Factors associated with clinically relevant pain reduction after a self-management program including education and exercise for people with knee and/or hip osteoarthritis: Data from the BOA register

Thérése Jönsson; Frida Eek; Eva Ekvall Hansson; Leif E Dahlberg; Andrea Dell’Isola

doi:10.1371/journal.pone.0282169

. 2023 Feb 24;18(2):e0282169. doi: 10.1371/journal.pone.0282169

Factors associated with clinically relevant pain reduction after a self-management program including education and exercise for people with knee and/or hip osteoarthritis: Data from the BOA register

Thérése Jönsson ^1,^*, Frida Eek ², Eva Ekvall Hansson ², Leif E Dahlberg ³, Andrea Dell’Isola ⁴

Editor: Hamid Reza Baradaran⁵

PMCID: PMC9955666 PMID: 36827245

Abstract

Aim

To examine the associations between individual- and disease-related factors and the odds of reaching a clinically relevant pain reduction in people with knee and/or hip osteoarthritis (OA) who underwent a first-line self-management program.

Materials and methods

An observational registry-based study including people with knee (n = 18,871) and hip (n = 7,767) OA who participated in a self-management program including education and exercise and had data recorded in the Better Management of patients with Osteoarthritis (BOA) register. We used multivariable logistic regression models to study the association between sex, age, body mass index (BMI), education, comorbidity, pain frequency, walking difficulties, willingness to undergo surgery and the odds of reaching a clinically relevant pain reduction (decrease of >33% on a 0–10 NRS scale) 3 and 12 months after the intervention. All analyses were stratified by joint (knee/hip).

Results

Both in the short- and long-term follow-up, a younger age (18–65 years), a lower BMI (< 25), a higher level of education (university), the absence of comorbidities impacting the ability to walk, less frequent pain and not being willing to undergo surgery were associated with higher odds of reaching a clinically relevant pain reduction in people with knee OA. We found similar results for people with hip OA, but with larger uncertainty in the estimates (wider 95% CI).

Conclusion

Our study suggests that early fist line self-management interventions delivered when people have unilateral hip or knee OA with less frequent pain and are unwilling to undergo surgery, may be important for reaching a clinically relevant pain reduction after participation. Providing the most appropriate treatment to the right patient at the right time is a step in reducing the burden of OA for society and the patient.

Introduction

Osteoarthritis (OA) in the knee and/or hip is the most common joint disease in the world and a high contributor to global disability [1]. In both knee and hip OA, pain is a cardinal symptom and typically become more severe, more frequent, and more disability over time significantly impacting a person quality of life and psychological wellbeing [1, 2]. In the absence of disease-modifying interventions, available first-line treatments including patient education and individualized exercise aim to reduce pain and improve function [3]. According to national and international guidelines, first-line core treatments should be offered to all people with OA of the knee and/or hip [4–7].

The Better Management of Patients with Osteoarthritis (BOA) is a Swedish National Quality register that evaluates the results from a self-management program following national and international guidelines and includes patient education and individual-adapted exercises, conducted at primary health care units all over Sweden [8]. Results from the BOA register has demonstrated improvement in pain at 3- and 12-months follow-up in people with knee and/or hip OA [9–11], but how different people respond to the self-management program in BOA, vary greatly [10, 11]. Previous studies have shown that factors like OA location (hip or knee), sex, age, body mass index (BMI), comorbidity, duration of symptoms, and pain at baseline are associated with outcome after a physiotherapy (PT) intervention in people with OA in the knee and/or hip [12–17]. However, most studies have shown an association between these factors and change in pain, but few studies have evaluated whether these associations are clinically relevant. Therefore, this study aimed to examine associations between individual- as well as disease-related factors and the odds of clinically relevant pain reduction after participation in a self-management program, delivered at a primary care level, in people with knee and/or hip OA.

Materials and method

Design and sample selection

The present study was an observational registry-based study and comprises data from the BOA register between 2008 and 2016. The BOA register contains data from people with knee and/or hip OA who have been participating in a self-management program including education and individual-adapted exercise [8]. The inclusion criteria for the participants to access the self-management program were symptoms from knee and/or hip that resulted in contact with the health care system. The exclusion criterions were, a reason other than OA for joint problems (e.g., sequel hip fractures, chronic widespread pain, inflammatory joint diseases, neuromuscular diseases or cancer); total joint replacement within the past 12 months; other surgery of the knee or hip joint within the past 3 months; and people not able to read or understand Swedish. The BOA register contains PT-reported data about the most affected joint, previous treatment, and compliance to the intervention and patient-reported outcomes from participants in the self-management program [8]. To be included in the present study, the participants must have received at least the theory part of the self-management program and have data from baseline, 3- and 12-months follow-up. A two months’ delay for the 3-months follow-up and a three months’ delay for the 12-months follow-up were allowed for pragmatic reasons, based on an expected delay for some people due to unforeseen circumstances. Data about the index joint (knee or hip), were extracted from the physiotherapy form; in the case of bilateral or multi-joint OA, the most affected joint was chosen by the PT. The participants in the BOA register were treated in more than 500 different care units at a primary care level in Sweden.

Intervention

The self-management program has previously been described [8, 11]. Briefly, it consists of a mandatory part with two theoretical group sessions led by a physiotherapist (PT) with 7–12 participants in each group. Following the education, participants can decide to undergo a face-to-face session with a trained PT who designs a personalized exercise program based on the participant’s needs and goals. Patients could thereafter choose to perform the exercises on their own (at home), or during PT-supervised group exercise classes twice a week for 6–8 weeks. The intervention is followed up by an individual visit at 3 months and by a postal questionnaire at 12 months. All participants in the self-management program are supposed to fill in a questionnaire at baseline, 3- and 12-months follow-up.

Ethics statement

The study was approved by the Regional Ethical Review Board in Gothenburg (1059–16).

The data we have used is manually registered in the BOA registry, which is a national quality register separate from patients’ medical records. Use of data from a national quality register is regulated by the Swedish patient data act. To be registered in a national quality register, it is required that the patient is informed and given the opportunity to opt out. All people in present study have received oral or written information about the registration to the BOA register. The information must include that the data may be used for research after approval from a research ethical board. The research ethical board decides if consent is required or not, and if data should be anonymized. The ethical board decision was that no further information or consent is required, and that data must be anonymized, which is the case in present study.

Measures

Outcome

Clinical relevant pain reduction. A Numeric Rating Scale (NRS pain 0–10) was used to record baseline pain intensity, asking for the mean pain during the last week [18, 19]. A clinically relevant pain reduction was defined as a decrease of >33% on NRS for pain. This cut-off is based on a prospective cohort study from Salaffi et al there they assessed patient’s pain intensity by the numerical rating scale (NRS) at baseline and at the 3-month follow-up, and by a patient’s global impression of change (PGIC) questionnaire [20]. A reduction of 33% was defined as a clinical relevant pain reduction and associated with feeling “much better” [20]. This cut-off has previously been validated in a sample of people with OA and other chronic rheumatic conditions [20, 21]. The decrease in NRS pain was calculated between baseline and 3- as well as 12-months follow-up.

Independent/exposure factors

Individual factors. Included independent variables regarding individual factors were sex (men/women), age categorized into three age groups: working age (18–64 years), younger retirees (65–74 years), and older retirees (≥75 years). BMI was classified according to WHO into underweight (<18.5 kg/m²), normal weight (18.5–24.9 kg/m²), overweight (25–29.9 kg/m²) and obese (≥30 kg/m²) [22]. Because of low numbers in the underweight category, underweight and normal-weight people were merged into one category. Education level was divided into three groups: compulsory school, high school, and university.

Disease-related factors. The Charnley classification is a measure on the impact of comorbidity on walking score and categorizes people into one of three groups: A–one joint with osteoarthritis (unilateral knee or hip); B–bilateral osteoarthritis (both knees or both hips); C–osteoarthritis in multiple joint sites (hip and knee) or presence of any other disease that affects walking ability [23]. Pain frequency was assessed by the question: “How often do you have pain in your knee/hip,” with five possible answers: never, every month, every week, every day, or all the time. Because of low numbers in the categories never and every month, the two were merged into one category. Walking disability was assessed by the question: “Do you have a walking disability caused by your OA” (Yes/No). Willingness to undergo surgery was assessed by the question: “Are your knee/hip symptoms so severe that you wish to undergo surgery?” (Yes/No).

Covariates. The covariates health-related quality of life (EQ-5D VAS), NRS pain at baseline, and previous surgery to the most affected joint were included in the analyses as potential confounders. Quality of life was measured using the EuroQol five dimensions visual analog scale (EQ-5D VAS 0–100) [24]. The EQ-5D VAS was used to adjust for baseline mental status as recommended by the International Consortium for Health Outcomes Measurement for hip and/or knee OA [25]. Previous surgery to the most affected joint was recorded by the PT at baseline, this question was used to adjust for worst symptoms due to surgery; studies indicate that previous surgery is associated longitudinally with worse symptoms in people with knee OA [26].

Statistics

All statistical analyses were performed using IBM SPSS Statistics (version 25.0, IBM Corp., Armonk, NY, USA). All the analyses were stratified based on the most affected joint (knee, or hip). Descriptive statistics were conducted to provide an overview of the specific characteristics of the participants in the study. Crude (separate for each independent/exposure variable) and multivariable logistic regression models were applied to examine the odds of reaching a clinically relevant pain reduction at 3- and 12-months follow-up for groups based on individual- and disease-related factors. The results are presented using odds ratios (ORs) and 95% confidence intervals (CIs) from both crude and adjusted models. The level of significance was set at p < 0.05.

Results

A total of 51,627 people (mean age 66 years, 70% female) with knee or hip OA participated in the mandatory theory part and were eligible for the study. Of these, 26,638 people with the knee (n = 18,871) and hip (n = 7,767) had data from at least one of the follow-ups and were included in the study. The baseline characteristics of included and excluded people with knee and hip OA and the response rate are described in Tables 1 and 2. The reason for dropouts is described in Fig 1. At the 3-month follow-up, 43% of people with knee OA and 37% of people with hip OA experienced clinically relevant pain reduction. At the 12-month follow up 38% of people with knee OA and 29% of people with hip OA reach clinically relevant pain reduction.

Table 1. Characteristics of patients with knee OA population (n = 18871).

Variables	Knee
			3-month follow-up		12-month follow-up
			Pain reduction		Pain reduction
	Excluded	Total group	≥ 33%	< 33%	≥ 33%	< 33%
	n = 1 6497	n = 1 8871	n = 8 197	n = 1 0674	n = 7 161	n = 11 495
Sex, % (n)
women	69 (11 424)	70 (13 297)	71 (5 802)	70 (7 495)	71 (5 111)	70 (8 027)
Missing, n	44	0	0	0	0	0
Age, % (n)
18–64	43 (7 111)	39 (7 272)	39 (3 210)	38 (4 062)	40 (2 833)	38 (4 372)
65–74	40 (6 562)	43 (8 208)	44 (3 635)	43 (4 573)	45 (3 196)	43 (4 903)
> = 75	17 (2 780)	18 (3 391)	17 (1 352)	19 (2 039)	16 (1 132)	19 (2 220)
Missing, n	44	0	0	0	0	0
Body mass index, % (n)
˂ 25	22 (3 666)	26 (4 808)	28 (2 228)	25 (2 580)	29 (2 054)	24 (2 692)
≥25–30	42 (6 951)	44 (8 171)	45 (3 601)	44 (4 570)	45 (3 161)	44 (4 920)
>30	33 (5 470)	30 (5 571)	28 (2 233)	32 (3 338)	26 (1 839)	33 (3 672)
Missing, n	410	321	135	186	107	211
Education, % (n)
Compulsory school	35 (5 666)	34 (6 346)	32 (2 612)	35 (3 734)	30 (2 129)	36 (4 124)
High school	38 (6 268)	37 (6 914)	37 (2 982)	37 (3 932)	37 (2 607)	37 (4 232)
University	27 (4 447)	29 (5 560)	32 (2 582)	28 (2 978)	34 (2 410)	27 (3 103)
Missing, n	116	51	21	30	15	36
Charnley Category^*, % (n)
A	37 (6 099)	39 (7 360)	45 (3 661)	35 (3 699)	48 (3 439)	33 (3 828)
B	22 (3 661)	24 (4 502)	23 (1 890)	25 (2 612)	22 (1 594)	25 (2 856)
C	40 (6 672)	37 (6 986)	32 (2 642)	41 (4 344)	30 (2 122)	42 (4 794)
Missing, n	65	23	4	19	6	17
NRS pain^** (0–10), mean (SD)	5.4 (2)	5.1 (1.9)	5.4 (1.8)	5 (2)	5.3 (1.9)	5 (2)
Missing, n	109	0	0	0	0	0
Pain frequency, % (n)
Less than every month	7 (1 155)	6 (1 215)	7 (551)	6 (660)	7 (518)	6 (674)
Every week	13 (2 145)	13 (2 455)	14 (1 132)	12 (1 312)	14 (1 033)	12 (1 383)
Every day	61 (1 0063)	62 (11 840)	64 (5 245)	61 (6 536)	64 (4 549)	62 (7 109)
All the time	19 (3 134)	18 (3 391)	15 (1 251)	20 (2 130)	15 (1 043)	20 (2 294)
Missing	49	63	18	36	18	35
Walking difficulties % (n)
Yes	79 (13 032)	78 (14 787)	78 (6 371)	78 (8 346)	76 (5 425)	80 (9 122)
Missing, n	164	107	40	61	40	59
Previous surgery, % (n)
Yes	19 (3 061)	17 (3 206)	16 (1 318)	18 (1 888)	15 (1.070)	18 (2103)
Missing, n	46	44	12	20	13	19
EQ-%D VAS^*** (0–100), mean (SD)	66 (19)	68 (19)	70 (18)	67 (19)	71 (18)	67 (19)
Missing, n	2 520	3 698	1 488	2 210	1 306	2 308
Willingness of surgery, % (n)
Yes	27 (4 480)	20 (3 777)	17 (1 378)	22 (2 319)	15 (1 073)	23 (2 570)
Missing, n	247	160	63	97	57	100

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** Numeric rating scale,

*** EuroQol five-dimensional visual analogue scale.

Table 2. Characteristics of patients with hip OA (n = 7767).

Variables	Hip
			3-month follow-up		12-month follow-up
			Pain reduction		Pain reduction
	Excluded	Total group	≥ 33%	< 33%	≥ 33%	< 33%
	n = 8 399	n = 7 767	n = 2 862	n = 4 868	n = 2 259	n = 5 363
Sex, % (n)
women	67 (5 616)	70 (5 462)	71 (2 036)	70 (3 396)	71 (1 610)	70 (3 756)
Missing, n	18	0	0	0	0	0
Age, % (n)
18–64	37 (3 117)	33 (2 573)	33 (957)	33 (1 609)	32 (722)	34 (1 809)
65–74	43 (3 603)	46 (3 605)	48 (1 373)	46 (2 216)	49 (1 099)	46 (2 447)
> = 75	20 (1 661)	21 (1 589)	19 (532)	21 (1 043)	19 (438)	21 (1 107)
Missing, n	18	0	0	0	0	0
Body mass index, % (n)
˂ 25	32 (2 688)	37 (2 834)	38 (1 083)	36 (1 738)	41 (918)	35 (1 862)
≥25–30	43 (3 643)	42 (3 267)	43 (1 216)	43 (2 039)	43 (962)	43 (2 249)
>30	23 (8 225)	20 (1 546)	19 (527)	21 (1 010)	16 (349)	22 (1 168)
Missing, n	174	120	36	81	30	84
Education, % (n)
Compulsory school	35 (2 946)	35 (2 687)	34 (956)	35 (1 714)	33 (740)	35 (1 880)
High school	37 (3 072)	35 (2 697)	34 (960)	36 (1 728)	34 (754)	36 (1 897)
University	28 (2 331)	30 (2 355)	33 (937)	29 (1 407)	34 (760)	29 (1 563)
Missing, n	50	28	9	19	5	23
Charnley Category^*, % (n)
A	38 (3 186)	38 (2 911)	39 (1 143)	36 (1 753)	43 (967)	35 (1 878)
B	9 (766)	12 (896)	12 (347)	11 (546)	13 (289)	11 (596)
C	53 (4 420)	51 (3 949)	48 (1 366)	53 (2 564)	44 (1 001)	54 (2 880)
Missing, n	27	11	6	5	2	9
NRS pain^** (0–10), mean (SD)	5.6 (1.9)	5.1 (1.9)	5.4 (1.8)	5 (2)	5.4 (1.8)	5.1 (2)
Missing, n	45	50	0	0	0	0
Pain frequency, % (n)
Less than every month	4 (297)	5 (416)	6 (172)	5 (241)	6 (130)	5 (279)
Every week	9 (792)	13 (1 023)	14 (405)	13 (612)	15 (344)	12 (662)
Every day	63 (5 273)	64 (4 947)	65 (1 845)	63 (3 081)	65 (1 471)	63 (3 398)
All the time	24 (1 999)	17 (1 350)	15 (425)	19 (920)	14 (305)	19 (1 004)
Missing	38	31	14	15	9	20
Walking difficulties % (n)
Yes	85 (7 165)	78 (6 022)	76 (2 177)	79 (3 822)	73 (1 658)	79 (4 244)
Missing, n	66	44	21	22	14	29
Previous surgery, % (n)
Yes	2 (172)	2 (135)	2 (45)	2 (88)	1 (32)	2 (102)
Missing, n	21	20	9	10	4	16
EQ-5D VAS^***(0–100), mean (SD)	66 (19)	69 (19)	69 (18)	66 (19)	69 (18)	66 (19)
Missing, n	1294	1429	492	937	404	1081
Willingness of surgery, % (n)
Yes	36 (3 005)	20 (3 713)	16 (463)	23 (1 096)	15 (325)	22 (1 184)
Missing, n	109	175	18	45	16	48

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** Numeric rating scale,

*** EuroQol five-dimensional visual analogue scale.

Individual and disease-related factors

Individual factors

Adjusted models showed that people with knee OA with younger age, lower BMI, and a higher level of education were more likely to reach a clinically relevant pain reduction both in the short and long term (Table 3). In people with hip OA, adjusted models showed that people with a lower BMI were more likely to reach clinically relevant pain reduction at the 12-month follow-up (Table 4). A younger age decreased the odds to reach clinically relevant pain reduction at the 12-month follow-up for people with hip OA (Table 4).

Table 3. Factors associated with reaching a clinically relevant pain reduction at 3- and 12-month follow-up in people with knee OA.

	Knee
Independent factors	3-month follow-up			12-month follow-up
Independent factors	≥ 33% pain reduction			≥ 33% pain reduction
	n	Crude	Adjusted	n	Crude	Adjusted
	n	OR (95% CI)	OR (95% CI)	n	OR (95% CI)	OR (95% CI)
Sex
women	10 178	0.97 (0.91–1.04)	0.98 (0.91–1.06)	10 085	1.08 (1.01–1.15)	0.97 (0.9–1.05)
men	4 442	1	1	4 407	1	1
Age
18–64	5 471	1.19 (1.1–1.3)	1.18 (1.06–1.3)	5 436	1.27 (1.17–1.39)	1.24 (1.11–1.37)
65–74	6 441	1.2 (1.1–1.3)	1.16 (1.05–1.23)	6 375	1.28 (1.18–1.39)	1.21 (1.09–1.33)
> = 75	2 704	1	1		1	1
Body mass index
˂ 25	3 859	1.29 (1.2–1.4)	1.28 (1.17–1.41)	3 822	1.52 (1.41–1.65)	1.38 (1.25–1.52)
≥25–30	6 417	1.18 (1.1–1.26)	1.13 (1.04–1.23)	6 361	1.28 (1.19–1.38)	1.23 (1.13–1.43)
>30	4 340	1	1	1	1	1
Education
Compulsory school	4 775	1	1	4 721	1	1
High school	5 473	1.08 (1.01–1.16)	1.05 (0.97–1.15)	5 426	1.19 (1.11–1.28)	1.16 (1.07–1.27)
University	4 369	1.24 (1.15–1.33)	1.2 (1.11–1.32)	4 345	1.5 (1.4–1.62)	1.45 (1.33–1.59)
Charnley Category^*
A	5 934	1.63 (1.52–1.74)	1.62 (1.5–1.76)	5 878	2.03 (1.9–2.17)	1.96 (1.8–2.1)
B	3 069	1.19 (1.1–1.28)	1.14 (1.04–1.26)	3 045	1.26 (1.16–1.37)	1.2 (1.08–1.3)
C	5 613	1	1	5 569	1	1
Pain frequency
Less than every month	981	1.42 (1.25–1.62)	2.18 (1.8–2.6)	968	1.69 (1.48–1.94)	2.12 (1.78–2.54)
Every week	1 914	1.47 (1.32–1.63)	1.9 (1.7–2.18)	1 893	1.64 (1.47–1.83)	1.82 (1.58–2.09)
Every day	9 198	1.37 (1.26–1.48)	1.46 (1.33–1.61)	9 127	1.41 (1.3–1.53)	1.42 (1.29–1.58)
All the time	2 523	1	1	2 504	1	1
Walking difficulties
No	3 208	1.03 (0.96–1.1)	1.0 (0.92–1.1)	3177	1.23 (1.14–1.3)	1.14 (1.04–1.25)
Yes	11 408	1	1	11 315	1	1
Willingness of surgery
No	11 521	1.38 (1.3–1.48)	1.6 (1.4–1.7)	12 125	1.64 (1.5–1.77)	1.7 (1.54–1.88)
Yes	2 781	1	1	2 367	1	1

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* Charnley Category A, one joint with OA (unilateral knee or hip); B, bilateral OA (both knees or both hips); C, OA in multiple joint sites (hip and knee), or presence of any other disease that affects walking ability. All adjusted analyses are adjusted for all variables in the model including health-related quality of life (EQ-5D-VAS), baseline pain (NRS pain), and previous surgery to the knee. Bold text is an increased or decreased odds ratio (p<0.05).

Table 4. Factors associated with reaching a clinically relevant pain reduction at 3- and 12-month follow-up in people with hip OA.

	Hip
Independent factors	3-month follow-up			12-month follow-up
Independent factors	Pain reduction			≥ 33% pain reduction
	n	Crude	Adjusted	n	Crude	Adjusted
	n	OR (95% CI)	OR (95% CI)	n	OR (95% CI)	OR (95% CI)
Sex
women	4 279	1.07 (0.97–1.18)	0.97 (0.86–1.09)	4 244	1.06 (0.95–1.18)	0.94 (0.83–1.07)
men	1 831	1	1	1 811	1	1
Age
18–64	1 949	1.17 (1.02–1.33)	1.15 (0.98–1.34)	1 932	1.01 (0.88–1.16)	0.96 (0.81–0.98)
65–74	2 871	1.22 (1.07–1.38)	1.11 (0.97–1.28)	2 853	1.14 (0.99–1.3)	1.02 (0.88–1.19)
> = 75	1 290	1	1	1	1	1
Body mass index
˂ 25	2 255	1.19 (1.05–1.36)	1.11 (0.96–1.29)	2 236	1.65 (1.43–1.9)	1.5 (1.28–1.78)
≥25–30	2 578	1.14 (1.01–1.3)	1.06 (0.92–1.23)	2 555	1.43 (1.24–1.65)	1.35 (1.15–1.58)
>30		1	1	1.264	1	1
Education
Compulsory school	2 086	1	1	2 058	1	1
High school	2 153	0.99 (0.89–1.11)	0.95 (0.83–1.09)	2 132	1.01 (0.89–1.14)	0.99 (0.86–1.15)
University	1 871	1.19 (1.07–1.34)	1.14 (0.99–1.31)	1 865	1.23 (1.09–1.39)	1.15 (0.99–1.33)
Charnley Category^*
A	2 244	1.22 (1.1–1.35)	1.23 (1.1–1.39)	2 219	1.48 (1.33–1.65)	1.44 (1.27–1.63)
B	529	1.19 (1.03–1.39)	1.24 (1.02–1.5)	527	1.39 (1.19–1.63)	1.29 (1.23–1.32)
C	3 337	1	1	3 309	1	1
Pain frequency
Less than every month	343	1.55 (1.23–1.94)	2.39 (1.76–3.1)	338	1.53 (1.2–1.96)	2.2 (1.63–2.98)
Every week	828	1.43 (1.21–1.7)	1.72 (1.39–2.13)	823	1.71 (1.43–2.05)	1.9 (1.51–2.39)
Every day	3 902	1.29 (1.14–1.47)	1.39 (1.19–1.62)	3 873	1.43 (1.24–1.64)	1.46 (1.23–1.73)
All the time	1 037	1	1	1 019	1	1
Walking difficulties
No	1 339	1.14 (1.02–1.27)	1.11(0.97–1.28)	1331	1.38 (1.23–1.55)	1.32 (1.15–1.53)
Yes	4 771	1	1	4724	1	1
Willingness of surgery
No	4 880	1.5 (1.34–1.71)	1.75 (1.5–2.04)	4 842	1.69 (1.48–1.93)	1.86 (1.57–2.2)
Yes	1 230	1	1	1 213	1	1

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Disease-related factors

Adjusted models showed that people with knee OA and/or hip OA with Charnley A and Charnley B, less frequent pain and not having the willingness to undergo surgery were more likely to reach a clinically relevant pain reduction both at the three and 12-month follow-up (Tables 3 and 4). People with no walking difficulties were more likely to reach clinically relevant pain reduction at the 12-month follow-up (Tables 3 and 4).

Discussion

This study aimed to explore the association of individual and disease-related factors and clinically relevant pain reduction after participation in a self-management program for people with knee or hip OA. The results showed that those with unilateral OA, less frequent pain, and unwillingness to undergo surgery were more likely to reach clinically relevant pain reduction in both the short and long term.

The result from the present study suggests that participation in a self-management program for OA early in the disease course may increase the patient’s odds to reach a clinically relevant pain reduction. An increased pain frequency or intermittent pain has previously been shown to be correlated with unacceptable symptoms for patients with OA [27]. In the present study, people with pain frequency less than every month had higher odds to reach a clinically relevant pain reduction than people with pain all the time. Furthermore, the results indicate a trend towards increasing odds to reach clinically relevant pain reduction with decreasing pain frequency (Tables 3, 4). OA is a chronic disease that requires continuous treatment accompanied by behavioral changes. Reaching a clinically relevant pain reduction early in the disease may, therefore, foster an active approach and facilitate the behavioral changes necessary for the long-term self-management of OA symptoms [28]. Furthermore, it seems to be more important to reach the patients early in the disease course than in younger age. In the present study, we included all the people who participated in the self-management program which can be accessed by any person with OA from an age of 18 years. Patients younger than 65 years with knee OA had higher odds to reach a clinically relevant pain reduction at 12-month follow-up OR (95% CI), 1.24 (1.11-1-.37), while the same pattern was not found among patients with hip OA. One reason for the difference may be due to the higher prevalence of hip OA due to abnormal anatomy or hip diseases in childhood among younger patients. The presence of such abnormalities may potentially reduce the benefit associated with exercise and physical activity, partially explaining the observed results. Nevertheless, we could not verify the presence of such abnormalities in our sample.

In the present study, people with unilateral OA (Charnley A) and bilateral OA without other comorbidities (Charnley B) were more likely to reach clinically relevant pain reduction to the self-management program than people with OA in multiple joint sites (hip and knee), or presence of any other disease that affects walking ability (Charnley C). The association between comorbidities and response is in line with previous studies [12, 14, 15]. A high number of comorbidities may restrict a patient’s ability to participate in certain parts of the program, which may affect the result of the intervention. One treatment does not fit all people and we probably need to individualize the treatment better for people with comorbidities.

To be unwilling to undergo surgery was associated with higher odds to reach a clinically relevant pain reduction. People who are willing to undergo surgery before starting the first-line intervention may see surgery as the best solution for their problem and may have lower expectations and hence lower motivation for a self-management program [29]. Furthermore, people seeking surgical management may have more severe symptoms as suggested by a recently published study using BOA data which an association between willingness to undergo surgery and higher pain intensity [30]. Finally, it must be considered that in some regions in Sweden it is mandatory to participate in a first-line treatment program before surgery. While it is important to maximize the number of people receiving education and exercise before undergoing surgical interventions, the lack of a shared decision-making process behind the choice of the treatment has the potential to negatively impact the results of an intervention [29]. This may partially explain why people willing to undergo surgery had lower odds of response in our study.

The results from the present study indicate that it seems important to undergo a first-line self-management program early in the disease course, as long the people only have unilateral OA, less frequent pain, and do not have a willingness of surgery. Currently, only 50% of patients with OA receive the treatments as recommended by existing guidelines [31]. Reports from many different countries have shown similar situations suggesting an overall lack of implementation of first-line treatments. This in turn indicates the importance of continuing to work on the implementation of guidelines for OA to help to reduce the rising burden of OA.

Strengths and limitations of the study

This study has important strengths as it investigates the association of patients’ characteristics and response to a first-line intervention in a large sample of more than 26 000 patients with knee and hip OA. Moreover, randomized controlled trials often apply stringent inclusion criteria which may result in study samples that do not reflect the OA population seeking care. The intervention analyzed in the study is provided nationwide in primary care settings and therefore reflects closely current clinical practices in real-world settings. This study includes “real-world” data which increases the generalizability of the results even if only to people attending the self-management program. Some limitations need to be addressed. The number of excluded people at 3- and 12-months follow-up was high, as expected in real-world settings for registry-based studies. This limits the generalizability of the results only to people attending the follow-ups after participating in a self-management program. However, the baseline characteristics of the excluded people only differed from those included in the study regarding the willingness to undergo surgery (Tables 1 and 2). In the present study, a previously suggested cut-off on improvement in NRS pain, corresponding to “much better”, was used to define the outcome of clinically relevant pain reduction [20]. When measuring outcomes on a continuous scale as it is routinely done for pain, the “regression-to-the-mean effect” can occur [32]. At the extreme ends of the scale, people can only change in one direction. Therefore, people with baseline scores far above the average show higher improvements in change scores than people with low pain. As expected, we also observed a difference in pain intensity at baseline, where people who reached a clinically relevant pain reduction had on average higher baseline pain than the people who did not reach a clinically relevant pain reduction. We attempted to adjust for the regression-to-the-mean effect by adjusting for baseline pain, and by using the percentage change instead of the change of score to define responders. Thus, we believe that these results are relevant and may help to identify people who are likely to reach a clinically relevant pain reduction following education and individual-adapted exercise both in the short and long term. Finally, due to the observational nature of the study, our results should not be interpreted as inferring causality.

Conclusions

In this study, we showed that people with unilateral OA, less frequent pain, and unwillingness to undergo surgery were more likely to reach clinically relevant pain reduction after participating in a self-management program including education and exercise directed to people with knee and/or hip OA. Furthermore, people with a lower BMI were more likely to respond in the long term. Providing the most appropriate treatment to the right patient at the right time is a step in reducing the burden of OA for society and the patient.

Acknowledgments

The authors would like to acknowledge all participating patients, PTs reporting data to the BOA registry, and others involved in the BOA registry.

Data Availability

A non-author point of contact (i.e., an email address) through which researchers can contact Lund University and request access to your data have been added:DHSdataaccess@med.lu.se.

Funding Statement

This work was supported by Region Skåne (TJ) and Kockska foundation (TJ) https://www.skane.se/en/ http://www.kockskastiftelsen.se. The authors FE, EEH, LD and AD received no specific funding for this work. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. There was no additional external funding received for this study.

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PLoS One. doi: 10.1371/journal.pone.0282169.r001

Decision Letter 0

Hamid Reza Baradaran

9 Sep 2022

PONE-D-21-40195Factors associated with clinically relevant pain reduction after a self-management program including education and exercise for people with knee and/or hip osteoarthritis: data from the BOA registerPLOS ONE

Dear Dr. Jönsson,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Interesting study with large sample size and outcomes.

1- It might be better to explain more and elaborate about how to estimate and use a cut-off 33 percent

2- I would suggest to consider another age group ( younger ) in category however it might not affect the results but methodologically would be sound and robust

3- Please elaborate co-existing diseases however Charnley score mentioned but needs more explanation about what excatlly included and how to calculate

4- Please draw separate tables for Knee and Hip for better presentation and make it easier to look for reader

5- I would suggest to consult with an expert in biostatics regarding to use Linear Mixed Model instead of Logistic with considering the uncertainly in determining the cut off and also some variability in 500 centers however this is only a suggestion

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Interesting study with large sample size and outcomes. I

1- It might be better to explain more and elaborate about how to estimate and use a cut-off 33 percent

2- I would suggest to consider another age group ( younger ) in category however it might not affect the results but methodologically would be sound and robust

3- Please elaborate co-existing diseases however Charnley score mentioned but needs more explanation about what excatlly included and how to calculate

4- Please draw separate tables for Knee and Hip for better presentation and make it easier to look for reader

[Note: HTML markup is below. Please do not edit.]

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Reviewer #1: Yes

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Reviewer #1: Yes

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Reviewer #1: PONE-D-21-40195

Thank you for the opportunity to review the manuscript entitled “Factors associated with clinically relevant pain reduction after a self-management”.

• The study is well-designed and provides findings to support the appropriate treatment to the right patient at the right time; however, there are some issues with the writing quality that need to be addressed before publication acceptance.

• The study's main strengths are the sample size and completion of follow-up, though it is unclear whether any patients withdraw from the study after 12 months. Furthermore, the inclusion criteria for the study were not carefully chosen.

• It would have been preferable, in my opinion, if patients with knee or hip osteoarthritis had been included in the study. Why did the researchers choose to study both diseases?

• Authors are advised to list the inclusion criteria in detail including pain intensity, …

• Were data from patients who had an evaluation included in the study?

• It seems that the exclusion criteria should be more than the mentioned items, such as neuromuscular disease, bone implants; history of knee intra-articular injection in the past three months, …

• Fig. 1 does not provide enough detailed information about how to conduct and evaluate the study. This figure does not include the number of patients enrolled in the study or the possible withdrawal of some of them.

• Why did you consider the age range of osteoarthritis patients to be so broad, beginning at the age of 18?

• Given that primary osteoarthritis begins in middle age, wouldn't it be better, in my opinion, to consider the age range beginning around 40 years? Then, the samples were more homogeneous in this study, making the study results more reliable.

• Because people with osteoarthritis participate in this study, and because the majority of sufferers seek treatment and rehabilitation programs due to pain, there is no need to include "never" in the Pain frequency category.

• The number of patients who were excluded from the study is unknown.

• The authors did not investigate the reasons for the relationships revealed between the study variables in the discussion.

• The findings of this study can be guessed to some extent based on the results of previous studies; however, the authors should emphasize the study's strengths more.

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PLoS One. 2023 Feb 24;18(2):e0282169. doi: 10.1371/journal.pone.0282169.r002

Author response to Decision Letter 0

8 Dec 2022

Dear Editor,

Thank you for your response and for the reviewers’ constructive comments and suggestions providing us with the opportunity to improve our manuscript. Changes have been made in order to meet the criticism raised, and in the few cases where we have not made the suggested changes, our reasons for not doing so are given.

We hereby submit the revised version of the paper along with the response to each of the specific comments provided by you and the reviewers.

EDITOR'S SPECIFIC COMMENT

Interesting study with large sample size and outcomes.

1. Editor comment - It might be better to explain more and elaborate about how to estimate and use a cut-off 33 percent

Author response – Thank you to get us the opportunity to explain our choice of cut-off for clinically relevant pain reduction. As all of us are aware of, it is hard to define a cut-off for clinically relevant pain reduction in patients with osteoarthritis. The reference we used, was a prospective cohort study assessing a patient's pain intensity by the numerical rating scale (NRS) at baseline and the 3-month follow-up, and by a patient's global impression of change (PGIC) questionnaire. A one-unit difference at the lowest end of the PGIC (“slightly better”) was used to define MCID as it reflects the minimum and lowest degree of improvement that could be detected. In addition, they also calculated the NRS changes best associated with “much better”. To characterize the association between specific NRS change scores (raw or per cent) and clinically important improvement, the sensitivity and specificity were calculated by the receiver operating characteristic (ROC) method. They used PGIC as an external criterion to distinguish between improved or non-improved patients. Their results showed that on average, a reduction of one point or a reduction of 15.0% in the NRS represented an MCID for the patient. A change in the NRS score of −2.0 and a per cent change score of −33.0% were best associated with the patients reporting feeling “much better” [1]. For this reason, these values can be considered appropriate cut-off points for this measure.

Author action – To motivate our choice of cut-off for clinically relevant pain reduction, the following sentence has been added: lines 110-115, This cut-off is based on a prospective cohort study from Salaffi et al there they assessed patient's pain intensity by the numerical rating scale (NRS) at baseline and at the 3-month follow-up, and by a patient's global impression of change (PGIC) questionnaire [20]. This cut-off is based on a prospective cohort study from Salaffi et al there they assessed patient's pain intensity by the numerical rating scale (NRS) at baseline and at the 3-month follow-up, and by a patient's global impression of change (PGIC) questionnaire [20]. A reduction of 33% was defined as a clinical relevant pain reduction and associated with feeling “much better” [20].

2. Editor comment - I would suggest considering another age group ( younger ) in the category however it might not affect the results but methodologically would be sound and robust.

Author response - Although it is not common for people around 18 years old with OA, people with OA from 18 years old are included in the BOA registry. We agree with the reviewer that exploring this age group may be interesting and information on younger age groups is seldomly reported. In our study, we are interested to describe the whole population who attend the supported self-management program in Sweden. Unfortunately, the proportion of younger persons (ie <40 years) in our sample is small (n < 180). Considering the small number of patients in this age group, we would like to refrain to perform the analysis with this added subgroup which we expect will not provide meaningful results due to the potentially very large 95% CIs that will accompaign the estimates.

Author action – The following sentences have been added to the discussion part, line 271-281. Furthermore, it seems to be more important to reach the patients early in the disease course than in younger age. In the present study, we included all the people who participated in the self-management program which can be accessed by any person with OA from an age of 18 years. Patients younger than 65 years with knee OA had higher odds to reach a clinically relevant pain reduction at 12-month follow-up OR (95% CI), 1.24 (1.11-1-.37), while the same pattern was not found among patients with hip OA. One reason for the difference may be due to the higher prevalence of hip OA due to abnormal anatomy or hip diseases in childhood among younger patients. The presence of such abnormalities may potentially reduce the beefit associated with exercise and physical activity, partially explaining the observed results. Nevertheless we could not verify the presence of such abnormalities in our sample.

3. Editor comment - Please elaborate on co-existing diseases however Charnley score mentioned but needs more explanation about what excatlly included and how to calculate.

Author response – Thank you for letting us explain what the Charnley score includes. Charnley score is a measure of the impact of comorbidities on walking. It categorizes people with OA into 3 classes based on the disease(s) that affect walking ability (categorical variable – Charnley Score; A = unilateral hip or knee OA / B = bilateral hip or knee OA / C = multiple joint OA or some other condition). Unfortunately, we do not have any more data about comorbidities. In our analysis we have used Charnley A/B/C and evaluated the association with reaching a clinically relevant pain reduction, so no other calculations have been done.

Author action – Line 126-130 have been changed to: The Charnley classification is a measure on the impact of comorbidity on walking score and categorizes people into one of three groups: A – one joint with osteoarthritis (unilateral knee or hip); B – bilateral osteoarthritis (both knees or both hips); C – osteoarthritis in multiple joint sites (hip and knee) or presence of any other disease that affects walking ability [23].

4. Editor comment - Please draw separate tables for Knee and Hip for better presentation and make it easier to look for reader.

Author response – Thank you for this comment. We agree with you that it will be easier to read the tables if we separate them into 2 tables.

Author action – Table 1 has been dived to Table 1, line 166 and Table 2, line 174.

5. Editor comment - I would suggest consulting with an expert in biostatics regarding to use Linear Mixed Model instead of Logistic with considering the uncertainly in determining the cut off and also some variability in 500 centers however this is only a suggestion.

Author response - Thank you for your suggestion. We partly agree with your concern, since we are aware that the use of continuous variables is generally considered advantageous. However, in our study, we had the aim to examine the relation to “clinically relevant” improvements, based on a defined cut-offs for clinically relevant improvements. Although it is not to be considered a “black or white” change in the pain, this cutoff has been defined, evaluated and supported in previous studies. We also consider the interpretation of “odds of a clinically relevant improvement” to be more clinically interpretable. Also, we are aware that some variability between centres can be expected. Nevertheless, the self-management programme provided in the clinics is standardized which should considerably reduce the between-centres variability. Thus we don’t expect systematic differences between centres large enough that would require some form of “cluster adjustment”. We would therefore appreciate if we could keep our previously defined dichotomous outcome, and hence also the logistic regression model as we do consider that it responds to our aim with the study.

Author action - We kept our binary outcome, but as previously mentioned we added a more clear motivation for the cut-off, line 110-115, This cut-off is based on a prospective cohort study from Salaffi et al there they assessed patient's pain intensity by the numerical rating scale (NRS) at baseline and at the 3-month follow-up, and by a patient's global impression of change (PGIC) questionnaire [20]. A reduction of 33% was defined as a clinical relevant pain reduction and associated with feeling “much better” [20].

REVIEWERS SPECIFIC COMMENTS:

Thank you for the opportunity to review the manuscript entitled “Factors associated with clinically relevant pain reduction after a self-management”. The study is well-designed and provides findings to support the appropriate treatment to the right patient at the right time; however, there are some issues with the writing quality that need to be addressed before publication acceptance.

1. Reviewers comment - The study's main strengths are the sample size and completion of follow-up, though it is unclear whether any patients withdraw from the study after 12 months.

Author response – Thank you for highlighting this. Since we have used “real-world” data it is very common with missing follow-ups. However, we have added a flowchart to make the data transparent for all.

Author action – The reason for dropouts is described in Fig 1, line 165.

Fig 1. Flowchart of the study population

2. Reviewers comment - Furthermore, the inclusion criteria for the study were not carefully chosen.

Author response – Thank you for letting us clarify the inclusion/exclusion criteria in this study. The patients included in this study underwent a standardized self-management intervention for OA which is provided nationwide in Sweden and for which the inclusion criteria are pre-specified and based on national and international guidelines (e.g. EULAR, NICE) for the management of OA, this means that it was not possible for us to modify the inclusion criteria to the intervention, line 82-88. For what concerns the criteria used to include patients in the study they were described in, line 74-81, “To be included in the present study, the participants must have received at least the theory part of the self-management program and have data from baseline, 3- and 12-months follow-up. A two months delay for the 3-months follow-up and a three months delay for the 12-month follow-up were allowed for pragmatic reasons, based on an expected delay for some people due to unforeseen circumstances. Data about the index joint (knee or hip), were extracted from the physiotherapy form; in the case of bilateral or multi-joint OA, the most affected joint was chosen by the PT”. These criteria were selected to be as inclusive as possible while minimizing the risk of selection bias that can arise from the use of more stringent criteria. However, we agree with the reviewer that more clarity regarding our choice of inclusion criteria may further improve our manuscript.

Author action – Line 68-74, “People with OA were allowed to access the self-management program if they had symptoms from knee and/or hip that resulted in contact with the health care system. People were not allowed to access the program if, there was a reason other than OA for joint problems (e.g., sequel hip fractures, chronic widespread pain, inflammatory joint diseases, neuromuscular diseases or cancer); they received total joint replacement within the past 12 months; other surgery of the knee or hip joint within the past 3 months; if they were not able to read or understand Swedish”.

Line: 74-77, “The BOA register contains PT-reported data about the most affected joint, previous treatment, and compliance to the intervention and patient-reported outcomes from participants in the self-management program [8]. To be included in the present study, the participants must have received at least the theory part of the self-management program and have data from baseline, 3- and 12-month follow-up. A two months delay for the 3-month follow-up and a three months delay for the 12-month follow-up were allowed for pragmatic reasons, based on an expected delay for some people due to unforeseen circumstances. Data about the index joint (knee or hip), were extracted from the physiotherapy form; in the case of bilateral or multi-joint OA, the most affected joint was chosen by the PT”.

3. Reviewer's comment - It would have been preferable, in my opinion, if patients with knee or hip osteoarthritis had been included in the study. Why did the researchers choose to study both diseases?

Author response – Thank you for the comments, we can see both positive and negative aspects to including both patients with knee and hip OA. However, the supported self-management program with patient education and exercise is usually conducted with both patients with knee and hip OA together, so we believe that it is interesting to include both. We also believe it is interesting to compare and believe that is easier if all data is in the same article. However, to make the manuscript easier to read we have made 2 tables instead of 1 to describe patients with knee or hip separately.

Author action - None

4. Reviewers comment - Authors are advised to list the inclusion criteria in detail including pain intensity, …

Author response – We thank the reviewer for the comment. The inclusion in the self-management programme analysed in this study is not based on the level of pain but on the presence of a clinical diagnosis of OA which does not require a specific pain intensity [2]. Nevertheless, based on the reviewer previous comment we have provided clarifications to the inclusion criteria which we hope will answer all the reviewer’s concerns.

Author action – Please see our response to the reviewer’s comment number 2.

5. Reviewers comment - Were data from patients who had an evaluation included in the study?

Author response – We thank the reviewer for the comment. To be included in this study the patients needed to have the following inclusion criteria (as described in line 77-79), “To be included in the present study, the participants must have received at least the theory part of the self-management program and have data from baseline, 3- and 12-months follow-up”.

Author action - None

6. Reviewers’ comment - It seems that the exclusion criteria should be more than the mentioned items, such as neuromuscular disease, bone implants; history of knee intra-articular injection in the past three months, …

Author response – We thank the reviewer for the comment, we have provided some examples of

diseases to further help the reader in understanding the exclusion criteria. Nevertheless, we cannot provide a comprehensive list of conditions as the choice to include the patients is ultimately left to the clinicians assessing the patient at baseline.

Author action – At line 72, neuromuscular diseases has been added to the list: “ The inclusion criteria for the participants to access the self-management program were symptoms from knee and/or hip that resulted in contact with the health care system. The exclusion criterions were, a reason other than OA for joint problems (e.g., sequel hip fractures, chronic widespread pain, inflammatory joint diseases, neuromuscular diaseases or cancer); total joint replacement within the past 12 months; other surgery of the knee or hip joint within the past 3 months; and people not able to read or understand Swedish.”, line 68-74.

7. Reviewers comment - Fig. 1 does not provide enough detailed information about how to conduct and evaluate the study. This figure does not include the number of patients enrolled in the study or the possible withdrawal of some of them.

Author response – We thank the reviewer for the comment, Fig 1 has been removed and replaced with a flowchart of the study to better understand the number of patients enrolled in the study and the reason for withdrawal.

Author action – At line 165, Fig 1. Flowchart of the study population has been added.

8. Reviewers comment - Why did you consider the age range of osteoarthritis patients to be so broad, beginning at the age of 18? Given that primary osteoarthritis begins in middle age, wouldn't it be better, in my opinion, to consider the age range beginning around 40 years? Then, the samples were more homogeneous in this study, making the study results more reliable.

Author response – We thank the reviwer for the comment. Although it is not common for people around 18 years old with OA, people with OA from 18 years old are included in the BOA registry. We agree with the reviewer that exploring this age group may be interesting and information on younger age groups is seldomly reported. In our study, we are interested to describe the whole population who attend the supported self-management program in Sweden. Unfortunately, the proportion of younger persons (ie <40 years) in our sample is small (n < 180). Considering the small number of patients in this age group, we would like to refrain to perform the analysis with this added subgroup which we expect will not provide meaningful results due to the potentially very large 95% CIs that will accompaign the estimates.

Author action - The following sentences have been added to the discussion part, line 271-281. Furthermore, it seems to be more important to reach the patients early in the disease course than in younger age. In the present study, we included all the people who participated in the self-management program which can be accessed by any person with OA from an age of 18 years. Patients younger than 65 years with knee OA had higher odds to reach a clinically relevant pain reduction at 12-month follow-up OR (95% CI), 1.24 (1.11-1-.37), while the same pattern was not found among patients with hip OA. One reason for the difference may be due to the higher prevalence of hip OA due to abnormal anatomy or hip diseases in childhood among younger patients. The presence of such abnormalities may potentially reduce the beefit associated with exercise and physical activity, partially explaining the observed results. Nevertheless we could not verify the presence of such abnormalities in our sample.

9. Reviewers comment - Because people with osteoarthritis participate in this study, and because the majority of sufferers seek treatment and rehabilitation programs due to pain, there is no need to include "never" in the Pain frequency category.

Author response – Thank you for your comment. We agree with you that pain is the cardinal symptom and the most common cause of patients seeking health care, however in the BOA registry, a question about pain frequency is taken from the KOOS and described in the manuscripts in lines 130-133: “Pain frequency was assessed by the question: “How often do you have pain in your knee/hip,” with five possible answers: never, every month, every week, every day, or all the time. Because of low numbers in the categories never and every month, the two were merged into one category”. Thus, we decided to maintain the category to reflect the formulation included in the questionnaire.

Author action - None

10. Reviewers comment - The number of patients who were excluded from the study is unknown.

Author response – We thank the reviewer for the comment. We agree that more clarity regarding the exclusion of participants is needed. We have thus added a flowchart to clarify the selection process.

Author action: At line 165, Fig 1. Flowchart of the study population has been added.

11. Reviewers comment - The authors did not investigate the reasons for the relationships revealed between the study variables in the discussion.

Author response: We thank the reviewer for the comment. We agree that investigating the reason for the association between some of the included variables and the response to the treatment is of great interest. Nevertheless, this would not be possible with the current study design which was planned to answer a different research question and did not aim to (and cannot) explain causality. Nevertheless, we discussed possible hypotheses behind the observed association. However, we tried to keep these speculations to a minimum since high-quality data supporting a causal link behind the observed association is lacking.

Author action – No further action has been taken.

12. Reviewers comment - The findings of this study can be guessed to some extent based on the results of previous studies; however, the authors should emphasize the study's strengths more.

Author response – We agree with the reviewer that clearly stating the strength of this study will further improve our manuscript.

Author action – Line 311-318, “This study has important strengths as it investigates the association of patients’ characteristics and response to a first-line intervention in a large sample of more than 26 000 patients with knee and hip OA. Moreover, randomized controlled trials often apply stringent inclusion criteria which may result in study samples that do not reflect the OA population seeking care. The intervention analyzed in the study is provided nationwide in primary care settings and therefore reflects closely current clinical practices in real-world settings. This study includes “real-world” data which increases the generalizability of the results even if only to people attending the self-management program.”

1. Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W: Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain 2004, 8(4):283-291.

2. Nationella riktlinjer för rörelseorganens sjukdomar 2012 [Elektroniska resurser]: osteoporos, artros, inflammatorisk ryggsjukdom och ankyloserande spondylit, psoriasisartrit och reumatoid artrit : stöd för styrning och ledning. Stockholm: Socialstyrelsen; 2012.

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PLoS One. doi: 10.1371/journal.pone.0282169.r003

Decision Letter 1

Hamid Reza Baradaran

9 Feb 2023

Factors associated with clinically relevant pain reduction after a self-management program including education and exercise for people with knee and/or hip osteoarthritis: data from the BOA register

PONE-D-21-40195R1

Dear Dr. Jönsson,

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PLoS One. doi: 10.1371/journal.pone.0282169.r004

Acceptance letter

Hamid Reza Baradaran

14 Feb 2023

PONE-D-21-40195R1

Factors associated with clinically relevant pain reduction after a self-management program including education and exercise for people with knee and/or hip osteoarthritis: data from the BOA register

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Factors associated with clinically relevant pain reduction after a self-management program including education and exercise for people with knee and/or hip osteoarthritis: Data from the BOA register

Thérése Jönsson

Frida Eek

Eva Ekvall Hansson

Leif E Dahlberg

Andrea Dell’Isola

Roles

Abstract

Aim

Materials and methods

Results

Conclusion

Introduction

Materials and method

Design and sample selection

Intervention

Ethics statement

Measures

Outcome

Independent/exposure factors

Statistics

Results

Table 1. Characteristics of patients with knee OA population (n = 18871).

Table 2. Characteristics of patients with hip OA (n = 7767).

Fig 1. Flow-chart of the study population.

Individual and disease-related factors

Individual factors

Table 3. Factors associated with reaching a clinically relevant pain reduction at 3- and 12-month follow-up in people with knee OA.

Table 4. Factors associated with reaching a clinically relevant pain reduction at 3- and 12-month follow-up in people with hip OA.

Disease-related factors

Discussion

Strengths and limitations of the study

Conclusions

Acknowledgments

Data Availability

Funding Statement

References

Decision Letter 0

Hamid Reza Baradaran

Roles

Author response to Decision Letter 0

Decision Letter 1

Hamid Reza Baradaran

Roles

Acceptance letter

Hamid Reza Baradaran

Roles

Associated Data

Supplementary Materials

Data Availability Statement

ACTIONS

PERMALINK

RESOURCES

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