an of death”, bridge the gap between research and clinical intervention that contains several interacting compo- practice, guiding the sustainable and effective large-scale nents [12]. There are several dimensions of complexity implementation of the CONNACT MoC for knee OA. that can exist including the interaction between compo- In addition, CONNACT can serve as a basis for similar nents of the control and intervention arms, difficulty of multidisciplinary complex MoC for chronic degenerative behaviours change required to deliver or receive the musculoskeletal conditions to be developed in line with intervention, number of groups targeted, variability of the MRC guidelines. Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 11 of 13 Supplementary information Received: 7 July 2020 Accepted: 1 October 2020 The online version contains supplementary material available at https://doi. org/10.1186/s12891-020-03695-3. References Additional file 1. Appendix 1 – Intervention Description. (DOCX 26 kb) 1. Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, et al. The global burden of hip and knee osteoarthritis: estimates from the global burden of Additional file 2. Appendi× 2 – Patient Reported Exercise Compliance disease 2010 study. Ann Rheum Dis. 2014;73(7):1323–30. Questionnaire. (PDF 265 kb) 2. McGrory B, Weber K, Lynott JA, Richmond JC, Davis CM 3rd, Yates A Jr, et al. Additional file 3. Appendi× 3 – Cost Questionnaire. (DOCX 43 kb) The American Academy of Orthopaedic surgeons evidence-based clinical Additional file 4. Appendix 4 – SPIRIT diagram. (DOC 74 kb) practice guideline on surgical Management of Osteoarthritis of the knee. J Bone Joint Surg Am. 2016;98(8):688–92. Additional file 5. Appendix 5 – SPIRIT checklist. (DOC 124 kb) 3. McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma- Zeinstra SM, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthr Cartil. 2014;22(3):363–88. Abbreviations 4. Australian Institute for Health and Welfare (2010). Use of health services for CONNACT: Collaborative Model of Care between Orthopaedics and Allied arthritis and osteoporosis, in Arthritis Series no. 14. Cat. no. PHE 130. AIHW: Health Professionals Trial; MSK: Musculoskeletal; OA: Osteoarthritis; Canberra. MoC: Model of Care; RCT: Randomized Controlled Trial; NICE: National 5. Basedow M, Esterman A. Assessing appropriateness of osteoarthritis care Institute of Health and Care Excellence; ACSM: American College of Sports using quality indicators: a systematic review. J Eval Clin Pract. 2015;21(5): Medicine; NEMEX: Neuromuscular Exercise; OARSI: OA Research Society 782–9. International; KOOS: Knee Injury and OA Outcome Score; EQ-5D-5L: EuroQol 6. Hagen KB, Smedslund G, Osteras N, Jamtvedt G. Quality of community- 5 dimensions 5 level; BMI: Body Mass Index; PHQ-4: Patient Health based osteoarthritis care: a systematic review and meta-analysis. Arthritis Questionnaire 4; PEG: Pain, Enjoyment, General Activity Scale; Care Res (Hoboken). 2016;68(10):1443–52. ACT: Acceptance and Commitment Therapy; FFQ: Food Frequency 7. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and Questionnaire; ITT: Intention-to-treat; PAM: Patient Activation Measure; revision hip and knee arthroplasty in the United States from 2005 to 2030. J GPE: Global Perceived Effect; PASS: Patient Acceptable Symptom State; SIRA Bone Joint Surg Am. 2007;89(4):780–5. S: Sports Injury Rehabilitation Adherence Scale; PI: Principal Investigator; 8. Coggon D, Reading I, Croft P, McLaren M, Barrett D, Cooper C. Knee SD: Standard Deviation; GLMM: Generalized Linear Mixed Model osteoarthritis and obesity. Int J Obes Relat Metab Dis. 2001;25(5):622–7. 9. Mulcahy H, Chew FS. Current concepts in knee replacement: complications. Acknowledgements AJR Am J Roentgenol. 2014;202(1):W76–86. NA 10. Grover A, Joshi A. An overview of chronic disease models: a systematic literature review. Global J Health Sci. 2014;7(2):210–27. Authors’ contributions 11. Allen KD, Choong PF, Davis AM, Dowsey MM, Dziedzic KS, Emery C, et al. BYT was the lead investigator. All the authors (BYT, MJP, YSY, DJH, STS, JT, JC) Osteoarthritis: models for appropriate care across the disease continuum. were involved in the study methodology design and the preparation of the Best Pract Res Clin Rheumatol. 2016;30(3):503–35. manuscript and have approved the final manuscript. 12. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ (Clin Res ed). 2008;337:a1655. Funding 13. Tan BY, Ding BTK, Pereira MJ, Skou ST, Thumboo J, Car J. Collaborative Ng Teng Fong Health Innovation Program Grant $200,000. The funding body Model of Care between Orthopaedics and Allied Healthcare Professionals was not involved in the study design. Trial (CONNACT) – A Feasibility Study in patients with knee osteoarthritis using a mixed method approach. PREPRINT (Version 1) available at Research Availability of data and materials Square. 2020. Not applicable. 14. Peters D, Tran N, Adam T, Alliance for Health Policy and Systems Research, World Health Organization. Implementation research in health: a practical guide. 2013. Ethics approval and consent to participate 15. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness- Ethics approval was obtained through the Institution Review Board prior to implementation hybrid designs: combining elements of clinical the conduct of the study (National Healthcare Group Domain Specific effectiveness and implementation research to enhance public health Review Board Ref: 2018/00408). Written consent will be obtained from the impact. Med Care. 2012;50(3):217–26. study participants. 16. Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011;104(12): Consent for publication 510–20. NA 17. Klesges LM, Estabrooks PA, Dzewaltowski DA, Bull SS, Glasgow RE. Beginning with the application in mind: designing and planning health Competing interests behavior change interventions to enhance dissemination. Ann Behav Med. The authors declare that they have no competing interest. 2005;29(2):66–75. 18. Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The Author details PRECIS-2 tool: designing trials that are fit for purpose. BMJ (Clin Res ed). Department of Orthopaedic Surgery, Woodlands Health Campus, National 2015;350:h2147. Healthcare Group, Singapore, Singapore. Singapore General Hospital, 19. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Singapore City, Singapore. Health Services Outcome Research, National et al. SPIRIT 2013 statement: defining standard protocol items for clinical Healthcare Group, Singapore City, Singapore. Tan Tock Seng Hospital, trials. Ann Intern Med. 2013;158(3):200–7. Singapore City, Singapore. Institute of Bone and Joint Research, Kolling 20. McAlindon TE, Driban JB, Henrotin Y, Hunter DJ, Jiang GL, Skou ST, et al. Institute, University of Sydney and Rheumatology Department, Royal North OARSI clinical trials recommendations: design, conduct, and reporting of Shore Hospital, Sydney, Australia. Department of Sports Science and Clinical clinical trials for knee osteoarthritis. Osteoarthr Cartil. 2015;23(5):747–60. Biomechanics, Research Unit for Musculoskeletal Function and Physiotherapy, 21. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, University of Southern Denmark, Odense M, Denmark. Department of et al. CONSORT 2010 explanation and elaboration: updated guidelines for Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted reporting parallel group randomised trials. BMJ (Clin Res ed). 2010;340:c869. Hospitals, Slagelse, Denmark. Lee Kong Chian School of Medicine, Nanyang 22. National Institute for Health and Care Excellence (NICE) Guideline 2014. Technological University, Singapore City, Singapore. Osteoarthritis: care and management. Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 12 of 13 23. Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann knee osteoarthritis. Effectiveness of Supplementing a Home Exercise Rheum Dis. 1957;16(4):494–502. Programme With a Class Based Exercise Programme in the Treatment of 24. Roos EM, Lohmander LS. The knee injury and osteoarthritis outcome score Knee Osteoarthritis. 2001:1-. (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003; 49. Burke S, Carron A, Eys M, Ntoumanis N, Estabrooks P. Group versus 1:64. individual approach? A meta-analysis of the effectiveness of interventions to 25. Tan BY, Ding BTK, Pereira MJ, Skou ST, Thumboo J, Car J. Collaborative promote physical activity. Sport Exer Psychol Rev. 2005;2. model of care between Orthopaedics and allied healthcare professionals 50. Messier SP, Callahan LF, Golightly YM, Keefe FJ. OARSI clinical trials trial (CONNACT) - a feasibility study in patients with knee osteoarthritis recommendations: design and conduct of clinical trials of lifestyle diet and using a mixed method approach. BMC Musculoskelet Disord. 2020;21(1):592. exercise interventions for osteoarthritis. Osteoarthr Cartil. 2015;23(5):787–97. 26. Sanders JO, Murray J, Gross L. Non-arthroplasty treatment of osteoarthritis of 51. EuroQol--a new facility for the measurement of health-related quality of life. the knee. J Am Acad Orthop Surg. 2014;22(4):256–60. Health policy (Amsterdam, Netherlands). 1990;16(3):199–208. 27. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. 52. Neelakantan N, Whitton C, Seah S, Koh H, Rebello SA, Lim JY, et al. Better reporting of interventions: template for intervention description and Development of a Semi-Quantitative Food Frequency Questionnaire to replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. Assess the Dietary Intake of a Multi-Ethnic Urban Asian Population. 28. Slade S, Dionne C, Underwood M, Buchbinder R, Beck B, Bennell K, et al. Nutrients. 2016;8(9). Consensus on exercise reporting template (CERT): modified Delphi study. 53. Scott W, McCracken LM. Patients' impression of change following treatment Phys Ther. 2016;96. for chronic pain: global, specific, a single dimension, or many? J Pain. 2015; 29. American College of Sport Medicine (ACSM) Guidelines for Exercise Testing 16(6):518–26. and Prescription. 54. Dougados M, Moore A, Yu S, Gitton X. Evaluation of the patient acceptable 30. Skou ST, Roos EM. Good life with osteoArthritis in Denmark (GLA:D): symptom state in a pooled analysis of two multicentre, randomised, evidence-based education and supervised neuromuscular exercise delivered double-blind, placebo-controlled studies evaluating lumiracoxib and by certified physiotherapists nationwide. BMC Musculoskelet Disord. 2017; celecoxib in patients with osteoarthritis. Arthritis Res Ther. 2007;9:R11. 18(1):72. 55. Kolt GS, Brewer BW, Pizzari T, Schoo AMM, Garrett N. The sport injury 31. National Institute for Health and Care Excellence (NICE) Guideline 2014. rehabilitation adherence scale: a reliable scale for use in clinical Weight management: lifestyle services for overweight or obese adults. . physiotherapy. Physiotherapy. 2007;93(1):17–22. 32. Hayes SC SK, Wilson KG. Acceptance and commitment therapy (an 56. Naal FD, Impellizzeri FM, Leunig M. Which is the best activity rating scale for experiential approach to behavior change): New York: a division of patients undergoing total joint arthroplasty? Clin Orthop Relat Res. 2009; Guildford publications Inc; 1999. 467(4):958–65. 33. Yang S-Y, McCracken L. Acceptance and commitment therapy for chronic 57. Schoenthaler M, Miernik A, Offner K, Karcz WK, Hauschke D, Sevcenco S, pain. J Clin Outcomes Manag. 2014;21:134–44. et al. The cumulative analgesic consumption score (CACS): evaluation of a 34. Ngooi B. What are the crucial components of patient activation new score to describe postsurgical analgesic consumption as a surrogate interventions? Biomedical Journal of Scientific & Technical Research. 2017;1. parameter for postoperative pain and invasiveness of surgical procedures. 35. Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for Int Braz J Urol. 2014;40(3):330–6. anxiety and depression: the PHQ-4. Psychosomatics. 2009;50(6):613–21. 58. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying 36. Krebs EE, Lorenz KA, Bair MJ, Damush TM, Wu J, Sutherland JM, et al. prognostic comorbidity in longitudinal studies: development and validation. Development and initial validation of the PEG, a three-item scale assessing J Chronic Dis. 1987;40(5):373–83. pain intensity and interference. J Gen Intern Med. 2009;24(6):733–8. 59. Mahoney FI, Barthel DW. FUNCTIONAL EVALUATION: The BARTHEL index. 37. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of Maryland State Med J. 1965;14:61–5. a short form of the patient activation measure. Health Serv Res. 2005;40(6 Pt 60. Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip 1):1918–30. fracture. J Bone Joint Surg Br Volume. 1993;75(5):797–8. 38. Sharma A, Kudesia P, Shi Q, Gandhi R. Anxiety and depression in patients 61. Skou ST, Rasmussen S, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen with osteoarthritis: impact and management challenges. Open Access O, et al. The efficacy of 12 weeks non-surgical treatment for patients not Rheumatol. 2016;8:103–13. eligible for total knee replacement: a randomized controlled trial with 1- 39. Sharma L, Cahue S, Song J, Hayes K, Pai Y-C, Dunlop D. Physical functioning year follow-up. Osteoarthr Cartil. 2015;23(9):1465–75. over three years in knee osteoarthritis: role of psychosocial, local mechanical, 62. Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, et al. Cross-cultural and neuromuscular factors. Arthritis Rheum. 2003;48(12):3359–70. adaptation and validation of Singapore English and Chinese versions of the 40. Cleeland CS, Ryan KM. Pain assessment: global use of the brief pain knee injury and osteoarthritis outcome score (KOOS) in Asians with knee inventory. Ann Acad Med Singap. 1994;23(2):129–38. osteoarthritis in Singapore. Osteoarthr Cartil. 2006;14(11):1098–103. 41. Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. 63. Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, et al. Interpreting the clinical importance of treatment outcomes in chronic pain OARSI recommended performance-based tests to assess physical function clinical trials: IMMPACT recommendations. J Pain. 2008;9(2):105–21. in people diagnosed with hip or knee osteoarthritis. Osteoarthr Cartil. 2013; 21(8):1042–52. 42. Wise BL, Niu J, Zhang Y, Wang N, Jordan JM, Choy E, et al. Psychological factors and their relation to osteoarthritis pain. Osteoarthr Cartil. 2010;18(7): 64. Terwee CB, Bouwmeester W, van Elsland SL, de Vet HC, Dekker J. 883–7. Instruments to assess physical activity in patients with osteoarthritis of the 43. Hibbard JH, Greene J. What the evidence shows about patient activation: hip or knee: a systematic review of measurement properties. Osteoarthr better health outcomes and care experiences; fewer data on costs. Health Cartil. 2011;19(6):620–33. affairs (Project Hope). 2013;32(2):207–14. 65. Luo N, Wang P, Thumboo J, Lim YW, Vrijhoef HJ. Valuation of EQ-5D-3L 44. Hibbard JH, Greene J, Tusler M. Improving the outcomes of disease health states in Singapore: modeling of time trade-off values for 80 management by tailoring care to the patient's level of activation. Am J empirically observed health states. PharmacoEconomics. 2014;32(5):495–507. Manag Care. 2009;15(6):353–60. 66. Roddy E, Zhang W, Doherty M, Arden NK, Barlow J, Birrell F, et al. Evidence- 45. Hsu WC, Araneta MRG, Kanaya AM, Chiang JL, Fujimoto W. BMI cut points based recommendations for the role of exercise in the management of to identify at-risk Asian Americans for type 2 diabetes screening. Diabetes osteoarthritis of the hip or knee--the MOVE consensus. Rheumatology Care. 2015;38(1):150. (Oxford, England). 2005;44(1):67–73. 46. Yang S-Y, McCracken LM, Moss-Morris R. Psychological treatment needs for 67. McLean S, Holden MA, Potia T, Gee M, Mallett R, Bhanbhro S, et al. Quality chronic pain in Singapore and the relevance of the psychological flexibility and acceptability of measures of exercise adherence in musculoskeletal model. Pain Med. 2016;18(9):1679–94. settings: a systematic review. Rheumatology (Oxford, England). 2017;56(3): 47. Lally P, van Jaarsveld CHM, Potts HWW, Wardle J. How are habits formed: 426–38. Modelling habit formation in the real world. Eur J Soc Psychol. 2010;40(6): 68. Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, et al. 998–1009. Recommendations for conduct, methodological practices, and reporting of 48. McCarthy CJ. The effectiveness of supplementing a home exercise cost-effectiveness analyses: second panel on cost-effectiveness in health programme with a class based exercise programme in the treatment of and medicine. Jama. 2016;316(10):1093–103. Tan et al. BMC Musculoskeletal Disorders (2020) 21:684 Page 13 of 13 69. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEE RS) statement. BMJ (Clin Res ed). 2013;346:f1049. 70. Rice DP. Estimating the cost of illness. Am J Public Health Nation’s Health. 1967;57(3):424–40. 71. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. PharmacoEconomics. 1993; 4(5):353–65. 72. Pinto D, Robertson MC, Hansen P, Abbott JH. Good agreement between questionnaire and administrative databases for health care use and costs in patients with osteoarthritis. BMC Med Res Methodol. 2011;11:45. 73. Davis AM, Kennedy D, Wong R, Robarts S, Skou ST, McGlasson R, et al. Cross-cultural adaptation and implementation of good life with osteoarthritis in Denmark (GLA:D): group education and exercise for hip and knee osteoarthritis is feasible in Canada. Osteoarthr Cartil. 2018;26(2):211–9. 74. Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ (Clin Res ed). 2015;350:h1258. 75. Briggs AM, Jordan JE, Jennings M, Speerin R, Bragge P, Chua J, et al. Supporting the evaluation and implementation of musculoskeletal models of care: a globally informed framework for judging readiness and success. Arthritis Care Res (Hoboken). 2017;69(4):567–77. 76. Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, et al. Standards for Reporting Implementation Studies (StaRI) Statement. BMJ (Clin Res Ed). 2017;356:i6795. 77. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:117. 78. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349–57. 79. Roos EM, Juhl CB, Roos EM, Juhl CB. Osteoarthritis 2012 year in review: rehabilitation and outcomes. Osteoarthritis Cartilage. 2012;20(12):1477–83. 80. Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, et al. Designing and evaluating complex interventions to improve health care. BMJ (Clin Res Ed). 2007;334(7591):455–9. Publisher’sNote Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Journal

BMC Musculoskeletal Disorders – Springer Journals

Published: Oct 16, 2020

There are no references for this article.