Effectiveness of rehabilitation based on recreational activities: A systematic review

Table 4 Evaluation of the quality of randomized controlled trials by using the CONSORT 2010 checklist and the checklist for reporting trials nonpharmacologic treatments

Paper Section/Topic	ID	CONSORT 2010; items	Checklist for reporting trials of nonpharmacologic treatment: items	Ref.											Present description1
				[27]	[28]	[29]	[30]	[31]	[32]	[33]	[34]	[4]	[5]	[6]	No/sum	Rate (%)
Title and abstract	1a	Identification as a randomised trial in the title		p	p	p	p	a	?	p	p	a	a	p	7/11	64
	1b	Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)		n/a	n/a	p	p	p	p	p	p	?	?	p	7/9	78
			In the abstract, description of the experimental treatment, comparator, care providers, centers, and blinding status	p	p	p	?	?	?	?	p	?	?	?	4/11	36
Introduction
Background and objectives	2a	Scientific background and explanation of rationale		p	p	p	p	p	p	?	p	p	p	p	10/11	91
	2b	Specific objectives or hypotheses		p	p	p	p	p	p	p	p	p	p	p	11/11	100
Methods
Trial design	3a	Description of trial design (such as parallel, factorial) including allocation ratio		p	?	p	p	p	p	p	p	p	p	p	10/11	91
	3b	Important changes to methods after trial commencement (such as eligibility criteria), with reasons		p	p	?	p	a	?	p	a	a	a	a	4/11	36
Participants	4a	Eligibility criteria for participants		p	p	p	p	p	p	p	p	p	p	p	11/11	100
	4b	Settings and locations where the data were collected	When applicable, eligibility criteria for centers and those performing the interventions	p	?	p	p	p	?	p	p	p	p	p	9/11	82
Interventions	5	The interventions for each group with sufficient details to allow replication, including how and when they were actually administered	Precise details of both the experimental treatment and comparator	p	p	p	p	?	p	p	?	p	p	p	9/11	82
			Description of the different components of the interventions and, when applicable, descriptions of the procedure for tailoring the interventions to individual participants	a	a	p	p	a	p	a	a	p	p	p	6/11	55
			Details of how the interventions were standardized	a	a	a	p	a	p	n/a	a	p	?	p	4/10	40
			Details of how adherence of care providers with the protocol was assessed or enhanced	a	?	a	n/a	a	p	n/a	a	?	?	?	1/9	11
Outcomes	6a	Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed		p	p	p	p	p	p	p	p	?	?	p	9/11	82
	6b	Any changes to trial outcomes after the trial commenced, with reasons		p	p	a	n/a	a	n/a	n/a	a	a	a	a	2/8	25
Sample size	7a	how sample size was determined		p	p	a	?	a	?	p	a	a	p	p	5/11	45
	7b	when applicable, explanation of any interim analyses and stopping guidelines		p	a	a	n/a	a	n/a	?	a	a	p	p	3/9	33
			When applicable, details of whether and how the clustering by care providers or centers was addressed	p	a	a	n/a	a	n/a	?	a	?	?	p	2/9	22
Randomisation:
Sequence generation	8a	Method used to generate the random allocation sequence		?	p	?	p	p	p	p	p	p	a	p	8/11	73
	8b	Type of randomisation; details of any restriction (such as blocking and block size)		n/a	n/a	p	n/a	?	n/a	p	?	a	a	a	2/7	29
			When applicable, how care providers were allocated to each trial group	n/a	n/a	a	n/a	?	n/a	a	?	p	?	p	2/7	29
Allocation concealment mechanism	9	Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned		a	a	p	p	?	p	p	?	p	a	p	6/11	55
Implementation	10	Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions		a	a	p	p	?	p	p	?	a	a	p	5/11	45
			Details of the experimental treatment and comparator as they were implemented	a	a	p	p	?	p	p	?	p	?	p	6/11	55
Blinding	11a	If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how		p	p	p	p	a	p	p	p	a	a	a	7/11	64
			Whether or not those administering co-interventions were blinded to group assignment	?	?	a	?	a	?	a	?	a	a	a	0/11	0
	11b	if relevant, description of the similarity of interventions	If blinded, method of blinding and description of the similarity of interventionist	?	?	a	p	a	p	a	a	a	a	a	2/11	18
Statistical methods	12a	Statistical methods used to compare groups for primary and secondary outcomes		?	?	p	p	p	p	p	p	p	p	p	9/11	82
	12b	Methods for additional analyses, such as subgroup analyses and adjusted analyses		a	a	n/a	n/a	a	n/a	p	a	p	a	p	3/8	38
			when applicable, details of whether and how the clustering by care providers or centers was addressed	a	a	n/a	n/a	a	n/a	a	a	p	p	p	3/8	38
Results
Participant flow (a diagram is strongly recommended)	13a	For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome	The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider or in each center	a	a	p	p	p	?	p	p	p	p	p	8/11	73
	13b	For each group, losses and exclusions after randomisation, together with reasons		?	?	p	p	p	p	p	p	p	p	p	9/11	82
Recruitment	14a	Dates defining the periods of recruitment and follow-up		?	?	p	?	p	?	p	p	p	p	p	7/11	64
	14b	Why the trial ended or was stopped		?	?	p	n/a	p	n/a	p	p	p	a	p	6/9	67
Baseline data	15	A table showing baseline demographic and clinical characteristics for each group	When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group	p	p	p	p	a	p	p	a	a	a	p	7/11	64
Numbers analysed	16	For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups		p	p	p	p	p	p	p	p	p	p	p	11/11	100
Outcomes and estimation	17a	For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)		p	p	p	p	a	p	p	p	p	p	p	10/11	91
	17b	For binary outcomes, presentation of both absolute and relative effect sizes is recommended		?	?	p	n/a	a	n/a	a	a	a	a	a	1/9	11
Ancillary analyses	18	Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory		a	a	n/a	n/a	a	n/a	n/a	a	p	a	a	1/7	14
Harms	19	All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)		a	p	a	?	p	?	p	a	a	a	a	3/11	27
Discussion
Limitations	20	Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses		p	p	p	p	a	p	p	p	p	p	a	9/11	82
Generalisability	21	Generalisability (external validity, applicability) of the trial findings	In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care provides or centers in each group	p	p	p	p	?	p	?	?	p	a	a	6/11	55
Interpretation	22	Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence		p	p	p	p	?	p	p	?	p	?	p	8/11	73
			Generalizability (external validity) of the trial findings according to the intervention, comparators, patients, and care providers and centers involved in the trial	?	?	p	p	?	?	?	?	p	?	?	3/11	27
Other information
Registration	23	Registration number and name of trial registry		p	a	?	?	p	?	?	?	?	?	?	2/11	18
Protocol	24	Where the full trial protocol can be accessed, if available		p	a	p	?	a	?	a	a	a	a	a	2/11	18
Funding	25	Sources of funding and other support (such as supply of drugs), role of funders		p	?	p	?	a	p	p	p	p	p	p	8/11	73

¹Present description means present No. and sum except “n/a” and its percentage. a: Absent; ?: Unclear or inadequately described.